Package Leaflet: Information for the User

Lisinopril Teva-ratiopharm 5 mg Tablets EFG

Lisinopril dihydrate

Contents of the pack and additional information

Lisinopril belongs to a group of medications known asACE inhibitors(angiotensin-converting enzyme inhibitors). Lisinopril acts by dilating your blood vessels, which helps tolower your blood pressureand facilitates 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 diarrhea. 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 desensitization 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 diarrhea;
  • 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 beginning of pregnancy, and in any case should not be administered after the third month of pregnancy, as it may cause serious damage 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, fainting and nausea.
• 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 check-ups. Do not miss these appointments even if you feel well. Your doctor will determine the frequency of medical check-ups.

Children and adolescents

Do not administer lisinopril 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 have to take any other medicine. This includes remedies based on plants, 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)oraliskiren(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; andheparina, a medicine used to dilute 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 asefedrina,pseudoefedrinaandsalbutamol, 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) orprocainamida(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 the section “Warnings and precautions”.
• Vildagliptina, a medicine used to treat diabetes (see section “Warnings and precautions”).
• Racecadotrilo,used to treat diarrhea (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 beginning of pregnancy, and in any case should not be administered after the third month of pregnancy, as it may cause serious damage 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 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 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 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.

Therecommended doseis:

Hypertension

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

For children (from6 to16 years) with high blood pressure

The initial recommended dose is half a tablet of Lisinopril Teva-ratiopharm 5 mg (2.5 mg lisinopril) once a day in patients with a weight of20 to50 kgand 1 tablet of Lisinopril Teva-ratiopharm (5 mg of lisinopril) once a day in patients with a weight over50 kg. Your doctor may adjust the individual dose up to a maximum of 20 mg daily 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 half a tablet of Lisinopril Teva-ratiopharm 5 mg (2.5mg of lisinopril) once a day. The normal long-term dose is of1 to7 tablets of Lisinopril Teva-ratiopharm 5 mg (of5 to35 mg of lisinopril) once a day.

After acute myocardial infarction

The initial normal recommended 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 (10mg of lisinopril) once a day.

Complications related to diabetes

The normal dose is of2 to4 tablets of Lisinopril Teva-ratiopharm 5 mg (10mg or 20mg of lisinopril) once a day.

Patients with renal function 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 5 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 agreater decrease in blood pressurethan what will be presented 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-ratiopharm5 mgthan you should

If you take more Lisinopril Teva-ratiopharm5 mgthan you should, consult yourdoctor,pharmacist orhospitalimmediately. An overdose may 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 immediatelyor call the Toxicological 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 compensate for the missed dose.

If you interrupt treatment with Lisinopril Teva-ratiopharm 5 mg

Do not stop taking your tablets unless your doctor tells you to.

If you have any other doubts 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 see 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 infection with symptoms such as fever and severe deterioration of your general state, or fever with local infection symptoms such as throat, pharynx, or 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 state, or fever with local infection symptoms such as throat, pharynx, or mouth irritation, or urinary disorders, you should see 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

The safety 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 effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for 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 conditions for conservation.

Medicinesmust notbe thrown into thedrains or trash.Dispose of the packaging and medicines that you no longer need at the SIGRE collection point at the pharmacy. Please ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Lisinopril Teva-ratiopharm 5 mg Composition

• Theactive ingredient is lisinopril dihydrate.

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

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

Product appearance and packaging contents

White, round, biconvex tablets without coatings or printing marks and with a splitting groove.

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

They are available in PVC-Aluminum blisters in packaging 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 some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid (Spain)

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse, 3

89143 Blaubeuren (Germany)

Last review date of this leaflet:June 2019

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