IBUPROFEN FARMALIDER 200 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Ibuprofeno Farmalider 200 mg Film-Coated Tablets

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 Ibuprofeno Farmalider and what is it used for
2. What you need to know before taking Ibuprofeno Farmalider
3. How to take Ibuprofeno Farmalider
4. Possible side effects
5. Storage of Ibuprofeno Farmalider
6. Package Contents and Additional Information

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

Ibuprofeno belongs to the group of medications known as 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 toothache, 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 Ibuprofeno Farmalider

Do not take Ibuprofeno Farmalider:

• If you are allergic to ibuprofen or any of the other components of this medication (included 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 NSAID treatment.
• If you have had a stomach or duodenal ulcer (peptic ulcer) or gastrointestinal bleeding (two or more confirmed episodes of ulcer 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.

Adverse 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 adverse effects of NSAIDs, especially gastrointestinal perforations and bleeding, which can be fatal in some cases. They are also at higher risk of suffering the consequences of adverse effects.

Gastrointestinal bleeding, ulcers, and perforations

Ulcers, perforations, and gastrointestinal bleeding, sometimes fatal, 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 adverse 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 ulcer 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 Ibuprofeno Farmalider).

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

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

Severe 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 Ibuprofeno Farmalider and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

The use of ibuprofen should be avoided during chickenpox.

Ibuprofeno Farmalider may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno Farmalider 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 Ibuprofeno Farmalider immediately and contact your doctor or emergency medical 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 had 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 liver insufficiency, those taking diuretics and ACE inhibitors, and the elderly.

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

Hypersensitivity 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 carefully 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 adverse effects related to the active ingredient, especially those affecting the digestive tract and central nervous system.

Prolonged use of any type of analgesic to treat headaches may worsen them. If this occurs or is suspected, a doctor should be consulted and treatment discontinued. 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, habitual consumption of analgesics, especially a combination of several analgesic substances, may cause permanent kidney damage with a risk of kidney failure (analgesic nephropathy).

Children and adolescents

There is a risk of kidney failure in dehydrated adolescents.

This medication should not be administered to adolescents weighing less than 40 kg or children under 12 years of age.

Other medications and Ibuprofeno Farmalider

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): 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) like 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 the blood concentrations of these medications.
• Antiplatelet agents, like selective serotonin reuptake inhibitors, 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 kidney.
• ACE inhibitors (to treat heart failure and high blood pressure). Additionally, there may be an increased risk of renal dysfunction.
• Low-dose acetylsalicylic acid: the antithrombotic effect of low-dose 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 ibuprofen blood levels. The possibility of reducing the ibuprofen dose should be considered, especially if high doses are used, when administered 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.
• Cyclosporin (to reduce immune reactions): kidney damage may occur.
• Colestyramine (to lower cholesterol): prolongs and reduces (25%) the absorption of ibuprofen. The medications should be administered with an interval of at least 2 hours between them.
• Zidovudine (to treat HIV/AIDS): increased risk of joint bleeding 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 analytical tests:

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

Taking Ibuprofeno Farmalider with alcohol:

Consumption of alcoholic beverages should be avoided during treatment with ibuprofen, as it 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 taking ibuprofen, inform your doctor.

Do not take Ibuprofeno Farmalider 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 labor more than expected. You should not take Ibuprofeno Farmalider during the first 6 months of pregnancy unless it is clearly necessary and as directed 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, Ibuprofeno Farmalider 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 monitoring.

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.

Ibuprofeno Farmalider contains lactose monohydrate.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ibuprofeno Farmalider

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

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 of weight or in children under 12 years old.

Method of administration

For oral administration. The tablets should be swallowed whole, with a glass of water.

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

If you take more Ibuprofeno Farmalider than you should

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

If you have taken more Ibuprofeno Farmalider than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital 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), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of 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 problems have been reported. In asthmatic patients, it may cause worsening of asthma.

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 bring the package and the prospectus of the medication to the healthcare professional.

If you forget to take Ibuprofeno Farmalider

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 the shape of a target or circular 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, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The 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 daily doses up to a maximum of 1200 mg of ibuprofen for oral formulations and a maximum of 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.

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 observe:

• signs of intestinal bleeding such as: relatively intense 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 generalized blisters or skin shedding.

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 this case, the doctor should be informed immediately and ibuprofen should be stopped.
• central nervous system disorders such as headache, drowsiness, agitation, irritability, or fatigue.
• vision changes. In this case, the doctor should be informed immediately and ibuprofen should be stopped.
• 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 meningeal inflammation (aseptic meningitis) such as headache, nausea, vomiting, fever, neck stiffness, 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, the medication should be stopped immediately and a doctor should be consulted. NO self-medication with pain or fever-reducing medications should be administered.
• severe generalized hypersensitivity reactions. It can manifest as: facial edema, tongue and larynx swelling 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 the 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 unknown (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).
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Stop taking Ibuprofeno Farmalider if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Reporting adverse effects

If you experience any adverse effects, consult your doctor, even if they are possible adverse effects that do 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 Farmalider

Keep this medication out of 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 blister or box 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

Composition of Ibuprofeno Farmalider

• The active ingredient is ibuprofen. Each tablet contains 200 mg of ibuprofen.
• The other excipients are:

Core

Hypromellose, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate.

Coating

Hypromellose, titanium dioxide (E-171), talc, propylene glycol (E-1520).

Appearance of the product and package contents

Ibuprofeno Farmalider are white, oblong, biconvex, film-coated tablets, with one side scored and the other smooth. The dimensions of the film-coated tablets are: 6 mm in width, 12 mm in length, and 4.2 mm in thickness.

The packaging material consists of aluminum/PVC/PVDC blister packs.

Each box contains 20 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

FARMALIDER, S.A.

La Granja, 1, 3rd floor 28108

Alcobendas, Madrid

(Spain)

Manufacturer

Toll Manufacturing Services, S.L.

Aragoneses, 2 28108

Alcobendas, Madrid

(Spain)

Farmalider, S.A.

Aragoneses, 2 28108

Alcobendas, Madrid

(Spain)

Date of the last revision of this prospectus: December 2024