Ibuprofen Winadol 600 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Ibuprofen Winadol 600 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, since it could harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

What Ibuprofen Winadol is and what it is used for
What you need to know before taking Ibuprofen Winadol
How to take Ibuprofen Winadol
Possible adverse effects
How to store Ibuprofen Winadol
Contents of the pack and other information

1. What Ibuprofeno Winadol is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used to treat fever, moderate pain including migraine, arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic condition causing damage to cartilage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibuprofeno Winadol

Do not take Ibuprofeno Winadol

If you are allergic to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to acetylsalicylic acid, or to any of the other components of this medicine (listed in section 6). Signs of allergy may include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
If you have severe liver or kidney disease.
If you have an inflammatory bowel disease.
If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the digestive tract.
If you are vomiting blood.
If you have black stools or bloody diarrhea.
If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants simultaneously, your doctor will perform blood coagulation tests.
If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
If you have heart disease.
If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take ibuprofen:

If you have edema (fluid retention).
If you have or have had heart problems or high blood pressure.
If you have asthma or any other respiratory disorder.
If you are receiving treatment with ibuprofen, as it may mask fever—a key sign of infection—making diagnosis more difficult.
If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
This risk is higher when high doses or prolonged treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.
If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
If you have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
If you are taking diuretics (medicines to increase urination), as your doctor should monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
If you are in the first or second trimester of pregnancy.
If you are breastfeeding.
If you have a disease called porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease).
If you suffer from headaches after prolonged treatment (more than 3 months), do not take higher doses of the medicine. If this occurs, stop treatment and consult your doctor.
Allergic reactions may occur with this medicine.
Your doctor will perform stricter monitoring if you receive ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.
Patients treated with ibuprofen long-term should undergo regular medical supervision to monitor for adverse reactions.
If you have an infection; see the section “Infections” below.
Signs of allergic reaction to this medicine, such as breathing difficulties, facial or neck swelling (angioedema), or chest pain, have been reported with ibuprofen. Stop using Ibuprofeno Farmalider immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Infections

Ibuprofeno Winadol may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno Winadol may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Skin reactions

Serious skin reactions have been reported with ibuprofen treatment. Stop taking ibuprofen and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

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 ibuprofen treatment. Discontinue treatment with Ibuprofeno Farmalider and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

It is important to use the lowest dose that relieves/controls pain and not to take this medicine longer than necessary to control your symptoms.

Precautions in elderly patients

Elderly patients are more likely to experience adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Children and adolescents

In dehydrated children and adolescents, there is a risk of kidney failure.

Cardiovascular precautions

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

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary 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.

Also, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Precautions during pregnancy and in women of childbearing potential

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

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing potential, it should be noted that medicines like ibuprofen have been associated with a reduced ability to conceive.

Use of Ibuprofeno Winadol with other medicines

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

Ibuprofen may interact with or be affected by other medicines. For example:

Other non-steroidal anti-inflammatory drugs such as acetylsalicylic acid, which may increase the risk of gastrointestinal ulcer and bleeding.
Antiplatelet agents (prevent blood clot formation in blood vessels) such as ticlopidine.
Anticoagulant medicines (e.g., to treat coagulation problems or prevent clotting, such as acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (a medicine used to treat high cholesterol).
Methotrexate (used in cancer and inflammatory disease treatment). Your doctor may adjust the dose of this medicine.
Selective serotonin reuptake inhibitors (used to treat depression).
Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
Mifepristone (an abortion-inducing agent).
Digoxin and other cardiac glycosides (used in treating heart disorders).
Hydantoins such as phenytoin (used in treating epilepsy).
Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in treating certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in gout patients or with penicillin in infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycemia.
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Zidovudine (a medicine to treat HIV virus).
Thrombolytics (medicines that dissolve blood clots).
Aminoglycoside antibiotics such as neomycin.
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
Herbal extracts of Ginkgo biloba.
CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

Bleeding time (may be prolonged for up to 1 day after stopping treatment).
Blood glucose concentration (may decrease).
Creatinine clearance (may decrease).
Hematocrit or hemoglobin (may decrease).
Blood urea nitrogen and serum creatinine and potassium concentrations (may increase).
Liver function tests: increased transaminase values.

