DICLODUO

DicloDuo, 75 mg, modified-release capsules
Diclofenacum natricum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What DicloDuo is and what it is used for

Diclofenac belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and is a derivative of phenylacetic acid. In addition to its anti-inflammatory effect, it has analgesic and antipyretic properties and inhibits platelet aggregation. Diclofenac does not affect glucose metabolism. The mechanism of action of diclofenac, as with other non-steroidal anti-inflammatory drugs, involves inhibition of cyclooxygenase-mediated prostaglandin synthesis, which is responsible for the inflammatory process.

DicloDuo is indicated for symptomatic treatment of:

• Inflammatory forms of rheumatic diseases (e.g. rheumatoid arthritis, ankylosing spondylitis, degenerative joint diseases);
• Rheumatic and post-traumatic inflammatory conditions of tendons, ligaments, and periarticular soft tissues.

For pain relief:

• After surgical procedures;
• In painful menstruation.

2. Important information before taking DicloDuo

When not to use DicloDuo

• If the patient suspects hypersensitivity to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other non-steroidal anti-inflammatory drug (NSAID), or to any of the other ingredients of DicloDuo (listed at the end of this leaflet). Symptoms of hypersensitivity include facial and lip swelling (angioedema), difficulty breathing, chest pain, nasal congestion, rash, or any other allergic-type reactions.
• In patients with active or recurrent peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding or perforation.
• In women during the third trimester of pregnancy.
• In patients with severe hepatic, renal or cardiac insufficiency.
• As with other non-steroidal anti-inflammatory drugs (NSAIDs), DicloDuo should not be used in patients in whom administration of acetylsalicylic acid or other drugs inhibiting prostaglandin synthesis may trigger an asthma attack, urticaria, or acute rhinitis.
• In patients who have previously experienced gastrointestinal bleeding or perforation following the use of NSAIDs.
• In patients with cerebral haemorrhage or other active bleeding.
• In patients with unexplained blood disorders.
• In patients diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or after procedures to restore blood flow or bypass blocked vessels.
• In patients with existing or previous circulatory disorders (peripheral vascular disease).

Before taking diclofenac, inform your doctor

• if the patient smokes
• if the patient has diabetes
• if the patient suffers from angina pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

Before using DicloDuo, tell your doctor if the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as DicloDuo may sometimes impair intestinal wound healing after surgery.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.

