Lisinopril/amlodipine Alkaloid-int

Leaflet accompanying the packaging: 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lisinopril/Amlodipine Alkaloid-INT and what is it used for
• 2. Important information 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 packaging 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 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 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 of lisinopril and 5 mg of amlodipine.

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

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

In patients with high blood pressure, amlodipine dilates 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 high blood pressure symptoms do not occur, the risk of certain complications (such as stroke or heart attack) may still increase if the patient does not take their blood pressure medication regularly.

2. Important information before taking 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 ACE inhibitors (such as enalapril, captopril, or ramipril) or to other calcium channel blockers (such as nifedipine, felodipine, or nimodipine),

you have had angioedema (a severe allergic reaction with symptoms such as itching, hives, wheezing, or swelling of the hands, throat, mouth, or eyelids) in connection with or without connection to ACE inhibitor treatment,

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

you have very low blood pressure (severe hypotension),

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

you have circulatory failure (including cardiogenic shock),

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

you are pregnant after the third month (taking Lisinopril/Amlodipine Alkaloid-INT in early pregnancy is also not recommended - see "Pregnancy and breastfeeding"),

you have diabetes or kidney problems and are taking blood pressure-lowering medicines containing aliskiren,

you have taken or are taking sacubitril/valsartan, a medicine used to treat long-term (chronic) heart failure in adults, as the risk of angioedema (sudden swelling of the subcutaneous tissue, e.g., in the throat area) is increased.

Warnings and precautions

Tell your doctor if you think you might be pregnant. Taking Lisinopril/Amlodipine Alkaloid-INT is not recommended in early pregnancy and may cause serious harm to the fetus if taken after the third month of pregnancy (see "Pregnancy and breastfeeding").

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

have heart problems,

have collagen disease (connective tissue disease),

have kidney problems,

have liver problems,

are scheduled for surgery (including dental surgery) or anesthesia,

are on dialysis,

are to undergo LDL apheresis to remove cholesterol,

are over 65 years old,

are on a low-salt diet and use salt substitutes containing potassium or its supplements, or have high potassium levels in the blood (hyperkalemia),

have diabetes,

have diarrhea or vomiting,

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

are of black race, 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 in diabetic kidney disease,

aliskiren.

Tell your doctor if you are taking any of the following medicines, as the risk of angioedema (sudden swelling of the subcutaneous tissue, e.g., in the throat area) will be higher:

racecadotril, a medicine used to treat diarrhea,

medicines used to prevent transplant rejection or 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 the dose and/or take other precautions:

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

Taking 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.

While taking Lisinopril/Amlodipine Alkaloid-INT, do not eat grapefruit or drink grapefruit juice, as consuming grapefruit or grapefruit juice may increase the levels of the active substance amlodipine in the blood, which may cause unpredictable lowering of blood pressure, reducing the effectiveness of Lisinopril/Amlodipine Alkaloid-INT.

Pregnancy and breastfeeding

Pregnancy

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

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. Lisinopril/Amlodipine Alkaloid-INT is not recommended for mothers who are breastfeeding, especially if the baby is a newborn or premature. Your doctor will probably recommend a different medicine if you want to breastfeed.

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 and use machines safely (especially at the beginning of treatment).

Do not drive or use machines if you notice that Lisinopril/Amlodipine Alkaloid-INT affects your ability to drive or use machines, e.g., causes dizziness, headache, fatigue, or nausea.

Lisinopril/Amlodipine Alkaloid-INT contains sodium

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

3. How to take Lisinopril/Amlodipine Alkaloid-INT

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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 every day.

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

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

The 20mg+10mg Lisinopril/Amlodipine Alkaloid-INT 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

Do not give Lisinopril/Amlodipine Alkaloid-INT to children under 18 years of age, as there is no data on safety and efficacy.

Elderly patients

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

Liver impairment

Liver disease may affect the levels of amlodipine in the blood. In this case, your doctor will recommend more frequent checks.

Kidney impairment

While taking Lisinopril/Amlodipine Alkaloid-INT, regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) is necessary. If kidney function worsens, Lisinopril/Amlodipine Alkaloid-INT will be discontinued and replaced with a therapy consisting of appropriately adjusted doses of the individual components.

Taking more than the recommended dose of Lisinopril/Amlodipine Alkaloid-INT

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

Taking more than the recommended dose 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), rapid heartbeat, palpitations, slow heartbeat, dizziness, anxiety, and cough. The patient may feel dizzy, faint, or weak. In case of a significant drop in blood pressure, shock may occur. The skin may become cold, wet, and pale, and there may be loss of consciousness.

Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

If characteristic symptoms occur (such as dizziness and headache), lie on your back. Further actions will be taken by your doctor.

Missing a dose of Lisinopril/Amlodipine Alkaloid-INT

Do not take a double dose to make up for a forgotten 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 tell you how long to take the medicine. Do not stop taking the medicine even if you feel better, as your condition may worsen if you stop the medicine too early.

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

4. Possible side effects

Like all medicines, this medicine 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 in combination, common side effects were headache, cough, and dizziness.

While taking 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 make swallowing difficult,

severe skin reaction, including severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

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

Amlodipine

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

Edema.

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

Headache, edema of the feet, muscle cramps, fatigue, weakness, drowsiness, visual disturbances, nausea, indigestion, changes in bowel movements (diarrhea and constipation), dizziness, abdominal pain, palpitations (faster or irregular heartbeat), sudden reddening of the face, breathing difficulties.

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

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

Skin rash, itching, hair loss, red spots on the skin, skin discoloration, hives, vomiting, muscle or joint pain, back pain, chest pain, mood changes (including anxiety), depression, insomnia, tremors, ringing in the ears, irregular heartbeat (arrhythmia), low blood pressure, cough, taste disturbances, sensation disturbances (feeling of numbness or tingling), runny nose, frequent urination at night, urination disturbances, dryness of the mucous membranes in the mouth, loss of pain sensation, increased sweating, fainting, pain, malaise, gynecomastia (breast enlargement in men), erectile dysfunction, 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 test results, liver inflammation, yellowing of the skin and/or eyes (jaundice), reduced white blood cell and platelet count, increased blood glucose levels, heart attack (myocardial infarction), severe skin reactions (rash, peeling, and blistering skin), severe allergic reactions with accompanying fever, red spots on the skin, joint and/or eye disorders (Stevens-Johnson syndrome), gum swelling or ulceration, pancreatitis, inflammation of the stomach lining, sensitivity to light, increased muscle tension, peripheral neuropathy (nerve disorder: feeling of weakness and tingling), inflammation of blood vessels.

Unknown frequency (cannot be estimated from the available data)

Tremors, unnatural stiffness, 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 "emptiness" in the head - especially when standing up quickly, diarrhea, cough, vomiting, kidney problems.

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

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

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 sometimes 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 levels. Increased bilirubin levels. Low sodium levels in the blood.

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

Low blood glucose levels (hypoglycemia), sinusitis, wheezing, pneumonia, yellowing of the skin and/or eyes (jaundice), liver or pancreatitis, liver failure, severe skin diseases (symptoms include: redness, blistering, and peeling skin), sweating.

Significant decrease in urine output (or absence of urine). Intestinal edema.

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 side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181 C, 02-222 Warsaw

Phone: +48 22 49 21 301

Fax: + 48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

You can also report side effects to the marketing authorization holder or its representative.

By reporting side effects, you can help 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 storage temperature instructions.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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 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 into equal doses.

Tablets are packaged in a PVC/PVDC/Aluminum blister pack 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, convex 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.

Tablets are packaged in a PVC/PVDC/Aluminum blister pack 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, convex 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 into equal doses.

Tablets are packaged in a PVC/PVDC/Aluminum blister pack 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 authorization 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

Phone: + 386 1 300 42 90

Fax: + 386 1 300 42 91

Email: info@alkaloid.si

This medicinal product is authorized 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: