Package Insert: Information for the User

Ibufén Xpress 400 mg Granule for Oral Solution

Ibuprofen (arginine)

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.

• For advice on any matter relating to this medicine or for information about any side effects, consult your pharmacist.

• Consult your doctor or pharmacist if you experience any side effects, even if they do not appear in this package insert. See section 4.
• You should consult a doctor if symptoms worsen, or fever persists for more than 3 days or pain for more than 5 days.

Ibuprofen, the active ingredient of this medication, acts by reducing pain and fever.

This medication is used in adults and adolescents 12 years of age or older (weight equal to or greater than 40 kg), for symptomatic relief of occasional mild to moderate pain, such as headaches, toothaches, menstrual cramps, muscle spasms, or back pain (lumbago), as well as febrile states.

Do not take Ibufén Xpress

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial, lip, or tongue swelling, nasal discharge, difficulty breathing, bronchospasm, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer, or have experienced gastrointestinal bleeding.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have an active cerebral or other bleeding.
• If you have bleeding disorders or coagulation problems, or are taking anticoagulant medications used to "thin" the blood). If anticoagulants are necessary, your doctor will perform coagulation tests.
• If you have severe heart failure.
• If you have severe dehydration caused by vomiting, diarrhea, or inadequate fluid intake.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibufén Xpress.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration. Do not take more than 3 sachets of granules (1200 mg of ibuprofen) per day to avoid possible cardiovascular or heart problems.

Inform your doctor

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you have an infection.
• Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay the proper treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the symptoms persist or worsen, consult a doctor without delay.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause renal insufficiency as a consequence of dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.
• If you take anticoagulant medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications to urinate), as your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and may cause symptoms such as urine discoloration, bloody urine, or liver disease), so your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• If you experience visual disturbances during ibuprofen treatment, discontinue treatment and consult your doctor for an ophthalmological examination.
• It is possible to experience allergic reactions with this medication. Treatment should be discontinued if redness, inflammation, or skin lesions appear.
• 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 (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibufén Xpress treatment and seek medical attention immediately if you notice any symptoms related to these severe cutaneous reactions described in section 4.
• Stop taking this medication and consult your doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe cutaneous reaction. See section 4.
• Your doctor will perform a more stringent control if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Discontinue Ibufén Xpress use immediately and contact your doctor or emergency medical services if you observe any of these signs.

It isimportantto use the smallest effective dose that alleviates or controlsyour painand not to take this medication for longer than necessary to control your symptoms.

Avoid concurrent administration withotherNSAIDs, includingthoseknown asCox-2 inhibitors.

Precautions in elderly patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

NSAIDs like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses.

Do not exceed the recommended dose or treatment duration.

Inform your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, 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 are a smoker.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Respiratory problems

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial allergies, or other respiratory problems, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in these patients.

Children and adolescents

There is a risk of renal insufficiency in dehydrated children and adolescents.

This medication is not recommended for children and adolescents weighing less than 40 kg or under 12 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Precautions during pregnancy and in women of childbearing age

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause renal and cardiac problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless strictly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible.

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

For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Interference with laboratory tests

• Bleeding time (may be prolonged for 1 day after discontinuing treatment).
• Blood glucose concentration (may decrease).
• Clearance of creatinine (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase).
• With liver function tests: increased values of transaminases.

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Other medications and Ibufén Xpress

Inform your doctor or pharmacist if you aretaking,have taken recentlyor may need to take anyother medication.

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

The following medications should not be taken with ibuprofen without consulting your doctor:

• Aspirin or other NSAIDs increase the risk of gastrointestinal ulcers and bleeding.
• Beta-blockers, ACE inhibitors, and angiotensin II receptor antagonists: NSAIDs may reduce the effect of these medications and other substances that lower blood pressure. Concurrent administration of ibuprofen and diuretics that save potassium may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent blood clots in blood vessels) like ticlopidine.
• Anticoagulant medications (thin the blood) like warfarin.
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite (slows down the growth of certain cells produced by the body).
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hypnotics like phenobarbital.
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like prednisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas like tolbutamide or insulin (used to treat diabetes), may need to adjust the dose.
• Some antidepressants (selective serotonin reuptake inhibitors).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Trombolytics (dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba.
• Inhibitors of CYP2C9 (responsible for metabolizing numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medications may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using ibuprofen with other medications.

Taking Ibufén Xpress with food, drinks, and alcohol

Take this medication with meals or with milk.

