Prospecto: information for the patient

Lisinopril Sandoz Pharmaceutical 20 mg tablets EFG

lisinopril

Read this prospect carefully before starting to take this medicine because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people 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 not listed in this prospect. See section 4.

1.What is Lisinopril Sandoz Pharmaceutical and what is it used for

2.What you need to know before starting to take Lisinopril Sandoz Pharmaceutical

3.How to take Lisinopril Sandoz Pharmaceutical

4.Possible adverse effects

5.Storage of Lisinopril Sandoz Pharmaceutical

6.Contents of the package and additional information

LisinoprilSandoz Pharmaceuticalis used for the treatment of:

• high blood pressure,
• symptomatic heart failure (heart failure),
• patients recovering from a heart attack,
• kidney diseases
caused by diabetes and high blood pressure.

Lisinopril is recommended in children (over 6 years of age) only for the treatment of high blood pressure (hypertension).

Lisinopril Sandoz Pharmaceutical contains a medicine called lisinopril. This belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Lisinopril acts by dilating your blood vessels. This reduces your blood pressure and facilitates the heart to pump blood to all parts of the body.

Do not take Lisinopril Sandoz Farmacéutica

• if you areallergicto lisinopril or to any of the other ingredients of this medicine (listed in section 6) or to other ACE inhibitors,
• if you have experiencedswelling of the face, lips, tongueand/orthroatwith difficulty swallowing, breathing or in the joints during previous use of ACE inhibitors.
• Do not take lisinopril if you have any of these reactions:

• without a known cause or
• if you have confirmed hereditary angioedema or
• another form of fluid accumulation (angioedema),

• If you have taken or are currently taking sacubitril/valsartán, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high,
• if you have diabetes or kidney failure and are being treated with a medicine to lower blood pressure that contains aliskirén.
• if you arepregnantfor more than 3 months. (It is also best to avoid lisinopril at the beginning of pregnancy, see section pregnancy).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril Sandoz Farmacéutica:

• if you havelow blood pressure. You may notice it by feeling dizzy or lightheaded, especially when standing up. This can occur at the beginning of treatment if you havedehydrationdue to diuretic treatment, dialysis, low-salt diet, vomiting or diarrhea.
• if you haveheart problemssuch as heart failure, a narrowing (stenosis) of the aorta (a heart artery) or a narrowing of the heart valves (mitral valve), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy or HOCM) or if you have a disease that involves the blood vessels of the brain,
• if you havekidney problems, including narrowing (stenosis) of the renal artery
• if you are under,

• treatment with dialysiswith high-flow membranes,
• a treatment called “apheresis LDL”, a blood separation treatment to remove cholesterol from your blood with a machine using dextran sulfate

or

• treatment with desensitizationto reduce the effects of an allergy to abee or wasp sting. In these cases, inform your doctor that you are taking lisinopril. Your doctor may decide to interrupt your treatment with lisinopril to prevent a possible allergic reaction,

• if you haveliver problems.

If you develop jaundice during the use of lisinopril, stop taking it and consult your doctor,

• if you have ablood vessel diseaseknown as vascular collagen disease,

• if you are ablack person or of Afro-Caribbean originas lisinopril may be less effective. Also, you have a higher risk of experiencing a severe allergic reaction (angioedema):

• rapid accumulation of fluid under the skin and mucous membranes such as the throat or tongue,
• difficulty breathing,

• pruritus and skin rashes, if you havecough.

Inform your doctor if it worsens,

• if you needsurgery(including dental surgery)or anesthesia, remember to inform your doctor or dentist that you are taking lisinopril. This is because it may lower your blood pressure (hypotension) if you receive certain local or general anesthetics while taking lisinopril,
• if you aretaking other medicinessuch as potassium supplements, lithium (for mental disorders) or medicines for diabetes,
• 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 “sartanes”, for example valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes,
• aliskirén.

Your doctor may monitor your renal function, blood pressure, and blood electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Lisinopril Sandoz Farmacéutica”,

• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in an area such as the throat) may increase:

• racecadotrilo, a medicine used to treat diarrhea,
• medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus and other medicines belonging to the class called mTOR inhibitors),
• vildagliptina, a medicine used to treat diabetes,
• medicines to dissolve blood clots (tissue plasminogen activators), usually administered in hospitals,

• if you experience aninfectionwith symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat, mouth or urinary problems, consult your doctor immediately.

If you are unsure whether any of the above conditions apply to you, consult your doctor.

Consult your doctor if you think you could be (or could stay) pregnant. Lisinopril is not recommended at the beginning of pregnancy and may cause serious harm to your baby after 3 months of pregnancy, as this may cause serious damage to your baby if used in this period (see section “Pregnancy”).

Children and adolescents

Lisinopril has been studied in children. For more information, consult your doctor. This medicine is not recommended for children under 6 years of age or for children with severe kidney problems.

Other medicines and Lisinopril Sandoz Farmacéutica

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. This is because lisinopril may affect the way some medicines work and some medicines may have an effect on lisinopril. Your doctor may need to adjust your dose and/or take other precautions.

