Amlodipine/valsartan/hydrochlorothiazide STADA 10 mg/320 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Amlodipine/Valsartan/Hydrochlorothiazide STADA 10 mg/320 mg/25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 known as «angiotensin II receptor antagonists». Angiotensin II is produced by the body and causes blood vessels to narrow, thereby 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, amlodipine/valsartan/hydrochlorothiazide is recommended to be avoided also during 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 tract infections), or to any of the other components 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 in the blood.
• if your blood calcium levels are too high despite treatment to reduce blood 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 arteries to the kidneys.

• if you have liver problems.

• if you have or have had heart failure or coronary artery disease, particularly 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 abnormal thickening of your heart muscle (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 unwell (with vomiting or diarrhoea).

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

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

• an angiotensin-converting enzyme inhibitor (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, particularly 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 exposure to sunlight and UV rays 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, see your doctor 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”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea 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 three substances amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be monitored periodically in elderly patients, particularly those taking the maximum dose of amlodipine/valsartan/hydrochlorothiazide (10 mg/320 mg/25 mg).

Other medicines and Amlodipine/Valsartan/Hydrochlorothiazide Stada

Inform 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 medicines:

Do not take together with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase potassium levels in the blood. 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 anaesthetics;
• amantadine (treatment for Parkinson’s disease, also used to treat or prevent certain viral illnesses);
• 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 anaesthesia);
• anticonvulsant and mood-stabilizing medicines 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 lipid levels in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporine (a medicine used in organ transplants 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 procedures);
• medicines for treating diabetes (oral medicines such as metformin or insulin);
• medicines for treating gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may induce torsades de pointes (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that may reduce sodium levels in the blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce potassium levels in the blood, such as diuretics (medicines to increase urine production), 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 oesophageal inflammation and ulceration (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (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 (by infusion for serious body temperature abnormalities);
• vitamin D and calcium salts.

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

People 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 cause an unpredictable increase in the blood pressure-lowering effect 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 severe harm to your baby when used from that time.

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 use in women who are breastfeeding. Your doctor may decide to prescribe 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 make you feel dizzy, drowsy, nauseous, or give you a headache. If you experience these symptoms, do not drive or operate tools or machinery.

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

Amlodipine/Valsartan/Hydrochlorothiazide Stada contains sodium and orange-yellow

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

This medicine contains an azo dye, orange-yellow, which may cause allergic-type reactions.

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.
• You may take amlodipine/valsartan/hydrochlorothiazide 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 amlodipine/valsartan/hydrochlorothiazide tablets, 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 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 once) 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 with the use of 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 breathing
• severe skin reactions including intense rash, hives, widespread redness of the skin, severe itching, blistering, peeling and inflammation of the skin, 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 illness
• weakness, bruising, fever, and frequent infections
• stiffness
• acute breathing difficulty (signs include severe shortness of breath, 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

Common (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 rash
• inability to achieve or maintain an erection

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

• rapid heartbeat
• sensation of spinning (vertigo)
• vision disorder
• 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 sense of taste
• 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
• altered taste
• fainting
• sudden transient loss of consciousness
• low blood pressure upon standing
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• altered taste
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears (tinnitus)
• 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 the breasts in men
• pain
• feeling of discomfort
• 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
• purpuric skin spots
• kidney disorders
• confusion

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

• decreased number of white blood cells in the blood
• decreased blood platelets which may cause unusual bruising or easy bleeding (damage to red blood cells)
• inflammation of the gums
• abdominal swelling (gastritis)
• inflammation of the liver (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 destruction of red blood cells in blood vessels or other body parts)
• confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatitis)
• 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, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• changes in blood test results for kidney function, increased blood potassium levels, low number of red blood cells
• 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 choroidal layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney impairment 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 is the last day of the month indicated.

Store below 30°C.

Keep in the original packaging to protect from moisture.

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

6. Contents of the container 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 besylate), 320 mg of valsartan and 25 mg of hydrochlorothiazide.

The other components are: microcrystalline cellulose (E460); povidone K30 (E1201); colloidal anhydrous silica (E551); sodium carboxymethyl starch (type A) (E468) (derived from potato starch); magnesium stearate (E470b); crospovidone (E1202); pregelatinized corn starch; hypromellose 2910 (E464); macrogol 4000 (E1521); titanium dioxide (E171); yellow iron oxide (E172); and yellow aluminium lake FD&C No. 6 (E110).

Appearance of the product and contents of the pack

Film-coated tablets of Amlodipine/Valsartan/Hydrochlorothiazide Stada 10 mg/320 mg/25 mg are biconvex, oval-shaped, brownish-yellow in colour, approximately 19.1 mm in length and 9.1 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 Authorization Holder and Manufacturer

Marketing Authorization 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 authorized in the European Economic Area member states under the following names:

Date of the last revision of this leaflet: February 2025

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