Enalapril and lercanidipine Teva: detailed information

PACKAGE LEAFLET

Package leaflet: information for the user

Enalapril and Lercanidipine Teva 10 mg/10 mg film-coated tablets

Enalapril maleate and lercanidipine hydrochloride
Generic medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Enalapril and Lercanidipine Teva 10 mg/10 mg film-coated tablets are and

what they are used for

2. What you need to know before taking Enalapril and Lercanidipine Teva 10 mg/10 mg,

film-coated tablets

3. How to take Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets

4. Possible side effects
5. How to store Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets
6. Contents of the pack and other information
1. What Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets is and what it is used for
Enalapril and Lercanidipine Teva is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two medicines that reduce blood pressure.
Enalapril and Lercanidipine Teva is indicated for the treatment of high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipine as separate tablets.

2. What you need to know before taking Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets

DO NOT take Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets

If you are allergic to enalapril or lercanidipine, or to any of the other ingredients of this medicine (listed in section 6).
If you have previously had an allergic reaction to a medicine of the same class as those contained in Enalapril and Lercanidipine Teva, e.g., drugs known as ACE inhibitors or calcium channel blockers.
If you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing (angioedema) after taking a medicine known as an ACE inhibitor, or if you have had angioedema without a known cause or due to hereditary causes.
If you have diabetes or kidney problems and are taking blood pressure-lowering medicines containing aliskiren.
If you are more than three months pregnant (Enalapril and Lercanidipine Teva should also be avoided during the first months of pregnancy – see section on pregnancy).
If you have certain heart conditions:
- obstruction of blood flow from the heart, including narrowing of the heart's aortic valve;
- untreated heart failure;
- chest pain occurring at rest, worsening progressively, or occurring more frequently (unstable angina);
- if you have had a heart attack within the last month.
If you have severe kidney problems, or if you are undergoing dialysis.
If you have severe liver problems.
If you are taking medicines that inhibit liver metabolism such as:
- antifungal agents (e.g., ketoconazole, itraconazole);
- macrolide antibiotics (e.g., erythromycin, troleandomycin);
- antiviral agents (e.g., ritonavir).
If you are currently taking a medicine called cyclosporine (used after organ transplantation to prevent organ rejection).
Together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets:

If you have low blood pressure (you may feel faint or dizzy, especially when standing up).
If you have been severely ill (excessive vomiting) or have recently had diarrhoea.
If you are on a low-salt diet.
If you have heart problems.
If you have a condition affecting the blood vessels in the brain.
If you have kidney problems (including kidney transplant).
If you have liver problems.
If you have blood disorders such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia).
If you have connective tissue vascular diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma).
If you are of Black African or Caribbean origin, you should be aware that patients of Black origin have a higher risk of allergic reactions with swelling of the face, lips, tongue, and throat, causing difficulty in swallowing and breathing, while taking ACE inhibitors.
If you have diabetes.
If you develop a persistent dry cough.
If you are taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes.
If you are taking any of the following medicines used to treat high blood pressure:
- an "angiotensin II receptor antagonist" (ARAII) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
- aliskiren.
If you are taking any of the following medicines, your risk of angioedema (rapid swelling under the skin, e.g., in the throat) is increased:
- sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

Your doctor may regularly check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).
See also the section "Do not take Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets".
Inform your doctor if you are about to undergo treatment
Inform your doctor that you are taking Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets if you are about to undergo any of the following procedures:

surgery or anaesthesia (including dental anaesthesia);
a treatment to remove cholesterol from the blood called “LDL apheresis”;
desensitisation therapy to reduce the effects of allergies from bee or wasp stings.

Inform your doctor if you think you may be pregnant (or are planning to become pregnant) or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there is no information on its efficacy and safety in this age group.

Other medicines and Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets
Enalapril and Lercanidipine Teva must not be taken together with certain medicines.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This is because when Enalapril and Lercanidipine Teva is taken together with certain medicines, the effect of Enalapril and Lercanidipine Teva or of the other medicines may be altered, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

potassium-containing medicines (including salt substitutes used in diets);
other medicines used to lower blood pressure, such as angiotensin II receptor blockers, diuretics (medicines that increase the need to urinate), or a medicine called aliskiren;
other medicines that may increase potassium levels in the body (including heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole);
lithium (a medicine used to treat a certain type of depression);
antidepressants known as “tricyclic antidepressants”;
medicines for mental disorders known as “antipsychotics”;
non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain);
certain medicines for pain or arthritis, including gold therapy;
certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic agent”;
medicines for diabetes (including oral antidiabetic medicines and insulin), astemizole or terfenadine (allergy medicines);
amiodarone or quinidine (medicines used to treat fast heart rate);
phenytoin or carbamazepine (medicines for epilepsy);
rifampicin (a medicine used to treat tuberculosis);
digoxin (a medicine used to treat heart problems);
midazolam (a medicine that helps with sleep);
beta-blockers (medicines used to treat high blood pressure and heart problems);
a medicine for ulcers and heartburn called cimetidine, taken at daily doses exceeding 800 mg;
medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

if you are taking an angiotensin II receptor blocker (ARAII) or aliskiren (see also the sections "Do not take Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets" and "Warnings and precautions").

Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets with food, drinks, and alcohol

Enalapril and Lercanidipine Teva should be taken at least 15 minutes before a meal.
Alcohol may increase the effects of Enalapril and Lercanidipine Teva. Therefore, it is recommended not to drink alcohol or to keep alcohol consumption to a minimum.
Enalapril and Lercanidipine Teva must NOT be taken with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you may be pregnant (or are planning to become pregnant). Enalapril and Lercanidipine Teva should be avoided in women who may become pregnant and during early pregnancy. It must NOT be taken if you are more than three months pregnant, as the medicine may cause serious harm to your unborn baby if used after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to start breast-feeding. Breast-feeding of newborns (during the first weeks after birth), and especially of premature newborns, should be avoided if you are taking Enalapril and Lercanidipine Teva. For older infants, your doctor will advise you on the benefits and risks of taking Enalapril and Lercanidipine Teva while breast-feeding, compared to other treatments.

Driving and using machines
DO NOT drive a vehicle or operate machinery if, while taking this medicine, you experience dizziness, weakness, fatigue, or drowsiness.

3. How to take Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets

film
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Adults: unless otherwise prescribed by your doctor, the recommended dose is one tablet daily, taken at the same time every day. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. Swallow the tablets whole with a glass of water.
Patients with kidney problems/elderly patients: your doctor will decide the appropriate dose based on how well your kidneys are functioning.
If you take more Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets than you should
If you take more tablets than you should, consult your doctor or go to hospital immediately. Take the medicine pack with you.
Taking too high a dose of this medicine may cause an excessive drop in blood pressure and may lead to irregular heartbeat or increased heart rate.
If you forget to take Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets

If you forget to take a tablet, skip the missed dose.
Take your next dose at the usual time.
DO NOT take a double dose to make up for the forgotten tablet.

If you stop taking Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets

Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, Enalapril and Lercanidipine Teva can cause side effects, although not
everyone experiences them. The following side effects may occur with the use of
this medicine:
Some side effects may be serious.
If any of the following occur, contact your doctor immediately:

Allergic reaction with swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing.

At the beginning of treatment with Enalapril and Lercanidipine Teva, you may feel faint or
dizzy, or experience blurred vision; this is caused by a sudden drop in blood
pressure. If this occurs, lying down may help. If you are concerned about this, speak
with your doctor.
Side effects observed with Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets
Common (may affect up to 1 in 10 people)
Cough, dizziness, headache.
Uncommon (may affect up to 1 in 100 people)
Changes in blood test values such as reduced platelet count, increased potassium levels, nervousness (anxiety), dizziness when standing up, vertigo, tachycardia, rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper chest (flushing), low blood pressure, abdominal pain, constipation, feeling unwell (nausea), elevated liver enzymes, skin redness, joint pain, increased frequency of urination, feeling of weakness, fatigue, sensation of warmth, swelling of the ankles.
Rare (may affect up to 1 in 1,000 people)
Anaemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty taste sensation, diarrhoea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing and breathing, skin rash, urticaria, need to get up at night to urinate, production of a large amount of urine, impotence.
Additional side effects with enalapril or lercanidipine taken separately
Enalapril
Very common (may affect more than 1 in 10 people)
Blurred vision.
Common (affects less than 1 in 10 people)
Depression, chest pain, changes in heart rhythm, angina, shortness of breath, altered taste sensation, increased blood creatinine levels (usually detected by a blood test).
Uncommon (affects less than 1 in 100 people)
Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, insomnia or drowsiness, tingling or numb skin sensation, heart attack (likely caused by very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (likely caused by very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma, reduced intestinal motility, pancreatitis, feeling unwell, irritated stomach (gastric irritation), ulcer, anorexia, increased sweating, itching or hives, hair loss, reduced kidney function, kidney failure, elevated levels of protein in urine (measured by testing), muscle cramps, general feeling of being unwell (malaise), high temperature (fever), low blood sugar or sodium levels, elevated blood urea levels (all detected by blood tests).
Rare (affects less than 1 in 1,000 people)
Changes in laboratory values such as reduced white blood cell count, bone marrow depression, autoimmune disorders, abnormal dreams or sleep disturbances, Raynaud's phenomenon (where hands and feet may become very cold and white due to reduced blood flow), pulmonary infiltrates, inflammation of the nose, pneumonia, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin and/or whites of the eyes), increased bilirubin levels (measured by blood test), erythema multiforme (red skin spots of various shapes), Stevens-Johnson syndrome (a serious skin condition causing redness and peeling of the skin, blistering or sores, or detachment of the outer skin layer), reduced urine production, breast enlargement in men.
Very rare (affects less than 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Lercanidipine
Rare (affects less than 1 in 1,000 people)
Angina pectoris (chest pain caused by insufficient blood supply to the heart), vomiting, heartburn, muscle pain.
Very rare (affects less than 1 in 10,000 people)
Chest pain.
Considering the class of medicines to which lercanidipine belongs, patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks. Isolated cases of myocardial infarction may occur.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contact your doctor or pharmacist for further information about side effects. Both can provide a more complete list of possible side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your
doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enalapril and Lercanidipine Teva 10 mg/10 mg, film-coated tablets

