Leaflet: information for the user

Artrinovo 50 mg suppositories

indometacin

Read this leaflet carefully before you start taking this medicine, because 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. Do not give it 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 isArtrinovo and what it is used for

2. What you need to know before starting to useArtrinovo

3. How to useArtrinovo

4. Possible side effects

5. Storage ofArtrinovo

6. Contents of the pack and additional information

Artrinovo contains indometacin as the active ingredient, which belongs to the group of medications known as non-steroidal anti-inflammatory and anti-rheumatic drugs.

Artrinovo is indicated for symptomatic treatment in patients suffering from:

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

Do not use Artrinovo:

• If you are allergic to indometacin, 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 had asthma, urticaria, rhinitis, or other allergic reactions after taking acetylsalicylic acid or other NSAIDs.
• If you have had a history of gastrointestinal bleeding, intestinal bleeding, or perforation related to previous treatment with NSAIDs.
• If you have an active or recurrent gastrointestinal ulcer (two or more episodes of ulceration or bleeding confirmed).
• If you have a serious heart disease.
• If you are in the third trimester of pregnancy or breastfeeding.
• If you are undergoing perioperative pain treatment in the case of coronary artery bypass grafting (CABG), heart surgery to treat a blocked coronary artery.
• If you are under 14 years old.
• If you have a recent history of rectal inflammation, hemorrhoids, or rectal bleeding (bleeding through the rectum).

Warnings and precautions

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

You should avoid taking Artrinovo with other NSAIDs, including other anti-inflammatory medications such as selective cyclooxygenase-2 (COX-2) inhibitors.

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

Consult your doctor before starting to use Artrinovo:

Gastrointestinal risks

The most common adverse effects that occur with medications like Artrinovo are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in older adults. Less frequently, gastritis has been observed. These may occur at any time during treatment with or without prior warning.

The risk of gastrointestinal bleeding is higher when using high doses, if you have a history of peptic ulcers, or are an older adult. In these cases, your doctor may consider associating a stomach protector medication.

If you experience abdominal pain, vomiting of blood or coffee ground material, or black stools, these may be symptoms of gastrointestinal bleeding. Stop taking Artrinovo and seek medical help immediately.

Cardiovascular precautions

Medications like Artrinovo may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarction") or strokes. This risk is more likely to occur when used in high doses and for prolonged periods. Your doctor should evaluate the suitability of treatment. It is essential to use the lowest dose of Artrinovo that alleviates/controls symptoms for the shortest time necessary. Do not exceed the recommended dose or duration of treatment.

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

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

Risk of severe skin reactions

This medication may be associated with rare and 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 eruptions, possibly with the formation of blisters or mucosal ulcers (for example, in the mouth), or other symptoms of an allergic reaction, stop using Artrinovo and consult your doctor immediately.

Risk of liver reactions

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

Vision

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

Other precautions

Inform your doctor if you experience headaches, possibly with dizziness and drowsiness after taking Artrinovo. 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, the medication should be discontinued.

In some cases, Artrinovo may worsen psychiatric disorders, epilepsy, and Parkinson's disease. Therefore, if you suffer from any of these conditions and notice an improvement, you should consult this treatment with your doctor.

Like other NSAIDs, Artrinovo may mask the symptoms of an infection.

Care should be taken in post-operative patients, as bleeding time is prolonged. If you have undergone a surgical procedure or are about to undergo one, contact your doctor before using this medication.

Your doctor may instruct you to undergo blood tests during treatment with Artrinovo to monitor your blood cells, liver function, renal function, or blood levels of other medications.

Children and adolescents

This medication is contraindicated in children under 14 years old.

Patients over 65 years old

Older adults experience a higher incidence of adverse reactions, such as bleeding and gastrointestinal perforation.

Other medications and Artrinovo

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

Certain medications may interact with Artrinovo. In these cases, it may be necessary to change the dose or discontinue treatment with one of the other medications.

