Prospect: Information for the user

Atriscal 300 mg coated tablets

Dexibuprofen

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

6. Contents of the package and additional information

Dexibuprofeno, the active substance ofAtriscal, belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs, such as dexibuprofeno, are indicated for the treatment of pain and inflammation. They act by reducing the amount of prostaglandins (substances that control inflammation and pain) produced by the body.

What is Atriscal used for

Atriscalis indicated in adults to relieve:

?pain and inflammation caused by arthritis (when joints wear out);

?menstrual pain;

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

Do not take Atriscal if:

• You are allergic to dexibuprofen or to any of the other components of this medication (listed in section 6);
• You are allergic to acetylsalicylic acid or to other pain-relieving medications (your allergy could cause difficulty breathing, asthma, nasal secretion, skin rash, or facial swelling);
• You have had gastrointestinal bleeding or perforation caused by NSAIDs;
• You have recurrent stomach or duodenal ulcers (vomiting blood, black stools, or diarrhea with blood may be a sign that your stomach or intestine is bleeding);
• You have cerebral hemorrhage (cerebrovascular hemorrhage) or other active bleeding;
• You have an exacerbation of an inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• You are severely dehydrated (e.g., caused by vomiting, diarrhea, or inadequate fluid intake);
• You have severe heart failure or a serious liver or kidney disease;
• You are a woman in the third trimester of pregnancy;
• You have an unknown condition that causes abnormal blood cell formation.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atriscal, if:

• You have had stomach or duodenal ulcers;
• You have had intestinal ulcers, ulcerative colitis, or Crohn's disease;
• You have kidney or liver disease or are an alcoholic;
• You have coagulation disorders (see "Other medications and Atriscal");
• You have edema (fluid retention);
• You have heart disease or high blood pressure;
• You have systemic lupus erythematosus (a disease that affects joints, muscles, and skin) or mixed collagenosis (a disease of the connective tissue);
• You are trying to become pregnant and have difficulty doing so;
• You have asthma or allergies, as it may cause difficulty breathing;
• You have hay fever (allergic rhinitis), nasal polyps, or chronic obstructive respiratory diseases, there is a higher risk of allergic reactions. Allergic reactions may present as asthma (called analgesic asthma), Quincke's edema (swelling mainly in the facial area, lips, eyelids, or genitals) or urticaria;
• You have recently undergone major surgery;
• You have certain hereditary disorders that affect your blood (e.g., intermittent acute porphyria);
• You have an infection - see the heading "Infections" below.

Bleeding, ulceration, or perforation of the gastrointestinal tract, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or previous history of severe gastrointestinal reactions. When bleeding or ulceration occurs, treatment should be discontinued immediately. The risk of bleeding, ulceration, or perforation is higher with increased doses of NSAIDs, in patients with a history of ulcers, particularly if complicated by bleeding or perforation (see section 2), and in elderly patients.

Patients at increased risk should start treatment with the lowest available dose. Consider concomitant treatment with gastroprotective agents (e.g., misoprostol or proton pump inhibitors) for these patients, and also for patients requiring low-dose acetylsalicylic acid concomitantly or other medications that may increase the risk of gastrointestinal bleeding.

If you have had gastrointestinal toxicity, particularly in elderly patients, inform your doctor of any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment.

NSAIDs, such as dexibuprofen, may be associated with a small increase in the risk of myocardial infarction or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking Atriscal if:

• You have heart problems, including heart failure, angina pectoris (chest pain), or if you have had a myocardial infarction, coronary artery bypass surgery, peripheral artery disease, 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 are a smoker.

Rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock with symptoms such as shortness of breath, wheezing, and decreased blood pressure) have been observed with dexibuprofen. Leave off Atriscal immediately and contact your doctor or emergency medical services if you observe any of these symptoms.

Headaches may occur after prolonged treatment with high doses of analgesics (off-label use). In this case, consult your doctor; do not take higher doses of Atriscal for headaches.

Long-term use of analgesics, especially in combination with multiple active analgesic principles, may cause permanent kidney damage, including the risk of renal insufficiency (analgesic nephropathy).

Severe skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis, have been reported in association with treatment. Discontinue Atriscal treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Infections

Atriscal may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Atriscal may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to varicella. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid administering NSAIDs if you have varicella-zoster virus infection.

Other medications and Atriscal

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

-Anticoagulant medications (e.g., for treating coagulation problems/preventing coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine, rivaroxaban, apixaban, or dabigatran) may prolong bleeding time.

-Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, 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 medications may also affect or be affected by Atriscal treatment. Therefore, always consult your doctor or pharmacist before using Atriscal with other medications.Particularly, inform your doctor or pharmacist if you are taking any of the following medications in addition to those mentioned above:

Youmust nottake the following medications withAtriscal, unless under strict medical control:

- Nonsteroidal anti-inflammatory drugs (medications for pain relief, fever, and inflammation). There is an increased risk of developing ulcers or bleeding in the digestive system if you takeAtriscalwith other NSAIDs or acetylsalicylic acid as an analgesic.

Youmaytake the following medications, but for safety reasons, inform your doctor:

• Lithium: a medication used to treat certain mood disorders.Atriscalmay increase the effect of lithium.

?Methotrexate (a medication for cancer or rheumatoid arthritis treatment).Atriscalmay increase the adverse effects of methotrexate.

?Diuretics (medications used to increase urine production), as dexibuprofen may decrease the effects of these medications.

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

?Some antidepressant medications (selective serotonin reuptake inhibitors) may increase the risk of gastrointestinal bleeding.

?Digoxin (a medication for heart disease).Atriscalmay increase the adverse effects of digoxin.

?Immunosuppressants (such as ciclosporin, tacrolimus, sirolimus), sulfonilurea (certain oral diabetes medications), and aminoglycoside antibiotics (medications for infections) - may cause kidney damage.

?Quinolone antibiotics, as it may increase the risk of seizures

?Diuretics that conserve potassium, as they may increase potassium levels in the blood.

?Phenytoin, a medication used to treat epilepsy.Atriscalmay increase the adverse effects of phenytoin.

?Pemetrexed (a medication for certain types of cancer).

?Zidovudine (a medication for HIV/AIDS); dexibuprofen may increase the risk of bleedingin a joint or bleeding that causes inflammation.

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

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

Taking Atriscal with food, drinks, and alcohol

You can takeAtriscalalone, but it is recommended to take it with meals to reduce the possibility of stomach discomfort, especially in prolonged treatments.

Limit or avoid alcohol intake while takingAtriscalas it may increase gastrointestinal problems.

Pregnancy, fertility, and breastfeeding

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

Pregnancy

You should not takeAtriscalin the last 3 months of pregnancy as it may seriously harm your fetus, even at very low doses.It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong labor more than expected.

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

From week 20 of pregnancy, Atriscal may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Fertility

You should not takeAtriscalif you are trying to become pregnantas it may make it difficult to become pregnant.

In rare cases, medications like Atriscal may affect a woman's fertility. Your fertility will return to normal when you stop taking Atriscal.

Breastfeeding

Only small amounts ofAtriscalpass into breast milk. However, if you are breastfeeding your baby, do not takeAtriscalfor long periods or at high doses.

Driving and operating machinery

If you experience side effects such as dizziness, fatigue, vertigo, or blurred vision after takingAtriscal, do not drive or operate hazardous machinery (see section 4. "Possible side effects").

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

You should takeAtriscalwith a glass of water or another liquid.Atriscalacts more quickly if taken without food. Nevertheless, it is recommended to take it with food as it may help you avoid stomach problems, particularly if taken for prolonged periods.

Your doctor may also prescribe another dose. The following dosing instructions refer only to the 300 mg dose prescribed to you.

Do not take more than1tablet ofAtriscalat a time.

Do not take more than4tablets ofAtriscalper day.

Artrosis

The recommended dose is 1 tablet ofAtriscaltwice or three times a day. For acute symptoms, your doctor may increase the dose to 4 tablets ofAtriscalper day.

Dolor durante la menstruación

The recommended dose is 1 tablet ofAtriscaltwice or three times a day.

Dolor leve o moderado

The recommended dose is 1 tablet ofAtriscaltwice a day. If you need higher doses, your doctor may prescribe up to 4 tablets ofAtriscalper day.

You should use the most effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Pacientes con enfermedades de los riñones y/o del hígado

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

Pacientes de edad avanzada

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

Uso en niños y adolescentes

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

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

Si usted toma más Atriscal del que debe:

If you have taken more tablets than you should, or if children have taken this medication accidentally, contact your doctor immediately or visit the nearest hospital to obtain an opinion on the risk and advice on the measures to be taken.

Symptoms may include nausea, stomach pain, vomiting (which may be with blood spots), headache, ringing in the ears, ataxia, confusion, and eye tremors. In high doses, somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low blood pressure, feeling cold, and respiratory problems have been reported.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Si olvidó tomar Atriscal:

Do not take a double dose to compensate for the missed doses. Take the next tablet at the next dose.

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

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

Side effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. Patients over 65 who take this medicine have a higher risk of developing problems associated with side effects.

Side effects depend mainly on the dose and vary from person to person, especially the risk of gastrointestinal side effects depends on the dosage range and treatment duration.

Stop takingAtriscaland seek medical help immediately:

?If you have severe stomach pain, especially when you start takingAtriscal.

