IBUPROFEN WINADOL 200 mg SOFT GEL CAPSULES

Introduction

Package Leaflet: Information for the Patient

Ibuprofen Winadol 200 mg Soft Capsules EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve.

• after 3 days, in adolescents:
• after 3 days in the treatment of fever and after 4 days in the treatment of pain, in adults.

Contents of the Package Leaflet

1. What is Ibuprofen Winadol and what is it used for
2. What you need to know before taking Ibuprofen Winadol
3. How to take Ibuprofen Winadol
4. Possible side effects
5. Storage of Ibuprofeno Winadol
6. Contents of the pack and further information

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

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

This medication is used for the short-term symptomatic treatment of fever and pain of mild or moderate intensity, such as dental pain, headache, or pain caused by minor injuries, in adolescents over 40 kg in weight (from 12 years) and in adults.

2. What you need to know before taking Ibuprofen Winadol

Do not take Ibuprofen Winadol:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• If you have suffered any reaction such as bronchospasm, asthma attack, nasal mucosa inflammation, angioedema, or skin rash after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If you have unexplained blood coagulation disorders.
• If you have severe liver or kidney disease.
• If you have had gastrointestinal bleeding or perforation (i.e., of the digestive tract) related to treatment with NSAIDs.
• If you have had or have recurrent stomach or duodenal ulcers (peptic ulcers) or gastrointestinal bleeding (two or more confirmed episodes of ulcers or bleeding).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy (see section 2, Pregnancy, breastfeeding, and fertility).
• In case of cerebrovascular hemorrhage or other active bleeding.
• In case of severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Ibuprofen should only be used after a strict assessment of the benefit-risk ratio in case of:

• certain hereditary diseases that affect the blood (e.g., acute intermittent porphyria);
• certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease).

Close medical supervision is required in case of:

• gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• kidney or liver dysfunction;
• dehydration;
• high blood pressure or heart failure;
• allergies (e.g., skin reactions to other substances, asthma, seasonal allergy), nasal polyps, chronic inflammation of the nasal mucosa, or chronic obstructive respiratory disease, as the risk of experiencing hypersensitivity reactions is higher;
• recent major surgery.
• if you have an infection; see the "Infections" heading below.

Side effects can be reduced by using the lowest effective dose for the shortest possible time to control symptoms.

Other NSAIDs

The simultaneous use of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

Elderly population

Elderly patients are more likely to experience the adverse effects of NSAIDs, especially gastrointestinal perforations and bleeding, which can be fatal in some cases. They are also at greater risk of suffering the consequences of adverse effects.

Gastrointestinal bleeding, ulcers, and perforations

Ulcers, perforations, and gastrointestinal bleeding have been reported with all NSAIDs, at any time during treatment, with or without prior warning symptoms, and with or without a history of serious gastrointestinal events.

The risk of ulcer, perforation, or gastrointestinal bleeding is higher with higher doses of the NSAID, if you have previously suffered an ulcer, especially if it was complicated by bleeding or perforation, and if you are elderly. Treatment should be started with the lowest possible dose. Consult your doctor, as they may prescribe combined treatment with protective agents (e.g., misoprostol or proton pump inhibitors). The same applies if you are taking low doses of acetylsalicylic acid (aspirin) or other medications that may increase the gastrointestinal risk.

If you have already experienced gastrointestinal side effects, especially if you are elderly, you should inform your doctor of any unusual abdominal symptoms (particularly gastrointestinal bleeding) especially during the initial stages of treatment. You should be cautious if you are taking other medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants like warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents like acetylsalicylic acid (see section 2, Other medications and Ibuprofen Winadol).

In the event of an ulcer or gastrointestinal bleeding during treatment with ibuprofen, treatment should be discontinued and your doctor consulted.

If you have had or have a gastrointestinal disorder (ulcerative colitis, Crohn's disease), be cautious when taking NSAIDs, as it may worsen (see section 4).

Severe skin reactions have been reported, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), associated with ibuprofen treatment. Stop taking ibuprofeno 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 skin reaction. See section 4.

It is advised to avoid the use of ibuprofen during chickenpox.

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular precautions

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

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using ibuprofen immediately and contact your doctor or medical emergency services immediately if you observe any of these signs.

Consult your doctor or pharmacist before taking ibuprofen if you:

• have heart problems such as heart failure or angina pectoris (chest pain) or if you have had a heart attack, undergone bypass surgery, have peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or have suffered any type of stroke (including a transient ischemic attack or TIA).
• have high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if you are a smoker.

