Lisinopril Teva-Ratiopharm 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lisinopril Teva-ratiopharm 20 mg tablets EFG

Lisinopril dihydrate

Package leaflet

1. What Lisinopril Teva-ratiopharm is and what it is used for
2. What you need to know before taking Lisinopril Teva-ratiopharm
3. How to take Lisinopril Teva-ratiopharm
4. Possible side effects
5. How to store Lisinopril Teva-ratiopharm
6. Contents of the pack and other 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 lower your blood pressure and makes it easier for your heart to pump blood throughout 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 is unable to pump blood properly to the rest of the body
• you have had a heart attack (myocardial infarction), which may have resulted 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 components 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, 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

Consult your doctor or pharmacist before starting to take 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 or aortic valve), or of the aorta.

• if you have low blood pressure. You may notice this 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 supplying 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 undergoing surgery and will receive general or local anaesthesia; inform your doctor, dentist, or hospital staff.

• if you are undergoing 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 under no circumstances be used after the third month of pregnancy, as it may cause severe harm to your baby when used from that point 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 develop 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 be a sign of 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 failure. There is limited safety and efficacy data in children under 6 years 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 you have used some time ago. Some medicines may interact with other medicines.

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 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 to prevent clots).
• Oral antidiabetic medicines (tablets to lower blood glucose) or insulin (medicine for treating diabetes).
• Sympathomimetic medicines (stimulate the central nervous system), such as ephedrine, pseudoephedrine, and salbutamol, which may also be found in some decongestants, cold remedies, and asthma medicines.
• Immunosuppressants (medicines that suppress the body’s immune response), allopurinol (for treatment of gout), or procainamide (to treat abnormal heartbeats).
• Gold.

The following medicines may increase the risk of angioedema (signs 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 salt substitutes containing potassium while taking Lisinopril Teva-ratiopharm. This may raise your blood potassium level too much.

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. 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 when used from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Use of Lisinopril Teva-ratiopharm is not recommended during breastfeeding. Your doctor will choose an alternative treatment for you 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 when 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; 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 directed 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 half a tablet of Lisinopril Teva-ratiopharm 20 mg (10 mg of lisinopril) once daily. The usual long-term dose is 1 tablet of Lisinopril Teva-ratiopharm 20 mg (20 mg of lisinopril) once daily.

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

The recommended initial dose is 2.5 mg of lisinopril once daily in patients weighing 20 to 50 kg, and 5 mg of lisinopril once daily in patients weighing over 50 kg. For these doses, there are formulations with a more suitable active ingredient content. Your doctor may individually adjust the dose 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 you a lower initial dose or recommend a longer dosing interval for children with reduced kidney function.

Symptomatic heart failure

The normally recommended initial dose is 2.5 mg taken once daily. The usual long-term dose is 5 to 35 mg taken once daily. For these doses, formulations with a more suitable active ingredient content are available.

After acute myocardial infarction

The normally recommended initial dose is 5 mg on the first and second day, followed by half a tablet of Lisinopril Teva-ratiopharm 20 mg (10 mg of lisinopril) once daily. For initial dosing, formulations with a more suitable active ingredient content are available.

Complications related to diabetes

The usual dose is half a tablet or 1 tablet of Lisinopril Teva-ratiopharm 20 mg (10 mg or 20 mg of lisinopril) once daily.

Patients with impaired renal function

Your doctor may prescribe you 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 20 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.

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

If you think 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 20 mg than you should

If you take more Lisinopril Teva-ratiopharm 20 mg than you should, contact your doctor, pharmacist, or nearest hospital immediately. An overdose may cause very low blood pressure, which may result in 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: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Lisinopril Teva-ratiopharm 20 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 missed dose.

If you stop taking Lisinopril Teva-ratiopharm 20 mg

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

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, skin 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 accompanied by signs 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 signs 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

Patients with ischemic heart disease or 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.

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 such adverse 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 pack and container 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 wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Lisinopril Teva-ratiopharm 20 mg

• The active substance is lisinopril dihydrate.

Each tablet contains 20 mg of lisinopril dihydrate as the active substance.

• The other components are: manitol, dibasic calcium phosphate dihydrate, pregelatinized starch (from maize), sodium croscarmellose, magnesium stearate, red iron oxide (E-172), black iron oxide (E-172) and yellow iron oxide (E-172).

Appearance of the product and contents of the container

Pink, round, biconvex tablets, uncoated and without printed marks, with a score line for splitting.

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

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

Only certain pack sizes may be commercially available.

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 the most recent review of this leaflet: June 2019

Other sources of information

Detailed and up-to-date information on this medicinal product 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 on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63962/P_63962.html

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