DEFLAMAT

Package Leaflet: Information for the Patient

DEFLAMAT

75 mg modified-release hard capsules
100 mg modified-release hard capsules
Diclofenac sodium
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If any adverse reaction occurs, including any not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Deflamat is and what it is used for
2. What you need to know before taking Deflamat
3. How to take Deflamat
4. Possible side effects
5. How to store Deflamat
6. Contents of the pack and other information

1. What Deflamat is and what it is used for

Deflamat contains the active substance sodium diclofenac, which belongs to a group of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Deflamat is indicated in adults for the treatment of:

• inflammatory and degenerative diseases affecting muscles, bones and joints (rheumatic diseases):
• chronic inflammatory joint diseases of immune origin (rheumatoid arthritis, ankylosing spondylitis)
• chronic disease characterized by progressive joint damage (osteoarthritis)
• acute and chronic conditions characterized by pain and inflammation affecting tissues surrounding the joints, such as tendons and ligaments (extra-articular rheumatism)
• pain due to inflammation of non-rheumatic origin (i.e. not involving muscles, bones and joints) or following trauma
• menstrual pain (primary dysmenorrhea).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Deflamat

Do not take Deflamat

• if you are allergic or think you may be allergic to sodium diclofenac, aspirin, ibuprofen, any other NSAID (non-steroidal anti-inflammatory drug), or to any of the other ingredients of this medicine (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic-type reaction
• if in the past, after treatment with other NSAIDs, you have experienced bleeding (haemorrhage) or perforation of the stomach or intestine (see section “Other medicines and Deflamat”)
• if you have previously had frequent bleeding and/or damage to the inner walls of the stomach and intestine (peptic ulcer), (two or more distinct episodes of confirmed ulceration or bleeding)
• if you currently have an ulcer, bleeding, or perforation of the stomach or intestine
• if you suffer from severe impairment of liver function (severe hepatic insufficiency) or have previously suffered from liver disease (see section “Warnings and precautions”)
• if you suffer from severe impairment of kidney function (severe renal insufficiency) (see section “Warnings and precautions”)
• if you suffer from established heart disease and/or cerebrovascular disease, e.g. you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or have undergone surgery to remove or prevent such blockages
• if you suffer from or have suffered from circulation problems (peripheral arterial disease)
• if you are in the last 3 months of pregnancy
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
• if you suffer from severe stomach or intestinal disorders (gastrointestinal disturbances)
• if you are undergoing intensive treatment with medicines to increase urine elimination (intensive diuretic therapy) (see section “Other medicines and Deflamat”)
• if you currently have bleeding or suffer from diseases that make you prone to bleeding
• if you suffer from blood disorders related to blood cell production (alterations of haemopoiesis)
• if after treatment with acetylsalicylic acid or other NSAIDs you have experienced asthma attacks, skin redness accompanied by itching (urticaria), or nasal irritation (acute rhinitis). Do not give Deflamat to children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Deflamat.
Before taking diclofenac, make sure your doctor is aware:

• if you smoke
• if you have diabetes
• if you suffer from angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

In particular, your doctor should be informed in the following cases:

