DONEKA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Doneka 5mg tablets

Lisinopril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Doneka and what is it used for
2. What you need to know before you take Doneka
3. How to take Doneka
4. Possible side effects
5. Storage of Doneka
6. Contents of the pack and other information

1. What is Doneka and what is it used for

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

Doneka is indicated for:

• Treatment of high blood pressure (hypertension).
• Treatment of symptomatic heart failure.
• Short-term treatment of acute myocardial infarction.
• Treatment of renal complications of type 2 diabetes in hypertensive patients.

2. What you need to know before you take Doneka

Do not take Doneka if:

• You are more than 3 months pregnant. (It is also better to avoid lisinopril in the first months of pregnancy – see section on pregnancy and breastfeeding).
• You are allergic to lisinopril, to other medicines of the same group (ACE inhibitors), or to any of the components of this medicine.
• You have previously received a medicine of the same group as lisinopril (ACE inhibitors) and have presented 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doneka.

Be especially careful with Doneka:

• 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 if you 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 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 it as fainting or dizziness, especially in the initial doses and when standing up. In these cases, lying down may help).
• You must inform your doctor if you think you are (or may be) pregnant. Lisinopril is not recommended in the first months of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used during this period (see section on pregnancy and breastfeeding).

In all these cases, inform your doctor as you may need a dose adjustment or to stop taking Doneka.

Stop taking Doneka 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 Doneka before they administer a local or general anesthetic.

Children

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

Other medicines and Doneka

Tell your doctor or pharmacist if you are taking, or have recently taken, 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 Doneka. In these cases, it may be necessary to change the dose or interrupt 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:

• 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 medicines (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 the formation of blood clots).

Pregnancy and breastfeeding

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. Normally, your doctor will advise you to stop taking lisinopril before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead of lisinopril. Lisinopril is not recommended in the first months of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used during this period (see section on pregnancy and breastfeeding).

Lisinopril is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if it is a newborn or premature baby.

Driving and using machines

Doneka tablets are unlikely to affect your ability to drive or use machines; however, if you notice symptoms of dizziness or fatigue, do not perform tasks that require special attention until you know how you tolerate the medicine.

3. How to take Doneka

Follow exactly the instructions of administration of the medicine contained in this leaflet or as indicated by your doctor. In case of doubt, ask your doctor or pharmacist. Remember to take your medicine.

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

The recommended dose is:

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.

• Renal complications of diabetes

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

Patient with renal function 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 if you take Doneka 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 Doneka may cause a greater decrease in blood pressure than the one that will occur when continuing treatment. This effect may be noticed as dizziness, in which case lying down will help.

If you think the action of Doneka is too strong or too weak, consult your doctor or pharmacist.

If you take more Doneka than you should:

If you take more Doneka than you should, consult your doctor or pharmacist immediately.

The most frequent 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Doneka:

Do not take a double dose to make up for the forgotten dose, 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:

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 patients but more than 1 in 10,000 patients

Very rare:less than 1 in 10,000 patients

If you notice any side effects not mentioned in this leaflet, or if any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doneka

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

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 that month.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Doneka

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

Appearance of the product and pack contents

Doneka 5 mg is presented in the form of orange, round, biconvex tablets with a score line on one face and the mark "5" on the other. Each pack contains 60 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 leaflet: September 2016

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