CATAFLAM 50

Patient Information Leaflet

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Cataflam 50, 50 mg, coated tablets
Diclofenacum kalicum
Please read this 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Cataflam 50 is and what it is used for
2. Important information before taking Cataflam 50
3. How to take Cataflam 50
4. Possible side effects
5. How to store Cataflam 50
6. Contents of the pack and other information

1. What Cataflam 50 is and what it is used for

Cataflam 50 contains diclofenac potassium, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It has anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Cataflam 50 involves inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain and fever.
Cataflam 50 is used for the short-term treatment of the following acute conditions:

• Traumatic pain, inflammatory conditions and oedema, e.g. following joint sprains.
• Postoperative pain, inflammation and oedema, e.g. after dental or orthopaedic procedures.
• Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis.
• Migraine attacks.
• Spinal pain syndromes.
• Extra-articular rheumatism.
• As an adjunctive treatment in severe painful infections of the ear, nose or throat, e.g. pharyngitis, tonsillitis or otitis. According to general therapeutic principles, causal treatment should be initiated first. Fever, when the only symptom of disease, is not an indication for administration of this medicine.

Monitoring during treatment with Cataflam 50
In patients with diagnosed heart disease or significant cardiovascular risk factors, the treating physician should periodically assess the patient's need for symptomatic treatment and response to the drug, especially if treatment lasts longer than 4 weeks.
Regular blood tests should be performed during treatment if there are any liver function disorders, kidney function impairments or abnormalities in blood parameters. Liver function (transaminase levels), kidney function (creatinine levels) and blood cell counts (white blood cells, red blood cells and platelets) should be monitored. The treating physician will consider blood test results when deciding whether to discontinue treatment with Cataflam 50 or adjust the dosage.

2. Important information before using Cataflam 50

When not to use Cataflam 50:

• if the patient is allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced an allergic reaction after taking anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid, diclofenac or ibuprofen). Reactions may include asthma, rhinitis, skin rash, facial, lip, tongue, throat and/or limb swelling (symptoms of angioedema), breathing difficulties, chest pain or any other allergic-type reactions. If the patient suspects they may be allergic, they should consult a doctor for advice;
• if the patient has active or previously diagnosed peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding or perforation; if the patient previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines;
• if the patient is in the last trimester of pregnancy;
• if the patient has liver failure;
• if the patient has kidney failure;
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after a heart attack, stroke, mini-stroke (transient ischaemic attack), or arterial blockage in the heart or brain, or after a procedure to unblock or bypass blocked blood vessels;
• if the patient has current or previous circulatory disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Cataflam 50 should not be used in individuals in whom administration of acetylsalicylic acid or other drugs inhibiting prostaglandin synthesis may trigger an asthma attack, urticaria or acute rhinitis.

Patients should inform their doctor if any of the above conditions apply.

Warnings and precautions

Before using Cataflam 50, discuss with your doctor:

• if the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if the patient is a smoker. If the doctor decides to prescribe Cataflam 50, the dose must not exceed 100 mg per day if treatment lasts longer than 4 weeks;
• if the medicine is to be used in patients with a history of gastrointestinal ulcers or in elderly patients. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation (which may be fatal). This risk is particularly significant when high doses of diclofenac are used. If any unusual abdominal symptoms occur during treatment with Cataflam 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should contact their doctor;
• if the patient has ulcerative colitis or Crohn’s disease; diclofenac may worsen the condition;
• if the patient suffers from asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, they are at higher risk of allergic reactions to diclofenac (worsening of asthma, Quincke’s edema or urticaria). This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching or hives). The medicine should be administered with particular caution (preferably under medical supervision);
• if the patient has impaired liver function; diclofenac may worsen the course of the disease. Strict adherence to the doctor’s recommendations regarding periodic liver function tests is essential;
• if the patient suffers from hepatic porphyria. Diclofenac may trigger an attack of porphyria.

Before taking diclofenac, inform your doctor:

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

The risk of adverse effects can be minimized by using the medicine at the lowest effective dose and for the shortest duration necessary.

Use the lowest effective dose of Cataflam 50 that relieves pain and/or swelling, and use it for the shortest possible time to minimize the risk of adverse effects.

If at any time during treatment with Cataflam 50 the patient experiences symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness or slurred speech, they should contact a doctor or emergency department immediately.

Use of 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 skin and mucosal lesions, high fever and severe general condition). At the first signs of rash, mucosal lesions or other symptoms of allergic reaction, the medicine should be discontinued and the patient should contact their doctor.

The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and may complicate accurate diagnosis. Inform any doctor during medical examinations that you are taking this medicine.

Do not use Cataflam 50 simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.

Before using the medicine, inform your doctor or pharmacist if any of the above conditions apply.

Taking medicines such as Cataflam 50 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 durations than recommended.

If the patient has heart problems, has had a stroke, or suspects they may be at risk of such conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), they should consult their doctor or pharmacist about treatment options.

The medicine may transiently inhibit platelet aggregation.

Before taking Cataflam, inform your doctor if the patient has recently undergone or is scheduled for stomach or gastrointestinal surgery, as Cataflam may sometimes impair intestinal wound healing after surgery.

Children and adolescents

This medicine should not be used in children and adolescents under 14 years of age. For children and adolescents under 14 years of age, diclofenac in suppository form at a dose of 25 mg per day is recommended. Cataflam 50 should not be used in children under 1 year of age.

Elderly patients (aged 65 years and above)

Elderly patients may be more sensitive to the effects of the medicine than younger adults. Follow the instructions in the leaflet, use the lowest effective dose as directed by the doctor, and report any adverse effects occurring during treatment to the doctor.

Cataflam 50 and other medicines

Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.

Especially inform your doctor if you are taking any of the following medicines:

• Lithium or medicines belonging to the group of antidepressants (selective serotonin reuptake inhibitors).
• Digoxin – a medicine used in the treatment of heart conditions.
• Diuretics – medicines that increase urine output.
• Angiotensin-converting enzyme inhibitors, beta-blockers – groups of medicines used in the treatment of hypertension and heart failure.
• Non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to relieve inflammation in affected body areas).
• Anticoagulants and platelet inhibitors.
• Antidiabetic medicines, except insulin.
• Methotrexate – a medicine used in the treatment of certain cancers or arthritis.
• Cyclosporine and tacrolimus – medicines used in organ transplant recipients.
• Trimethoprim – a medicine used to prevent and treat urinary tract infections.
• Quinolone antibiotics – medicines used to treat infections.
• Colestipol and cholestyramine – medicines that lower blood cholesterol levels.
• Voriconazole – a medicine used to treat fungal infections.
• Phenytoin – a medicine used to treat epileptic seizures.

Taking Cataflam 50 with food and drink

Tablets should be swallowed whole with water, preferably before a meal.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult a doctor before using this medicine.

Do not take Cataflam 50 if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. It 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. Do not use the medicine during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Cataflam 50 may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Do not use Cataflam 50 in breastfeeding women, as it may have harmful effects on the infant.

The doctor will discuss with the patient the potential risks of using Cataflam 50 during pregnancy and breastfeeding.

Taking Cataflam 50 may make it more difficult to conceive. If the patient plans to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery

The effect of Cataflam 50 on the ability to drive, operate machinery or perform other tasks requiring special attention is unlikely.

Cataflam 50 contains sucrose

Cataflam 50 film-coated tablets contain sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

Cataflam 50 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Cataflam 50

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Do not exceed the recommended doses. If you are taking Cataflam 50 coated tablets for longer than a few weeks, regular medical check-ups are necessary to rule out any unnoticed adverse effects.
The general recommendation is to individually adjust the dose and use the lowest effective dose for the shortest possible duration.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Adults
The recommended initial dose is 100 mg per day up to 150 mg per day.
In milder cases, a dose of 75 mg to 100 mg per day is considered sufficient.
Tablets for oral administration. The total daily dose should be divided and administered in 2 to 3 doses, as applicable.
Do not exceed a daily dose of 150 mg.

For women with primary dysmenorrhoea (painful menstruation), the initial dose is 50 mg, taken at the onset of the first symptoms, followed by continued treatment with 50 mg administered up to three times a day for several consecutive days, as needed. If a daily dose of 150 mg does not provide sufficient pain relief over two to three consecutive menstrual cycles, the treating physician may recommend an initial dose of 100 mg and up to 200 mg per day, divided into 2 to 3 doses during subsequent menstrual cycles. Do not exceed a daily dose of 200 mg.

For the treatment of migraine, the initial dose is 50 mg, taken at the first signs of an attack. If pain relief is not sufficient within 2 hours after the first dose, an additional 50 mg dose may be taken. If necessary, further 50 mg doses may be taken at intervals of 4 to 6 hours. Do not exceed a daily dose of 200 mg.

Use in children and adolescents
Due to the strength of the dose, Cataflam 50 is not recommended for children and adolescents under 14 years of age. For children and adolescents under 14 years of age, diclofenac in suppository form at a dose of 25 mg per day is recommended.
For adolescents aged over 14 years, a dose of 75 mg to 100 mg per day, divided into 2 to 3 doses, is usually sufficient. Do not exceed the maximum daily dose of 150 mg.
Cataflam 50 must not be used in children and adolescents (under 18 years of age) for the treatment of migraine.

