Rantudil Forte

Leaflet attached to the packaging: patient information

Rantudil Forte, 60 mg, hard capsules
Acemetacin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 side effects, including any side 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 Rantudil Forte and what is it used for
• 2. Important information before taking Rantudil Forte
• 3. How to take Rantudil Forte
• 4. Possible side effects
• 5. How to store Rantudil Forte
• 6. Contents of the pack and other information

1. What is Rantudil Forte and what is it used for

The active substance of Rantudil Forte is acemetacin, which has anti-inflammatory, analgesic, and antipyretic effects, and also inhibits platelet aggregation. After oral administration, acemetacin accumulates in inflamed areas, where it is present in higher concentrations than in the blood.

Indications for use

As a pain reliever and anti-inflammatory in:

• degenerative joint diseases,
• lower back pain,
• rheumatoid arthritis,
• ankylosing spondylitis,
• postoperative pain,
• acute gout attacks.

2. Important information before taking Rantudil Forte

When not to take Rantudil Forte

• if the patient is allergic to acemetacin, indomethacin, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has unexplained blood disorders,
• if the patient has a history of gastrointestinal bleeding or perforation after taking nonsteroidal anti-inflammatory drugs (NSAIDs),
• if the patient has active or recurrent peptic ulcer disease and bleeding,
• in patients who have experienced bronchospasm, asthma, urticaria, or allergic rhinitis after taking acetylsalicylic acid or other NSAIDs,
• if the patient has severe heart failure,
• if the patient is in the third trimester of pregnancy,
• in children and adolescents.

Warnings and precautions

Before starting treatment with Rantudil Forte, discuss it with your doctor or pharmacist.

• if the patient is taking other nonsteroidal anti-inflammatory drugs (NSAIDs) at the same time. It is recommended to avoid concurrent use of Rantudil Forte with other NSAIDs, including selective cyclooxygenase-2 inhibitors.
• if the patient is elderly. Elderly people are more likely to experience side effects when taking NSAIDs, especially gastrointestinal bleeding and perforation, which can be life-threatening. In elderly people, Rantudil Forte should only be used under close medical supervision.
• if the patient (especially the elderly) has a history of gastrointestinal side effects. The patient should report any worrying abdominal symptoms (especially gastrointestinal bleeding) to their doctor, especially at the beginning of treatment.
• if the patient has a tendency to bleed. During treatment with Rantudil Forte, bleeding may increase.
• if the patient is taking medications that may increase the risk of ulcers or bleeding, such as oral glucocorticoids, anticoagulants (e.g., warfarin, acenocoumarol), and selective serotonin reuptake inhibitors and antiplatelet agents
• if the patient has gastrointestinal diseases (ulcerative colitis, Crohn's disease)
• if the patient has liver or kidney failure
• if the patient has a history of hypersensitivity reactions to NSAIDs (e.g., asthma, skin reactions, or allergic rhinitis)
• if the patient has asthma, allergic rhinitis, nasal congestion, and chronic respiratory diseases, as they are more prone to hypersensitivity reactions
• if the patient has epilepsy, Parkinson's disease, or mental disorders, as Rantudil Forte may exacerbate symptoms of these diseases
• in patients with varicella or herpes zoster, due to the risk of severe skin side effects
• if the patient has systemic lupus erythematosus (inflammatory disease of the body's tissues) and (or) mixed connective tissue disease (disease of connective tissue)
• if the patient is taking potassium-sparing diuretics. During treatment with Rantudil Forte, an increase in potassium levels in the blood has been observed.

When to exercise special caution when taking Rantudil Forte:

• if a skin rash, mucosal lesions, or any other hypersensitivity symptom occurs after taking Rantudil Forte. In this case, the patient should contact their doctor, who may decide to discontinue treatment.
• during long-term treatment with Rantudil Forte. The patient should undergo regular blood tests and coagulation tests. Ophthalmological monitoring and liver and kidney function tests are also recommended.
• if Rantudil Forte is taken immediately before or after surgery.

Taking medications like Rantudil Forte may be associated with a small increased risk of arterial thrombosis (e.g., heart attack or stroke). Long-term use of high doses of the medicine increases this risk. Do not take higher doses or use the medicine for longer than recommended. If you have heart problems, have had a stroke, or suspect that you are at risk of these conditions (e.g., high blood pressure, diabetes, high cholesterol, smoking), discuss your treatment with your doctor or pharmacist.

Rantudil Forte and other medicines

Tell your doctor about all the medicines you are taking, have recently taken, or plan to take.