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

?If you have chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

?If you have flat, red, circular, or target-shaped patches on your trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions can be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

?If you have a generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

?If you have a generalized, red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

?If you have symptoms such as fever, sore throat, and mouth, flu-like symptoms, fatigue, nasal and skin bleeding. These symptoms may be caused by a reduction in white blood cells in your body (agranulocytosis).

?If you have severe or persistent headache.

?If you have yellowing of the skin and eyes (jaundice).

?If you have facial, tongue, or throat swelling, difficulty swallowing or breathing (angioedema), worsened asthma.

?If you urinate less than normal, have swelling, cloudy urine, or general discomfort, as these may be the first signs of kidney damage or renal insufficiency.

Very common: may affect more than 1in 10 people

• Abdominal discomfort, nausea, indigestion, diarrhea, flatulence, constipation, stomach burning, vomiting, and mild blood loss in the stomach and/or intestines that can cause anemia in exceptional cases.

Common: may affect up to 1in 10 people

- Gastrointestinal ulcers, sometimes with bleeding and perforation (see section 2), black stools (melena), vomiting blood (hematemesis), mouth ulcers, and inflammation (stomatitis ulcerosa), colon inflammation (colitis), worsening of inflammatory bowel disease, complications of diverticulitis of the colon (perforation, fistula).

- Central nervous system disorders such as headaches, dizziness, insomnia, agitation, irritability, or drowsiness, vertigo, fatigue (fatigue).

Rare: may affect up to 1in 100 people

- Gastritis

- Visual disorders

- Hypersensitivity reactions such as urticaria, itching, purple hematoma, and exanthema, as well as asthma attacks (possibly with a drop in blood pressure)

-Facial or throat swelling (angioedema)

• Anxiety
• Tinnitus (ringing in the ears)
• Rhinitis (nasal secretion)
• Dermatitis
• Edema, especially in patients with hypertension or kidney problems, including kidney inflammation and renal insufficiency.

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

-Psychotic reaction

- Toxic amblyopia (loss of vision)

- Auditory disorders

- Renal damage (papillary necrosis), elevated urea levels in the blood, and elevated uric acid levels in the blood

- Liver function problems (usually reversible)

- Depression, confusion, hallucinations

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

- Difficulty breathing (mainly in patients with asthma)

- Inflammation of the esophagus or pancreas, formation of a membrane-like narrowing in the small and large intestine (intestinal stenosis, type diaphragm)

- Edema, high blood pressure, vascular inflammation, palpitations, heart failure

- Liver dysfunction, liver damage, especially during long-term treatment, liver insufficiency, acute liver inflammation (hepatitis), and jaundice

- Photosensitivity reactions

- Blood cell production problems (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding. In these cases, you should stop treatment immediately and consult a doctor. Do not treat these symptoms with painkillers or antipyretic medications.

- There have been reports of worsening of infections related to infection (e.g., necrotizing fasciitis) associated with the use of certain analgesics (NSAIDs). If you experience signs of infection or worsening during the use of dexibuprofen, seek medical attention without delay to investigate if antibiotic treatment is necessary.

- Exceptionally, severe skin infections and complications of soft tissue during varicella infection

- There have been reports of symptoms of aseptic meningitis with neck stiffness, headache, feeling unwell, fever, or altered consciousness when using dexibuprofen. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may be more likely to be affected. Contact a doctor immediately if this occurs.

- Severe forms of skin reactions, such as skin rash with redness and blisters (e.g., Stevens-Johnson syndrome), erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis/Lyell syndrome, hair loss (alopecia)

- Severe hypersensitivity reactions (facial, tongue, and laryngeal edema, dyspnea, tachycardia, hypotension, severe shock), worsened asthma

Not known (the frequency cannot be estimated from available data)

• A severe skin reaction known as DRESS syndrome may occur. DRESS symptoms include: skin rash, fever, lymph node inflammation, and an increase in eosinophils (a type of white blood cell).
• A red, scaly, and generalized rash with subcutaneous nodules and blisters, mainly located on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop using Atriscal if you develop these symptoms and seek medical attention immediately. See section 2.

Medicines likeAtriscalmay be associated with a slight increase in the risk of suffering heart or brain attacks (“myocardial infarction” or “cerebral infarction”).

Reporting of side effects:

If you experience anysideeffects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side 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 store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging and on the blister 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 the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atriscal

• The active ingredient is dexibuprofen. A 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 content of the container

The 300 mg tablets are white and round.

Diameter: approximately 11.2 mm

Height: approximately 5.2 mm

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

Not all container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Gebro Pharma

Av. Tibidabo 29 (Barcelona)

08022 Spain

Responsible for manufacturing:

GEBRO PHARMA GmbH

A-6391 Fieberbrunn (Austria)

This medicine is authorized in the Member States of the European Economic Area (EEA) with 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 last review of this leaflet: December 2024

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