Package leaflet: Information for the patient

Rantudil Retard, 90 mg, prolonged-release capsules
Acemetacinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Rantudil Retard is and what it is used for
Important information before taking Rantudil Retard
How to take Rantudil Retard
Possible side effects
How to store Rantudil Retard
Contents of the pack and other information

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

The active substance in Rantudil Retard is acemetacin, which has anti-inflammatory, analgesic, antipyretic and antiplatelet aggregation properties. After oral administration, acemetacin accumulates in inflamed tissues, where it reaches higher concentrations than in the blood.
Indications
As an analgesic and anti-inflammatory agent in:

degenerative joint diseases,
lumbosacral pain,
rheumatoid arthritis,
ankylosing spondylitis,
postoperative pain,
acute gout attacks.

2. Important information before using Rantudil Retard

When not to use Rantudil Retard

if the patient is allergic to acemetacin, indometacin, or any of the other ingredients of this medicine (listed in section 6),
if the patient has blood dyscrasias of unknown origin,
if the patient has previously experienced gastrointestinal bleeding or perforation after taking non-steroidal anti-inflammatory drugs (NSAIDs),
if the patient has active or recurrent peptic ulceration of the stomach and/or duodenum or gastrointestinal bleeding,
in patients who have previously experienced bronchospasm, asthma attack, urticaria, or acute rhinitis after treatment with acetylsalicylic acid or 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 this with your doctor or pharmacist.

if the patient is taking other non-steroidal anti-inflammatory drugs (NSAIDs). Concomitant use of Rantudil Retard with other NSAIDs, including selective COX-2 inhibitors, should be avoided.
if the patient is elderly. Elderly patients are more likely to experience adverse effects during NSAID therapy, particularly gastrointestinal bleeding and perforation, which may even be fatal. Rantudil Retard should be used in elderly patients only under close medical supervision.
if the patient (especially if elderly) has previously experienced adverse gastrointestinal effects. The patient should report any concerning gastrointestinal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
if the patient has a tendency to bleeding. Bleeding may increase during treatment with Rantudil Retard.
if the patient is taking concomitant medications that may increase the risk of ulcers or bleeding, such as oral glucocorticosteroids, anticoagulants (e.g. warfarin, acenocoumarol), selective serotonin reuptake inhibitors (SSRIs), or antiplatelet agents.
if the patient has gastrointestinal disorders (e.g. ulcerative colitis, Crohn's disease),
if the patient has hepatic or renal insufficiency,
if the patient has previously experienced hypersensitivity reactions to NSAIDs (e.g. asthma attack, skin reactions, or acute rhinitis),
if the patient has bronchial asthma, hay fever, nasal mucosal edema, or chronic respiratory diseases, as such patients are more prone to hypersensitivity reactions,
if the patient has epilepsy, Parkinson's disease, or psychiatric disorders, as treatment with Rantudil Retard may exacerbate symptoms of these conditions,
in patients infected with the varicella-zoster virus, due to the risk of severe skin adverse reactions,
if the patient has systemic lupus erythematosus (an inflammatory condition of body tissues) and/or mixed connective tissue disease,
if the patient is taking potassium-sparing diuretics. Increased serum potassium levels have been observed during treatment with Rantudil Retard.

When to exercise particular caution when using Rantudil Retard:

if a skin rash, mucosal changes, or any other sign of hypersensitivity occurs after taking Rantudil Retard. In such a case, contact your doctor, who may decide to discontinue therapy.
during long-term treatment with Rantudil Retard. Blood tests and coagulation parameters should be monitored regularly. Ophthalmological examinations and assessments of liver and kidney function are also recommended.
if Rantudil Retard has been administered immediately before or after surgical procedures.

The use of medicines such as Rantudil Retard may be associated with a small increased risk of arterial thrombosis (e.g. heart attack (myocardial infarction) or stroke). Long-term use of high doses increases this risk. Do not use higher doses or longer treatment duration than recommended. If you have heart problems, have had a stroke, or suspect you may be at risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment approach with your doctor or pharmacist.

Rantudil Retard and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.

