Cataflam 50

Leaflet accompanying 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, enteric-coated tablets

Diclofenac potassium

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform 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 using Cataflam 50
• 3. How to use 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 the group of nonsteroidal anti-inflammatory drugs (NSAIDs), acting anti-rheumatically, 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 short-term treatment of the following acute conditions:

• Painful conditions after injuries, inflammatory conditions, and swelling, e.g., after spraining a joint.
• Postoperative pain, inflammatory conditions, and swelling, e.g., after dental and 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. In accordance with 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 the case of diagnosed heart disease or significant risk factors for cardiovascular disease, the doctor will periodically assess the patient's need for symptomatic treatment and their response to the medicine, especially if the 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 changes in the blood picture.

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 blood tests when deciding to discontinue treatment with Cataflam 50 or change the dose of the medicine.

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 had an allergic reaction after using 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 their doctor,
• if the patient has active or past 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 cerebral ischemia, or vascular occlusion of the heart or brain, or after a surgical procedure to clear or bypass blocked vessels,
• if the patient has circulation disorders (peripheral vascular disease).

Like other nonsteroidal anti-inflammatory drugs (NSAIDs), Cataflam 50 should not be used in 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 using 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 the treatment lasts longer than 4 weeks,
• if the medicine is used in people with a history of gastrointestinal ulcers or in the elderly. Diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (with possible fatal outcome). This effect may be particularly dangerous when using high doses of diclofenac. If any unusual abdominal symptoms occur during the use of Cataflam 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the doctor should be 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, or chronic respiratory infections, they are more likely to experience an allergic reaction to diclofenac (exacerbation of asthma symptoms, angioedema, or urticaria). The warning also applies to patients allergic to other substances (e.g., those who experience skin reactions, itching, or urticaria). The medicine should be administered with caution (preferably under medical supervision);

and

• 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 cause 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 risk of adverse reactions 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 time necessary to minimize the risk of adverse reactions.

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

The medicine 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 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.

The patient should follow the recommendations in the leaflet, use the smallest effective dose as recommended by the doctor, and report all adverse reactions 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 - a group of medicines used to treat high blood pressure and heart failure
• -Nonsteroidal 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 arthritis
• -Cyclosporine and tacrolimus - medicines used in patients with organ transplants
• -Trimethoprim - a medicine used to prevent and treat urinary tract infections
• -Quinolone antibacterial medicines - 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

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 child, they should consult their doctor before using this medicine.

Cataflam 50 should not be taken 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 risk of bleeding in the patient and their child and cause delayed or prolonged labor. During the first 6 months of pregnancy, the medicine should not be used unless it is absolutely necessary and recommended by the doctor. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Cataflam 50 may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

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 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 vehicles, operate machinery, or perform other activities that require special attention 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 the medicine is considered "sodium-free".

3. How to use Cataflam 50

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

The recommended dose should not be exceeded. When using Cataflam 50 tablets for more than a few weeks, regular medical check-ups should be performed to rule out any unnoticed adverse reactions.

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.

Tablets are for oral administration. The total daily dose should be divided and taken 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 the treatment should be 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 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, an additional dose of 50 mg can be taken. If necessary, additional doses of 50 mg can be taken at 4 to 6 hour intervals. 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, divided into 2 to 3 doses, is usually sufficient. The maximum daily dose should not exceed 150 mg.

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 those with low body weight, the smallest effective dose is recommended.

Method of administration

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 recommended by the doctor.

When taking Cataflam 50 for a long time, the patient should regularly consult their doctor to ensure that no adverse reactions 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 number of tablets than recommended, the patient should immediately contact their doctor, pharmacist, or hospital emergency department.

Missing a dose of Cataflam 50

If a dose is missed, it should be taken as soon as the patient remembers. However, if more than half of the time between two doses has passed, 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 pseudoanaphylactic reactions (including decreased blood pressure and shock),
• drowsiness,
• asthma (including shortness of breath),
• gastritis, gastrointestinal bleeding, hematemesis, melena,
• peptic ulcer (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 bloody colitis and exacerbation of ulcerative colitis and 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.

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, during the use of 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 inform 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 pain in the upper abdomen,
• 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 legs,
• 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 severe allergic reaction called Kounis syndrome.

Some side effects can be serious

These uncommon side effects may occur in 1-10 patients out of 1000, especially when using 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 legs (symptoms of heart failure).

When taking Cataflam 50 for more than a few weeks, the patient 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 inform 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

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 the sight and reach of children.

Store in a temperature below 30°C, protected 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 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.
• Other ingredients are: colloidal anhydrous silica, calcium phosphate, magnesium stearate, corn starch, povidone, sodium carboxymethylcellulose. The composition of the coating is: microcrystalline cellulose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 8000, povidone, sucrose, talc.

What Cataflam 50 looks like and contents of the pack

One package 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 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 by:

Delfarma Sp. z o.o.

ul. Św. Teresy od Dzieciątka Jezus 111

91-222 Łódź

Belgian marketing authorization number: BE147402

Parallel import authorization number: 319/22

Date of leaflet approval: 11.01.2024

[Information about the trademark]