Atriscal 300 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Atriscal 300 mg film-coated tablets

Dexibuprofen

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Atriscal is and what it is used for

2. What you need to know before taking Atriscal

3. How to take Atriscal

4. Possible side effects

5. How to store Atriscal

6. Contents of the container and other information

1. What Atriscal is and what it is used for

Dexibuprofen, the active substance in Atriscal, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs, such as dexibuprofen, are indicated for the treatment of pain and inflammation. They work by reducing the amount of prostaglandins (substances that regulate inflammation and pain) produced by the body.

What Atriscal is used for

Atriscal is indicated in adults for the relief of:

• pain and inflammation caused by osteoarthritis (when joints wear down);

• menstrual pain;

• mild to moderate pain, such as muscle and joint pain or dental pain.

2. What you need to know before taking Atriscal

Do not take Atriscal if:

• you are allergic to dexibuprofen or to any of the other components of this medicine (listed in section 6);
• you are allergic to acetylsalicylic acid or to other pain-relieving medicines (your allergy may cause breathing difficulties, asthma, runny nose, skin rash, or swelling of the face);
• you have had gastrointestinal bleeding or perforation caused by NSAIDs;
• you currently have or have previously had recurrent stomach or duodenal ulcers (vomiting blood, black stools, or bloody diarrhea may be signs that your stomach or intestine is bleeding);
• you have active cerebral hemorrhage (cerebrovascular hemorrhage) or other active bleeding;
• you have an exacerbation of an inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• you suffer from severe dehydration (e.g., caused by vomiting, diarrhea, or insufficient fluid intake);
• you have severe heart failure or severe kidney or liver disease;
• you are a woman in the third trimester of pregnancy;
• you have an undiagnosed condition causing abnormal blood cell formation.

Warnings and precautions

Talk to your doctor or pharmacist before taking Atriscal if:

• you have previously had stomach or duodenal ulcers;
• you have previously had intestinal ulcers, ulcerative colitis, or Crohn's disease;
• you have kidney or liver disease or are alcohol-dependent;
• you have a blood clotting disorder (see "Other medicines and Atriscal");
• you have edema (fluid retention);
• you have heart problems or high blood pressure;
• you have systemic lupus erythematosus (a disease affecting joints, muscles, and skin) or mixed connective tissue disease (a collagen disorder affecting connective tissue);
• you are trying to become pregnant but are having difficulty;
• you currently suffer or have previously suffered from asthma or allergic diseases, as breathing difficulties may occur;
• you have hay fever (allergic rhinitis), nasal polyps, or chronic obstructive respiratory disorders, as you may be at higher risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), Quincke's edema (swelling mainly in the face, lips, eyelids, or genitals), or urticaria;
• you have recently undergone major surgery;
• you have certain inherited blood disorders (e.g., acute intermittent porphyria);
• you have an infection – see the "Infections" heading below.

Gastrointestinal bleeding, ulceration, or perforation, which may be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or prior history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, treatment must be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation increases with higher NSAID doses, in patients with a history of ulcers (particularly if complicated by bleeding or perforation – see section 2), and in elderly patients.

These patients should start treatment with the lowest available dose. Concomitant treatment with gastroprotective agents (e.g., misoprostol or proton pump inhibitors) should be considered for these patients, as well as for those requiring concomitant low-dose acetylsalicylic acid or other medications that may increase gastrointestinal risk.

If you previously experienced gastrointestinal toxicity, especially in old age, inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment.

Anti-inflammatory/analgesic medicines such as dexibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.

Discuss your treatment with your doctor or pharmacist before taking Atriscal if:

• you have heart problems, including heart failure, angina (chest pain), previous heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock with symptoms such as shortness of breath, wheezing, and low blood pressure) have been observed. With dexibuprofen, signs of allergic reaction to this medicine such as breathing difficulties, facial and neck swelling (angioedema), and chest pain have been reported. Stop using Atriscal immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

You may experience headaches after prolonged use of high doses of analgesics (use outside approved indications). In this case, consult your doctor; do not take higher doses of Atriscal for headache relief.