Inform your doctor if you are scheduled for clinical testing and are taking or have recently taken ibuprofen.

Taking Ibuprofeno Winadol with food, drinks, and alcohol

You may take it alone or with food. It is generally recommended to take it during or after meals or with milk to reduce the possibility of stomach discomfort. Alcohol consumption should be avoided during treatment with ibuprofen.

Pregnancy, breastfeeding, and fertility

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

Do not take Ibuprofeno Winadol during the last 3 months of pregnancy, as it may harm the fetus or cause delivery complications. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor beyond expected. Do not take Ibuprofeno Winadol 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 conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno Winadol may cause kidney problems in your fetus if taken for more than a few days, leading 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 is needed for longer than a few days, your doctor may recommend additional monitoring.

The use of this medicine is not recommended in women attempting to become pregnant.

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section “Precautions during pregnancy and in women of childbearing potential”).

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

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

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are generally not necessary.

Ibuprofen may delay your reaction time; this should be considered before engaging in activities requiring high alertness, such as driving or operating machinery.

This is especially relevant when combined with alcohol.

Ibuprofeno Winadol contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Ibuprofeno Winadol

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

Your doctor will indicate the duration of treatment with ibuprofen. Do not stop treatment earlier, as this may prevent the expected results. Likewise, do not use this medicine for longer than indicated by your doctor.

The lowest effective dose for the shortest necessary time to relieve symptoms should be used. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Method of administration

This medicine is administered orally.

To achieve a faster onset of action, the dose may be taken on an empty stomach. Patients with a sensitive stomach are advised to take ibuprofen with food.

Take ibuprofen with sufficient water. The tablets must be swallowed whole with a glass of water, without chewing, breaking, crushing, or sucking, to avoid mouth discomfort and throat irritation.

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

Adults and adolescents over 14 years

The recommended dose for adults and adolescents aged 14 years and older is one tablet (600 mg) every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

Higher doses may be required in some conditions, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg in adults and 1,600 mg in adolescents aged 14 to 18 years.

Use in children and adolescents under 14 years

The use of this medicine is not recommended in children and adolescents under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended dosing in this patient group.

Elderly patients

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

Patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take exactly the dose prescribed by your doctor.

If you take more Ibuprofeno Winadol than you should

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

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

Normally, overdose symptoms occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, chills, and breathing difficulties have been reported. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, low blood potassium levels, coma, temporary cessation of breathing (apnea), central nervous system depression, and respiratory depression have occurred. Cardiovascular toxicity (low blood pressure, decreased or increased heart rate) has also been reported.

In cases of severe poisoning, kidney failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

In case of ingestion of large amounts, activated charcoal should be administered. Gastric emptying should be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.

If you forget to take Ibuprofeno Winadol

Do not take a double dose to make up for missed doses.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatments and when the daily dose is below the recommended maximum dose.

Frequencies are defined according to the following classification: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Infections and infestations:

Uncommon: Rhinitis (nasal mucus, sneezing, nasal congestion, and/or nasal itching).

Very rare: Aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria). In most reported cases of aseptic meningitis associated with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which represented a risk factor, although cases have also been reported in patients without any chronic illness. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Exacerbation of inflammation associated with infections (e.g., development of necrotizing fasciitis) has been described in connection with the use of NSAIDs. If signs of infection occur or worsen during treatment with ibuprofen, immediate medical attention is recommended.

Blood and lymphatic system disorders:

Rare: Decreased platelet count, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe decrease in granulocytes), aplastic anemia (bone marrow failure to produce various types of blood cells), or hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding.

Very rare: Prolonged bleeding time.

Immune system disorders:

Uncommon: Transient swelling of the skin, mucous membranes, or sometimes internal organs (angioedema), bronchospasm (spasm of the airways preventing airflow to the lungs).

Rare: Severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.

Very rare: Joint pain and fever (lupus erythematosus).

Psychiatric disorders:

Uncommon: Insomnia, anxiety, restlessness.

Rare: Disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Nervous system disorders:

Common: Headache, dizziness, or feeling of unsteadiness.

Uncommon: Paresthesia (numbness, tingling, pins and needles, etc., more frequent in hands, feet, arms, or legs), somnolence or drowsiness.