• if you have any infection currently, as diclofenac, like other similar anti-inflammatory drugs, may mask signs and symptoms of ongoing infections
• if you have previously suffered from peptic ulcer, especially if complicated by bleeding or perforation (fewer than two distinct episodes of confirmed ulceration or bleeding), as this increases the risk of gastrointestinal bleeding, ulceration, or perforation, particularly with high-dose use. Therefore, your doctor will start treatment with the lowest available dose (see section “How to take Deflamat”) and may prescribe additional medicines to protect the stomach and intestine (misoprostol or proton pump inhibitors)
• if you have previously experienced gastrointestinal toxicity. In this case, inform your doctor if you develop any stomach discomfort, especially during the initial stages of treatment
• if you are taking medicines that may increase the risk of ulceration or bleeding (see “Other medicines and Deflamat”)
• if you suffer from severe chronic diseases of the stomach and intestine ( ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section “Possible side effects”)
• if you suffer from impaired liver function ( hepatic insufficiency). Your doctor will monitor you closely, as this condition may deteriorate. For prolonged treatment, your doctor will perform regular checks to assess liver function and/or detect possible liver disease
• if you suffer from a rare liver disease called “ hepatic porphyria”, as the use of Deflamat may trigger an attack
• if you suffer from impaired kidney function ( renal insufficiency), as the use of Deflamat may lead to fluid retention (water retention) and swelling (oedema)
• if you suffer from or have previously suffered from high blood pressure ( arterial hypertension), as the use of Deflamat may cause fluid retention and oedema. Therefore, your doctor will monitor you closely
• if you are taking medicines to increase urine elimination ( diuretics) or medicines that significantly affect kidney function (see section “Other medicines and Deflamat”)
• if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/taking/using Deflamat, as Deflamat may sometimes impair wound healing in the intestine following surgery
• if for any reason you have or are about to undergo substantial loss of blood and/or fluids from the body, for example before or after major surgery. In such cases, as a precaution, your doctor will monitor kidney function
• if you suffer from reduced blood flow to the kidneys ( renal hypoperfusion)
• if you suffer from impaired heart function ( heart failure)
• if you suffer from or have previously suffered from blood clots ( thromboembolic events)
• if you suffer from blood clotting disorders, as the use of Deflamat may inhibit platelet aggregation, resulting in an anticoagulant effect. In this case, your doctor will monitor you with appropriate tests
• if you suffer from or are predisposed to asthma attacks, as you are more likely to develop lung diseases and/or infections, facial swelling (angioedema), or urticaria. Additionally, you may experience worsening of asthma, breathing difficulties (bronchospasm), and possibly loss of consciousness (shock) or other allergic reactions
• if you suffer from allergic nasal irritation ( rhinitis) or seasonal allergic rhinitis and/or swelling of the nasal mucosa (e.g. nasal polyps), as you are more likely to develop lung diseases and/or infections, facial swelling, or urticaria
• if you are allergic to any substance, as you are at higher risk of experiencing side effects such as skin reactions, itching, or urticaria.

Medicines such as Deflamat may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any such risk is more likely with higher doses or prolonged treatment.
If you are elderly and/or underweight
If you are elderly and/or underweight, take Deflamat with caution, as you are at higher risk of experiencing adverse effects from NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal, particularly with high doses.
Therefore, your doctor will start treatment with the lowest available dose of Deflamat (see section “How to take Deflamat”) and may prescribe additional medicines to protect the stomach and intestine (misoprostol or proton pump inhibitors).
If you are elderly and/or underweight, inform your doctor if you experience any stomach discomfort, especially during the initial stages of treatment.
If you are elderly and/or underweight, your doctor will monitor your kidney function.
Children and adolescents
Do not give Deflamat to children under 14 years of age.
In adolescents aged 14 to 18 years, Deflamat is not recommended.
Other medicines and Deflamat
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines.
Medicines to avoid:

• other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, to reduce inflammation and pain), including “selective COX-2 inhibitors” (a class of NSAIDs), due to the possible increased risk of gastrointestinal side effects.
  Medicines to use with caution:
• medicines to make the blood thinner ( anticoagulants such as warfarin and antiplatelet agents such as aspirin) due to the risk of bleeding
• medicines for treating depression (selective serotonin reuptake inhibitors) due to the risk of bleeding
• medicine for treating certain psychiatric conditions ( lithium), as it may increase lithium levels in the blood. Your doctor will monitor lithium blood levels
• medicine for treating heart conditions ( digoxin), as it may increase digoxin levels in the blood. Your doctor will monitor digoxin blood levels
• diuretics and medicines for treating high blood pressure (e.g. beta-blockers, “angiotensin-converting enzyme inhibitors”, potassium-sparing agents), as they may reduce the antihypertensive effect of these medicines. Your doctor, especially if you are elderly, will carefully monitor your blood pressure, kidney function, and blood potassium levels as deemed necessary
• medicines for treating diabetes ( antidiabetics), as they may cause changes in blood sugar levels (hypoglycaemia, hyperglycaemia). Therefore, your doctor will monitor your blood sugar levels and, if necessary, adjust the dose of your antidiabetic medicine
• medicine for treating certain tumours ( methotrexate), as it may increase methotrexate side effects
• medicine used to reduce immune system activity, e.g. after organ transplantation ( cyclosporine), as it may increase cyclosporine’s adverse effects on the kidneys. Your doctor will reduce the dose of diclofenac to prevent such side effects
• medicines for treating infections ( quinolone antibiotics), as they may cause seizures
• medicine used to treat epilepsy ( phenytoin). Your doctor will monitor phenytoin blood levels
• medicines to lower blood cholesterol ( colestipol and cholestyramine). In this case, your doctor will advise you to take diclofenac at least one hour before or 4–6 hours after taking colestipol/cholestyramine
• medicines such as sulfinpyrazone (used in post-infarction treatment) and voriconazole (used for fungal infections), as they may increase the effect of diclofenac.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Deflamat is not recommended in women intending to become pregnant and during the first 6 months of pregnancy, except when strictly necessary. In such cases, the dose and duration of treatment prescribed by your doctor will be kept as low as possible.
Do not use Deflamat after the first 6 months of pregnancy (see section “Do not use Deflamat”)
as it may cause serious harm to the mother and the unborn child.
Breastfeeding
Do not use Deflamat if you are breastfeeding (see section “Do not use Deflamat”).
Fertility
Deflamat administration should be discontinued if you have fertility problems or are undergoing fertility investigations.
Driving and use of machines
Deflamat may impair your ability to drive or operate machinery, especially if taken with alcohol. Do not drive or operate machinery if during treatment with Deflamat you experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disturbances.
Deflamat contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Deflamat

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults

• The recommended dose is one 75 mg capsule or one 100 mg capsule once daily, according to the physician's judgment.
• If necessary, the doctor may increase the daily dose up to 150 mg, administering one 75 mg capsule twice daily, or as a single dose in cases of particularly severe symptoms, especially morning symptoms.

Swallow the capsule whole without chewing, with an adequate amount of liquid.
If you are elderly and/or underweight
If you are elderly and/or underweight, you may have an increased frequency of adverse effects
(particularly gastrointestinal bleeding and perforation), therefore your doctor will carefully assess
the appropriate dose and any need for reduction of the doses indicated above. If necessary, the doctor will start treatment with the lowest available dose.
Duration of treatment
The duration of treatment varies depending on the individual case.
Your doctor will tell you how long to use Deflamat.
If you take more Deflamat than you should
If you take an excessive dose of Deflamat, you may experience symptoms such as vomiting, bleeding,
gastrointestinal disturbances, diarrhoea, dizziness, ringing in the ears (tinnitus), or seizures. In severe cases, you may develop sudden reduction in kidney function (acute renal failure), liver damage, low blood pressure (hypotension), and respiratory depression (reduced or stopped breathing).
In case of overdose, contact your doctor or the nearest hospital immediately.
If you forget to take Deflamat
Do not take a double dose to make up for the missed capsule.
If you stop taking Deflamat
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop treatment with Deflamat and inform your doctor immediately if you notice:

• Severe stomach and intestinal problems (rare, may affect up to 1 in 1,000 people)
• Lesions in the inner walls of the stomach and intestines (ulceration)
• Bleeding from the walls of the stomach or intestines (gastrointestinal haemorrhage)
• Perforation. These effects may also lead to death, particularly in elderly patients
• Liver function disorders or worsening of liver function, which may manifest, for example, as:
• Yellowing of the skin and whites of the eyes (jaundice) (rare, may affect up to 1 in 1,000 people)
• Severe skin or mucous membrane reactions (very rare, may affect up to 1 in 10,000 people), including:
• Mucosal lesions, superficial skin inflammation characterized by skin swelling and blister-like lesions (exfoliative dermatitis)
• Severe skin lesions characterized by erythema, blistering, and areas of skin detachment (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis). These reactions may also be fatal. Onset of these reactions usually occurs within the first month of treatment.
• Allergic reactions and anaphylactic shock, a severe, rapidly developing allergic reaction including abnormally low blood pressure (hypotension) and loss of consciousness (shock)
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.
• Mild cramps and abdominal tenderness occurring shortly after starting treatment with Deflamat, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).

In addition, the following side effects may occur, according to the frequency listed below:
Common (may affect up to 1 in 10 people)

• Headache, dizziness
• Vertigo
• Nausea, vomiting, diarrhoea
• Persistent or recurring discomfort and/or pain in the upper abdomen (dyspepsia, abdominal pain)
• Gas formation in the intestine (flatulence)
• Decreased appetite with weight loss (anorexia)
• Increase in certain liver function values (transaminases)
• Skin rash

Uncommon (may affect up to 1 in 1,000 people)

• Drowsiness
• Asthma, including shortness of breath (dyspnoea)
• Inflammation of the stomach (gastritis)
• Vomiting blood originating from the stomach or intestines (haematemesis)
• Diarrhoea with blood
• Dark stools due to presence of blood (melena)
• Inflammation of the liver (hepatitis)
• Liver disorders
• Skin redness accompanied by itching (urticaria)
• Swelling (oedema) due to fluid accumulation in the body (fluid retention)

Very rare (may affect up to 1 in 10,000 people):

• Decreased number of platelets in the blood (thrombocytopenia)
• Decreased number of white blood cells in the blood (leucopenia/agranulocytosis)
• Reduced haemoglobin in the blood, the substance that carries oxygen in the blood (anaemia, haemolytic and aplastic anaemia)
• Swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioneurotic oedema)
• Disorientation
• Depression
• Insomnia, nightmares
• Irritability, psychotic reactions
• Sensation of numbness and tingling in legs, arms, or other parts of the body (paraesthesiae)
• Memory disturbances
• Seizures, anxiety, tremors
• Inflammation of the area near the brain (aseptic meningitis)
• Taste disturbances
• Disorders affecting blood flow to the brain (cerebrovascular events), including stroke
• Vision disturbances, blurred vision, double vision (diplopia)
• Ringing sensation in the ears (tinnitus), worsening of hearing
• Palpitations
• Chest pain
• Condition in which the heart fails to supply adequate blood to the body (heart failure)
• Heart attack (myocardial infarction)
• High blood pressure (hypertension)
• Inflammation of blood vessels (vasculitis)
• Lung infection (pneumonia)
• Inflammation of the colon, the final part of the intestine (colitis), which may lead to bleeding (haemorrhagic colitis)
• Worsening of chronic inflammatory bowel diseases (Crohn’s disease, ulcerative colitis)
• Constipation
• Inflammation of the mouth (stomatitis), possibly with lesion formation (ulcerative stomatitis)
• Inflammation of the tongue (glossitis)
• Oesophageal disorders
• Intestinal narrowing
• Inflammation of the pancreas (pancreatitis)
• Sudden inflammation of the liver (fulminant hepatitis)
• Destruction of liver cells (hepatic necrosis)
• Reduced liver function (hepatic failure)
• Blistering rashes
• Skin irritations (eczema, erythema)
• Skin irritation characterized by the appearance of bright red, target-like lesions (erythema multiforme)
• Hair loss
• Photosensitivity reaction
• Appearance of red, blotchy skin patches of varying sizes (purpura), including allergic forms (allergic purpura)
• Itching (pruritus)
• Sudden reduction in kidney function (acute renal failure)
• Presence of blood in the urine (haematuria)
• Presence of protein in the urine (proteinuria)
• Kidney disease causing loss of protein in the urine (nephrotic syndrome)
• Inflammation of the kidneys (interstitial nephritis)
• Disease causing destruction of kidney cells (renal papillary necrosis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deflamat

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep the blister pack in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after "Exp." The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Deflamat contains
Deflamat 75 mg modified-release hard capsules

• The active substance is: sodium diclofenac. Each capsule contains 75 mg of sodium diclofenac equivalent to 69.60 mg of diclofenac.
• The other components are: microcrystalline cellulose, povidone, colloidal anhydrous silica, methacrylic acid - ethyl acrylate copolymer (1:1), propylene glycol, ammonium methacrylate copolymer (type A), ammonium methacrylate copolymer (type B), triethyl citrate, talc, indigo carmine (E 132), titanium dioxide (E 171), purified water, gelatin.

Deflamat 100 mg modified-release hard capsules

• The active substance is: sodium diclofenac. Each capsule contains 100 mg of sodium diclofenac equivalent to 92.80 mg of diclofenac.
• The other components are: microcrystalline cellulose, povidone, colloidal anhydrous silica, methacrylic acid - ethyl acrylate copolymer (1:1), propylene glycol, ammonium methacrylate copolymer (type A), ammonium methacrylate copolymer (type B), triethyl citrate, talc, indigo carmine (E 132), titanium dioxide (E 171), purified water, gelatin.

Description of the appearance of Deflamat and contents of the pack
Deflamat is available as 75 mg or 100 mg modified-release hard capsules, packed in blisters in a carton containing 20 capsules.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
MORGANCEUTICAL S.r.l.,
Viale Varese 39
22100 Como,
Italy

Manufacturer
Swiss Caps GmbH,
Grassingerstrasse 9
Bad Aibling
Germany

Patient Information Leaflet

DEFLAMAT

25 mg/ml injectable solution
Sodium diclofenac
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Deflamat is and what it is used for
2. What you need to know before using Deflamat
3. How to use Deflamat
4. Possible side effects
5. How to store Deflamat
6. Contents of the pack and other information

1. What Deflamat is and what it is used for

Deflamat contains the active substance sodium diclofenac, which belongs to a group of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
Deflamat is indicated in adults for the treatment of:

• acute pain occurring during inflammatory diseases of muscles, bones, and joints
• acute pain due to contractions of smooth muscles (for example, in the stomach and intestine).

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before using Deflamat

Do not use Deflamat

• if you are allergic or think you may be allergic to sodium diclofenac, aspirin, ibuprofen, any other NSAID, or to any of the other ingredients of this medicine (listed in section 6). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic-type reaction
• if in the past, after treatment with other NSAIDs, you have experienced bleeding (haemorrhage) or perforation of the stomach or intestine (see section “Other medicines and Deflamat”)
• if in the past you have frequently suffered from bleeding and/or damage to the inner walls of the stomach and intestine (peptic ulcer), (two or more distinct episodes of proven ulceration or bleeding)
• if you currently have an ulcer, bleeding, or perforation of the stomach or intestine
• if you suffer from severe impairment of liver function (severe hepatic insufficiency) or have previously suffered from liver disease (see section “Warnings and precautions”)
• if you suffer from severe impairment of kidney function (severe renal insufficiency) (see section “Warnings and precautions”)
• if you have established heart disease and/or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke (TIA), or obstruction of blood vessels supplying the heart or brain, or undergone surgery to remove or prevent such obstructions
• if you suffer from circulatory problems (peripheral arterial disease)
• if you are in the last 3 months of pregnancy
• if you are breastfeeding (see “Pregnancy, breastfeeding and fertility”)
• if you suffer from severe gastrointestinal disorders (gastrointestinal disturbances)
• if you are undergoing intensive treatment with drugs to increase urine elimination (intensive diuretic therapy) (see section “Other medicines and Deflamat”)
• if you currently have bleeding or suffer from diseases that predispose you to bleeding
• if you suffer from blood disorders related to blood cell production (haematological disturbances)
• if after treatment with acetylsalicylic acid or other NSAIDs you have experienced asthma attacks, skin redness accompanied by itching (urticaria), or nasal irritation (acute rhinitis)

Do not give Deflamat to children and adolescents under 14 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Deflamat.
Deflamat injectable solution is not a simple painkiller and its use requires strict medical supervision. Injections must be administered according to strict hygiene standards (see section 3 “How to use Deflamat”).
Before taking diclofenac, make sure your doctor is aware:

• if you smoke
• if you have diabetes
• if you suffer from angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

In particular, inform your doctor in the following cases:

• if you currently have any infection, as diclofenac, like other similar anti-inflammatory drugs, may mask the signs and symptoms of ongoing infections
• if you have previously suffered from ulcer, especially if complicated by bleeding or perforation (fewer than two distinct episodes of proven ulceration or bleeding), as this increases the risk of gastrointestinal bleeding, ulceration, or perforation, particularly with high-dose use. Therefore, your doctor will start treatment with the lowest available dose (see section “How to use Deflamat”) and may prescribe additional medicines to protect your stomach and intestine (misoprostol or proton pump inhibitors)
• if you have previously experienced gastrointestinal toxicity. In this case, inform your doctor if you develop any stomach discomfort, especially during the initial stages of treatment
• if you are taking medicines that may increase the risk of ulceration or bleeding (see “Other medicines and Deflamat”)
• if you suffer from severe chronic diseases of the stomach and intestine ( ulcerative colitis , Crohn’s disease ), as these conditions may worsen (see section “Possible side effects”)
• if you suffer from impaired liver function ( hepatic insufficiency ). Your doctor will monitor you closely as this condition may deteriorate. For prolonged treatment, your doctor will perform regular checks to assess liver function and/or possible onset of liver disease
• if you suffer from a rare liver disease called “ hepatic porphyria ”, as use of Deflamat may trigger an attack
• if you suffer from impaired kidney function ( renal insufficiency ), as use of Deflamat may lead to fluid retention in the body (fluid retention) and swelling (edema)
• if you suffer or have previously suffered from high blood pressure ( arterial hypertension ), as use of Deflamat may cause fluid retention and edema. Therefore, your doctor will monitor you closely
• if you are taking diuretics or medicines that significantly affect kidney function (see section “Other medicines and Deflamat”)
• if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/using Deflamat, as Deflamat may sometimes impair wound healing in the intestine following surgery
• if for any reason you have or are about to undergo substantial loss of blood and/or fluids from the body, for example before or after major surgery . In such cases, as a precaution, your doctor will monitor kidney function
• if you suffer from reduced blood flow to the kidneys ( renal hypoperfusion )
• if you suffer from impaired heart function ( heart failure )
• if you suffer or have previously suffered from blood clots ( thromboembolic events )
• if you suffer from blood clotting disorders , as use of Deflamat may inhibit platelet aggregation, resulting in an anticoagulant effect. In this case, your doctor will monitor you with appropriate tests
• if you suffer from or are predisposed to asthma attacks , as you may be more likely to develop lung diseases and/or infections, facial swelling (angioedema), or urticaria. Additionally, you may experience worsening of asthma, breathing difficulties (bronchospasm), and possibly loss of consciousness (shock) or other allergic reactions
• if you suffer from allergic nasal irritation ( rhinitis ) or seasonal nasal mucosa swelling (e.g. nasal polyps ), as you may be more likely to develop lung diseases and/or infections, facial swelling, or urticaria
• if you are allergic to any substance, as you are at higher risk of experiencing side effects such as skin reactions, itching, or urticaria.

Medicines such as Deflamat may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any such risk is more likely with high doses or prolonged treatment.
Switching from Deflamat injectable solution to oral Deflamat capsules
After the first two days of treatment with Deflamat by intramuscular route, your doctor may, if appropriate, switch you to oral therapy with Deflamat capsules, as serious adverse effects occur less frequently with oral treatment (see section “How to use Deflamat”).
If you are elderly and/or underweight
Use Deflamat with caution if you are elderly and/or underweight, as you are at higher risk of adverse effects from NSAIDs, especially gastrointestinal bleeding and perforation, which can even be fatal, particularly at high doses.
Therefore, your doctor will start treatment with the lowest available dose of Deflamat (see section “How to use Deflamat”) and may prescribe additional medicines to protect your stomach and intestine (misoprostol or proton pump inhibitors).
If you are elderly and/or underweight, inform your doctor if you experience any stomach discomfort, especially during the initial stages of treatment.
If you are elderly and/or underweight, your doctor will monitor your kidney function.
Use in children and adolescents
Do not give Deflamat to children under 14 years of age.
Deflamat injectable solution is not recommended for adolescents aged 14 to 18 years.
Other medicines and Deflamat
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.
In particular, inform your doctor if you are taking the following medicines:
Medicines to avoid:

• other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, to reduce inflammation and pain), including “selective COX-2 inhibitors” (a class of NSAIDs), due to the possible increased risk of gastrointestinal side effects
  Medicines to use with caution :
• medicines to make the blood thinner ( anticoagulants such as warfarin and antiplatelet agents like aspirin ) due to the risk of bleeding
• medicines for depression (selective serotonin reuptake inhibitors) due to the risk of bleeding
• medicine for certain psychiatric conditions ( lithium ), as it may increase lithium levels in the blood. Your doctor will monitor lithium blood levels
• medicine for heart conditions ( digoxin ), as it may increase digoxin levels in the blood. Your doctor will monitor digoxin blood levels
• diuretics and medicines for high blood pressure (e.g. beta-blockers, "angiotensin-converting enzyme inhibitors", potassium-sparing agents), as Deflamat may reduce the antihypertensive effect of these medicines. Your doctor, especially if you are elderly, will carefully monitor your blood pressure, kidney function, and blood potassium levels as deemed necessary
• medicines for diabetes ( antidiabetics ), as blood sugar levels (hypoglycaemia, hyperglycaemia) may fluctuate. Your doctor will monitor blood sugar levels and adjust your antidiabetic dose if necessary
• medicine used to treat certain cancers ( methotrexate ), as adverse effects of methotrexate may increase
• medicine used to suppress the immune system, e.g. after organ transplantation ( cyclosporine ), as kidney-related adverse effects of cyclosporine may increase. Your doctor may reduce the dose of diclofenac to prevent such side effects
• medicines for infections ( quinolone antibiotics ), as seizures may occur
• medicine used to treat epilepsy ( phenytoin ). Your doctor will monitor phenytoin blood levels
• medicines to lower blood cholesterol ( colestipol and cholestyramine ). In this case, your doctor will advise you to take diclofenac at least one hour before or 4–6 hours after colestipol/cholestyramine administration
• medicines such as sulfinpyrazone (used in post-infarction treatment) and voriconazole (used for fungal infections), as they may increase the effect of diclofenac.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Use of Deflamat is not recommended in women intending to become pregnant and during the first 6 months of pregnancy, except when strictly necessary. In such cases, the dose and duration of treatment prescribed by your doctor will be kept as low as possible.
Do not use Deflamat after the first 6 months of pregnancy (see section “Do not use Deflamat”)
as it may cause serious harm to mother and baby.
Breastfeeding
Do not use Deflamat if you are breastfeeding (see section “Do not use Deflamat”).
Fertility
Deflamat administration should be discontinued if you have fertility problems or are undergoing fertility investigations.
Driving and use of machines
Deflamat may impair your ability to drive or operate machinery, especially if taken with alcohol. Do not drive or operate machinery if during treatment with Deflamat you experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disturbances.
Deflamat contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically 'sodium-free'.
Deflamat contains benzyl alcohol
This medicine contains 105 mg of benzyl alcohol per 3 ml.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to use Deflamat

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults

• The recommended dose is one vial per day administered by injection into the upper-outer part of one of the two buttocks. In severe cases (e.g., colic), your doctor may prescribe a second vial to be administered several hours later, changing the injection site (one injection in each buttock). Your doctor may also associate Deflamat capsules with the injectable treatment, up to a maximum daily dose of 150 mg. Injections must be performed according to strict hygienic standards; please seek advice from your doctor or pharmacist. The injection must be administered very slowly and deeply, using a sufficiently long needle, and after aspiration to avoid injecting into a blood vessel. The solution, in addition to being injected very slowly, should be warmed to body temperature by holding it in the hand. Do not mix Deflamat with other products or medicines.

Duration of treatment
The duration of treatment varies depending on the individual case. Your doctor will tell you how long to use Deflamat.
After the first two days of therapy, it is advisable to switch to non-parenteral formulations.
If you are elderly and/or underweight
If you are elderly and/or underweight, you may have an increased frequency of adverse effects
(especially gastrointestinal bleeding and perforation), therefore your doctor will carefully evaluate the appropriate dose and may consider reducing the doses indicated above. If necessary, your doctor will start treatment with the lowest available dose.
If you use more Deflamat than you should
If you use an excessive dose of Deflamat, you may experience symptoms such as vomiting, bleeding and
gastrointestinal disturbances, diarrhoea, dizziness, ringing in the ears (tinnitus), or
seizures. In severe cases, you may develop sudden reduction in kidney function
(acute renal failure), liver damage, low blood pressure (hypotension), and
respiratory depression (blockage/reduction of respiratory activity).
In case of overdose, contact your doctor or the nearest hospital immediately.
If you forget to use Deflamat
Do not use a double dose to make up for the forgotten dose.
If you stop using Deflamat
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Side effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Stop treatment with Deflamat and inform your doctor immediately if you notice:

• Severe stomach and intestinal disorders (rare, may affect up to 1 in 1,000 people)
• Lesions in the inner walls of the stomach and intestine (ulceration)
• Bleeding from the walls of the stomach or intestine (gastrointestinal hemorrhage)
• Perforation. These effects can also lead to death, particularly in elderly patients
• Liver function disorders or worsening manifesting, for example, as:
• Yellowing of the skin and whites of the eyes (jaundice) (rare, may affect up to 1 in 1,000 people)
• Severe skin or mucous membrane reactions (very rare, may affect up to 1 in 10,000 people), including:
• Mucosal lesions, superficial skin inflammation characterized by skin swelling and blister-like lesions (exfoliative dermatitis)
• Severe skin lesions characterized by erythema, blistering, and areas of skin detachment (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis). These effects can also lead to death. Onset of these reactions usually occurs within the first month of treatment.
• Allergic reactions and anaphylactic shock, a severe, rapidly developing allergic reaction including abnormally low blood pressure (hypotension) and loss of consciousness (shock)
• Chest pain, which may indicate a potentially serious allergic reaction known as Kounis syndrome.
• Mild cramps and abdominal tenderness occurring shortly after starting Deflamat treatment, followed by rectal bleeding or bloody diarrhea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).

Additionally, the following side effects may occur with the following frequencies:
Common (may affect up to 1 in 10 people)

• Headache, dizziness
• Vertigo
• Nausea, vomiting, diarrhea
• Persistent or recurring discomfort and/or pain in the upper abdomen (dyspepsia, abdominal pain)
• Gas formation in the intestine (flatulence)
• Decreased appetite with weight loss (anorexia)
• Reactions, pain, or hardening at the injection site
• Increased levels indicating liver function (transaminases)
• Skin rash

Uncommon (may affect up to 1 in 1,000 people)

• Drowsiness
• Asthma, including shortness of breath (dyspnea)
• Inflammation of the stomach (gastritis)
• Vomiting blood originating from the stomach or intestine (hematemesis)
• Diarrhea with blood
• Dark stools due to presence of blood (melena)
• Inflammation of the liver (hepatitis)
• Liver disorders
• Skin redness accompanied by itching (urticaria)
• Swelling (edema) due to fluid accumulation in the body (fluid retention)

Very rare (may affect up to 1 in 10,000 people):

• Decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of white blood cells in the blood (leukopenia/agranulocytosis)
• Decrease in hemoglobin in the blood, the substance that carries oxygen (anemia, hemolytic and aplastic anemia)
• Swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioneurotic edema)
• Disorientation
• Depression
• Insomnia, nightmares
• Irritability, psychotic reactions
• Sensation of numbness and tingling in legs, arms, or other body parts (paresthesia)
• Memory disturbances
• Seizures, anxiety, tremors
• Inflammation of the area near the brain (aseptic meningitis)
• Taste disturbances
• Disorders affecting blood flow to the brain (cerebrovascular events), including stroke
• Vision disorders, blurred vision, double vision (diplopia)
• Ringing sensation in the ears (tinnitus), worsening of hearing
• Palpitations
• Chest pain
• Condition in which the heart fails to supply adequate blood to the body (heart failure)
• Heart attack (myocardial infarction)
• High blood pressure (hypertension)
• Inflammation of blood vessels (vasculitis)
• Lung infection (pneumonia)
• Inflammation of the colon, the final part of the intestine (colitis), which may lead to bleeding (hemorrhagic colitis)
• Worsening of chronic inflammatory bowel diseases (Crohn’s disease, ulcerative colitis)
• Constipation
• Inflammation of the mouth (stomatitis), possibly with lesion formation (ulcerative stomatitis)
• Inflammation of the tongue (glossitis)
• Esophageal disorders
• Intestinal narrowing
• Inflammation of the pancreas (pancreatitis)
• Sudden inflammation of the liver (fulminant hepatitis)
• Destruction of liver cells (hepatic necrosis)
• Reduced liver function (hepatic failure)
• Bullous eruptions
• Skin irritations (eczema, erythema)
• Skin irritation characterized by the appearance of bright red target-like lesions (erythema multiforme)
• Hair loss
• Photosensitivity reaction
• Appearance of reddish skin patches of varying sizes (purpura), including allergic forms (allergic purpura)
• Itching
• Sudden reduction in kidney function (acute renal failure)
• Presence of blood in urine (hematuria)
• Presence of protein in urine (proteinuria)
• Kidney disease leading to loss of protein in urine (nephrotic syndrome)
• Inflammation of the kidneys (interstitial nephritis)
• Disease causing destruction of kidney cells (renal papillary necrosis)
• Pus formation (abscess) at the injection site.

Not known (frequency cannot be estimated from available data):

• Tissue damage at the injection site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deflamat

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep the blister pack containing the vials in the outer packaging, to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Deflamat contains

• The active substance is: sodium diclofenac. Each vial contains 75 mg of sodium diclofenac equivalent to 69.60 mg of diclofenac.
• The other components are: benzyl alcohol 35 mg/ml, propylene glycol, acetylcysteine, mannitol, sodium hydroxide, water for injections.

Description of the appearance of Deflamat and contents of the pack
Deflamat is a solution for injectable use, intended for intramuscular administration. It is supplied in 3 ml glass vials, packed in cartons containing 5 vials of 25 mg/ml. The vials are placed in blister packs.
Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
MORGANCEUTICAL S.r.l.,
Viale Varese 39
22100 Como
Manufacturer
Haupt Pharma Wülfing GmbH,
Bethelner Landstrasse 18
Gronau
Germany