film-coated
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after Exp.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Enalapril and Lercanidipine Teva 10 mg/10 mg film-coated tablets contain
The active substances are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains: 10 mg of enalapril maleate and 10 mg of lercanidipine hydrochloride.
The other components are:
Core: Microcrystalline cellulose, Sodium bicarbonate, Pregelatinized starch, Sodium carboxymethyl starch (type A), Anhydrous colloidal silica, Magnesium stearate
Film coating: Hypromellose, Macrogol 6000, Talc, Titanium dioxide (E171)

Description of the appearance of Enalapril and Lercanidipine Teva 10 mg/10 mg film-coated tablets and contents of the pack
Enalapril and Lercanidipine Teva 10 mg/10 mg tablets are white to almost white, round, biconvex, film-coated tablets.
Enalapril and Lercanidipine Teva 10 mg/10 mg is available in packs containing 14, 28, 30, 50, 56, 90 and 100 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 – 20123 Milan - Italy

Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg – 89143 Germany
TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen – 4042 Hungary
Teva Pharma S.L.U., C/C, n. 4, Poligono Industrial Malpica, Zaragoza – 50016 Spain

Patient Information Leaflet: Information for the User

Enalapril and Lercanidipine Teva 20 mg/10 mg film-coated tablets

Enalapril maleate and lercanidipine hydrochloride
Equivalent medicine
Please read this leaflet carefully before 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Enalapril and Lercanidipine Teva 20 mg/10 mg film-coated tablets are and

what they are used for

2. What you need to know before taking Enalapril and Lercanidipine Teva 20 mg/10 mg,

film-coated tablets

3. How to take Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets

4. Possible side effects
5. How to store Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets
6. Contents of the pack and other information
1. What Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets are and
what they are used for
Enalapril and Lercanidipine Teva is a fixed combination of an ACE inhibitor (enalapril) and a calcium channel blocker (lercanidipine), two medicines that reduce blood pressure.
Enalapril and Lercanidipine Teva is indicated for the treatment of high blood pressure (hypertension) in patients in whom adequate control has not been achieved with enalapril 20 mg alone. Enalapril and Lercanidipine Teva is not indicated for the initial treatment of hypertension.

2. What you need to know before taking Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets

DO NOT take Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets

If you are allergic to enalapril or lercanidipine or to any of the other ingredients of this medicine (listed in section 6).
If you have previously had an allergic reaction to a medicine similar to those contained in Enalapril and Lercanidipine Teva, e.g., medicines called ACE inhibitors or calcium channel blockers.
If you have previously experienced swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or if such swelling occurred without a known cause or due to hereditary causes.
If you have diabetes or kidney problems and are taking blood pressure-lowering medicines containing aliskiren.
If you are more than three months pregnant (in addition, Enalapril and Lercanidipine Teva is best avoided during the first months of pregnancy – see section on pregnancy).
If you suffer from certain heart conditions:
- obstruction of blood flow from the heart, including narrowing of the heart's aortic valve;
- untreated heart failure;
- chest pain occurring at rest, progressively worsening, or occurring more frequently (unstable angina);
- if you have had a heart attack less than one month ago.
If you have severe kidney problems, or if you are undergoing dialysis.
If you have severe liver problems.
If you are taking medicines that inhibit liver metabolism such as:
- antifungal agents (e.g., ketoconazole, itraconazole);
- macrolide antibiotics (e.g., erythromycin, troleandomycin);
- antiviral agents (e.g., ritonavir).
If you are currently taking a medicine called cyclosporine (used after organ transplants to prevent organ rejection).
Together with grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets:

If you have low blood pressure (you may feel faint or dizzy, especially when standing up).
If you have been very ill (excessive vomiting) or have recently had diarrhoea.
If you are on a low-salt diet.
If you have heart problems.
If you have a condition affecting the blood vessels in the brain.
If you have kidney problems.
If you have liver problems.
If you have blood disorders such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia).
If you have collagen vascular diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma).
If you are of Black African or Caribbean origin, you should be aware that patients of this background have a higher risk of allergic reactions with swelling of the face, lips, tongue, and throat, causing difficulty in swallowing and breathing, while taking ACE inhibitors.
If you have diabetes.
If you develop a persistent dry cough.
If you are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium.
If you are taking any of the following medicines used to treat high blood pressure:
- an "angiotensin II receptor antagonist" (ARB) (also known as sartans – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
- aliskiren.
If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin, for example in the throat) is increased:
- sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also the section "Do not take Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets".
Inform your doctor if you are about to undergo treatment
Inform your doctor that you are taking Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets if you are about to undergo any of the following:

surgery or anaesthesia (including dental anaesthesia);
a treatment to remove cholesterol from the blood, called "LDL apheresis";
desensitisation therapy to reduce the effects of allergies from bee or wasp stings.

Inform your doctor if you think you are pregnant (or are planning to become pregnant) or if you are breastfeeding (see section "Pregnancy, breastfeeding and fertility").

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there is no information available on its efficacy and safety in this age group.

Other medicines and Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets
Enalapril and Lercanidipine Teva must not be taken together with certain medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because when Enalapril and Lercanidipine Teva is taken together with certain medicines, the effect of Enalapril and Lercanidipine Teva or of the other medicines may be altered, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

potassium-containing medicines (including salt substitutes used in low-salt diets);
other medicines used to lower blood pressure, such as angiotensin II receptor blockers, diuretics (medicines that increase the need to urinate), or a medicine called aliskiren;
other medicines that may increase potassium levels in the body (including heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole);
lithium (a medicine used to treat a certain type of depression);
antidepressants called "tricyclic antidepressants";
medicines for mental disorders called "antipsychotics";
non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain);
certain medicines for pain or arthritis, including gold therapy;
certain cough and cold medicines and weight-reduction medicines containing a substance called a "sympathomimetic agent";
medicines for diabetes (including oral antidiabetic medicines and insulin), astemizole or terfenadine (allergy medicines);
amiodarone or quinidine (medicines used to treat fast heart rate);
phenytoin or carbamazepine (medicines for epilepsy);
rifampicin (a medicine used to treat tuberculosis);
digoxin (a medicine used to treat heart problems);
midazolam (a medicine that helps with sleep);
beta-blockers (medicines used to treat high blood pressure and heart problems);
a medicine for ulcers and heartburn called cimetidine, taken at daily doses exceeding 800 mg;
medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section "Warnings and precautions".

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also sections "Do not take Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets" and "Warnings and precautions").

Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets with food, drinks, and alcohol

Enalapril and Lercanidipine Teva should be taken at least 15 minutes before a meal.
Alcohol may increase the effects of Enalapril and Lercanidipine Teva. Therefore, it is recommended not to drink alcohol or to keep alcohol consumption to a minimum.
Enalapril and Lercanidipine Teva must NOT be taken with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility

Pregnancy and fertility
Inform your doctor if you think you are pregnant (or are planning to become pregnant). Enalapril and Lercanidipine Teva should be avoided in women who may become pregnant and during early pregnancy. It must NOT be taken if you are more than three months pregnant, as the medicine may cause serious harm to your unborn baby if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed. Breastfeeding of newborns (in the first weeks after birth), and especially of premature infants, should be avoided if you are taking Enalapril and Lercanidipine Teva. For older infants, your doctor will advise you on the benefits and risks of taking Enalapril and Lercanidipine Teva while breastfeeding, compared to other treatments.

Driving and using machines
DO NOT drive a vehicle or operate machinery if you experience dizziness, weakness, fatigue, or drowsiness while taking this medicine.

