Cataflam 50

Package Leaflet: Information for the User

Cataflam 50 50 mg Coated Tablets

Diclofenac Potassium

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 a group of non-steroidal anti-inflammatory drugs (NSAIDs), acting as an anti-rheumatic, anti-inflammatory, analgesic, and antipyretic. 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 adjunct in severe painful infections of the ear, nose, or throat, e.g., pharyngitis or tonsillitis. In accordance with general therapeutic principles, causal treatment should be initiated 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 the case of diagnosed heart disease or significant risk factors for heart disease, the treating 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 the 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 blood cell count, red blood cell count, and platelet count) should be monitored. The treating doctor will take into account the results of 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 swelling, tongue swelling, throat swelling, and/or limb swelling (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 ulcers and/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, 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, hives, or acute rhinitis after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors. The patient should inform their doctor about 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 (which can be fatal). This effect can be particularly dangerous when taking high doses of diclofenac. If any unusual abdominal symptoms occur (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, angioedema, or hives). This warning also applies to

patients allergic to other substances (e.g., those who experience skin reactions, itching, or hives). The medicine should be administered with caution (preferably under medical supervision);

• If the patient has liver function disorders; diclofenac may worsen 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, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

The occurrence of side effects can be reduced by taking the medicine in the smallest effective dose and for no longer than necessary. The smallest dose of Cataflam 50 that relieves pain and/or inflammation should be used, and it should be taken for the shortest possible time to minimize the risk of side effects. If, at any point 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, they should immediately contact their doctor or visit 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 and take the smallest effective dose, as recommended by the 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 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 - 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 relieve inflammation in the body)
• - Anticoagulant and antiplatelet medicines
• - Oral hypoglycemic medicines (except insulin)
• - Methotrexate - a medicine used to treat certain cancers or arthritis
• - Cyclosporine and tacrolimus - medicines used in organ transplant patients
• - Trimethoprim - a medicine used to prevent or treat urinary tract infections
• - Quinolone antibacterial medicines - medicines used to treat infections
• - Cholestyramine and colestipol - medicines used to 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 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 also increase the risk of bleeding in the patient and their baby and prolong or delay labor. During the first 6 months of pregnancy, the medicine should not be taken unless it is absolutely necessary and recommended by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. 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 arterial duct 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 is having trouble conceiving, they should inform their doctor.

Driving and Using Machines

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

Cataflam 50 Contains Sugar

Cataflam 50 tablets contain sugar. If the patient has 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 exactly as directed by the doctor. If the patient has any doubts, they 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 side effects. The general recommendation is to adjust the dose individually and use the smallest effective dose for the shortest possible period. 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 into 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, which 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 treating 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, which should be taken when the first symptoms of the disease appear. If pain relief is not sufficient within 2 hours of taking the first dose, an additional dose of 50 mg may be taken. If necessary, additional doses of 50 mg may 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 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 is recommended in the form of suppositories, at a dose of 25 mg per day. In 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 patient should not exceed the maximum daily dose of 150 mg. In children and adolescents (under 18 years of age), Cataflam 50 should not be taken to treat migraine.

Elderly Patients (65 Years and Older)

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

Method of Administration

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

How Long to Take Cataflam 50

Cataflam 50 should always be taken exactly 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. If the patient has any doubts about how long to take the medicine, they should consult their doctor or pharmacist.

Taking More Than the Recommended Dose of Cataflam 50

Overdosing on 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. If the patient has taken more tablets than recommended, they should immediately consult their doctor, pharmacist, or visit 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, they 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>

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,
• stomach ulcers and/or duodenal ulcers (with or without bleeding and perforation),
• hepatitis, jaundice, liver function disorders,
• hives,
• 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 bloody colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, oral mucositis (including ulcerative stomatitis), glossitis, esophageal disorders, intestinal obstruction, pancreatitis,
• fulminant hepatitis, liver necrosis, liver failure,
• bullous rash, urticaria, 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

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

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

If the Patient Experiences Any of the Following Side Effects, They Should Stop Taking Cataflam 50 and Inform Their Doctor Immediately:

• discomfort in the stomach, heartburn, or pain in the upper abdomen,
• vomiting blood, 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 taking Cataflam 50, followed by bleeding from the rectum or bloody diarrhea, usually within 24 hours of abdominal pain (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 1,000, 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 side effects have occurred.

Reporting Side Effects

Reporting suspected side effects If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to Store Cataflam 50

Keep out of the sight and reach of children. Do not take this medicine after the expiry date stated on the carton and blister. Store in a temperature below 30°C. Keep away from moisture.

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 silica, calcium phosphate, magnesium stearate, corn starch, povidone, sodium carboxymethylcellulose. The coating contains: microcrystalline cellulose, Macrogol 8000, povidone, sugar, talc, titanium dioxide (E 171), iron oxide red (E 172).

What Cataflam 50 Looks Like and Contents of the Pack

One pack contains 10 coated tablets.

Marketing Authorization Holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, tel. +48 22 37 54 888

Importer

Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany, Novartis Farmacéutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain, Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw

Date of Last Revision of the Leaflet: