Lisinopril Teva-Ratiopharm 5 mg tablets EFG: detailed information

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lisinopril Teva-ratiopharm 5 mg tablets EFG

Lisinopril dihydrate

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet

What Lisinopril Teva-ratiopharm is and what it is used for
Before taking Lisinopril Teva-ratiopharm
How to take Lisinopril Teva-ratiopharm
Possible side effects
How to store Lisinopril Teva-ratiopharm

Pack contents and additional information

1. What Lisinopril Teva-ratiopharm is and what it is used for

Lisinopril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). Lisinopril works by dilating your blood vessels, which helps to lower your blood pressure and makes it easier for your heart to pump blood to all parts of your body. Your doctor has prescribed Lisinopril Teva-ratiopharm for one of the following reasons:

your blood pressure is too high (hypertension)
you have a heart condition known as symptomatic heart failure, in which the heart does not pump blood to the rest of the body as it should.
you have had a heart attack (myocardial infarction), which may result in weakening of your heart.
you have kidney problems related to your diabetes and hypertension.

2. What you need to know before taking Lisinopril Teva-ratiopharm

Do not take Lisinopril Teva-ratiopharm

if you are allergic to lisinopril, or to any of the other ingredients of this medicine (listed in section 6), or to other ACE inhibitors.
if you have ever had an allergic reaction to any other ACE inhibitor medicine that caused swelling of the hands, feet or ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema),
if any member of your family has had angioedema (there may be a familial predisposition), or if you have ever had angioedema under any other circumstances or due to any other cause,
if you are more than three months pregnant (it is also best to avoid Lisinopril Teva-ratiopharm during the first months of pregnancy – see pregnancy section).
if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin in areas such as the throat) is increased.

If you are unsure whether you should start taking Lisinopril Teva-ratiopharm, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Lisinopril Teva-ratiopharm.

if you are dehydrated due to treatment with diuretics, dialysis, a low-salt diet, or as a result of severe and prolonged vomiting or diarrhoea. You are more likely to experience a sudden drop in blood pressure (hypotension) when starting the tablets, and may feel weak or dizzy.
if you have been diagnosed with thickening of the heart muscle or narrowing of the heart valves (mitral valve or aortic valve), or narrowing of the aorta.
if you have low blood pressure. This may present as dizziness or lightheadedness, especially when standing up.
if you are taking potassium supplements or salt substitutes containing potassium,
if you are taking any of the following medicines used to treat high blood pressure (hypertension):
- an angiotensin II receptor antagonist (ARA) (also known as “sartans” – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
- aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Lisinopril Teva-ratiopharm”

if you have any kidney disease or narrowing of the blood vessels to the kidneys.
if you are undergoing dialysis.
if you have liver problems.
if you have diabetes.
if you suffer from a collagen vascular disease, e.g. scleroderma, SLE (lupus).
if you are scheduled for surgery and will receive general or local anaesthesia; inform your doctor, dentist, or hospital staff.
if you are scheduled for blood separation treatment (apheresis) or desensitisation treatment to reduce the effect of an allergy (e.g. bee or wasp sting); your doctor may temporarily stop your treatment with Lisinopril Teva-ratiopharm to prevent a possible allergic reaction.
if you are of Black race, as Lisinopril ratiopharm may be less effective. You are also more likely to develop the adverse effect “angioedema” (a serious allergic reaction).
if you are taking lithium, used in the treatment of mania or depression.
if you are taking any of the following medicines, the risk of angioedema may increase:
- racecadotril, a medicine used to treat diarrhoea;
- medicines used to prevent rejection of organ transplants and for cancer (e.g. temsirolimus, sirolimus, everolimus);
- vildagliptin, a medicine used to treat diabetes.
Inform your doctor if you are pregnant (or suspect you may be pregnant). Use of Lisinopril Teva-ratiopharm is not recommended during early pregnancy, and must not be used after the third month of pregnancy, as it may cause severe harm to your baby when used from that stage onward (see pregnancy section).

If you develop a persistent dry cough after starting treatment with Lisinopril ratiopharm, consult your doctor.

