Metindol Retard

Package Leaflet: Information for the User

Metindol Retard, 75 mg, Prolonged-Release Tablets

Indometacin

Read the package 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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. Contents of the pack and other information

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

Metindol Retard is a medicine belonging to the group of nonsteroidal anti-inflammatory drugs. It has strong anti-inflammatory, analgesic, and antipyretic effects.
Metindol Retard is used:

• to treat acute rheumatoid arthritis;
• to treat ankylosing spondylitis, osteoarthritis, hip joint inflammation;
• to treat acute inflammatory conditions of the skeletal muscles;
• to relieve 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 hypersensitive to indomethacin or any of the other ingredients of this medicine (listed in section 6) or to other nonsteroidal anti-inflammatory drugs;
• if the patient has experienced asthma attacks, urticaria, or nasal polyps after taking nonsteroidal anti-inflammatory drugs or acetylsalicylic acid;
• if the patient has severe heart failure, kidney or liver failure;
• if the patient has active peptic ulcer disease and (or) a history of gastrointestinal tract damage;
• 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, the patient should discuss it with their doctor or pharmacist.
Care should be taken:

• if there are liver, kidney, or heart function disorders, hypertension, heart failure, or conditions predisposing to fluid retention in the body (e.g., Conn's syndrome), diabetes, extracellular fluid loss (e.g., extensive burns, bleeding), or sepsis, and when the patient is also taking other nephrotoxic drugs, such as phenacetin (periodic monitoring of kidney function may be necessary);
• when the risk of bleeding is increased for any reason, e.g., after surgery, blood diseases, etc. (Metindol Retard significantly increases this risk);
• if the patient currently has or has a history of bronchial asthma (the risk of bronchospasm is increased);
• when the patient is elderly (the risk of side effects is increased);
• if gastrointestinal disorders occur or worsen (the patient should consult a doctor);
• when the patient is also taking other drugs 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 the patient has bleeding disorders, psychiatric disorders, epilepsy, or Parkinson's disease (the medicine may exacerbate them);
• if gastrointestinal bleeding occurs (the patient should stop taking the medicine and consult a doctor immediately);
• if the patient has systemic lupus erythematosus or mixed connective tissue disease (the risk of aseptic meningitis may be increased);
• if an infectious disease occurs (indomethacin may mask the symptoms of such a disease, so it is essential to follow the doctor's instructions carefully);
• when the patient is vaccinated with a live vaccine.

Indomethacin may:

• make it difficult to conceive (if the patient plans to conceive or has difficulty conceiving, 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).

Patient's taking Metindol Retard are at risk of developing eye disorders (corneal deposits, retinal changes), so regular ophthalmological examinations are necessary during treatment (especially in patients with rheumatoid arthritis), and if changes occur, the medicine may need to be discontinued.
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.
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), consult your doctor or pharmacist.
To minimize the risk of side effects, Metindol Retard should be used in the smallest effective dose for the shortest duration necessary to relieve symptoms.
Avoid taking two or more nonsteroidal anti-inflammatory drugs at the same time.

Metindol Retard and other medicines

Tell your doctor or pharmacist about all medicines you are 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:

• nonsteroidal 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 agents - 4-quinolones, e.g., norfloxacin, ciprofloxacin;
• antiviral agents - zalcitabine, zidovudine, ritonavir;
• cytotoxic agents - cyclophosphamide, methotrexate;
• antidepressants - so-called selective serotonin reuptake inhibitors (e.g., fluoxetine, paroxetine);
• antidiabetic agents - e.g., glimepiride, metformin;
• anticoagulants - e.g., warfarin, acenocoumarol;
• antihypertensive agents - 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's 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.
Do not take it with high-pH liquids (strongly alkaline) or antacids (unless necessary to alleviate side effects).

Pregnancy and breastfeeding

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.
Do 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 mother and child and prolong labor. During the first 6 months of pregnancy, do not take the medicine unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, use the smallest effective dose for the shortest possible time. From the 20th week of pregnancy, Metindol Retard may cause kidney function disorders 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 arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.
Do not take Metindol Retard during breastfeeding, as it passes into breast milk and may harm infants.

Driving and using machines

Do 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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.
Note:to minimize the risk of gastrointestinal irritation, Metindol Retard should always be taken with food or milk. Treatment should be started with a low dose, which can be increased if necessary.
Taking the medicine in the smallest effective dose for the shortest duration necessary to alleviate symptoms reduces the risk of side effects.

Overdose of Metindol Retard

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 procedure in case of overdose involves securing basic life functions and symptomatic treatment. If the overdose occurred less than an hour ago, consider administering activated charcoal. In adults, as an alternative, consider performing gastric lavage.
If necessary, the doctor should take actions 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 dose of indomethacin. In case of frequent and (or) prolonged seizures, administer diazepam.
In case of overdose, contact a doctor immediately.

Missed dose of Metindol Retard

If a dose is missed, the patient should take it as soon as possible. However, if it is close to the time of the next dose, skip the missed dose.
Do 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 prescribed.
If you have any further doubts about taking this medicine, 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, flatulence, 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 the disease in patients with 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 of the gastrointestinal tract (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 low 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 disorders, 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 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 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, urticaria, angioedema, photosensitivity, erythema multiforme, rash, exfoliative dermatitis, Stevens-Johnson syndrome (erythematous-bullous-exfoliative changes, 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, corneal deposits and retinal changes have been observed (similar symptoms have also been observed in patients not taking this medicine).
Immune system disorders: nonspecific allergic reactions and anaphylaxis, increased respiratory tract reactivity, including asthma, worsening of asthma, bronchospasm, and dyspnea, skin reactions, including various types of rashes, itching, urticaria, angioedema, and dermatoses with blistering and peeling of the skin (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 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, white blood cell count, neutrophil count, aplastic and hemolytic anemia, agranulocytosis, bone marrow suppression, disseminated intravascular coagulation, and associated bleeding, bruising, and petechiae. In some patients, anemia may occur due to gastrointestinal bleeding (visible or invisible).
Reproductive system and breast disorders: genital tract bleeding, breast changes (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.
Nonsteroidal anti-inflammatory drug (NSAID) treatment has been associated with an increased risk 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 not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides,
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Metindol Retard

Store in a temperature below 25°C. Store in the original package.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
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 no longer required. This will help protect the environment.

6. Contents of the pack 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: potato starch, microcrystalline cellulose, Eudragit RSPO, talc, magnesium stearate.

What Metindol Retard looks like and contents of the pack

Tablets are round, flat on both sides with a beveled edge, white to cream-colored.
Metindol Retard is available in a pack containing 25 or 50 tablets (1 or 2 blisters of PVC/Aluminum foil containing 25 tablets, in a cardboard box).

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel.: +48 17 865 51 00

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa Street 2
35-105 Rzeszów

Date of last revision of the leaflet: April 2025