Product Information for the Patient

Inacid Retard 75 mg Long-Acting Hard Capsules

Indometacin

Read this entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Inacid Retard contains indometacin as the active ingredient, which belongs to a class of medications known as non-steroidal anti-inflammatory and anti-rheumatic drugs.

Inacid Retard is indicated for symptomatic treatment in patients suffering from:

• Rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the spine's joints) and osteoarthritis.
• Acute musculoskeletal processes.
• Post-traumatic inflammation, pain and swelling.

Do not take Inacid Retard:

• if you are allergic to indomethacin or any of the other components of this medication (listed in section 6),
• if you have had asthma, rhinitis, urticaria, or other allergic reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• if you have active or recurrent peptic ulcer or gastrointestinal bleeding,
• if you have a serious heart condition,
• if you are in the third trimester of pregnancy or breastfeeding your child,
• if you are undergoing postoperative pain treatment in the case of coronary artery bypass grafting (CABG), or surgery to treat a blocked heart artery.
• if you are under 14 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting this medication.

You should avoid taking Inacid Retard with other NSAIDs, including other anti-inflammatory medications such as selective cyclooxygenase-2 (COX-2) inhibitors.

Inform your doctor if you experience any of the following conditions:

• Gastrointestinal bleeding, ulcers, or perforations in the stomach or intestine.
• Hypertension, heart problems, or have had a stroke.
• Severe skin alterations.
• Any serious liver disease or abnormal liver function tests.
• Renal insufficiency.
• Bleeding or other coagulation problems.
• Psychiatric disorders, epilepsy, or Parkinson's disease.
• Infections.
• Blood disorders, such as decreased white blood cells, red blood cells, or platelets.
• Allergy to saccharose or any other component of Inacid Retard 75 mg capsules.

Inform your doctor

• If you are taking medications that alter blood coagulation, such as corticosteroids, oral anticoagulants, or antiplatelet agents like aspirin. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease or ulcerative colitis, as indomethacin-type medications may worsen these conditions. If you experience abdominal pain, diarrhea, or vomiting, stop taking Inacid Retard and inform your doctor immediately.

Gastrointestinal risks:

The most common adverse effects that occur with medications like Inacid Retard are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in older adults. Less frequently, gastritis has been observed. These may occur at any time during treatment with or without prior warning.

The risk of gastrointestinal bleeding is higher when using high doses if you have a history of peptic ulcers or are an older adult. In these cases, your doctor may consider associating a stomach protector.

If you experience abdominal pain, vomiting blood or coffee ground-like material, or black stools, these may be symptoms of gastrointestinal bleeding. Stop taking Inacid Retard and seek medical help immediately.

Cardiovascular risks:

Medications like Inacid Retard may be associated with a moderate increase in the risk of having a heart attack (myocardial infarction) or stroke.This risk is more likely to occur when using high doses and prolonged treatment. Your doctor may monitor your blood pressure as Inacid Retard may cause it to increase.

It is essential to take the lowest dose of Inacid Retard that alleviates/controls your symptoms for the shortest time necessary.

If you have heart problems, have had a heart attack, a history of strokes, or think you may be at risk for these conditions (e.g., have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult this treatment with your doctor.

Risk of severe skin reactions:

Medications like Inacid Retard may be associated, in very rare cases, with severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The highest risk of experiencing these reactions is at the beginning of treatment (usually within the first month of treatment). If you experience skin eruptions, possibly with the formation of blisters or mucosal ulcers (e.g., in the mouth), or other symptoms of an allergic reaction, stop taking Inacid Retard and consult your doctor immediately.

Risk of liver reactions:

Medications like Inacid Retard may be associated with liver disorders that cause yellowing of the skin and eyes, sometimes with elevated fever or swelling and sensitivity in the upper abdomen.

Vision:

If you experience blurred vision while taking Inacid Retard, stop taking Inacid Retard and inform your doctor.

Other precautions:

Inform your doctor if you experience headaches, possibly with dizziness and somnolence after taking Inacid Retard.

In some cases, Inacid Retard may worsen psychiatric disorders, epilepsy, and Parkinson's disease. Therefore, if you suffer from any of these conditions and notice a worsening, you should consult this treatment with your doctor.

Like other NSAIDs, Inacid Retard may mask the symptoms of an infection.

Your doctor may instruct you to undergo blood tests during treatment with Inacid Retard to monitor your blood cells, liver function, renal function, or blood levels of other medications.

Children and adolescents:

Do not administer to children under 14 years old.

Use of Inacid Retard with other medications:

Inform your doctor or pharmacist if you are using or have used recently, or may need to use any other medication.

Certain medications may interact with Inacid Retard. In these cases, you may need to change the dose or discontinue one of the other medications.

This is especially important if you are taking:

• Anticoagulants, antiplatelet agents (to prevent blood coagulation).
• Corticosteroids (e.g., cortisone, prednisone) (used to treat various types of inflammation or autoimmune diseases).
• Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression).
• Aspirin or other NSAIDs, including COX-2 inhibitors and diflunisal (used to treat fever, pain, or inflammation).
• Probenecid (used to treat gout).
• Methotrexate (used to treat certain types of cancer, psoriasis, or rheumatic diseases).
• Ciclosporin (used to suppress the immune system).
• Lithium (used to treat a certain type of depression).
• Diuretics, angiotensin II receptor antagonists, angiotensin-converting enzyme (ACE) inhibitors, or renin-angiotensin system (RAS) blockers (used to treat high blood pressure).
• Digoxin (used to treat heart diseases).
• Phenylpropanolamine (appetite suppressant).