This applies particularly to :

• diureticsused to treat high blood pressure,
• othermedicinesused totreat high blood pressure,
• if you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Lisinopril Sandoz Farmacéutica” and “Warnings and precautions”),
• medicines that reduce inflammation and treat pain or arthritis such as doses ofaspirin(if you are taking more than3 gramsper day),ibuprofen,indomethacin or selective COX-2 inhibitors(COX-2 inhibitors),
• medicines for mental disorders or depression such as :

• lithium,
• medicines to treat psychosis,
• tricyclic antidepressants, such as amitriptilina,

• potassium supplements(including salt substitutes), diuretics that save potassium (such as spironolactone, triamterene or amiloride) and other medicines that may increase the amount of potassium in the blood (e.g. trimetoprim and cotrimoxazol, also known as trimetoprim/sulfametoxazol, for bacterial infections; ciclosporinas, an immunosuppressive medicine used to prevent rejection in organ transplants; and heparin, a medicine used to thin the blood to prevent clots).
• medicines that are often used toprevent rejection in organ transplants(temsirolimus, sirolimus, everolimus and other medicines belonging to the class called mTOR inhibitors). See section “Warnings and precautions”,
• racecadotriloused to treat diarrhea. See section “Warnings and precautions”,
• medicines to lower blood sugar, such as insulin or those taken orally (including vildagliptina),
• the dose of antidiabetic medicines may require an adjustment of the dose. See also section “Warnings and precautions”,
• sacubitril/valsartán(used to treat heart failure). See section “Do not take Lisinopril Sandoz Farmacéutica”,
• medicines to dissolve blood clots(tissue plasminogen activators, usually administered in hospitals). See section warnings and precautions.
• medicines that stimulate the central nervous system such as :
• ephedrineorpseudoephedrine, which may be included in medicines to treat nasal congestion or sinusitis or in other cold and cough remedies
• salbutamol, a medicine to treat asthma,
• medicinestosuppresstheimmunesystem,
• alopurinol,a medicine to treat gout,
• procainamide, used to treat cardiac arrhythmias,
• beta-blockers(such as atenolol and propranolol),used to regulate heart rhythm,
• nitrate medicines, used for heart problems (such as angina pectoris),
• gold injections (sodium aurothiomalate),a medicine against rheumatoid arthritis.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medicine.

Pregnancy

You must inform your doctor if you think you are (or plan to be) pregnant.

Consult your doctor if you think you could be (or could stay) pregnant.

Normally, your doctor will advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant and will recommend taking another medicine instead of lisinopril. Lisinopril is not recommended at the beginning of pregnancy, and it should not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Consult your doctor if you are breastfeeding or plan to start breastfeeding. Lisinopril is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you want to start breastfeeding, initially if your baby is newborn or premature.

Driving and operating machines

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

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

Lisinopril Sandoz Farmacéutica contains sodium

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

Follow the exact administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Lisinopril should be taken once a daypreferably in the morning. Take the whole tablets with a glass of water. Try to take the tablets at the same time every day. It does not matter if you take this medication before or after meals.

Continue taking this medication for the time your doctor tells you, it is a long-term treatment. It is essential to take the medication every day.

The tablet can be divided into equal doses.

First dose

• Be extra careful when taking the first dose of this medication or if your doctor increases the dose. It may cause a greater decrease in blood pressure than the subsequent doses.
• This effect may make you feel dizzy or with vertigo. If this happens, lying down may help. If you are concerned, consult your doctor as soon as possible.

Adults

Your dose depends on your condition and if you are taking any other medication. Once you have started taking this medication, your doctor may perform blood tests. Your doctor will tell you how many tablets you should take each day. If you are unsure, consult your doctor or pharmacist.

• Hypertension

The usual initial recommended dose is 10 mg once a day.

For severe cases, your doctor may decide that you start between 2.5 mg and 5 mg once a day.

Once blood pressure control is achieved, the long-term dose is 20 mg once a day.

Patients treated with diuretics

If possible, diuretics should be discontinued from2 to3 days before starting treatment with lisinopril. Patients with high blood pressure who cannot discontinue diuretic treatment should start lisinopril treatment with 5 mg once a day.

• Heart failure

The usual initial recommended dose is 2.5 mg once a day.

The usual long-term dose is 5 mg to 35 mg once a day.

• After an acute myocardial infarction

The usual initial recommended dose is 5 mg within the first 24 hours after the infarction and 5 mg the next day.

• Diabetic patients with renal problems

The recommended dose is 10 mg or 20 mg once a day.

Use in children and adolescents (6 to 16 years old) with high blood pressure

• This medication is not recommended for children under 6 years of age or children with severe renal problems,
• your doctor will recommend the correct dose for your child. The dose depends on your child's body weight,
• for children weighing between 20 and 50 kg, the initial recommended dose is 2.5 mg once a day. The dose can be increased up to a maximum of 20 mg once a day,
• for children weighing more than 50 kg, the initial recommended dose is 5 mg once a day. The dose can be increased up to a maximum of 40 mg once a day.

Patients with renal function impairment

If you have renal function impairment, your doctor will prescribe the lowest possible dose and monitor your renal function.

