Doneka 20 mg tablets
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Doneka 20mg tablets
Lisinopril
Read the entire leaflet carefully before you start using this medicine, because 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Doneka is and what it is used for
- What you need to know before taking Doneka
- How to take Doneka
- Possible side effects
- How to store Doneka
- Contents of the pack and other information
1. What Doneka is and what it is used for
Doneka belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.
Doneka 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 Doneka
Do not take Doneka if:
- You are more than 3 months pregnant. (It is also advisable to avoid lisinopril during the first months of pregnancy – see the pregnancy and breastfeeding section).
- You are allergic to lisinopril, to other medicines in the same group (ACE inhibitors), or to any of the components of this medicine.
- You have previously received a medicine from the same 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).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Doneka.
Take special care with Doneka:
- If you have narrowing of the aorta (aortic stenosis), of the renal arteries (renal artery stenosis), or of the heart valves (mitral valve stenosis), or thickening of the heart muscle (hypertrophic cardiomyopathy).
- If you have 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 cardiac 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 to undergo a treatment called low-density lipoprotein (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 experience fainting or dizziness, especially with initial doses and when standing up. In such cases, lying down may help).
- You must inform your doctor if you think you are (or might become) pregnant. Lisinopril is not recommended during the first months of pregnancy, and should not be taken if you are more than 3 months pregnant, as it may cause severe harm to the baby if used during this period (see pregnancy and breastfeeding section).
In all these cases, inform your doctor, as you may require a dose adjustment or discontinuation of Doneka.
Stop taking Doneka and seek immediate medical assistance 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. Inform your doctor or dentist that you are taking Doneka before receiving local or general anesthesia.
Children
Doneka is not recommended for use in children, as information on safety and efficacy in this age group is limited.
Other medicines and Doneka
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Please note that these instructions may also apply to medicines previously used or those that may be used in the future.
Certain medicines may interact with Doneka; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.
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 elimination).
- 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 for the treatment of arthritis or muscle pain.
- Antihypertensives (medicines that reduce high blood pressure).
- Sympathomimetic medicines (stimulate the central nervous system).
- Medicines for the treatment of diabetes, such as insulin or oral antidiabetic agents.
- Thrombolytic medicines (prevent blood clot formation).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will usually advise you to stop taking lisinopril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of lisinopril. Lisinopril is not recommended during the first months of pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the baby if used beyond the third month of pregnancy.
Lisinopril is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
It is unlikely that Doneka tablets will affect your ability to drive or operate machinery. However, if you experience symptoms such as dizziness or tiredness, avoid performing tasks requiring special attention until you know how you tolerate the medicine.
3. How to take Doneka
Follow exactly the instructions for use provided in this leaflet or those given by your physician. If in doubt, ask your doctor or pharmacist. Remember to take your medication.
Your doctor will tell you how many tablets to take each day and the duration of your treatment with Doneka. Do not stop treatment prematurely.
The recommended dose is:
Adults
- Hypertension
The usual recommended initial dose is 10 mg once daily.
The usual long-term dose is 20 mg once daily.
- Symptomatic heart failure
The usual recommended initial 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 initial dose is 5 mg on the first and second day after the infarction, followed by 10 mg once daily.
- Diabetic renal complications
The usual dose is 10 mg or 20 mg once daily.
Patients with impaired renal function
Your doctor will adjust the dose accordingly.
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 Doneka before or after meals.
- Do not stop taking your tablets if you feel well, unless your doctor instructs you otherwise.
- Be aware that the first dose of Doneka may cause a greater drop in blood pressure than subsequent doses. This effect may manifest as dizziness; in such a case, lying down will help.
If you think that the effect 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, contact 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Doneka:
Do not take a double dose to make up for the missed dose. Wait until the next scheduled dose.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets 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: | decreased hemoglobin (a blood protein), decreased hematocrit (proportion of blood cells in the blood). |
Very rare: | bone marrow depression, anemia, thrombocytopenia (increased tendency to bruise), changes in certain blood cells or components. |
Nervous and psychiatric system disorders: | |
Common: | decreased blood glucose. |
Nervous and psychiatric system disorders: | |
Common: | dizziness, headache. |
Uncommon: | mood disturbances, tingling and/or numbness in certain limbs, vertigo, changes in taste, sleep disorders. |
Rare: | mental confusion. |
Cardiac and vascular disorders: | |
Common: | dizziness or lightheadedness upon standing quickly. |
Uncommon: | myocardial infarction or stroke, palpitations, rapid heartbeat, numbness and spasms in fingers, followed by heat and pain (Raynaud's phenomenon). |
Respiratory disorders: | |
Common: | cough. |
Uncommon: | rhinitis. |
Very rare: | wheezing, sinusitis, lung inflammation. |
Gastrointestinal disorders: | |
Common: | diarrhea, vomiting. |
Uncommon: | nausea, abdominal pain, and indigestion. |
Rare: | dry mouth. |
Very rare: | inflammation of the liver or pancreas, jaundice (yellowing of the skin and/or eyes). |
Skin disorders: | |
Uncommon: | rash, itching. |
Rare: | severe skin burning (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 may include redness, blistering, and peeling). |
Sometimes 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.
Renal and urinary disorders: | |
Common: | 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: | gynecomastia in males. |
General disorders: | |
Uncommon: | fatigue, tiredness. |
Lab test findings: | |
Uncommon: | increased blood urea, increased blood creatinine, increased liver enzymes, increased blood potassium. |
Rare: | increased blood bilirubin, decreased blood sodium. |
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
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 Medicinal Products website: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This way, you 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 components are: mannitol, calcium hydrogen phosphate dihydrate, corn starch, pregelatinized starch, and magnesium stearate.
Appearance of the product and contents of the pack
Doneka 20 mg is presented as orange-colored, round, biconvex tablets, with a score line on one side and the mark "20" on the other. Each pack contains 28 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: 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/