Package Insert: Information for the User

Lisinopril Qualigen 5 mg TabletsEFG

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Lisinopril Qualigenbelongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Lisinopril Qualigenis 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 Qualigen if:

• You are allergic to lisinopril, other medications in the same group (ACE inhibitors), or any of the other components of this medication (listed in section 6).
• 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).
• You are pregnant. (See section "Pregnancy and breastfeeding")
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril Qualigen:

• If you have a narrowing of the aorta (aortic stenosis), the renal arteries (renal artery stenosis), or 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 kidney function disorder or if you are on dialysis.
• If you have liver failure.
• If you have a blood vessel disease (collagen vascular disease) and/or are being treated with allopurinol (for gout), procainamide (for arrhythmias), immunosuppressants (medications that suppress the body's immune response).
• If you have diabetes.
• If you are on 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 going to undergo a treatment called LDL apheresis or a desensitization treatment to reduce the effect of an allergy to a bee or wasp sting.
• If you have low blood pressure (you may feel dizzy or lightheaded, especially at the start and when standing up. In these cases, lying down may help).

Consult your doctor or pharmacist before starting to take Lisinopril Qualigen 5 mg tablets 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), particularly if you have kidney problems related to diabetes.
• Aliskiren

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as potassium) at regular intervals.

See also the information under the heading "Do not take Lisinopril Qualigen 5 mg tablets".

Stop taking Lisinopril Qualigen and seek medical help immediatelyif you have 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 Qualigen before they administer a local or general anesthetic.

Children

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

Other medications and Lisinopril Qualigen

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

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

Certain medications may interact with Lisinopril Qualigen, in which case it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications, as your doctor may need to modify your dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Lisinopril Qualigen" and "Warnings and precautions")
• Diuretics (medications used to increase urine elimination).
• Potassium supplements or salt substitutes that contain potassium.
• Medications 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.
• Anti-hypertensive medications (medications that lower elevated blood pressure).
• Sympathomimetic medications (stimulate the central nervous system).
• Medications for the treatment of diabetes, such as insulin or oral antidiabetic medications.

Thrombolytic medications (prevent blood clot formation).

Pregnancy and breastfeeding

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

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

ACE inhibitors, including lisinopril, 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 Qualigen tablets will affect your ability to drive vehicles or operate machines; 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 the medication contained in this leaflet unless your doctor has given you different instructions. In case of doubt, ask your doctor or pharmacist. Remember to take your medication.

Your doctor will tell you how many tablets to take per day and the duration of your treatment with Lisinopril Qualigen. Do not stop 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.

Patients with renal function impairment

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 Qualigen before or after meals.
• Do not stop taking your tablets unless your doctor tells you to.
• Remember, the first dose of Lisinopril Qualigen 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 Qualigen is too strong or too weak, consult your doctor or pharmacist.

If you take more Lisinopril Qualigen than you should:

If you take more Lisinopril Qualigen 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 the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Lisinopril Qualigen:

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

If you interrupt treatment with Lisinopril Qualigen

If you have any other doubt about the use of this medication, ask your doctor or pharmacist.

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:

Frequent: less than 1 in 10 but more than 1 in 100 patients

Infrequent: less than 1 in 100 but more than 1 in 1,000 patients

Rare: less than 1 in 1,000 patients but more than 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients

Blood and lymphatic system disorders:

Rare:decreased hemoglobin (a blood protein), decreased 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 nutritional disorders:

Very rare:decreased blood glucose.

Nervous system and psychiatric disorders:

Frequent:dizziness, headache.

Infrequent:mood changes, tingling and/or numbness of certain limbs, 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 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 (yellowish discoloration of the skin and/or eyes).

Skin 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 (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:increased urea in the urine, acute renal insufficiency.

Very rare:pain or inability to urinate.

Reproductive and breast disorders:

Infrequent:impotence.

Rare:breast development in males.

General disorders:

Infrequent:fatigue, tiredness.

Laboratory determinations:

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

Rare:increased bilirubin in blood, decreased sodium in blood.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 side effects, 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 Lisinopril Qualigen after the expiration date shown on the packaging. 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 unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Lisinopril Qualigen Composition

• The active ingredient is lisinopril in the form of lisinopril dihydrate.
• The other components are: mannitol, calcium dihydrogen phosphate dihydrate, cornstarch, pregelatinized starch, and magnesium stearate.

Appearance of the product and content of the container

Lisinopril Qualigen 5 mg is presented in the form of orange-colored, round, biconvex tablets with a groove on one face and the mark "5" on the other. Each container contains 60 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Responsible manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: November 2017

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