Package Insert: Information for the User

Doneka 20mg tablets

Lisinopril

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 should not be given 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.

Donekabelongs to a group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors).

Doneka is indicated for:

• Treatment of hypertension (elevated 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 Doneka if:

• You are more than 3 months pregnant.
• You are allergic to lisinopril, other medications in the same group (ACE inhibitors), or any of the components of this medication.
• You have previously received a medication in the same group of medications 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).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doneka.

Be extra careful with Doneka:

• 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 insufficiency.
• If you have a blood vessel 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 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 about to undergo 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).
• You must inform your doctor if you think you are (or may become) pregnant. Lisinopril is not recommended in the first months of pregnancy, and it 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 pregnancy and breastfeeding section).

In all these cases, inform your doctor as you may need a dose adjustment or discontinue Doneka medication.

Stop taking Doneka and seek medical assistance 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 Doneka before they administer a local or general anesthetic.

Children

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

Other medications and Doneka

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

Be aware that these instructions may also apply to medications that have been used before or may be used afterwards.

Certain medications may interact with Doneka, 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 recently taken any of the following medications:

• 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.
• Antihypertensive medications (medications that reduce high blood pressure).
• Sympathomimetic medications (stimulate the central nervous system).
• Medications for diabetes, such as insulin or oral antidiabetic medications.
• Thrombolytic medications (prevent blood clot formation).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication. Normally, your doctor will advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant and recommend taking another medication instead of lisinopril. Lisinopril is not recommended in the first months of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.

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

Driving and operating machinery

It is unlikely that Doneka tablets will affect your ability to drive vehicles or use machines; however, if you notice symptoms of dizziness or fatigue, avoid performing 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 or those indicated by your doctor. 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 Doneka. Do not discontinue 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.

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 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 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 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 insufficiency, 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 medication and the amount ingested.

If you forgot to take Doneka:

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

Like all medicines, this medicine can 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

In some cases, fatigue or sore throat may occur, which may be accompanied by fever, joint and muscle pain, swelling of the joints or glands, or sensitivity to sunlight.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

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 leaflet. You can also report them directly through the Spanish Medicines for Human Use Pharmacovigilance System website: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.

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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Doneka

• 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 contents of the packaging

Doneka 20 mg is presented in the form of orange-colored, round, biconvex tablets with a notch on one face and the mark “20”on the other. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: September 2016

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/