Metindol Retard

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Metindol Retard (Metindol), 75 mg, prolonged-release tablets

Indometacinum
Metindol Retard and Metindol are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific 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 side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Metindol Retard is a medicine belonging to the group of non-steroidal anti-inflammatory drugs.
Metindol Retard is used:

• in the treatment of acute rheumatoid arthritis;
• in the treatment of ankylosing spondylitis, degenerative joint disease, hip joint inflammation;
• in the treatment of acute inflammatory conditions of the skeletal muscles;
• in the treatment of lower back pain;
• in inflammatory conditions of the periarticular tissues (bursitis, tendinitis, synovitis, tenosynovitis, joint capsule inflammation);
• in inflammatory conditions, pain, and swelling associated with orthopedic procedures;
• in primary dysmenorrhea.

2. Important information before taking Metindol Retard

When not to take Metindol Retard

• if the patient is allergic to indomethacin or any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs;
• if the patient has had asthma attacks, hives, or nasal inflammation after taking non-steroidal anti-inflammatory drugs or acetylsalicylic acid in the past;
• if the patient has severe heart, kidney, or liver failure;
• if the patient has active stomach or duodenal ulcers, and if they have had gastrointestinal damage in the past or currently have it;
• if the patient has angioedema or nasal polyps;
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting treatment with Metindol Retard, you should discuss it with your doctor or pharmacist.
You should be careful:

• if you have liver, kidney, or heart dysfunction, hypertension, heart failure, or conditions that predispose to fluid retention in the body (e.g., Conn's syndrome), diabetes, loss of extracellular fluid (e.g., extensive burns, bleeding), or sepsis, and if you are also taking other medicines that are toxic to the kidneys, such as phenacetin (it may be necessary, among other things, to periodically monitor kidney function);
• if the risk of bleeding is increased for any reason, e.g., after surgery, blood disease, etc. (Metindol Retard significantly increases this risk);
• if you currently have or have had asthma (the risk of bronchospasm is increased);
• if you are elderly (the risk of side effects is increased);
• if you experience or worsen symptoms of gastrointestinal disorders (you should then consult a doctor);
• if you are taking other medicines that may have a negative effect on the gastrointestinal tract or increase the risk of bleeding, such as corticosteroids (e.g., cortisol), anticoagulants (e.g., warfarin), or antiplatelet agents (e.g., acetylsalicylic acid);
• if you have bleeding disorders, psychiatric disorders, epilepsy, or Parkinson's disease (the medicine may worsen them);
• if you experience gastrointestinal bleeding (you should immediately stop taking the medicine and consult a doctor);
• if you have systemic lupus erythematosus or mixed connective tissue disease (the risk of aseptic meningitis may be increased);
• if you have an infectious disease (indomethacin may mask the symptoms of such a disease, so it is important to follow the doctor's instructions during treatment);
• if you are being vaccinated with a live vaccine.

Indomethacin may:

• make it difficult to get pregnant (if the patient plans to get pregnant or has problems getting pregnant, they should inform their doctor);
• change the results of some laboratory tests (increase liver enzyme activity and change the result of the so-called dexamethasone test).

In patients taking Metindol Retard, there is a risk of changes in the eyes (deposits in the cornea, changes in the retina), so periodic ophthalmological examinations are necessary during treatment (especially in patients with rheumatoid arthritis), and if changes occur, it may be necessary to discontinue the medicine.
Taking such medicines as Metindol Retard may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. You should 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), you should discuss your treatment with your doctor or pharmacist.
To minimize the risk of side effects, Metindol Retard should be used in the smallest effective dose for the shortest period necessary to alleviate symptoms.
You should avoid taking two or more non-steroidal anti-inflammatory drugs at the same time.

Metindol Retard and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Indomethacin may change the effect of some medicines, and some medicines may change the effect of indomethacin. These medicines include:

• non-steroidal anti-inflammatory drugs, acetylsalicylic acid, and other acetylsalicylic acid derivatives (these medicines are used, among other things, in colds and are often available without a prescription);
• antibacterial medicines - 4-quinolones, e.g., norfloxacin, ciprofloxacin;
• antiviral medicines - zalcitabine, zidovudine, ritonavir;
• cytotoxic medicines - cyclophosphamide, methotrexate;
• antidepressants - so-called selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine);
• antidiabetic medicines - e.g., glimepiride, metformin;
• anticoagulants - e.g., warfarin, acenocoumarol;
• antihypertensive medicines - e.g., metoprolol, prazosin, enalapril, losartan, hydralazine, nifedipine;
• diuretics - e.g., furosemide, chlorthalidone;
• cardiac glycosides - e.g., digoxin;
• corticosteroids - e.g., hydrocortisone;
• benzodiazepines - e.g., diazepam;
• vasodilators - e.g., pentoxifylline;
• phenytoin;
• haloperidol;
• clopidogrel;
• probenecid;
• cyclosporine;
• lithium salts;
• triamterene;
• diflunisal;
• tacrolimus;
• tiludronate;
• desmopressin;
• mifepristone;
• muromonab-CD3;
• baclofen.

