Enalapril/hidroclorotiazida sandoz 20/12,5 mg comprimidos efg

Patient Information Leaflet

Enalapril/Hidroclorotiazida Sandoz 20 mg/12.5 mg Tablets EFG

Enalapril maleate/hydrochlorothiazide

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Enalapril/Hidroclorotiazida Sandoz is and what it is used for

2.What you need to know before starting to take Enalapril/Hidroclorotiazida Sandoz

3.How to take Enalapril/Hidroclorotiazida Sandoz

4.Possible side effects

5.Storage of Enalapril/Hidroclorotiazida Sandoz

6.Contents of the pack and additional information

Enalapril/Hidroclorotiazida Sandoz contains a combination of enalapril and hidroclorotiazida and are used as a treatment for high blood pressure when treatment with enalapril as a single medication has been shown to be insufficient on its own.

Your doctor may also prescribe Enalapril/Hidroclorotiazida Sandoz instead of separate tablets of the same doses of enalapril and hidroclorotiazida.

This fixed-dose combination is not suitable as initial treatment.

You should speak with a doctor if you do not feel better or if you feel worse.

Enalaprilbelongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors), which reduces blood pressure by dilating blood vessels.

Hidroclorotiazidabelongs to a group of medications called diuretics and reduces blood pressure by increasing urine production.

Do not take Enalapril/Hidroclorotiazida Sandoz

• if you are allergic to enalapril, to hidroclorotiazida or to any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to sulfonamide-derived medicines (most are antibiotics, e.g. sulfametoxazol),
• if you have previously experienced swelling of the extremities, face, lips, throat, mouth or tongue (angioedema) when treated with other medicines belonging to the group of medicines called ACE inhibitors (inhibitors of the angiotensin-converting enzyme),
• if you have previously experienced swelling of the extremities, face, lips, throat, mouth or tongue (angioedema) under any other circumstances,
• if a member of your family has previously experienced swelling of the extremities, face, lips, throat, mouth or tongue (angioedema),
• if you have severe kidney problems,
• if you have problems urinating,
• if you have diabetes or kidney insufficiency and are being treated with a blood pressure-lowering medicine that contains aliskirén,
• if you have severe liver problems or a neurological disorder as a result of severe liver problems (hepatic encephalopathy),
• if you are more than 3 months pregnant (also it is better to avoid enalapril maleate/hidroclorotiazida at the beginning of pregnancy, see section pregnancy).
• if you have taken or are taking sacubitril/valsartán, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril/Hidroclorotiazida Sandoz if:

• you have atherosclerosis (narrowing of the arteries), cerebrovascular problems such as a stroke or transient ischaemic attack (TIA, a "mini-stroke"),
• you have a disease characterized by a reduction in blood supply to the heart muscle, usually due to coronary artery disease (ischaemic cardiomyopathy),
• you have heart failure,
• you have low blood pressure, follow a low-salt diet or are taking diuretics,
• you have irregular levels of water and minerals in your body (electrolyte imbalance), distinguished by nausea, abdominal pain, and/or vomiting, headache, oedema (swelling), muscle weakness and/or tremors, etc.,
• you have hypertrophic cardiomyopathy, a narrowing of the main artery that carries blood from the heart, the aorta (aortic stenosis),or a narrowing of the functional kidney artery, have a transplanted kidneyor another type of heart problem called outflow obstruction,
• you are undergoing LDL apheresis (removal of cholesterol from the blood using a machine),
• you are undergoing desensitization treatment for an insect venom, such as bee or wasp sting,
• you have diabetes,
• you have gout, have high levels of uric acid in your blood or are being treated with allopurinol,
• you need to undergo anaesthesia,
• you have recently experienced violent, prolonged vomiting or severe diarrhoea,
• you are about to have a test to check your parathyroid function,
• you have or have had liver or kidney problems, or have a narrowing of the arteries in your kidneys (renal artery stenosis), or only have one functional kidney, or are undergoing haemodialysis,
• you have a vascular disease of collagen such as systemic lupus erythematosus (SLE) or scleroderma, which may be associated with skin rashes, joint pain and fever,
• if you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, particularly its 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 exposure to the sun and UV rays while taking Enalapril/Hidroclorotiazida Sandoz,
• you have allergy or asthma problems,
• if you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking enalapril/hidroclorotiazida, seek medical attention immediately,
• you are taking lithium, used to treat certain psychiatric disorders,
• you are taking any of the following medicines, which increase the risk of angioedema (rapid swelling under the skin in areas such as the throat):

• racecadotril, a medicine used to treat diarrhoea,
• medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus and other medicines that belong to the pharmacological class of mTOR inhibitors),
• vildagliptina, a medicine used to treat diabetes.

