IBUFEN INFANTIL 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibufén Infantil 20 mg/ml Oral Suspension

ibuprofen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this 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, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days or 24 hours in children aged 3 to 5 months.

Contents of the Package Leaflet

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

1. What is Ibufén Infantil and what is it used for

Ibufén Infantil contains ibuprofen as the active substance, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in infants over 3 months and children up to 12 years for the symptomatic relief of occasional mild or moderate pain, as well as in febrile conditions.

2. What you need to know before taking Ibufén Infantil

Do not take Ibufén Infantil

• if you are allergic (hypersensitive) to ibuprofen or any of the other components of this medicine (listed in section 6), or to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs) or to aspirin. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• if you have a severe liver or kidney disease.
• if you have had a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are already receiving treatment with this medicine, as it may mask fever, which is an important 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 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 have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested 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 treatments, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications can worsen these conditions.
• If you are undergoing treatment with diuretics (medicines used to increase urine production), as your doctor should 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 acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that 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 medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection; see the "Infections" section below.
• With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibufén Infantil immediately and contact your doctor or medical emergency service immediately if you observe any of these signs.

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

Skin reactions

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 Ibufén Infantil treatment. Discontinue Ibufén Infantil treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Stop taking Ibufén Infantil 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.

Cardiovascular precautions

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

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

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

Similarly, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Precautions during pregnancy and in women of childbearing age

Because the administration of Ibufén Infantil-type medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Ibufén Infantil is contraindicated.

For women of childbearing age, it should be taken into account that Ibufén Infantil-type medications have been associated with a decrease in fertility.

Infections

Ibufén Infantil may mask the signs of an infection, such as fever and pain. Consequently, Ibufén Infantil may delay the 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 take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Taking Ibufén Infantil with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those purchased without a prescription.

Ibufén Infantil may affect or be affected by other medicines. For example:

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

Other medicines may also affect or be affected by treatment with Ibufén Infantil. Therefore, you should always consult your doctor or pharmacist before using Ibufén Infantil with other medicines.

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 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 going to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Taking Ibufén Infantil with food, drinks, and alcohol

It is recommended to take Ibufén Infantil with milk or with food, or immediately after eating, to reduce the possibility of stomach upset. Do not drink alcohol, as it may increase gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended in women who are trying to become pregnant. 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 Ibufén Infantil 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 Ibufén Infantil 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, Ibufén Infantil may cause kidney problems in your fetus if taken for more than a few days, which may cause 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.

Pregnancy

Because the administration of Ibufén Infantil-type medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Ibufén Infantil is contraindicated.

Fertility

For women of childbearing age, it should be taken into account that Ibufén Infantil-type medications have been associated with a decrease in fertility.

Breastfeeding

Although only small amounts of the medicine pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, you do not need to take special precautions.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and using machinery.

This applies to a greater extent to the combination with alcohol.

Ibufén Infantil contains maltitol liquid, sodium, sodium benzoate, benzyl alcohol, and ethanol

This medicine contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may have a slight laxative effect. Caloric value: 2.3 kcal/g of maltitol.

This medicine contains 3.60 mg of sodium (main component of table salt/cooking salt) per milliliter. This is equivalent to 0.18% of the maximum recommended daily sodium intake for an adult.

This medicine contains 1 mg of sodium benzoate (E-211) per milliliter.

Sodium benzoate (E-211) may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains 0.00021 mg of benzyl alcohol per milliliter. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This product should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist indicates otherwise.

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

This medicine contains less than 0.00007 mg of alcohol (ethanol) per milliliter. The amount of alcohol in this medicine is much less than 1 ml of beer. The small amount of alcohol in this medicine does not produce any noticeable effect.

3. How to take Ibufén Infantil

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

Only for occasional use and during limited periods.

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

Children from 3 months to 12 years:

The recommended dose of ibuprofen depends on the child's age and weight.

As a general rule, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight, depending on the intensity of the symptoms, and is divided into three doses.

The use of this medication in children under 2 years of age will always be done under medical prescription.

As a guide, the following doses can be followed:

The suspension can also be dosed following a schedule of 4 daily doses. In this case, the maximum daily doses (see last column of the previous table) should not be exceeded in 24 hours. The dose to be administered in each dose, every 6 hours, will be recalculated/reduced proportionally.

The use of this medication is not recommended in children under 3 months or weighing less than 5 kg.

Patients with kidney, liver, or heart disease

They should reduce the dose and consult their doctor. Ibuprofen should not be used in patients with severe cardiac, renal, or hepatic failure.

If this medication needs to be used for more than 3 days or if symptoms worsen in children from 6 months to 12 years, a doctor should be consulted.

In children aged 3 to 5 months, a doctor should be consulted if symptoms worsen or persist after 24 hours.

Method of administration

Ibufén Infantil is an oral suspension. It can be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the perforated cap opening
3. Invert the bottle and withdraw the necessary dose
4. Administer the contents of the syringe directly into the mouth or into a spoon.
5. The syringe should be washed after each dose and can be sterilized by boiling in water or immersing it in the sterilizing solution used for baby bottles.

A burning sensation in the mouth or throat may occur when taking the oral ibuprofen suspension; make sure the bottle has been shaken well before administering the medication.

Patients with stomach discomfort should take the medication with milk and/or during meals. The administration of the medication is subject to the appearance of pain or fever. As these disappear, the medication should be suspended.

If you take more Ibufén Infantil than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medication, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), diarrhea, headache, ringing in the ears, confusion, and involuntary movement of the eyes and lack of muscle coordination. Agitation or disorientation may also occur. 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. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. In rare cases, there have been cases of increased blood acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. There have also been cases of cardiovascular toxicity (decreased blood pressure, decreased heart rate, and increased heart rate).

If a severe poisoning has occurred, kidney failure and liver damage may occur. In these cases, the doctor will take the necessary measures.

Exacerbation of asthma is possible in asthmatics.

If you forget to take Ibufén Infantil

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

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

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

4. Possible side effects

Like all medications, Ibufén Infantil can cause side effects, although not everyone will experience them. The incidence of side effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

Common side effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastric secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

Uncommon side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, hives, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or burning, more frequent in hands, feet, arms, or legs), drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function anomalies, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Interstitial nephritis (kidney disorder) nephrotic syndrome (disorder characterized by protein in the urine and swelling of the body) and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

Rare side effects(may affect up to 1 in 1,000 people): Disorientation or confusion, depression, vertigo, tinnitus (beats or sounds in the ear), hearing impairment, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, the signs can be facial swelling, tongue and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock)), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other side effects are 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), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudo-flu-like symptoms, extreme fatigue, bleeding, and bruises of unknown cause.

Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and lesions of a purplish color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Liver failure, heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation-related infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening of symptoms occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

Frequency not known(cannot be estimated from available data): Exacerbation of colitis and Crohn's disease (chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea). A severe skin reaction known as DRESS syndrome (by its English acronym) 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, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibufén Infantil if you experience these symptoms and seek medical attention immediately. See also section 2.

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

If any of the following side effects occur, discontinue treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like material.
• Blood in the stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blisters.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth sores, 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].
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red 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).

Reporting 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibufén Infantil

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Once the container is opened, store below 25°C for a maximum of 6 months.

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

Medications should not be thrown away in drains or trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Content of the container and additional information

Composition of Ibufén Infantil

• The active ingredient is ibuprofen. Each ml of suspension contains 20 mg of ibuprofen.
• The other components are: Sodium benzoate (E-211), citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, glycerol (E-422), strawberry flavor (contains benzyl alcohol and ethanol), and purified water.

Appearance of the product and container content

Ibufén Infantil is a viscous oral suspension, white or almost white in color, and has a strawberry flavor.

It contains a 5 ml graduated syringe with a polypropylene cylinder and a polyethylene piston.

It is presented in containers of 100, 150, and 200 ml. Only some container sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

San Sebastián de los Reyes

Madrid

Spain

“or”

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191 Spain

“or”

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

The Netherlands

“or”

FARMALIDER, S.A.

C/ Aragoneses 2

28108- Alcobendas

Madrid

Spain

“or”

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10.

Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this prospectus: November 2024

Other sources of information

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