Lisinopril/amlodipine Alkaloid-int

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

Lisinopril + Amlodipine

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

• You should 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 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 Lisinopril/Amlodipine Alkaloid-INT and what is it used for
• 2. Before you take 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 is Lisinopril/Amlodipine Alkaloid-INT and what is it used for

Lisinopril/Amlodipine Alkaloid-INT tablets are a combination medicine that contains 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 inhibitors (ACE inhibitors). Lisinopril/Amlodipine Alkaloid-INT is used to treat high blood pressure in adults.

Lisinopril/Amlodipine Alkaloid-INT, 10 mg+5 mg tablet, is indicated in adult patients whose blood pressure is adequately controlled with 10 mg lisinopril and 5 mg amlodipine given separately.

Lisinopril/Amlodipine Alkaloid-INT, 20 mg+10 mg tablet, is indicated in adult patients whose blood pressure is adequately controlled with 20 mg lisinopril and 10 mg amlodipine given separately.

Lisinopril/Amlodipine Alkaloid-INT, 20 mg+5 mg tablet, is indicated in adult patients whose blood pressure is adequately controlled with 20 mg lisinopril and 5 mg amlodipine given separately.

In patients with high blood pressure, amlodipine widens the blood vessels, making it easier for the heart to pump blood. It also improves blood supply to the heart muscle. Lisinopril lowers the blood pressure by reducing the resistance in the blood vessels and by reducing the amount of fluid in the blood.

Even if you do not have symptoms of high blood pressure, it is still important to take your medicine, as high blood pressure can cause damage to your heart, brain, and kidneys, and increase the risk of heart attack and stroke.

2. Before you take Lisinopril/Amlodipine Alkaloid-INT

When not to take Lisinopril/Amlodipine Alkaloid-INT

Do not take this medicine if:

you are allergic to lisinopril or amlodipine or any of the other ingredients of this medicine (listed in section 6),

you are allergic to other ACE inhibitors (such as enalapril, captopril, or ramipril) or other calcium channel blockers (such as nifedipine, felodipine, or nimodipine),

you have had angioedema (a severe allergic reaction with symptoms such as itching, hives, swelling of the face, lips, tongue, or throat, and difficulty breathing) in the past, whether or not it was related to ACE inhibitor treatment,

a family member has had a severe allergic reaction (hereditary angioedema) or you have had a severe allergic reaction of unknown cause (idiopathic angioedema),

you have low blood pressure (severe hypotension),

you have a narrowing of the aortic valve (aortic stenosis) or a narrowing of the heart valve (mitral stenosis) or an abnormal thickening of the heart muscle (hypertrophic cardiomyopathy),

you have heart failure (including cardiogenic shock),

you have had a heart attack (myocardial infarction) with heart failure,

you are more than 3 months pregnant (use of Lisinopril/Amlodipine Alkaloid-INT in early pregnancy is also not recommended - see section "Pregnancy and breastfeeding"),

you have diabetes or kidney problems and are taking aliskiren, a medicine used to lower blood pressure,

you are taking or have recently taken sacubitril/valsartan, a medicine used to treat long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling of the skin and mucous membranes) is increased.

Warnings and precautions

Tell your doctor if you think you might be pregnant or are planning to become pregnant. The use of Lisinopril/Amlodipine Alkaloid-INT is not recommended during pregnancy and may cause serious harm to the baby if used after the third month of pregnancy (see section "Pregnancy and breastfeeding").

Before taking Lisinopril/Amlodipine Alkaloid-INT, tell your doctor if you:

have heart problems,

have collagen disease (a disease of the connective tissue),

have kidney problems,

have liver problems,

are going to have surgery (including dental surgery) or anesthesia,

are on dialysis,

are going to have LDL apheresis to remove cholesterol from your blood,

are over 65 years old,

are on a low-salt diet and use salt substitutes that contain potassium or take potassium supplements, or have high levels of potassium in your blood (hyperkalemia),

have diabetes,

have diarrhea or vomiting,

are undergoing desensitization (to reduce your allergy) to reduce your allergy to bee or wasp stings,

are black, as ACE inhibitors may be less effective and more likely to cause angioedema (swelling of the face, lips, tongue, and/or throat),

are taking any of the following medicines for high blood pressure:

angiotensin II receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney disease caused by diabetes,

aliskiren.

