Package leaflet: Information for the user

Warning! Please keep the leaflet. Information on the immediate packaging 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 doubts, 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 someone else, even if their symptoms are the same.
If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Cataflam 50 is and what it is used for
Important information before taking Cataflam 50
How to take Cataflam 50
Possible side effects
How to store Cataflam 50
Contents of the package 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 swelling, e.g., due to joint sprains.
Postoperative pain, inflammation, and swelling, e.g., following dental or orthopedic procedures.
Painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhea 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 media. According to general therapeutic principles, causal treatment should be applied first. Fever as the sole symptom of a 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 need for symptomatic treatment and the patient's response to the medicine, especially if treatment lasts longer than 4 weeks.
Regular blood tests should be performed during treatment in case of any liver function disorders, kidney function disorders, or blood abnormalities. 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 the blood test results when deciding whether to discontinue treatment with Cataflam 50 or adjust the dose.

2. Important 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, facial swelling, swelling of the 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 a doctor for advice,
if the patient has active or a history of peptic ulcer disease 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 liver failure,
if the patient has kidney failure,
if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, mini-stroke (transient ischaemic attack), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass blocked blood vessels,
if the patient has current or past 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 the doctor about the presence of the above-mentioned conditions.
Warnings and precautions
Before using Cataflam 50, discuss the following 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, and 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 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 effect may be particularly dangerous when high doses of diclofenac are used. If any unusual gastrointestinal 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 course of the disease,
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 more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, 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 the doctor:

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

The risk of adverse effects can be reduced by using the medicine at the lowest effective dose and for the shortest duration necessary.
Use the lowest 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 indicating 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 (e.g.: 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). If early signs of rash, mucosal changes or other symptoms of an allergic reaction occur, discontinue the medicine and contact a doctor.
The medicine may mask signs of infection (e.g. headache, elevated body temperature) and complicate accurate diagnosis. Inform the doctor about use of this medicine during medical examinations.
Do not use Cataflam 50 simultaneously with other systemically acting non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
Before using the medicine, inform the doctor or pharmacist about any of the above-mentioned conditions.
Use of 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 duration than recommended.
If the patient has heart problems, has had a stroke, or suspects risk of such conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), consult a doctor or pharmacist about treatment options.
The medicine may transiently inhibit platelet aggregation.
Before taking Cataflam 50, inform the doctor if the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as Cataflam 50 may sometimes impair intestinal wound healing after surgery.
Children and adolescents
Do not use Cataflam 50 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.
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 all adverse effects occurring during treatment to the doctor.
Cataflam 50 and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Inform the doctor especially about use 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 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 inflammatory conditions 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
Colestyramine and colestipol – 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 meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or plans to have a child, she should consult a doctor before using this medicine.
Do not take Cataflam 50 if the patient is in the last 3 months of pregnancy, as it may harm the unborn child 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 the mother and the 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 disturbances 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 the 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 become pregnant. If the patient plans to become pregnant or has difficulty conceiving, she should inform the 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 in the form of coated tablets contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, contact the doctor before taking the 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 the physician. If in doubt, consult your
doctor or pharmacist.
Do not exceed the recommended doses. When using Cataflam 50 enteric-coated tablets for longer
than a few weeks, regular medical check-ups should be performed to rule out undetected adverse
effects.
The general recommendation is 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.
Oral dosage tablets. The total daily dose should be divided and administered in 2 to 3 doses, if
applicable.
Do not exceed a daily dose of 150 mg.
In women with primary dysmenorrhea, the initial dose is 50 mg, which should be 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 dose of 150 mg per day does not provide adequate
pain relief over two to three consecutive menstrual cycles, the treating physician 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.
In the treatment of migraine, the initial dose is 50 mg, which should be 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 administered. 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.
In 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 over)
This medicine should be used with caution in elderly patients. In elderly patients and those with low
body weight, the lowest effective dose should be used.
Method of administration
Tablets should be swallowed whole with water, preferably before meals. Do not divide or chew the
tablets.
How long to use Cataflam 50
Cataflam 50 should always be used as directed by the physician.
When using Cataflam 50 long-term, regular contact with the physician 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.
Use of 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, diarrhea, dizziness, tinnitus, or seizures. In cases of severe
poisoning, acute renal failure and liver damage may occur.
If an overdose is accidentally taken, contact your doctor, pharmacist, or go immediately to the
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 the time between
doses has passed, do not take the missed dose and take the next dose according to the previous
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 they do not occur in everyone.
The frequency of occurrence 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); not known (frequency cannot be estimated from available data).

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

Adverse effects:
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 pseudoallergic reactions (including hypotension and shock),
somnolence,
asthma (including dyspnoea),
gastric mucosal inflammation, gastrointestinal bleeding, haematemesis, bloody diarrhoea, melaena,
gastric and/or duodenal ulcer (with or without bleeding or perforation),
hepatitis, jaundice, hepatic dysfunction,
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 swelling),
disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
paraesthesia, memory impairment, convulsions, 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 hemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucosal inflammation (including oral ulceration), glossitis, esophageal 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.

Frequency not known

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

Use of medicines such as Cataflam 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some people may experience other adverse effects while taking 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 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 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 not known - 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, 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 effects have occurred.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 181
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 the 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 the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Cataflam 50 contains

The active substance is diclofenac potassium. One tablet of Cataflam 50 contains 50 mg of diclofenac potassium.
Other ingredients are: colloidal anhydrous silica, calcium phosphate, magnesium stearate, corn starch, povidone, sodium carboxymethyl starch.
Coating ingredients: microcrystalline cellulose, titanium dioxide (E 171), iron oxide red (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 marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Belgium, country of export:
Novartis Pharma NV
Medialaan 40, B-1800 Vilvoorde, Belgium
Manufacturer:
Novartis Pharma NV, Medialaan 40, B-1800 Vilvoorde, Belgium
Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Novartis Farmacéutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgium, country of export, marketing authorisation number: BE147402
Parallel import licence number: 319/22