Rantudil Retard

Leaflet attached to the packaging: patient information

Rantudil Retard, 90 mg, prolonged-release capsules
Acemetacinum

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 to a specific person. 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 Retard and what is it used for
• 2. Important information before taking Rantudil Retard
• 3. How to take Rantudil Retard
• 4. Possible side effects
• 5. How to store Rantudil Retard
• 6. Package contents and other information

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

The active substance of Rantudil Retard 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 attacks of gout.

2. Important information before taking Rantudil Retard

When not to take Rantudil Retard

• 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/or bleeding,
• in patients who have experienced bronchospasm, asthma, urticaria, or acute 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 concomitant use of Rantudil Retard 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 Retard 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 start of treatment.
• if the patient has a tendency to bleed. During treatment with Rantudil Retard, 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 acute rhinitis)
• if the patient has asthma, hay fever, 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 Retard may exacerbate the symptoms of these diseases
• in patients infected with the varicella-zoster virus, 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 collagenosis (connective tissue disease)
• if the patient is taking potassium-sparing diuretics. During treatment with Rantudil Retard, an increase in blood potassium levels has been observed.

When to exercise special caution when taking Rantudil Retard:

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

Taking medications like Rantudil Retard 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 disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), discuss your treatment with your doctor or pharmacist.

Rantudil Retard 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
• anticoagulants (e.g., warfarin, acenocoumarol) - may increase the risk of bleeding
• glucocorticoids - may increase the risk of stomach ulcers and/or bleeding
• acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) - may increase the risk of bleeding or stomach ulcers. Concomitant use of Rantudil Retard and another NSAID should be avoided.
• probenecid - may slow down the elimination of Rantudil Retard
• penicillin antibiotics - may delay the elimination of penicillins
• diuretics and blood pressure-lowering medications - may reduce the effectiveness of these medications. In patients with kidney problems (e.g., dehydration or elderly), concomitant use of Rantudil Retard 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 should be exercised, especially in elderly patients. Patients should drink adequate amounts of fluids. After starting such treatment, the attending physician will consider regular monitoring of kidney function test results in these patients.
• potassium-sparing diuretics - may increase blood potassium levels, so patients taking these medications should have their potassium levels checked periodically
• antiplatelet agents and selective serotonin reuptake inhibitors (used to treat depression) - may increase the risk of gastrointestinal bleeding. Rantudil Retard may reduce the effectiveness of selective serotonin reuptake inhibitors.
• antacids (used to treat heartburn and excess stomach acid) - may reduce the absorption of Rantudil Retard.

Taking Rantudil Retard with food, drink, and alcohol

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

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 or pharmacist before taking this medicine. Rantudil Retard should not be taken during the last 3 months of pregnancy (in the third trimester), as it may increase the risk of serious complications during delivery, which can be life-threatening 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. Rantudil Retard should not be taken during the first 6 months of pregnancy (in the first or second trimester), unless it is absolutely necessary and recommended by a 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 Retard 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 arterial duct in the child's heart. If treatment is to last longer 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 Retard should not be taken during breastfeeding. Rantudil Retard may make it harder to get pregnant. If the patient plans to get pregnant or has problems getting pregnant, they should inform their doctor.

Driving and operating machinery

Do not drive vehicles, as Rantudil Retard may cause fatigue and dizziness. Special caution should be exercised at the start of treatment, after increasing the dose, or when switching from Rantudil Forte to another medicine, as well as when consuming alcohol. Do not operate any machinery or use tools.

Rantudil Retard contains lactose and sodium

The medicine contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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 Retard

This medicine should always be taken as directed by the doctor. If you have any doubts, consult your doctor or pharmacist. The recommended dose of Rantudil Retard for adults is usually 1 capsule 1 to 2 times a day.

How to take the medicine

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

Taking a higher dose of Rantudil Retard 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 maintenance. 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 Retard

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

Stopping treatment with Rantudil Retard

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

4. Possible side effects

Like all medicines, Rantudil Retard 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 accompanying 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 Ocular disorders:eye diseases (retinal pigmentary degeneration and corneal clouding) characterized by 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 blood potassium levels (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 Rantudil Retard, they should consult their doctor, who may recommend appropriate infection treatment.
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 exacerbate bleeding disorders. If anemia symptoms 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 asthma attacks, tachycardia, decreased blood pressure leading to life-threatening shock. If any symptoms of severe, generalized hypersensitivity reactions occur (which can appear even after taking the medicine for the first time), 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 disorders
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 mucosa inflammation and tongue changes, esophageal changes, lower abdominal problems (e.g., non-specific colitis with bleeding), worsening of Crohn's disease or ulcerative colitis symptoms, constipation, intestinal obstruction, pancreatitis
Skin and subcutaneous tissue disorders:vasculitis, rash, excessive sweating, flushing, photosensitivity, 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:urination 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, 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 Retard

Keep the medicine out of sight and reach of children. Store in a temperature below 25°C. Do not use after the expiration date stated on the packaging. The expiration date refers to the last day of the specified 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. Package contents and other information

What Rantudil Retard contains

• The active substance of Rantudil Retard is acemetacin (Acemetacinum).
• Other ingredients are: lactose monohydrate (D80 powder), lactose monohydrate (D20 crystalline) (see section 2 "Rantudil Retard contains lactose and sodium"), magnesium stearate, colloidal silica, talc, cellulose octanoate, crospovidone, povidone, titanium dioxide (E 171), triacetin, iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), gelatin, sodium lauryl sulfate (see section 2 "Rantudil Retard contains lactose and sodium").

What Rantudil Retard looks like and what the package contains

PP/Al or PVC/PVDC/Al blisters in a cardboard box. The package contains 7, 20, 21, or 50 prolonged-release capsules.

Marketing authorization holder

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

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 update of the leaflet:02/2024