AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE STADA 10 mg/160 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Amlodipine/Valsartan/Hydrochlorothiazide Stada is and what it is used for
2. What you need to know before you take Amlodipine/Valsartan/Hydrochlorothiazide Stada
3. How to take Amlodipine/Valsartan/Hydrochlorothiazide Stada
4. Possible side effects
5. Storage of 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 active substances called amlodipine, valsartan, and hydrochlorothiazide. All these substances help to control high blood pressure.

• Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing.
• Valsartan belongs to a group of substances called “angiotensin II receptor antagonists”. Angiotensin II is produced by the body and makes the blood vessels 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 the three mechanisms, the 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 and who can benefit from taking a single tablet containing all three substances.

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

DO NOT take Amlodipine/Valsartan/Hydrochlorothiazide Stada

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking amlodipine/valsartan/hydrochlorothiazide also at the beginning of your pregnancy - see section Pregnancy).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulphonamide-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 (biliary cirrhosis) leading to the accumulation of bile in the liver (cholestasis).
• if you have severe kidney problems or if you are having dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase blood potassium or sodium levels.
• 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 situation where your heart is unable to supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney impairment 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 applies to you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine/Valsartan/Hydrochlorothiazide Stada:

• if you have low blood potassium or magnesium levels (with or without symptoms such as muscle weakness, muscle spasms, irregular heart rhythm).
• if you have low blood sodium levels (with or without symptoms such as tiredness, confusion, muscle contractions, convulsions).
• if you have high blood calcium levels (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle contractions, and muscle weakness).
• if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the arteries to your kidneys.
• if you have liver problems.
• if you have or have had heart failure or coronary heart disease, in particular 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 the dosage. Your doctor may also check your kidney function.
• if your doctor has told you that you have narrowing of the heart valves (so-called “aortic or mitral stenosis”) or that the thickness of your heart muscle has increased in an abnormal way (so-called “hypertrophic cardiomyopathy”).
• if you suffer from aldosteronism. A disease where the adrenal glands produce too much of the hormone aldosterone. In this case, the use of amlodipine/valsartan/hydrochlorothiazide is not recommended.
• if you suffer from a disease called systemic lupus erythematosus (also known as “lupus” or “SLE”).
• if you have diabetes (high blood sugar levels).
• if you have high cholesterol or triglyceride levels in your blood.
• if you experience skin reactions such as rash after exposure to the sun.
• if you have had an allergic reaction to other blood pressure medicines or diuretics, especially if you suffer from asthma and allergies.
• if you have been ill (with vomiting or diarrhoea).
• if you have experienced swelling, particularly in the face and throat, while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking amlodipine/valsartan/hydrochlorothiazide and contact your doctor immediately. You should 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 a decrease in vision or eye pain. These can be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and can occur within hours to weeks of administration of amlodipine/valsartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at greater risk of developing this if you have previously had an allergy to penicillin or sulphonamides.
• if you are taking any of the following medicines used to treat high blood pressure:

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

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

Your doctor may check 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”.

Tell 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.

Tell your doctor if any of the above applies to you.

Children and adolescents

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

Elderly (65 years and older)

Amlodipine/valsartan/hydrochlorothiazide can be used in people 65 years and older at the same dose as used in other adults and in the same way as they have previously taken the three substances called amlodipine, valsartan, and hydrochlorothiazide. The blood pressure of elderly patients should be regularly monitored, 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 using, have recently used, or might use any other medicines. Your doctor may need to change 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 using any of the medicines listed below:

Do not take with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also the 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 diseases);
• anticholinergic medicines (medicines used to treat various disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anaesthesia);
• anticonvulsant medicines and mood stabilisers used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances used mainly to treat high lipid levels in the blood);
• simvastatin (a medicine used to control high cholesterol levels);
• cyclosporin (a medicine used in 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 media (agents used in imaging procedures);
• medicines for treating diabetes (oral medicines such as metformin or insulins);
• medicines for treating gout, such as allopurinol;
• medicines that can increase blood sugar levels (beta-blockers, diazoxide);
• medicines that can induce “torsades de pointes” (irregular heartbeat), such as anti-arrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that can reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics;
• medicines that can reduce the amount of potassium in your blood, such as diuretics (medicines for urination), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines used to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used for treating fungal infections (e.g. ketoconazole, itraconazole);
• medicines used for inflammation and ulceration of the oesophagus (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory medicines (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines used to relax muscles during operations);
• 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 (in infusion for severe abnormalities of body temperature);
• vitamin D and calcium salts.

