Amlodipine/valsartan/hydrochlorothiazide STADA 10 mg/160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipine/Valsartan/Hydrochlorothiazide STADA 10 mg/160 mg/12.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. 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 experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Amlodipine/Valsartan/Hydrochlorothiazide STADA is and what it is used for
2. What you need to know before taking Amlodipine/Valsartan/Hydrochlorothiazide STADA
3. How to take Amlodipine/Valsartan/Hydrochlorothiazide STADA
4. Possible side effects
5. How to store Amlodipine/Valsartan/Hydrochlorothiazide STADA
6. Contents of the pack and other information

1. What Amlodipine/Valsartan/Hydrochlorothiazide Stada is and what it is used for

Amlodipine/Valsartan/Hydrochlorothiazide Stada tablets contain three substances called amlodipine, valsartan and hydrochlorothiazide. All of these substances help control high blood pressure.

• Amlodipine belongs to a group of substances known as «calcium channel blockers». Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing.
• Valsartan belongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances known as «thiazide diuretics». Hydrochlorothiazide increases urine production, which also lowers blood pressure.

As a result of these three mechanisms, blood vessels relax and blood pressure decreases.

Amlodipine/valsartan/hydrochlorothiazide is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan and hydrochlorothiazide separately, and who may benefit from taking a single tablet containing the three substances.

2. What you need to know before taking Amlodipine/Valsartan/Hydrochlorothiazide Stada

DO NOT take Amlodipine/Valsartan/Hydrochlorothiazide Stada

• if you are more than 3 months pregnant. (In any case, use of amlodipine/valsartan/hydrochlorothiazide is not recommended even in early pregnancy – see Pregnancy section).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulfonamide-derived medicines (medicines used to treat chest or urinary infections), or to any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, do not take amlodipine/valsartan/hydrochlorothiazide and inform your doctor.

• if you have liver disease, destruction of the small bile ducts within the liver (primary biliary cirrhosis), leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney problems or are undergoing dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels.
• if your blood calcium levels are too high despite treatment to reduce calcium levels.
• if you have gout (uric acid crystals in the joints).
• if you have severe low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

DO NOT take amlodipine/valsartan/hydrochlorothiazide and inform your doctor if any of the above apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine/Valsartan/Hydrochlorothiazide Stada:

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).

• if you have low levels of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, seizures).

• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle twitching, and muscle weakness).

• if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the kidney arteries.

• if you have liver problems.

• if you have or have had heart failure or coronary artery disease, especially if you have been prescribed the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).

• if you have had a heart attack. Follow your doctor’s instructions for carefully starting treatment. Your doctor may also check your kidney function.

• if your doctor has told you that you have narrowing of the heart valves (called “aortic or mitral stenosis”) or that the thickness of your heart muscle has abnormally increased (called “obstructive hypertrophic cardiomyopathy”).

• if you have aldosteronism. A condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of amlodipine/valsartan/hydrochlorothiazide is not recommended.

• if you have a disease called systemic lupus erythematosus (also known as “lupus” or “SLE”).

• if you have diabetes (high blood sugar).

• if you have high cholesterol or triglyceride levels in your blood.

• if you experience skin reactions such as rash after sun exposure.

• if you have had an allergic reaction to other high blood pressure medicines or diuretics, especially if you have asthma and allergies.

• if you have been ill (with vomiting or diarrhea).

• if you experience swelling, particularly in the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking amlodipine/valsartan/hydrochlorothiazide and contact your doctor immediately. You must never take amlodipine/valsartan/hydrochlorothiazide again.

• if you experience dizziness and/or fainting during treatment with amlodipine/valsartan/hydrochlorothiazide, inform your doctor as soon as possible.

• if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking amlodipine/valsartan/hydrochlorothiazide. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you previously had an allergy to penicillin or sulfonamides.

• if you are taking any of the following medicines for high blood pressure (hypertension):

• an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

• aliskiren.

  • if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking amlodipine/valsartan/hydrochlorothiazide.
  • if you have had breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking amlodipine/valsartan/hydrochlorothiazide, seek medical help immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “DO NOT take Amlodipine/Valsartan/Hydrochlorothiazide Stada”.

Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking amlodipine/valsartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking amlodipine/valsartan/hydrochlorothiazide on your own.

Inform your doctor if any of the above conditions apply to you.

Children and adolescents

The use of amlodipine/valsartan/hydrochlorothiazide is not recommended in children and adolescents under 18 years of age.

Elderly people (65 years and older)

Amlodipine/valsartan/hydrochlorothiazide can be used in people aged 65 years and older at the same dose as in other adults, and in the same way as they would have taken the individual components amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be monitored periodically in elderly patients, especially those taking the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).

Other medicines and Amlodipine/Valsartan/Hydrochlorothiazide Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important if you are taking any of the following:

Do not take together with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also information under the headings “DO NOT take Amlodipine/Valsartan/Hydrochlorothiazide Stada” and “Warnings and precautions”).

Should be used with caution with:

• alcohol, sleeping pills, and anesthetics;
• amantadine (used to treat Parkinson’s disease, also used to treat or prevent certain viral infections);
• anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances mainly used to treat high blood lipid levels);
• simvastatin (a medicine used to control high cholesterol);
• cyclosporine (a medicine used in organ transplantation to prevent organ rejection or for other conditions, e.g., rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• verapamil, diltiazem (heart medicines);
• iodinated contrast agents (used in imaging scans);
• medicines for diabetes (oral medicines such as metformin or insulin);
• medicines for gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may cause torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines for heart problems) and some antipsychotics;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce blood potassium levels, such as diuretics (water pills), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used for esophageal inflammation and ulceration (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, e.g., to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (intravenous use for serious body temperature abnormalities);
• vitamin D and calcium salts.

Taking Amlodipine/Valsartan/Hydrochlorothiazide Stada with food, drinks, and alcohol

Patients prescribed amlodipine/valsartan/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to unpredictable increases in the blood pressure-lowering effects of amlodipine/valsartan/hydrochlorothiazide. Consult your doctor before drinking alcohol. Alcohol may greatly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking amlodipine/valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Amlodipine/valsartan/hydrochlorothiazide is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/valsartan/hydrochlorothiazide is not recommended for women during this period. Your doctor may choose a treatment more suitable for breastfeeding, especially if the infant is a newborn or premature.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

As with other medicines used to treat high blood pressure, this medicine may cause dizziness, drowsiness, nausea, or headache. If you experience these symptoms, do not drive or operate tools or machinery.

Use in athletes

This medicine contains hydrochlorothiazide, which may lead to a positive result in doping tests.

Amlodipine/Valsartan/Hydrochlorothiazide Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse effects.

Dosage

• The recommended dose of amlodipine/valsartan/hydrochlorothiazide is one tablet daily.

Depending on your response to treatment, your doctor may recommend a higher or lower dose.

Do not exceed the prescribed dose.

Method of administration

• It is best to take the tablet at the same time each day. The optimal time is in the morning.
• Swallow the tablet whole with a glass of water.
• Amlodipine/valsartan/hydrochlorothiazide may be taken with or without food. Do not take amlodipine/valsartan/hydrochlorothiazide with grapefruit or grapefruit juice.

If you take more Amlodipine/Valsartan/Hydrochlorothiazide Stada than you should

If you have accidentally taken too many tablets of amlodipine/valsartan/hydrochlorothiazide, contact your doctor immediately. You may require medical attention.

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty in breathing, which may develop within 24–48 hours after ingestion.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medicine packaging and package leaflet to the healthcare professional.

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide Stada

If you forget to take a dose of this medicine, take it as soon as you remember, and then take the next dose at your usual time. If it is almost time for your next dose, you should only take the next tablet at the usual time. Do not take a double dose (two tablets at the same time) to make up for a missed dose.

If you stop taking Amlodipine/Valsartan/Hydrochlorothiazide Stada

Stopping your treatment with amlodipine/valsartan/hydrochlorothiazide may cause your condition to worsen. Do not stop taking the medicine unless your doctor tells you to.

