DICLOREUM

Package leaflet: information for the user

Dicloreum, 75 mg/3 ml, solution for injection
Diclofenacum natricum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

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

1. What Dicloreum is and what it is used for

Dicloreum contains sodium diclofenac, which belongs to a group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Dicloreum involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain and fever.
The medicine is also available in the form of enteric-coated tablets with a strength of 50 mg and extended-release tablets with a strength of 100 mg.
Dicloreum is used for symptomatic treatment of acute pain episodes in inflammatory diseases of the musculoskeletal system.

2. Important information before using Dicloreum

When not to use Dicloreum

• if the patient is allergic to diclofenac, sodium metabisulfite, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has active peptic ulceration of the stomach and/or duodenum, gastrointestinal bleeding or perforation, or such conditions have occurred in the past during treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or for other reasons at least twice
• Dicloreum is contraindicated during the third trimester of pregnancy
• if the patient has severe renal, hepatic, and/or cardiac insufficiency
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. following myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or following revascularization or bypass surgery of blocked vessels
• if the patient has existing or previous circulatory disorders (peripheral vascular disease)
• if the patient has experienced asthma attacks, urticaria, or acute rhinitis after taking acetylsalicylic acid (aspirin) or other prostaglandin synthetase inhibitors (e.g. ibuprofen or naproxen)
• Dicloreum is contraindicated in children under 18 years of age.

Warnings and precautions

• in patients with asthma or predisposition to asthma attacks, as administration of Dicloreum may provoke bronchospasm or severe allergic reactions
• when patients are concurrently taking medications that may increase the risk of gastrointestinal ulcers or bleeding, such as: oral corticosteroids, anticoagulants (e.g. warfarin), serotonin reuptake inhibitors (e.g. fluoxetine, sertraline), or antiplatelet agents such as aspirin or ticlopidine
• in elderly patients, due to increased risk of adverse effects associated with non-steroidal anti-inflammatory drugs (NSAIDs), particularly gastrointestinal bleeding and perforation
• in elderly or ill patients who have previously experienced gastrointestinal ulceration, especially complicated by bleeding or perforation
• if the patient has ever had gastrointestinal disorders such as ulcerative colitis or Crohn's disease (chronic inflammatory bowel disease)
• in patients with hypertension and/or cardiac dysfunction
• in cases of hypoperfusion (reduced blood flow) or renal insufficiency, history of thrombosis with embolism, and in patients treated with diuretics or after major surgical procedures
• in patients with severe hepatic dysfunction or hepatic porphyria
• the lowest therapeutic dose should be used in underweight patients
• during intensive diuretic therapy
• in patients with a tendency to bleeding
• in cases of abnormal haematopoiesis (blood cell formation and differentiation)
• during treatment with anticoagulant drugs (e.g. acenocoumarol, warfarin), as Dicloreum may enhance their effect
• in patients with hepatic dysfunction, diclofenac may worsen the course of the disease; liver function tests should be monitored closely as advised by the physician
• before using Dicloreum, inform the doctor if the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as Dicloreum may impair wound healing in the intestines after surgery.

Use of medicines such as Dicloreum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended. If you have heart problems, a history of stroke, or suspect you are at risk (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss treatment options with your doctor or pharmacist.
Do not use Dicloreum together with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors such as celecoxib.
Diclofenac may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). This risk is particularly dangerous when high doses of diclofenac are used, or in patients with a history of gastrointestinal ulceration or in the elderly.
If any abdominal symptoms occur during treatment with Dicloreum (especially gastrointestinal bleeding), discontinue the medicine immediately and contact your doctor.
Diclofenac may, very rarely (especially at the beginning of treatment), cause life-threatening skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever and joint pain, or toxic epidermal necrolysis with lesions of the skin and mucous membranes, accompanied by high fever and severe general condition. If the first signs of rash, mucosal lesions, or other symptoms of allergic reaction appear, discontinue the medicine and contact your doctor.
If any of the above conditions apply, inform your doctor before using Dicloreum.
The medicine may transiently inhibit platelet aggregation.
Close medical supervision is required in patients with severe hepatic insufficiency.
Dicloreum injection solution is not an immediate analgesic and must be used under strict medical supervision.
Some people should NOT be given Dicloreum.
Before taking diclofenac, inform your doctor:

• if the patient smokes
• if the patient has diabetes
• if the patient has angina pectoris, thrombosis, hypertension, high cholesterol, or high triglyceride levels
• if the patient suspects allergy to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients of Dicloreum (listed at the end of this leaflet). Symptoms of hypersensitivity include facial and lip swelling (angioedema), breathing difficulties, chest pain, rhinitis, rash, or any other allergic-type reactions.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.
Dicloreum and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, and any medicines you plan to take.
Especially inform your doctor if you are taking the following medicines:

• Lithium or antidepressants (selective serotonin reuptake inhibitors)
• Digoxin (a medicine used in heart conditions)
• Angiotensin-converting enzyme (ACE) inhibitors, beta-blockers (used to treat hypertension and heart failure)
• Diuretics (medicines that increase urine output)
• Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (used to reduce inflammatory skin conditions)
• Anticoagulants and antiplatelet agents
• Antidiabetic drugs, except insulin
• Methotrexate (used in certain cancers or rheumatoid arthritis)
• Cyclosporine and tacrolimus (used in organ transplant recipients)
• Antibacterial quinolones and certain drugs used to treat infections
• Cardiac glycosides
• Mifepristone
• Phenytoin
• Colestipol and cholestyramine
• Strong inhibitors of the CYP2C9 enzyme, such as sulfinpyrazone and voriconazole

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Dicloreum during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Dicloreum may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in both mother and child and may delay or prolong labour. Dicloreum should not be used during the first six months of pregnancy unless the doctor considers it absolutely necessary. From week 20 of pregnancy, Dicloreum may cause kidney problems in the unborn child if used for more than a few days. This may lead to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Dicloreum should not be used during breastfeeding, as it may have harmful effects on the infant.
Fertility
Diclofenac may impair fertility. If the patient is planning to become pregnant or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Patients experiencing dizziness or other central nervous system disorders, including visual disturbances, should refrain from driving or operating machinery and should inform their doctor of any adverse effects experienced.
Elderly patients may be more sensitive to the effects of the medicine. Follow the instructions in the leaflet, use the lowest effective dose as recommended by the doctor, and report any adverse effects to your doctor.
Dicloreum contains benzyl alcohol, propylene glycol, sodium metabisulfite and sodium.
The medicine contains 119 mg of benzyl alcohol in each ampoule (3 ml). Benzyl alcohol may cause allergic reactions. Pregnant or breastfeeding women should consult their doctor before using the medicine, as high amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (metabolic acidosis). Patients with liver or kidney disease should consult their doctor before using the product, as high amounts of benzyl alcohol may accumulate and cause adverse effects (metabolic acidosis).
The medicine contains 581 mg of propylene glycol in each ampoule (3 ml).
The medicine contains sodium metabisulfite. Rarely, this may cause severe hypersensitivity reactions and bronchospasm.
The medicine contains less than 1 mmol (23 mg) of sodium per ampoule (3 ml), meaning it is considered "sodium-free".

3. How to use Dicloreum

This medicine should always be used according to the doctor's or pharmacist's instructions. If in doubt,
consult your doctor or pharmacist.
Do not exceed the recommended doses or duration of treatment.
As a general rule, the doctor should individually adjust the dose for each patient and use the lowest effective dose for the shortest possible time.
The recommended dosage is one ampoule of Dicloreum containing 75 mg of sodium diclofenac per day.
It should be administered deep intramuscularly into the upper outer quadrant of the buttock (the injection should be alternated between both buttocks). In severe cases, two ampoules per day may be given, and oral tablets should be started as soon as possible.
The dosing regimen for elderly patients must be determined by the doctor, who should consider reducing the recommended doses.
If you feel the medicine's effect is too strong or too weak, consult your doctor.
Taking the medicine at the lowest effective dose for the shortest necessary period to relieve symptoms reduces the risk of adverse effects.
Use of a higher than recommended dose of Dicloreum
Overdose with Dicloreum does not produce characteristic symptoms.
If more medicine has been taken by accident than recommended, contact your doctor, pharmacist, or go to hospital immediately.
Missed dose of Dicloreum
If a dose is missed, it should be taken as soon as remembered.
However, if more than half of the time between two doses has passed, the missed dose should not be taken; instead, continue with the next dose according to the previous schedule.
Do not take a double dose to make up for a missed dose.
Stopping Dicloreum treatment
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.
Treatment with Dicloreum should be discontinued in case of gastrointestinal bleeding or ulceration, as well as rash, mucosal lesions, or any other signs of hypersensitivity.
If abnormal liver function parameters persist or worsen, Dicloreum treatment must be discontinued. The decision to discontinue treatment will be made by the doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some adverse effects may be serious.
The frequency of adverse effects is estimated as follows:
very common (affects 1 or more patients in 10); common (affects 1 to 10 patients in 100);
uncommon (affects 1 to 10 patients in 1,000); rare (affects 1 to 10 patients in 10,000);
very rare (affects less than 1 patient in 10,000), unknown (frequency cannot be determined from
available data).
The adverse effects listed below include those reported for Dicloreum injection solution as well
as those observed during the use of other forms of diclofenac, administered either short-term or
long-term.