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

• an angiotensin II receptor antagonist (ARA) (also known as "sartanes", e.g. valsartán, telmisartán, irbersartán), particularly if you have kidney problems related to diabetes.
• aliskirén.

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

See also the information under the heading "Do not take Enalapril/Hidroclorotiazida Sandoz".

You should consult your doctor if you think you are (or may become) pregnant. Enalapril maleate/hidroclorotiazida is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as this could cause serious harm to your baby if you take it during this period (see section pregnancy). Enalapril/Hidroclorotiazida Sandoz is not recommended during breastfeeding.

Generally, Enalapril/Hidroclorotiazida Sandoz is not recommended if the following occurs, so you should consult your doctor before starting to take this medicine:

• if you have recently undergone a kidney transplant.
• if you have high levels of potassium in your blood, your potassium levels should be controlled during treatment. The risk factors for increased potassium levels include reduced renal function, age (> 70 years), dehydration, acute heart failure, metabolic acidosis, diabetes (diabetes mellitus), concurrent use of potassium-sparing diuretics, potassium supplements or salts containing potassium substitutes, or taking medicines that increase the concentration of potassium in the blood. You may also develop low potassium levels in the blood, which are detected by high blood pressure, altered heart rhythm, etc. (e.g. caused by interactions with medicines, excessive urine loss, etc.).

See also the section "Other medicines and Enalapril/Hidroclorotiazida Sandoz" later in this leaflet.

Inform your doctor if you are a sportsman who has a doping control, as Enalapril/Hidroclorotiazida Sandoz contains an active ingredient that may produce positive results in a doping test.

Patients aged over 70 years or who are malnourished should take special care when using Enalapril/Hidroclorotiazida Sandoz.

Enalapril/Hidroclorotiazida Sandoz may be less effective in people of black race.

Children and adolescents

This medicine is not recommended for use in children.

If you develop any of the following symptoms while taking Enalapril/Hidroclorotiazida Sandoz, inform your doctor immediately:

• you feel dizzy after the first dose. Some people react to their first dose or when increasing their dose, experiencing mild weakness and discomfort,
• swelling of the lips, face and neck, possibly also hands and feet, difficulty breathing or hoarseness. This condition is called angioedema. This can occur at any time during treatment. ACE inhibitors produce a higher rate of angioedema in black patients or in patients of other races,
• elevated temperature, sore throat or ulcers in the mouth (these may be symptoms of infection caused by a decrease in white blood cells),
• yellowing of the skin and the white of the eyes (jaundice) which may be a sign of liver disease,
• a persistent dry cough. A cough has been observed with the use of ACE inhibitors but may also be a symptom of another upper respiratory tract disease,
• sudden myopia,
• if you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal haemorrhage) or increased pressure in the eye and may occur within a few hours to weeks after taking Enalapril/Hidroclorotiazida Sandoz. This may lead to permanent loss of vision if not treated. If you have previously experienced an allergy to penicillins or sulfonamides, you may have a higher risk of developing this,

Other medicines and Enalapril/Hidroclorotiazida Sandoz

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

You should not takeenalapril/hidroclorotiazida at the same time as the following medicines:

• potassium supplements (including potassium substitutes),
• diuretics used to treat high blood pressure, including potassium-sparing diuretics such as spironolactone, triamterene or amiloride, and other medicines that may increase the amount of potassium in your body (e.g. trimetoprima and cotrimoxazol, also known as trimetoprima/sulfametoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to dilute the blood to prevent clots),
• other medicines used to treat high blood pressure.

Your doctor may need to change your dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the sections "Do not take Enalapril/Hidroclorotiazida Sandoz" and "Be careful with Enalapril/Hidroclorotiazida Sandoz").

