Valsartan/hydrochlorothiazide Stada 160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Valsartan/Hydrochlorothiazide Stada 80 mg/12.5 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Stada 160 mg/12.5 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Stada 320 mg/12.5 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Stada 160 mg/25 mg film-coated tablets EFG

Valsartan/Hydrochlorothiazide Stada 320 mg/25 mg film-coated tablets EFG

Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to others, even if they have the same symptoms as you, because it could 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.

Leaflet contents

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

1. What Valsartán/Hidroclorotiazida Stada is and what it is used for

Valsartán/Hidroclorotiazida Stada film-coated tablets contain two active substances known as valsartan and hydrochlorothiazide. These components help control high blood pressure (hypertension).

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists” which help control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, resulting in increased blood pressure. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure decreases.
• Hydrochlorothiazide belongs to a class of medicines known as thiazide diuretics. Hydrochlorothiazide increases urine production, which also helps lower blood pressure.

Valsartán/hydrochlorothiazide is used to treat high blood pressure that is not adequately controlled with the use of a single component.

High blood pressure increases the workload on the heart and arteries. If left untreated, it can damage blood vessels in the brain, heart, and kidneys, leading to stroke, heart failure, or kidney failure. High blood pressure increases the risk of heart attacks. Lowering blood pressure to normal levels reduces the risk of developing these complications.

2. What you need to know before taking Valsartán/Hidroclorotiazida Stada

DO NOT take Valsartán/Hidroclorotiazida Stada

• if you are allergic to valsartan, hydrochlorothiazide, sulfonamide derivatives (substances chemically related to hydrochlorothiazide), or to any of the other components of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also during early pregnancy – see Pregnancy section)
• if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis) leading to bile accumulation in the liver (cholestasis)
• if you have severe kidney disease
• if you are unable to produce urine (anuria)
• if you are undergoing dialysis
• if you have abnormally low levels of potassium or sodium in your blood, or if your blood calcium levels are higher than normal despite treatment
• if you have gout
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren

If any of these situations apply to you, do not take this medicine and consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Valsartán/Hidroclorotiazida Stada.

• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase potassium levels in the blood, such as heparin. Your doctor may consider regular monitoring of potassium levels necessary.

• if you have low potassium levels in your blood.

• if you experience severe diarrhea or vomiting.

• if you are taking high doses of a diuretic.

• if you have severe heart disease.

• if you have heart failure or have had a heart attack. Follow your doctor’s instructions carefully when starting treatment. Your doctor may also monitor your kidney function.

• if you have renal artery stenosis (narrowing of the artery to the kidney).

• if you have recently undergone a kidney transplant.

• if you have hyperaldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, valsartan/hydrochlorothiazide is not recommended.

• if you have kidney or liver disease.

• if you have previously experienced swelling of the tongue and face due to an allergic reaction called angioedema while taking other medicines (including ACE inhibitors), inform your doctor. If you develop these symptoms while taking valsartan/hydrochlorothiazide, stop treatment immediately and never take it again. See also section 4 “Possible side effects”.

• if you develop fever, skin rash, and joint pain, which may be signs of systemic lupus erythematosus (a known autoimmune disease).

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

• if you have previously had an allergic reaction to another medicine of this class used to lower blood pressure (angiotensin II receptor antagonists), or if you suffer from any type of allergy or asthma.

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

• it may cause increased skin sensitivity to sunlight.

• 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 sun exposure and UV radiation while taking valsartan/hydrochlorothiazide.

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

• 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 previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking valsartan/hydrochlorothiazide, seek medical attention immediately.

If any of these situations apply to you, consult your doctor.

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

See also the information under the heading “Do not take Valsartán/Hidroclorotiazida Stada”.

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

Children and adolescents

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of valsartan/hydrochlorothiazide is not recommended during early pregnancy (first 3 months) and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby (see section Pregnancy).

Taking Valsartán/Hidroclorotiazida Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

The effect of treatment with valsartan/hydrochlorothiazide may be altered when taken together with certain medicines. It may be necessary to adjust the dose, take additional precautions, or in some cases discontinue treatment with one of the medicines. This is particularly important for the following medicines:

• lithium, a medicine used to treat certain psychiatric disorders
• 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
• medicines that may decrease potassium levels in the blood, such as diuretics (medicines to increase urine production), corticosteroids, laxatives, carbenoxolone, amphotericin, or penicillin G
• certain antibiotics (rifampicin group), a drug used to prevent transplant rejection (cyclosporine), or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may enhance the effect of valsartan/hydrochlorothiazide
• medicines that may cause “torsades de pointes” (irregular heartbeats), 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 for treating gout, such as allopurinol, probenecid, sulfinpyrazone
• therapeutic vitamin D and calcium supplements
• medicines for treating diabetes (oral antidiabetics such as metformin or insulin)
• other blood pressure-lowering medicines including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren
• medicines that increase blood pressure, such as noradrenaline or adrenaline
• digoxin or other digitalis glycosides (medicines used to treat heart problems)
• medicines that may increase blood sugar levels, such as diazoxide or beta-blockers
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide
• pain medicines such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors and acetylsalicylic acid at doses above 3 g
• muscle relaxants, such as tubocurarine
• anticholinergic medicines (used to treat a wide range of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, travel sickness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia)
• amantadine (a medicine used to treat Parkinson’s disease and also to treat or prevent certain viral diseases)
• cholestyramine and colestipol (medicines mainly used to treat high blood lipid levels)
• cyclosporine, a medicine used to prevent rejection of transplanted organs
• alcohol, sleeping medicines, and anesthetics (medicines with sedative or pain-relieving effects used, for example, during surgery)
• iodinated contrast agents (used in diagnostic imaging procedures)

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take Valsartán/Hidroclorotiazida Stada” and “Warnings and precautions”).

