ENALAPRIL/HYDROCHLOROTHIAZIDE SANDOZ 20/12.5 mg TABLETS

Introduction

Patient Information Leaflet

Enalapril/Hydrochlorothiazide Sandoz 20 mg/12.5 mg tablets EFG

enalapril maleate/hydrochlorothiazide

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 get 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 is Enalapril/Hydrochlorothiazide Sandoz and what is it used for
2. What you need to know before you take Enalapril/Hydrochlorothiazide Sandoz
3. How to take Enalapril/Hydrochlorothiazide Sandoz
4. Possible side effects
5. Storage of Enalapril/Hydrochlorothiazide Sandoz
6. Contents of the pack and other information

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

Enalapril/Hydrochlorothiazide Sandoz contains a combination of enalapril and hydrochlorothiazide and is used to treat high blood pressure when treatment with enalapril alone has been shown to be insufficient on its own.

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

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

You should talk to a doctor if you do not feel better or if you feel worse.

Enalaprilbelongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors), it lowers blood pressure by dilating blood vessels.

Hydrochlorothiazidebelongs to a group of medicines called diuretics and lowers blood pressure by increasing urine production.

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

Do not take Enalapril/Hydrochlorothiazide Sandoz

• if you are allergic to enalapril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to sulphonamide-derived medicines (most are antibiotics, e.g. sulfamethoxazole),
• if you have previously suffered from swelling of the extremities, face, lips, throat, tongue or mouth (angioedema) when treated with other medicines belonging to the group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors),
• if you have previously suffered from swelling of the extremities, face, lips, throat, tongue or mouth (angioedema) under any other circumstances,
• if a member of your family has previously suffered from swelling of the extremities, face, lips, throat, tongue or mouth (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 aliskiren,
• if you have severe liver problems or a neurological disorder as a result of severe liver problems (hepatic encephalopathy),
• if you are pregnant more than 3 months (it is also recommended to avoid enalapril maleate/hydrochlorothiazide at the start of pregnancy, see section pregnancy).
• if you have taken or are taking sacubitril/valsartan, 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 areas such as the throat) is increased.

Warnings and precautions

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

• you have narrowing of the arteries (atherosclerosis), 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 heart disease),
• you have heart failure,
• you have low blood pressure, are on a low-salt diet or are taking diuretics,
• you have irregular water and mineral levels in your body (fluid/electrolyte imbalance), distinguished by nausea, abdominal pain, and/or vomiting, headache, oedema (swelling), muscle weakness and/or tremors among others,
• you have a heart muscle disease (cardiomyopathy), a narrowing of the main artery that carries blood from the heart, the aorta (aortic stenosis), or a narrowing of the kidney artery, have a transplanted kidney or another type of heart problem called outflow obstruction,
• you are undergoing LDL apheresis (removal of cholesterol from the blood by machine),
• you are undergoing desensitization treatment for insect venom, such as bee or wasp sting,
• you have diabetes,
• you suffer from gout, have high levels of uric acid in your blood or are being treated with allopurinol,
• you need to undergo anaesthesia,
• you have recently suffered from severe and prolonged vomiting and/or severe diarrhoea,
• you are going to have a test to check your parathyroid function,
• you have or have had liver or kidney problems, or have narrowing of the arteries in your kidneys (renal artery stenosis), or only have one functioning kidney, or are undergoing haemodialysis,
• you have a vascular disease of the 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 you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular 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 sun and UV radiation while taking Enalapril/Hydrochlorothiazide Sandoz,
• you have allergy or asthma problems,
• 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 enalapril/hydrochlorothiazide, see a doctor 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),
• vildagliptin, 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 "sartans", e.g. valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
• aliskiren.

Your doctor may need to 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 Enalapril/Hydrochlorothiazide Sandoz".

You should consult your doctor if you think you are (or might become) pregnant. Enalapril maleate/hydrochlorothiazide is not recommended at the start of pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy (see section pregnancy). Breast-feeding is not recommended when taking Enalapril/Hydrochlorothiazide Sandoz.

Generally, Enalapril/Hydrochlorothiazide 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 monitored during treatment. Risk factors for high potassium levels include reduced kidney function, age (> 70 years), dehydration, acute heart failure, metabolic acidosis, diabetes (diabetes mellitus), concurrent use of potassium-sparing diuretics, potassium supplements or salt substitutes that contain potassium or taking medicines that increase potassium levels in the blood. You may also develop low potassium levels in the blood, which can be 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/Hydrochlorothiazide Sandoz" later in the leaflet.

Inform your doctor if you are an athlete and have doping control, as Enalapril/Hydrochlorothiazide Sandoz contains an active substance that may produce positive results in a doping control.

Elderly patients (> 70 years) or malnourished patients should be carefully monitored when using Enalapril/Hydrochlorothiazide Sandoz.

Enalapril/Hydrochlorothiazide Sandoz may be less effective in black patients.

Children and adolescents

This medicine is not recommended for use in children.