• digoxin - may increase digoxin levels in the blood
• phenytoin - may increase phenytoin levels in the blood
• lithium - may increase lithium levels in the blood
• blood thinners, e.g., warfarin, acenocoumarol - may increase the risk of bleeding
• glucocorticoids - may increase the risk of stomach ulcers and bleeding
• acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) - may increase the risk of bleeding or stomach ulcers. Do not take Rantudil Forte with another NSAID.
• probenecid - may slow down the elimination of Rantudil Forte
• penicillin antibiotics - may delay the elimination of penicillin
• diuretics and blood pressure-lowering medications - may reduce the effectiveness of these medications. In patients with kidney problems (e.g., dehydration or elderly), concurrent use of Rantudil Forte and blood pressure-lowering medications (ACE inhibitors and (or) angiotensin II receptor antagonists) may cause further deterioration of kidney function (including severe kidney failure), which is usually reversible. Therefore, caution is advised, especially in elderly patients. Patients should drink sufficient fluids. After starting such treatment, the doctor will consider regular monitoring of kidney function tests in these patients.
• potassium-sparing diuretics - may increase potassium levels in the blood, so patients taking these medications should have their potassium levels checked regularly
• antiplatelet agents and selective serotonin reuptake inhibitors (used to treat depression) - may increase the risk of gastrointestinal bleeding. Rantudil Forte may reduce the effectiveness of selective serotonin reuptake inhibitors.
• antacids (used to treat heartburn and excess stomach acid) - may reduce the absorption of Rantudil Forte.

Taking Rantudil Forte with food, drink, and alcohol

Rantudil Forte capsules should be taken with food, washed down with a liquid. Concurrent consumption of alcohol may increase the risk of side effects such as hidden gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. Do not take Rantudil Forte during the last 3 months of pregnancy (in the third trimester), as it may increase the risk of serious complications during delivery, dangerous for both the mother and the unborn child. The unborn child may experience kidney and heart problems. There may be a tendency to bleed in the mother and child, and delivery may be delayed or prolonged. Do not take Rantudil Forte during the first 6 months of pregnancy (in the first or second trimester), unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. Rantudil Forte taken for more than a few days, starting from the 20th week of pregnancy, may cause kidney problems in the unborn child, leading to low amniotic fluid levels or narrowing of the fetal artery. If treatment is to be continued for more than a few days, the doctor may recommend additional monitoring. Small amounts of the active substance (acemetacin) and its metabolites pass into breast milk, so Rantudil Forte should not be taken during breastfeeding. Rantudil Forte may make it harder to conceive. If you plan to conceive or have problems conceiving, tell your doctor.

Driving and using machines

Do not drive vehicles, as Rantudil Forte may cause fatigue and dizziness. Be especially careful when starting treatment, increasing the dose, or switching from one medicine to another, and when consuming alcohol. Do not operate any machines or use tools.

Rantudil Forte contains lactose and sodium

The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Rantudil Forte

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist. The recommended dose of Rantudil Forte for adults is usually 1 capsule 1 to 3 times a day.

How to take the medicine

Rantudil Forte capsules should be taken with food. Swallow the capsules whole, washed down with a large amount of liquid.

Taking a higher dose of Rantudil Forte than recommended

If you take too much of the medicine, tell your doctor immediately, who will perform gastric lavage or forced diuresis with fluid balance. The following symptoms may occur: headache, dizziness, confusion, disorientation, lethargy, loss of consciousness, nausea, vomiting, abdominal pain, gastrointestinal bleeding, sweating, increased electrolyte levels, increased blood pressure, swelling around the ankles, oliguria, hematuria, respiratory depression, seizures, coma.

Missing a dose of Rantudil Forte

Do not take a double dose to make up for a missed capsule.

Stopping treatment with Rantudil Forte

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Rantudil Forte can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people)

Gastrointestinal disorders:nausea, vomiting, abdominal pain, diarrhea, and minor gastrointestinal bleeding, which can rarely cause anemia. In any case of sudden abdominal pain and (or) black stools or bloody vomiting, stop taking the medicine and consult your doctor immediately.

Common side effects (may affect up to 1 in 10 people)

Immune system disorders:hypersensitivity reactions (rash and itching)
Psychiatric disorders:agitation
Nervous system disorders:headache, drowsiness, dizziness
Gastrointestinal disorders:indigestion, bloating, abdominal pain, loss of appetite, stomach and intestinal ulcers (sometimes with bleeding and perforation)
Hepatobiliary disorders:increased liver enzyme activity
General disorders and administration site conditions:feeling tired.