Taking Valsartán/Hidroclorotiazida Stada with food and drinks

You may take valsartan/hydrochlorothiazide with or without food.

Avoid drinking alcohol until you have discussed it with your doctor. Alcohol may further lower your blood pressure and/or increase the likelihood of dizziness and weakness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

•You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking valsartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and recommend an alternative antihypertensive medicine. Valsartán/hidroclorotiazida 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 administered from that point.

• Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as valsartan/hydrochlorothiazida is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Before driving a vehicle, using tools, operating machinery, or engaging in other activities requiring concentration, make sure you are aware of how valsartan/hydrochlorothiazida affects you. Like many other medicines used to treat high blood pressure, valsartan/hydrochlorothiazide may rarely cause dizziness and affect your ability to concentrate.

Use in athletes

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

Valsartán/Hidroclorotiazida Stada contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Valsartán/Hidroclorotiazida Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

People with high blood pressure often do not notice any symptoms of the condition and frequently feel perfectly well. Therefore, it is very important to keep your appointments with your doctor, even if you feel fine.

Your doctor will tell you exactly how many tablets of valsartan/hydrochlorothiazide you should take. Depending on how you respond to treatment, your doctor may decide to increase or decrease the dose.

• The usual dose of valsartan/hydrochlorothiazide is one tablet daily.
• Do not change the dose or stop treatment without consulting your doctor.
• This medicine should be taken at the same time each day, usually in the morning.
• You may take valsartan/hydrochlorothiazide with or without food.
• Swallow the tablet with a glass of water.

If you take more Valsartán/Hidroclorotiazida Stada than you should

If you experience severe dizziness and/or fainting, lie down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.

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 medicine and the amount ingested.

If you forget to take Valsartán/Hidroclorotiazida Stada

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

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

If you stop taking Valsartán/Hidroclorotiazida Stada

If you stop treatment with valsartan/hydrochlorothiazide, your high blood pressure may worsen. Do not stop taking the medicine unless instructed by your doctor.

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 experiences them.

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

• You should see your doctor immediately if you notice symptoms of angioedema, such as:

• swelling of the face, tongue, or pharynx

• difficulty swallowing

• hives and difficulty breathing

• Severe skin disease causing skin rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (toxic epidermal necrolysis)

• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

• Fever, sore throat, increased frequency of infections (agranulocytosis)

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

These adverse effects are very rare or of unknown frequency.

If you experience any of these symptoms, stop taking valsartan/hydrochlorothiazide and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other adverse effects include:

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

• cough
• low blood pressure
• dizziness
• dehydration (with symptoms such as thirst, dry mouth and tongue, reduced frequency of urination, dark-colored urine, dry skin)
• muscle pain
• fatigue
• tingling or numbness
• blurred vision
• noises (e.g., ringing or buzzing) in the ears

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

• dizziness
• diarrhea
• joint pain

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

• difficulty breathing
• severe decrease in urine output
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)
• low potassium levels in the blood (sometimes with muscle weakness, muscle cramps, irregular heartbeat)
• low white blood cell count (with symptoms such as fever, skin infections, sore throat, or mouth ulcers due to infections, weakness)
• increased bilirubin levels in the blood (which, in severe cases, may cause yellowing of the skin and eyes)
• increased blood urea nitrogen and creatinine levels (which may indicate abnormal kidney function)
• increased uric acid levels in the blood (which, in severe cases, may trigger a gout attack)
• syncope (fainting)

The following adverse effects have been observed with medicines containing valsartan or hydrochlorothiazide separately

Valsartan

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

• sensation of spinning
• abdominal pain

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

• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

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

• blisters on the skin (sign of bullous dermatitis)
• skin rash with or without itching along with one or more of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes, and/or flu-like symptoms
• skin rash, red-purple spots, fever, itching (symptoms of inflammation of blood vessels)
• low platelet count (sometimes with increased bleeding or bruising)
• high potassium levels in the blood (sometimes with muscle cramps, irregular heartbeat)
• low sodium levels in the blood (sometimes with nausea, fatigue, confusion, malaise, seizures)
• allergic reactions (with symptoms such as skin rash, itching, hives, difficulty breathing or swallowing, dizziness)
• swelling mainly of the face and throat; skin rash; itching
• elevated liver function test values
• decreased hemoglobin levels and reduced percentage of red blood cells in the blood (which, in severe cases, may lead to anemia)
• renal failure
• low sodium levels in the blood (which, in severe cases, may cause fatigue, confusion, muscle fasciculations, and/or seizures)

