LISINOPRIL STADA 5 mg TABLETS

2. What you need to know before you take Lisinopril Stada

Do not take Lisinopril Stada:

• If you are allergic to lisinopril, to other medicines of the same group (ACE inhibitors), or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously taken a medicine of the same group of drugs as lisinopril (ACE inhibitors) and have presented an allergic reaction that caused swelling of hands, feet or ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing, or if you or a member of your family has had a similar reaction (angioedema).
• If you are pregnant. (See section "Pregnancy and lactation")
• 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 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

Consult your doctor or pharmacist before starting to take Lisinopril Stada.

• If you have a narrowing of the aorta (aortic stenosis), of the renal arteries (renal artery stenosis), or of the heart valves (mitral valve stenosis), or an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• If you have had a heart attack.
• If you have kidney problems or are on dialysis.
• If you have liver failure.
• If you have a disease of the blood vessels (collagen vascular disease) and/or are being treated with allopurinol (for gout), procainamide (for heart rhythm disorders), immunosuppressants (medicines that suppress the body's immune response).
• If you have diabetes.

• If you follow a salt-free diet, take potassium supplements, potassium-sparing diuretics, or salt substitutes that contain potassium, or if you have recently had excessive vomiting or diarrhea.
• If you have a cough.
• If you are going to undergo a treatment called low-density lipoprotein (LDL) apheresis, or a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice it as dizziness or lightheadedness, especially in the initial doses and when standing up. In these 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), especially if you have kidney problems related to diabetes.
• aliskiren
• 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 of 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 to stop taking Lisinopril Stada.

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

Inform your doctor if you are going to be hospitalized for surgery. Tell your doctor or dentist that you are taking Lisinopril Stada before they administer a local or general anesthetic.

Children

The use of Lisinopril Stada is not recommended in children as the 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 take any other medicines.

Note that these instructions may also apply to medicines that have been used before or may be used after.

Certain medicines may interact with Lisinopril Stada; in these cases, your doctor may need to change 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 production).
• Medicines for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Non-steroidal anti-inflammatory medicines (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 the 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 applies especially if you are also taking:

• Medicines used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other medicines of the mTOR inhibitor class). See section "Warnings and precautions".
• Potassium supplements (including salt substitutes), diuretics (especially potassium-sparing diuretics), and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

It is unlikely that Lisinopril Stada tablets will affect your ability to drive or use machines; however, if you notice symptoms of dizziness or fatigue, avoid performing tasks that require special attention until you know how you tolerate the medicine.

3. How to take Lisinopril Stada

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate how many tablets you should take each day and the duration of your treatment with Lisinopril Stada. Do not stop treatment before.

Adults

• High blood pressure

The usual initial recommended dose is 10 mg once a day. The usual long-term dose is 20 mg once a day.

• Symptomatic heart failure

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

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

• Acute myocardial infarction

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

• Renal complications of diabetes

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

Kidney failure

Your doctor will adjust the dose.

Method of administration:

• Swallow the tablet with water.

• Try to take your tablets at the same time every 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 to.

• Remember, the first dose of Lisinopril Stada may cause a greater decrease in blood pressure than will be present when continuing treatment. This effect may be noticed as dizziness, in which case lying down may help.

If you think the action 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, consult your doctor or pharmacist immediately. The most frequent symptoms in case of overdose are: hypotension, shock, kidney 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. Phone 91 562 04 20, indicating the medicine and the amount administered. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Lisinopril Stada

Do not take a double dose to make up for forgotten doses and wait for the next administration.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been described according to the following frequency categories: very common (?1/10), common (?1/100 to <1>

Blood and lymphatic system disorders

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

Very rare: bone marrow depression, anemia, thrombocytopenia (greater tendency to bruise), changes in some blood cells or components.

Metabolism and nutrition disorders

Very rare: decrease in blood glucose.

Nervous system and psychiatric disorders

Common: dizziness, headache.

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

Rare: mental confusion.

Cardiac and vascular disorders

Common: dizziness or lightheadedness when standing up quickly.

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

Respiratory, thoracic, and mediastinal disorders

Common: cough.

Uncommon: rhinitis.

Very rare: shortness of breath, sinusitis, lung inflammation.

Gastrointestinal disorders

Common: diarrhea, vomiting.

Uncommon: nausea, abdominal pain, and indigestion.

Rare: dry mouth.

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

Skin and subcutaneous tissue disorders

Uncommon: rash, itching.

Rare: intense skin itching (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 (whose symptoms may include redness, blisters, and peeling)

Sometimes fatigue or sore throat may appear, which may be accompanied by fever, joint and muscle pain, swelling of the joints or glands, or sensitivity to sunlight.

Renal and urinary disorders

Common: changes in kidney function.

Rare: increase in urea in the urine, acute kidney failure.

Very rare: pain or inability to urinate.

Reproductive system and breast disorders:

Uncommon: impotence.

Rare: development of breasts in males.

General disorders and administration site conditions

Uncommon: fatigue, tiredness.

Investigations

Uncommon: increase in blood urea, increase in blood creatinine, increase in liver enzymes, increase in blood potassium.

Rare: increase in blood bilirubin, decrease in blood sodium.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lisinopril Stada

• The active substance is lisinopril.

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

• The other ingredients are calcium hydrogen phosphate dihydrate, mannitol, maize starch, pregelatinized maize starch, and magnesium stearate.

Appearance of the product and pack contents

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

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

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

Not all 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 last revision of this leaflet:November 2019

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