LISINOPRIL QUALIGEN 5 mg TABLETS

2. What you need to know before taking Lisinopril Qualigen

Do not take Lisinopril Qualigen if:

• You are allergic to lisinopril, other ACE inhibitors, or any of the other ingredients of this medicine (listed in section 6).
• You have previously taken an ACE inhibitor and have experienced an allergic reaction that caused 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 has had a similar reaction (angioedema).
• You are pregnant. (See section "Pregnancy and Breastfeeding")
• You have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine 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), renal arteries (renal artery stenosis), or 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 problems.
• 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), or immunosuppressants (medicines that suppress the body's immune response).
• If you have diabetes.
• If you follow a low-salt 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 desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice this as dizziness or lightheadedness, especially when standing up. In these cases, lying down may help).

Consult your doctor or pharmacist before starting to take Lisinopril Qualigen if you are taking any of the following medicines used to treat high blood pressure:

• 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

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 Qualigen 5 mg tablets".

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

Tell your doctor if you are going to be hospitalized for surgery. 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 Medicines and Lisinopril Qualigen

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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 Qualigen. In these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential that you inform your doctor if you are taking or have recently taken any of the following medicines, as your doctor may need to adjust 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 (medicines used to increase urine production).
• Potassium supplements or salt substitutes that contain potassium.
• 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.
• Antihypertensive medicines (medicines that lower high blood pressure).
• Sympathomimetic medicines (stimulate the central nervous system).
• Medicines for the treatment of diabetes, such as insulin or oral antidiabetics.

Thrombolytic medicines (prevent blood clots from forming).

Pregnancy and Breastfeeding

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

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, the administration of this medicine should be discontinued as soon as possible.

Driving and Using Machines

Lisinopril Qualigen tablets are unlikely to 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 the medicine affects you.

3. How to Take Lisinopril Qualigen

Follow the instructions for administration of the medicine contained in this package leaflet, unless your doctor has given you different instructions. If in doubt, ask your doctor or pharmacist. Remember to take your medicine.

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

Adults

• Hypertension

The recommended initial dose is 10 mg once daily.

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

• Symptomatic Heart Failure

The recommended initial dose is 2.5 mg once daily.

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

• Acute Myocardial Infarction

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

• Diabetic Nephropathy

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

Patients with Renal Impairment

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 Qualigen 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 Qualigen may cause a greater decrease in blood pressure than will be seen with continued treatment. This effect can be noticed as dizziness, in which case lying down will help.

If you think the effect of Lisinopril Qualigen is too strong or too weak, talk to your doctor or pharmacist.

If you take more Lisinopril Qualigen than you should:

If you take more Lisinopril Qualigen than you should, talk to your doctor or pharmacist immediately.

The most common symptoms in case of overdose are: low blood pressure, shock, kidney failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take Lisinopril Qualigen:

Do not take a double dose to make up for the forgotten dose. Wait for the next administration.

If you stop taking Lisinopril Qualigen

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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:

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

Uncommon: 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 (increased tendency to bruise), changes in some blood cells or components.

Metabolic and Nutritional Disorders:

Very Rare: decreased 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 heart rate, numbness and spasms in the fingers, followed by heat and pain (Raynaud's phenomenon).

Respiratory 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 can 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: increased urea in the urine, acute kidney failure.

Very Rare: pain or inability to urinate.

Reproductive System and Breast Disorders:

Uncommon: impotence.

Rare: development of breast tissue in men.

General Disorders:

Uncommon: fatigue, tiredness.

Laboratory Tests:

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

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their 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 Qualigen

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

No special storage conditions are required.

Do not use Lisinopril Qualigen after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any questions, ask your pharmacist. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lisinopril Qualigen

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

Appearance of the Product and Package Contents

Lisinopril Qualigen 5 mg is presented in the form of orange, round, biconvex tablets with a score line on one side and the mark "5" on the other. Each package contains 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of Last Revision of this Package Leaflet: November 2017

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