Uncommon side effects (may affect up to 1 in 100 people)

• )Immune system disorders:urticaria Eye disorders:eye diseases (pigmentary retinopathy and corneal clouding) with symptoms of blurred or double vision Gastrointestinal disorders:blood in the stomach contents (during vomiting), blood in the stool, bloody diarrhea Skin and subcutaneous tissue disorders:hair loss Renal and urinary disorders:edema formation (e.g., peripheral edema), especially in patients with hypertension and (or) kidney problems Hepatobiliary disorders:liver damage (toxic hepatitis with or without jaundice, very rarely with a fulminant course, sometimes without warning signs).

Rare side effects (may affect up to 1 in 1,000 people)

Metabolic and nutritional disorders:increased potassium levels in the blood (hyperkalemia)
Psychiatric disorders:confusion
General disorders and administration site conditions:irritability.

Very rare side effects (may affect up to 1 in 10,000 people)

Infections and infestations:worsening of infection symptoms (e.g., development of necrotizing fasciitis). If the patient experiences a recurrence or worsening of any infection symptoms while taking the medicine, they should consult their doctor, who may recommend appropriate treatment for the infection.
Blood and lymphatic system disorders:various types of anemia (e.g., caused by hidden gastrointestinal bleeding, hemolytic, pancytopenia). Initial symptoms may include: fever, sore throat, changes in the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds, and subcutaneous bleeding. The medicine may affect platelet aggregation and worsen bleeding tendencies. If symptoms of anemia occur, stop taking the medicine and consult your doctor immediately. Do not take any pain or antipyretic medications on your own.
Immune system disorders:severe, generalized hypersensitivity reactions, which may manifest as facial and eyelid edema, tongue edema, internal throat edema with respiratory tract narrowing (angioedema), respiratory failure that can cause an asthma attack, increased heart rate, decreased blood pressure leading to life-threatening shock. If any symptoms of severe, generalized hypersensitivity reactions occur (which can occur even after the first dose of the medicine), medical help is necessary.
Metabolic and nutritional disorders:increased blood sugar levels (hyperglycemia), glucose in the urine
Psychiatric disorders:mental disorders, disorientation, anxiety disorders, nightmares, psychosis, hallucinations, depression, sleep disorders, exacerbation of pre-existing mental illnesses
Nervous system disorders:loss of consciousness that can lead to coma, taste disorders, memory disorders, seizures, tremors, exacerbation of epilepsy and Parkinson's disease symptoms
Ear and labyrinth disorders:tinnitus, hearing disorders
Cardiac disorders:palpitations, angina pectoris, heart failure
Vascular disorders:hypertension
Respiratory, thoracic, and mediastinal disorders:allergic pneumonia
Gastrointestinal disorders:oral mucositis and tongue changes, esophageal changes, lower abdominal symptoms (e.g., nonspecific colitis with bleeding), exacerbation of Crohn's disease or ulcerative colitis symptoms, constipation, intestinal obstruction, pancreatitis
Skin and subcutaneous tissue disorders:vasculitis, rash, excessive sweating, flushing, photosensitivity, minor and extensive subcutaneous bleeding, exfoliative dermatitis and blistering rash, which can also have a severe course (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis)
Musculoskeletal and connective tissue disorders:muscle weakness
Renal and urinary disorders:urinary disorders, increased urea levels in the blood, acute kidney failure, proteinuria, hematuria, kidney damage (interstitial nephritis, nephrotic syndrome, renal papillary necrosis)
Reproductive system and breast disorders:vaginal bleeding
General disorders and administration site conditions:rash localized inside the body.

Side effects with unknown frequency

Vascular disorders:circulatory collapse.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel. 22 49 21 301, fax 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, you can help provide more information on the safety of this medicine.

5. How to store Rantudil Forte

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. 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. Ask your 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 Rantudil Forte contains

• The active substance of Rantudil Forte is acemetacin (Acemetacin).
• The other ingredients are: lactose monohydrate (D80 powder), lactose monohydrate (D20 crystals) (see section 2 "Rantudil Forte contains lactose and sodium"), magnesium stearate, colloidal silica, talc, yellow iron oxide (E 172), red iron oxide (E 172), gelatin, titanium dioxide (E 171), sodium lauryl sulfate (see section 2 "Rantudil Forte contains lactose and sodium").

What Rantudil Forte looks like and contents of the pack

PP/Al or PVC/PVDC/Al blisters in a cardboard box. The pack contains 7, 10, 20, 21, or 50 hard capsules.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warszawa

Manufacturer

Madaus GmbH
51101 Köln
Germany
To obtain more detailed information, contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00
Date of last revision of the leaflet:02/2024