3. How to take Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Adults: unless otherwise prescribed by your doctor, the recommended dose is one tablet daily, taken at the same time every day. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. Swallow the tablets whole with a glass of water.
Patients with kidney problems/elderly patients: your doctor will decide the appropriate dose based on how well your kidneys are functioning.
If you take more Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets than you should
If you take more tablets than you should, contact your doctor or go to hospital immediately. Take the medicine pack with you.
Taking too high a dose of this medicine may cause an excessive drop in blood pressure and may lead to irregular heartbeat or increased heart rate.
If you forget to take Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets

If you forget to take a tablet, skip the missed dose.
Take the next dose at the usual time.
DO NOT take a double dose to make up for the forgotten tablet.

If you stop taking Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets

Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Enalapril and Lercanidipine Teva may cause side effects, although not
everyone experiences them. The following side effects may occur with the use of
this medicine:
Some side effects may be serious.
If any of the following occur, contact your doctor immediately:

Allergic reaction with swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing.

At the beginning of treatment with Enalapril and Lercanidipine Teva you may experience fainting or
dizziness, or blurred vision; this is caused by a sudden drop in blood
pressure, and lying down may help. If this concerns you, discuss it
with your doctor.
Side effects observed with Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets
Common (may affect up to 1 in 10 people)
Cough, dizziness, headache.
Uncommon (may affect up to 1 in 100 people)
Changes in blood test values such as reduced platelet count, increased potassium levels, nervousness (anxiety), dizziness when standing up, vertigo, tachycardia, rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper chest (flushing), low blood pressure, abdominal pain, constipation, feeling unwell (nausea), elevated liver enzyme levels, skin redness, joint pain, increased frequency of urination, feeling of weakness, fatigue, sensation of warmth, swelling of the ankles.
Rare (may affect up to 1 in 1,000 people)
Anaemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty taste sensation, diarrhoea, dry mouth, gum swelling, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing and breathing, skin rash, urticaria, need to get up at night to urinate, production of a large amount of urine, impotence.
Additional side effects with enalapril or lercanidipine taken separately
Enalapril
Very common (affects more than 1 in 10 people)
Blurred vision.
Common (affects less than 1 in 10 people)
Depression, chest pain, changes in heart rhythm, angina, shortness of breath, altered taste sensation, increased creatinine levels in blood (usually detected by a blood test).
Uncommon (affects less than 1 in 100 people)
Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, insomnia or drowsiness, tingling sensation in hands or numb skin, heart attack (likely due to very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (likely due to very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma, reduced intestinal motility, pancreatitis, feeling unwell, irritated stomach (gastric irritation), ulcer, anorexia, increased sweating, itching or hives, hair loss, reduced kidney function, kidney failure, elevated protein levels in urine (measured by testing), muscle cramps, general feeling of being unwell (malaise), high temperature (fever), low blood sugar or sodium levels, elevated blood urea levels (all detected by blood tests).
Rare (affects less than 1 in 1,000 people)
Changes in laboratory values such as reduced white blood cell count, bone marrow depression, autoimmune disorders, abnormal dreams or sleep disturbances, Raynaud's phenomenon (where hands and feet may become very cold and white due to reduced blood flow), pulmonary infiltrates, inflammation of the nose, pneumonia, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin and/or whites of the eyes), increased bilirubin levels (measured by blood test), erythema multiforme (red skin patches of various shapes), Stevens-Johnson syndrome (a serious skin condition causing redness and peeling of the skin, blistering or sores, or detachment of the outer layer of skin), reduced urine production, breast enlargement in men.
Very rare (affects less than 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Lercanidipine
Rare (affects less than 1 in 1,000 people)
Angina pectoris (chest pain due to insufficient blood supply to the heart), vomiting, heartburn, muscle pain.
Very rare (affects less than 1 in 10,000 people)
Chest pain.
Considering the class of medicines to which lercanidipine belongs, patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks. Isolated cases of myocardial infarction may occur.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contact your doctor or pharmacist for further information about side effects. Both have a more complete list of possible side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your
doctor or pharmacist. You may also report side effects directly via the national reporting system at the website www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enalapril and Lercanidipine Teva 20 mg/10 mg, film-coated tablets

Film-coated tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after "Exp."
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Enalapril and Lercanidipine Teva 20 mg/10 mg film-coated tablets contain
The active substances are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains: 20 mg of enalapril maleate and 10 mg of lercanidipine hydrochloride.
The other components are:
Core: Microcrystalline cellulose, Sodium bicarbonate, Pregelatinized starch, Sodium carboxymethyl starch (type A), Anhydrous colloidal silica, Magnesium stearate
Film coating: Hypromellose, Macrogol 6000, Talc, Titanium dioxide (E171), Iron oxide yellow (E172)

Description of the appearance of Enalapril and Lercanidipine Teva 20 mg/10 mg film-coated tablets and pack sizes
Enalapril and Lercanidipine Teva 20 mg/10 mg tablets are film-coated, light yellow to yellowish in colour, round and biconvex.
Enalapril and Lercanidipine Teva 20 mg/10 mg is available in packs containing 14, 28, 30, 50, 56, 90 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 – 20123 Milan - Italy

Enalapril and Lercanidipine Teva 20 mg/20 mg film-coated tablets
Enalapril maleate and lercanidipine hydrochloride
Equivalent medicinal product

PACKAGE LEAFLET: INFORMATION FOR

Read this leaflet carefully before 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. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
1. What Enalapril and Lercanidipine Teva is and what it is used for
2. What you need to know before taking Enalapril and Lercanidipine Teva
3. How to take Enalapril and Lercanidipine Teva
4. Possible side effects
5. How to store Enalapril and Lercanidipine Teva
6. Contents of the pack and other information

1. What Enalapril and Lercanidipine Teva is and what it is used for
Enalapril and Lercanidipine Teva is a fixed combination of an ACE inhibitor (enalapril) and a calcium antagonist (lercanidipine), two medicines that reduce blood pressure.
Enalapril and Lercanidipine Teva is indicated for the treatment of high blood pressure (hypertension) in adult patients who are currently taking enalapril and lercanidipine as separate tablets.

2. What you should know before taking Enalapril and Lercanidipine Teva

DO NOT take Enalapril and Lercanidipine Teva

If you are allergic to enalapril or lercanidipine or to any of the other ingredients of this medicine (listed in section 6).
If you have previously had an allergic reaction to a medicine of the same type as Enalapril and Lercanidipine Teva, for example, medicines called ACE inhibitors or calcium antagonists.
If you have previously experienced swelling of the face, lips, mouth, tongue or throat causing difficulty in swallowing or breathing (angioedema) after taking a medicine called an ACE inhibitor, or if such swelling occurred without a known cause or due to hereditary causes.
If you have diabetes or kidney problems and are being treated with blood pressure-lowering medicines containing aliskiren.
If you are more than three months pregnant (in addition, Enalapril and Lercanidipine Teva is best avoided during the first months of pregnancy – see section “Pregnancy, breastfeeding and fertility”).
If you have certain heart conditions:
- obstruction of blood flow from the heart, including narrowing of the aortic heart valve;
- untreated heart failure;
- chest pain occurring at rest, progressively worsening, or occurring more frequently (unstable angina);
- if you have had a heart attack within the last month.
If you have severe kidney problems, or if you are undergoing dialysis.
If you have severe liver problems.
If you are taking medicines that inhibit liver metabolism such as:
- antifungal agents (e.g., ketoconazole, itraconazole);
- macrolide antibiotics (e.g., erythromycin, troleandomycin);
- antiviral agents (e.g., ritonavir).
If you are currently taking a medicine called cyclosporine (used after organ transplants to prevent organ rejection).
Together with grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril and Lercanidipine Teva:

If you have low blood pressure (you may feel faint or dizzy, especially when standing up).
If you have recently experienced excessive vomiting or diarrhoea.
If you are on a low-salt diet.
If you have heart problems.
If you have a condition affecting the blood vessels in the brain.
If you have kidney problems (including kidney transplant).
If you have liver problems.
If you have blood disorders such as reduced or absent white blood cells (leucopenia, agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia).
If you have collagen vascular diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis or scleroderma).
If you are of African or Afro-Caribbean descent, you should be aware that patients of this background have a higher risk of allergic reactions with swelling of the face, lips, tongue or throat, and difficulty swallowing and breathing, while taking ACE inhibitors.
If you have diabetes.
If you develop a persistent dry cough.
If you are taking potassium supplements, potassium-sparing agents, or salt substitutes containing potassium.
If you are taking any of the following medicines used to treat high blood pressure:
- an "angiotensin II receptor antagonist" (ARAII) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes;
- aliskiren.
If you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, e.g., in the throat) is increased:
- sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to prevent rejection of transplanted organs).

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 section "Do not take Enalapril and Lercanidipine Teva".
Inform your doctor if you are about to undergo treatment
Inform your doctor that you are taking Enalapril and Lercanidipine Teva if you are about to undergo any of the following treatments:

surgery or anaesthesia (including dental anaesthesia)
a treatment to remove cholesterol from the blood, called “LDL apheresis”
desensitisation therapy to reduce the effects of allergies from bee or wasp stings. Inform your doctor if you think you may be pregnant (or are planning to become pregnant) or if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

Children and adolescents
Do not give this medicine to children and adolescents under 18 years of age, as there is no information available on its efficacy and safety in this age group.
Other medicines and Enalapril and Lercanidipine Teva
Enalapril and Lercanidipine Teva must not be taken together with certain medicines.
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. This is because when Enalapril and Lercanidipine Teva is taken together with certain medicines, the effect of Enalapril and Lercanidipine Teva or of the other medicines may be altered, or certain side effects may occur more frequently.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

potassium-containing medicines (including salt substitutes in diets)
other medicines used to lower blood pressure, such as angiotensin II receptor antagonists, diuretics (medicines that increase the need to urinate) or a medicine called aliskiren
other medicines that may increase potassium levels in the body (including heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole)
lithium (a medicine used to treat a certain type of depression)
medicines for depression called “tricyclic antidepressants”
medicines for mental disorders called “antipsychotics”
non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain)
certain medicines for pain or arthritis, including gold therapy
certain medicines for cough and colds and weight-reducing medicines containing a substance called “sympathomimetic agent”
medicines for diabetes (including oral antidiabetic medicines and insulin)
astemizole or terfenadine (medicines for allergies)
amiodarone or quinidine (medicines to treat rapid heartbeat)
phenytoin or carbamazepine (medicines for epilepsy)
rifampicin (a medicine used to treat tuberculosis)
digoxin (a medicine used to treat heart problems)
midazolam (a medicine to help sleep)
beta-blockers (medicines used to treat high blood pressure and heart problems)
a medicine for ulcers and heartburn called cimetidine, taken at daily doses exceeding 800 mg
medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

if you are taking an angiotensin II receptor antagonist (ARAII) or aliskiren (see also the sections “Do not take Enalapril and Lercanidipine Teva” and “Warnings and precautions”).

Enalapril and Lercanidipine Teva with food, drinks and alcohol

Enalapril and Lercanidipine Teva should be taken at least 15 minutes before a meal.
Alcohol may increase the effects of Enalapril and Lercanidipine Teva. Therefore, it is recommended not to drink alcohol or to limit alcohol consumption as much as possible.
Enalapril and Lercanidipine Teva must NOT be taken with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility
Pregnancy and fertility
Inform your doctor if you think you may be pregnant (or are planning to become pregnant). The use of Enalapril and Lercanidipine Teva is not recommended in women who may become pregnant. It is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as the medicine may cause serious harm to the unborn child if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or are planning to breastfeed. Breastfeeding of newborns (in the first weeks after birth), and especially of premature infants, should be avoided if you are taking Enalapril and Lercanidipine Teva. For an older child, your doctor will advise you on the benefits and risks of taking Enalapril and Lercanidipine Teva while breastfeeding compared to other treatments.
Driving and using machines
DO NOT drive or operate machinery if you experience dizziness, weakness, fatigue or drowsiness while taking this medicine.
Enalapril and Lercanidipine Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Enalapril and Lercanidipine Teva

Take this medicine exactly as your doctor has instructed you. If you have any doubts,
consult your doctor or pharmacist.
Adults: unless otherwise prescribed by your doctor, the recommended dose is one tablet daily,
taken at the same time every day. The tablet should preferably be taken in the morning, at least 15 minutes before breakfast. Swallow the tablet whole with a little water.
Patients with kidney problems/elderly patients: your doctor will decide the appropriate dose based on how well your kidneys are functioning.
If you take more Enalapril and Lercanidipine Teva than you should
If you take more medicine than you should, consult your doctor or go immediately to a hospital.
Take the product packaging with you.
Taking an excessive dose of this medicine may cause an excessive drop in blood pressure and the onset of irregularities or an increased heart rate.
If you forget to take Enalapril and Lercanidipine Teva

If you forget to take a tablet, skip the missed dose.
Take your next dose as usual.
DO NOT take a double dose to make up for the forgotten dose.

If you stop taking Enalapril and Lercanidipine Teva

Do not stop taking this medicine unless your doctor tells you to.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Enalapril and Lercanidipine Teva can cause side effects, although not
everyone experiences them. The following side effects may occur with the use of this
medicine:
Some side effects may be serious.
If any of the following occur, contact your doctor immediately:

Allergic reaction with swelling of the face, lips, tongue or throat, which may cause difficulty swallowing or breathing.

