Ibuprofen Farmalid 20 mg/ml oral suspension. EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Farmalid 20 mg/ml oral suspension.

Read the entire leaflet carefully before you start taking this medicine, because 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of the leaflet

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

1. What Ibuprofen Farmalid 20 mg/ml oral suspension is and what it is used for

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

Ibuprofen is indicated for the treatment of fever and mild to moderate pain.

2. Before taking Ibuprofeno Farmalid

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

Do not take Ibuprofeno Farmalid

If you are allergic (hypersensitive) to ibuprofen, to other medicines in the NSAID group (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other ingredients of this medicine. Signs of allergy may include: itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the
gastrointestinal tract.
If you are vomiting blood.
If you have black stools or diarrhoea with blood.
If you have severe liver or kidney disease.
If you have bleeding or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used concomitantly, your doctor will perform blood coagulation tests.
If you have severe heart failure.
If you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor:

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-protecting medicine.
If you have oedema (fluid retention).
If you suffer from asthma or any other respiratory disorder.
If you have or have had heart problems or high blood pressure.
If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
If you experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen in such cases could lead to renal failure due to dehydration.
If you are taking concomitant medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
If you have Crohn's disease or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.
If you are taking diuretics (medicines to increase urination), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis may occur.
If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.
If you are receiving treatment with ibuprofen, as it may mask fever, an important sign of infection, thereby delaying diagnosis.
If you suffer from headaches after prolonged treatment, do not take higher doses of the medicine.
Allergic reactions may occur with this medicine.
Your doctor will monitor you more closely if you are receiving ibuprofen after major surgery.
It is advisable not to take this medicine if you have chickenpox.
It is important to use the lowest effective dose and not to take this medicine longer than necessary to control your symptoms.
If you have an infection; see the section “Infections” below.

Infections

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

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 Ibuprofeno Farmalid if:

You have heart problems, including heart failure, angina (chest pain), a history of 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 ischaemic attack "TIA").
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.
Serious allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking Ibuprofeno Farmalid immediately and contact your doctor or emergency medical services if you notice any of these signs.

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

Skin reactions

Severe skin reactions have been reported with Ibuprofeno Farmalid treatment. Stop taking Ibuprofeno Farmalid 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 serious skin reaction. 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 treatment with Ibuprofeno Farmalid and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Pregnancy and fertility precautions

As the use of medicines like Ibuprofeno has been associated with an increased risk of congenital malformations and miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be kept to a minimum.

Administration of Ibuprofeno is contraindicated during the third trimester of pregnancy.

For women of childbearing potential, it should be noted that medicines like Ibuprofeno have been associated with reduced fertility.

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 levels

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

Use of Ibuprofeno Farmalid with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Do not take ibuprofen with other painkillers without consulting your doctor.

Ibuprofeno Farmalid may affect or be affected by other medicines. For example:

Anticoagulants (e.g. medicines to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
Antiplatelet agents (prevent formation of blood clots) such as ticlopidine
Corticosteroids such as cortisone and prednisolone
Selective serotonin reuptake inhibitors (used for depression)
Other NSAIDs such as aspirin
Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
Mifepristone (abortion-inducing agent)
Digoxin and other cardiac glycosides (used to treat heart disorders)
Hydantoins such as phenytoin (used to treat epilepsy)
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections)
Diuretics (medicines used to increase urine output)
Pentoxifylline (used to treat intermittent claudication)
Probenecid (used in gout patients or with penicillin for infections)
Quinolone antibiotics such as norfloxacin
Sulfinpyrazone (for gout)
Sulfonylureas such as tolbutamide (for diabetes)
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection)
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan)
Thrombolytics (medicines that dissolve blood clots)
Zidovudine (an anti-HIV medicine)
Aminoglycoside antibiotics such as neomycin
Herbal extracts (from Ginkgo biloba tree)

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

Taking Ibuprofeno Farmalid with food and drinks

It is recommended to take Ibuprofeno Farmalid with milk or food, or immediately after eating, to reduce the possibility of stomach discomfort.

Pregnancy, breastfeeding and fertility

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Do not take Ibuprofeno Farmalid during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labour. Do not take Ibuprofeno Farmalid during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno Farmalid 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 for more than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen passes into breast milk, but it is not necessary to interrupt breastfeeding during short-term treatment with the recommended dose for pain and fever.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only a single dose of ibuprofen or use it for a short period, no special precautions are necessary.

Important information about some of the ingredients of Ibuprofeno Farmalid

This medicine may cause headache, stomach discomfort and diarrhoea because it contains glycerol (E-422).

This medicine contains maltitol syrup (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

It may cause a mild laxative effect because it contains 0.25 g of maltitol syrup per ml.

Calorific value: 2.3 kcal/g of maltitol/isomaltase

3. How to take Ibuprofeno Farmalid

Follow exactly the administration instructions for Ibuprofeno Farmalid as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

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

Ibuprofeno Farmalid is an oral suspension.

For accurate dosing, the packaging contains a graduated oral dosing device. First, shake the solution, then insert the dosing device into the perforated cap, invert the bottle, pull the plunger until the liquid reaches the amount prescribed by the doctor, return the bottle to its upright position, and remove the dosing device. The dosing device should be disassembled, washed, and dried.

Patients experiencing stomach discomfort should take the medicine with milk and/or during meals.

Children:

The dose of ibuprofen to be administered depends on the child's age and weight. Generally, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four individual doses (see table). It is recommended not to exceed the maximum daily dose of 40 mg of ibuprofen per kg of body weight.

The use of this medicine is not recommended in children under 3 months of age.

The interval between doses will depend on the progression of symptoms, but must never be less than 4 hours.

However, as a general guideline, the following dosing schedule is recommended:

*Age*	*Body weight*	*Dosage*
Children 3 to 6 months	Approx. 5 to 7.6 kg	2.5 ml three times daily (equivalent to 150 mg of ibuprofen/day)
Children 6 to 12 months	Approx. 7.7 kg to 9 kg	2.5 ml three to four times daily (equivalent to 150 mg–200 mg of ibuprofen/day)
Children 1 to 3 years	Approx. 10 kg to 15 kg	5.0 ml three to four times daily (equivalent to 300 mg–400 mg of ibuprofen/day)
Children 4 to 6 years	Approx. 16 kg to 20 kg	7.5 ml three to four times daily (equivalent to 450 mg–600 mg of ibuprofen/day)
Children 7 to 9 years	Approx. 21 kg to 29 kg	10.0 ml three to four times daily (equivalent to 600 mg–800 mg of ibuprofen/day)
Children 10 to 12 years	Approx. 30 kg to 40 kg	15.0 ml three to four times daily (equivalent to 900 mg–1200 mg of ibuprofen/day)

Adults and adolescents:

Due to the amount of ibuprofen contained in Ibuprofeno Farmalid, it is recommended to use other more suitable formulations for ibuprofen treatment in adults and adolescents (over 12 years of age). The recommended dose is 20 ml 3 to 4 times daily (equivalent to 1200–1600 mg of ibuprofen/day), for as long as symptoms persist.

Elderly patients:

If you are over 60 years of age, your doctor may prescribe a lower than usual dose. In such case, you may only increase the dose once your doctor has confirmed that you tolerate the medication well.

Patients with renal or hepatic impairment:

If you suffer from kidney and/or liver disease, your doctor may prescribe a lower than usual dose. In such case, take exactly the dose prescribed by your doctor.

Your doctor will determine the duration of treatment with Ibuprofen. Do not discontinue treatment prematurely, as otherwise the expected results may not be achieved.

Likewise, do not use Ibuprofen for longer than indicated by your doctor.

Consult your doctor if symptoms persist or worsen during the treatment period.