While taking Lisinopril Teva-ratiopharm,

If you experience any of the following symptoms, inform your doctor immediately:

If you feel dizzy after the first dose. Some people react to the first dose or when the dose is increased, experiencing dizziness, weakness, fainting, and nausea.
Sudden swelling of lips, face, neck, and possibly also hands and feet, difficulty swallowing, hives, difficulty breathing or wheezing, or hoarseness. This condition is called angioedema. This can occur at any time during treatment. ACE inhibitors cause a higher rate of angioedema in Black patients compared to non-Black patients.
High fever, sore throat, or mouth ulcers (these may be symptoms of an infection caused by a reduction in white blood cells).
Yellowing of the skin and whites of the eyes (jaundice), which may indicate liver disease.

At the beginning of treatment and/or during the dose adjustment period, medical visits should be more frequent. Do not miss these appointments even if you feel well. Your doctor will determine how often check-ups are needed.

Children and adolescents

Do not administer lisinopril to children under 6 years of age or to children with severe renal impairment. There is limited safety and efficacy information in children under 6 years of age with high blood pressure, and no experience in other indications.

Other medicines and Lisinopril Teva-ratiopharm

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. This includes herbal remedies, health store products, or supplements you have purchased yourself. This also applies to medicines used some time ago. Some medicines may interact with others.

Inform your doctor if you are taking any of the following medicines:

Diuretics (including potassium-sparing diuretics).
Antihypertensives (other medicines for treating hypertension).
An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Lisinopril ratiopharm” and “Warnings and precautions”).
Beta-blockers, such as atenolol and propranolol.
Nitroglycerin and other nitrates (for ischemic heart disease, angina pectoris).
Acetylsalicylic acid (high-dose aspirin, more than 3 grams per day) and other non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin (used to treat arthritis or muscle pain).
Lithium (for manic-depressive disorder).
Antipsychotics or tricyclic antidepressants (medicines for mental disorders) or barbiturates.
Potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).
Oral antidiabetic medicines (tablets to lower blood glucose) or insulin (medicines for the treatment of diabetes).
Sympathomimetic medicines (stimulating the central nervous system), such as ephedrine, pseudoephedrine, and salbutamol, which may also be found in some decongestants, cold remedies, and asthma medicines.
Immunosuppressants, allopurinol (for gout treatment), or procainamide (to treat abnormal heartbeats).
Gold.

The following medicines may increase the risk of angioedema (symptoms of angioedema include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing):

Medicines to dissolve blood clots (tissue plasminogen activator), usually administered in hospital.
Medicines more commonly used to prevent rejection of organ transplants (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
Vildagliptin, a medicine used to treat diabetes (see section “Warnings and precautions”).
Racecadotril, used to treat diarrhoea (see section “Warnings and precautions”).
Sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure (see section “Do not take Lisinopril ratiopharm”).

Taking Lisinopril Teva-ratiopharm with food, drinks and alcohol

Do not take potassium supplements or potassium-containing salt substitutes while taking Lisinopril Teva-ratiopharm. This may excessively increase blood potassium levels.

Do not consume excessive amounts of salt (sodium chloride), as salt may raise blood pressure and reduce the effectiveness of Lisinopril Teva-ratiopharm.

Alcohol may enhance the effect of Lisinopril Teva-ratiopharm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you may be). Your doctor will usually advise you to stop taking Lisinopril Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Lisinopril Teva-ratiopharm is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Use of Lisinopril Teva-ratiopharm during breastfeeding is not recommended. Your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some people may feel dizzy or tired while taking this medicine. If this occurs, do not drive or operate any tools or machinery.

You should wait to see how the medicine affects you before attempting these activities.

Lisinopril Teva-ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Lisinopril Teva-ratiopharm

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

How much to take

Your doctor will tell you how many tablets you should take each day. The dose is individual, and it is important that you take it exactly as prescribed by your doctor. Your initial dose and long-term dose will depend on your medical condition and whether you are taking other medicines. Consult your doctor or pharmacist if you are unsure.

The recommended dose is:

High blood pressure

The recommended initial dose is 2 tablets of Lisinopril Teva-ratiopharm 5 mg (10 mg of lisinopril) once daily. The usual long-term dose is 4 tablets of Lisinopril Teva-ratiopharm 5 mg (20 mg of lisinopril) once daily.

For children (6 to 16 years) with high blood pressure

The recommended initial dose is half a tablet of Lisinopril Teva-ratiopharm 5 mg (2.5 mg lisinopril) once daily in patients weighing 20 to 50 kg, and 1 tablet of Lisinopril Teva-ratiopharm 5 mg (5 mg lisinopril) once daily in patients weighing over 50 kg. Your doctor may adjust the dose individually up to a maximum of 20 mg daily in patients weighing 20 to 50 kg and 40 mg daily in patients weighing over 50 kg.

Your doctor may prescribe a lower initial dose or recommend a longer dosing interval for children with reduced kidney function.

Symptomatic heart failure

The usual recommended initial dose is half a tablet of Lisinopril Teva-ratiopharm 5 mg (2.5 mg of lisinopril) once daily. The usual long-term dose is 1 to 7 tablets of Lisinopril Teva-ratiopharm 5 mg (5 to 35 mg of lisinopril) once daily.

After acute myocardial infarction

The usual recommended initial dose is 1 tablet of Lisinopril Teva-ratiopharm 5 mg (5 mg of lisinopril) on the first and second day, followed by 2 tablets of Lisinopril Teva-ratiopharm 5 mg (10 mg of lisinopril) once daily.

Complications related to diabetes

The usual dose is 2 to 4 tablets of Lisinopril Teva-ratiopharm 5 mg (10 mg or 20 mg of lisinopril) once daily.

Patients with impaired renal function

Your doctor may prescribe a lower dose.

How to take Lisinopril Teva-ratiopharm

Swallow the tablet with a glass of water. Try to take your tablets at the same time every day. It does not matter whether you take Lisinopril Teva-ratiopharm 5 mg before or after meals.

Continue taking Lisinopril ratiopharm for as long as your doctor has instructed you, as it is a long-term treatment. It is important that you continue taking Lisinopril ratiopharm every day.

The tablet may be divided into equal doses.

Please remember that the first dose of Lisinopril Teva-ratiopharm may cause a greater drop in blood pressure than occurs during continued treatment. You may experience this as dizziness or vertigo, and lying down may help. If this happens to you, please consult your doctor as soon as possible.

If you think that the effect of lisinopril is too strong or too weak, consult your doctor or pharmacist as soon as possible.

If you take more Lisinopril Teva-ratiopharm 5 mg than you should

If you take more Lisinopril Teva-ratiopharm 5 mg than you should, contact your doctor, pharmacist, or nearest hospital immediately. An overdose may cause very low blood pressure, which can lead to dizziness or vertigo. Other symptoms may include difficulty breathing, fast or slow pulse, palpitations, anxiety, or cough.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Lisinopril Teva-ratiopharm 5 mg

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for the forgotten one.

If you stop taking Lisinopril Teva-ratiopharm 5 mg

Do not stop taking your tablets even if you feel well, unless your doctor tells you to do so.

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

4. Possible adverse effects

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

If you experience any of the following reactions, stop taking Lisinopril ratiopharm and contact your doctor immediately.

?? Severe allergic reactions (rare, may affect up to 1 in 1,000 people). Signs may include sudden onset of:

Swelling of the face, lips, tongue, or throat. This may make swallowing difficult.
Severe or sudden swelling of the hands, feet, or ankles.
Difficulty breathing.
Severe skin itching (with hives).

?? Serious skin disorders, such as sudden and unexpected rash, redness, or skin peeling (very rare, may affect up to 1 in 10,000 people).

An infection with symptoms such as fever and severe deterioration in your general condition, or fever with symptoms of localized infection such as sore throat/pharynx/mouth or urinary disorders (very rare, may affect up to 1 in 10,000 people).

Lisinopril ratiopharm may cause a reduction in the number of white blood cells and may decrease your resistance to infection. If you experience an infection with symptoms such as fever and severe deterioration in your general condition, or fever with symptoms of localized infection such as sore throat/pharynx/mouth or urinary disorders, you must contact your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about your medication.

Other possible adverse effects

Common

(may affect up to 1 in 10 people)

Headache

Dizziness or vertigo, especially when standing up quickly

Diarrhea

Dry and persistent cough

Vomiting

Reduced kidney function

Uncommon

(may affect up to 1 in 100 people)

Mood changes

Visual and/or auditory hallucinations

Myocardial infarction or stroke

Palpitations

Changes in skin color (pale or blue followed by redness) and/or numbness or tingling in fingers or toes (Raynaud's syndrome)

Dizziness

Changes in taste

Drowsiness or difficulty sleeping, sleep disorders

Heart attack or stroke, possibly secondary to very low blood pressure in high-risk patients

Awareness of heartbeat

Fast heartbeats

Runny nose (rhinorrhea)

Nausea

Stomach pain or indigestion

Skin rash

Itching

Impotence

Tiredness or weakness (lack of strength)

Physical weakness (loss of strength)

Increased blood urea, serum creatinine, or liver enzymes

High potassium levels (hyperkalemia)

Patients with ischemic heart disease or with narrowing of the aorta (aortic stenosis), renal artery (renal artery stenosis), or heart valves (mitral valve stenosis), or patients with thickening of the heart muscle (hypertrophic cardiomyopathy) may experience a significant decrease in blood pressure.

Rare

(may affect up to 1 in 1,000 people)

Decrease in the substance of red blood cells that carries oxygen throughout the body (hemoglobin) and in the number of red blood cells in the blood (hematocrit)

Inappropriate secretion of antidiuretic hormone (SIADH)

Confusion

Change in the perception of smell

Dry mouth

Angioedema: an allergic reaction with sudden swelling of the hands, feet, or ankles, face, lips, tongue, and/or throat, causing difficulty in swallowing and breathing

Loss of hair

Psoriasis

Uremia (accumulation in the bloodstream of waste products normally excreted in urine)

(may affect up to 1 in 10,000 people)

Acute kidney failure

Development of breasts in men

Increased bilirubin in blood (a yellow-orange pigment in bile)

Low levels of sodium (hyponatremia)

Very rare

(may affect up to 1 in 10,000 people)

Suppression of bone marrow, red blood cell deficiency, low platelet count (thrombocytopenia), decreased white blood cell count (neutropenia, leucopenia, agranulocytosis), which increases the likelihood of infection, lymph node disorder, autoimmune disease, in which the body attacks itself.

Decreased blood glucose

Sinusitis

Wheezing

Lung inflammation

Allergic reaction in the small intestine (intestinal angioedema)

Yellowing of the skin and/or eyes (jaundice)

Inflammation of the liver or pancreas

Serious skin disorders (symptoms such as redness, blistering and peeling), transient inflammation of skin lymph nodes

Sweating

Reduced urine output (oliguria) or inability to urinate (anuria)

Not known

(cannot be estimated from the available data)

Severe allergic (anaphylactic) reactions

Depressive symptoms

Fainting

A syndrome complex has been reported, which may include one or more of the following symptoms: fever, pain and inflammation of blood vessels (vasculitis), muscle pain, inflammation of one or more joints (arthralgia/arthritis), positive antinuclear antibody test (ANA), elevated erythrocyte sedimentation rate (ESR), eosinophilia and leukocytosis, rash, light sensitivity (photosensitivity), or other dermatological manifestations.

Additional adverse effects in children and adolescents

Safety data from clinical studies suggest that lisinopril is generally well tolerated in pediatric hypertensive patients, and that the safety profile in children aged 6–16 years is comparable to that observed in adults.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lisinopril Teva-ratiopharm

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via sewers or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Lisinopril Teva-ratiopharm 5 mg

The active substance is lisinopril dihydrate.

Each tablet contains 5 mg of lisinopril dihydrate as the active substance.

The other components are: mannitol (E421), dibasic calcium phosphate dihydrate, starch (corn), pregelatinized, sodium croscarmellose and magnesium stearate.

Appearance of the product and pack contents

White, round, biconvex tablets without coating or printed marks, with a score line for splitting.

Lisinopril Teva-ratiopharm tablets are available in 2 strengths: 5 mg and 20 mg.

Available in PVC-aluminum blisters in pack sizes of 1, 14, 20, 28, 30, 30x1, 50, 56, 60, 98, 100, 100x1, 400 (10x40), 500 tablets, and in bottles of 100 and 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

Date of most recent review of this package leaflet: June 2019

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63961/P_63961.html

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