Lisinopril/amlodipine holsten

Package leaflet: Information for the user

Lisinopril/Amlodipine Alkaloid-INT, 10 mg+5 mg, tablets
Lisinopril/Amlodipine Alkaloid-INT, 20 mg+10 mg, tablets
Lisinopril/Amlodipine Alkaloid-INT, 20 mg+5 mg, tablets
Lisinoprilum + Amlodipinum
Please read all of 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 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Lisinopril/Amlodipine Alkaloid-INT is and what it is used for
2. What you need to know before taking Lisinopril/Amlodipine Alkaloid-INT
3. How to take Lisinopril/Amlodipine Alkaloid-INT tablets
4. Possible side effects
5. How to store Lisinopril/Amlodipine Alkaloid-INT tablets
6. Contents of the pack and other information

1. What Lisinopril/Amlodipine Alkaloid-INT is and what it is used for

Lisinopril/Amlodipine Alkaloid-INT tablets is a combination medicine containing amlodipine,
which belongs to a group of medicines called calcium channel blockers, and lisinopril, which
belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.
Lisinopril/Amlodipine Alkaloid-INT is used to treat high blood pressure (hypertension) in adults.
Lisinopril/Amlodipine Alkaloid-INT 10 mg+5 mg tablet is indicated for adult patients whose blood
pressure is adequately controlled with 10 mg lisinopril and 5 mg amlodipine given concomitantly.
Lisinopril/Amlodipine Alkaloid-INT 20 mg+10 mg tablet is indicated for adult patients whose blood
pressure is adequately controlled with 20 mg lisinopril and 10 mg amlodipine given concomitantly.
Lisinopril/Amlodipine Alkaloid-INT 20 mg+5 mg tablet is indicated for adult patients whose blood
pressure is adequately controlled with 20 mg lisinopril and 5 mg amlodipine given concomitantly.
In patients with high blood pressure, amlodipine relaxes blood vessels, making it easier for blood to
flow. It also improves blood flow to the heart muscle. Lisinopril reduces blood vessel tension and
lowers blood pressure.
Even if you do not have symptoms of high blood pressure, your risk of certain complications (such
as stroke or heart attack) may still increase if you do not take antihypertensive medicines regularly.

2. Important information before taking Lisinopril/Amlodipine Alkaloid-INT

When not to take Lisinopril/Amlodipine Alkaloid-INT
Do not take this medicine if:
- the patient is allergic to lisinopril or amlodipine, or to any of the other ingredients of this medicine (listed in section 6),
- the patient is allergic to angiotensin-converting enzyme (ACE) inhibitors (such as enalapril, captopril or ramipril) or to other calcium channel blockers (such as nifedipine, felodipine or nimodipine),
- the patient has had angioedema (a serious allergic reaction with symptoms such as itching, hives, wheezing, or swelling of hands, throat, lips or eyelids), with or without previous treatment with ACE inhibitors,
- a family member has ever had a serious allergic reaction (hereditary angioedema), or if the patient has ever had a serious allergic reaction of unknown origin (idiopathic angioedema),
- the patient has low blood pressure (severe hypotension),
- the patient has aortic stenosis (narrowing of the aortic valve) or mitral stenosis (narrowing of the heart valve), or abnormal thickening of the heart muscle (hypertrophic cardiomyopathy),
- the patient has circulatory failure (including cardiogenic shock),
- the patient has had a heart attack (myocardial infarction) complicated by heart failure,
- the patient is beyond the 3rd month of pregnancy (taking Lisinopril/Amlodipine Alkaloid-INT in early pregnancy is also not recommended – see section “Pregnancy and breastfeeding”),
- the patient has diabetes or kidney impairment and is taking blood pressure-lowering medicines containing aliskiren,
- the patient has taken or is still taking sacubitril with valsartan, a medicine used to treat long-term (chronic) heart failure in adults, because this increases the risk of angioedema (sudden swelling under the skin, for example in the throat area).

Warnings and precautions
Inform your doctor if the patient suspects she is (or might be) pregnant.
Use of Lisinopril/Amlodipine Alkaloid-INT is not recommended during early pregnancy and may cause severe harm to the unborn baby if used after the 3rd month of pregnancy (see section “Pregnancy and breastfeeding”).

Before starting Lisinopril/Amlodipine Alkaloid-INT, discuss this with your doctor if the patient:
- has heart problems,
- has collagenosis (connective tissue disease),
- has kidney problems,
- has liver problems,
- has a planned surgical procedure (including dental surgery) or anaesthesia,
- is undergoing dialysis,
- is scheduled for LDL apheresis to remove cholesterol,
- is over 65 years of age,
- is on a low-salt diet and uses potassium-containing salt substitutes or potassium supplements, or has high blood potassium levels (hyperkalaemia),
- has diabetes,
- has diarrhoea or vomiting,
- is undergoing desensitisation treatment (to reduce sensitivity) to reduce allergy to bee or wasp stings,
- is of Black race, in which case ACE inhibitors may be less effective and may more frequently cause angioedema (swelling of the face, lips, tongue and/or throat),
- is taking any of the following medicines used to treat high blood pressure:
- angiotensin II receptor blockers (ARBs) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially in case of kidney disease due to diabetes,
- aliskiren,
- is taking any of the following medicines, which may increase the risk of angioedema (sudden swelling of subcutaneous tissue, e.g. in the throat area):
- racecadotril, a medicine used to treat diarrhoea,
- medicines used to prevent transplant rejection or to treat cancer (sirolimus, everolimus, temsirolimus and other mTOR inhibitors),
- tissue plasminogen activators (medicines used to dissolve blood clots), usually administered in hospital,
- vildagliptin, a medicine used to treat diabetes,
- is taking any of the above-mentioned medicines (see “Lisinopril/Amlodipine Alkaloid-INT and other medicines”).

Contact your doctor if a persistent dry cough develops after starting Lisinopril/Amlodipine Alkaloid-INT.
Your doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium).
See also information in the section “When not to take Lisinopril/Amlodipine Alkaloid-INT”.

Children and adolescents
Lisinopril/Amlodipine Alkaloid-INT must not be used in children under 18 years of age.

Lisinopril/Amlodipine Alkaloid-INT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take.

Potassium-sparing diuretics (such as spironolactone, amiloride, triamterene used to reduce fluid retention) and potassium-containing salt substitutes or potassium supplements may be taken together with Lisinopril/Amlodipine Alkaloid-INT only under strict medical supervision.

Exercise particular caution if Lisinopril/Amlodipine Alkaloid-INT is taken together with the following medicines:
- diuretics (used to reduce fluid retention),
- other medicines used to lower blood pressure (antihypertensives),
- medicines used to treat heart disease (e.g. verapamil, diltiazem),
- non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid (used to reduce joint inflammation, muscle pain, headache, inflammatory conditions, fever),
- lithium, tricyclic antidepressants, antipsychotics (used to treat psychiatric disorders),
- insulin and oral antidiabetic medicines (used to treat high blood glucose levels),
- autonomic nervous system stimulants (sympathomimetics), such as ephedrine, phenylephrine, xylometazoline and salbutamol (used to treat mucus congestion, cough, colds and asthma), immunosuppressants (used to prevent organ transplant rejection, e.g. corticosteroids, cytotoxic drugs and antimetabolites),
- allopurinol (used to treat gout),
- procainamide (used to treat heart arrhythmias),
- potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole used for bacterial infections, cyclosporine – an immunosuppressant used to prevent organ transplant rejection, heparin – a medicine used to thin the blood to prevent clots),
- simvastatin (used to lower cholesterol and blood lipid levels),
- opioid medicines, morphine and derivatives (used for severe pain),
- anticancer medicines,
- anaesthetics used during surgical and dental procedures. Inform your doctor or dentist that you are taking Lisinopril/Amlodipine Alkaloid-INT before receiving local or general anaesthesia, as there is a risk of sudden, short-term drop in blood pressure,
- anticonvulsants (such as carbamazepine, phenobarbital and phenytoin) used to treat epilepsy,
- medicines used to treat bacterial infections (antibiotics such as rifampicin, erythromycin or clarithromycin), HIV (so-called protease inhibitors such as ritonavir, indinavir, nelfinavir) or fungal infections (e.g. ketoconazole, itraconazole),
- herbal medicines containing St. John’s wort (Hypericum perforatum),
- gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis),
- dantrolene (a skeletal muscle relaxant used to treat high body temperature [malignant hyperthermia] caused by anaesthetics used during surgery),
- tacrolimus (used to regulate the immune response to help the body accept a transplanted organ).

The following medicines may increase the risk of angioedema (angioedema may present as swelling of the face, lips, tongue and/or throat, difficulty swallowing or breathing):
- medicines used to dissolve blood clots (tissue plasminogen activators), mainly used during hospitalisation,
- medicines most commonly used to prevent rejection of transplanted organs or to treat cancer (sirolimus, everolimus, temsirolimus and other mTOR inhibitors). See “Warnings and precautions”,
- vildagliptin, a medicine used to treat diabetes,
- racecadotril, a medicine used to treat diarrhoea.

Your doctor may decide to adjust the dose and/or take other precautions:
- if the patient is taking angiotensin II receptor blockers (ARBs) or aliskiren (see also information in sections “When not to take Lisinopril/Amlodipine Alkaloid-INT” and “Warnings and precautions”).

Taking Lisinopril/Amlodipine Alkaloid-INT with food, drink and alcohol
Lisinopril/Amlodipine Alkaloid-INT can be taken independently of meals. However, alcohol consumption should be avoided during treatment.
Do not drink grapefruit juice or eat grapefruits while taking Lisinopril/Amlodipine Alkaloid-INT. This is because consuming grapefruit or grapefruit juice may increase blood levels of the active substance – amlodipine – which could cause unpredictable lowering of blood pressure and reduce the effectiveness of Lisinopril/Amlodipine Alkaloid-INT.

Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant or suspects she may be pregnant, inform her doctor. Usually, the doctor will advise stopping Lisinopril/Amlodipine Alkaloid-INT before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Lisinopril/Amlodipine Alkaloid-INT is not recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it may cause severe harm to the unborn baby.

Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk. Inform your doctor if the patient is breastfeeding or plans to breastfeed. Lisinopril/Amlodipine Alkaloid-INT is not recommended for breastfeeding mothers. The doctor will most likely recommend an alternative medicine if the patient wishes to breastfeed, especially if the baby is a newborn or premature infant.

Driving and operating machinery
Before driving, operating machinery or performing other tasks requiring concentration, ensure how Lisinopril/Amlodipine Alkaloid-INT affects the patient.
Lisinopril/Amlodipine Alkaloid-INT may affect the ability to drive and operate machinery safely (especially during the initial phase of treatment).
Do not drive or operate machinery if the patient notices that Lisinopril/Amlodipine Alkaloid-INT negatively affects their ability to drive or operate machinery, for example by causing nausea, dizziness, fatigue or headache.

Lisinopril/Amlodipine Alkaloid-INT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Lisinopril/Amlodipine Alkaloid-INT

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is one tablet of Lisinopril/Amlodipine Alkaloid-INT per day.
The Lisinopril/Amlodipine Alkaloid-INT tablet may be taken independently of meals.
Each tablet should be swallowed whole with a small amount of water. The tablet should be taken daily at the same time.
The break line on the 10 mg + 5 mg tablet is only intended to facilitate breaking the tablet for easier swallowing.
The break line on the 20 mg + 5 mg tablet is only intended to facilitate breaking the tablet for easier swallowing.
The Lisinopril/Amlodipine Alkaloid-INT 20 mg + 10 mg tablet may be divided into equal doses.

If the patient feels that the effect of Lisinopril/Amlodipine Alkaloid-INT is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents
Lisinopril/Amlodipine Alkaloid-INT should not be used in children under 18 years of age, as there is insufficient data on safety and efficacy.

Elderly patients
Dosage adjustment is not required in patients over 65 years of age.

Hepatic impairment
Liver disease may affect the blood concentration of amlodipine. In such cases, the doctor may recommend more frequent monitoring.

Renal impairment
During treatment with Lisinopril/Amlodipine Alkaloid-INT, regular monitoring of kidney function and serum potassium and sodium levels is necessary. If kidney function deteriorates, Lisinopril/Amlodipine Alkaloid-INT will be discontinued and replaced with therapy consisting of appropriately adjusted doses of the individual components.

Overdose of Lisinopril/Amlodipine Alkaloid-INT
Seek immediate medical advice from a doctor or go to the nearest emergency department.

Taking an excessive dose of Lisinopril/Amlodipine Alkaloid-INT may cause severely low blood pressure, which must be closely monitored. Symptoms of overdose may include electrolyte disturbances, renal failure, rapid breathing (hyperventilation), fast heartbeat, palpitations, slow heartbeat, dizziness, anxiety, and cough. The patient may experience dizziness, fainting, or feel weak. In cases of severe drop in blood pressure, shock may occur. The skin may become cold, clammy, and loss of consciousness may occur.

Breathing difficulties due to fluid accumulation in the lungs (pulmonary edema) may occur up to 24–48 hours after taking the medicine.

If characteristic symptoms occur (such as dizziness and headache), the patient should lie down on their back. Further management will be carried out by the doctor.

Missed dose of Lisinopril/Amlodipine Alkaloid-INT
Do not take a double dose to make up for a missed tablet, as this may increase the risk of overdose. Take the next dose at the usual time.

Stopping treatment with Lisinopril/Amlodipine Alkaloid-INT
Your doctor will advise how long you should take this medicine. Do not stop taking the medicine even if you feel better. Stopping treatment earlier than advised by your doctor may lead to worsening of your condition.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common adverse reactions (may occur in up to 1 in 10 patients):
In a clinical trial using amlodipine and lisinopril in combination therapy, common adverse reactions included headache, cough and dizziness.
Allergic reactions (hypersensitivity) may occur during treatment with Lisinopril/Amlodipine Alkaloid-INT. You must stop taking Lisinopril/Amlodipine Alkaloid-INT and seek immediate medical help if any of the following symptoms of angioedema occur:
­ difficulty breathing with or without swelling of the face, lips, tongue and (or) throat,
­ swelling of the face, lips, tongue and (or) throat, which may make swallowing difficult,
­ severe skin reaction, including severe rash, urticaria, redness of the skin over the entire body, intense itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

Other reported adverse reactions associated with the use of amlodipine or lisinopril separately (the active substances of the medicine), which may occur during treatment with Lisinopril/Amlodipine Alkaloid-INT, are as follows:

Amlodipine

Very common adverse reactions (may occur in more than 1 in 10 patients)
Swelling (oedema).

Common adverse reactions (may occur in up to 1 in 10 patients)
Headache, swelling of the ankles, muscle cramps, fatigue, weakness, drowsiness, visual disturbances, nausea, indigestion, changes in bowel habits (diarrhoea and constipation), dizziness, abdominal pain, palpitations (faster or irregular heartbeat), sudden flushing of the face, difficulty breathing.
If these symptoms are troublesome or persist for more than one week, inform your doctor.

Uncommon adverse reactions (may occur in up to 1 in 100 patients)
Skin rash, itching, hair loss, red spots on the skin, skin discoloration, urticaria, vomiting, muscle or joint pain, back pain, chest pain, mood changes (including anxiety), depression, insomnia, tremor, ringing in the ears, irregular heart rhythm (arrhythmia), low blood pressure, cough, taste disturbances, sensory disturbances (tingling or numbness sensations), nasal congestion, frequent urination at night, urinary disturbances, dryness of the oral mucosa, loss of pain sensation, excessive sweating, fainting, pain, malaise, breast enlargement in men, erectile dysfunction, weight gain, weight loss.

Rare adverse reactions (may occur in up to 1 in 1,000 patients)
Disorientation.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients)
Allergic reactions, abnormal liver function test results, hepatitis, yellowing of the skin (jaundice), decreased white blood cell and platelet counts, increased blood glucose levels, heart attack (myocardial infarction), serious skin reactions (rash, scaly or peeling skin), serious allergic reactions accompanied by fever, red spots on the skin, joint pain and (or) eye disturbances (Stevens-Johnson syndrome), swelling or ulceration of the gums, pancreatitis, gastric mucosal inflammation, photosensitivity, increased muscle tone, peripheral neuropathy (a nervous system disorder characterized by weakness and tingling), vasculitis.

Not known (frequency cannot be estimated from available data)
Tremor, abnormally rigid posture, mask-like face, slowed movements and dragging gait, unsteady gait.

Lisinopril

Common adverse reactions (may occur in up to 1 in 10 patients)
Headache, dizziness or a feeling of "emptiness" in the head – especially when standing up quickly, diarrhoea, cough, vomiting, kidney function disturbances.

Uncommon adverse reactions (may occur in up to 1 in 100 patients)
Mood changes, skin discoloration of the face (bluish, turning into redness) and (or) stiffness or tingling in fingers or toes (Raynaud's phenomenon), taste disturbances, hallucinations (seeing things that are not real), fatigue, drowsiness or difficulty sleeping, vertigo, paresthesia (tingling, itching, burning sensations), rapid, irregular heartbeat (palpitations), heart attack (myocardial infarction), stroke, nasal congestion, nausea, abdominal pain or indigestion, impotence, fatigue, changes in certain laboratory test results (regarding kidney and liver function), rash, itching, rapid heartbeat (tachycardia).

