Leaflet:information for the patient

Aliviosin 100 mg suppositories

Indometacin

Read this 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, consult your doctor or pharmacist.

- This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Aliviosin is and for what it is used

2. What you need to know before starting to use Aliviosin

3. How to use Aliviosin

4. Possible side effects

5. Storage of Aliviosin

6. Contents of the pack and additional information

Aliviosin contains indometacin as the active ingredient, belonging to the group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.

It is indicated for symptomatic treatment in patients who suffer from:

- Rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the joints of the spine) and osteoarthritis.

- Acute gout attack.

- Acute musculoskeletal processes.

- Post-traumatic inflammation, pain, and swelling situations.

It is essential to use the smallest effective dose to alleviate/control pain and not to use Aliviosin for a longer period than necessary to control symptoms.

Do not use Aliviosin:

- If you are allergic to indomethacin, salicylates, and other nonsteroidal anti-inflammatory drugs (NSAIDs) or to any of the other components of this medication (listed in section 6).

- If you have asthma, urticaria, or rhinitis after taking acetylsalicylic acid or other NSAIDs.

- If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract. History of recurrent stomach injuries.

- If you have active gastrointestinal ulcers (two or more episodes of ulceration or bleeding confirmed).

- If you have a recent history of rectal inflammation, hemorrhoids, or rectal bleeding (bleeding through the rectum).

- If you have severe heart failure.

- If you are in the third trimester of pregnancy or breastfeeding.

- Children under 14 years old.

- If you are taking other NSAIDs (e.g., naproxen) or COX-2 inhibitors (e.g., celecoxib).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Aliviosin:

- If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, in patients with a history of stomach or duodenal ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector. Your doctor should prescribe the lowest doses that provide sufficient pain relief. Inform your doctor if you experience any unusual abdominal symptoms.

- If gastrointestinal bleeding or ulcers occur, discontinue treatment immediately.

Inform your doctor:

- If you experience bleeding or coagulation disorders.

- If you are taking medications that alter blood coagulation, such as corticosteroids, oral anticoagulants, or antiplatelet agents like acetylsalicylic acid. 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, Aliviosin-type medications may worsen these conditions.

- If you have a history of high blood pressure or congestive heart failure, kidney or liver disease.

- If you have fluid retention due to liver, kidney, or heart disease.

- If you have peripheral artery disease (a problem with leg circulation).

- If you have diabetes mellitus, hyperlipidemia, or are a smoker.

- If you have Systemic Lupus Erythematosus (SLE) or other connective tissue disorders.

The use of anti-inflammatory medications (indomethacin) may be associated with a moderate increase in the risk of myocardial infarction or stroke. This risk is higher when using high doses and prolonged treatment. Your doctor should assess the suitability of treatment. It is essential to take the lowest dose of Aliviosin that alleviates/control symptoms for the minimum necessary time.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

During prolonged treatment, periodic eye examinations are recommended, as corneal deposits and retinal changes have been reported.

At the beginning of treatment, headaches may occur, sometimes accompanied by dizziness. The incidence is minimized by starting with low doses that will be gradually increased. These symptoms usually disappear as treatment continues or when the dose is reduced, but if they persist after reducing the dose, treatment should be discontinued.

It will be used with caution in patients with psychiatric disorders, epilepsy, or Parkinson's disease, as the medication may exacerbate these conditions in some cases.

Like all potent anti-inflammatory medications, it may mask the symptoms of an underlying infection. Use with caution in patients with a controlled existing infection.

Be cautious in post-operative patients, as bleeding time is prolonged. If you have undergone surgery or are about to undergo it, contact your doctor before using this medication.

In patients with blood disorders, such as decreased white blood cells, red blood cells, or platelets, use should be avoided.

Women trying to become pregnant or undergoing fertility studies. Inform your doctor of your intention to become pregnant and if you have had difficulty becoming pregnant.

In rare cases, liver toxicity (liver damage) has been associated with the use of indomethacin. As with many other NSAIDs, a temporary elevation of liver-related parameters in blood tests may be expected. However, if abnormal liver values persist or worsen, or if signs or symptoms of liver disease appear, or if other effects occur, such as eosinophilia (increased levels of a type of white blood cell) or skin rashes, treatment should be discontinued. In chronic treatments, it is recommended to periodically control liver function.