Patients recently transplanted with a kidney

The use of lisinopril tablets is not recommended.

Older adults, over 65 years old

No dose adjustment is necessary. However, if you have renal dysfunction, the dose should be adjusted carefully.

If you take more Lisinopril Sandoz Farmacéutica than you should

If you have taken more LisinoprilSandoz Farmacéuticathan you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Carry this leaflet or some tablets with you so they know what you have taken. The following effects are more likely to occur: dizziness and strong heartbeats that may be rapid.

If you forget to take Lisinopril Sandoz Farmacéutica

Take the next dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lisinopril Sandoz Farmacéutica

Do not stop treatment before consulting your doctor, even if you feel well. This will reduce the effect of the treatment.

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

Like all medicines, this medicinecan cause side effects, although not everyone will experience them.

Stop taking lisinopril and seek immediate medical attentionif you develop any of the following reactions:

Other possible side effects

Frequent:may affect up to 1 in 10 people

• Dizziness,
• Headache,
• Low blood pressure due to, for example, standing up quickly from a seated or lying position, sometimes accompanied by dizziness,
• Dry cough that does not go away,
• Diarrhea,
• Uncomfortable feeling (vomiting),
• Renal problems (shown in blood tests).

Rare:may affect up to 1 in 100 people

• Mood changes,
• Sensation of dizziness,
• Changes in the taste of things (taste disorders),
• Difficulty sleeping,
• Seeing, feeling, or hearing things that are not real (hallucinations),
• Change in the color of your fingers or toes (blue pale followed by redness) or tingling or pins and needles in your fingers or toes,
• Runny nose,
• Feeling sick (nausea),
• Abdominal pain,
• Indigestion,
• Rash and/or itching,
• Inability to maintain an erection (impotence),
• Fatigue,
• General weakness,
• Changes in blood tests to determine the correct functioning of your liver and kidneys,
• Too much potassium in the blood, sometimes manifesting as muscle cramps, diarrhea, nausea, dizziness, headache (hyperkalemia).

Rare:may affect up to 1 in 1,000 people

• Decrease in hemoglobin and red blood cell count (hematocrit),
• Confusion,
• Dry mouth,
• Hives,
• Hair loss,
• Poriasis, a skin disorder,
• Kidney failure leading to excess urea in the blood,
• Enlargement of one or both breasts in men,
• Increased bilirubin, a substance produced in the liver,
• Low sodium levels in the blood (symptoms are fatigue, confusion, and muscle spasms),
• Change in the smell of things.

Very rare:may affect up to 1 in 10,000 people

• Low blood sugar. The signs may include feeling hungry or weak, sweating, and rapid heartbeat,
• Inflammation of the nasal sinuses (sensation of pain and fullness behind the cheeks and eyes),
• Difficulty breathing or wheezing,
• Certain form of lung inflammation. Symptoms include cough, feeling of lack of air, and high temperature (fever),
• Pancreatitis,
• Allergic reaction in the small intestine (intestinal angioedema),
• Change in lymph nodes,
• Autoimmune disease, a condition when your immune system attacks your healthy tissues,
• Yellowing of the skin and/or white of the eyes (jaundice),
• Excessive sweating (diaphoresis),
• Decreased urine output or inability to urinate.

Unknown frequency:frequency cannot be estimated from available data

• Depression symptoms,
• Syncope.

A complex of symptoms, where one or more of the following symptoms may occur: fever, inflammation of blood vessels (vasculitis) with skin rash, purple-red spots, and itching, muscle and joint pain (arthralgia), increased number of antibodies (ANA), increased sedimentation of red blood cells (ESR), increased number of white blood cells (eosinophilia and leukocytosis), skin rash, light sensitivity, and other skin reactions.

Children

The side effects in children are comparable to those 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 possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Lisinopril Sandoz Pharmaceutical Composition

• The active ingredient is lisinopril. Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate).
• The other components are dihydrate calcium hydrogen phosphate, mannitol (E421), cornstarch, croscarmellose sodium, magnesium stearate, red iron oxide (E172).

Appearance of the product and packaging contents

Lisinopril Sandoz Pharmaceutical 20 mg are round, biconvex, and scored on one of their faces.

The tablets are a uniform red color, speckled, with a smooth surface and packaged in blisters.

Blister packs made of polyvinyl chloride/aluminum inserted into cardboard boxes containing: 10, 14, 28, 30, 50, 56, 98, 100, and 100x1 tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Sandoz Pharmaceutical, S.A.

Corporate Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticalsd.d.

Verovškova, 57

SLO-1526Ljubljana

Slovenia

or

Rowa Pharmaceuticals Ltd

Newton Bantry

Co. Cork

Ireland

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Austria:Lisinopril “1A Pharma” 20 mg – Tablets

Bélgica:Lisinopril Sandoz 20 mg – tablets

Irlanda:Lispril 20 mg Tablets

Italia:LISINOPRIL SANDOZ

Paises Bajos:LISINOPRIL SANDOZ 20 MG, TABLETTEN

Reino Unido (Irlanda del Norte):Lisinopril 20 mg Tablets

Last review date of thisleaflet:March 2022

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