In general, habitual use of analgesics, especially in combinations of more than one analgesic active ingredient, may cause permanent kidney damage, including risk of kidney failure (analgesic nephropathy).

Skin reactions

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with treatment. Discontinue treatment with Atriscal and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Infections

Atriscal may mask signs of infection, such as fever and pain. Therefore, Atriscal may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with varicella. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor without delay.

You should avoid administration of NSAIDs if you have an infection with varicella zoster virus (chickenpox).

Other medicines and Atriscal

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

Atriscal may affect or be affected by other medicines. For example:

• anticoagulants (e.g., drugs to treat or prevent clotting, such as acetylsalicylic acid, warfarin, ticlopidine, rivaroxaban, apixaban, or dabigatran) may prolong bleeding time.
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan).
• voriconazole and fluconazole (CYP2C9 inhibitors), used for fungal infections, as the effect of dexibuprofen may increase.

Other medicines may also affect or be affected by treatment with Atriscal. Therefore, you should always consult your doctor or pharmacist before using Atriscal with other medicines. In particular, inform your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

You must not take the following medicines with Atriscal unless under strict medical supervision:

• Non-steroidal anti-inflammatory drugs (medicines for pain, fever, and inflammation). The risk of gastrointestinal ulcers or bleeding increases if you take Atriscal together with other NSAIDs or acetylsalicylic acid as an analgesic.

You may take the following medicines, but for safety reasons, you should inform your doctor:

• Lithium: a medicine used to treat certain mood disorders. Atriscal may increase the effect of lithium.

? Methotrexate (a medicine used to treat cancer or rheumatoid arthritis). Atriscal may increase the adverse effects of methotrexate.

? Diuretics (medicines used to increase urine elimination), as dexibuprofen may reduce the effectiveness of these medicines.

? Corticosteroids: The risk of gastrointestinal ulcers and bleeding may be increased.

? Certain antidepressants (selective serotonin reuptake inhibitors) may increase the risk of gastrointestinal bleeding.

? Digoxin (a medicine used to treat heart disorders). Atriscal may increase the adverse effects of digoxin.

? Immunosuppressants (such as cyclosporine, tacrolimus, sirolimus), sulfonylureas (certain oral antidiabetic medicines), and aminoglycoside antibiotics (medicines used to treat infections) – kidney damage may occur.

? Quinolone antibiotics, as they may increase the risk of seizures.

? Potassium-sparing diuretics, as they may increase blood potassium levels.

? Phenytoin, a medicine used to treat epilepsy. Atriscal may increase the adverse effects of phenytoin.

? Pemetrexed (a medicine used to treat certain types of cancer).

? Zidovudine (a medicine used to treat HIV/AIDS); dexibuprofen may increase the risk of bleeding into a joint or hemorrhagic inflammation.

? Baclofen (a muscle relaxant): side effects of baclofen may develop after starting dexibuprofen treatment.

? Sulfinpyrazone, probenecid (medicines for gout), as the excretion of dexibuprofen may be delayed.

Taking Atriscal with food, drinks, and alcohol

You may take Atriscal alone, but it is recommended to take it with food to reduce the possibility of stomach discomfort, especially during prolonged treatment.

You should limit or avoid alcohol intake while taking Atriscal, as gastrointestinal problems may be increased.

Pregnancy, fertility, and breastfeeding

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

Pregnancy

You must not take Atriscal during the last 3 months of pregnancy, as it may seriously harm the fetus, even at very low doses. It may cause kidney and heart problems in your fetus. It may affect your and your baby's ability to bleed normally and may delay or prolong labor beyond expected.

You should not take Atriscal during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, Atriscal may cause kidney problems in your fetus if taken for more than a few days, which may lead 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.

Fertility

You should not take Atriscal if you are trying to become pregnant, as it may make it more difficult to conceive.

Rarely, medicines such as Atriscal may affect female fertility. Your fertility will return to normal once treatment with Atriscal is stopped.

Breastfeeding

Only small amounts of Atriscal pass into breast milk. However, if you are breastfeeding, you should not take Atriscal for prolonged periods or at high doses.

Driving and Use of Machines

If you experience adverse effects such as dizziness, fatigue, vertigo, or blurred vision after taking Atriscal, you should not drive or operate dangerous machinery (see section 4. "Possible adverse effects").

3. How to take Atriscal

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

You should take Atriscal with a glass of water or another liquid. Atriscal works faster if taken without food. However, it is recommended to take it with food, as this may help you avoid stomach problems, particularly if you take it for prolonged periods.

Your doctor may also prescribe you a different dose. The following dosage instructions refer only to the 300 mg dose prescribed to you.

Do not take more than 1 tablet of Atriscal in a single dose.

Do not take more than 4 tablets of Atriscal per day.

Osteoarthritis

The recommended dose is 1 tablet of Atriscal two or three times a day. For acute symptoms, your doctor may increase your dose up to 4 tablets of Atriscal per day.

Menstrual pain

The recommended dose is 1 tablet of Atriscal two or three times a day.

Mild or moderate pain

The recommended dose is 1 tablet of Atriscal twice a day. If higher doses are needed, your doctor may prescribe up to 4 tablets of Atriscal per day.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe you a lower than usual dose. Do not increase the dose prescribed by your doctor.

Elderly patients

If you are over 60 years old, your doctor may prescribe you a lower than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Use in children and adolescents

There is insufficient experience in children and adolescents; therefore, Atriscal should not be used in patients under 18 years of age.

If you think that the effect of Atriscal is too strong or too weak, inform your doctor or pharmacist.

If you take more Atriscal than you should:

If you have taken more tablets than you should, or if children have accidentally taken this medicine, contact your doctor immediately or go to the nearest hospital for advice on the risk and measures to take.

Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, ataxia, confusion, and eye tremors. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood pressure, feeling cold, and breathing difficulties have been reported.

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

It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Atriscal:

Do not take a double dose to make up for forgotten doses. Take the next tablet at the next scheduled dose.

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 may cause adverse effects, although not everyone experiences them.

Adverse effects can be minimized by taking the lowest effective dose for the shortest time necessary to relieve symptoms. Elderly patients using this medicine are at higher risk of developing problems associated with adverse effects.

Adverse effects are mainly dose-dependent and may vary from patient to patient. In particular, the risk of gastrointestinal adverse effects depends on the dosage range and duration of treatment.

Stop taking Atriscal and seek immediate medical help if:

? you have severe stomach pain, especially when you start taking Atriscal.

? you have black stools, bloody diarrhea, or you vomit blood.

? you have chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

? you develop flat, red, target-shaped or circular skin rashes on the trunk, often with blisters in the center, skin peeling, or mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

? you develop a widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).

? you develop a widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

? you experience symptoms such as fever, sore throat and mouth, flu-like symptoms, feeling tired, nosebleeds, or skin bleeding. These symptoms may be due to a reduction in white blood cells (agranulocytosis).

? you have severe or persistent headache.

? you develop yellowing of the skin or whites of the eyes (jaundice).

? you have swelling of the face, tongue, or throat, difficulty swallowing or breathing (angioedema), or worsening asthma.

? you pass less urine than normal, have swelling, cloudy urine, or feel generally unwell, as these could be early signs of kidney damage or kidney failure.

Very common: may affect more than 1 in 10 people

• Gastrointestinal discomfort such as abdominal pain, discomfort, indigestion, diarrhea, flatulence, constipation, heartburn, vomiting, and minor gastrointestinal bleeding which may rarely lead to anemia.