Renal effects

Ibuprofen may cause sodium, potassium, and fluid retention in patients who have not previously suffered from kidney disease, due to its effects on renal perfusion. This may lead to edema (fluid retention) or even heart failure or hypertension in predisposed patients. Cases of acute interstitial nephritis and renal toxicity have been reported. Patients at higher risk are those with renal insufficiency, heart failure, or hepatic insufficiency, those taking diuretics and ACE inhibitors, and the elderly.

Discontinuation of NSAID treatment usually leads to recovery to the pre-treatment state.

Allergic reactions

Very rare cases of severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been observed. Treatment should be discontinued at the first signs of a hypersensitivity reaction after taking/administering ibuprofen. According to the symptoms, specialized personnel should apply the necessary medical procedures.

Other information

Ibuprofen, the active ingredient of this medication, may temporarily inhibit platelet function in the blood (platelet aggregation). Patients with coagulation disorders should be closely monitored.

In long-term treatments with ibuprofen, liver enzymes and renal function should be regularly checked, as well as a blood count if necessary.

Adequate fluids should be consumed during treatment, especially in case of fever, diarrhea, or vomiting.

NSAIDs like ibuprofen may mask the symptoms of an infection or fever.

Consuming alcohol while using NSAIDs may worsen the adverse effects related to the active ingredient, especially those affecting the digestive tract and the central nervous system.

Prolonged use of any type of analgesic to treat headaches may worsen them. If this happens or is suspected, consult your doctor and discontinue treatment. Medication-overuse headache should be suspected in patients who suffer from daily or very frequent headaches despite (or due to) the habitual use of medications to treat them.

In general, the habitual consumption of analgesics, especially a combination of several analgesic substances, may produce permanent kidney damage with a risk of renal failure (analgesic nephropathy).

Children and adolescents

There is a risk of renal failure in dehydrated adolescents.

This medication should not be administered to adolescents under 40 kg in weight or to children under 12 years.

Other medications and Ibuprofen Winadol

Inform your doctor or pharmacist if you are taking or have recently taken any other medication.

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

• Anticoagulant medications (i.e., to prevent blood clot formation; e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications to lower blood pressure (ACE inhibitors like captopril, beta-blockers like products containing atenolol, and angiotensin II receptor antagonists like losartan).

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

They enhance its action, with a possible increase in adverse effects:

• Acetylsalicylic acid and other non-steroidal anti-inflammatory analgesics, as well as corticosteroids (medications containing cortisone and similar substances to cortisone), may increase the risk of gastrointestinal bleeding.
• Methotrexate (to treat cancer and certain types of rheumatic diseases): the administration of ibuprofen in the 24 hours prior to or after methotrexate administration may increase methotrexate concentrations and increase its adverse effects.
• Anticoagulants (to prevent blood clot formation) such as warfarin.
• Digoxin (to strengthen the heart), phenytoin (to treat seizures), or lithium (to treat certain psychiatric disorders); ibuprofen may increase the concentration of these medications in the blood. If ibuprofen is taken as recommended (for 3 or 4 days at most), it is not necessary to monitor blood concentrations of these medications.
• Antiplatelet agents, as well as selective serotonin reuptake inhibitors (to treat depression), may also increase the risk of gastric and intestinal bleeding.

They weaken its action:

• Diuretics and medications to lower blood pressure (antihypertensives): there may be an increased risk for the kidneys.
• ACE inhibitors (to treat heart failure and high blood pressure). Additionally, there may be an increased risk of renal dysfunction.
• Acetylsalicylic acid in low doses: the antithrombotic effect of low doses of acetylsalicylic acid may be altered.
• Mifepristone (used to induce abortion): the use of NSAIDs during the 8 to 12 days following mifepristone administration may reduce the effect of mifepristone.

Other possible interactions:

• Potassium-sparing diuretics: may increase blood potassium levels.
• Probenecid and sulfinpyrazone (to treat gout): may delay the excretion of ibuprofen. This may cause ibuprofen to accumulate in the body and increase its adverse effects.
• Quinolones: may increase the risk of seizures.
• Voriconazole, fluconazole (CYP2C9 inhibitors; used to treat fungal infections): may increase blood ibuprofen levels. The possibility of reducing the ibuprofen dose should be considered, especially if high doses are used, when administered together with voriconazole or fluconazole.
• Sulfonylureas (for diabetes): NSAIDs may enhance the hypoglycemic effect of sulfonylureas. It is recommended to monitor blood glucose levels as a precaution during combined use.
• Tacrolimus: if both medications are administered simultaneously, kidney damage may occur.
• Cyclosporine (to reduce immune reactions): kidney damage may occur.
• Colestyramine (to lower cholesterol): prolongs and reduces (25%) the absorption of ibuprofen. Medications should be administered with an interval of at least 2 hours between them.
• Zidovudine (to treat HIV/AIDS): increased risk of joint effusion and hematomas in HIV-positive hemophiliac patients.
• Aminoglycosides (antibiotics): may reduce their elimination and increase toxicity.
• Herbal medicines: Ginkgo biloba (used to treat dementia) may increase the risk of bleeding.

Ibuprofen may alter the results of some laboratory tests:

Consult your doctor if you are going to have laboratory tests and are taking or have recently taken ibuprofen, as it may alter the results.

Taking Ibuprofen Winadol with alcohol

Consumption of alcoholic beverages should be avoided during treatment with ibuprofen, as they may enhance its adverse effects, especially those affecting the stomach, intestine, and brain.

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 medication.

Pregnancy

If you become pregnant while being treated with ibuprofen, inform your doctor.

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 kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected. You should not take ibuprofen 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 minimum dose for the shortest possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Breastfeeding

The active ingredient, ibuprofen, and its degradation products pass into breast milk in small amounts. Since, to date, no negative consequences for the breastfed infant are known, it is not necessary, as a rule, to interrupt breastfeeding during short-term treatments at the recommended doses for mild or moderate pain and fever.

Fertility

Ibuprofen belongs to a group of medications (NSAIDs) that may reduce fertility in women. The effects are reversible upon discontinuation of treatment.

Driving and using machines

In isolated cases, patients taking ibuprofen may experience an adverse reaction characterized by fatigue, dizziness, and visual disturbances, which may affect their reaction time and ability to drive and operate machinery. These effects are enhanced by simultaneous alcohol consumption.

Ibuprofen Winadol contains sorbitol

This medication contains 99.16 mg of sorbitol in each capsule.

3. How to take Ibuprofeno Winadol

Follow the administration instructions for this medication contained in this prospectus or as indicated by your doctor or pharmacist or nurse. In case of doubt, consult your doctor or pharmacist or nurse again.

For short-term use only.

You can reduce the appearance of adverse effects if you take the lowest effective dose possible for the shortest time necessary to control symptoms.

The recommended dose is:

The recommended doses are detailed in the following table

The respective dosage intervals should be chosen according to the symptomatic picture and the maximum daily dose. The interval between doses will not be less than 6 hours. The maximum recommended daily dose should not be exceeded.

If an adolescent over 12 years old needs to take this medication for more than 3 days, or if symptoms worsen, consult a doctor.

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

If an adult needs to take this medication for more than 3 days in case of fever or 4 days in pain treatment, or if symptoms worsen, consult a doctor.

Use in children

This medication is not intended for use in adolescents under 40 kg in weight or in children under 12 years old.

Form of administration

For oral administration.

It is recommended that patients with stomach problems take the medication during meals.

If you take more Ibuprofeno Winadol than you should

If ingestion far exceeds the recommended dose, seek immediate medical attention.

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital immediately to find out about the risk and ask for advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Also, symptoms of agitation, drowsiness, disorientation, or coma may appear. In some cases, patients develop convulsions.

At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported. Also, the prothrombin time/INR may be prolonged, probably due to the interaction in the action of blood clotting factors. Acute kidney failure or liver damage may occur. In asthmatic patients, worsening of asthma may occur. Additionally, hypotension and respiratory depression may occur.

If you have taken more ibuprofen than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist or the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to take the package and the prospectus of the medication to the healthcare professional.

If you forgot to take Ibuprofeno Winadol

Do not take a double dose to make up for the forgotten dose.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

Stop treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Reddish patches, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Adverse effects can be reduced by using the lowest effective dose for the shortest time possible to relieve symptoms. The following list of adverse effects includes all those known to be associated with ibuprofen treatment, including those that occur during prolonged treatment with high doses in rheumatic patients. The frequency data, apart from very rare reports, are based on short-term administration of up to 1200 mg of ibuprofen per day for oral formulations and up to 1800 mg for suppositories.

Regarding the following adverse effects, it should be noted that they are largely dose-dependent and vary between different patients.

The most frequent adverse effects are those that affect the digestive tract. Stomach/duodenal ulcers (peptic ulcers), perforation (hole in the stomach or intestinal wall), or gastrointestinal bleeding, sometimes fatal, especially in elderly patients (see section 2), may occur. After using ibuprofen, the following have been reported: nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, blood in the stool, inflammation of the mucous membrane lining the stomach (stomatitis), and worsening of colitis and Crohn's disease.

Less frequently, stomach inflammation (gastritis) has been observed.