Warnings and precautions

• Discuss use of DicloDuo with your doctor or pharmacist before starting treatment.
• Using the lowest effective dose for the shortest duration needed to relieve symptoms reduces the risk of adverse effects.
• Gastrointestinal bleeding, ulceration, or perforation, which may lead to life-threatening adverse effects (sometimes fatal), have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms, and regardless of previous gastrointestinal complications. These complications are more dangerous in elderly patients. If gastrointestinal bleeding or ulceration occurs in patients receiving DicloDuo, the doctor will recommend discontinuation of the drug.
• Serious skin reactions, potentially leading to life-threatening adverse effects (sometimes fatal), including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (see section 4), have very rarely been reported with NSAIDs, including diclofenac. Patients at highest risk of such reactions typically developed symptoms during the initial phase of treatment, mostly within the first month. DicloDuo must be discontinued immediately if a rash, mucosal lesions, or any other signs of hypersensitivity occur.
• Talk to your doctor before starting treatment if the patient has ever experienced severe skin rash, skin peeling, blistering, or oral ulcers after taking DicloDuo or other pain-relieving medications.
• As with other non-steroidal anti-inflammatory drugs (NSAIDs), allergic reactions, including anaphylactic and pseudoanaphylactic reactions, may rarely occur, even if the drug has not been previously used.
• Like other NSAIDs, DicloDuo may mask signs of infection.
• Diclofenac may impair fertility. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.
• Avoid concomitant use of DicloDuo with other systemic NSAIDs, including selective COX-2 inhibitors, due to lack of evidence of benefit from combination therapy and potential increase in adverse effects.
• Use with caution in elderly patients. In elderly patients and those with low body weight, the doctor will recommend the lowest effective dose.
• In patients with asthma, seasonal allergic rhinitis, nasal mucosal oedema (e.g. nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory infections (especially with symptoms resembling allergic rhinitis), exacerbations of asthma (drug-induced asthma), Quincke's oedema, or urticaria occur more frequently after NSAID use than in other patients. Therefore, special caution is advised in these patients (ensure rapid access to medical help). Particular caution is required in patients allergic to other substances, e.g. those with skin reactions, itching, or urticaria.
• Use of drugs such as DicloDuo 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 exceed recommended doses or duration of treatment. If the patient has heart problems, history of stroke, or risk factors for these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss treatment approach with a doctor or pharmacist.
• The drug may transiently inhibit platelet aggregation.
• In patients with symptoms indicating gastrointestinal disorders or with a history suggestive of gastric or intestinal ulcer disease, bleeding, or perforation, close medical supervision is required, as with other NSAIDs. The doctor will prescribe the drug particularly cautiously to such patients.
• The risk of gastrointestinal bleeding increases with higher NSAID doses and in patients with a history of peptic ulcer disease, especially if it involved bleeding or perforation, and in elderly patients.
• To reduce the risk of gastrointestinal toxicity, treatment in patients with a history of peptic ulcer disease, particularly if complicated by bleeding or perforation, and in elderly patients, should be initiated and continued using the lowest effective doses.
• The doctor may consider concomitant gastroprotective therapy (e.g. proton pump inhibitors or misoprostol) in these patients, as well as in patients requiring concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders.
• Patients with a history of gastrointestinal disorders, especially elderly patients, should inform their doctor about any unusual abdominal symptoms (particularly gastrointestinal bleeding). Caution is advised in patients receiving concomitant medications that may increase the risk of gastric or duodenal ulceration or bleeding, such as systemic corticosteroids, anticoagulants, antiplatelet agents, or selective serotonin reuptake inhibitors (SSRIs).
• Patients with ulcerative colitis or Crohn's disease should be under close medical supervision due to the risk of disease exacerbation.
• Close medical monitoring is necessary when prescribing DicloDuo to patients with hepatic dysfunction due to the risk of worsening liver disease.
• Like other non-steroidal anti-inflammatory drugs (NSAIDs), DicloDuo may increase the activity of one or more liver enzymes. During long-term treatment with DicloDuo, periodic monitoring of liver function is recommended.
• Discontinue DicloDuo if abnormal liver function test results persist or worsen, or if clinical signs or symptoms of liver dysfunction or other symptoms (e.g. eosinophilia, rash, etc.) occur. Hepatitis may occur without prodromal symptoms.
• Use DicloDuo with caution in patients with hepatic porphyria, as it may provoke an acute attack.

During long-term use of diclofenac, the doctor will recommend regular monitoring of kidney function and blood counts.
During prolonged use of painkillers, headaches may occur, which should not be treated with higher doses of the drug.
Excessive use of painkillers, especially simultaneous use of multiple drugs with different active ingredients, may lead to permanent kidney damage and risk of kidney failure.

Children and adolescents
Due to the dosage strength, this medicinal product is not recommended for use in children and adolescents under 18 years of age.

DicloDuo and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, or those planned for use.
Concomitant use of DicloDuo may alter the effect of the following medicines, or the use of these medicines may alter the effect of DicloDuo:

