Lisinopril Sandoz Farmaceutica 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lisinopril Sandoz Farmacéutica 20 mg tablets EFG

lisinopril

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Lisinopril Sandoz Farmacéutica is used to treat:

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

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

Lisinopril Sandoz Farmacéutica contains a medicine called lisinopril. This belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors). Lisinopril works by dilating your blood vessels. This lowers your blood pressure and makes it easier for the heart to pump blood to all parts of the body.

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

Do not take Lisinopril Sandoz Farmacéutica

• if you are allergic to lisinopril or to any of the other components of this medicine (listed in section 6) or to other ACE inhibitors,

• if during previous use of ACE inhibitors you have experienced swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing, or joint swelling.

• Do not take lisinopril if you have had any of these reactions:

• without a known cause, or

• you have been diagnosed with 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 areas such as the throat) is high,

• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.

• if you are more than 3 months pregnant. (It is also advisable to avoid lisinopril early in pregnancy; see section on pregnancy).

Warnings and precautions

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

• if you have low blood pressure. You may feel dizzy or lightheaded, especially when standing up. This may occur at the beginning of treatment if you are dehydrated due to diuretic therapy, dialysis, a low-salt diet, vomiting, or diarrhea.

• if you have heart problems such as heart failure, narrowing (stenosis) of the aorta (an artery of your heart), narrowing of heart valves (mitral valve), thickening of the heart muscle (hypertrophic cardiomyopathy or HOCM), or if you have a disease affecting the blood vessels in the brain,

• if you have kidney problems, including narrowing (stenosis) of the renal artery,

• if you are undergoing:

• dialysis treatment with high-flux membranes,

• a treatment called “LDL apheresis”, a blood separation procedure to remove cholesterol from your blood using a dextran sulfate machine,

or

• desensitization treatment to reduce the effects of an allergy to bee or wasp stings. In these cases, inform your doctor that you are taking lisinopril. Your doctor may decide to stop your lisinopril treatment 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 disease known as collagen vascular disease,

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

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

• difficulty breathing,

• itching and skin rashes, if you have cough.

Inform your doctor if this worsens,

• if you need surgery (including dental surgery) or anesthesia, remember to tell your doctor or dentist that you are taking lisinopril. This is because your blood pressure may drop (hypotension) if you receive certain local or general anesthetics while taking lisinopril,

• if you are taking other medicines, such 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”, e.g. 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 (e.g. 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 areas 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 infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized infection such as sore throat, mouth sores, or urinary problems, you should consult your doctor immediately.

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

Talk to your doctor if you think you might be (or might become) pregnant. Lisinopril is not recommended in early pregnancy and may cause serious harm to your unborn child after 3 months of pregnancy, as it can lead to serious fetal damage if used during this period (see section “Pregnancy”).

Children and adolescents

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

Other medicines and Lisinopril Sandoz Farmacéutica

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because lisinopril may affect how some medicines work, and some medicines may affect lisinopril. Your doctor may need to adjust your dose and/or take other precautions.

This particularly applies to:

• diuretics used to treat high blood pressure,

• other medicines used to treat high blood pressure,

• if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also 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 high doses of acetylsalicylic acid (if taking more than 3 grams per day), ibuprofen, indomethacin, or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors),

• medicines for mental disorders or depression such as:

• lithium,

• medicines to treat 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 blood potassium levels (e.g. trimethoprim and cotrimoxazole, also known as trimethoprim/sulfamethoxazole, for bacterial infections; cyclosporine, an immunosuppressant used to prevent transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

• medicines often used to prevent rejection of transplanted organs (temsirolimus, sirolimus, everolimus and other medicines belonging to the mTOR inhibitor class). See section “Warnings and precautions”,

• racecadotril used to treat diarrhea. See section “Warnings and precautions”,

• medicines to lower blood sugar, such as insulin or oral antidiabetics (including vildagliptin),

• the dose of antidiabetic medicines may require adjustment. See also section “Warnings and precautions”,

• sacubitril/valsartan (used to treat chronic heart failure). See section “Do not take Lisinopril Sandoz Farmacéutica”,

• medicines to dissolve blood clots (tissue plasminogen activators, usually administered in hospital). See section “Warnings and precautions”.