This medication may be associated with rare but severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. The highest risk is at the beginning of treatment. If skin rashes, blisters, mouth ulcers, or any allergic reaction symptoms appear, discontinue Aliviosin and consult your doctor.

Your doctor may ask you to undergo some tests to monitor your liver function, blood cell counts, and effects on your stomach and intestines, especially if you are an elderly patient. If you have a history of high blood pressure or congestive heart failure, your doctor may request additional monitoring.

Children and adolescents

It is contraindicated in children under 14 years old.

Elderly patients

Elderly patients have a higher incidence of adverse reactions, such as bleeding and gastrointestinal perforation.

Use of Aliviosin with other medications

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

The use ofacetylsalicylic acidmay decrease indomethacin plasma levels.

The administration withdiflunisalmay increase indomethacin plasma levels by one-third, with decreased renal elimination. Concomitant use of both medications is not recommended.

Take usual precautions in combined treatments ofanticoagulants and anti-inflammatory medications.

This medication may reduce the effect ofdiuretics and anti-hypertensives. It may reduce the anti-hypertensive effect of beta-blockers (e.g., atenolol), alpha-blockers (e.g., prazosin), angiotensin-converting enzyme inhibitors (ACEIs) (e.g., captopril), angiotensin II receptor antagonists (e.g., valsartan), thiazide diuretics (e.g., hydrochlorothiazide), loop diuretics (e.g., furosemide), or medications like hydralazine, nifedipine. In case of concomitant administration, the anti-hypertensive treatment should be reassessed.

It may also increase lithium plasma levels in patients undergoing maintenance treatment with lithium carbonate, by decreasing renal elimination. Therefore, frequent plasma level determinations of lithium should be performed when starting combined treatment.

Theprobencidmay also elevate indomethacin plasma levels. It may be necessary to reduce the dose during combined treatment.

Inform your doctor or pharmacist if you are using:

- Other NSAIDs, including acetylsalicylic acid, naproxen, or COX-2 inhibitors (e.g., celecoxib) or diflunisal (for pain and inflammation).

- Medications used to thin the blood: oral anticoagulants like warfarin, antiplatelet agents like clopidogrel.

- Digoxin (for heart failure and irregular heart rhythm).

- Phenylpropanolamine (decongestant in cold medications).

- Quinolone antibiotics.

- Cyclosporine (immunosuppressant).

- Methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis).

- Corticosteroids.

- Selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, citalopram, paroxetine.

- Haloperidol (antipsychotic).

- Sulfonilureas (oral antidiabetic).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not administer during pregnancy or breastfeeding. Indomethacin is excreted in breast milk.

Precautions during pregnancy and in women of childbearing age

Due to the association of Aliviosin-type medications with an increased risk of congenital anomalies/abortions, their 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 should be limited to the minimum possible.

During the third trimester of pregnancy, the administration of Aliviosin is contraindicated.

For women of childbearing age, consider that Aliviosin-type medications have been associated with a decrease in the ability to become pregnant.

Driving and operating machinery

Due to the risk of dizziness, somnolence, or vision problems, take precautions when driving or operating machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 Aliviosin for more time than necessary to control symptoms.

The recommended dose is:

Adults

The usual dose is 100 mg to 200 mg of indometacina (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 response of the patient and how the patient tolerates the medication.

Maximum daily dose

You should not use more than 200 mg of indometacina per day.

Older adults

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

Use in children and adolescents

Aliviosin should not be used in children under 14 years old.

Patients with kidney problems

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

Administration form:

Rectal route.

If you use more Aliviosin than you should

In case of accidental massive ingestion, the symptoms of overdose are: nausea, vomiting, upper stomach pain, abdominal pain, intestinal bleeding, diarrhea, disorientation, excitement, coma, dizziness, fainting, occasional convulsions, feeling sick, loss of appetite, drowsiness, headache, buzzing or noise in the ears, restlessness, and agitation.

The treatment in these cases will consist of a stomach wash and supportive treatment. The patient should be monitored for several days considering the possibility of a delayed reaction of ulceration or digestive bleeding. Administering antacids may be useful to minimize the risk.

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 use Aliviosin

Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Aliviosin

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.