• anaesthetics and medicines for mental disorders or depression, medicines for treating psychosis, tricyclic antidepressants or sedatives,
• litio (medicine for treating psychiatric disorders),
• analgesics and anti-inflammatory medicines, such as acetylsalicylic acid, indometacina and selective cyclooxygenase-2 inhibitors (COX-2 inhibitors),
• gold injections (aurotiomalato sódico), a medicine for rheumatoid arthritis,
• medicines such as efedrina, used in some cough and cold medicines, or noradrenaline and adrenaline, used for low blood pressure, shock, heart failure, asthma or allergies,
• medicines that lower blood sugar, such as insulin and those taken orally,
• cholestyramine and cholestipol, substances that reduce lipid levels in the blood,
• corticosteroids, anti-inflammatory hormones,
• corticotropin (ACTH) is mainly used to determine if your adrenal glands are functioning correctly,
• muscle relaxants (e.g. tubocurarine chloride, medicines used to relax muscles used in operations),
• alopurinol, probenecid, sulfinpirazona, medicines for treating gout,
• medicines such as atropine or biperideno used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, dizziness, muscle spasms such as help for anaesthesia,
• medicines for treating cancer, such as ciclofosfamida or metotrexato,
• medicines that inhibit the immune system, medicines used to prevent organ transplant rejection or bone marrow transplant rejection such as ciclosporina,
• cardiac glycosides (e.g. digoxina, medicines used to strengthen the heart),
• medicines that, as an adverse effect, may cause abnormal conduction of stimuli in the heart, such as medicines used to treat arrhythmias, some medicines used to treat psychosis and other medicines used to treat bacterial infections,
• calcium salts and vitamin D, high levels of calcium in the blood (may lead to gastrointestinal disorders, excessive thirst, excessive urination, fatigue, weakness and weight loss),
• carbamazepina, a medicine used mainly to treat epilepsy and bipolar disorder,
• anfotericina B, medicines used to treat fungal infections,
• laxatives, medicines used to promote defecation,
• ionized contrast media, increase the visibility of vascular structures and organs during radiography procedures,
• barbiturates, medicines that act as central nervous system depressants producing sedation,
• opioid analgesics, strong analgesics with non-anti-inflammatory effect,
• carbenoxolona, a medicine used to treat gastrointestinal inflammation,
• salicylates, medicines used to treat pain and/or inflammatory diseases,
• medicines that are usually used to prevent organ transplant rejection (sirólimus, everólimus and other medicines that belong to the pharmacological class of mTOR inhibitors). See section "Warnings and precautions".

Inform your doctor or pharmacist if you are using or have used recently other medicines, including those acquired without a prescription, natural products or herbs.

Taking Enalapril/Hidroclorotiazida Sandoz with food, drink and alcohol

Enalapril/Hidroclorotiazida Sandoz can be taken without regard to meals. Drinking alcohol with this medicine may increase the blood pressure-lowering effect of the medicine (and may cause dizziness when standing up, etc.).

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you think you are (or may become) pregnant. Your doctor will usually recommend stopping treatment with enalapril/hidroclorotiazida before becoming pregnant or as soon as you become pregnant and will recommend taking another medicine instead of enalapril/hidroclorotiazida. Enalapril/hidroclorotiazida is not recommended at the beginning of pregnancy, and should not be taken if you are more than 3 months pregnant, as this could cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Consult your doctor if you are breastfeeding or plan to start breastfeeding.

The use of enalapril/hidroclorotiazida is not recommended in mothers who are breastfeeding.

Driving and operating machines

Dizziness and fatigue have been detected in people treated with enalapril/hidroclorotiazida. If you experience any of these symptoms, do not drive or operate machines (see also section "4. Possible side effects").

Enalapril/Hidroclorotiazida Sandoz contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Enalapril/Hidroclorotiazida contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is one tablet once a day.

Advanced age

Your doctor may adjust the dose of enalapril and hydrochlorothiazide carefully.

Renal insufficiency

Your doctor will adjust the dose of enalapril and hydrochlorothiazide carefully.

If you are taking other diuretic tablets

If you are taking other diuretic tablets, your doctor will inform you that you must stop taking them 2 or 3 days before starting to take enalapril/hydrochlorothiazide.

Administration form

The tablets should be swallowed with a glass of water.

Enalapril/Hidroclorotiazida Sandoz can be taken with meals or on an empty stomach.

The groove is only for breaking and facilitating swallowing and not for dividing into equal doses.

If you take more Enalapril/Hidroclorotiazida Sandoz than you should

If you have taken more Enalapril/Hidroclorotiazida Sandoz than you should, consult your doctor immediately, your pharmacist or go to the nearest hospital immediately, or call the Toxicological Information Service, Teléfono: 91 562 04 20, indicating the medication and the amount ingested.

If you (or someone) ingest many tablets at once, or if you think a child has swallowed any of the tablets, seek immediate medical attention. A overdose may cause decreased blood pressure, an excessively fast or slow heart rate, palpitations (sensation of an excessively fast or irregular heart rate), shock, rapid breathing, cough, discomfort, cramps, dizziness, numbness and confusion or anxiety, excessive urination or inability to urinate. Go to the doctor or hospital with this leaflet, the remaining tablets and the packaging, so that they know the tablets that have been taken.

If you forgot to take Enalapril/Hidroclorotiazida Sandoz

Do not take a double dose to compensate for the missed doses, take the next dose at the usual time. If you have any other questions about the use of this medication, ask your doctor or pharmacist.

If you interrupt the treatment with Enalapril/Hidroclorotiazida Sandoz

The treatment of hypertension is a long-term treatment and the interruption of this treatment should be consulted with the doctor. Stopping or suspending your treatment may cause an increase in blood pressure.

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

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

If you experience any of the following, stop taking Enalapril/Hidroclorotiazida Sandoz and tell your doctor immediately or go to the nearest hospital emergency department:

• A severe allergic reaction called angioedema (rash, itching, swelling of the extremities, face, lips, mouth, or throat that may cause difficulty swallowing or breathing). This is a serious and frequent side effect (may affect up to 1 in 10 patients). You may need urgent medical attention or hospitalization.
• A severe allergic reaction called anaphylaxis that causes difficulty breathing or dizziness. This is a rare side effect (may affect up to 1 in 1,000 people).
• Severe blisters, Stevens-Johnson syndrome (blisters on the skin, mouth, eyes, and genitals), the skin appears burned and exfoliated, skin sensitivity to light, skin conditions with red and scaly patches on the nose and cheeks (lupus erythematosus), pemphigus (a disease that causes blisters and lesions that usually start in the mouth, urticaria, hair loss, and itching). These are rare side effects (may affect up to 1 in 1,000 people).
• Jaundice (yellowing of the skin and white of the eyes).

This is a potentially serious but rare side effect (may affect up to 1 in 10 patients) indicative of liver inflammation. You may need urgent medical attention or hospitalization.

• Sudden myopia. Side effect of unknown frequency (cannot be estimated from available data).
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma). Side effect of unknown frequency (cannot be estimated from available data).
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion), this is a very rare side effect (may affect up to 1 in 10,000 patients).

Enalapril maleate/hydrochlorothiazide frequently (may affect up to 1 in 10 patients) causes a decrease in blood pressure that may be associated with dizziness and weakness. In some patients, this may occur after the first dose or when the dose is increased. If you experience these symptoms, you should contact your doctor immediately.

Enalapril maleate/hydrochlorothiazide rarely (may affect up to 1 in 1,000 patients) may cause a reduction in the number of white blood cells and may decrease your resistance to infections. If you have an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, you should see your doctor immediately. They will do a blood test to check for possible reduction of white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

With the use of enalapril maleate/hydrochlorothiazide and other ACE inhibitors, there have been frequent reports (may affect more than 1 in 10 patients) of a dry cough, which may persist for a long time, but may also be a symptom of another upper respiratory tract disease. You should contact your doctor if this symptom appears.

The following side effects have also been reported:

Frequent (may affect more than 1 in 10 patients)

• Blurred vision,
• Dizziness,
• Nausea,
• Weakness,
• Cough.

