Package Leaflet: Information for the User

Lisinopril Teva-ratiopharm 20 mg Tablets EFG

Lisinopril dihydrate

1. What is Lisinopril Teva-ratiopharm 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. Storage of Lisinopril Teva-ratiopharm

6. Contents of the pack and additional information

Lisinopril belongs to a group of medications known as angiotensin-converting enzyme (ACE) inhibitors. Lisinopril acts by dilating your blood vessels, which helps to lower your blood pressure and facilitate your heart pumping blood to all parts of your body. Your doctor has prescribed Lisinopril Teva-ratiopharm for one of the following reasons:

• yourblood pressureis toohigh(hypertension)
• you have a heart condition known assymptomatic heart failure, in which your heart does not pump blood to the rest of your body as it should.
• you have experienced aheart attack(myocardial infarction) that may lead to aweakening of your heart.

- you havekidney problemsrelated to your diabetes and hypertension.

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 that caused swelling of 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 (you may have a family predisposition) or if you have had angioedema in any other circumstances or for any other reason,
• if you arepregnantover three months (it is better 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 that contains aliskiren.
• if you have taken or are currently taking sacubitrilo/valsartán, 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 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 diuretics, dialysis, low-salt diet or as a result of prolonged and severe vomiting or diarrhoea. It is more likely that you will experience 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 increase in the 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 vertigo, 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” - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
• aliskiren

Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (for example, 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 in the kidney.
• if you are undergoing dialysis.
• if you have liver problems.
• if you have diabetes.
• if you have a disease of the blood vessels of the collagen, e.g. scleroderma, LES (lupus).
• if you are about to undergo surgery and will be given general or local anaesthesia; inform your doctor, dentist or hospital staff.
• if you are about to undergo a blood separation treatment (apheresis) or a desensitisation treatment to reduce the effect of an allergy (e.g. bee sting or wasp sting); your doctor may suspend 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. It is also more likely that you will develop the adverse 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:

• racecadotrilo, a medicine used to treat diarrhoea;
• medicines used to prevent the rejection of transplanted organs and for cancer (for example, temsirolimus, sirolimus, everolimus);
• vildagliptina, a medicine used to treat diabetes.

• Inform your doctor if you are pregnant (or if you suspect that you may be). Lisinopril Teva-ratiopharm should not be used at the start of pregnancy, and in any case should not be administered if you are pregnant over three months, as it may cause serious harm to your baby when administered from that time onwards (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, feeling dizzy, weak, faint and nauseous.
• Sudden swelling of lips, face, neck and possibly also hands and feet, difficulty swallowing, urticaria and 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 than in patients who are not black.
• High fever, sore throat or ulcers in the mouth (these may be symptoms of an infection caused by a reduction in the number of white blood cells).
• Yellowing of the skin and the white 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. Do not miss these visits even if you feel well. Your doctor will determine the frequency of medical check-ups.

Children and adolescents

Do notadministerlisinopril tochildren under 6 yearsor to children withsevere kidney failure.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

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. These include herbal remedies, health food products or supplements that you have bought yourself. This also applies to medicines that 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).
• Anti-hypertensives(other medicines for treating high blood pressure).
• An angiotensin II receptor antagonist (ARA) or aliskiren(see also the information under the headings “Do not take Lisinopril ratiopharm” and “Warnings and precautions”).
• Beta-blockers, such as atenolol and propranolol.
• Nitroglycerinand other nitrates (for angina pectoris, heart failure).
• Acid acetylsalicylic(high doses of aspirin, more than3 gramsper day) and othernon-steroidal anti-inflammatory drugs (NSAIDs) such asindometacina(medicine used for the treatment of arthritis or muscle pain).
• Lithium(for manic-depressive disorder).
• Antipsychotics or tricyclic antidepressants(medicines for mental disorders) orbarbiturates.
• Potassium supplements(including salt substitutes), diureticspotassium-sparing diureticsand other medicines that may increase the amount of potassium in the blood (for example,trimetoprim and cotrimoxazolfor bacterial infections;ciclosporina, an immunosuppressant used to prevent the rejection of transplanted organs; andheparin, a medicine used to thin the blood to prevent blood clots).
• Oral antidiabetic medicines(tablets to reduce blood sugar) orinsulin(medicine for the treatment of diabetes).
• Sympathomimetics(stimulate the central nervous system), such asephedrine, pseudoephedrineandsalbutamol, which may also be found in some decongestants, antihistamines and asthma medicines.
• Immunosuppressants(medicines that suppress the immune response of the body),alopurinol(for the treatment of gout) orprocainamide(for abnormal heartbeats).
• Gold.

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

• Medicines to dissolve blood clots(tissue plasminogen activator) that are normally administered in hospital.
• Medicinesthat are more often usedto prevent the rejection of transplanted organs(sirolimus, everolimus, temsirolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
• Vildagliptina, a medicine used to treat diabetes (see section “Warnings and precautions”).
• Racecadotrilo,used to treat diarrhoea (see section “Warnings and precautions”).
• Sacubitrilo/valsartán,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. This may increase the level of potassium in your blood too much.

Do not take excessive amounts of salt (sodium chloride), as salt may raise your 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, or if you suspect that you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually recommend that you stop taking Lisinopril Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Lisinopril Teva-ratiopharm. Lisinopril Teva-ratiopharm should not be used at the start of pregnancy, and in any case should not be administered if you are pregnant over three months, as it may cause serious harm to your baby when administered from that time onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. Lisinopril Teva-ratiopharm should not be used during breastfeeding. Your doctor will choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and operating 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 attempting to do 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”.

Follow exactly the administration instructions of this medication as indicated 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 to 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.

Therecommended doseis:

Hypertension

The initial recommended dose is half a tablet of Lisinopril Teva-ratiopharm 20 mg (10mg of lisinopril) once a day. The normal long-term dose is 1 tablet of Lisinopril Teva-ratiopharm 20 mg (20mg of lisinopril) once a day.

For children (6 to16 years) with high blood pressure

The initial recommended dose is 2.5 mg of Lisinopril once a day in patients with a weight of20 to50 kgand 5 mg of Lisinopril once a day in patients with a weight over50 kg. For these doses, there is a formulation with a more suitable active ingredient content. Your doctor may adjust the individual dose up to a maximum of 20 mg per day in patients with a weight of20 to50 kgand 40 mg per day in patients with a weight over50 kg.

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

Symptomatic heart failure

The initial normal recommended dose is 2.5 mg taken once a day. The normal long-term dose is5 to35 mg taken once a day. For these doses, there are formulations with a more suitable active ingredient content.

After acute myocardial infarction

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

Complications related to diabetes

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

Patients with renal impairment

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 if you takeLisinopril Teva-ratiopharm 20 mgbefore or after meals.

Continue taking Lisinopril ratiopharm for the time your doctor tells you, as it is a long-term treatment. It is important that you continue to take Lisinopril ratiopharm every day.

The tablet can be divided into equal doses.

Remember,the first doseof Lisinopril Teva-ratiopharmmay cause a greater decrease in blood pressure than what will occur when continuing treatment. You may notice this asdizzinessorvertigoand lying down will help. If this happens to you, please consult yourdoctoras soon as possible.

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

If you take more Lisinopril Teva-ratiopharm20 mgthan you should

If you take more Lisinopril Teva-ratiopharm20 mgthan you should, consult yourdoctor,pharmacist or the nearesthospitalimmediately. An overdose can cause very low blood pressure, which can cause dizziness or vertigo. It may also include symptoms such as 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lisinopril Teva-ratiopharm20 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 nottake a double doseto compensate for the missed dose.

If you interrupt treatment with 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will 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 may make it difficult to swallow.

-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).

A severe infection with symptoms such as fever and a significant deterioration in your general condition, or a fever with local infection symptoms such as throat, pharynx, or mouth irritation, or urinary tract 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 a significant deterioration in your general condition, or a fever with local infection symptoms such as throat, pharynx, or mouth irritation, or urinary tract disorders, you should consult your doctor immediately. A blood test will be performed to check for possible white blood cell reduction (agranulocytosis). It is essential to inform your doctor about your medication.

Other possible side effects

Patients with ischemic heart disease or aortic stenosis, renal artery stenosis, or heart valve stenosis, or patients with hypertrophic cardiomyopathy may experiencea significant decrease in blood pressure.

A complex of symptoms that 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 (arthritis), positive test for antinuclear antibodies (ANA), elevated erythrocyte sedimentation rate (ESR), eosinophilia, and leucocytosis, rash, sensitivity to light (photosensitivity), or other dermatological manifestations.

Additional side effects in children and adolescents

Security data obtained 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 side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medicinesshould notbe disposed of throughdrains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Lisinopril Teva-ratiopharm 20 mg Composition

• Theactive ingredient is lisinopril dihydrate.

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

• The other components are: mannitol, calcium phosphate dihydrate, pregelatinized cornstarch, 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 content of the container

Pink, round, biconvex tablets, without coatings or printing marks, and with a notch for breaking them.

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

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

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

Last review date of this leaflet:June 2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/