Lisinopril Stada 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lisinopril STADA 5 mg tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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.

Leaflet contents

1. What Lisinopril STADA is and what it is used for

2. What you need to know before taking Lisinopril STADA

3. How to take Lisinopril STADA

4. Possible adverse effects

5. How to store Lisinopril STADA

6. Contents of the pack and other information

1. What Lisinopril Stada is and what it is used for

Lisinopril Stada belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors).

Lisinopril Stada is indicated for:

• Treatment of hypertension (high blood pressure).
• Treatment of symptomatic heart failure.
• Short-term treatment of acute myocardial infarction.
• Treatment of renal complications of type II diabetes in hypertensive patients.

2. What you need to know before taking Lisinopril Stada

Do not take Lisinopril Stada:

• If you are allergic to lisinopril, to other medicines in the same group (ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously received a medicine from the same class as lisinopril (ACE inhibitors) and experienced an allergic reaction causing swelling of the hands, feet or ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing, or if you or a family member have had a similar reaction (angioedema).
• If you are pregnant. (See section "Pregnancy and breastfeeding")
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• 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.

Warnings and precautions

Talk to your doctor or pharmacist before starting Lisinopril Stada.

• If you have narrowing of the aorta (aortic stenosis), narrowing of the renal arteries (renal artery stenosis), narrowing of heart valves (mitral valve stenosis), or thickening of the heart muscle (hypertrophic cardiomyopathy).

• If you have acute myocardial infarction.

• If you have impaired kidney function or if you are on dialysis.

• If you have liver failure.

• If you have a blood vessel disorder (collagen vascular disease) and/or are being treated with allopurinol (for gout), procainamide (for heart rhythm disorders), or immunosuppressants (medicines that suppress the body's immune response).

• If you have diabetes.

• If you are on a salt-free diet, take potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium, or if you have recently had excessive vomiting or diarrhea.

• If you have a cough.

• If you are scheduled to undergo a treatment called low-density lipoprotein (LDL) apheresis, or desensitization treatment to reduce the effect of an allergy to bee or wasp stings.

• If you have low blood pressure (you may experience fainting or dizziness, especially with initial doses and when standing up. In such cases, lying down may help).

• 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
  • If you are taking any of the following medicines, your risk of developing 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 in the mTOR inhibitor class
  • Vildagliptin, a medicine used to treat diabetes

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 Stada”.

In all these cases, inform your doctor, as you may need a dose adjustment or discontinuation of Lisinopril Stada.

Stop taking Lisinopril Stada and seek immediate medical help if you experience difficulty breathing or swallowing, with or without swelling of the face, lips, tongue and/or throat.

Inform your doctor if you are to be admitted to hospital for surgery. Tell your doctor or dentist that you are taking Lisinopril Stada before you are given a local or general anesthetic.

Children

The use of Lisinopril Stada is not recommended in children, as information on safety and efficacy in this age group is limited.

Other medicines and Lisinopril Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Please note that these instructions may also apply to medicines that have been used previously or may be used in the future.

Certain medicines may interact with Lisinopril Stada; in such cases, your doctor may need to adjust your dose and/or take other precautions.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Diuretics (medicines used to increase urine output).
• Medicines for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and high doses of aspirin (more than 3 grams per day) used to treat arthritis or muscle pain.
• Antihypertensives (medicines that lower 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 Stada” and “Warnings and precautions”).
• Sympathomimetic medicines (stimulate the central nervous system).
• Medicines for the treatment of diabetes, such as insulin or oral antidiabetics.
• Thrombolytic medicines (prevent blood clot formation).

This is especially important if you are also taking:

• Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitor class medicines). See section “Warnings and precautions”.
• Potassium supplements (including salt substitutes), diuretics (water tablets, especially potassium-sparing ones), and other medicines that may increase blood potassium levels (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Lisinopril Stada is contraindicated during pregnancy and should not be used if you are breastfeeding.

Angiotensin-converting enzyme (ACE) inhibitors (the group to which lisinopril belongs) can cause fetal harm and death when administered during the second and third trimesters of pregnancy. If pregnancy is detected, this medicine should be discontinued as soon as possible.

Driving and use of machines

It is unlikely that Lisinopril Stada tablets will affect your ability to drive or operate machinery; however, if you experience symptoms such as dizziness or fatigue, avoid tasks requiring special attention until you know how you tolerate the medicine.

