Product Information for the User

Atriscal 400 mg Film-Coated Tablets

Dexibuprofen

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, 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 product information. See section 4.

6. Contents of the pack 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 may cause difficulty breathing, asthma, nasal secretion, skin rash, or facial swelling);
• You have had gastrointestinal bleeding or perforation caused by NSAIDs;
• You have recurring 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 accident) 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 get pregnant and have difficulty doing so;
• You have asthma or allergies, as it may cause breathing difficulties;
• 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 (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 blood disorders (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 stopped 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 who require low-dose acetylsalicylic acid concomitantly or other medications that may increase the risk of gastrointestinal bleeding.

If you have previously experienced 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, including dexibuprofen, may be associated with a small increase in the risk of myocardial infarction or stroke, especially 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 heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the 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 are a smoker.

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

You may experience headaches 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 combinations of more than one active analgesic principle, may cause permanent kidney damage, including the risk of renal insufficiency (analgesic nephropathy).

Cutaneous reactions

Severe cutaneous 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 (GAP), have been reported in association with treatment. Interrupt treatment with Atriscal and seek medical attention immediately if you notice any of the symptoms related to these severe cutaneous 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 chickenpox. If you take this medication while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Avoid administering NSAIDs if you have a varicella-zoster virus infection (chickenpox).

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., to treat coagulation problems/prevent 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 treatment with Atriscal. 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 you are under strict medical supervision:

- 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 a pain reliever.

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).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 medications for depression (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), sulfonylureas (certain oral diabetes medications), and aminoglycoside antibiotics (medications for infections) - there may be 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 bleeding in a joint or bleeding that causes inflammation.

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

?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 risk of stomach discomfort, especially with prolonged treatment.

Limit or avoid alcohol consumption 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.Atriscalmay cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and delay or prolong labor.

You should not take Atriscal during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor.Atriscalmay cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding your baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

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 your baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your 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 get pregnant as 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 any other 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 dosage instructions refer only to the 400 mg dose prescribed to you.

Do not take more than1tablet ofAtriscalat a time.

Do not take more than3tablets ofAtriscalper day.

Arthritis

The recommended dose is 1 tablet ofAtriscaltwice a day (1 tablet in the morning and 1 at night). For acute symptoms, your doctor may increase the dose to 3 tablets ofAtriscalper day.

Menstrual pain

The recommended dose is 1 tablet ofAtriscaltwice a day.

Mild or moderate pain

The recommended dose is 200 mg ofAtriscal(break a 400 mg tablet) three times a day. If you need higher doses, your doctor may prescribe up to 3 tablets ofAtriscalper day.

You should use the lowest 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).

The tablet can be divided into two equal doses. To divide the tablet,place it on a hard surface and press down with your two index fingers or thumbs.

Patients with kidney and/or liver disease

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

Older patients

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.

Use in children and adolescents

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

If you estimate that the action ofAtriscalis too strong or 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 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.

If you forgot to take Atriscal:

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

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 dose 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 red, non-elevated patches, in the shape of a target or circles on the 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, and 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), worsening 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 1 in 10 people

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

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 (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.

Rare: may affect up to 1 in 100 people

• Gastritis
• Visual disorders
• Hypersensitivity reactions such as urticaria, itching, purple hematoma (purpura), and exanthema, as well as asthma attacks (possibly with a drop in blood pressure)

-Swelling of the face or throat (angioedema)

• Anxiety
• Tinnitus (ringing in the ears)

-Nasal secretion (rhinitis)

• Skin eruptions
• Edema, especially in patients with hypertension or kidney problems, including kidney inflammation and renal insufficiency

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

-Psychotic reaction

-Loss of vision (amblyopia toxica)

• 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 1 in 10,000 people

- Difficulty breathing (predominantly in patients with asthma),

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

- Edema, high blood pressure, inflammation of blood vessels, 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, pancitopenia, 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 loss of 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 skin reactions, such as skin rash with redness and blisters (e.g., Stevens-Johnson syndrome), erythema multiforme, toxic epidermal necrolysis/Lyell syndrome, hair loss (alopecia)

- Severe hypersensitivity reactions (swelling of the face, tongue, and larynx, dyspnea, tachycardia, hypotension, severe shock), worsening asthma

Unknown (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, located mainly 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 any type ofsideeffects, consult your doctor or pharmacist, even if it is a side effect that does not appear 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 pack after CAD.The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAtriscal

• The active principle is dexibuprofen. A coated tablet contains 400 mg of dexibuprofen.

• The other components are:

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

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

Appearance of the product and contents of the packagingThe 400 mg tablets are white and are scored on both sides.

Length: approximately 18.2 mm

Width: approximately 8.2 mm

Height: approximately 5.9 mm

Atriscalis presented in packaging of 4, 10, 20, 30, 50, 60, 90 and 100 coated tablets in transparent and colourless PVC/PVDC/aluminium blisters.

Not all packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratorios Gebro Pharma

Av. Tibidabo 29 (Barcelona)

08022 Spain

Responsible manufacturer:

GEBRO PHARMA GmbH

A-6391 Fieberbrunn (Austria)

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

Austria:Movone 400 mg Filmtabletten

Spain:Atriscal 400 mg coated tablets

GermanyDeltaran 400 mg Filmtabletten

Spain:Atriscal 400 mg coated tablets

Romania:Seractil 400 mg film-coated tablets

Last review date of this leaflet:December 2024

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