Patient taking Metindol Retard should remember to consult their doctor before taking any over-the-counter medicine (especially cold medicine).

Metindol Retard with food and drink

Metindol Retard should always be taken with food or milk.
You should not take it with high-pH liquids (strongly alkaline) or antacids (unless it is necessary to alleviate side effects).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
You should not take Metindol Retard if you are 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 delivery. During the first 6 months of pregnancy, the medicine should not be used unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period or during attempts to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, Metindol Retard 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 ductus arteriosus in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Metindol Retard should not be used during breastfeeding, as it passes into breast milk and may be harmful to infants.

Driving and operating machinery

You should not drive vehicles, operate moving machinery, or perform tasks that require full physical and mental fitness, as Metindol Retard may cause dizziness, drowsiness, fatigue, and vision disturbances.

3. How to take Metindol Retard

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Recommended dose
Adults:
Musculoskeletal disorders: 1 prolonged-release tablet once or twice a day, depending on the effectiveness and tolerance of the treatment.
Painful menstruation: 1 prolonged-release tablet once a day from the onset of painful cramps or bleeding, for the usual duration.
Children: Metindol Retard is not recommended for use in children due to a lack of safety data.
Elderly patients: In this age group, the frequency of side effects is higher, so special caution should be exercised, and the smallest effective dose should be used for the shortest possible time. All side effects (see section 4) should be reported to the doctor.
Warning:to minimize the risk of gastrointestinal irritation, Metindol Retard should always be taken with food or milk. Treatment should be started with small doses, which can be increased if necessary.
Taking the medicine in the smallest effective dose for the shortest period necessary to alleviate symptoms reduces the risk of side effects.

Taking a higher dose of Metindol Retard than recommended

In case of overdose, nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea, headache, dizziness, disorientation, excitement, coma, drowsiness, tinnitus, fainting, and, in rare cases, seizures may occur.
The treatment of overdose consists of securing basic life functions and symptomatic treatment. If the overdose occurred less than an hour ago, the administration of activated charcoal should be considered. In adults, as an alternative treatment, gastric lavage should be considered.
If necessary, the doctor should take measures to ensure proper diuresis (urine output) and monitor kidney and liver function.
The patient should be observed for at least 4 hours after taking a potentially toxic amount of indomethacin. In case of frequent and/or prolonged seizures, diazepam should be administered.
In case of overdose, you should immediately consult a doctor.

Missing a dose of Metindol Retard

If the patient misses a dose at the scheduled time, they should take it as soon as possible. However, if it is close to the time of the next dose, the missed dose should be skipped.
You should not take a double dose to make up for the missed dose.