Keep taking this medicine, even if you feel well

People with high blood pressure often do not experience any symptoms. Many feel perfectly well. It is very important that you take this medicine exactly as prescribed by your doctor to achieve the best results and reduce the risk of adverse effects. Continue attending your doctor's appointments even if you feel well.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

As with any combination containing three active substances, adverse effects associated with each individual component cannot be excluded. The adverse effects observed with amlodipine/valsartan/hydrochlorothiazide or one of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur when using amlodipine/valsartan/hydrochlorothiazide.

Some adverse effects may be serious and require immediate medical attention.

Contact your doctor immediately if you experience any of the following serious adverse effects after taking this medicine:

Frequent (may affect up to 1 in 10 people):

• dizziness
• low blood pressure (feeling faint, dizziness, sudden loss of consciousness)

Uncommon (may affect up to 1 in 100 people):

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• sudden wheezing, chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat causing severe difficulty in breathing
• severe skin reactions including intense rash, hives, widespread skin redness, severe itching, blistering, skin peeling, skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of malaise
• weakness, bruising, fever, and frequent infections
• stiffness
• acute breathing difficulty (signs include severe breathlessness, fever, weakness, and confusion)

Other adverse effects may include:

Very common (may affect more than 1 in 10 people):

• low blood potassium levels
• increased blood lipid levels

Frequent (may affect up to 1 in 10 people):

• drowsiness
• palpitations (awareness of heartbeat)
• hot flushes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high blood uric acid levels
• low blood magnesium levels
• low blood sodium levels
• dizziness, dizziness upon standing
• decreased appetite
• nausea and vomiting
• itchy rash and other types of rashes
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 people):

• rapid heartbeat
• sensation of spinning (vertigo)
• vision disorders
• stomach discomfort
• chest pain
• increased blood urea nitrogen, creatinine, and uric acid levels
• high blood calcium, lipid, or sodium levels
• decreased blood potassium levels
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered taste sensation
• back pain
• joint swelling
• muscle cramps, weakness, or pain
• limb pain
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• sudden transient loss of consciousness
• low blood pressure upon standing
• cough
• breathlessness
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• tinnitus (ringing in the ears)
• sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• changes in bowel habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urinary disorders
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of breasts in men
• pain
• feeling unwell
• weight loss

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

• low blood platelet count (sometimes with bleeding or bruising under the skin)
• glucose in urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders, which may present with yellowing of the skin and eyes or dark-colored urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purplish spots on the skin
• kidney disorders
• confusion

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

• decreased number of white blood cells
• decreased blood platelets, which may cause unusual bruising or easy bleeding (damage to red blood cells)
• gum inflammation
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• increased liver enzymes, which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rashes
• light sensitivity
• disorders combining stiffness, tremor, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal decrease due to rupture of red blood cells in blood vessels or other body parts)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatic inflammation)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease causing rash, skin redness, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (frequency cannot be estimated from available data):

• abnormal blood test results for kidney function, increased blood potassium levels, low red blood cell count
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in the blood
• increased blood creatinine levels
• abnormal liver function test
• inflammation of blood vessels
• weakness, bruising, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the choroid layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney dysfunction or kidney failure)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• muscle spasm
• fever (pyrexia)
• blistering skin disease (sign of a condition called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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 Amlodipine/Valsartan/Hydrochlorothiazide Stada

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

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

Store below 30°C.

Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amlodipine/Valsartan/Hydrochlorothiazide Stada

The active substances are amlodipine, valsartan and hydrochlorothiazide.

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate), 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

The other components are: microcrystalline cellulose (E460); povidone K30 (E1201); colloidal anhydrous silica (E551); sodium carboxymethylstarch (type A) (E468) (derived from potato starch); magnesium stearate (E470b); crospovidone (E1202); pregelatinized corn starch; hypromellose 2910 (E464); macrogol 8000 (E1521); titanium dioxide (E171); talc (E553b); and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Amlodipine/Valsartan/Hydrochlorothiazide Stada 10 mg/160 mg/12.5 mg film-coated tablets are biconvex, oval-shaped, pale yellow tablets, approximately 15.6 mm in length and 6.2 mm in width.

Amlodipine/Valsartan/Hydrochlorothiazide Stada is available in packs containing 28, 30, 60, 90, 98, 100, 105 or 120 film-coated tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18,

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2,

1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: February 2025

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