If you take more Ibuprofeno Farmalid than you should

If you have taken more Ibuprofeno Farmalid than you should, or if a child has accidentally ingested the medication, contact a doctor immediately or the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

Mild symptoms of overdose include abdominal pain, nausea, vomiting, apathy, drowsiness, headache, rapid involuntary eye movements, tinnitus, and lack of muscle coordination.

Severe symptoms such as gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingestion of large quantities) are rare.

In case of severe poisoning, the doctor will take the necessary measures.

In the event of ingestion of large amounts, activated charcoal should be administered.

Gastric lavage should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Ibuprofeno Farmalid

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

If you forget to take your scheduled 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 the usual time.

4. Possible adverse effects

Like all medicines, ibuprofen may have adverse effects, although not everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

Adverse effects of medicines such as ibuprofen are more common in people aged 65 years and older.

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

The following adverse effects have been observed with the use of ibuprofen.

Gastrointestinal:

The most common adverse effects associated with medicines such as ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been reported.

Other adverse effects: Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: inflammation of the esophagus, esophageal narrowing (esophageal stenosis), exacerbation of intestinal diverticular disease, nonspecific hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

Medicines such as ibuprofen may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke. Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatment with medicines of the ibuprofen type. Frequency not known: chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Dermatological:

Medicines such as ibuprofen may, very rarely, be associated with 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).

Other adverse effects: Common: skin rash. Uncommon: skin redness, itching or swelling of the skin, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), photosensitivity reactions, inflammation of blood vessels in the skin. Severe skin infections and soft tissue complications during chickenpox may exceptionally occur. Frequency not known: 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). A generalized red, scaly rash with bumps under the skin and blisters, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), may also occur. Stop taking Ibuprofeno Farmalid if you experience these symptoms and seek immediate medical attention. See also section 2.

The skin may become sensitive to light.

Immune system:

Uncommon: transient swelling in areas of the skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of the nasal mucosa, bronchospasm (spasm of the bronchi obstructing airflow to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of a 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).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or feeling unsteady. Rare: paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs). 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 with ibuprofen, the patient had an underlying autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms observed included neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: vertigo. Uncommon: tinnitus (ringing or buzzing in the ears). Rare: hearing impairment.

Ocular:

Uncommon: visual disturbances. Rare: abnormal or blurred vision.

Hematological:

Rare: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may increase susceptibility to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anemia (bone marrow failure to produce various 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.

Renal:

Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in urine and body swelling), and renal failure (sudden loss of kidney function) cannot be excluded.

Hepatic:

Medicines such as ibuprofen may, rarely, be associated with liver injury. Other rare adverse effects include: hepatitis (liver inflammation), abnormalities in liver function, and jaundice (yellowing of the skin and eyes). Frequency not known: liver failure (severe deterioration of liver function).

General:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, 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 difficulties, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor:

Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhea.
Severe stomach pain.
Blisters or significant peeling of the skin.
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 arms or legs.
Flat, non-elevated, target-like or circular red spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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).
Generalized red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms typically appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Farmalid

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the packaging after
EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines.

This way, you will help protect the environment.

6. Additional Information

Composition of Ibuprofeno Farmalid.

The active substance is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
The other components (excipients) are: glycerol (E-422), maltitol syrup (E-965), microcrystalline cellulose, xanthan gum, anhydrous citric acid, sodium citrate, sodium benzoate (E-211), polysorbate 80, sodium saccharin, orange flavor, and purified water.

Appearance of the product and contents of the container

After shaking, the medicine will form a white-colored suspension with an orange odor.

It is presented in a 200 ml bottle and includes a 5 ml dosing syringe.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Farmalider, S.A.

c/Aragoneses 15

28108 - Alcobendas - Madrid.

Spain

Manufacturer:

Laboratorio Aldo-Unión, S.A.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Farmalider S.A.

C/ Aragoneses 2

28108 – Alcobendas, Madrid

Spain

This leaflet was last reviewed in October 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/