• Lithium;
• Digoxin;
• Phenytoin;
• Glucocorticosteroids;
• Probenecid;
• Colestipol;
• Cholestyramine;
• CYP2C9 inhibitors, e.g. sulfinpyrazone and voriconazole;
• Diuretics and antihypertensive drugs (e.g. β-blockers, ACE inhibitors);
• Non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids: concomitant use of diclofenac with other NSAIDs or corticosteroids may increase the frequency of gastrointestinal adverse effects;
• Anticoagulants and antiplatelet agents: caution is required, as concomitant use with diclofenac may increase the risk of bleeding;
• Selective serotonin reuptake inhibitors (SSRIs): concomitant use of NSAIDs and SSRIs may increase the risk of gastrointestinal bleeding;
• Antidiabetic agents: blood glucose monitoring is necessary during combination therapy;
• Methotrexate: caution is advised when using NSAIDs within 24 hours before or after methotrexate therapy, as this may increase methotrexate blood levels and its toxicity;
• Cyclosporine and tacrolimus: diclofenac should be administered at lower doses than in patients not receiving cyclosporine or tacrolimus;
• Antibacterial quinolones;
• Mifepristone: diclofenac and other NSAIDs should not be used within 8–12 days after mifepristone administration.

DicloDuo with food, drink or alcohol
Take capsules preferably with food, swallowed whole with liquid. Do not chew or crush.
Concomitant use of DicloDuo and alcohol may increase the risk of adverse effects, particularly gastrointestinal or central nervous system effects.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not take DicloDuo during the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.
DicloDuo should not be used during the first six months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, DicloDuo may cause kidney dysfunction in the unborn child if used for longer than a few days. This may lead to low amniotic fluid levels (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.
Diclofenac passes into breast milk in small amounts; therefore, it should not be given to breastfeeding women.

Driving and using machines
If dizziness, fatigue or visual disturbances occur during treatment with diclofenac, do not drive or operate machinery.

DicloDuo contains sodium and propylene glycol
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".
The medicine contains 1 mg of propylene glycol per capsule.

3. How to use DicloDuo

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Do not exceed the recommended doses or duration of treatment.
Adults
The dose should be individually adjusted according to the indication and the patient's condition. The recommended daily dose is up to 150 mg of sodium diclofenac (2 capsules). Adults are usually given 1 capsule of DicloDuo 75 mg per day. If necessary, this dose may be increased to 2 capsules per day (2 times 75 mg of sodium diclofenac). In particularly severe cases, 2 capsules of DicloDuo 75 mg may be administered once daily for a short period (total 150 mg of sodium diclofenac). Capsules should preferably be taken with meals. Do not chew or crush the capsules.
If the effect of the medicine seems too strong or too weak, consult your doctor.
The doctor will individually adjust the dose for each patient and will use the lowest effective dose for the shortest possible duration.
Use in children and adolescents
Due to the dose size, this medicine is not recommended for use in children and adolescents under 18 years of age.
Use of DicloDuo in patients with renal and/or hepatic impairment
Dose reduction is not necessary in patients with mild or moderate renal and/or hepatic impairment (recommendations for patients with severe renal and/or hepatic impairment, see section 2).
Use of DicloDuo in elderly patients
There are no contraindications. Dose modification is not required. However, this medicine should be used with caution in elderly individuals.
In elderly patients and those with low body weight, it is recommended to use the lowest effective dose.
Overdose of DicloDuo
In case of ingestion of a dose higher than recommended, or accidental ingestion by a child, contact a doctor or pharmacist immediately.
Overdose may cause vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions. In cases of severe poisoning, acute renal failure and liver damage may occur.
There is no specific antidote for diclofenac. Treatment is symptomatic.
Missed dose of DicloDuo
Do not take a double dose to make up for a missed dose.
Discontinuation of DicloDuo
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Some adverse effects may be serious.
DicloDuo must be discontinued and medical advice should be sought immediately if any of the
following serious adverse effects occur — the patient may require urgent treatment:

• mild abdominal cramps and tenderness starting soon after beginning DicloDuo treatment, 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).
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• severe allergic skin reaction, which may manifest as widespread red and (or) dark spots, skin swelling, blisters, and itching (generalized fixed bullous eruption).

