Package Insert: Information for the User

Lisinopril STADA 5 mg Tablets EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, 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 should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. How to Take Lisinopril Stada
2. Possible Side Effects
3. Storage of Lisinopril Stada

1. Contents of the Package and Additional Information

Lisinopril Stada belongs to a group of medicines called angiotensin-converting enzyme (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 2 diabetes in hypertensive patients.

Do not take Lisinopril Stada:

• If you are allergic to lisinopril, to other medications in the same group (ACE inhibitors), or to any of the other components of this medication (listed in section 6).
• If you have previously received a medication in 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 family member has had a similar reaction (angioedema).
• If you are pregnant. (See section "Pregnancy and breastfeeding")
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area 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 an acute myocardial infarction.
• If you have a renal function disorder or if you are on dialysis.
• If you have liver insufficiency.
• If you have a vascular disease (collagen vascular disease) and/or are being treated with allopurinol (for gout), procainamide (for cardiac arrhythmias), immunosuppressants (medications that suppress the body's immune response).
• If you have diabetes.

• If you are following a low-sodium diet, taking potassium supplements, diuretics that save potassium, or salt substitutes that contain potassium, or if you have recently had excessive vomiting or diarrhea.
• If you have a cough.
• If you are undergoing a treatment called 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 medications used to treat high blood pressure (hypertension):

-An angiotensin II receptor antagonist (ARA) (also known as "sartans" - for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.

-Aliskiren

• If you are using any of the following medications, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
• Racecadotril, a medication used to treat diarrhea
• Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) and other medications of the mTOR inhibitor class
• Vildagliptin, a medication used to treat diabetes

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as 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 to adjust the dose or discontinue the medication with Lisinopril Stada.

Stop taking Lisinopril Stada and seek medical assistance immediatelyif 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 a hospital for a surgical procedure. Inform your doctor or dentist that you are taking Lisinopril Stada before they administer a local or general anesthetic.

Children

Lisinopril Stada is not recommended for use in children as the information on safety and efficacy in this age group is limited.

Other medications and Lisinopril Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medications.

These instructions may also apply to medications that have been used before or may be used afterwards.

Certain medications may interact with Lisinopril Stada; in these cases, your doctor may need to modify your dose and/or take other precautions.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Diuretics (medications used to increase urine production).
• Medications for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Nonsteroidal 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.
• Anti-hypertensives (medications that lower elevated blood pressure).
• If you aretakingan angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Lisinopril Stada” and “Warnings and precautions”)
• Medications that stimulate the central nervous system.
• Medications for the treatment of diabetes, such as insulin or oral antidiabetic medications.
• Trombolytic medications (preventing blood clot formation).

This applies especially if you are taking:

• Medications used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”.
• Potassium supplements (including salt substitutes), diuretics (especially those called potassium-sparing diuretics), and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute the blood to prevent clots).

Pregnancy, breastfeeding, and fertility

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

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

ACE inhibitors, to which lisinopril belongs, may cause fetal damage and death when administered during the second and third trimesters of pregnancy. If pregnancy is detected, the administration of this medication should be discontinued as soon as possible.

Driving and operating machinery

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

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

Remember to take your medication.

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

Adults

• Hypertension

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.

• Diabetic renal complications

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

Renal insufficiency

Your doctor will adjust the dose.

Administration form:

• Swallow the tablet with water.

• Try to take your tablets at the same time every day. It does not matter if 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 what will be seen when continuing treatment. This effect may be felt as dizziness, in which case lying down will help.

If you estimate that 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, renal insufficiency, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount administered. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Lisinopril Stada

Do not take a double dose to compensate for the missed doses and wait for the next administration.

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

The following side effects have been described according to the following frequency categories:very frequent (?1/10),frequent(?1/100 to <1)infrequent(?1/1,000 to <1)rare(?1/10,000 to <1)(<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 (easier bleeding), changes in some blood cells or components.

Metabolism and nutrition disorders

Very rare:decrease in blood glucose.

Nervous system and psychiatric disorders

Frequent:dizziness, headache.

Infrequent:mood changes, tingling and/or numbness in certainmembers, vertigo, changes in the taste of things, sleep disorders.

Rare:confusion.

Cardiac and vascular disorders

Frequent:dizziness or lightheadedness when standing up quickly.

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

Respiratory, thoracic, and mediastinal disorders

Frequent:cough.

Infrequent:rhinitis.

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

Gastrointestinal disorders

Frequent:diarrhea, vomiting.

Infrequent: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

Infrequent:eruption, itching.

Rare:intense skin burning (with blisters), 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).

In some cases, 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

Frequent:changes in kidney function.

Rare:increase in urea in the urine, acute renal insufficiency.

Very rare:pain or inability to urinate.

Reproductive and breast system disorders

Infrequent:impotence.

Rare:breast development in males.

General disorders and administration site conditions

Infrequent:fatigue, tiredness.

Complementary examinations

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

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

Reporting of adverse reactions

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

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

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Lisinopril Stada Composition

• The active ingredient is lisinopril.

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

• The other components are calcium dihydrogen phosphate dihydrate, mannitol, cornstarch, pregelatinized cornstarch, and magnesium stearate.

Appearance of the product and content of the packaging

Lisinopril Stada 5 mg is presented in the form of white, round, biconvex tablets with a groove on one face and the mark of a “5” on the other.

The groove is only for breaking the tablet if it is difficult to swallow whole.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible for manufacturing.

Marketing authorization holder

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: November 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob .es/