LISINOPRIL TEVA-RATIOPHARM 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lisinopril Teva-ratiopharm 5 mg Tablets EFG

Lisinopril Dihydrate

Contents of the Package Leaflet

1. What is Lisinopril Teva-ratiopharm and what is it used for
2. Before taking Lisinopril Teva-ratiopharm
3. How to take Lisinopril Teva-ratiopharm
4. Possible side effects
5. Storage of Lisinopril Teva-ratiopharm

Contents of the pack and other information

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

Lisinopril belongs to a group of medicines called ACE inhibitors(angiotensin-converting enzyme inhibitors). Lisinopril works by widening your blood vessels, which helps to lower your blood pressureand 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 pressureis too high(hypertension)
• you have a heart condition known as symptomatic heart failure, in which your heart does not pump blood to the rest of your body as it should.
• you have had a heart attack(myocardial infarction) that may lead to weakening of your heart.
• you have kidney problemsrelated to your diabetes and hypertension.

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

Do not take Lisinopril Teva-ratiopharm

• if you are allergic to lisinopril or 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 your 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 family predisposition) or if you have had angioedema in any other circumstance or for any other reason,
• if you are pregnantfor more than three months (it is also better to avoid Lisinopril Teva-ratiopharm during the first months of pregnancy - see section pregnancy).
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains 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 under the skin in an area such as the throat) is increased.

If you are not sure if 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, low-salt diet, or as a result of severe and prolonged vomiting or diarrhea. You are more likely to suffer a sudden drop in blood pressure (hypotension) when you start taking the tablets, and you may feel weak or dizzy.
• if you have been told that you have an increased thickness of the heart muscle or a narrowing of the heart valves (mitral or aortic valve), or in the aorta.
• if you have low blood pressure. You may notice it as a feeling of dizziness or lightheadedness, especially when standing up.
• if you are taking potassium supplements or salt substitutes that contain 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" - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
  • aliskiren

Your doctor may check 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 of the kidney.
• if you are on dialysis.
• if you have liver problems.
• if you have diabetes.
• if you suffer from any vascular disease of the collagen, e.g., scleroderma, SLE (lupus).
• if you are going to undergo surgery and will be given general or local anesthesia; inform your doctor, dentist, or hospital staff.
• if you are going to undergo a blood separation treatment (apheresis) or a desensitization treatment to reduce the effect of an allergy (e.g., bee or wasp sting); your doctor may 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 side effect “angioedema” (a severe 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 diarrhea;
  • medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus);
  • vildagliptin, a medicine used to treat diabetes.
• Tell your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Lisinopril Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril Teva-ratiopharm. It is not recommended to take Lisinopril Teva-ratiopharm at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see section pregnancy).

If you develop a dry cough that persists for a long time after starting treatment with Lisinopril ratiopharm, consult your doctor.

While taking Lisinopril Teva-ratiopharm,

If you develop any of the following symptoms, you must 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, feeling dizzy, weak, faint, and nauseous.
• Sudden swelling of lips, face, neck, and possibly hands and feet, difficulty swallowing, urticaria, and difficulty breathing or wheezing or hoarseness. This condition is called angioedema. It can occur at any time during treatment. ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
• High fever, sore throat, or ulcers in the mouth (these may be symptoms of an infection caused by a low white blood cell count).
• Yellowing of the skin and the whites of the eyes (jaundice), which may be a sign of liver disease.

At the start of treatment and/or during the dose adjustment period, it is necessary to increase the frequency of medical visits. You should not miss these visits, even if you feel well. Your doctor will determine the frequency of medical check-ups.

Children and adolescents

Do not givelisinopril to children under 6 yearsor to children with severe kidney problems. There is limited information on safety and efficacy in children under 6 years with high blood pressure, but there is no experience in other indications.

Other medicines and Lisinopril Teva-ratiopharm

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. These include herbal remedies, health food shop products, or supplements that you have bought yourself. This also applies to medicines that you have used for some time. Some medicines may interact with others.

Tell 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 the information under the headings “Do not take Lisinopril ratiopharm” and “Warnings and precautions”).
• Betablockers, such as atenolol and propranolol.
• Nitroglycerinand other nitrates (for ischemic heart disease, angina pectoris).
• Acetylsalicylic acid(high doses of aspirin, more than 3 grams per day) and other non-steroidal anti-inflammatory medicines(NSAIDs) such as indomethacin(a medicine used to treat arthritis or muscle pain).
• Lithium(for manic-depressive disorder).
• Antipsychotic or tricyclic antidepressant medicines(medicines for mental disorders) or barbiturates.
• Potassium supplements(including salt substitutes), potassium-sparing diuretics, and other medicines that may increase the amount of potassium in the blood (e.g., trimethoprim and cotrimoxazolefor bacterial infections; cyclosporin, an immunosuppressive medicine 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 sugar) or insulin(a medicine for treating diabetes).
• Sympathomimetic medicines(stimulating the central nervous system), such as ephedrine, pseudoephedrine, and salbutamol, which may also be found in some decongestant, anti-cold, and asthma medicines.
• Immunosuppressants(medicines that suppress the body's immune response), allopurinol(for treating gout), or procainamide(for treating abnormal heart rhythms).
• Gold.

The following medicines may increase the risk of angioedema (the 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) that are usually given in the hospital.
• Medicinesthat are more often used to prevent organ transplant rejection(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 diarrhea (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 that contain potassium while taking Lisinopril Teva-ratiopharm. It can increase the level of potassium in your blood too much.

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

Alcohol can enhance the effect of Lisinopril Teva-ratiopharm.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Lisinopril Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril Teva-ratiopharm. It is not recommended to take Lisinopril Teva-ratiopharm at the start of pregnancy, and in no case should it be administered after the third month of pregnancy, as it may cause serious harm to your baby when administered from that time on (see section pregnancy).

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to use Lisinopril Teva-ratiopharm during breastfeeding. Your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Some people may feel dizzy or tired when taking this medicine. If this happens, do not drive or use any tools or machines.

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

Lisinopril Teva-ratiopharm contains sodium

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

3. How to take Lisinopril Teva-ratiopharm

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

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

The recommended doseis:

Arterial hypertension

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

For children (from6 to16 years) with high blood pressure

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

Your doctor may prescribe a lower initial dose or recommend an increase in the dosage interval for children with decreased renal function.

Symptomatic heart failure

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

After acute myocardial infarction

The 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 a day.

Diabetes-related complications

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

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 the time indicated by your doctor, as it is a long-term treatment. It is important that you continue taking Lisinopril ratiopharm every day.

The tablet can be divided into equal doses.

Remember, the first doseof Lisinopril Teva-ratiopharm may cause a greater decrease in blood pressurethan what will occur when continuing treatment. You may notice this as dizzinessor vertigoand lying down will help. If this happensto you, please consult your doctoras 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-ratiopharm5 mgthan you should

If you take more Lisinopril Teva-ratiopharm 5 mg than you should, consult your doctor, pharmacist, or the nearest hospitalimmediately. An overdose can cause very low blood pressure, which can produce dizziness or vertigo. Other symptoms may include difficulty breathing, rapid or slow pulse, palpitations, anxiety, or cough.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lisinopril Teva-ratiopharm5 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 treatment with Lisinopril Teva-ratiopharm 5 mg

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people experience them.

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

?? Severe allergic reactions (rare, may affect up to 1 in 1,000 people). The signs may include the sudden appearance of:

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

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

An infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as throat/pharynx/mouth irritation 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 of your general condition, or fever with symptoms of local infection such as throat/pharynx/mouth irritation or urinary disorders, you should consult 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 side effects

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.

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

Additional side effects in children and adolescents

The safety data obtained in clinical studies suggest that lisinopril is generally well-tolerated in pediatric patients with hypertension, and that the safety profile in children aged 6-16 years is comparable to that observed in adults.

Reporting of side effects:

If you experience any of the side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use, Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Lisinopril Teva-ratiopharm

Keep out of sight and reach of children.

Do not use this medication after the expiration datethat appears on the blister pack and carton after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should notbe thrown away through drains or in the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lisinopril Teva-ratiopharm 5 mg

• The active ingredient is lisinopril dihydrate.

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

• The other ingredients are: mannitol (E421), basic calcium phosphate dihydrate, cornstarch, pregelatinized, sodium croscarmellose, and magnesium stearate.

Appearance of the product and package contents

White, round, biconvex tablets without coatings or engravings and with a score line to break them.

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

They are available in PVC-Aluminum blisters in packs of 1, 14, 20, 28, 30, 30x1, 50, 56, 60, 98, 100, 100x1, 400 (10x40), and 500 tablets, and in bottles of 100 and 250 tablets.

Not all 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 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

Date of the last revision of this leaflet:June 2019

Other sources of information

Detailed and updated information on this medication 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 updated information about this medication by scanning the QR code included in the packaging with your mobile phone (smartphone). 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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