Very rare: thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of
leukocytes in peripheral blood), anaemia (including haemolytic and aplastic anaemia),
agranulocytosis (deficiency of white blood cells – neutrophil granulocytes), angioedema (including
facial swelling), disorientation, depression, insomnia, nightmares, irritability, psychotic
disorders, paraesthesia, memory impairment, seizures, anxiety, tremor, aseptic meningitis,
taste disturbances, stroke; visual disturbances, blurred vision, double vision, tinnitus,
hearing disturbances; palpitations, chest pain, heart failure, myocardial infarction;
hypertension, vasculitis; pneumonia; colitis (including haemorrhagic colitis and exacerbation
of ulcerative colitis, Crohn's disease), constipation, stomatitis, glossitis, oesophageal
disorders, membranous stricture of the intestine, pancreatitis, fulminant hepatitis;
bullous rash, rash, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions,
purpura, Schönlein-Henoch disease, pruritus, acute renal failure, haematuria, proteinuria,
nephrotic syndrome, interstitial nephritis, necrosis of renal papillae.

Rare: hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including hypotension and
shock), hepatitis, jaundice, liver function abnormalities, somnolence, asthma (including
dyspnoea), gastritis, gastrointestinal haemorrhage, haematemesis, bloody diarrhoea, melaena,
peptic ulcer of the stomach and/or duodenum (with or without bleeding and perforation),
urticaria, oedema.

Common: headache, dizziness of various origins, nausea, vomiting, diarrhoea, dyspepsia, abdominal
pain, flatulence, anorexia, increased aminotransferase activity; rash.

Frequency unknown: tissue damage at the injection site, Kounis syndrome, ischaemic colitis.

Use of medicines such as Dicloreum may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke.

If any of the above-mentioned or other unlisted adverse effects occur, inform your doctor.
You should stop using Dicloreum and contact your doctor immediately if the patient notices:

• stomach discomfort, heartburn or pain in the upper abdomen
• vomiting blood, blood in stool, blood in urine
• skin problems such as rash or itching
• wheezing or shortness of breath
• yellowing of the skin or whites of the eyes
• persistent sore throat or increased body temperature
• swelling of the face, feet or legs
• severe migraine
• chest pain associated with cough
• mild painful abdominal cramps and tenderness, beginning shortly after starting Dicloreum, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome (frequency unknown – cannot be determined from available data).
• injection site reactions, including pain at the injection site, redness, swelling, hard nodule, ulceration and bruising. This may lead to blackening and necrosis of the skin and surrounding tissues at the injection site, healing with scarring, a condition also known as Nicolau syndrome.

If Dicloreum is used for longer than a few weeks, regular contact with a doctor is recommended to ensure that no adverse effects have occurred.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
ul. Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: +48 22 49 21 301,
fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects allows more information on the safety of the medicine to be collected.

5. How to store Dicloreum

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label or on the
cardboard box after: Expiry date. The expiry date refers to the last day of the stated
month.
Do not use this medicine if visible particles are present or if the solution is cloudy or has changed colour.
Do not use Dicloreum from packages that have been previously damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Dicloreum contains

• The active substance is sodium diclofenac.
• 1 ampoule contains 75 mg/3 ml (25 mg/ml) of sodium diclofenac.
• The other components are propylene glycol, benzyl alcohol, sodium hydroxide, sodium pyrosulfite, water for injections.

What Dicloreum looks like and contents of the pack
Dicloreum is supplied in 6 amber glass ampoules packed in a cardboard box.
Marketing Authorisation Holder
Alfasigma S.p.A.
Via Ragazzi del ’99, n. 5
40133 Bologna (BO), Italy
Manufacturer
Alfasigma S.p.A.
Via Enrico Fermi 1
65 020 Alanno (PE), Italy
For further information, please contact the local representative of the Marketing Authorisation Holder:
Alfasigma Polska Sp. z o.o.
Al. Jerozolimskie 96
00-807 Warsaw
Tel. +48 22 824 03 64
Logo of the Marketing Authorisation Holder Alfasigma