LISINOPRIL SANDOZ FARMACEUTICA 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Lisinopril Sandoz Pharmaceutical 20 mg Tablets EFG

lisinopril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Lisinopril Sandoz Pharmaceutical and what is it used for
2. What you need to know before you take Lisinopril Sandoz Pharmaceutical
3. How to take Lisinopril Sandoz Pharmaceutical
4. Possible side effects
5. Storage of Lisinopril Sandoz Pharmaceutical
6. Contents of the pack and other information

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

Lisinopril Sandoz Pharmaceutical is used to treat:

• high blood pressure,
• symptomatic heart failure (heart failure),
• patients who are recovering from a heart attack,
• kidney diseasecaused 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 ACE inhibitors (angiotensin-converting enzyme inhibitors). Lisinopril works by widening your blood vessels. This reduces your blood pressure and makes it easier for your heart to pump blood to all parts of your body.

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

Do not take Lisinopril Sandoz Pharmaceutical

• if you are allergicto lisinopril or any of the other ingredients of this medicine (listed in section 6) or to other ACE inhibitors,
• if you have ever had swelling of the face, lips, tongueand/or throatwith difficulty swallowing, breathing or swelling of the joints, when taking an ACE inhibitor,
• Do not take lisinopril if you have had any of these reactions:

• without a known cause or
• it has been confirmed that you have hereditary angioedema or
• another form of fluid accumulation (angioedema),

• 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, 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 problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• if you are pregnantfor more than 3 months. (It is also best to avoid lisinopril at the start of pregnancy, see section pregnancy).

Warnings and precautions

Tell your doctor or pharmacist before you start taking Lisinopril Sandoz Pharmaceutical:

• if you have low blood pressure. You may notice this as dizziness or lightheadedness, especially when standing up. This can happen at the start of treatment if you are dehydrated due to treatment with diuretics, dialysis, low-salt diet, vomiting or diarrhea.
• if you have heart problemssuch as heart failure, a narrowing (stenosis) of the aorta (an artery of your heart) 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 affects the blood vessels of the brain,
• if you have kidney problems, including narrowing (stenosis) of the renal artery
• if you are under

• dialysis treatmentwith high-flux membranes,
• a treatment called “LDL apheresis”, a blood separation treatment to remove cholesterol from your blood with a machine with dextran sulfate

or

• desensitization treatmentto reduce the effects of an allergy to bee or wasp stings.In these cases, tell your doctor that you are taking lisinopril. Your doctor may decide to stop your treatment with lisinopril to prevent a possible allergic reaction,

• if you have liver problems.

If you develop jaundice while taking lisinopril, stop taking it and consult your doctor,

• if you have a blood vessel diseaseknown as collagen vascular disease,

• if you are of black or Afro-Caribbean originas lisinopril may be less effective. You also have a higher risk of suffering a severe allergic reaction (angioedema):

• sudden accumulation of fluid in the skin and mucous membranes such as the throat or tongue,
• breathing difficulties,

• itching and skin rashes, if you have a cough.

Tell your doctor if this gets worse,

• if you need surgery(including dental surgery) or anesthesia, remind your doctor or dentist that you are taking lisinopril. This is because it can lower your blood pressure (hypotension) if you receive certain local or general anesthetics while taking lisinopril,
• if you are taking 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 “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 at regular intervals.

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

• 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:

• racecadotril, 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),
• vildagliptin, a medicine used to treat diabetes,
• medicines to dissolve blood clots (tissue plasminogen activators), usually administered in hospitals,

• if you experience an infectionwith 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, you should consult your doctor immediately.

If you are not sure if any of the above conditions apply to you, consult your doctor.

Consult your doctor if you think you may be (or are planning to become) pregnant. Lisinopril is not recommended at the start of pregnancy and may cause serious harm to your baby if used after 3 months of pregnancy (see section “Pregnancy”).

Children and adolescents

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

Other medicines and Lisinopril Sandoz Pharmaceutical

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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 change your dose and/or take other precautions.

