ARTRINOVO 25 mg HARD CAPSULES

2. What you need to know before taking Artrinovo

Do not take Artrinovo

• if you are allergic to indomethacin, salicylates, and other non-steroidal anti-inflammatory drugs or to any of the other components of this medication (listed in section 6).
• if you have had asthma, hives, rhinitis, or other allergic reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• if you have had a history of stomach bleeding, intestinal bleeding, or perforation related to previous treatments with NSAIDs.
• if you have active or recurrent gastrointestinal ulcers (two or more different episodes of ulceration or bleeding confirmed).
• if you have severe heart disease.
• if you are in the third trimester of pregnancy or breastfeeding.
• if you are undergoing treatment for perioperative pain 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 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:

• Gastrointestinal bleeding, ulcers, or perforations in the stomach or intestine, which may be manifested by severe or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• Hypertension, heart problems, or having suffered 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 decreased white blood cells, red blood cells, or platelets.
• If you have coagulation disorders or are receiving treatment with anticoagulants.

Consult your doctor before starting to take Artrinovo:

• If you are taking medications that alter blood coagulation or increase the risk of ulcers, such as 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 medications like Artrinovo may worsen these conditions. If you experience abdominal pain, diarrhea, or vomiting, stop taking Artrinovo and inform your doctor immediately.

Gastrointestinal risks

The most frequent adverse effects that occur with medications like Artrinovo 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 if you are elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

If you experience abdominal pain, vomiting blood or material resembling coffee grounds, 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 in prolonged treatments. Your doctor should assess the suitability of the treatment. It is essential to use the lowest dose of Artrinovo that alleviates/controls the symptoms for the minimum necessary time. Do not exceed the recommended dose or treatment duration.

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

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

Risk of severe skin reactions

This medication may be associated, in very rare cases, with severe adverse reactions in the skin, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. The higher 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 (for example, in the mouth), or other symptoms of an allergic reaction, stop taking 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 headache, possibly with dizziness and drowsiness after taking Artrinovo. The incidence is minimized by starting with low doses that will be progressively increased. These symptoms usually disappear as treatment continues or when the dose is reduced, but if they persist after dose reduction, 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 disorders and notice worsening, you should consult your doctor about this treatment.

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

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

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

Children and adolescents

This medication is contraindicated in children under 14 years old.

Patient over 65 years old

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

Other medications and Artrinovo

Inform your doctor or pharmacist if you are using, have recently used, 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 interrupt treatment with one of the other medications.

This is especially important if you are taking:

• 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 (SSRIs) (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 (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 (medications to treat high blood pressure).
• Digoxin (for the treatment of heart diseases).
• Phenylpropanolamine (decongestant in cold medications).
• Sulfonylureas (oral antidiabetic)

Pregnancy, breastfeeding, and fertility

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

Pregnancy and breastfeeding:

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

Precautions during pregnancy and in women of childbearing age

Since the administration of medications like Artrinovo has been associated with an increased risk of congenital anomalies/abortions, their administration is not recommended during the first and second trimester of pregnancy unless 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 take Artrinovo").

Fertility:

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

Driving and using machines

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

3. How to take Artrinovo

Follow 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 take and the duration of the treatment. It is essential to use the lowest dose that controls your pain and not to take Artrinovo for longer than necessary to control the symptoms.

The recommended dose is:

Adults

The recommended dose is 50 mg to 200 mg of indomethacin per day, administered in divided doses.

In chronic processes (rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis): it should be started with low doses (1 capsule: 25 mg of indomethacin, every 8-12 hours). If necessary, the dose can be progressively increased by 25 mg (1 capsule) to 50 mg (2 capsules) up to a maximum of 200 mg of indomethacin (8 capsules) per day.

In acute attack of gout: it is recommended to take 2 capsules (50 mg of indomethacin) every 8 hours, up to a maximum of 200 mg of indomethacin (8 capsules) per day.

In musculoskeletal processes, muscle pain, and inflammation: the usual dose is 1 capsule (25 mg of indomethacin) every 6 or 8 hours, until the disappearance of symptoms (usually one or two weeks).

Maximum daily dose:

Do not take more than 8 capsules (200 mg of indomethacin) per day.

Use in children and adolescents

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

Patient over 65 years old

Elderly patients may be more sensitive to the effects of this medication. Therefore, it is especially important that elderly patients immediately inform their doctor of any adverse reactions that occur. Your doctor may prescribe a lower dose and reduce the duration of treatment.

Patient withkidney problems

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

Form 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 Artrinovo than you should

In case of accidental massive ingestion, the symptoms of overdose are nausea, vomiting, severe headache, dizziness, confusion, disorientation, drowsiness, paresthesia, stupor, and convulsions.

Treatment in these cases will consist of stomach lavage and supportive treatment. The patient should be kept under surveillance for several days considering the possibility of a delayed reaction of digestive ulceration or bleeding.

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 forget to take Artrinovo

Do not take a double dose to make up for forgotten doses. Take the capsule as soon as you remember and continue with the next one at the usual time.

If you interrupt treatment with Artrinovo

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of these side effects, stop taking this medication 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 stools.
• Black stools.
• Vomiting blood or dark material that resembles coffee grounds.
• Jaundice (yellowing of the skin and the white part 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):

Tinnitus, hearing disorders, changes in liver enzyme test results, abdominal pain, bleeding, or perforation of the intestine, mouth inflammation, stomach irritation, flatulence, swelling due to fluid retention, hair loss.

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

Itching of the skin, hives, inflammation of blood vessels, skin rash, sudden difficulty breathing, asthma, fluid in the lungs, psychological disorders, delirium, 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 the 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):

Decreased white blood cells, deficiency of a type of white blood cells, deficiency of red blood cells, decreased platelets, bleeding in 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 available data):

Pancreatitis.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Artrinovo

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the indicated month.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medications at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

1. Package contents and additional information

Composition of Artrinovo

• The active ingredient is indomethacin. Each hard capsule contains 25 mg of indomethacin.
• The other components (excipients) are: aluminum chlorhydroxyallantoinate, aluminum dihydroxyallantoinate, microcrystalline cellulose, magnesium stearate, quinoline yellow, titanium dioxide, and gelatin.

Appearance of the product and package contents

Artrinovo is presented in the form of hard yellow capsules. Artrinovo is packaged in aluminum/PVC blisters containing 30 hard capsules, 100 hard capsules, or 500 hard capsules (clinical packaging).

Marketing authorization holder

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona, Spain

Manufacturer

Laboratorios Llorens, S.L.

C/ Llacuna, 19-21

08005 Barcelona, Spain

Date of the last revision of this leaflet: July 2020

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

6. Package contents and additional information

Composition of Artrinovo

• The active ingredient is indomethacin. Each hard capsule contains 25 mg of indomethacin.
• The other components (excipients) are: aluminum chlorhydroxyallantoinate, aluminum dihydroxyallantoinate, microcrystalline cellulose, magnesium stearate, quinoline yellow, titanium dioxide, and gelatin.

Appearance of the product and package contents

Artrinovo is presented in the form of hard yellow capsules. Artrinovo is packaged in aluminum/PVC blisters containing 30 hard capsules, 100 hard capsules, or 500 hard capsules (clinical packaging).

Marketing authorization holder

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona, Spain

Manufacturer

Laboratorios Llorens, S.L.

C/ Llacuna, 19-21

08005 Barcelona, Spain

Date of the last revision of this leaflet: July 2020

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