Edema (fluid retention), increased blood pressure, and heart failure associated with NSAID treatment have been reported.

Medications like ibuprofen have been linked to a small increase in myocardial infarctions and stroke.

STOP TAKING and consult your doctor immediately if you notice:

• signs of intestinal bleeding such as: relatively severe abdominal pain, blood in the stool or bloody diarrhea, vomiting blood and dark particles that resemble coffee grounds.
• signs of severe allergic reactions such as skin rash, swelling of the face, tongue, or throat, wheezing or shortness of breath, worsening of asthma, difficulty breathing, palpitations, or decreased blood pressure that can lead to shock.
• severe skin reactions such as rashes that cover the entire body, peeling, and blisters, or skin detachment.

Other adverse effects

Frequent (may affect up to 1 in 10 people)

• gastrointestinal symptoms such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and minor gastrointestinal bleeding that can cause anemia in exceptional cases.

Uncommon (may affect up to 1 in 100 people)

• hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with decreased blood pressure). In that case, you should inform your doctor immediately and stop taking ibuprofen.
• central nervous system disorders such as headache, drowsiness, agitation, irritability, or fatigue.
• vision disorders. In that case, you should inform your doctor immediately and stop taking ibuprofen.
• inflammation of the mucous membrane lining the stomach (gastritis).
• gastrointestinal ulcers, in some cases with bleeding and perforation.
• stomatitis, worsening of colitis and Crohn's disease.
• skin rash, hives, itching, purpura (including allergic purpura).

Rare (may affect up to 1 in 1,000 people)

• ringing in the ears (tinnitus), hearing disorders.
• kidney tissue damage (papillary necrosis), especially with long-term treatment, and increased uric acid concentration in the blood.

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

• worsening of infection-related inflammation (e.g., necrotizing fasciitis). If signs of infection or worsening of symptoms during ibuprofen treatment (e.g., redness, swelling, heat, pain, fever) are observed, the patient should consult a doctor immediately.
• signs of meningitis such as headache, nausea, vomiting, fever, stiff neck, or disorientation. Patients who seem to be at higher risk are those who have previously experienced certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease).
• blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, and nasal and skin bleeding. In such cases, you should stop the medication immediately and consult a doctor. DO NOT administer any self-treatment with medications to treat pain or reduce fever.
• severe generalized hypersensitivity reactions. It can manifest as: facial edema, swelling of the tongue and larynx with constriction of the airways, shortness of breath, palpitations, decreased blood pressure, and potentially life-threatening shock.
• psychotic reactions, depression.
• reversible toxic amblyopia.
• palpitations, heart failure, myocardial infarction.
• increased blood pressure.
• esophageal and pancreatic inflammation.
• formation of intestinal stenosis.
• liver dysfunction or acute liver inflammation. Liver damage or failure, especially with prolonged use, is manifested by yellowing of the skin and eyes, as well as soft stools and dark urine.
• alopecia (hair loss).
• photosensitivity reactions, allergic vasculitis.
• severe skin reactions, with generalized redness and blistering (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell syndrome). In isolated cases, severe skin infections with soft tissue complications may occur during chickenpox.
• decreased urine excretion and fluid accumulation in tissues (edema), especially in patients with high blood pressure or kidney dysfunction; nephrotic syndrome (fluid accumulation in the body (edema) and excess protein in the urine); inflammatory kidney disease (interstitial nephritis), which may be accompanied by acute kidney failure. Decreased urine production, fluid accumulation in the body (edema), and general feeling of discomfort may be signs of kidney disease and even kidney failure.

Frequency not known (cannot be estimated from available data)

• 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, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you experience these symptoms and seek immediate medical attention. See also section 2.
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Skin becomes sensitive to light

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Winadol

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the package after "CAD.". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

• The active ingredient is ibuprofen. Each soft capsule contains 200 mg of ibuprofen.
• The other components are:

Core of the capsule:

macrogol, polysorbate 80, potassium hydroxide (E-525), butylhydroxytoluene (E-321), purified water.

Coating:

gelatin, partially dehydrated liquid sorbitol (E-420), brilliant blue (E-133), quinoline yellow (E-104), purified water.

Appearance of the product and package contents

Soft gelatin capsules, oval-shaped, and green in color, with a length of 14.1 mm and a width of 9.2 mm approximately.

The packages contain 10 or 20 soft capsules packaged in PVC/PVDC/Aluminum blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Nutra Essential OTC, S.L

C/ La Granja, 1, 3rd floor

28108, Alcobendas (Madrid)

Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Date of the last revision of this prospectus: July 2024

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