At the beginning of treatment with Enalapril and Lercanidipine Teva, you may feel faint
or dizzy, or experience blurred vision; this is caused by a sudden drop in blood
pressure, and lying down may help. If this concerns you, discuss it with your doctor.
Side effects observed with Enalapril and Lercanidipine Teva
Common (may affect up to 1 in 10 people)
Cough, dizziness, headache.
Uncommon (may affect up to 1 in 100 people)
Changes in blood test results such as reduced platelet count, increased potassium levels, nervousness (anxiety), dizziness when standing up, vertigo, tachycardia, rapid or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper chest (flushing), low blood pressure, abdominal pain, constipation, feeling unwell (nausea), elevated liver enzymes, skin redness, joint pain, increased frequency of urination, feeling of weakness, fatigue, sensation of warmth, swelling of the ankles.
Rare (may affect up to 1 in 1,000 people)
Anaemia, allergic reactions, ringing in the ears (tinnitus), fainting, dry throat, sore throat, indigestion, salty taste in the mouth, diarrhoea, dry mouth, swollen gums, allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing and breathing, skin rash, urticaria, need to get up at night to urinate, production of a large amount of urine, impotence.
Additional side effects with enalapril or lercanidipine taken separately
Enalapril
Very common (may affect more than 1 in 10 people)
Blurred vision.
Common (may affect up to 1 in 10 people)
Depression, chest pain, changes in heart rhythm, angina, shortness of breath, altered taste sensation, increased creatinine levels in blood (usually detected by a blood test).
Uncommon (may affect up to 1 in 100 people)
Anaemia (including aplastic and haemolytic anaemia), sudden drop in blood pressure, confusion, insomnia or drowsiness, tingling or numbness sensation, heart attack (likely caused by very low blood pressure in some high-risk patients, including those with impaired blood flow to the heart or brain), stroke (likely caused by very low blood pressure in high-risk patients), runny nose, sore throat and hoarseness, asthma, reduced intestinal motility, pancreatitis, vomiting, irritated stomach (gastric irritation), ulcer,
anorexia, increased sweating, itching or hives, hair loss, reduced kidney function, kidney failure, elevated protein levels in urine (measured by urine test), muscle cramps, general feeling of malaise, fever, low blood sugar or sodium levels, elevated blood urea levels (all detected by blood tests).
Rare (may affect up to 1 in 1,000 people)
Changes in laboratory values such as reduced white blood cell count, bone marrow depression, autoimmune diseases, abnormal dreams or sleep disturbances, Raynaud's phenomenon (where hands and feet may become very cold and white due to reduced blood flow), pulmonary infiltrates, nasal inflammation, pneumonia, liver problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin and/or whites of the eyes), increased bilirubin levels (measured by blood test), erythema multiforme (red skin patches of various shapes), Stevens-Johnson syndrome (a severe skin condition causing redness, peeling, blistering or sores, or detachment of the outer layer of skin), reduced urine production, gynecomastia (breast enlargement in men).
Very rare (may affect up to 1 in 10,000 people)
Intestinal swelling (intestinal angioedema).
Lercanidipine
Rare (may affect up to 1 in 1,000 people)
Angina pectoris (chest pain due to insufficient blood supply to the heart), vomiting, heartburn, muscle pain.
Very rare (may affect up to 1 in 10,000 people)
Chest pain.
Given the drug class to which lercanidipine belongs, patients with pre-existing angina pectoris may experience an increase in frequency, duration or severity of attacks. Isolated cases of myocardial infarction may occur.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contact your doctor or pharmacist for further information about side effects. Both have a more complete list of possible side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enalapril and Lercanidipine Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Enalapril and Lercanidipine Teva contains
The active substances are enalapril maleate and lercanidipine hydrochloride.
Each film-coated tablet contains: 20 mg of enalapril maleate (equivalent to 15.28 mg of enalapril) and 20 mg of lercanidipine hydrochloride (equivalent to 18.88 mg of lercanidipine).
Other components are:
Core: microcrystalline cellulose, sodium bicarbonate, pregelatinized starch (maize), sodium starch glycolate (type A), anhydrous colloidal silica, magnesium stearate.
Film coating: hypromellose, macrogol 6000, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of Enalapril and Lercanidipine Teva and package contents
Enalapril and Lercanidipine Teva 20 mg/20 mg are round, biconvex film-coated tablets, orange to light orange in colour, with a diameter of approximately 11 mm and a thickness of approximately 5 mm.
Enalapril and Lercanidipine Teva 20 mg/20 mg is available in packs containing 14, 28, 30, 50, 56, 90 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 – 20123 Milan - Italy
Manufacturer
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg – 89143 Germany
TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen – 4042 Hungary
Teva Pharma S.L.U., C/C, n. 4, Poligono Industrial Malpica, Zaragoza – 50016 Spain