Cataflam 50

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the outer packaging in a foreign language!
Cataflam 50
50 mg, coated tablets
Diclofenacum kalicum
Please read the entire leaflet carefully before using this 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, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Cataflam 50 is and what it is used for
2. What you need to know 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 play 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, inflammatory conditions, 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 and tonsillitis, 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 therapy, especially if treatment lasts longer than 4 weeks.
Regular blood tests should be performed during treatment if there are any signs of liver dysfunction, kidney impairment, or blood abnormalities. Liver function (transaminase levels), kidney function (creatinine levels), and blood cell counts (white and 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 dose.

2. Information before using Cataflam 50

When not to use Cataflam 50:

• if the patient is allergic to diclofenac or 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, swelling of the face, lips, tongue, throat and/or limbs (symptoms of angioedema), difficulty breathing, chest pain or any other allergic-type reactions. If the patient suspects they may be allergic, they should consult their doctor for advice,
• if the patient has active or a history of peptic ulceration of the stomach and/or duodenum, bleeding or perforation; if the patient has 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 hepatic insufficiency,
• if the patient has renal insufficiency,
• if the patient has been 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 a revascularization or bypass procedure,
• 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
patients in whom administration of acetylsalicylic acid or other drugs inhibiting prostaglandin
synthesis may trigger an asthmatic attack, urticaria or acute rhinitis.
Inform your 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 ulceration or in elderly patients. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation (which may be fatal). This risk may be particularly high when high doses of diclofenac are used. If any unusual gastrointestinal symptoms occur during treatment with Cataflam 50 (especially gastrointestinal bleeding), discontinue the medicine immediately and contact your 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, as they are more likely to experience an allergic reaction 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
urticaria). 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. Strictly follow the doctor's recommendations regarding regular liver function tests,
• 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 suffers from angina pectoris, thrombosis, hypertension, elevated cholesterol or elevated triglyceride levels.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".
The occurrence of adverse effects can be minimized by using the lowest effective dose for the
shortest duration necessary.
Use the lowest effective dose of Cataflam 50 that relieves pain and/or inflammation, 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,
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 changes or other symptoms of
allergic reaction, discontinue the medicine and contact your doctor.
The medicine may mask signs of infection (e.g. headache, increased body temperature) and may
interfere with accurate diagnosis. Inform your doctor during medical examinations that you are
taking this medicine.
Do not use Cataflam 50 together with other systemic non-steroidal anti-inflammatory drugs,
including selective cyclooxygenase-2 inhibitors. Before using the medicine, inform your doctor or
pharmacist about any of the above conditions.
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 exceed the recommended dose or duration of treatment.
If the patient has heart problems, has had a stroke, or suspects they are at risk of these conditions
(e.g. high blood pressure, diabetes, high cholesterol, smoking), consult your doctor or
pharmacist about treatment options.
The medicine may transiently inhibit platelet aggregation.
Before taking Cataflam 50, inform your doctor if the patient has recently undergone or is
scheduled for stomach or gastrointestinal surgery, as Cataflam 50 may occasionally impair
intestinal wound healing after surgery.
Children and adolescents
Do not use in children and adolescents under 14 years of age. For children and adolescents under
14 years, diclofenac in suppository form at a dose of 25 mg per day is recommended. Do not use
Cataflam 50 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 other adults. Follow the
instructions in the leaflet, use the lowest effective dose as recommended by the doctor, and report
any adverse effects occurring during treatment to your 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 taking 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 disease
• 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 antiplatelet medicines
• Antidiabetic medicines except insulin
• Methotrexate – a medicine used in the treatment of certain cancers or joint inflammation
• 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
Swallow the tablets 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 become
pregnant, she should consult her doctor before using this medicine.
During pregnancy, in the first two trimesters, Cataflam 50 should not be used unless absolutely
necessary.
As with other anti-inflammatory medicines, use of Cataflam 50 during the last three months of
pregnancy is contraindicated, as it may seriously harm the unborn child or adversely affect labour.
Do not use Cataflam 50 in breastfeeding women, as it may have harmful effects on the infant.
Your doctor will discuss with you the potential risks of using Cataflam 50 during pregnancy and
breastfeeding.
Taking Cataflam 50 may make it more difficult to become pregnant. If the patient plans to become
pregnant or has difficulty conceiving, she should inform her doctor.
Driving and using machines
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 in the form of coated tablets contains sucrose. If the patient has previously been
diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

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 Cataflam 50 is used for longer than a few weeks, regular medical check-ups are necessary to rule out any unnoticed adverse effects.

It is generally recommended to individualize 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.

In women with primary dysmenorrhea, 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 daily 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 doctor may recommend an initial dose of 100 mg and administration of 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 onset of the first symptoms indicating 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 above 14 years of age, 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. In elderly patients and those with low body weight, it is recommended to use the lowest effective dose.

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.

Taking more than the recommended dose of Cataflam 50
Overdose with Cataflam 50 does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions. In cases of severe poisoning, acute kidney failure and liver damage may occur.
If an overdose is taken by accident, seek immediate medical advice from your doctor, pharmacist, or go to the nearest hospital emergency department.

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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of adverse reactions 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 determined from
available data).
The adverse reactions 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 reactions:
Common

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

Uncommon

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

Rare

• hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock),
• somnolence,
• asthma (including dyspnoea),
• gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
• gastric and (or) duodenal ulcer disease (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 neutrophilic granulocytes),
• angioedema (including facial swelling),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders, paraesthesia, memory disturbances, 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 mucositis (including ulcerative stomatitis), glossitis, oesophageal disorders, membranous stricture of the intestine, 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.

Unknown

• concomitant 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 reactions may occur in some individuals during treatment with Cataflam 50.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur,
inform your doctor or pharmacist.
If any of the following reactions occur, stop taking Cataflam 50 immediately and inform your
doctor:

• stomach discomfort, heartburn or upper abdominal pain,

• 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 high 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 Cataflam 50, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – cannot be determined from available data),

• chest pain which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

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

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

If Cataflam 50 is taken for longer than a few weeks, regular contact with a doctor is recommended
to ensure that no adverse reactions have occurred.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist
or nurse. Adverse reactions 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cataflam 50

Keep this medicine out of sight and reach of children.
Store below 30°C and protect from moisture.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine Cataflam 50 contains

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

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.
Marketing Authorization Holder in Belgium, the country of export:
Novartis Pharma NV
Medialaan 40
B - 1800 Vilvoorde
Belgium
Manufacturer:
Novartis Pharma NV
Medialaan 40
B - 1800 Vilvoorde
Belgium
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190
91-610 Łódź
Belgium Marketing Authorization number: BE147402
Parallel Import Authorization number: 366/22