• central nervous system stimulants such as:

• ephedrine or pseudoephedrine, which may be included in medicines to treat nasal or sinus congestion or in other cold and cough remedies,

• salbutamol, a medicine used to treat asthma,

• medicines to suppress the immune system,

• allopurinol, a medicine used to treat gout,

• procainamide, used to treat irregular heartbeats,

• beta-blockers (such as atenolol and propranolol), used to regulate heart rhythm,

• 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

Inform your doctor if you think you are (or plan to become) pregnant.

Talk to your doctor if you think or know (or suspect) you are pregnant.

Your doctor will usually advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Lisinopril is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Consult your doctor if you are breastfeeding or planning to breastfeed. Lisinopril is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you plan to breastfeed, especially if your baby is newborn or was premature.

Driving and using machines

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

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

Lisinopril Sandoz Farmacéutica contains sodium

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

3. How to take Lisinopril Sandoz Farmacéutica

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Continue taking this medicine for as long as your doctor has instructed you; it is a long-term treatment. It is important that you take the medicine every day.

The tablet may be divided into equal doses.

Taking the first dose

• Take special care when taking the first dose of this medicine or if your dose is increased. It may cause a greater decrease in blood pressure than subsequent doses.
• This effect may make you feel dizzy or lightheaded. If this occurs, 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 medication. Once you have started taking this medicine, your doctor may carry out blood tests. Your doctor will tell you how many tablets you should take each day. If you are unsure, consult your doctor or pharmacist.

• High blood pressure

The usual recommended starting dose is 10 mg once daily.

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

Once blood pressure is under control, the usual long-term dose is 20 mg once daily.

Patients treated with diuretics

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

• Heart failure

The usual recommended starting dose is 2.5 mg once daily.

The usual long-term dose ranges from 5 mg to 35 mg once daily.

• After acute myocardial infarction (heart attack)

The usual recommended starting dose is 5 mg within the first 24 hours after the infarction, followed by another 5 mg one day later.

• Diabetic patients with kidney problems

The recommended dose is 10 mg or 20 mg once daily.

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

• This medicine is not recommended for children under 6 years of age or for children with severe kidney problems.
• Your doctor will determine the correct dose for your child. The dose depends on your child's body weight.
• For children weighing between 20 and 50 kg, the recommended starting dose is 2.5 mg once daily. The dose may be increased up to a maximum of 20 mg once daily.
• For children weighing more than 50 kg, the recommended starting dose is 5 mg once daily. The dose may be increased up to a maximum of 40 mg once daily.

Patients with impaired renal function

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

Patients recently undergoing kidney transplantation

The use of lisinopril tablets is not recommended.

Elderly patients, aged over 65 years

Dose adjustment is not usually necessary. However, if renal dysfunction is present, the dose should be carefully adjusted.

If you take more Lisinopril Sandoz Farmacéutica than you should

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

Take this leaflet or some tablets with you so that it is known what you have taken. The following effects are more likely to occur: dizziness and strong, possibly rapid, heartbeats.

If you forget to take Lisinopril Sandoz Farmacéutica

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

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

If you stop taking Lisinopril Sandoz Farmacéutica

Do not stop treatment before consulting your doctor, even if you feel well. Stopping treatment prematurely may reduce the effectiveness of the therapy.

If you have any further 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 everyone will experience them.

Stop taking lisinopril and contact your doctor immediately if you develop any of the following reactions:

• Severe allergic reactions (rare, may affect up to 1 in 1,000 people). Signs may include sudden onset 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).
• Serious skin disorders including Stevens-Johnson syndrome and pemphigus (symptoms include sudden unexpected skin rash or burning sensation, redness, blisters on lips, eyes or mouth, genitals, skin peeling, fever) and accumulation of mature or abnormal lymphocytes in the dermis (cutaneous pseudolymphoma) (very rare, may affect up to 1 in 10,000 people).
• Suppression of blood cell formation in the bone marrow leading to weakness, bruising, and increased frequency of infections. Other symptoms include sudden sore throat, fever, fatigue, paleness, mouth pain (very rare, may affect up to 1 in 10,000 people).
• Infection with symptoms such as fever and severe deterioration in general physical condition, or fever with signs of localized infection such as sore throat/larynx/mouth, lymph node abnormalities, or urinary problems (very rare, may affect up to 1 in 10,000 people).
• Inflammation of the liver (hepatitis) or liver failure. This may cause loss of appetite, yellowing of the skin and eyes, fever, chills, fatigue, stomach pain, malaise, and darkening of the urine (very rare, may affect up to 1 in 10,000 people).
• Inflammation of the pancreas. This causes moderate to severe stomach pain (very rare, may affect up to 1 in 10,000 people).
• Possible heart attack (chest pressure or pain) or stroke (weakness or paralysis of limbs or face, difficulty speaking) in patients at high risk (with heart disease due to narrowing or blockage of blood vessels supplying the heart muscle or with blood vessel disease affecting the brain), increased heart rate and rapid, irregular heartbeat (palpitations) (uncommon, may affect up to 1 in 100 people).
• Not urinating (low urine output), which may occur along with high temperature (fever), nausea, fatigue, flank pain, swelling in legs, ankles, feet, face and hands, or blood in the urine. These may be 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 unwell, muscle cramps, confusion and seizures which may be due to inappropriate ADH secretion (antidiuretic hormone) (rare, may affect up to 1 in 1,000 people).

Other possible adverse effects

Common: may affect up to 1 in 10 people

• dizziness,
• headache,
• drop in blood pressure, for example when standing up quickly from a sitting or lying position, sometimes accompanied by dizziness,
• persistent dry cough,
• diarrhoea,
• nausea,
• kidney problems (shown in blood tests).

Uncommon: may affect up to 1 in 100 people

• mood changes,
• sensation of dizziness (vertigo),
• altered taste perception (taste disturbances),
• difficulty sleeping,
• seeing, feeling or hearing things that are not real (hallucinations),
• change in color of fingers or toes (pale blue followed by redness) or tingling or prickling sensations in 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 used to monitor proper liver and kidney function,
• too much potassium in the blood, sometimes manifesting as muscle cramps, diarrhoea, nausea, dizziness, headache (hyperkalaemia).

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

• decrease in haemoglobin and red blood cell count (haematocrit),
• mental confusion,
• dry mouth,
• urticaria,
• hair loss,
• psoriasis, 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 level in the blood (symptoms include fatigue, confusion and muscle spasms),
• change in sense of smell.

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

• low blood sugar levels. Signs may include feeling hungry or weak, sweating, and rapid heartbeat,
• inflammation of the sinuses (feeling of pain and fullness behind cheeks and eyes),
• difficulty breathing or wheezing,
• a certain form of lung inflammation. Symptoms include cough, shortness of breath, and high temperature (fever),
• inflammation of the pancreas,
• allergic reaction in the small intestine (intestinal angioedema),
• changes in your lymph nodes,
• autoimmune disease, a condition in which your immune system attacks your own healthy tissues,
• yellowing of the skin and/or whites of the eyes (jaundice),
• excessive sweating (diaphoresis),
• decreased amount of urine or absence of urine.

Frequency not known: frequency cannot be estimated from available data

• Symptoms of depression,
• syncope.

A complex of symptoms has been reported, in which one or more of the following may occur: fever, inflammation of blood vessels (vasculitis) with skin rash, purple-red spots and itching, muscle and joint pain (arthralgia), increased levels of antibodies (ANA), increased erythrocyte sedimentation rate (ESR), increased white blood cell count (eosinophilia and leucocytosis), skin rash, photosensitivity and other skin reactions.

Children

Adverse effects in children are comparable to those observed in adults.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lisinopril Sandoz Farmacéutica

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

Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lisinopril Sandoz Farmacéutica

• The active substance 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 contents of the pack

Lisinopril Sandoz Farmacéutica 20 mg are round, biconvex tablets, scored on one side.

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

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, 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 medicinal product is authorized in the European Economic Area (EEA) Member States and in the United Kingdom (Northern Ireland) under 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 latest revision of the package leaflet: March 2022

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