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 of lisinopril and 5 mg of 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 of lisinopril and 10 mg of 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 of lisinopril and 5 mg of amlodipine given separately.

In patients with high blood pressure, amlodipine widens the blood vessels, making it easier for the blood to flow. It also improves blood supply to the heart muscle. Lisinopril reduces the tension in the blood vessels and lowers blood pressure.

Even if you do not have symptoms of high blood pressure, it can still increase the risk of certain complications (such as stroke or heart attack) if you do not take your blood pressure medicines regularly.

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 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, swelling of the hands, throat, mouth, or lips) in connection with ACE inhibitors,

a member of your family 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 problems (mitral stenosis) or 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 (taking 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 that lowers 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. The use of Lisinopril/Amlodipine Alkaloid-INT is not recommended during early pregnancy and may cause serious harm to the baby if used after the 3rd 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,

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 the blood (hyperkalemia),

have diabetes,

have diarrhea or vomiting,

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

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

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 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 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 hospital,

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").

Children and adolescents

Lisinopril/Amlodipine Alkaloid-INT should not be used in children under 18 years of age.

Interactions with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take.

Diuretics that spare potassium (such as spironolactone, amiloride, triamterene used to reduce fluid retention) and potassium-sparing salt substitutes or potassium supplements can be taken with Lisinopril/Amlodipine Alkaloid-INT only under close medical supervision.

Particular caution is needed if Lisinopril/Amlodipine Alkaloid-INT is taken with:

diuretics (used to reduce fluid retention),

other medicines used to lower blood pressure (antihypertensive medicines),

medicines used to treat heart conditions (e.g., verapamil, diltiazem),

non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (used to reduce inflammation, pain, headache, fever),

lithium, tricyclic antidepressants, antipsychotics (used to treat mental disorders),

insulin and oral antidiabetic medicines (used to treat high blood sugar),

sympathomimetic medicines (such as ephedrine, phenylephrine, xylometazoline, and salbutamol) used to treat nasal congestion, cough, colds, and asthma,

immunosuppressants (used to prevent transplant rejection, e.g., corticosteroids, cytotoxic medicines, and antimetabolites),

allopurinol (used to treat gout),

• procainamide (used to treat irregular heartbeat),
• potassium supplements (including potassium-sparing salt substitutes) and potassium-sparing diuretics and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole used for bacterial infections, cyclosporin - an immunosuppressant used to prevent transplant rejection, heparin - a medicine used to thin the blood to prevent clots),

simvastatin (used to lower cholesterol and lipid levels in the blood),

opioid medicines, morphine, and derivatives (used for severe pain),

anticancer medicines,

anesthetics used during surgical and dental procedures. You should inform your doctor or dentist that you are taking Lisinopril/Amlodipine Alkaloid-INT before receiving local or general anesthesia, as there is a risk of a sudden, short-term drop in blood pressure.

antiepileptic medicines (such as carbamazepine, phenobarbital, and phenytoin) used to treat epilepsy,

• medicines used to treat bacterial infections (antibiotics, e.g., rifampicin, erythromycin, or clarithromycin), HIV (protease inhibitors, e.g., ritonavir, indinavir, nelfinavir), or fungal infections (e.g., ketoconazole, itraconazole),
• herbal medicines containing St. John's Wort (Hypericum perforatum),
• gold salts, especially when given intravenously (used to treat symptoms of rheumatoid arthritis),
• dantrolene (a muscle relaxant used to treat malignant hyperthermia caused by anesthetics during surgical procedures),
• 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 cause swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing):

• medicines used to dissolve blood clots (tissue plasminogen activators), usually given in hospital,
• medicines used to prevent transplant rejection 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 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").

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.

Do not drink grapefruit juice or eat grapefruits while taking Lisinopril/Amlodipine Alkaloid-INT, as this may increase the levels of the active substance amlodipine in the blood, leading to unpredictable lowering of blood pressure and reduced efficacy 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 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. Breastfeeding is not recommended while taking Lisinopril/Amlodipine Alkaloid-INT. Your doctor will probably recommend a different medicine if you want to breastfeed, 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, lightheadedness, or other symptoms that may affect your ability to drive or use machines safely.

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. 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 little water. Take the tablet at the same time each day.

The score line on the 10mg+5mg tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

The score line on the 20mg+5mg tablet is only to facilitate breaking the tablet to make it easier to swallow 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 are no data on safety and efficacy.

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 the blood. In such cases, your doctor will monitor you more closely.

Impaired kidney function

Regular monitoring of kidney function and potassium and sodium levels in the blood is necessary while taking Lisinopril/Amlodipine Alkaloid-INT. If 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 emergency department of the nearest hospital immediately.

Taking too much Lisinopril/Amlodipine Alkaloid-INT may cause very low blood pressure, which must 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 case of severe drop in blood pressure, shock may occur. The skin may become cold, clammy, and pale, and you may lose 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 you experience characteristic symptoms (such as dizziness and headache), lie down on your back. Further actions will be taken by your doctor.

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 unless your doctor tells you to, even if you feel better. 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, 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 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, itching, blistering, peeling, and swelling of the skin, and 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 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, peripheral edema, muscle cramps, fatigue, weakness, somnolence, visual disturbances, nausea, dyspepsia, changes in bowel habits (diarrhea and constipation), dizziness, abdominal pain, palpitations (rapid or irregular heartbeat), flushing, dyspnea (difficulty breathing).

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)

Rash, itching, hair loss, redness of the skin, skin discoloration, hives, vomiting, muscle or joint pain, back pain, chest pain, mood changes (including anxiety), depression, insomnia, tremor, tinnitus (ringing in the ears), irregular heartbeat (arrhythmia), low blood pressure, cough, taste disturbances, paresthesia (tingling, itching, burning), rhinitis, nocturia (frequent urination at night), urinary disturbances, dryness of the mucous membranes, 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, hepatitis, jaundice (yellowing of the skin and eyes), reduced white blood cell count and platelet count, elevated blood glucose levels, myocardial infarction (heart attack), severe skin reactions (rash, scaling, or peeling skin), severe allergic reactions with fever, redness of the skin, joint pain, and eye disturbances (Stevens-Johnson syndrome), gum hypertrophy or ulceration, pancreatitis, gastritis, increased sensitivity to sunlight, muscle stiffness, peripheral neuropathy (nerve damage: weakness and tingling), vasculitis (inflammation of blood vessels).

Unknown frequency (cannot be estimated from the available data)

Tremor, 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 "emptiness" in the head - especially when standing up quickly, diarrhea, cough, nausea, vomiting, kidney problems.

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

Mood changes, changes in skin color of the face (paleness followed by flushing) and/or coldness or numbness or tingling in the fingers or toes (Raynaud's phenomenon), changes in taste, hallucinations, fatigue, drowsiness or sleep disturbances, vertigo, paresthesia (tingling, itching, burning), palpitations (rapid or irregular heartbeat), myocardial infarction (heart attack), stroke, rhinitis, nausea, abdominal pain or dyspepsia, impotence, fatigue, changes in some laboratory tests (related to kidney and liver function), rash, itching, tachycardia (rapid heartbeat).

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

Angioedema (allergic reaction with sudden swelling of the lips, face, throat, and/or tongue - more frequent in black patients than in 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: reduced hemoglobin and hematocrit values. Elevated 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 (yellowing of the skin and eyes), hepatitis, liver failure, severe skin diseases (symptoms include redness, blistering, and peeling of the skin), sweating.

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

Abnormal blood test results: reduced red blood cell count (anemia), reduced platelet count (thrombocytopenia), reduced white blood cell count (neutropenia, leukopenia, agranulocytosis). These disturbances may cause prolonged bleeding, fatigue, weakness, lymph node disease, autoimmune diseases (a condition where 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 or anaphylactoid reaction).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in the "Contact details for the reporting of side effects" section below. 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 package to protect from light.

No special storage temperature is required.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 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).

• The other ingredients are calcium hydrogen phosphate, mannitol, maize starch, sodium starch glycollate (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 "L A" embossed on the other side.

The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

The tablets are packaged in a blister pack of 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 "L A 2" embossed on the other side.

The tablet can be divided into equal doses.

The tablets are packaged in a blister pack of 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 "L A 1" embossed on the other side.

The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.

The tablets are packaged in a blister pack of 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 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

Tel.: + 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:

Country

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 package leaflet: