Cataflam 50

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Cataflam 50

50 mg, effervescent 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, pharmacist, or nurse.
• 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging and other information

1. WHAT IS CATAFLAM 50 AND WHAT IS IT USED FOR

Cataflam 50 contains diclofenac potassium, which belongs to a 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 fundamental 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 adjunctive treatment for severe painful infections of the ear, nose, or throat, e.g., pharyngitis and tonsillitis. According to general therapeutic principles, causal treatment should be applied first. Fever as the only symptom of the 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 should 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, or blood count abnormalities.

Both liver function (transaminase levels), kidney function (creatinine levels), and blood cell count (white blood cell count, 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:

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

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 medicine in the smallest effective dose and for no longer than 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 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 hospital 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 surgical procedures.

Children and adolescents

The medicine should not be taken by children and adolescents under 14 years of age. Children and adolescents under 14 years of age are recommended to take diclofenac 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. They should follow the recommendations in the leaflet, take the medicine according to the doctor's instructions, use the smallest effective dose, 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 conditions
• -Diuretics - medicines that increase urine production
• -Angiotensin-converting enzyme inhibitors, beta-blockers - groups of medicines used to treat high blood pressure and heart failure
• -Non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen) and corticosteroids (groups of medicines used to alleviate inflammatory conditions)
• -Anticoagulant and antiplatelet medicines
• -Antidiabetic medicines (except insulin)
• -Methotrexate - a medicine used to treat certain cancers or arthritis
• -Cyclosporine and tacrolimus - medicines used in organ transplantation
• -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, or thinks they may be pregnant or plans to have a child, they should consult their doctor before taking this medicine.

During pregnancy, in the first two trimesters, Cataflam 50 should not be taken unless absolutely necessary.

As with other anti-inflammatory drugs, taking Cataflam 50 in the last three months of pregnancy is contraindicated, as it may seriously harm the fetus or have an unfavorable effect on delivery.

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

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 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 effervescent tablets contain 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 TAKE CATAFLAM 50

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.

The patient should not exceed the recommended dose. If the patient is taking Cataflam 50 effervescent tablets for more than a few weeks, they should regularly undergo medical check-ups 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 into 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 continued at 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 within 2 hours of taking the first dose, the pain relief is not sufficient, a second dose of 50 mg can be taken. If necessary, additional doses of 50 mg can be taken at 4 to 6 hour intervals. The daily dose should not exceed 200 mg.

Use in children and adolescents

Due to the high dose, Cataflam 50 is not recommended for children and adolescents under 14 years of age.

Children and adolescents under 14 years of age are recommended to take diclofenac 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, divided into 2 to 3 doses, is usually sufficient. The maximum daily dose should not be exceeded.

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. In the case of elderly patients and those 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 take Cataflam 50

Cataflam 50 should always be taken according to the doctor's instructions.

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 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 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, 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, stroke,
• visual disturbances, blurred vision, double vision,
• tinnitus, hearing disorders,
• palpitations, chest pain, heart failure, myocardial infarction,
• hypertension, vasculitis,
• pneumonitis,
• ulcerative colitis (including hemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucositis (including aphthous 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, pruritus,
• acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

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

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

• discomfort in the stomach, heartburn, or pain in the upper abdomen,
• 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,
• swelling of the face, 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 that 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 in the case of high daily doses (150 mg) taken for a long time

• sudden, crushing chest pain (symptoms of myocardial infarction or heart attack).
• shortness of breath, difficulty breathing while 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, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 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

The medicine should be stored out of sight and reach of children.

Do not store above 30°C. Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging. 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 Cataflam 50 tablet contains 50 mg of diclofenac potassium.
• -The other ingredients are: colloidal anhydrous silica, calcium phosphate, magnesium stearate, carmellose sodium (type A), povidone K 30, cornstarch. The coating contains: microcrystalline cellulose, macrogol 8000, povidone K 30, sucrose, talc, titanium dioxide (E 171), red iron oxide (E 172).

What Cataflam 50 looks like and contents of the pack

One pack contains 10 effervescent tablets.

For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

Manufacturer:

Novartis Farma S.p.A, Via Provinciale Schito 131, 80058 Torre Annunziata, Italy; Novartis Farmacéutica S.A., Gran Via de les Corts Catalanes 764, 08013 Barcelona, Spain; Novartis Pharma GmbH, Roonstrasse 25, Nürnberg, Germany

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; Marketing authorization number in Ireland, the country of export: PA0896/004/001

Marketing authorization number for parallel import: 105/13 Date of leaflet approval: 13.01.2023

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