Inacid Retard 75 mg prolonged-release hard capsules

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Inacid Retard 75 mg prolonged-release hard capsules

Indometacin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents

1. What Inacid Retard is and what it is used for
2. What you need to know before taking Inacid Retard
3. How to take Inacid Retard
4. Possible side effects
5. How to store Inacid Retard
6. Contents of the pack and other information

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

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

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

• Rheumatoid arthritis, ankylosing spondylarthropathy (inflammation affecting the joints of the spine), and osteoarthritis.
• Acute musculoskeletal conditions.
• Post-traumatic inflammation, pain, and swelling.

2. What you need to know before taking Inacid Retard

Do not take Inacid Retard:

• if you are allergic to indometacin or to any of the other components of this medicine (listed in section 6),
• if acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) have caused you asthma, rhinitis, urticaria, or another allergic reaction,
• if you have a history of gastrointestinal bleeding or perforation related to previous treatment with NSAIDs,
• if you have active or recurrent peptic ulcer/gastrointestinal bleeding,
• if you suffer from severe heart disease,
• if you are in the third trimester of pregnancy or are breastfeeding,
• if you are being treated for pain related to coronary artery bypass graft (CABG) surgery, a procedure to treat a blocked heart artery,
• if you are under 14 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

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

Inform your doctor if you currently suffer or have previously suffered from 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 disorders.
• Severe liver disease or abnormal liver function tests.
• Renal failure.
• Bleeding disorders 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 sucrose or any other component of Inacid Retard 75 mg capsules.

Inform your doctor

• if you are simultaneously taking medications that affect blood coagulation, such as corticosteroids, oral anticoagulants, or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• if you have Crohn’s disease or ulcerative colitis, as medicines like indometacin 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 frequent adverse effects associated with medicines like Inacid Retard are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Gastritis has also been observed less frequently. These may occur at any time during treatment, with or without prior warning.

The risk of gastrointestinal bleeding is higher when high doses are used, if you have a history of peptic ulcer, or if you are elderly. In such cases, your doctor may consider prescribing a stomach-protective medicine.

If you experience abdominal pain, vomiting blood or material resembling coffee grounds, or black stools, these may be symptoms of gastrointestinal bleeding. Stop taking Inacid Retard immediately and seek medical help without delay.

Cardiovascular risks:

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

It is important that you take the lowest effective dose of Inacid Retard for the shortest duration necessary to relieve/control your symptoms.

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

Risk of serious skin reactions:

Medicines like Inacid Retard may rarely be associated with serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

The highest risk of such reactions occurs at the beginning of treatment (usually within the first month). If you develop skin rashes, possibly with blistering 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 hepatic reactions:

Medicines like Inacid Retard may be associated with liver disorders causing yellowing of the skin and eyes (jaundice), sometimes accompanied by high fever, swelling, or tenderness in the upper abdomen.

Vision:

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

Other precautions:

Inform your doctor if you experience headache, possibly accompanied by dizziness and drowsiness after taking Inacid Retard.

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

Like other non-steroidal anti-inflammatory drugs, Inacid Retard may mask the symptoms of an infection.

Your doctor may recommend periodic blood tests during treatment with Inacid Retard to monitor your blood cells, liver and kidney function, or blood levels of other medicines.

Children and adolescents

Do not administer to children under 14 years of age.

Taking Inacid Retard with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medicines may interact with Inacid Retard. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the other medicines.

This is especially important if you are taking:

• Anticoagulants, platelet aggregation inhibitors (to prevent blood clotting).
• Corticosteroids (e.g., cortisone, prednisone) (used to treat various types of inflammation or autoimmune diseases).
• Selective serotonin reuptake inhibitors (used to treat depression).
• Acetylsalicylic acid (aspirin) or other NSAIDs, including selective 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).
• Cyclosporine (used to suppress the immune system).
• Lithium (used to treat certain types of depression).
• Diuretics, angiotensin II receptor antagonists, angiotensin-converting enzyme (ACE) inhibitors, renin antagonists (medicines used to treat high blood pressure).
• Digoxin (used to treat heart conditions).
• Phenylpropanolamine (appetite suppressant).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

Do not take Inacid Retard during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby’s tendency to bleed and may delay or prolong labor more than expected. You should not take Inacid Retard during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. If taken for more than a few days starting from week 20 of pregnancy, Inacid Retard may cause kidney problems in your fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Because the use of medicines like Inacid Retard has been associated with an increased risk of congenital malformations/spontaneous abortions, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration of treatment should be kept to a minimum.

Breastfeeding

Indometacin is excreted in breast milk; therefore, you should not take this medicine if you are breastfeeding.

Fertility

Inacid Retard may reduce your ability to conceive. Inform your doctor if you are planning to have a baby or if you have difficulty becoming pregnant.

Driving and using machines

Inacid Retard may cause drowsiness, dizziness, and blurred vision. If this occurs, do not drive or operate any tools or machinery that require alertness.

Inacid Retard contains sucrose

This medicine contains sucrose. Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.

3. How to take Inacid Retard

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Recommended dose:

Adults

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

Maximum daily dose

Do not take more than 200 mg of indometacin per day.

Elderly patients

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

Use in children and adolescents

Inacid Retard must not be used in children under 14 years of age.

Patients with kidney problems

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

Method of administration:

Oral use.

The capsules must 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 Toxicology Information Service, Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Inacid Retard

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

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

If you stop treatment with Inacid Retard

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following adverse effects, stop taking this medicine and consult your doctor immediately.

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

The following adverse effects have been reported:

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

Headache, dizziness, lightheadedness, 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):

Tinnitus, hearing disorders, increase in liver enzyme test results, abdominal pain, bleeding or perforation of the large intestine, inflammation of the mouth, stomach irritation, flatulence, swelling due to fluid retention, hair loss.

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

Itching of the skin, hives, inflammation of blood vessels, skin rash, sudden difficulty breathing, asthma, fluid in the lungs, psychological disorders, delirium, mental confusion, anxiety, fainting, drowsiness, tingling or numbness in the limbs, 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, increased heart rate, irregular heartbeat, heart failure, chest pain, high blood pressure, low blood pressure, hepatitis, liver disorders, gastrointestinal ulcers in the esophagus, stomach, and small or large intestine, blood in urine, vaginal bleeding, breast enlargement (also in men), breast tenderness, redness, sweating, nosebleeds, elevated levels of potassium or glucose in the blood, glucose in urine, high levels of urea in blood.

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

Decrease in white blood cells, deficiency of a type of white blood cells, deficiency of red blood cells, decrease in platelets, bleeding into the skin, coagulation disorders, deposits in the cornea of the eye, retinal disturbances, abnormal amounts of protein in urine, kidney disorders, kidney failure.

Frequency not known (cannot be estimated from available data):

Inflammation of the pancreas.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Inacid Retard

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at the pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

No special storage conditions are required.

6. Contents of the pack and other information

Composition of Inacid Retard 75 mg

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

Appearance of the product and contents of the pack

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

H.A.C. PHARMA

Péricentre II

43, Avenue de la Côte de Nacre

14000 CAEN

France

Manufacturer

allphamed Pharbil Arzneimittel GmbH

Hildebrandstrasse 10-12

37081 Göttingen, Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Euromed Pharma Spain, S.L.

C/Eduard Maristany, 430-432

08918 Badalona

Barcelona - Spain

Tel: +34 932 684 208

Fax: +34 933 150 469

Date of the most recent revision of this leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es