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, consult your doctor before using this medication.

Do not take Inacid Retard if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery. Do not take Inacid Retard during the first 6 months of pregnancy unless it is clearly necessary and as instructed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. If you take it for more than a few days after week 20 of pregnancy, Inacid Retard may cause renal problems in your fetus, which may cause low amniotic fluid levels or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Due to the association of administering medications like Inacid Retard with a higher risk of congenital anomalies/abortions, its administration is not recommended during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration of treatment will be limited to the minimum possible.

Breastfeeding:

Indomethacin is secreted in breast milk, so you should not take this medication if you are breastfeeding.

Fertility:

Inacid Retard may decrease your ability to conceive. Inform your doctor if you are planning to become pregnant or if you have any difficulty becoming pregnant.

Driving and operating machinery:

Inacid Retard may cause drowsiness, dizziness, and blurred vision. In these cases, do not drive or use any hazardous tools or machinery that require alertness.

Inacid Retard contains saccharose:

This medication contains saccharose. Patients with hereditary fructose intolerance, glucose or galactose malabsorption, or saccharase-isomaltase insufficiency should not take this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you the dose you should take and the duration of treatment. It is essential to use the lowest dose that controls your pain and not to take Inacid Retard for longer than necessary to control symptoms.

The recommended dose is:

Adults

The usual dose is 75 mg to 150 mg of indomethacin per day (1 to 2 prolonged-release hard capsules), administered in divided doses.

Maximum daily dose

You should not take more than 200 mg of indomethacin per day.

Older adults

Your doctor may prescribe a lower daily dose and reduce the treatment duration.

Use in children and adolescents

Inacid Retard should not be used in children under 14 years old.

Patients with kidney problems

If you have any kidney disease, consult your doctor before taking this medication.

Administration form:

Oral.

The capsules should be swallowed whole with or after a meal, and with sufficient water or other liquid to reduce the risk of stomach discomfort.

If you take more Inacid Retard than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Inacid Retard

Do not take a double dose to compensate for the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you interrupt treatment with Inacid Retard

If you have any questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of these side effects, stop taking this medicine and see a doctor.

• Severe allergic reaction, such as swelling of the face, lips, or throat, sneezing, or difficulty breathing, sudden drop in blood pressure, skin rash.
• Severe abdominal pain (stomach pain) or other abdominal symptoms.
• Blood in stool.
• Black stools.
• Vomiting blood or dark material that looks like coffee grounds.
• Jaundice (yellowing of the skin and the white part of the eyes).
• Blisters or peeling of the skin.
• Irregular red patches on the skin of the hands and arms.

The following side effects have been reported:

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

Headache, dizziness, drowsiness, vertigo.

Common (may affect up to 1 in 10 people).

Depression, fatigue or tiredness, nausea, loss of appetite, vomiting, indigestion, stomach pain, constipation, diarrhea.

Uncommon (may affect up to 1 in 100 people).

Ringing in the ears, hearing disorders, liver enzyme test abnormalities, abdominal pain, intestinal bleeding or perforation, mouth inflammation, stomach irritation, flatulence, fluid retention, hair loss.

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

Itching skin, urticaria, blood vessel inflammation, skin rash, sudden difficulty breathing, asthma, fluid in the lungs, psychological disorders, delirium, confusion, anxiety, fainting, drowsiness, numbness or tingling in the extremities, speech problems, insomnia, worsening of epilepsy or Parkinson's disease, involuntary muscle movements, muscle weakness, seizures, coma, blurred vision, double vision, eye pain, hearing loss, rapid heart rate, irregular heartbeat, heart failure, chest pain, high blood pressure, low blood pressure, hepatitis, liver disorders, ulcers in the esophagus, stomach, and small or large intestine, blood in urine, vaginal bleeding, breast enlargement (also in men), breast tenderness, redness, sweating, nasal bleeding, high potassium or glucose levels in the blood, glucose in urine, high urea levels in the blood.

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

Decreased white blood cells, deficiency of a type of white blood cell, deficiency of red blood cells, decreased platelets, skin hemorrhages, coagulation disorders, deposits in the cornea of the eye, retinal alterations, abnormal amounts of protein in the urine, kidney disorders, renal insufficiency.

Unknown frequency (cannot be estimated from available data).

Pancreatitis inflammation.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

No special conservation conditions are required.

Composition of Inacid Retard 75 mg

• The active ingredient is indometacin. Each prolonged-release hard capsule contains 75 mg of indometacin.
• The other components (excipients) are: sucrose, hydroxypropyl methylcellulose, cornstarch, microcrystalline cellulose, polyvinyl acetate, indigotin blue (E132), magnesium stearate, gelatin, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Inacid Retard 75 mg are prolonged-release hard capsules. The capsules are hard, ivory-colored gelatin with an opaque cap and a clear body.

Inacid Retard 75 mg capsules are packaged in PVC/aluminum blisters, presented in cardboard containers containing 20 prolonged-release hard capsules.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

H.A.C. PHARMA

Péricentre II

43 , Avenue de la Côte de Nacre

14000 CAEN

France

Responsible for Manufacturing

allphamed Pharbil Arzneimittel GmbH

Hildebrandstrasse 10-12

37081 Göttingen, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Euromed Pharma Spain, S.L.

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Phone: + 34 932 684 208

Fax: + 34 933 150 469

Last review date of this leaflet: December 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es