Do not administer ibuprofen with alcohol to avoid damaging the stomach. Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy and breastfeeding

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

Ibuprofenshould not be taken during pregnancy, especially during the third trimester (see section “precautions during pregnancy and in women of childbearing age”).

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no undesirable effects have been reported in the infant, it is usually not necessary to discontinue breastfeeding during short-term use at recommended doses.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take a single dose ofibuprofen (arginine)or take it for a short period, no special precautions are necessary.

Ibufén Xpress contains aspartame, saccharose, and sodium

This medication contains 25 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 57.5 mg of sodium (main component of table salt/for cooking) in each sachet, which is equivalent to 2.9% of the recommended daily maximum sodium intake for an adult.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

The recommended dose is:

-Adults and adolescents over 12 years of age and weighing 40 kg or more: Take one packet (400 mg of ibuprofen) every 6 or 8 hours as needed. Do not take more than 3 packets (1,200 mg of ibuprofen) in 24 hours.

-Older patients: The dose should be established by the doctor, as there may be a need to reduce the usual dose.

-Patients with kidney, liver, or heart disease: Reduce the dose and consult a doctor.

Always use the lowest effective dose.

The administration of this medication is dependent on the appearance of pain or fever. As these symptoms disappear, the medication should be discontinued.

You should consult a doctor if symptoms worsen or do not improve, if fever persists for more than 3 days or pain for more than 3 days in adolescents or 5 days in adults.

Use in children

This medication is not recommended for use in children and adolescents weighing less than 40 kg or under 12 years of age, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Administration form

This medication is administered orally.

Dissolve the entire contents of a packet in a glass of water and ingest immediately. Take this medication with meals or with milk, especially if digestive discomfort is noted.

IfyoutakemoreIbufén Xpress than you should

If you have taken more Ibufén Xpress than you should, or if a child has taken the medication accidentally, consult a doctor immediately or the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

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, to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), diarrhea, dizziness, spasms, hypotension, or depression of the nervous system (reduction of consciousness) headache, ringing in the ears, confusion, and involuntary eye movement. It may also cause agitation, disorientation, or coma. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

Rarely, more severe symptoms such as gastrointestinal bleeding, low blood pressure, seizures, and respiratory disturbances may occur. Asthma exacerbation is possible in asthmatics. In case of significant overdose, renal insufficiency and liver damage may occur.

Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if significant amounts have been ingested and within the 60 minutes following ingestion.

If you forget to take Ibufén Xpress

Do not take a double dose to compensate for the missed doses.

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at your usual time.

If you have any other doubts 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.

The side effects of medicines like ibuprofen (arginine) are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

Frequencies are established according to the following classification: very common (can affect more than 1 in 10 patients), common (can affect up to 1 in 10 patients), uncommon (can affect up to 1 in 100 patients), rare (can affect up to 1 in 1,000 patients), very rare (can affect up to 1 in 10,000 patients) and unknown frequency (cannot be estimated from available data).

The following side effects have been observed:

Infections and infestations

Very rare: Exacerbation of infections-related inflammation (for example, the development of necrotizing fasciitis), coinciding with the use of nonsteroidal anti-inflammatory drugs.

Nota:If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to see a doctor immediately, if necessary to initiate anti-infective/antibiotic therapy.

Blood and lymphatic system disorders

Rare: Aplastic anemia (insufficiency of the bone marrow to produce different types of cells).

Very rare: Decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red, white, and platelet cells in the blood), agranulocytosis (very large decrease in granulocytes), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, nasal and cutaneous bleeding. Prolonged bleeding time.

Immune system disorders

Uncommon: Allergic reaction, hypersensitivity reactions with skin rash and pruritus, as well as asthma attacks (possibly accompanied by a drop in blood pressure).

Rare: Anaphylaxis (generalized allergic reaction).

Very rare: Severe hypersensitivity reactions (these may be characterized by swelling of the face, tongue, and larynx with bronchospasm, dyspnea, tachycardia, and hypotension that may include potentially fatal shock).

Nota:In the event of these symptoms, which may occur with the first use, immediate assistance from a doctor is required.

Mental disorders

Uncommon: Insomnia, anxiety, restlessness.

Rare: Psychotic reaction, nervousness, irritability, depression, confusion, disorientation.

Nervous system disorders

Common: Fatigue or drowsiness, headache, and dizziness or sensation of instability.

Uncommon: Insomnia, excitement, irritability.

Rare: Paresthesia (numbness, tingling, burning, etc. more frequent in hands, feet, arms, or legs).