The following medicines may interact with Rantudil Retard, so inform your doctor if you are taking any of the following:

digoxin – serum digoxin levels may increase,
phenytoin – serum phenytoin levels may increase,
lithium – serum lithium levels may increase,
anticoagulant medicines, e.g. warfarin, acenocoumarol – risk of bleeding may increase,
glucocorticosteroids – risk of gastric and/or duodenal ulcers or bleeding may increase,
acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs) – risk of bleeding or peptic ulcer disease of the stomach and/or duodenum may increase. Concomitant use of Rantudil Retard with another NSAID should be avoided.
probenecid – may delay elimination of Rantudil Retard,
penicillin antibiotics – excretion of penicillins may be delayed,
diuretics and antihypertensive medicines – their effects may be reduced. In patients with renal impairment (e.g. dehydrated patients or elderly patients), concomitant use of Rantudil Retard with antihypertensive agents (ACE inhibitors and/or angiotensin II receptor antagonists) may lead to further deterioration of renal function (including severe renal failure), which is usually reversible. Therefore, caution is advised when using such combinations, especially in elderly patients. Patients should maintain adequate fluid intake. After initiating such treatment, the physician should consider regular monitoring of renal laboratory parameters in these patients.
potassium-sparing diuretics – may lead to increased serum potassium levels; therefore, patients taking these medicines should undergo periodic monitoring of serum potassium levels,
antiplatelet agents and selective serotonin reuptake inhibitors (used in the treatment of depression) – risk of gastrointestinal bleeding may increase. Rantudil Retard may reduce the effectiveness of selective serotonin reuptake inhibitors.
antacids (used for heartburn and treatment of gastric hyperacidity) – may reduce absorption of Rantudil Retard.

Taking Rantudil Retard with food, drink, and alcohol
Rantudil Retard capsules should be taken with food and with liquid.
Concomitant alcohol consumption may worsen adverse effects such as occult gastrointestinal blood loss.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not take Rantudil Retard during the last 3 months of pregnancy (third trimester), as it may increase the risk of serious complications during delivery, dangerous for both mother and unborn child. In the unborn child, kidney and heart problems may occur. There may be an increased tendency to bleeding in both mother and child, and delivery may be delayed or prolonged.
Do not take Rantudil Retard during the first 6 months of pregnancy (first or second trimester), unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. Rantudil Retard taken for more than a few days starting from week 20 of pregnancy may cause impaired renal function in the unborn child, leading to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart. If treatment lasts 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; therefore, Rantudil Retard should not be used during breastfeeding.
Rantudil Retard may impair fertility. If the patient is planning to become pregnant or has difficulty conceiving, she should inform her doctor.

Driving and operating machinery
Do not drive, as fatigue and dizziness may occur after taking Rantudil Retard. Particular caution should be exercised at the beginning of treatment, after dose increase, when switching from Rantudil Forte to another medicine, or when consuming alcohol.
Do not operate machinery or use tools.

Rantudil Retard contains lactose and sodium
This medicine contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Rantudil Retard

This medicine should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
The usual recommended dose of Rantudil Retard in adults is 1 capsule once or twice daily.
Instructions for use
Rantudil Retard capsules should be taken with meals. Swallow the capsules whole, with a large amount of fluid.
Accidental overdose of Rantudil Retard
In case of overdose, inform your doctor immediately. The doctor may perform gastric lavage or forced diuresis while maintaining fluid balance.
The following symptoms may occur: headache and dizziness, confusion, disorientation, lethargy, loss of consciousness, nausea, vomiting, abdominal pain, gastrointestinal bleeding, sweating, increased electrolyte concentration, elevated blood pressure, ankle swelling, oliguria, haematuria, respiratory centre depression, seizures, coma.
Missed 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

Very common side effects (may affect more than 1 in 10 people)
Gastrointestinal disorders: nausea, vomiting, abdominal pain, diarrhoea, and minor gastrointestinal bleeding, which may exceptionally lead to anaemia. In case of sudden abdominal pain and (or) tarry stools or haematemesis (vomiting blood), discontinue the medicine immediately and consult a doctor without delay.

Common side effects (may affect up to 1 in 10 people)
Immune system disorders: hypersensitivity reactions (rash, itching)
Psychiatric disorders: restlessness
Nervous system disorders: headache, drowsiness, dizziness
Gastrointestinal disorders: dyspepsia, flatulence, abdominal pain, loss of appetite, gastric and intestinal ulcers (sometimes accompanied by bleeding and perforation)
Hepatobiliary disorders: increased liver enzyme activity
General disorders and administration site conditions: feeling of fatigue.