The adverse effects listed below include those reported during use of diclofenac formulations, administered either short- or long-term.
Common (occur in less than 1 in 10 but more than 1 in 100 patients): epigastric pain, other gastrointestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, bloating, loss of appetite), headache, dizziness, vertigo, skin rashes and eruptions, increased serum aminotransferase activity (AlAT, AspAT).
Uncommon (occur in less than 1 in 1,000 but more than 1 in 10,000 patients): gastric mucosal inflammation, gastrointestinal bleeding (haematemesis, melaena, bloody diarrhoea), gastrointestinal ulcers with or without concurrent bleeding or perforation, somnolence, fatigue, urticaria, oedema, hepatic function disorders including hepatitis (single cases with fulminant course), with or without concurrent jaundice, hypersensitivity reactions (e.g. asthma exacerbation, bronchospasm or dyspnoea, systemic anaphylactic or anaphylactoid reactions, including sudden drop in blood pressure and shock), oedema.
Rare (occur in less than 1 in 10,000 patients): aphthous stomatitis, glossitis, changes in oesophageal mucosa, lower large intestine disorders (e.g. non-specific haemorrhagic colitis, exacerbation of ulcerative colitis or proctocolitis in Crohn's disease, colon damage and stricture formation), pancreatitis, constipation, sensory disturbances, paresthesia, memory disorders, convulsions, anxiety states, tremor, aseptic meningitis (particularly in patients with autoimmune diseases such as systemic lupus erythematosus and mixed connective tissue disease), with fever, neck stiffness, headache, nausea and vomiting, taste disturbances, stroke, visual disturbances (blurred or double vision), tinnitus, hearing disorders, bullous eruptions, rash, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis), erythroderma (exfoliative dermatitis), alopecia, photosensitivity reactions, purpura including allergic purpura, erythema, pruritus, acute renal failure, urinary abnormalities (e.g. haematuria, proteinuria), interstitial nephritis, nephrotic syndrome, renal papillary necrosis, thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), agranulocytosis (very low number of a type of white blood cells), haemolytic anaemia, aplastic anaemia, impotence, angioedema (including facial swelling), vasculitis, pneumonia, palpitations, chest pain, heart failure, myocardial infarction, hypotension, disorientation, depression, insomnia, nightmares, irritability, psychotic disorders.
Frequency not known (cannot be estimated from available data):

• allergic skin reaction which may present as round or oval redness and swelling of the skin, blisters and itching (fixed drug eruption). The affected skin areas may also have a darker pigmentation, which may persist after healing. Upon re-exposure to the drug, fixed drug eruption usually recurs in the same locations.

Use of medicines such as DicloDuo 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.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C,
02-222 Warsaw,
Phone: +48 22 49 21 301,
Fax: +48 22 49 21 309.
Adverse effects can also be reported directly to the Marketing Authorisation Holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store DicloDuo

Store below 25°C. Keep in the original packaging to protect from light and moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: {EXP}. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What DicloDuo contains

• The active substance is sodium diclofenac, with 25 mg in enteric pellets and 50 mg in prolonged-release pellets.
• The other ingredients (excipients) are:
• in enteric pellets: microcrystalline cellulose, povidone K 25, colloidal anhydrous silica, copolymer of methacrylic acid and ethyl acrylate (1:1) with addition of 0.28 mg of sodium hydroxide (1N), propylene glycol, talc.
• in prolonged-release pellets: microcrystalline cellulose, povidone K 25, colloidal anhydrous silica, ammonium methacrylate copolymer (type B) – Eudragit RS 100, ammonium methacrylate copolymer (type A) – Eudragit RL 100, triethyl citrate, talc.
• in the capsule shell: titanium dioxide (E 171), indigo carmine (E 132), purified water, gelatin.
• in the printing ink on the capsule shell: shellac, propylene glycol, titanium dioxide (E 171).

What DicloDuo looks like and contents of the pack
PVC/PVDC/Aluminium blisters in a cardboard box.
30 capsules in blisters of 10 capsules each.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00
Manufacturer
Swiss Caps GmbH
Grassingerstraße 9
83043 Bad Aibling,
Germany
Importer
Bausch Health Poland sp. z o.o.
Kosztowska 21 Street
41-409 Mysłowice
Poland