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

People who have been prescribed amlodipine/valsartan/hydrochlorothiazide should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of amlodipine/valsartan/hydrochlorothiazide. Consult your doctor before drinking alcohol. Alcohol can greatly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breast-feeding

Pregnancy

You should tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant.Your doctor will normally advise you to stop taking amlodipine/valsartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another medicine to lower your blood pressure instead. Amlodipine/valsartan/hydrochlorothiazide should not be used during the first trimester of pregnancy and in any case should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered after this period.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding.It has been shown that amlodipine passes into breast milk in small amounts. Amlodipine/valsartan/hydrochlorothiazide should not be used during breast-feeding. Your doctor may decide to prescribe a treatment that is more suitable for you if you want to breast-feed, especially if you are breast-feeding a newborn or premature baby.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

As with other medicines used to treat high blood pressure, you may feel dizzy, sleepy, feel sick, or have a headache. If you experience these symptoms, do not drive or use tools or machines.

Use in athletes

This medicine contains hydrochlorothiazide, which can produce 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 the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again. This will help you obtain the best results and reduce the risk of adverse effects.

Dosage

• The recommended dose of amlodipine/valsartan/hydrochlorothiazide is one tabletper day.

Depending on your response to treatment, your doctor may suggest 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 every day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You can 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 tablets of amlodipine/valsartan/hydrochlorothiazide, consult your doctor immediately. You may need medical attention.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that can develop up to 24-48 hours after ingestion.

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

If You Forget to Take Amlodipine/Valsartan/Hydrochlorothiazide Stada

If you forget to take a dose of this medication, take it as soon as you remember and then take the next dose at the usual time. If it is almost time for the next dose, only take the next tablet at the usual time. Do nottake a double dose (two tablets at the same time) to make up for missed doses.

If You Stop Treatment with Amlodipine/Valsartan/Hydrochlorothiazide Stada

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

Always Take This Medication, Even If You Feel Well

Hypertensive people often do not notice any symptoms of their problem. Many feel well. It is very important that you take this medication exactly as your doctor has indicated to obtain the best results and reduce the risk of adverse effects. Keep your appointments with your doctor even if you feel well.

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

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

As with any combination that contains three active ingredients, the 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 can be serious and require immediate medical attention.

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

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

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

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

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

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

• sudden whistling when breathing (sudden wheezing), chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat that causes great difficulty breathing
• severe skin reactions that include intense skin rash, hives, redness of the skin all over the body, significant itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• heart attack
• pancreatitis that can cause severe abdominal pain and back pain accompanied by a great feeling of discomfort
• weakness, bruising, fever, and frequent infections
• stiffness
• acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion)

Other adverse effects may include:

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

• low potassium levels in the blood
• increased lipids in the blood

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

• drowsiness
• palpitations (feeling the heartbeat)
• hot flashes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, dizziness when standing up
• 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 100people):

• rapid heartbeat
• feeling that everything is spinning
• vision disorder
• stomach discomfort
• chest pain
• increased urea, creatinine, and uric acid in the blood
• high levels of calcium, lipids, or sodium in the blood
• decreased potassium in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• swelling of the joints
• cramps/weakness/pain in the muscles
• pain in the limbs
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness when standing up or after exercising
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden loss of consciousness
• low blood pressure when standing up
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• redness of the skin
• tremors
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual impairment
• ringing in the ears
• sneezing/nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• alteration of bowel habits
• indigestion
• hair loss
• itching of the skin
• skin discoloration
• urination disorder
• 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 1,000people):

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• sugar in the urine
• high blood sugar levels
• worsening of diabetic metabolic condition
• abdominal discomfort
• constipation
• liver disorders that may present with yellowing of the skin and eyes, or darkening of the urine (hemolytic anemia)
• increased sensitivity of the skin to the sun
• purple spots on the skin
• kidney disorders
• confusion

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

• decrease in the number of white blood cells in the blood
• decrease in blood platelets that can 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)
• increase in liver enzymes that can affect some medical tests
• increase in muscle tension
• inflammation of blood vessels often with skin rashes
• sensitivity to light
• disorders combining stiffness, tremors, 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 both in blood vessels and in other parts of the body)
• confusion, fatigue, muscle contractions and spasms, rapid breathing (hypochloremic alkalosis)
• severe pain in the upper part of the stomach (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease that causes skin rash, skin redness, blisters on the lips, eyes, or mouth, peeling of the skin, fever (toxic epidermal necrolysis)
• intestinal angioedema: swelling in the intestine that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency Not Known(frequency cannot be estimated from available data):

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide Stada

Keep this medication out of sight and reach of children.

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

Store below 30°C.

Keep in the original packaging to protect it from moisture.

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

6. Package Contents and Additional Information

Composition of Amlodipine/Valsartan/Hydrochlorothiazide Stada

The active ingredients are amlodipine, valsartan, and hydrochlorothiazide.

Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 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 carboxymethyl starch (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 Package Contents

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

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

Only some package 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

info@stada.es

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 medication is authorized in the member states of the European Economic Area with the following names:

Date of the Last Revision of this Leaflet:February 2025

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