Elderly patients (aged 65 years and above)
This medicine should be used with caution in elderly patients. For elderly patients and those with low body weight, the lowest effective dose is recommended.

Method of administration
Tablets should be swallowed whole with water, preferably before a meal. Do not divide or chew the tablets.

How long to use Cataflam 50
Cataflam 50 should always be used as directed by your doctor.
If Cataflam 50 is taken long-term, regular contact with your doctor is necessary to ensure that no adverse effects have occurred.
If in doubt about how long to use the medicine, consult your doctor or pharmacist.

Overdose of Cataflam 50
Overdose of Cataflam 50 does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or seizures. In cases of severe poisoning, acute renal failure and liver damage may occur.
If an overdose is taken by accident, contact your doctor, pharmacist, or go to a hospital emergency department immediately.

Missed dose of Cataflam 50
If a dose is missed, take it as soon as you remember. However, if more than half of the time between two doses has passed, do not take the missed dose and take the next dose according to the previous dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is estimated as follows:
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare
(≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (frequency cannot be estimated from
available data).

The adverse effects listed below include those observed with Cataflam 50 as well as those observed with other formulations of diclofenac, used either short-term or long-term.

Adverse effects:

Common

• headache, dizziness,
• nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, bloating, decreased appetite,
• increased aminotransferase activity,
• rash.

Uncommon

• myocardial infarction, heart failure, palpitations, chest pain.

Rare

• hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including hypotension and shock),
• somnolence,
• asthma (including dyspnoea),
• gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
• peptic ulcer of the stomach and/or duodenum (with or without bleeding or perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• oedema.

Very rare

• thrombocytopenia (reduced platelet count), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of neutrophil granulocytes),
• angioedema (including facial oedema),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paraesthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke,
• visual disturbances, blurred vision, diplopia,
• 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, oral mucosal inflammation (including oral ulcerative stomatitis), glossitis, oesophageal disorders, membranous intestinal stricture, pancreatitis,
• fulminant hepatitis, hepatic necrosis, liver failure,
• bullous rash, exanthema, 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, renal papillary necrosis.

Frequency unknown

• concurrent occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome).

Taking medicines such as Cataflam 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Other adverse effects may occur in some individuals during treatment with Cataflam 50.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
If any of the following effects occur, stop taking Cataflam 50 immediately and contact your doctor:

• stomach discomfort, heartburn or upper abdominal pain,
• vomiting blood, blood in stools, 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 high fever,
• swelling of the face, feet or legs,
• severe migraine,
• chest pain associated with cough,
• mild painful abdominal cramps and tenderness beginning shortly after starting Cataflam 50, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of onset of abdominal pain (frequency unknown - cannot be estimated from available data),
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Some adverse effects may be serious
These uncommon adverse effects may occur in 1-10 patients per 1,000, especially when high daily doses (150 mg) are used for prolonged periods:

• sudden, constricting chest pain (symptoms of myocardial infarction or heart attack),
• dyspnoea, difficulty breathing when lying down, oedema of feet or legs (symptoms of heart failure).

If you are taking Cataflam 50 for longer than a few weeks, you should have regular contact with your doctor to ensure that no adverse effects have occurred.

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

5. How to store Cataflam 50

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the
last day of the stated month.
Do not store above 30°C. Store in the original packaging.
Translation of some information on the immediate packaging:
LOT – batch number
EXP – expiry date
MFD – manufacturing date.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Cataflam 50 contains

• The active substance is potassium diclofenac. One tablet of Cataflam 50 contains 50 mg of potassium diclofenac.
• The other ingredients are: colloidal anhydrous silica, calcium phosphate, magnesium stearate, maize starch, povidone K 30, sodium carboxymethyl starch (type A). Coating composition: microcrystalline cellulose, polyethylene glycol 8000, povidone, sucrose, talc, titanium dioxide (E 171), iron oxide red (E 172).

What Cataflam 50 looks like and contents of the pack
One pack contains 10 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Ireland, country of export:
Novartis Ireland Limited
Vista Building, Elm Park, Merrion Road
Ballsbridge, Dublin 4, Ireland
Manufacturer:
Novartis Pharma GmbH
Roonstrasse 25 and Obere Turnstrasse 8 – 10
90429 Nuremberg, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
Prodlekpol Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Ireland, country of export: PA0896/004/001
Parallel import licence number: 752/15