Cataflam 50

Before taking diclofenac, the patient should inform their doctor

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

The risk of side effects can be minimized by using the smallest effective dose for the shortest possible time.

The patient should use the smallest dose of Cataflam 50 that provides relief from pain and/or inflammation and use it for the shortest possible time to minimize the risk of side effects.

If the patient experiences any symptoms suggesting heart or blood vessel problems, such as chest pain, shortness of breath, weakness, or slurred speech, they should immediately contact their doctor or the hospital emergency department.

Taking diclofenac may transiently 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 Cataflam 50 may sometimes cause delayed wound healing in the intestines after surgical procedures.

Children and adolescents

The medicine should not be used in 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 used in 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 adult patients. They should follow the recommendations in the leaflet, use the smallest effective dose as recommended by their doctor, and report any side effects that occur during treatment to their 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 especially inform their doctor about taking the following medicines:

• -Lithium or antidepressant medicines (Selective Serotonin Reuptake Inhibitors)
• -Digoxin - a medicine used to treat heart diseases
• -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)
• -Anticoagulant and antiplatelet medicines
• -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

Using 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, or thinks they may be pregnant or plans to have a child, they should consult their 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 drugs, the use of Cataflam 50 in patients in the last 3 months of pregnancy is contraindicated, as it may seriously harm the fetus or have an unfavorable effect on delivery.

Cataflam 50 should not be used in breastfeeding women, as it may have a harmful effect on the infant.

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

Taking Cataflam 50 may make it more difficult to become pregnant. If the patient plans to become pregnant or is having trouble becoming pregnant, 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.

3. How to use Cataflam 50

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

The patient should not exceed the recommended dose. If enteric-coated tablets of Cataflam 50 are used for more than a few weeks, regular medical check-ups should be performed to rule out any unnoticed side 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 are for oral administration. The total daily dose should be divided and administered in 2 to 3 doses, if applicable.

The daily dose should not exceed 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 treatment should be continued with a dose of 50 mg administered 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 administration of up to 200 mg per day, divided into 2 to 3 doses during subsequent menstrual cycles. The dose should not exceed 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 pain relief is not sufficient within 2 hours of administration of the first dose, a second dose of 50 mg may be administered. If necessary, additional doses of 50 mg may be taken at intervals of 4 to 6 hours. The dose should not exceed 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.

In the case of adolescents over 14 years of age, a dose of 75 mg to 100 mg per day, administered in 2 to 3 divided doses, is usually sufficient. The maximum daily dose should not be exceeded.

Cataflam 50 should not be used in children and adolescents (under 18 years of age) for the treatment of migraine.

Elderly patients (65 years and older)

The medicine should be used with caution in elderly patients. In the case of elderly patients and patients with low body weight, the smallest effective dose is recommended.

Method of administration

The tablets should be swallowed whole, with a glass of water, preferably before meals. The tablets should not be divided or chewed.

How long to use Cataflam 50

Cataflam 50 should always be used 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 side effects have occurred.

In case of doubts about how long to use the medicine, the patient should consult their doctor or pharmacist.

Using a higher than recommended dose of Cataflam 50

Overdose of Cataflam 50 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In the case of significant poisoning, acute kidney failure and liver damage may occur.

In the event of accidental ingestion of a larger amount of tablets than recommended, the patient should immediately consult their doctor, pharmacist, or go to the hospital emergency department.

Missing a dose of Cataflam 50

If a dose is missed, the patient should take it as soon as they remember. However, if more than half of the time has passed between two doses, the missed dose should not be taken, and the next dose should be taken according to the previous dosing schedule. A double dose should not be taken 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, bloody vomiting, bloody diarrhea, melena,
• peptic ulcer disease of the stomach and/or duodenum (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, double vision,
• 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, oral mucositis (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.

Not known

• simultaneous 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 patients, Cataflam 50 may cause other side effects not listed in this leaflet.

If any of the side effects worsen or any side effects not listed in the leaflet occur, the patient should tell their doctor or pharmacist.

In the event of any of the following side effects, the patient should immediately stop taking Cataflam 50 and inform their doctor:

• discomfort in the stomach, heartburn, or abdominal pain,
• bloody vomiting, blood in the stool, blood in the urine,
• skin problems such as rash or itching,
• shortness of breath or difficulty breathing,
• yellowing of the skin or whites of the eyes,
• prolonged sore throat or high fever,
• swelling of the face, feet, or ankles,
• severe migraine,
• chest pain accompanied by coughing,
• mild painful abdominal cramps and tenderness, starting soon after the start of treatment with Cataflam 50, followed by rectal bleeding or bloody diarrhea, 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 serious allergic reaction called Kounis syndrome.

Some side effects can be serious

These uncommon side effects may occur in 1-10 patients per 1000, especially in the case of 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 side effects have occurred.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. 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

Al. Jerozolimskie 181

02-222 Warsaw

Phone: +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.

Store in a temperature below 30°C. Store in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.

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 packaging and other information

What Cataflam 50 contains

• -The active substance of the medicine is diclofenac potassium. One enteric-coated tablet of Cataflam 50 contains 50 mg of diclofenac potassium.
• -The other ingredients are: colloidal anhydrous silica, calcium phosphate, magnesium stearate, corn starch, povidone K 30, sodium carboxymethylcellulose. The coating contains: microcrystalline cellulose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 8000, povidone K 30, sucrose, talc.

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 Portugal, the country of export:

Laboratório Normal - Produtos Farmacêuticos, Lda.

Avenida Professor Doutor Cavaco Silva, 10E

Taguspark 2740-255 Porto Salvo

Portugal

Manufacturer:

Novartis Farma - Produtos Farmacêuticos, S.A.

Avenida Professor Doutor Cavaco Silva, 10E

Taguspark 2740-255 Porto Salvo

Portugal

Parallel importer:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Portuguese marketing authorization number: 4566196

9716522

4566790

9716530

Parallel import authorization number: 141/22 Date of leaflet approval: 24.03.2022

[Information about the trademark]