Hydrochlorothiazide

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

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

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

• low sodium levels in the blood
• low magnesium levels in the blood
• high uric acid levels in the blood
• itchy rash and other types of skin rashes
• decreased appetite
• mild vomiting and nausea
• dizziness, dizziness upon standing
• inability to achieve or maintain an erection

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

• swelling and blisters on the skin (due to increased sensitivity to sunlight)
• high calcium levels in the blood
• high blood sugar levels
• sugar in the urine
• worsening of diabetic metabolic status
• constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may occur with yellowing of the skin and eyes
• irregular heartbeat
• headache
• sleep disturbances
• sadness (depression)
• low platelet count (sometimes with bleeding or bruising under the skin)
• dizziness
• tingling or numbness
• vision disturbances

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

• inflammation of blood vessels with symptoms such as skin rash, red-purple spots, fever (vasculitis)
• rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• severe pain in the upper abdomen (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (breathing difficulty including pneumonitis and pulmonary edema)
• pale skin, fatigue, shortness of breath, dark-colored urine (hemolytic anemia)
• fever, sore throat, or mouth ulcers due to infections (leukopenia)
• confusion, fatigue, muscle twitching and cramps, rapid breathing (hypochloremic alkalosis)

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

• weakness, bruising, frequent infections (aplastic anemia)
• marked decrease in urine production (possible signs of kidney impairment or kidney failure)
• skin rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme)
• muscle cramps
• fever (pyrexia)
• weakness (asthenia)
• 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 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. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Do not use this medicine if you notice that the packaging is damaged or shows signs of deterioration.

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

6. Contents of the pack and other information

Composition of Valsartan/Hydrochlorothiazide Stada

The active substances are:

• valsartan
• hydrochlorothiazide

80 mg/12.5 mg: Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide.

160 mg/12.5 mg: Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide.

320 mg/12.5 mg: Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

160 mg/25 mg: Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide.

320 mg/25 mg: Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

Other components of the core are:

• Lactose monohydrate
• Microcrystalline cellulose
• Hypromellose
• Sodium croscarmellose
• Colloidal anhydrous silica
• Magnesium stearate

Other components of the coating are:

80 mg/12.5 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Red iron oxide (E172)

160 mg/12.5 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Red iron oxide (E172)
• Yellow iron oxide (E172)
• Black iron oxide (E172)

320 mg/12.5 mg and 160 mg/25 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Red iron oxide (E172)
• Yellow iron oxide (E172)
• Black iron oxide (E172)

320 mg/25 mg:

• Hypromellose
• Macrogol 8000
• Talc
• Titanium dioxide (E171)
• Yellow iron oxide (E172)

Nature of the product and contents of the pack

Valsartan/Hydrochlorothiazide Stada 80 mg/12.5 mg film-coated tablets EFG are oval, biconvex, pink tablets.

Valsartan/Hydrochlorothiazide Stada 160 mg/12.5 mg film-coated tablets EFG are oval, biconvex, brown tablets.

Valsartan/Hydrochlorothiazide Stada 320 mg/12.5 mg film-coated tablets EFG are oval, biconvex, pink tablets.

Valsartan/Hydrochlorothiazide Stada 160 mg/25 mg film-coated tablets EFG are oval, biconvex, orange tablets.

Valsartan/Hydrochlorothiazide Stada 320 mg/25 mg film-coated tablets EFG are oval, biconvex, yellow tablets.

Valsartan/Hydrochlorothiazide Stada 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg: available in Al/PVC/PVDC blister packs containing 10, 14, 28, 30, 50, 56, 90, 98 and 100 tablets.

Valsartan/Hydrochlorothiazide Stada 320 mg/12.5 mg, 320 mg/25 mg: available in Al/PVC/PVDC blister packs containing 7, 10, 28, 30, 56, 90, 98, 126, 154 and 182 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Eurogenerics N.V.

Heizel Esplanade Heysel b 22

B-1020 Brussels

Belgium

or

LAMP S. Prospero S.p.A.

Via della Pace, 25/A

I-41030 San Prospero (Modena)

Italy

or

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2

A-1190 Vienna

Austria

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:

Austria Valsartan HCT STADA Filmtabletten

Belgium Co-Valsartan EG filmomhulde tabletten

Bulgaria Valsavil Comp ????????? ????????

Denmark Valsartore Comp

Finland Valsartore Comp tabletti, kalvopäällysteisen

Germany Valsartan/HCT STADA Filmtabletten

Ireland Valtan Comp film-coated tablets

Italy Valsartan e Idroclorotiazide EG compresse rivestite con film

Luxembourg Co-Valsartan EG comprimés pelliculés

Portugal Valsartan + Hidroclorotiazida Ciclum comprimidos revestidos

Spain Valsartán/Hidroclorotiazida STADA comprimidos recubiertos con película EFG

Sweden Valsartore Comp filmdragerade tabletter

Netherlands Valsartan/HCT CF, filmomhulde tabletten

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

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