Common (may affect up to 1 in 10 patients)

• Low potassium levels in the blood, which may cause muscle weakness, spasms, or irregular heart rhythm,
• High levels of fats or uric acid in the blood,
• Headache, depression,
• Fainting, low blood pressure associated with changes in posture (such as dizziness or weakness when standing up), chest pain, irregular heart rhythm, rapid heart rate (tachycardia),
• Shortness of breath,
• Diarrhea, abdominal pain,
• Altered sense of taste,
• Rash,
• Fatigue,
• Elevated potassium levels in the blood, which may cause irregular heart rhythm; increased creatinine levels in the blood,
• Muscle cramps.

Rare (may affect up to 1 in 100 patients)

• Reduction in the number of red blood cells, which may cause pale skin and difficulty breathing (anemia),
• Hypoglycemia (low blood sugar levels) (see section 2 “Warnings and precautions”),
• Low magnesium levels in the blood,
• Uric acid crystals in the joints (gout),
• Confusion, drowsiness, insomnia, nervousness, restlessness, numbness or tingling, dizziness, decreased libido,
• Yellowish vision due to a yellowish discoloration of the optic medium of the eye (xanthopsia),
• Palpitations (sensation of rapid or irregular heart rhythm),
• Myocardial infarction or stroke (mini-stroke) (mainly in patients with low blood pressure),
• Vasculitis necrotizing (inflammation of blood vessels),
• Nasal discharge, sore throat, hoarseness, difficulty breathing, wheezing,
• Intestinal obstruction, pancreatitis (inflammation of the pancreas that causes severe abdominal and back pain), vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence,
• Sweating, itching, urticaria, hair loss,
• Sensitivity of the skin to the sun,
• Joint pain,
• Kidney problems, protein in the urine,
• Impotence,
• Flushing, tinnitus,
• Malaise, fever,
• Salivary gland inflammation,
• Abnormal levels of salts in the body (electrolyte imbalance), including low sodium levels in the blood, which may cause fatigue and confusion, muscle cramps, seizures, or coma, also leading to dehydration and low blood pressure that makes you feel dizzy when standing up,
• Increased urea levels in the blood.

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

• Intestinal inflammation,
• High calcium levels in the blood (see “Other medicines and Enalapril/Hidroclorotiazida Sandoz” in section 2).

Unknown (cannot be estimated from available data)

• A complex side effect that may include some or all of the following symptoms:

• Fever, inflammation of blood vessels, muscle or joint pain, and inflammation, blood disorders that affect blood components (usually detected by a blood test),
• Rash, light sensitivity, and other skin effects.

• Incorrect secretion of antidiuretic hormone (known as SIADH) causing among other general symptoms confusion, nausea, altered mood, seizures, and loss of consciousness.
• Glucose excretion in the urine (glucosuria),
• Decreased appetite, dizziness,
• Skin cancer and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

Do not store at a temperature above 30 °C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Sandoz

• The active principles are enalapril maleate and hidroclorotiazida. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hidroclorotiazida.
• The other components (excipients) are sodium hydrogen carbonate, cornstarch without gluten, lactose monohydrate, dihydrated calcium hydrogen phosphate, talc, magnesium stearate.

Appearance of the product and contents of the package

Enalapril/Hidroclorotiazida Sandoz 20/12.5 mg tablets are white, oval, biconvex, breakable, scored on both faces, and with the mark “E|H” on one face.

The tablets are presented in OPA-Al-PVC/Al blisters, which are contained in a cardboard box.

Enalapril/Hidroclorotiazida Sandoz 20/12.5 mg tablets are available in packaging sizes of 10, 14, 20, 28, 30, 49, 50, 50x1, 60, 84, 90, 98, and 100 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Sandoz A/S

Edvard Thomsens Vej 14

2300 København S

Denmark

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

Austria:Enalapril HCT Sandoz 20 mg/12.5 mg - Tablets

France:ENALAPRIL/HYDROCHLOROTHIAZIDE SANDOZ 20 mg/12.5 mg, scored tablet

Italy:ENALAPRIL IDROCLOROTIAZIDE HEXAL 20 mg + 12.5 mg tablets

Netherlands:ENALAPRILMALEAAT/HYDROCHLOORTHIAZIDE 20/12.5 MG, tablets 20/12.5 mg

Slovenia:ANATON 20 mg/12.5 mg tablets

Last review date of this leaflet: April 2022

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