This applies particularly to:

• diureticsused to treat high blood pressure,
• other medicinesused to treat high blood pressure,
• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Lisinopril Sandoz Pharmaceutical” and “Warnings and precautions”),
• medicines that reduce inflammation and treat pain or arthritis such as doses of acetylsalicylic acid(if you are taking more than 3 grams per day), ibuprofen, indomethacinor selective cyclooxygenase-2 (COX-2) inhibitors,
• medicines for mental disorders or depression such as:

• lithium,
• medicines for treating psychosis,
• tricyclic antidepressants, such as amitriptyline,

• potassium supplements(including salt substitutes), potassium-sparing diuretics (such as spironolactone, triamterene, or amiloride) and other medicines that may increase the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections; cyclosporins, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).
• medicines commonly used to prevent organ transplant rejection(temsirolimus, sirolimus, everolimus, and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”,
• racecadotrilused to treat diarrhea. See section “Warnings and precautions”,
• medicines to lower blood sugar, such as insulin or those taken orally (including vildagliptin),
• the dose of antidiabetic medicines may need to be adjusted. See also section “Warnings and precautions”,
• sacubitril/valsartan(used to treat long-term heart failure). See section “Do not take Lisinopril Sandoz Pharmaceutical”,
• 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:
• ephedrineor pseudoephedrine, which may be included as medicines to treat nasal or sinus congestion or in other remedies for colds and coughs
• salbutamol, a medicine to treat asthma,
• medicines to suppress the immune system,
• allopurinol, a medicine to treat gout,
• procainamide, used to treat irregular heartbeat,
• beta-blocker medicines(such as atenolol and propranolol), used to regulate heartbeat,
• nitrate-type medicines, used for heart problems (such as angina pectoris),
• gold injections (sodium aurothiomalate), a medicine for rheumatoid arthritis.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

You should tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking lisinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of lisinopril. Lisinopril is not recommended in early pregnancy, and must not be taken when 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 breastfeed. The use of lisinopril is not recommended in breastfeeding mothers, and your doctor may 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 tools or machines.

Wait until you know how your medicine affects you before trying these activities.

Lisinopril Sandoz Pharmaceutical contains sodium

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

3. How to take Lisinopril Sandoz Pharmaceutical

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist again.

Lisinopril should be taken once a day, preferably every morning. Take the tablets whole with a glass of water. Try to take the tablets at the same time each day. It does not matter if you take this medicine before or after food.

Keep taking this medicine for as long as your doctor tells you. It is a long-term treatment. It is important that you take the medicine every day.

The tablet can be divided into equal doses.

First dose

• Be especially careful when you take the first dose of this medicine or if your dose is increased. It can cause a greater decrease in blood pressure than with later doses.
• This effect can make you feel dizzy or lightheaded. 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 whether you are taking any other medicines. Once you have started taking this medicine, your doctor may perform blood tests. Your doctor will tell you how many tablets to take each day. If you are not sure, consult your doctor or pharmacist.

• High blood pressure

The usual recommended initial 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 is under control, the long-term dose is 20 mg once a day.

Patient treated with diuretics

If possible, diuretics should be discontinued 2 to 3 days before starting treatment with lisinopril. Patients with high blood pressure who cannot discontinue diuretic treatment should start treatment with lisinopril at a dose of 5 mg once a day.

• Heart failure

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

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

• After a heart attack

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

• Diabetic patients with kidney problems

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

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

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

Patient with impaired renal function

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

Patient with recent kidney transplant

The use of lisinopril tablets is not recommended.

Older people (over 65 years of age)

No dose adjustment is necessary. In case of renal dysfunction, the dose should be carefully adjusted.

If you take more Lisinopril Sandoz Pharmaceutical than you should

If you have taken more Lisinopril Sandoz Pharmaceutical than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount used.

Bring 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 can be rapid.

If you forget to take Lisinopril Sandoz Pharmaceutical

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

Do not take a double dose to make up for missed doses.

If you stop taking Lisinopril Sandoz Pharmaceutical

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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking lisinopril and go immediately to the doctorif you develop any of the following reactions:

• 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, tongue, and/or throat,
  • difficulty breathing and swallowing, dizziness,
  • sudden swelling of the hands, feet, and ankles,
  • severe skin itching (with hives).
• Severe skin disorders, including Stevens-Johnson syndrome and pemphigus (symptoms include sudden unexpected rash or skin burning, redness, blisters on the lips, eyes, or mouth, genitals, peeling, fever) and aggregation of mature or abnormal lymphocytes in the dermis (cutaneous pseudolymphoma) (very rare, may affect up to 1 in 10,000 people).
• Inhibition of blood cell production in the bone marrow, which causes weakness, bruising, and more frequent infections. Other symptoms include sudden sore throat, fever, fatigue, paleness, mouth pain (very rare, may affect up to 1 in 10,000 people).
• An infection with symptoms such as fever and severe deterioration of general physical condition, or fever with symptoms of local infection such as sore throat/larynx/mouth, lymph node abnormalities, or urinary problems (very rare, may affect up to 1 in 10,000 people).
• Liver inflammation (hepatitis) or liver failure. This can cause loss of appetite, yellowing of the skin and eyes, fever, shivering, fatigue, stomach pain, discomfort, and darkening of the urine (very rare, may affect up to 1 in 10,000 people).
• Pancreas inflammation. This causes moderate to severe stomach pain (very rare, may affect up to 1 in 10,000 people).
• Possible heart attack (pressure or pain in the chest) or stroke (weakness or paralysis of the limbs or face, difficulty speaking) in patients with high risk (with heart disease caused by narrowing or blockage of the blood vessels that supply the heart muscle or with disease of the blood vessels that supply the brain), increased heart rate, and rapid and irregular heartbeat (palpitations) (uncommon, may affect up to 1 in 100 people).
• Not urinating (low urine production) that can occur along with elevated temperature (fever), nausea, fatigue, pain in the sides, swelling in the legs, ankles, feet, face, and hands, or blood in the urine. These are due to a serious kidney problem (sudden kidney failure) (rare, may affect up to 1 in 1,000 people),
• concentrated urine (dark-colored), feeling or being sick, having muscle cramps, confusion, and convulsions that may be due to inadequate secretion of ADH (antidiuretic hormone) (rare, may affect up to 1 in 1,000 people).

Other Possible Adverse Effects

Frequent:may affect up to 1 in 10 people

• dizziness,
• headache,
• decrease in blood pressure as a result of, for example, getting up quickly from a sitting or lying position, sometimes accompanied by dizziness,
• dry cough that does not disappear,
• diarrhea,
• discomfort (vomiting),
• kidney problems (shown in blood tests).

Uncommon:may affect up to 1 in 100 people

• mood changes,
• feeling dizzy (vertigo),
• 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 (pale blue followed by redness) or tingling or numbness in your fingers or toes,
• runny nose,
• feeling sick (nausea),
• abdominal pain,
• indigestion,
• skin rash and/or itching,
• inability to maintain an erection (impotence),
• fatigue,
• general weakness,
• changes in blood tests to determine the proper 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),
• mental confusion,
• dry mouth,
• hives,
• hair loss,
• psoriasis, a skin disorder,
• kidney failure leading to excess urea in the blood,
• increase in one or both breasts in men,
• increase in bilirubin, a substance produced in the liver,
• low sodium level 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 level. The signs can include feeling hungry or weak, sweating, and rapid heartbeat,
• inflammation of the nasal sinuses (feeling of pain and fullness behind the cheeks and eyes),
• difficulty breathing or wheezing,
• a certain form of lung inflammation. The symptoms include cough, feeling short of breath, and high temperature (fever),
• pancreas inflammation,
• allergic reaction in the small intestine (intestinal angioedema),
• change in your lymph nodes,
• autoimmune disease, a condition when your immune system attacks your own healthy tissues,
• yellowing of the skin and/or the whites of the eyes (jaundice),
• excessive sweating (diaphoresis),
• decrease in the amount of urine or lack of urine.

Frequency Not Known:the frequency cannot be estimated from the available data

• symptoms of depression,
• fainting.

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

Children

The adverse effects in children are comparable to those observed in adults.

Reporting of Adverse Effects

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

5. Storage of Lisinopril Sandoz Pharmaceutical

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

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

This medicine does not require special storage conditions.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril Sandoz Pharmaceutical

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

Appearance of the Product and Package Contents

Lisinopril Sandoz Pharmaceutical 20 mg are round, biconvex, and scored on one side.

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

PVC/Aluminum blisters inserted in cardboard boxes containing: 10, 14, 28, 30, 50, 56, 98, 100, and 100x1 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

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 - Tabletten

Belgium: Lisinopril Sandoz 20 mg - tabletten

Ireland: Lispril 20 mg Tablets

Italy: LISINOPRIL SANDOZ

Netherlands: LISINOPRIL SANDOZ 20 MG, TABLETTEN

United Kingdom (Northern Ireland): Lisinopril 20 mg Tablets

Date of the Last Revision of this Prospectus:March 2022

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