Uncommon side effects (may affect up to 1 in 100 people)
Immune system disorders: urticaria
Eye disorders: eye disorders (pigmentary retinopathy and corneal opacity) manifesting as blurred or double vision
Gastrointestinal disorders: blood in gastric contents (during vomiting), blood in stool, haemorrhagic diarrhoea
Skin and subcutaneous tissue disorders: alopecia (hair loss)
Renal and urinary disorders: development of oedema (e.g. peripheral oedema), especially in patients with hypertension and (or) impaired renal function
Hepatobiliary disorders: liver damage (toxic hepatitis with or without jaundice; very rarely fulminant course, sometimes without preceding symptoms).

Rare side effects (may affect up to 1 in 1,000 people)
Metabolism and nutrition disorders: increased blood potassium levels (hyperkalaemia)
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: exacerbation of inflammatory symptoms due to infection (e.g. development of necrotizing fasciitis). If a patient experiences recurrence or worsening of any infection symptoms during treatment with Rantudil Retard, consult a doctor who may recommend appropriate treatment for the infection.

Blood and lymphatic system disorders: various types of anaemia (e.g. due to occult gastrointestinal bleeding, haemolytic anaemia, pancytopenia). Early symptoms may include: fever, sore throat, superficial changes in the oral mucosa, influenza-like symptoms, severe fatigue, nosebleeds, and subcutaneous petechiae. The medicine may affect platelet aggregation and increase the tendency to haemorrhage. If symptoms of anaemia occur, discontinue the medicine immediately and consult a doctor. Do not self-medicate with any analgesics and (or) antipyretics.

Immune system disorders: severe generalized hypersensitivity reactions, which may manifest as facial and eyelid swelling, tongue swelling, internal swelling of the throat with airway narrowing (angioedema), respiratory insufficiency possibly triggering an asthma attack, tachycardia, decreased blood pressure leading to life-threatening shock. In case of any of these symptoms of severe generalized hypersensitivity reactions (which may even occur after first use of this medicine), immediate medical assistance is required.

Metabolism and nutrition disorders: increased blood glucose levels (hyperglycaemia), presence of glucose in urine
Psychiatric disorders: psychiatric disturbances, disorientation, anxiety disorders, nightmares, psychosis, hallucinations, depression, sleep disorders, worsening of pre-existing psychiatric conditions
Nervous system disorders: loss of consciousness possibly leading to coma, taste disturbances, memory impairment, convulsions, tremor, worsening of symptoms of epilepsy and Parkinson's disease
Ear and labyrinth disorders: tinnitus, hearing disturbances
Cardiac disorders: palpitations, angina pectoris, heart failure
Vascular disorders: arterial hypertension
Respiratory, thoracic and mediastinal disorders: allergic pneumonia
Gastrointestinal disorders: mucositis (inflammation of the mucous membranes of the mouth and tongue), oesophageal lesions, lower abdominal discomfort (e.g. non-specific colitis with bleeding), exacerbation of symptoms of Crohn's disease or ulcerative colitis, constipation, fibrous strictures of the intestine, pancreatitis
Skin and subcutaneous tissue disorders: vasculitis, rash, excessive sweating, erythema, photosensitivity, minor and extensive subcutaneous petechiae, exfoliative dermatitis and bullous rash, which may be severe, for example Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell's syndrome)
Musculoskeletal and connective tissue disorders: muscle weakness
Renal and urinary disorders: disturbances in urination, increased blood urea levels, acute renal failure, proteinuria, haematuria, kidney damage (interstitial nephritis, nephrotic syndrome, renal papillary necrosis)
Reproductive system and breast disorders: vaginal bleeding
General disorders and administration site conditions: internal body rash.

Side effects with unknown frequency
Vascular disorders: circulatory collapse.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps 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 below 25°C.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Rantudil Retard contains

The active substance is acemetacin (Acemetacinum).
The other ingredients are: lactose monohydrate (powder D80), lactose monohydrate (crystalline D20) (see section 2 "Rantudil Retard contains lactose and sodium"), magnesium stearate, colloidal anhydrous silica, talc, cellulose acetate phthalate, 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 contents of the pack
PP/Al or PVC/PVDC/Al blisters in a cardboard carton.
The pack contains 7, 20, 21 or 50 prolonged-release capsules.
Marketing Authorisation Holder
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
Manufacturer
Madaus GmbH
51101 Cologne
Germany
For further information, please contact the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
tel.: 22 546 64 00