This is especially important if you are taking:

• Anticoagulants, antiplatelet agents (to prevent blood coagulation).
• Corticosteroids (e.g., cortisone, prednisone) (used to treat various types of inflammation or autoimmune diseases).
• Selective serotonin reuptake inhibitors (SSRIs) (used to treat depression).
• Acetylsalicylic acid (aspirin) or other NSAIDs, including selective COX-2 inhibitors.
• 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).
• Ciclosporin (used to suppress the immune system).
• Lithium (used to treat a certain type of depression).
• Diuretics, angiotensin receptor antagonists, angiotensin-converting enzyme inhibitors (ACE inhibitors), and renin-angiotensin system blockers (used to treat high blood pressure).
• Digoxin (used to treat heart diseases).
• Fenilpropanolamine (decongestant in cold medications).
• Sulfonilureas (oral antidiabetic).

Pregnancy, lactation, and fertility

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

Pregnancy and lactation:

In the case of pregnancy or lactation, the use of indometacin is not recommended. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor. Indometacin is excreted in breast milk.

Precautions during pregnancy and in fertile women

Due to the administration of medications like Artrinovo being associated with an increase in the risk of congenital anomalies/abortions, the administration of the same during the first and second trimesters of pregnancy is not recommended, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of this medication is contraindicated (see "Do not use Artrinovo").

Fertility:

For women of childbearing age, it should be noted that Artrinovo may reduce the ability to become pregnant.

Driving and operating machinery

This medication may cause drowsiness, dizziness, and blurred vision. In these cases, do not drive or use any hazardous tools or machinery that require being alert.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 essential to use the lowest dose that controls your pain and not to use Artrinovo for longer than necessary to control symptoms.

The recommended dose is:

Adults

The recommended dose is one suppository (50 mg) at bedtime. If necessary, a second dose of 50 mg (one suppository) in the morning.The dose is determined based on the individual patient's response and how the patient tolerates the medication.

Maximum daily dose:

You should not use more than 4 suppositories (200 mg of indometacin) per day.

Use in children and adolescents

This medication should not be used in children under 14 years old.

People over 65 years old

Older patients may be more sensitive to the effects of this medication. Therefore, it is especially important for older patients to immediately inform their doctor of any adverse reactions that occur.

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

Patients withkidney problems

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

Administration form:

Rectal route.

Using more Artrinovo than you should

In case of accidental massive ingestion, the symptoms of overdose arenausea, vomiting, intense headache, dizziness, mental confusion, disorientation, drowsiness, paresthesia, drowsiness, and seizures.

The treatment in these cases will consist of a stomach lavage and supportive treatment. You should maintain patient surveillance for several days due to the possibility of a delayed reaction of ulceration or digestive hemorrhage.

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 Artrinovo

Do not use a double dose to compensate for the missed doses.Insert the suppository as soon as you remember and continue with the next one at the usual time.

Stopping treatment with Artrinovo

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

Like all medicines,this medicinecan cause side effects, although not everyone will experience them.

If you experience any of these side effects, stop using this medicine and go to the doctor immediately:

• 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 stool.
• Black stools.
• Vomiting blood or dark material that looks like coffee grounds.
• Jaundice (yellowing of the skin and white part of the eyes).
• Blisters or peeling of the skin.
• Irregular red patches 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, liver enzyme test result abnormalities, abdominal pain, intestinal bleeding or perforation, mouth inflammation, stomach irritation, flatulence, fluid retention, hair loss.

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

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

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

Decreased white blood cells, deficiency of a type of white blood cell, red blood cell deficiency, decreased platelets, skin hemorrhages, coagulation disorders, corneal deposits in the eye, retinal alterations, abnormal protein levels in urine, kidney disorders, renal insufficiency.

Unknown frequency (cannot be estimated from available data):

Pancreatitis inflammation.

Adverse reactions reported due to the pharmaceutical form

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

Reporting of adverse effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for 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.

Do not store at a temperature above 30°C.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Artrinovo

• The active ingredient is indometacina. Each suppository contains 50 mg of indometacina.
• The other components are lactose monohydrate and semi-synthetic solid glycerides.

Appearance of the product and content of the packaging

Artrinovo 50 mg suppositoriesare presented in the form of white, torpedo-shaped suppositories.

They are presented in packaging of 12 suppositories and 100 suppositories (clinical packaging).

Holder of the marketing authorization

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona, Spain

Responsible for manufacturing

Laboratorios Llorens, S.L.

C/ Llacuna, 19-21

08005 Barcelona, Spain

Last review date of this leaflet: July 2020

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