Rare adverse reactions (may occur in up to 1 in 1,000 patients)
Angioedema (hypersensitivity reaction with sudden swelling of lips, face and neck, and sometimes feet and hands – the incidence of angioedema is higher in black patients than in patients of other races). Disorientation, inappropriate antidiuretic hormone secretion (affecting urine volume), acute kidney function disturbances, kidney failure, dry mouth, hair loss, psoriasis, urticaria, breast enlargement in men. Smell disturbances.
Worsening of blood test results: decreased haemoglobin concentration and haematocrit values.
Increased concentration of bile pigment (bilirubin), low blood sodium levels.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients)
Decreased blood glucose levels (hypoglycaemia), sinus pain, wheezing, pneumonia, yellowing of the skin and (or) eyes (jaundice), hepatitis or pancreatitis, liver failure, serious skin diseases (symptoms include redness, blistering and peeling of the skin), sweating.
Significant reduction in urine output (or absence of urine). Intestinal angioedema.
Worsening of blood count results: decreased number of red blood cells (anaemia), decreased platelet count (thrombocytopenia), decreased white blood cell count (neutropenia, leukopenia, agranulocytosis). These disorders may lead to prolonged bleeding, fatigue, weakness, lymph node disease, autoimmune diseases (a condition in which the immune system turns against itself), increased susceptibility to infections.

Not known (frequency cannot be estimated from available data)
Fainting, depression, severe allergic reaction (anaphylactic/anaphylactoid reaction).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its representative.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lisinopril/Amlodipine Alkaloid-INT

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect from light.
No special temperature storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Lisinopril/Amlodipine Alkaloid-INT contains

• The active substances are lisinopril and amlodipine.

Lisinopril/Amlodipine Alkaloid-INT 10 mg + 5 mg, tablets
Each tablet contains 10 mg of lisinopril (as lisinopril dihydrate) and 5 mg of amlodipine (as amlodipine besylate).
Lisinopril/Amlodipine Alkaloid-INT 20 mg + 10 mg, tablets
Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 10 mg of amlodipine (as amlodipine besylate).
Lisinopril/Amlodipine Alkaloid-INT 20 mg + 5 mg, tablets
Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 5 mg of amlodipine (as amlodipine besylate).

• Other components are: calcium hydrogen phosphate, mannitol, pregelatinized maize starch, sodium carboxymethyl starch (type A), and magnesium stearate.

What Lisinopril/Amlodipine Alkaloid-INT looks like and contents of the pack
Lisinopril/Amlodipine Alkaloid-INT 10 mg + 5 mg, tablets
Round, white or almost white, flat tablets with a diameter of 8.00 ± 0.15 mm, bevelled edge and a score line on one side, embossed with the letters "L A" on the other side.
The score line is intended only to facilitate breaking the tablet for easier swallowing and does not guarantee an equal division into doses.
The tablets are packed in PVC/PVDC/Aluminium foil blisters in a cardboard box.
The cardboard box contains 20, 30, 60 or 90 tablets in blisters and a patient leaflet.

Lisinopril/Amlodipine Alkaloid-INT 20 mg + 10 mg, tablets
Round, white or almost white, biconvex tablets with a diameter of 11.00 ± 0.15 mm, with a score line on one side, embossed with the letters "L A 2" on the other side.
The tablet can be divided into equal doses.
The tablets are packed in PVC/PVDC/Aluminium foil blisters in a cardboard box.
The cardboard box contains 20, 30, 60 or 90 tablets in blisters and a patient leaflet.

Lisinopril/Amlodipine Alkaloid-INT 20 mg + 5 mg, tablets
Round, white or almost white, biconvex tablets with a diameter of 11.00 ± 0.15 mm, with a score line on one side, embossed with the letters "L A 1" on the other side.
The score line is intended only to facilitate breaking the tablet for easier swallowing and does not guarantee an equal division into doses.
The tablets are packed in PVC/PVDC/Aluminium foil blisters in a cardboard box.
The cardboard box contains 20, 30, 60 or 90 tablets in blisters and a patient leaflet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
E-Mail: [email protected]

Manufacturer
Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče, Slovenia
Tel.: +386 1 300 42 90
Fax: +386 1 300 42 91
email: [email protected]

This medicinal product is authorised in the European Economic Area under the following names:
Hungary: Lisinopril/Amlodipine Alkaloid-INT 10 mg/5 mg; 20 mg/10 mg; 20 mg/5 mg tabletta
Bulgaria: Skopryl Combo 10 mg/5 mg; 20 mg/10 mg; 20 mg/5 mg tablets
Croatia: Skopryl Combo 10 mg/5 mg; 20 mg/10 mg; 20 mg/5 mg tablete
Malta: Lisinopril/Amlodipine Alkaloid-INT 10 mg/5 mg; 20 mg/10 mg; 20 mg/5 mg tablets
Poland: Lisinopril/Amlodipine Alkaloid-INT
Portugal: Lisinopril + Amlodipine Alkaloid-INT 10 mg + 5 mg; 20 mg + 10 mg; 20 mg + 5 mg comprimidos
Slovenia: Skopryl Combo 10 mg/5 mg; 20 mg/10 mg; 20 mg/5 mg tablete