3. How to take Lisinopril Stada

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

Remember to take your medicine.

Your doctor will tell you how many tablets to take each day and how long your treatment with Lisinopril Stada will last. Do not stop treatment prematurely.

Adults

• High blood pressure

The usual recommended starting dose is 10 mg once daily. The usual long-term dose is 20 mg once daily.

• Symptomatic heart failure

The usual recommended starting dose is 2.5 mg once daily.

The usual long-term dose is 5 mg up to a maximum of 35 mg once daily.

• Acute myocardial infarction

The usual recommended starting dose is 5 mg on the first and second day after the infarction, followed by 10 mg once daily.

• Diabetic renal complications

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

Renal impairment

Your doctor will adjust your dose.

Method of administration:

• Swallow the tablet with water.

• Try to take your tablets at the same time each day. It does not matter whether you take Lisinopril Stada before or after meals.

• Do not stop taking your tablets if you feel well, unless your doctor tells you otherwise.

• Remember, the first dose of Lisinopril Stada may cause a greater drop in blood pressure than subsequent doses. This effect may manifest as dizziness, in which case lying down may help.

If you think that the effect of Lisinopril Stada is too strong or too weak, consult your doctor or pharmacist.

If you take more Lisinopril Stada than you should

If you take more Lisinopril Stada than you should, contact your doctor or pharmacist immediately. The most common symptoms in case of overdose are: hypotension, shock, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Lisinopril Stada

Do not take a double dose to make up for missed doses. Wait until the next scheduled dose.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

The following adverse effects have been reported according to the following frequency categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known frequency (cannot be estimated from the available data).

Blood and lymphatic system disorders

Rare: decrease in hemoglobin (a blood protein), decrease in hematocrit (proportion of blood cells in the blood).

Very rare: bone marrow depression, anemia, thrombocytopenia (increased tendency to bruising), changes in certain blood cells or components.

Metabolism and nutrition disorders

Very rare: decrease in blood glucose.

Nervous and psychiatric system disorders

Common: dizziness, headache.

Uncommon: mood disturbances, tingling and/or numbness in certain limbs, vertigo, changes in taste, sleep disorders.

Rare: mental confusion.

Cardiac and vascular disorders

Common: dizziness or lightheadedness upon standing quickly.

Uncommon: myocardial infarction or stroke, palpitations, rapid heartbeat, numbness and spasms in fingers, followed by warmth and pain (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders

Common: cough.

Uncommon: rhinitis.

Very rare: wheezing, sinusitis, lung inflammation.

Gastrointestinal disorders

Common: diarrhea, vomiting.

Uncommon: nausea, abdominal pain and indigestion.

Rare: dry mouth.

Very rare: inflammation of the liver or pancreas, jaundice (yellowing of the skin and/or eyes).

Skin and subcutaneous tissue disorders

Uncommon: rash, itching.

Rare: severe skin burning sensation (with hives), hair loss, psoriasis, allergic reaction (angioedema) characterized by swelling of the face, limbs, lips, tongue and/or larynx.

Very rare: sweating, severe skin disorders (symptoms of which may include redness, blistering and peeling).

Occasionally, fatigue or sore throat may occur, which may be accompanied by fever, joint and muscle pain, joint or gland swelling, or sensitivity to sunlight.

Renal and urinary disorders

Common: changes in kidney function.

Rare: increased urea in urine, acute renal failure.

Very rare: pain or inability to urinate.

Reproductive system and breast disorders

Uncommon: impotence.

Rare: breast development in males.

General disorders and administration site conditions

Uncommon: fatigue, tiredness.

Investigations

Uncommon: increased blood urea, increased blood creatinine, increased liver enzymes, increased blood potassium.

Rare: increased blood bilirubin, decreased blood sodium.

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 not listed in this leaflet. You can 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 Stada

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Lisinopril Stada

• The active substance is lisinopril.

Each tablet contains 5 mg of lisinopril (as lisinopril dihydrate).

• The other components are calcium hydrogen phosphate dihydrate, manitol, corn starch, pregelatinized corn starch, and magnesium stearate.

Appearance of the medicine and contents of the pack

Lisinopril Stada 5 mg is presented as white, round, biconvex tablets, with a score on one side and the mark "5" on the other.

The score is intended only to facilitate breaking the tablet if you have difficulty swallowing it whole.

Each pack contains 60 or 500 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent review of this leaflet: November 2019

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