Ibuprofen Codramol 20 mg/ml oral suspension EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Codramol 20 mg/ml oral suspension.

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms, as it may harm them.
If you think you are experiencing any serious side effects or notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Ibuprofen Codramol is and what it is used for
What you need to know before taking Ibuprofen Codramol
How to take Ibuprofen Codramol
Possible side effects
How to store Ibuprofen Codramol
Further information

1. What Ibuprofeno Codramol 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 Ibuprofen Codramol

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

Do not take Ibuprofen Codramol

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 experienced 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 anticoagulant medicines must be used at the same time, your doctor will perform blood coagulation tests.
If you have severe heart failure.
If you are in the third trimester of pregnancy.

Take special care with Ibuprofen Codramol

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 greater when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective 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 of age, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out 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 this case could lead to kidney failure as a consequence of dehydration.
If you are taking 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 could 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 urine output), because your doctor needs to monitor your kidney function.
If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis 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 treatment with ibuprofen is appropriate.
If you are being treated with ibuprofen, as it may mask fever, an important sign of infection, thus complicating 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 receive 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 take this medicine longer than necessary to control your symptoms.
If you have an infection: see the section "Infections" below.

Infections

Ibuprofen Codramol may mask signs of infection such as fever and pain. Therefore, Ibuprofen Codramol may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection 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 Ibuprofen Codramol if:

You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA").
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.
Signs of allergic reaction to this medicine such as breathing difficulties, swelling of the face and neck area (angioedema), or chest pain have been reported with ibuprofen. Stop taking Ibuprofen Codramol immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

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

Skin Reactions

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

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofen Codramol and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing age

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

Administration of Ibuprofen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that medicines like Ibuprofen 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)
Haematocrit or haemoglobin (may decrease)
Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
Liver function tests: increased transaminase values

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

Use of Ibuprofen Codramol with other medicines

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

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

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

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.
Anticoagulant medicines (e.g. to treat or prevent blood clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine).
Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
Mifepristone (used for medical abortion).
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 patients with gout or together with penicillin for infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes).
Tacrolimus or ciclosporin (used in organ transplants to prevent rejection).
Antihypertensives (to reduce high blood pressure).
Thrombolytics (medicines that dissolve blood clots).
Zidovudine (an anti-HIV medicine).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts (from Ginkgo biloba).

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

Taking Ibuprofen Codramol with food and drink

It is recommended to take Ibuprofen Codramol with milk or with 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 Ibuprofen Codramol during 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 unborn baby. It may affect your own and your baby's tendency to bleed and may delay or prolong labour. You should not take this medicine during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofen Codramol 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, vision 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 Ibuprofen Codramol

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 with 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 Ibuprofen Codramol

Follow exactly the administration instructions for Ibuprofen Codramol provided by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Ibuprofen Codramol is an oral suspension for oral administration.

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

For accurate dosing, the packaging contains a graduated oral dosing dispenser. First, shake the solution, then insert the dosing dispenser into the pierced 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 dispenser. The dosing dispenser should then 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 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 body weight.

This medicine is not recommended for 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 a day (corresponds to 150 mg of ibuprofen/day)
Children 6 to 12 months	Approx. 7.7 to 9 kg	2.5 ml three to four times a day (corresponds to 150 mg–200 mg of ibuprofen/day)
Children 1 to 3 years	Approx. 10 to 15 kg	5.0 ml three to four times a day (corresponds to 300 mg–400 mg of ibuprofen/day)
Children 4 to 6 years	Approx. 16 to 20 kg	7.5 ml three to four times a day (corresponds to 450 mg–600 mg of ibuprofen/day)
Children 7 to 9 years	Approx. 21 to 29 kg	10.0 ml three to four times a day (corresponds to 600 mg–800 mg of ibuprofen/day)
Children 10 to 12 years	Approx. 30 to 40 kg	15.0 ml three to four times a day (corresponds to 900 mg–1200 mg of ibuprofen/day)

Adults and adolescents:

Due to the amount of ibuprofen contained in Ibuprofen Codramol, it is recommended to use other more appropriate 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. If so, 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. If so, take exactly the dose prescribed by your doctor.

Your doctor will determine the duration of treatment with Ibuprofen. Do not stop treatment prematurely, as this may prevent the expected results from being 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 Ibuprofen Codramol than you should

If you have taken more Ibuprofen Codramol than you should, or if a child has accidentally ingested the medicine, consult a doctor immediately or contact the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to find out about the risk and obtain advice on the measures to be taken. It is recommended to bring the medicine pack 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, 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 muscle incoordination.

Severe symptoms such as intestinal 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.

If a severe poisoning has occurred, the doctor will take the necessary measures.

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

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

If you forget to take Ibuprofen Codramol

Do not take a double dose to make up for a missed 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 can have adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed 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 maximum recommended 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 every 10 patients); common (in 1 to 10 out of every 100 patients); uncommon (in 1 to 10 out of every 1,000 patients); rare (in 1 to 10 out of every 10,000 patients); very rare (in less than 1 out of every 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 elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been reported.

Other adverse effects include:
Uncommon: inflammation of the oral mucosa with ulcer formation.
Rare: oesophagitis, oesophageal stricture (oesophageal stenosis), exacerbation of intestinal diverticular disease, nonspecific haemorrhagic colitis (gastroenteritis with bloody diarrhoea).
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. Oedema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using ibuprofen-type medicines.
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, predominantly on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis).

Other adverse effects include:
Common: skin rash.
Uncommon: skin redness, itching, or skin swelling, purpura (purple spots on the skin).
Very rare: hair loss, erythema multiforme (skin lesions), 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 widespread red, scaly rash with bumps under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), may also occur.
Stop taking Ibuprofen Codramol immediately if you experience these symptoms and seek medical attention immediately. See also section 2.
The skin may become sensitive to light.

Immune system disorders:

Uncommon: transient swelling in areas of skin, mucous membranes, or sometimes internal organs (angioedema), inflammation of nasal mucosa, bronchospasm (spasm of the bronchi restricting airflow to the lungs).
Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, swelling of the face, tongue, and larynx, bronchospasm, asthma, tachycardia, hypotension, and shock may occur.
Very rare: joint pain and fever (drug-induced lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or feeling unsteady.
Rare: paraesthesia (numbness, tingling, "pins and needles" sensation, more commonly in hands, feet, arms, or legs).
Very rare: aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—without bacterial infection). In most reported cases of aseptic meningitis associated 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.

Haematological:

Rare: decreased platelet count, decreased white blood cells (may present as frequent infections with fever, chills, or sore throat), decreased red blood cells (may present as shortness of breath and pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red blood cells, white blood cells, and platelets in the blood), agranulocytosis (severe reduction in granulocytes), aplastic anaemia (bone marrow failure to produce various blood cells), or haemolytic anaemia (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 (a disorder characterized by protein in the 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 damage. Other rare adverse effects include: hepatitis (liver inflammation), abnormal liver function tests, and jaundice (yellowing of the skin and eyes).
Frequency not known: liver failure (severe liver impairment).

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 without delay:

Allergic reactions such as skin rash, facial swelling, wheezing, or breathing difficulties.
Vomiting blood or material resembling coffee grounds.
Blood in stools or bloody diarrhoea.
Severe stomach pain.
Blisters or extensive skin peeling.
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.
Flat, non-elevated red spots on the trunk, often target-shaped or circular, sometimes with blisters in the centre, 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].
Widespread skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen Codramol

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 unused medicines and their containers at the SIGRE Point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need.

This way you will help protect the environment.

6. Additional Information

Composition of Ibuprofen Codramol.

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 forms a white-colored suspension with an orange odor.

It is supplied 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 Health Products (AEMPS) http://www.aemps.gob.es/