Tell your doctor if you are taking any of the following medicines, as the risk of angioedema (sudden swelling of the skin and mucous membranes) may be increased:

racecadotril, a medicine used to treat diarrhea,

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 given in a hospital setting,

vildagliptin, a medicine used to treat diabetes,

racecadotril, a medicine used to treat diarrhea.

Your doctor may decide to change your dose and/or take other precautions:

if you are taking ARBs or aliskiren (see also sections "When not to take Lisinopril/Amlodipine Alkaloid-INT" and "Warnings and precautions").

Using Lisinopril/Amlodipine Alkaloid-INT with food and drink and alcohol

Lisinopril/Amlodipine Alkaloid-INT can be taken with or without food, but you should avoid drinking alcohol during treatment.

Do not drink grapefruit juice or eat grapefruit while taking Lisinopril/Amlodipine Alkaloid-INT, as it may increase the levels of amlodipine in your blood, leading to unpredictable lowering of your blood pressure and reduced efficacy of the medicine.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or think you might be pregnant, tell your doctor. Your doctor will normally advise you to stop taking Lisinopril/Amlodipine Alkaloid-INT before you become pregnant or as soon as you know you are pregnant, and will advise you to take a different medicine instead of Lisinopril/Amlodipine Alkaloid-INT. Lisinopril/Amlodipine Alkaloid-INT is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

Breastfeeding

It has been shown that small amounts of amlodipine pass into breast milk. If you are breastfeeding or plan to breastfeed, tell your doctor. The use of Lisinopril/Amlodipine Alkaloid-INT is not recommended during breastfeeding. Your doctor will normally advise you to take a different medicine instead of Lisinopril/Amlodipine Alkaloid-INT, especially if your baby is a newborn or premature.

Driving and using machines

Before driving, using machines, or performing other activities that require concentration, make sure you know how Lisinopril/Amlodipine Alkaloid-INT affects you.

Lisinopril/Amlodipine Alkaloid-INT may affect your ability to drive or use machines (especially at the start of treatment). Do not drive or use machines if you experience dizziness, drowsiness, or other symptoms that may affect your ability to drive or use machines.

Lisinopril/Amlodipine Alkaloid-INT contains sodium

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

3. How to take Lisinopril/Amlodipine Alkaloid-INT

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one Lisinopril/Amlodipine Alkaloid-INT tablet per day.

Lisinopril/Amlodipine Alkaloid-INT tablets can be taken with or without food.

Swallow each tablet whole with a small amount of water. Take the tablet at the same time each day.

The score line on the 10mg+5mg tablet is only to facilitate breaking for ease of swallowing and not to divide it into equal doses.

The score line on the 20mg+5mg tablet is only to facilitate breaking for ease of swallowing and not to divide it into equal doses.

The 20mg+10mg tablet can be divided into equal doses.

If you think that the effect of Lisinopril/Amlodipine Alkaloid-INT is too strong or too weak, talk to 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 no experience with its use in this age group.

Elderly patients

No dose adjustment is necessary in patients over 65 years old.

Impaired liver function

Liver disease may affect the levels of amlodipine in your blood. Your doctor will monitor you closely.

Impaired kidney function

During treatment with Lisinopril/Amlodipine Alkaloid-INT, regular monitoring of kidney function, potassium, and sodium levels in your blood is necessary. If your kidney function worsens, Lisinopril/Amlodipine Alkaloid-INT will be stopped and replaced with a therapy consisting of individually adjusted doses of the separate components.

If you take more Lisinopril/Amlodipine Alkaloid-INT than you should

Contact your doctor or go to the nearest hospital emergency department immediately.

Overdose of Lisinopril/Amlodipine Alkaloid-INT may cause very low blood pressure, which should be closely monitored. Symptoms of overdose may include electrolyte disturbances, kidney failure, rapid breathing (hyperventilation), fast heartbeat, palpitations, slow heartbeat, dizziness, anxiety, and cough. You may feel dizzy, faint, or weak. In severe cases, it may lead to shock. Your skin may become cold, clammy, and pale, and you may lose consciousness.

Up to 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid building up in your lungs (pulmonary edema).

If you experience any of these symptoms (such as dizziness and headache), lie down. Your doctor will take further action.

If you forget to take Lisinopril/Amlodipine Alkaloid-INT

Do not take a double dose to make up for a forgotten tablet. Take the next dose at the usual time.

If you stop taking Lisinopril/Amlodipine Alkaloid-INT

Your doctor will tell you how long to take Lisinopril/Amlodipine Alkaloid-INT. Do not stop taking the medicine without talking to your doctor first. If you stop taking the medicine too early, your condition may worsen.

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

4. Possible side effects

Like all medicines, Lisinopril/Amlodipine Alkaloid-INT can cause side effects, although not everybody gets them.

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

In a clinical study where amlodipine and lisinopril were used together, common side effects were headache, cough, and dizziness.

During treatment with Lisinopril/Amlodipine Alkaloid-INT, allergic reactions (hypersensitivity) may occur. Stop taking Lisinopril/Amlodipine Alkaloid-INT and seek medical help immediately if you experience any of the following symptoms of angioedema:

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 cause difficulty swallowing,

severe skin reaction, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Other side effects that have been reported with amlodipine or lisinopril (the active substances in Lisinopril/Amlodipine Alkaloid-INT) are:

Amlodipine

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

Swelling.

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

Headache, swelling of the ankles, muscle cramps, tiredness, weakness, drowsiness, vision disturbances, nausea, vomiting, changes in bowel movements (diarrhea and constipation), dizziness, abdominal pain, palpitations (fast or irregular heartbeat), flushing, difficulty breathing.

If these symptoms are troublesome or persist for more than a week, tell your doctor.

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

Rash, itching, hair loss, redness of the skin, skin discoloration, hives, vomiting, muscle or joint pain, back pain, chest pain, changes in mood (including anxiety and depression), insomnia, tremors, ringing in the ears, irregular heartbeat (arrhythmia), low blood pressure, cough, changes in taste, changes in sensation (feeling of numbness or tingling), runny nose, frequent urination at night, urinary disturbances, dryness of the mouth, loss of pain sensation, increased sweating, fainting, pain, malaise, weight gain, weight loss.

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

Disorientation.

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

Allergic reactions, abnormal liver function tests, liver disease, jaundice, reduced white blood cell count and platelet count, increased blood sugar levels, heart attack (myocardial infarction), severe skin reactions (rash, blistering, peeling, and swelling of the skin), severe allergic reactions and accompanying fever, redness of the skin, joint and/or eye disorders (Stevens-Johnson syndrome), gum swelling or ulceration, pancreatitis, stomach inflammation, sensitivity to light, increased muscle tone, peripheral neuropathy (nerve disorder: feeling of weakness and tingling), vasculitis.

Unknown frequency (cannot be estimated from the available data):

Tremors, stiff posture, mask-like face, slow movements and shuffling gait, Lisinopril

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

Headache, dizziness or feeling of "empty head" - especially when standing up quickly, diarrhea, cough, vomiting, kidney problems.

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

Mood changes, changes in skin color (paleness followed by flushing) and/or stiffness or tingling in the fingers or toes (Raynaud's phenomenon), changes in taste, hallucinations, fatigue, drowsiness or sleep disturbances, feeling of spinning, paresthesia (feeling of tingling, itching, burning), fast or irregular heartbeat (palpitations), heart attack (myocardial infarction), stroke, runny nose, nausea, abdominal pain or indigestion, impotence, fatigue, changes in laboratory tests (kidney and liver function), rash, itching.

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

Angioedema (allergic reaction with sudden swelling of the lips, face, and throat, and possibly hands and feet - the frequency of angioedema is higher in black patients than in patients of other races). Disorientation, inappropriate secretion of antidiuretic hormone, acute kidney problems, kidney failure, dry mouth, hair loss, psoriasis, hives, gynecomastia (breast enlargement in men). Disturbances of smell.

Abnormal blood test results: decreased hemoglobin and hematocrit values. Increased bilirubin levels. Low sodium levels in the blood.

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

Low blood sugar levels (hypoglycemia), sinusitis, wheezing, pneumonia, jaundice, liver disease or pancreatitis, liver failure, severe skin diseases (including rash, blistering, peeling, and swelling of the skin), sweating.

Significant decrease in urine output (or no urine output). Intestinal swelling.

Abnormal blood test results: decreased red blood cell count (anemia), decreased platelet count (thrombocytopenia), decreased white blood cell count (neutropenia, leukopenia, agranulocytosis). These disorders may cause prolonged bleeding, fatigue, weakness, lymph node disease, autoimmune diseases (a condition in which the immune system turns against itself). Increased susceptibility to infections.

Unknown frequency (cannot be estimated from the available data):

Fainting, depression, severe allergic reaction (anaphylactic/anaphylactoid reaction).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section.

5. How to store Lisinopril/Amlodipine Alkaloid-INT

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

Store in the original package to protect from light.

There are no special storage instructions for this medicine.

Do not use this medicine after the expiry date which is stated on the carton.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 lisinopril (as lisinopril dihydrate) and 5 mg amlodipine (as amlodipine besylate).

Lisinopril/Amlodipine Alkaloid-INT, 20 mg+10 mg tablets

Each tablet contains 20 mg lisinopril (as lisinopril dihydrate) and 10 mg amlodipine (as amlodipine besylate).

Lisinopril/Amlodipine Alkaloid-INT, 20 mg+5 mg tablets

Each tablet contains 20 mg lisinopril (as lisinopril dihydrate) and 5 mg amlodipine (as amlodipine besylate).

• The other ingredients are calcium hydrogen phosphate, mannitol, maize starch, sodium carboxymethylcellulose (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, with a score line on one side and the inscription "L A" on the other side.

The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide it into equal doses.

The tablets are packed in a blister pack (PVC/PVDC/Aluminum) in a cardboard box.

The cardboard box contains 20, 30, 60, or 90 tablets in blisters and a patient information 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 and the inscription "L A 2" on the other side.

The tablet can be divided into equal doses.

The tablets are packed in a blister pack (PVC/PVDC/Aluminum) in a cardboard box.

The cardboard box contains 20, 30, 60, or 90 tablets in blisters and a patient information 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 and the inscription "L A 1" on the other side.

The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide it into equal doses.

The tablets are packed in a blister pack (PVC/PVDC/Aluminum) in a cardboard box.

The cardboard box contains 20, 30, 60, or 90 tablets in blisters and a patient information leaflet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Holsten Pharma GmbH

Hahnstraße 31-35

60528 Frankfurt am Main

Germany

Email: info@holstenpharma.de

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: info@alkaloid.si

This medicinal product is authorised in the Member States of 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 tablets

Bulgaria

Skopryl Combo 10 mg/5; 20 mg/10 mg; 20 mg/5 mg tablets

Croatia

Skopryl Combo 10 mg/5 mg; 20 mg/10 mg; 20 mg/5 mg tablets

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 tablets

Slovenia

Skopryl Combo 10 mg/5 mg; 20 mg/10 mg; 20 mg/5 mg tablets

Date of last revision of the leaflet: