Artrinovo 50 mg suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Artrinovo 50 mg suppositories

indometacin

Read the entire leaflet carefully before you start using 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, 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 Artrinovo is and what it is used for
2. What you need to know before using Artrinovo
3. How to use Artrinovo
4. Possible adverse effects
5. How to store Artrinovo
6. Contents of the pack and other information

1. What Artrinovo is and what it is used for

Artrinovo contains indometacin as the active substance, which belongs to a group of medicines known as non-steroidal anti-inflammatory and antirheumatic 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 disorders.
• Post-traumatic inflammatory conditions, pain, and swelling.

2. What you need to know before using Artrinovo

Do not use Artrinovo:

• if you are allergic to indometacin, salicylates, or other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other components of this medicine (listed in section 6).
• if you have experienced asthma, urticaria, rhinitis, or another allergic reaction after taking acetylsalicylic acid or other NSAIDs.
• if you have a history of gastrointestinal bleeding, intestinal bleeding, or perforation related to previous treatment with NSAIDs.
• if you currently have active or recurrent gastrointestinal ulceration (two or more distinct episodes of ulceration or bleeding confirmed).
• if you suffer from severe heart disease.
• if you are in the third trimester of pregnancy or during lactation.
• if you are undergoing treatment for perioperative pain in the case of 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 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 medicine.

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

Inform your doctor if you currently have or have previously had any of the following conditions:

• Gastrointestinal bleeding, ulcers, or perforations in the stomach or intestine, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• 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 reduced white blood cells, red blood cells, or platelets.
• If you have coagulation disorders or are receiving anticoagulant therapy.

Consult your doctor before starting to use Artrinovo:

• If you are simultaneously taking medications that affect blood coagulation or increase the risk of ulcers, such as 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 suffer from Crohn’s disease or ulcerative colitis, as medicines 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 associated with medicines like Artrinovo are gastrointestinal: peptic ulcers, gastrointestinal bleeding, and 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 prior warning.

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 medication.

If you experience abdominal pain, vomiting blood or material resembling ground coffee, or black stools, these may be symptoms of gastrointestinal bleeding. Stop taking Artrinovo immediately and seek medical help without delay.

Cardiovascular precautions

Medicines like Artrinovo 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 must assess the appropriateness of treatment. It is important to use the lowest effective dose of Artrinovo that relieves/controls symptoms for the shortest duration necessary. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of 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), you should discuss this treatment with your doctor or pharmacist.

In addition, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Risk of serious skin reactions

This medicine may very rarely be associated with serious skin adverse 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). If you develop skin rashes, possibly with blistering or mucosal ulcers (e.g., in the mouth), or other symptoms of an allergic reaction, stop using Artrinovo and consult your doctor immediately.

Risk of hepatic reactions

Medicines like Artrinovo may be associated with liver problems causing yellowing of the skin and eyes, sometimes accompanied by high fever or swelling and tenderness 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 develop headache, possibly accompanied by dizziness and drowsiness after taking Artrinovo. The incidence of these symptoms can be minimized by starting with low doses, which are gradually increased. These symptoms usually disappear during continued treatment or upon dose reduction, but if they persist after dose reduction, the medication should be discontinued.

In some cases, Artrinovo may worsen psychiatric disorders, epilepsy, or Parkinson’s disease. Therefore, if you suffer from any of these conditions and notice a 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 postoperative patients, as bleeding time may be prolonged. If you have undergone or are about to undergo surgery, contact your doctor before using this medicine.

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

Children and adolescents

This medicine is contraindicated in children under 14 years of age.

Patients over 65 years of age

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

Other medicines and Artrinovo

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

Certain medicines may interact with Artrinovo. 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 (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).
• 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 (a decongestant in cold medicines).
• Sulfonylureas (oral antidiabetic agents).

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 medicine.

Pregnancy and breastfeeding:

During pregnancy or breastfeeding, the use of indometacin is not recommended. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor. Indometacin is excreted in breast milk.

Precautions during pregnancy and in women of childbearing potential

Because administration of medicines like Artrinovo has been associated with an increased risk of congenital abnormalities or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless considered strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

In the third trimester, administration of this medicine is contraindicated (see section "Do not take Artrinovo").

Fertility:

For women of childbearing potential, it should be noted that Artrinovo may reduce the ability to conceive.

Driving and using machines

This medicine may cause drowsiness, dizziness, and blurred vision. In such cases, do not drive or operate any tools or machinery that require alertness.

3. How to use Artrinovo

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

Your doctor will determine the dose you should use and the duration of treatment. It is important 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 night, before going to bed. If necessary, a second dose of 50 mg (one suppository) 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 4 suppositories (200 mg of indometacina) per day.

Use in children and adolescents

This medicine must not be used in children under 14 years of age.

Patients aged 65 years and older

Elderly patients may be more sensitive to the effects of this medicine. Therefore, it is especially important that elderly patients inform their doctor immediately of any adverse reactions they experience.

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

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 Artrinovo than you should

In case of accidental overdose, symptoms may include nausea, vomiting, severe headache, dizziness, mental confusion, disorientation, drowsiness, paresthesia, ataxia, and convulsions.

Treatment in these cases will consist of gastric lavage and supportive treatment. The patient should be monitored for several days due to the possibility of delayed gastrointestinal ulceration or bleeding.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Artrinovo

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

If you stop using Artrinovo

If you have any further 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 will experience them.

If you experience any of the following adverse effects, stop using this medicine and seek immediate medical attention:

• 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 the stool.
• Black-colored stools.
• Vomiting blood or dark material that looks like coffee grounds.
• Jaundice (yellowing of the skin and the whites of the eyes).
• Blisters 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, increase in liver enzyme test results, 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, hives, 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, 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, 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 cell, deficiency of red blood cells, decrease in platelets, bleeding into the skin, coagulation disorders, deposits in the cornea of the eye, retinal disturbances, abnormal amounts of protein in the urine, kidney disorders, renal failure.

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

Inflammation of the pancreas.

Adverse reactions reported due to the pharmaceutical form

Specifically in the case of indometacin suppositories, the following have been described: sensation of needing to defecate (tenesmus), inflammation of the rectum (proctitis), vaginal bleeding or sensation of 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 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 of Artrinovo

Do not store at temperatures above 30°C.

Do not use this medicine after the expiry date 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Artrinovo

• The active substance is indometacin. Each suppository contains 50 mg of indometacin.
• The other components are monohydrate lactose and solid semisynthetic glycerides.

Nature of the product and pack contents

Artrinovo 50 mg suppositories are presented as white, torpedo-shaped suppositories.

They are available in packs of 12 suppositories and 100 suppositories (hospital pack).

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 most recent review of this leaflet: July 2020

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