INACID 100 mg SUPPOSITORIES

2. What you need to know before you use Inacid

Do not use Inacid:

• 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 drugs (NSAIDs) have caused you asthma, rhinitis, urticaria, or other allergic reaction,
• 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,
• if you have a history of proctitis (inflammatory lesions of the rectum) or recent rectal bleeding.

Warnings and precautions

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

You should avoid using Inacid 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 blood 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.
• Allergies to the components of Inacid 100 mg suppositories.

Tell your doctor

• If you are taking medications 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 medications 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 medications can worsen these conditions. If you experience abdominal pain, diarrhea, or vomiting, stop using Inacid and inform your doctor immediately.

Gastrointestinal risks:

The most frequent adverse effects that occur with medications like Inacid 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 protective medication.

If you experience abdominal pain, vomiting blood or dark material that looks like coffee grounds, or black stools, these can be symptoms of gastrointestinal bleeding.

Stop using Inacid and seek medical help immediately.

Cardiovascular risks:

Medications like Inacid 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 can cause it to increase.

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

If you have heart problems, have had a heart attack, 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:

Medications like Inacid 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 and consult your doctor immediately.

Risk of liver reactions:

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

Vision:

If you have blurred vision while using Inacid, stop using Inacid and inform your doctor.

Other precautions:

Tell your doctor if you have headaches, possibly with dizziness and drowsiness after using Inacid.

In some cases, Inacid 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 drugs, Inacid can mask the symptoms of an infection.

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

In the case of suppositories, you may occasionally experience the sensation of needing to defecate and irritation of the rectal mucosa.

Children and adolescents

Do not administer in children under 14 years old.

Using Inacid 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. 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 using:

• Anticoagulants, platelet aggregation inhibitors (to prevent blood coagulation).
• 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 if you are in the last 3 months of pregnancy, as it may harm your baby or cause problems during delivery. It can cause kidney and heart problems in your baby. It can affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. You should not take Inacid during the first 6 months of pregnancy unless it is clearly necessary and as your doctor indicates. 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 can cause kidney problems in your baby, 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 medications like Inacid has been associated with a higher 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 secreted in breast milk, therefore, you should not take this medicine if you are breastfeeding.

Fertility

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

Inacid 100 mg suppositories contain butylhydroxyanisole and butylhydroxytoluene

This medicine may produce local reactions on the skin (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxyanisole and butylhydroxytoluene.

3. How to use Inacid

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

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

The recommended dose is:

Adults

The usual dose is 100 mg to 200 mg of indomethacin (1 to 2 suppositories) per day.

It is recommended to administer a 100 mg suppository at night before going to bed and, if necessary, a second dose of 100 mg in the morning. The dose is determined according to the individual patient's response and how the patient tolerates the medication.

Maximum daily dose

Do not use 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 should not be used in children under 14 years old.

Patient with kidney problems

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

Method of administration:

Rectal route.

If you use more Inacid 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 medicine and the amount ingested.

If you forget to use Inacid

Do not take a double dose to make up for the forgotten dose. Take the suppository as soon as you remember and continue with the next one at the usual time. If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

If you stop using Inacid

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 the 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.
• Red, irregular 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 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, redness, 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, blood coagulation disorders, deposits in the cornea of the eye, retinal changes, abnormal protein amounts 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, even if it is possible side effects not listed in this leaflet. You can also report them 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

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 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. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

Store below 30°C.

6. Package Contents and Additional Information

Composition of Inacid 100 mg Suppositories

• The active ingredient is indomethacin. Each suppository contains 100 mg of indomethacin.
• The other components (excipients) are: polyethylene glycol 3350, polyethylene glycol 8000, butylhydroxyanisole (E320), butylhydroxytoluene (E321), ethylenediamine tetraacetic acid, glycerol, and purified water.

Appearance of the Product and Package Contents

The suppository is opaque, white in color with a yellowish tint. One end is flat and the other is pointed.

Inacid 100 mg suppositories are packaged in PE/aluminum blisters, presented in cardboard boxes containing 12 suppositories.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

HAC PHARMA

PERICENTRE II

43 AVENUE DE LA COTE DE NACRE

14000 CAEN

France

Manufacturer

Famar S.A.

Km 49 Atenas-Lamia (Avlona)

Greece

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