Cataflam 50

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Cataflam 50, 50 mg, enteric-coated tablets

Diclofenac potassium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 effects, including any adverse effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

Cataflam 50 contains diclofenac potassium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Cataflam 50 involves the 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:

• Pain, inflammation, and swelling, e.g., due to sprains.
• Post-operative pain, inflammation, and swelling, e.g., after dental or orthopedic surgery.
• Painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhea or adnexitis.
• Migraine attacks.
• Back pain syndromes.
• Extra-articular rheumatism.
• As an adjunct in severe painful infections of the ear, nose, or throat, e.g., pharyngitis and tonsillitis, otitis. In accordance with general therapeutic principles, causal treatment should be given first. Fever as the only symptom of disease is not an indication for the administration of the medicine.

Control tests during treatment with Cataflam 50

In patients with diagnosed heart disease or significant risk factors for heart disease, the doctor will periodically assess the patient's need for symptomatic treatment and their response to the medicine, especially if treatment lasts longer than 4 weeks.
During treatment, regular blood tests should be performed in case of any liver function disorders, kidney function disorders, and blood count abnormalities.
Both liver function (transaminase levels), kidney function (creatinine levels), and blood count (white and red blood cell count and platelet count) should be monitored. The doctor will take into account the results of the blood tests when deciding to discontinue treatment with Cataflam 50 or change the dose of the medicine.

2. Important information before taking Cataflam 50

When not to take 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 had an allergic reaction after taking anti-inflammatory or analgesic drugs (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). Reactions may include asthma, rhinitis, skin rash, facial swelling, lip, tongue, throat, and/or limb edema (symptoms of angioedema), difficulty breathing, chest pain, or any other allergic reactions. If the patient thinks they may be allergic, they should consult a doctor;
• if the patient has active or a history of stomach or duodenal ulcers, bleeding, or perforation; if the patient has previously experienced discomfort in the stomach area or heartburn after taking anti-inflammatory drugs;
• 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 heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient ischemic attack (TIA), or vascular occlusion of the heart or brain, or after a revascularization or bypass procedure;
• if the patient has circulatory disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Cataflam 50 should not be taken by people who may experience an asthma attack, urticaria, or acute rhinitis after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors.
The patient should inform their doctor about the presence of these diseases.

Warnings and precautions

Before taking Cataflam 50, the patient should discuss the following with their doctor:

• if the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, elevated lipid levels (cholesterol, triglycerides), or if the patient is a smoker, and the doctor decides to prescribe Cataflam 50, the dose should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• if the medicine is taken by people with a history of gastrointestinal ulcers or in the elderly. Taking diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (with possible fatal outcome). This effect may be particularly dangerous when taking high doses of diclofenac. If any unusual abdominal symptoms occur during treatment with Cataflam 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the doctor consulted;
• if the patient has ulcerative colitis or Crohn's disease; diclofenac may exacerbate the disease;
• if the patient has asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease (COPD), or chronic respiratory infections, they are more likely to experience an allergic reaction to diclofenac (exacerbation of asthma symptoms, angioedema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those with skin reactions, itching, or urticaria). The medicine should be administered with caution (preferably under medical supervision);

if the patient has liver function disorders; diclofenac may worsen the course of the disease. The patient should strictly follow the doctor's recommendations for regular liver function tests;

• if the patient has porphyria. Diclofenac may trigger a porphyria attack.

Before taking diclofenac, the patient should inform their doctor:

• if they smoke;
• if they have diabetes;
• if they have angina pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

The risk of adverse effects can be minimized by using the smallest effective dose and for the shortest duration necessary.
The patient should use the smallest dose of Cataflam 50 that provides relief from pain and/or inflammation and use it for the shortest time necessary to minimize the risk of adverse effects.
If at any point 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, they should immediately contact their doctor or go to the emergency department.
Taking diclofenac may temporarily inhibit platelet aggregation.
Before taking Cataflam 50, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as the medicine may sometimes cause delayed wound healing in the intestines after surgery.

Children and adolescents

The medicine should not be taken by children and adolescents under 14 years of age. For children and adolescents under 14 years of age, diclofenac is recommended in the form of suppositories, at a dose of 25 mg per day. Cataflam 50 should not be taken by children under 1 year of age.

Elderly patients (65 years and older)

Elderly patients may be more sensitive to the effects of the medicine than other adults. The patient should follow the recommendations in the leaflet, take the medicine as directed by the doctor, use the smallest effective dose, and report any adverse effects that occur during treatment to the doctor.

Cataflam 50 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The patient should inform their doctor especially about taking the following medicines:

• Lithium or antidepressant medicines (Selective Serotonin Reuptake Inhibitors).
• Digoxin - a medicine used to treat heart conditions.
• Diuretics - medicines that increase urine production.
• Angiotensin-converting enzyme inhibitors, beta-blockers - a group of medicines used to treat high blood pressure and heart failure.
• Non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (a group of medicines used to alleviate inflammatory conditions in the body).
• Anticoagulant medicines and platelet inhibitors.
• Antidiabetic medicines, except insulin.
• Methotrexate - a medicine used to treat certain cancers or rheumatoid arthritis.
• Cyclosporine and tacrolimus - medicines used in organ transplant patients.
• Trimethoprim - a medicine used to prevent and treat urinary tract infections.
• Quinolone antibacterials - medicines used to treat infections.
• Cholestyramine and colestipol - medicines that lower cholesterol levels in the blood.
• Voriconazole - a medicine used to treat fungal infections.
• Phenytoin - a medicine used to treat epileptic seizures.

Taking Cataflam 50 with food and drink

The tablets should be swallowed whole, with a glass of water, preferably before meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
The patient should not take Cataflam 50 if they are in the last 3 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 baby. It may increase the risk of bleeding in the patient and their baby and prolong labor. During the first 6 months of pregnancy, the medicine should not be taken unless absolutely necessary and under medical supervision. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest time possible. From the 20th week of pregnancy, Cataflam 50 may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the ductus arteriosus in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring. The patient should not take Cataflam 50 while breastfeeding, as it may have a harmful effect on the baby.
The doctor will discuss the potential risks of taking Cataflam 50 during pregnancy and breastfeeding with the patient.
Taking Cataflam 50 may make it more difficult to conceive. If the patient plans to conceive or has problems conceiving, they should inform their doctor.

Driving and using machines

The effect of Cataflam 50 on the ability to drive and use machines is unlikely.

Cataflam 50 contains sucrose

Cataflam 50 in the form of enteric-coated tablets contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Cataflam 50 contains sodium

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

3. How to take Cataflam 50

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
The patient should not exceed the recommended dose. If the patient is taking Cataflam 50 tablets for more than a few weeks, they should have regular medical check-ups to rule out any unnoticed adverse effects.
The general recommendation is to adjust the dose individually and use the smallest effective dose for the shortest possible time.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Adults

The recommended initial dose is 100 mg per day to 150 mg per day.
In milder cases, a dose of 75 mg to 100 mg per day is considered sufficient.
The tablets should be taken orally. The total daily dose should be divided and taken in 2 to 3 doses, if necessary.
The patient should not exceed the daily dose of 150 mg.
In patients with primary dysmenorrhea, the initial dose of the medicine is 50 mg and should be taken when the first symptoms appear, and then continued with a dose of 50 mg taken up to three times a day for several consecutive days, as needed. If a dose of 150 mg per day does not provide sufficient pain relief for two to three consecutive menstrual cycles, the doctor 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. The patient should not exceed the dose of 200 mg per day.
In the treatment of migraine, the initial dose of the medicine is 50 mg and should be taken when the first symptoms of the disease appear. If within 2 hours of taking the first dose, the pain relief is not sufficient, an additional dose of 50 mg can be taken. If necessary, additional doses of 50 mg can be taken at intervals of 4 to 6 hours. The patient should not exceed the dose of 200 mg per day.

Use in children and adolescents

Due to the high 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 is recommended in the form of suppositories, at a dose of 25 mg per day.
For adolescents over 14 years of age, a dose of 75 mg to 100 mg per day is usually sufficient, divided into 2 to 3 doses. The patient should not exceed the maximum daily dose of 150 mg.
Cataflam 50 should not be taken by children and adolescents under 18 years of age for the treatment of migraine.

Elderly patients (65 years and older)

The medicine should be taken with caution in elderly patients. For elderly patients and those with a low body mass, the smallest effective dose is recommended.

Method of administration

The tablets should be swallowed whole, with a glass of water, preferably before meals. The patient should not divide or chew the tablet.

How long to take Cataflam 50

Cataflam 50 should always be taken as directed by the doctor.
If the patient is taking Cataflam 50 for a long time, they should regularly consult their doctor to ensure that no adverse effects have occurred.
In case of doubt about how long to take the medicine, the patient should consult their doctor or pharmacist.

Taking a higher dose of Cataflam 50 than recommended

Overdose of Cataflam 50 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In case of significant poisoning, acute kidney failure and liver damage may occur.
If the patient has taken more tablets than recommended, they should immediately consult their doctor, pharmacist, or go to the emergency department.

Missing a dose of Cataflam 50

If the patient misses a dose, they should take it as soon as they remember. However, if more than half of the time has passed between two doses, the patient should not take the missed dose and should take the next dose according to the previous dosing schedule. The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Cataflam 50 can cause side effects, although not everybody gets them.
The frequency of side effects is estimated as follows:
very common (≥1/10); common (≥1/100 to <1>The following side effects include those reported with Cataflam 50, as well as those observed with other forms of diclofenac, used for short or long periods.

Side effects:

Common

• headache, dizziness,
• nausea, vomiting, diarrhea, indigestion, abdominal pain, bloating, decreased appetite,
• increased transaminase activity,
• rash.

Uncommon

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

Rare

• hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including decreased blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, hematemesis, melena,
• peptic ulcer disease (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• urticaria,
• edema.

Very rare

• thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (decreased granulocyte count),
• angioedema (including facial edema),
• disorientation, depression, insomnia, nightmares, irritability, psychotic disorders,
• paresthesia, memory disorders, seizures, anxiety, tremors, aseptic meningitis, taste disorders, cerebrovascular accident,
• visual disturbances, blurred vision, diplopia,
• tinnitus, hearing disorders,
• palpitations, chest pain, heart failure, myocardial infarction,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including bloody colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal stricture, pancreatitis,
• fulminant hepatitis, liver necrosis, liver failure,
• bullous rash, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Henoch-Schönlein purpura, pruritus,
• acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Frequency not known

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

Taking medicines like Cataflam 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
In some people, while taking Cataflam 50, other side effects may occur.
If any of the side effects get worse or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

If any of the following side effects occur, the patient should stop taking Cataflam 50 and inform their doctor:

• discomfort in the stomach, heartburn, or abdominal pain,
• hematemesis, melena, or hematuria,
• skin problems such as rash or itching,
• shortness of breath or difficulty breathing,
• jaundice or yellowing of the eyes,
• prolonged sore throat or high fever,
• facial swelling, swelling of the feet or ankles,
• severe migraine,
• chest pain accompanied by coughing,
• mild painful abdominal cramps and tenderness, starting soon after taking Cataflam 50, followed by rectal bleeding or melena, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from the available data),
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Some side effects can be serious

These uncommon side effects may occur in 1-10 patients per 1000, especially when taking high daily doses (150 mg) for a long time:

• sudden, crushing chest pain (symptoms of myocardial infarction or heart attack),
• shortness of breath, difficulty breathing when lying down, swelling of the feet or ankles (symptoms of heart failure).

If the patient is taking Cataflam 50 for more than a few weeks, they should regularly consult their doctor to ensure that no adverse effects have occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected 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 packaging. The expiry date refers to the last day of the month.
Store in a temperature below 30°C, protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cataflam 50 contains

• The active substance of the medicine is diclofenac potassium. One Cataflam 50 tablet contains 50 mg of diclofenac potassium.
• The other ingredients are: colloidal anhydrous silica, calcium phosphate, magnesium stearate, corn starch, povidone, sodium carboxymethylcellulose. The coating contains: microcrystalline cellulose, Macrogol 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 enteric-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

Novartis Pharma NV
Medialaan 40
B-1800 Vilvoorde
Belgium

Manufacturer:

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nuremberg, Germany
Novartis Pharma NV, Medialaan 40, B - 1800 Vilvoorde, Belgium
Novartis Farmacéutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain

Parallel importer:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Belgian marketing authorization number:BE 147402
Parallel import authorization number:493/12

Date of leaflet approval: 15.12.2023

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