If you experience any of these side effects, stop using 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 rashes.

- Severe abdominal pain (stomach pain) or other abdominal symptoms.

- Blood in stool.

- Black stools.

- Vomiting blood or dark material that looks like ground coffee.

- Jaundice (yellowing of the skin and white part of the eyes).

- Blisters or skin peeling.

- Irregular red patches on the skin of the hands and arms.

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

Loss of appetite, nausea, vomiting, stomach discomfort, abdominal pain, constipation or diarrhea. Oral inflammation, stomach inflammation, large intestine hemorrhages, either hidden or caused by intestinal wall injuries, or by perforation of pre-existing large intestine injuries.

Other described effects are ulcers (single or multiple) in the esophagus or small intestine, sometimes with bleeding or perforation, gastrointestinal bleeding without evidence of ulcers, increased abdominal pain in patients with pre-existing ulcerative colitis.

Common (may affect up to 1 in 10 people)

Headache, dizziness, or dizziness.

Rare (may affect up to 1 in 100 people)

Very low white blood cell counts in the blood, lack of blood cell production in the bone marrow, decrease in white blood cell counts in the blood.

Insomnia, hallucinations, psychotic episodes.

Blurred vision, double vision, eye pain and around it. Corneal deposits and retinal disorders, including the appearance of dark spots in the visual field.

Tinnitus (ringing in the ears).

Itching, urticaria, inflammation of blood vessels, angioneurotic edema (swelling of the skin in areas such as eyelids, lips, or genitals), erythema nodosum (inflammation of the skin in the form of painful nodules, usually on the front of the legs), skin rashes, skin peeling, hair loss, rapid drop in blood pressure resembling a "shock” state, bronchospasm, or acute respiratory insufficiency.

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

Depression, anxiety, and nervousness, changes in personality, mental confusion.

Somnolence, convulsions, coma, syncope, nerve root alterations, involuntary muscle movements or muscle weakness. Most of these effects are transient or disappear when the dose is reduced, but sometimes they require suspension of treatment.

Swelling, fluid retention, high blood pressure, and heart failure associated with treatment with NSAIDs. Medicines like Aliviosin may be associated with a moderate increase in the risk of suffering a heart attack (“myocardial infarction”) or stroke.

Acute kidney inflammation with blood in the urine, proteins in the urine, and sometimes large amounts of protein loss in the urine. Renal failure in patients with pre-existing severe or moderate renal insufficiency or sodium retention.

Intestinal ulceration followed by abnormal narrowing and obstruction.

Liver injury.

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

Blood disorders, including a decrease in platelet count, skin spots due to blood vessel rupture, decrease in red blood cell count due to altered production or increased destruction, and blood coagulation disorders.

Anemia due to iron deficiency, associated with maintained blood loss or gastrointestinal blood loss.

Loss of hearing.

Hepatitis or jaundice.

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

If any of the following reactions occur: yellowing of the skin or eyes, discontinue treatment and immediately inform the doctor.

Medicines like Aliviosin may be associated, in very rare cases, with severe blistering reactions on the skin and mucous membranes, such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Vaginal bleeding, high blood glucose levels, presence of glucose in urine (glucosuria), nasal bleeding (epistaxis), mouth ulcers (ulcers) in the oral mucosa.

Adverse reactions reported due to the pharmaceutical form of Aliviosin

In the case of indomethacin suppositories, the following have been described: feeling of needing to defecate (tenesmus), rectal inflammation (proctitis), vaginal bleeding or discomfort, pain, burning, or itching.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use. https://www.notificaram.es. By reporting adverse 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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Aliviosin

The active ingredient is indometacina. Each suppository contains 100 mg of indometacina.

The other components (excipients) are: Massa estearinum B.

Appearance of the product and contents of the packaging

Aliviosin suppositories are presented in packaging containing 20 suppositories (4 blisters with 5 suppositories each).

The suppository is of a light yellow color.

Holder of the marketing authorization and responsible for manufacturing

Especialidades Farmacéuticas Centrum, S.A.

C/ Sagitario, 14

03006, Alicante

Spain

Telephone: +34 965 28 67 00

Fax: +34 965 28 64 34

Email:[email protected]

Last review date of this leaflet: June 2017

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