Inacid 100 mg suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Inacid 100 mg suppositories

Indometacin

Read the entire leaflet carefully before you start using 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Inacid is and what it is used for

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

Inacid is indicated for symptomatic treatment in patients suffering from:

• Rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the joints of the spine), and osteoarthritis.
• Acute gout attack.
• Acute musculoskeletal disorders.
• Conditions involving inflammation, pain, and post-traumatic swelling.

2. What you need to know before using Inacid

Do not use Inacid:

• if you are allergic to indometacina 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 perioperative pain following coronary artery bypass graft (CABG) surgery, a procedure to treat a blocked heart artery,
• if you are under 14 years of age,
• if you have a history of proctitis (inflammatory lesions of the rectum) or recent rectal bleeding.

Warnings and precautions

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

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

Inform 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 have had a stroke.
• Severe skin disorders.
• Severe liver disease or abnormal liver function tests.
• Renal insufficiency.
• 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.
• Allergies to the components of Inacid 100 mg suppositories.

Inform your doctor:

• If you are 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 could 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 indometacina may worsen these conditions. If abdominal pain, diarrhea, or vomiting occurs, stop using Inacid and inform your doctor immediately.

Gastrointestinal risks:

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

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 using Inacid and seek immediate medical attention.

Cardiovascular risks:

Medicines like Inacid 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 may cause it to rise.

It is important to take the lowest effective dose of Inacid that relieves/controls your symptoms for the shortest necessary duration.

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

Risk of serious skin reactions:

Medicines like Inacid 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 of treatment). 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 and consult your doctor immediately.

Risk of hepatic reactions:

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

Vision:

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

Other precautions:

Inform your doctor if you experience headache, possibly with dizziness and drowsiness, after using Inacid.

In some cases, Inacid may worsen psychiatric disorders, epilepsy, or Parkinson’s disease. Therefore, if you suffer from any of these conditions and notice worsening symptoms, discuss this treatment with your doctor.

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

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

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

Children and adolescents

Do not administer to children under 14 years of age.

Using Inacid with other medicines

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

Certain medicines may interact with Inacid. 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, plasma 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 during the last three months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your fetus. 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 during the first six 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 after week 20 of pregnancy, Inacid 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 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 limited to the minimum possible.

Breastfeeding

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

Fertility

Inacid 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 may cause drowsiness, dizziness, and blurred vision. In such cases, do not drive or operate any tools or machinery requiring alertness.

Inacid 100 mg suppositories contain butylhydroxyanisole and butylhydroxytoluene

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

3. How to use Inacid

Follow exactly the instructions for administering 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 that you use the lowest dose that controls your pain and that you do not use Inacid for longer than necessary to control your symptoms.

The recommended dose is:

Adults

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

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

Maximum daily dose

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

Elderly patients

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

Use in children and adolescents

Inacid 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 using this medicine.

Method of administration:

Rectal use.

If you use more Inacid than you should

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

If you forget to use Inacid

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

If you stop treatment with Inacid

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 the stool.
• Black stools.
• Vomiting blood or dark material resembling coffee grounds.
• Jaundice (yellowing of the skin and whites of the eyes).
• Blistering 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 (ringing in the ears), hearing disorders, increased results in liver enzyme tests, 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, 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 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, increased 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 the urine, vaginal bleeding, breast enlargement (also in men), breast tenderness, redness, sweating, nosebleeds, elevated levels of potassium or glucose in the blood, glucose in the urine, elevated blood urea levels.

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, skin hemorrhages, coagulation disorders, deposits in the cornea of the eye, retinal disorders, abnormal amounts of protein in the urine, kidney disorders, renal failure.

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

Inflammation of the pancreas.

Reporting of adverse effects

If you experience any 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 instructions for 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

Store below 30 °C.

6. Contents of the pack and other information

Composition of Inacid 100 mg suppositories

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

Appearance of the product and contents of the pack

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

Inacid 100 mg suppositories are packed in PE/aluminum blisters, presented in cardboard packs 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 Athens-Lamia (Avlona)

Greece

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

Euromed Pharma Sapin, 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 review of this leaflet: December 2022

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