Lisinopril Qualigen 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lisinopril Qualigen 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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.

Contents of the leaflet:

1. What Lisinopril Qualigen is and what it is used for
2. What you need to know before taking Lisinopril Qualigen
3. How to take Lisinopril Qualigen
4. Possible adverse effects
5. How to store Lisinopril Qualigen
6. Contents of the pack and other information

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

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

Lisinopril Qualigen 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 Qualigen

Do not take Lisinopril Qualigen 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).
• You have previously received a medicine from the same drug 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 has had a similar reaction (angioedema).
• You are pregnant. (See section "Pregnancy and breastfeeding")
• You have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lisinopril Qualigen:

• 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 had an 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 for a treatment called low-density lipoprotein (LDL) apheresis or for desensitization therapy 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).

Talk to your doctor or pharmacist before taking Lisinopril Qualigen 5 mg tablets 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” – 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 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 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 Qualigen before receiving local or general anaesthesia.

Children

The use of Lisinopril Qualigen is not recommended in children, as 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 need to take any other medicines, including those obtained without a prescription.

Note that these instructions may also apply to medicines previously used or that may be used in the future.

Certain medicines may interact with Lisinopril Qualigen; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines. 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 output).
• Potassium supplements or salt substitutes containing potassium.
• Medicines for mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Non-steroidal anti-inflammatory drugs (NSAIDs) such as indomethacin and high-dose aspirin (more than 3 grams per day) used to treat arthritis or muscle pain.
• Antihypertensives (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 clot formation).

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.

Angiotensin-converting enzyme inhibitors (the class to which lisinopril belongs) may 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 using machines

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

3. How to take Lisinopril Qualigen

Follow exactly the dosing instructions provided in this leaflet unless your doctor has given you different advice. If in doubt, consult your doctor or pharmacist. Remember to take your medication.

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

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 kidney complications

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

Patients with impaired renal function

Your doctor will adjust your dose.

Administration method:

• 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 drop in blood pressure than subsequent doses. This effect may manifest as dizziness; in such a case, lying down may help.

If you think that the effect 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 prescribed, 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, 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 missed dose. Wait until the next scheduled dose.

If you stop taking Lisinopril Qualigen

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported according to the following frequency categories:

Frequent: 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 but more than 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients

Blood and lymphatic system disorders:

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

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

Metabolism and nutritional disorders:

Very rare: decrease in blood glucose.

Nervous and psychiatric system disorders:

Frequent: dizziness, headache.

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

Rare: mental confusion.

Cardiac and vascular disorders:

Frequent: dizziness or lightheadedness when rising quickly.

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

Respiratory disorders:

Frequent: cough.

Uncommon: rhinitis.

Very rare: wheezing, sinusitis, lung inflammation.

Gastrointestinal disorders:

Frequent: diarrhea, vomiting.

Uncommon: nausea, abdominal pain, indigestion.

Rare: dry mouth.

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

Skin 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, blisters, 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.

Kidney and urinary disorders:

Frequent: 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:

Uncommon: fatigue, tiredness.

Laboratory findings:

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 may 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 Qualigen

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Lisinopril Qualigen after the expiry date stated on the container. 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. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lisinopril Qualigen

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

Nature of the product and pack contents

Lisinopril Qualigen 5 mg is presented as orange-colored, round, biconvex tablets, with a score on one side and the mark "5" on the other. Each pack 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 the most recent review of this leaflet: November 2017

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