Common: may affect up to 1 in 10 people

• Gastrointestinal ulcers, sometimes with bleeding and perforation (see section 2), black stools (melena), vomiting blood (hematemesis), mouth ulcers and inflammation (ulcerative stomatitis), inflammation of the colon (colitis), worsening of inflammatory bowel disease, complications of colon diverticula (perforation, fistula).
• Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, drowsiness, vertigo, fatigue.

Uncommon: may affect up to 1 in 100 people

• Gastritis
• Visual disturbances
• Hypersensitivity reactions such as urticaria, itching, purple bruising (purpura), and rash, as well as asthma attacks (possibly with low blood pressure)
• Swelling of the face or throat (angioedema)
  • Anxiety
  • Ringing in the ears (tinnitus)
  • Nasal discharge (rhinitis)
  • Skin rashes
  • Development of edema, especially in patients with high blood pressure or kidney problems, including kidney inflammation and kidney failure

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

• Psychotic reaction
• Loss of vision (toxic amblyopia)
• Hearing disorders
• Kidney damage (papillary necrosis), elevated blood urea levels, and elevated blood uric acid levels
• Liver function disorders (usually reversible)
• Depression, confusion, hallucinations

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

• Difficulty breathing (predominantly in patients with bronchial asthma)
• Inflammation of the esophagus or pancreas, development of a membrane-like narrowing in the small and large intestine (intestinal strictures, diaphragm-type)
• Edema, high blood pressure, inflammation of blood vessels, palpitations, heart failure
• Liver dysfunction, liver damage (especially during long-term treatment), liver failure, acute liver inflammation (hepatitis), and jaundice
• Photosensitivity reactions
• Problems with blood cell production (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nosebleeds, and skin bleeding. In such cases, treatment must be stopped immediately and a doctor consulted. Do not treat these symptoms with painkillers or fever-reducing medicines (antipyretics).
• Worsening of infection-related inflammation (e.g., necrotizing fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen during dexibuprofen use, consult a doctor immediately to determine whether anti-infective/antibiotic treatment is needed.
• Very rarely, severe skin infections and soft tissue complications during varicella infection
• Symptoms of aseptic meningitis such as neck stiffness, headache, malaise, fever, or altered consciousness have been observed with dexibuprofen use. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor immediately if this occurs.
• Severe skin reactions such as rash with redness and blisters (e.g., Stevens-Johnson syndrome), erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis/Lyell syndrome, hair loss (alopecia)
• Severe generalized hypersensitivity reactions (facial, tongue, and laryngeal swelling, dyspnea, tachycardia, hypotension, severe shock), worsening asthma

Not known (frequency cannot be estimated from available data)

• A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell).
• A widespread, red, scaly rash with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Atriscal if you develop these symptoms and seek immediate medical attention. See also section 2.

Medicines like Atriscal may be associated with a slight increase in the risk of heart attacks ("myocardial infarction") or strokes.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can 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 Atriscal

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging and on the blister 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 containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atriscal

• The active substance is dexibuprofen. One film-coated tablet contains 300 mg of dexibuprofen.

• The other components are:

Tablet core: hypromellose, microcrystalline cellulose, calcium carmellose, anhydrous colloidal silica, talc.

Film coating: hypromellose, titanium dioxide (E171), triacetin, talc, macrogol 6000.

Appearance of the product and contents of the pack

The 300 mg tablets are white and round.

Diameter: approximately 11.2 mm
Height: approximately 5.2 mm

Atriscal is available in packs of 10, 20, 30, 50, 60, 90 and 100 film-coated tablets in transparent, colorless PVC/PVDC/aluminum blisters.

Not all pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Gebro Pharma
Av. Tibidabo 29 (Barcelona)
08022 Spain

Manufacturer:

GEBRO PHARMA GmbH
A-6391 Fieberbrunn (Austria)

This medicinal product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Austria: Movone 300 mg Filmtabletten
Germany: Deltaran 300 mg Filmtabletten
Spain: Atriscal 300 mg film-coated tablets
Romania: Seractil 300 mg film-coated tablets

Date of the most recent review of this package leaflet: December 2024

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