Stopping treatment with Metindol Retard

Stopping treatment with Metindol Retard may lead to worsening of the symptoms of the disease for which it was taken.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Metindol Retard can cause side effects, although not everybody gets them.
Gastrointestinal disorders: nausea, loss of appetite, vomiting, gastritis, abdominal pain, constipation, diarrhea, severe bloating, oral mucositis, ulcers that can occur in any part of the gastrointestinal tract (can cause narrowing or obstruction of the gastrointestinal tract), gastrointestinal bleeding (even without obvious ulcers or diverticula) or perforation of an existing diverticulum (such as cancer or diverticulum), worsening of abdominal pain or exacerbation of ulcerative colitis or Crohn's disease (or occurrence of this pathology) and local inflammation of the intestine, gastric and/or duodenal ulcers, and gastrointestinal bleeding and perforation (sometimes fatal), especially in elderly patients; in case of gastrointestinal bleeding, Metindol Retard should be discontinued.
Liver and biliary disorders: cholestasis, jaundice, and hepatitis (sometimes fatal).
Nervous system disorders: headache, dizziness, feeling of emptiness in the head (headache can be prevented by starting treatment with a small dose of indomethacin and gradually increasing it) - these symptoms usually disappear during continued treatment or after reducing the dose of indomethacin; if, despite reducing the dose, the headache persists, the medicine should be discontinued; aseptic meningitis (especially in patients with autoimmune diseases, such as lupus or mixed connective tissue disease) with symptoms such as neck stiffness, headache, nausea, vomiting, fever, or disorientation; dizziness, speech disorders, fainting, coma, brain edema, nervousness, confusion, drowsiness, seizures, paresthesia (tingling, numbness), peripheral neuropathy (nerve damage), involuntary movements, worsening of epileptic seizures, parkinsonism (these symptoms are usually temporary and disappear during treatment, but sometimes they require discontinuation of treatment).
Psychiatric disorders: disorientation, insomnia, depersonalization, hallucinations, depression, feeling of anxiety, excitement, other psychiatric disorders (these symptoms are usually temporary and disappear during treatment, but sometimes they require discontinuation of treatment).
General disorders and administration site conditions: feeling of fatigue, malaise, chest pain, excessive sweating, edema.
Cardiac disorders: rapid heartbeat, arrhythmia, palpitations, heart failure.
Vascular disorders: hypertension, hypotension, hot flashes, vasculitis.
Renal and urinary disorders: hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, and renal failure, worsening of renal function in patients with impaired renal function and/or liver function.
Skin and subcutaneous tissue disorders: itching, hives, angioedema, photosensitivity, erythema multiforme, rash, exfoliative dermatitis, Stevens-Johnson syndrome (erythematous-bullous-exfoliative lesions mainly on mucous membranes), erythema multiforme, toxic epidermal necrolysis (a type of severe skin damage), hair loss, worsening of psoriasis.
Ear and labyrinth disorders: tinnitus, hearing disorders, deafness.
Eye disorders: blurred vision, optic neuritis, double vision, eye pain and periorbital pain. In some patients with rheumatoid arthritis who have been taking indomethacin for a long time, deposits in the cornea and changes in the retina and macula have been observed (however, similar symptoms have also been observed in patients not taking this medicine).
Immune system disorders: non-specific allergic reactions and anaphylaxis, increased respiratory tract reactivity, including asthma, worsening of asthma, bronchospasm, and dyspnea, skin reactions, including various types of rashes, itching, hives, purpura, angioedema, dermatoses with blistering and exfoliation (including erythema multiforme and toxic epidermal necrolysis).
Diagnostic tests: increased blood urea levels, glycosuria, increased liver enzyme levels.
Metabolism and nutrition disorders: increased blood glucose levels, increased blood potassium levels.
Respiratory, thoracic, and mediastinal disorders: pulmonary eosinophilia, nosebleeds, bronchospasm in patients with asthma or other allergic diseases in their medical history.
Blood and lymphatic system disorders: decreased platelet count, decreased white blood cell count, decreased neutrophil count, aplastic and hemolytic anemia, agranulocytosis, bone marrow suppression, disseminated intravascular coagulation, and associated purpura, ecchymosis, and petechiae. In some patients, anemia may occur due to gastrointestinal bleeding (apparent or hidden).
Reproductive system and breast disorders: menstrual bleeding, changes in the breast (breast enlargement, increased breast tenderness, gynecomastia - breast enlargement in men).
Musculoskeletal and connective tissue disorders: muscle weakness, accelerated degenerative processes of cartilage.
The occurrence of gastrointestinal symptoms can often be prevented by taking the medicine with food or milk.
Non-steroidal anti-inflammatory drug (NSAID) treatment has been associated with reports of hypertension and heart failure.
Taking such medicines as Metindol Retard may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 (22) 49 21 301
fax: + 48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Metindol Retard

Do not store above 25°C. Store in the original packaging.
The medicine should be stored out of sight and reach of children.
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. You should 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 Metindol Retard contains

• The active substance of the medicine is indomethacin. One tablet contains 75 mg of indomethacin.
• The other ingredients are: microcrystalline cellulose, ammonium methacrylate copolymer (Eudragit RSPO), talc, magnesium stearate, potato starch.

What Metindol Retard looks like and what the package contains

The tablets are round, flat on both sides with a beveled edge, white to cream-colored.
Metindol Retard is available in a package containing 25 or 50 tablets (1 or 2 blisters containing 25 tablets, in a cardboard box).
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, country of export:

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15, Dublin
Ireland

Manufacturer:

ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
Poland

Parallel importer:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Lithuanian marketing authorization number, country of export:
LT/1/94/0782/001
LT/1/94/0782/002

Parallel import authorization number: 849/15

Date of leaflet approval: 27.01.2025

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