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

• you feel dizzy after the first dose. Some people react to their first dose or to an increase in dose by feeling weak and unwell,
• sudden swelling of the lips, face and throat, possibly also hands and feet, difficulty breathing or hoarseness. This disease 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,
• high temperature, sore throat or mouth ulcers (these can be symptoms of infection caused by a low white blood cell count),
• yellowing of the skin and the whites of the eyes (jaundice) which can be a sign of liver disease,
• a dry cough that persists for a long time. A cough has been observed with the use of ACE inhibitors but can also be a symptom of another disease of the upper respiratory tract,
• sudden visual impairment,
• if you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within hours to weeks after taking Enalapril/Hydrochlorothiazide Sandoz. This can lead to permanent vision loss if not treated. If you have previously experienced an allergy to penicillins or sulphonamides, you may have a higher risk of developing this.

Other medicines and Enalapril/Hydrochlorothiazide Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, natural products or herbal products.

Do not take enalapril/hydrochlorothiazide at the same time as the following medicines:

• potassium supplements (including potassium-sparing diuretics such as spironolactone, triamterene or amiloride),
• other medicines used to treat high blood pressure including diuretics that can increase the amount of potassium in your body (e.g. trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin 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 aliskiren (see also the sections "Do not take Enalapril/Hydrochlorothiazide Sandoz" and "Enalapril/Hydrochlorothiazide Sandoz with food, drinks and alcohol").

• anaesthetics and medicines for mental disorders or depression, medicines for psychosis, tricyclic antidepressants or sedatives,
• lithium (medicine for the treatment of mental disorders),
• analgesics and anti-inflammatory medicines, such as acetylsalicylic acid, indomethacin and selective cyclooxygenase-2 (COX-2) inhibitors,
• gold injections (sodium aurothiomalate), a medicine for rheumatoid arthritis,
• medicines such as ephedrine, 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 colestipol resins, substances that lower blood lipid levels,
• corticosteroids, anti-inflammatory medicines of a hormonal type,
• corticotropin (ACTH) is used primarily to determine if your adrenal glands are functioning properly,
• muscle relaxants (e.g. tubocurarine chloride, medicines used to relax muscles during operations),
• allopurinol, probenecid, sulfinpyrazone, medicines for the treatment of gout,
• medicines such as atropine or biperiden used to treat a variety of disorders such as gastrointestinal cramps, bladder spasms, asthma, dizziness, muscle spasms such as aid for anaesthesia,
• medicines used to treat cancer, such as cyclophosphamide or methotrexate,
• medicines that inhibit the immune system, medicines used to prevent organ transplant rejection or bone marrow transplants such as ciclosporin,
• cardiac glycosides (e.g. digoxin, medicines used to strengthen the heart),
• medicines that as a side effect can cause abnormalities in the conduction of stimuli in the heart, such as medicines for heart rhythm disorders, some medicines for psychosis and other medicines such as those used to treat bacterial infections,
• calcium salts and vitamin D, high levels of calcium in the blood (can lead to gastrointestinal disorders, excessive thirst, excessive urination, fatigue, weakness and weight loss),
• carbamazepine, a medicine used primarily in the treatment of epilepsy and bipolar disorder,
• amphotericin B, medicines used against fungal infections,
• laxatives, medicines used to promote bowel movements,
• 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 painkillers with no anti-inflammatory effect,
• carbenoxolone, a medicine used to treat inflammation of the gastrointestinal tract,
• salicylates, medicines used to treat pain and/or inflammatory diseases,
• medicines commonly used to prevent organ transplant rejection (sirolimus, everolimus and other medicines that belong to the pharmacological class of mTOR inhibitors). See section "Warnings and precautions".

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, natural products or herbal products.

Taking Enalapril/Hydrochlorothiazide Sandoz with food, drinks and alcohol

Enalapril/Hydrochlorothiazide Sandoz can be taken with or without food. Drinking alcohol with this medicine may increase the blood pressure-lowering effect of the medicine (and thus dizziness may occur when standing up, among other things).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop treatment with enalapril/hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of enalapril/hydrochlorothiazide. Enalapril/hydrochlorothiazide is not recommended at the start of pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breast-feeding

Ask your doctor or pharmacist for advice before breast-feeding.

The use of enalapril/hydrochlorothiazide is not recommended in breast-feeding women.

Driving and using machines

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

Enalapril/Hydrochlorothiazide Sandoz contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Enalapril/Hydrochlorothiazide contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Enalapril/Hydrochlorothiazide Sandoz

Follow the administration instructions for this medication exactly as 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.

Elderly

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

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.

Method of administration

The tablets should be swallowed with a glass of water.

Enalapril/Hydrochlorothiazide Sandoz can be taken with or without food.

The score line is only for breaking and facilitating swallowing, and not for dividing into equal doses.

If you take more Enalapril/Hydrochlorothiazide Sandoz than you should

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

If you (or someone) ingest many tablets at once, or if you believe a child has swallowed any of the tablets, seek immediate medical attention. It is likely that an overdose can cause a decrease in blood pressure, an excessively fast or slow heartbeat, palpitations (sensation of an excessively fast or irregular heartbeat), 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 prospectus, the remaining tablets, and the packaging, so they know which tablets have been taken.

