INACID RETARD 75 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before you take Inacid Retard

Do not take Inacid Retard:

• if you are allergic to indomethacin or any of the other ingredients of this medicine (listed in section 6),
• if acetylsalicylic acid or other non-steroidal anti-inflammatory medicines (NSAIDs) have caused you asthma, rhinitis, urticaria, or other allergic reactions,
• if you have a history of gastrointestinal bleeding or perforation related to previous treatments with NSAIDs,
• if you have active or recurrent peptic ulcer/gastrointestinal bleeding,
• if you have severe heart disease,
• if you are in the third trimester of pregnancy or if you are breastfeeding your child,
• if you are undergoing perioperative pain treatment in the case of coronary artery bypass grafting (CABG), surgery to treat a blocked heart artery.
• if you are under 14 years old.

Warnings and precautions

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

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

Tell your doctor if you suffer or have suffered from any of the following conditions:

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

Tell your doctor

• If you are taking medicines that alter blood coagulation, such as corticosteroids, oral anticoagulants, or antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as indomethacin-type medicines can 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 that occur with medicines like Inacid Retard are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly people. Less frequently, gastritis has been observed. These can 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 ulcers or are elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medicine.

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

Cardiovascular risks:

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

It is important that you take the lowest dose of Inacid Retard that relieves/controls your symptoms for the shortest necessary time.

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

Risk of severe skin reactions:

Medicines 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 suffering these reactions is at the beginning of treatment (usually within the first month of treatment). If you experience 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 liver reactions:

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

Vision:

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

Other precautions:

Tell your doctor if you have a headache, possibly with dizziness and drowsiness after taking Inacid Retard.

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

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

Your doctor may indicate the need for blood tests during treatment with Inacid Retard to monitor your blood cells, liver function, kidney function, or blood levels of other medicines.

Children and adolescents

Do not administer in children under 14 years old.

Using Inacid Retard with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Certain medicines may interact with Inacid Retard. In these cases, it may be necessary to change the dose or interrupt treatment with one of the other medicines.

This is especially important if you are taking:

• Anticoagulants, antiplatelet agents (to prevent blood clotting).
• Corticosteroids (e.g., cortisone, prednisone) (used to treat various types of inflammation or autoimmune diseases).
• Selective serotonin reuptake inhibitors (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 (to treat certain types of cancer, psoriasis, or rheumatic diseases).
• Cyclosporin (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, renin inhibitors (medicines to treat high blood pressure).
• Digoxin (for the treatment of heart conditions).
• Phenylpropanolamine (appetite suppressant).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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 can cause kidney and heart problems in your fetus. It can affect you and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Inacid Retard during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you will take the minimum dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, Inacid Retard may cause kidney problems in your fetus, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Because the administration of medicines like Inacid Retard has been associated with an increased risk of congenital anomalies/spontaneous abortions, its administration is not recommended during the first and second trimester of pregnancy, unless it is strictly necessary. In these cases, the dose and duration of treatment will be limited to the minimum possible.

Breastfeeding

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

Fertility

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

Driving and using machines

Inacid Retard can cause drowsiness, dizziness, and blurred vision. In these cases, do not drive or use any tools or machinery that require you to be alert.

Inacid Retard contains sucrose

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

3. How to take Inacid Retard

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

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

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

Elderly

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

Use in children and adolescents

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

Patient with kidney problems

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

Method of administration:

Oral.

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

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, Phone: 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 forgotten dose.

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

If you stop taking Inacid Retard

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

4. Possible side effects

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

If you experience any of these side effects, stop taking this medicine and go to your doctor.

• Severe allergic reaction, such as swelling of the face, lips, or throat, wheezing, or difficulty breathing, sudden drop in blood pressure, skin rashes.
• Severe abdominal pain (stomach pain) or other abdominal symptoms.
• Blood in stools.
• Black stools.
• Vomiting blood or dark material that looks like coffee grounds.
• Jaundice (yellowing of the skin and the white of the eyes).
• Blisters or peeling of the skin.
• Irregular red spots 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, disorders of increased liver enzyme test results, abdominal pain, bleeding, or perforation of the 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, urticaria, 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, convulsions, 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, gastrointestinal ulcers in the esophagus, stomach, or small or large intestine, blood in urine, vaginal bleeding, breast enlargement (also in men), breast tenderness, flushing, sweating, nosebleeds, elevated potassium or glucose levels in the blood, glucose in the urine, high levels of urea in the 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 changes, abnormal protein levels in the urine, kidney disorders, kidney failure.

Frequency not known (cannot be estimated from the available data).

Pancreatitis.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

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

5. Storing Inacid Retard

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

No special storage conditions are required.

6. Packaging Content and Additional Information

Composition of Inacid Retard 75 mg

• The active ingredient is indomethacin. Each prolonged-release hard capsule contains 75 mg of indomethacin.
• 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 Packaging Content

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

Inacid Retard 75 mg capsules are packaged in PVC/aluminum blisters, presented in cardboard boxes 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

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

Tel: + 34 932 684 208

Fax: + 34 933 150 469

Date of the last revision of this prospectus:December 2022

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es