Very rare: Aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases) which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Eye disorders

Uncommon: Vision disturbances.

Rare: Abnormal or blurred vision.

Unknown frequency: Papilledema (inflammation of the optic nerve).

Ear and labyrinth disorders

Common: Vertigo.

Uncommon: Ringing or buzzing in the ears.

Rare: Hearing difficulty.

Cardiac disorders

Medicines like ibuprofen (arginine) may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Very rare: Palpitations, heart failure.

Unknown frequency: Cardiac failure and chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Vascular disorders

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with ibuprofen (arginine) type medicines.

Very rare: Hypertension.

Unknown frequency: Arterial thrombosis.

Respiratory, thoracic, and mediastinal disorders

Uncommon: Asthma, worsening of asthma, bronchospasm, dyspnea (breathing difficulty).

Unknown frequency: Irritation of the throat.

Gastrointestinal disorders

The most common side effects that occur with medicines like ibuprofen (arginine) are gastrointestinal: Peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients.

Common: Gastrointestinal disturbances such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that may cause anemia in exceptional cases.

Uncommon: Gastrointestinal ulcers, potentially with bleeding and perforation, stomatitis, exacerbation of colitis and Crohn's disease, melena (blood in stool), gastritis.

Rare: Vomiting with blood.

Very rare: Inflammation of the esophagus, pancreatitis, intestinal stenosis.

Unknown frequency: Anorexia.

Hepatobiliary disorders

Rare: Liver damage, hepatitis (inflammation of the liver), abnormalities of liver function, and jaundice (yellowing of the skin and eyes).

Skin and subcutaneous tissue disorders

Common: Skin rash.

Uncommon: Redness of the skin, itching or swelling of the skin, purpura (purple spots on the skin).

Rare: Anaphylactic reaction.

Very rare: Medicines like ibuprofen (arginine) may be associated, in very rare cases, with severe bullous reactions such as Stevens-Johnson syndrome (disseminated erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis). Hair loss, erythema multiforme (skin lesion). Exceptionally, severe cutaneous infections and complications in the soft tissue may occur during chickenpox.

Unknown frequency: The skin becomes sensitive to light (photosensitivity), worsening of skin reactions.

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized red scaly rash, with bumps under the skin and blisters, located mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking ibuprofen (arginine) if you experience these symptoms and seek medical attention immediately. See section 2.

Renal and urinary disorders

Rare: Hematuria (blood in urine).

Very rare: Edema (signs that may indicate kidney disease, which may include renal insufficiency); renal tissue damage (papillary necrosis), increased serum uric acid concentration.

Based on the experience with nonsteroidal anti-inflammatory drugs in general, cases of interstitial nephritis, nephrotic syndrome, and renal insufficiency cannot be ruled out.

General disorders

Very rare: Exacerbation of inflammation during infectious processes.

Unknown frequency: Edema.

Complementary examinations

Rare: Alteration of liver function tests.

Unknown frequency: Alteration of renal function tests.

Until now, no severe allergic reactions have been reported with ibuprofen (arginine), although they cannot be ruled out. The manifestations of this type of side effect could be fever, skin rash, abdominal pain, severe headache, nausea, vomiting, angioedema, facial swelling, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure) or shock.

If any of the following side effects occur, discontinue treatment and seek immediate medical attention:

• Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee ground-like appearance.
• Blood in stool or diarrhea with blood.
• Severe abdominal pain.
• Significant blisters or peeling of the skin.
• Severe headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Visual disturbances.
• Red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized red scaly rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

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 that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: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.

This medication does not require special storage conditions.

Do not usethis medicationafter the expiration date that appears on the packaging 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.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of 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 ofIbufén Xpress

• The active ingredient is ibuprofen. Each blister pack contains 400 mg of ibuprofen as ibuprofen (arginine).

• The other components (excipients) are: L-Arginine, aspartame (E-951), sucrose, sodium saccharin (E-954), sodium hydrogen carbonate (E-500), peppermint aroma, anhydrous colloidal silica, and sodium lauryl sulfate.

Appearance ofIbufén Xpressand contents of the packaging

White granule with a characteristic peppermint odor.

It is presented in blister packs of a composite metal foil consisting of a printed coating on one side + extruded polyethylene + aluminum + heat-sealable resin.

Each package contains 12 or 20 blister packs.

Holder of the marketing authorization and responsible for manufacturing

LCinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Last review date of this leaflet:November 2024

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