If you forget to take Enalapril/Hydrochlorothiazide Sandoz

Do not take a double dose to make up for forgotten doses; take the next dose at the usual time. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

If you interrupt treatment with Enalapril/Hydrochlorothiazide Sandoz

Treatment for hypertension is long-term, and interruption of this treatment should be consulted with your doctor. Interrupting or suspending your treatment could lead to an increase in blood pressure.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

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

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

This is a potentially serious but rare side effect (can 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 effusion) or acute angle-closure glaucoma). Side effect of unknown frequency (cannot be estimated from available data).
• Acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion), this is a very rare side effect (can affect up to 1 in 10,000 people).

Enalapril maleate/hydrochlorothiazide frequently (can affect up to 1 in 10 patients) causes a decrease in blood pressure that can be associated with feelings of dizziness and weakness. In some patients, this can 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 (can affect up to 1 in 1,000 patients) can 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 perform a blood test to check for a possible reduction in 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, a dry cough has been reported very frequently (can affect more than 1 in 10 patients), which can persist for a long time, but can 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:

Very common (can affect more than 1 in 10 patients)

• blurred vision,
• dizziness,
• nausea,
• weakness,
• cough.

Common (can affect up to 1 in 10 patients)

• low potassium levels in the blood, which can cause muscle weakness, spasms, or irregular heartbeat,
• high levels of fats or uric acid in the blood,
• headache, depression,
• fainting, low blood pressure associated with postural changes (such as dizziness or weakness when getting up after lying down), chest pain, irregular heartbeat, rapid heartbeat (tachycardia),
• shortness of breath,
• diarrhea, abdominal pain,
• alteration of taste,
• rash,
• fatigue,
• high potassium levels in the blood, which can cause an irregular heartbeat; increased creatinine levels in the blood,
• muscle cramps.

Uncommon (can affect up to 1 in 100 patients)

• reduction in the number of red blood cells, which can cause pale skin and produce weakness or 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, sensation of tingling or numbness, vertigo, decreased libido,
• predominance of yellow in vision due to a yellowish color of the eye's optical medium (xanthopsia),
• palpitations (sensation of rapid or particularly strong heartbeat),
• infarction or stroke (mainly in patients with low blood pressure),
• inflammation of blood vessels (necrotizing vasculitis),
• runny nose, sore throat, hoarseness, difficulty breathing, wheezing,
• intestinal obstruction, inflammation of the pancreas that causes severe abdominal and back pain (pancreatitis), vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer, flatulence,
• sweating, itching, urticaria, hair loss,
• skin hypersensitivity to the sun,
• joint pain,
• kidney problems, protein in the urine,
• impotence,
• flushing, ringing in the ears,
• discomfort, fever,
• inflammation of the salivary glands,
• abnormal amount of salts in the body (electrolyte imbalance), including low sodium levels in the blood, which can cause fatigue and confusion, muscle twitching, 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.

Rare (can affect up to 1 in 1,000 patients)

• reduction in the number of white blood cells, which can make infections more frequent, reduction in the number of other blood cells, changes in blood composition, decreased bone marrow production, disease of the lymph nodes, autoimmune disease, in which the body attacks itself,
• strange dreams, sleep disorders,
• paresis,
• Raynaud's syndrome (a disorder of the blood vessels that causes tingling in the fingers of the hands and feet that turn pale, then blue, and then reddish),
• pulmonary problems, including pneumonia, inflammation of the nasal lining that causes runny nose (rhinitis),
• mouth ulcers, tongue inflammation,
• liver problems, inflammation of the gallbladder,
• skin rash, skin redness,
• reduced urine production,
• inflammation of the kidneys (interstitial nephritis),
• breast enlargement (including in men),
• increased levels of liver enzymes and waste products,
• increased blood sugar levels.

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

• inflammation of the intestines,
• high calcium levels in the blood (see "Other medications and Enalapril/Hydrochlorothiazide Sandoz" in section 2).

Unknown frequency (cannot be estimated from available data)

• A complex side effect has also been reported, which may include some or all of the following signs:

• fever, inflammation of blood vessels, pain, and inflammation of muscles or joints,
• blood disorders that affect the components of your blood (usually detected by a blood test),
• skin rash, hypersensitivity to sunlight, and other skin effects.

• Inappropriate 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 and lip cancer (non-melanoma skin cancer).

Reporting side effects

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

5. Conservation of Enalapril/Hydrochlorothiazide Sandoz

Keep this medication out of sight and reach of children.

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

Do not store above 30°C. Keep in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Enalapril/Hydrochlorothiazide Sandoz

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

Appearance of the product and package contents

Enalapril/Hydrochlorothiazide Sandoz 20/12.5 mg tablets are white, oval, biconvex, scored, and marked with "E|H" on one side.

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

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Sandoz A/S

Edvard Thomsens Vej 14

2300 København S

Denmark

This medication is authorized in the member states of the European Economic Area under 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

Date of the last revision of this prospectus: April 2022

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