Rare: Optic nerve inflammation (optic neuritis).

Eye disorders:

Uncommon: Visual disturbances.

Rare: Retinal degeneration.

Ear and labyrinth disorders:

Uncommon: Tinnitus (ringing or buzzing in the ears), vertigo, hearing difficulty.

Respiratory, thoracic and mediastinal disorders:

Uncommon: Asthma, bronchospasm, difficulty breathing.

Cardiac disorders:

Ibuprofen may be associated with a moderate increase in the risk of heart attack (myocardial infarction) or stroke. The risk may be higher when high doses are used (2,400 mg/day). Edema (fluid retention), high blood pressure, and heart failure have also been observed.

Very rare: Heart failure, myocardial infarction.

Vascular disorders:

Very rare: Elevated blood pressure.

Gastrointestinal disorders:

Common: Digestive discomfort such as heartburn (dyspepsia), diarrhea, nausea, vomiting, abdominal pain, flatulence, bloody stools (melena), vomiting blood (hematemesis), gastrointestinal bleeding.

Uncommon: Gastritis, duodenal ulcer, gastric ulcer, inflammation of the oral mucosa with ulcer formation, gastrointestinal perforation.

Very rare: Pancreatitis.

Frequency not known: Colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea).

Hepatobiliary disorders:

Rare: Liver injury, hepatitis (liver inflammation), abnormal liver function tests, and jaundice (yellowing of the skin and eyes).

Frequency not known: Liver failure (severe liver impairment).

Skin and subcutaneous tissue disorders:

Uncommon: Skin rash and redness, itching or swelling of the skin, purpura (purple spots on the skin), photosensitivity reactions.

Very rare: Severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), hair loss, erythema multiforme (skin lesions), light-induced skin reactions, inflammation of blood vessels in the skin. Rarely, severe skin infections and soft tissue complications may occur during chickenpox.

A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Frequency not known: Widespread red, scaly rash with bumps under the skin and blisters, primarily in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis); the skin may become light-sensitive. Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2.

Renal and urinary disorders:

Uncommon: Interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and renal failure (sudden loss of kidney function).

General disorders and administration site conditions:

Common: Fatigue.

Very rare: Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen 600 mg, although they cannot be ruled out. Manifestations of such reactions could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulty, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

Additional investigations:

Rare: Increased blood urea nitrogen, increased serum transaminases and alkaline phosphatase, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium, increased serum uric acid.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

Allergic reactions such as skin rashes, facial swelling, wheezing, or breathing difficulty.
Vomiting blood or material resembling coffee grounds.
Blood in the stool or bloody diarrhea.
Severe stomach pain.
Blisters or extensive peeling of the skin.
Severe or persistent headache.
Yellowing of the skin (jaundice).
Signs of severe hypersensitivity (allergy) (see above in this section).
Swelling of the limbs or fluid accumulation in the arms or legs.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
Flat, non-elevated, target-shaped or circular red spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
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).

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible side effects 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 Ibuprofen Winadol

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 the SIGRE collection point at your pharmacy. If you are unsure how to dispose of unused medicines and their containers, ask your pharmacist. This will help protect the environment.

6. Contents of the container and additional information

Composition of Ibuprofen Winadol

The active substance is ibuprofen. Each tablet contains 600 mg of ibuprofen.
The other components (excipients) are:

Core: croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate, purified water.

Coating: hypromellose, titanium dioxide (E-171), talc, and propylene glycol.

Appearance of the product and contents of the container

White, oval, biconvex coated tablets. They are packaged in blisters within containers containing 40 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider, S.A.

C/ La Granja, 1 3rd Floor

Alcobendas, Madrid

Spain

Manufacturer

Farmalider, S.A.

C/ Aragoneses, nº 2

28100 – Alcobendas (Madrid)

Spain

ROVI PHARMA INDUSTRIAL SERVICES, S.A

Vía Complutense, 140,

Alcalá de Henares,

28805 Madrid

Spain

TOLL MANUFACTURING SERVICES, S.L.

C/ Aragoneses 2,

28108 Alcobendas-Madrid

Spain

Date of the most recent review of this leaflet: November 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)