Doneka Plus 20/12.5 mg tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Doneka Plus 20 mg/12.5 mg Tablets

lisinopril/hydrochlorothiazide

Read the entire leaflet carefully before you start using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally and must not be given to others, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Doneka Plus is and what it is used for

Doneka Plus contains two medicines, lisinopril and hydrochlorothiazide. Each of these lowers blood pressure through a different mechanism. Lisinopril belongs to a group of medicines called ACE inhibitors. Lisinopril works by dilating blood vessels, helping to reduce blood pressure and making it easier for the heart to pump blood throughout the body. Hydrochlorothiazide is a diuretic that increases the amount of urine produced by your kidneys.

Lisinopril/hydrochlorothiazide is indicated for the treatment of high blood pressure (hypertension).

2. What you need to know before starting to take Doneka Plus

Do not take Doneka Plus

• If you are allergic to lisinopril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you have previously received a medicine from the same class as lisinopril (ACE inhibitors) and experienced an allergic reaction causing itching, hives, sudden drop in blood pressure, swelling of hands, feet or ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema).

-If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, because the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

-If any member of your family has had a severe allergic reaction (angioedema) to an ACE inhibitor, or if you have had a severe allergic reaction (angioedema) for unknown causes.

-If you have ever had an allergic-type reaction to diuretics of the hydrochlorothiazide type, which are medicines similar to sulfonamides (a type of antibiotic), or to any of the other components of this medicine.

• If you are more than 3 months pregnant. It is also advisable to avoid this medicine during early pregnancy – see section on pregnancy.
• If you have impaired kidney function.
• If you have recently undergone a kidney transplant.
• If you have decreased urine output or are unable to urinate (anuria).
• If you have impaired liver function.
• If you have diabetes or renal insufficiency and are being treated with an antihypertensive medicine containing aliskiren.

Do not take lisinopril/hydrochlorothiazide if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doneka Plus if:

• You have a narrowing (stenosis) of the aorta (one of the arteries in the heart) or of the mitral valve (one of the valves in the heart).
• You have a narrowing (stenosis) of the renal artery.
• You have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).
• You have low blood pressure (you may experience dizziness, especially when standing up. In such cases, lying down may help).

-Has heart failure (heart problem in pumping enough blood to the body) and normal or low blood pressure.

• You have kidney problems or are on dialysis.

-Has liver problems.

• You have diabetes and are being treated with oral antidiabetic medicines or insulin.
• 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 electrolyte levels in the blood (for example, potassium) at regular intervals.

See also the information under the heading “Do not take Doneka Plus”.

• If you are taking any medicine that may increase the risk of angioedema, see “Taking Doneka Plus with other medicines”:

  • racecadotril, a medicine used to treat diarrhoea.
  • medicines used to prevent rejection of transplanted organs and for cancer (e.g., temsirolimus, sirolimus, everolimus).

• vildagliptin, a medicine used to treat diabetes.

-Have gout.

• Have recently experienced diarrhea or vomiting.
• Are on a salt-restricted diet, taking potassium supplements, or using salt substitutes containing potassium.
• Are being treated with potassium-sparing diuretics (medications used to increase urine elimination) or medicines that may increase potassium in the blood, such as heparin.

-You have high cholesterol levels and are undergoing a treatment called "LDL apheresis."

• You are of Black race, as this medication may be less effective. You also have a higher risk of developing the adverse reaction "angioedema" (a severe allergic reaction).
• You have a long-lasting dry cough.
• You have persistently low levels of potassium in your blood.
• You have persistently high levels of calcium in your blood.
• You are undergoing tests for thyroid or parathyroid disorders.
• You must inform your doctor if you think you are (or are planning to become) pregnant. The use of lisinopril/hydrochlorothiazide is not recommended in early pregnancy, and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby if used during this period (see section on pregnancy).
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Doneka Plus.
• If you experience a decrease in vision or eye pain, as these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within a few hours to one week after taking Doneka Plus.
• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Doneka Plus, seek medical attention immediately.

If you are unsure whether you fall under any of the situations described above, consult your doctor or pharmacist before taking this medicine.

Stop taking Doneka Plus and seek immediate medical assistance if:

-Has difficulty breathing with or without swelling of the face, lips, tongue, and/or throat.

• Has swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing.
• Develops intense itching of the skin (with hives).

Treatment of allergies such as insect sting allergies

Inform your doctor if you are receiving or are about to receive treatment to reduce the effect of an allergy to insect stings (desensitization treatment). If you take lisinopril/hydrochlorothiazide while undergoing this treatment, it may cause you a severe allergic reaction.

Surgery

If you are going to undergo a surgical procedure (including dental surgery), inform your doctor or dentist that you are taking this medicine. This is because you may experience low blood pressure (hypotension) if certain local or general anesthetics are administered while you are taking lisinopril/hydrochlorothiazide.

Take special care with the initial dose of this medication, as it may cause a more pronounced decrease in blood pressure than is normally seen with continued treatment. This effect may manifest as dizziness or vertigo; in such cases, lying down will help. However, if you are concerned, consult your doctor.

Taking Doneka Plus with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because this medicine may affect how some medicines work, and some medicines may affect this medicine. Your doctor may need to adjust your dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines that cause a decrease in blood potassium levels, such as for example, amphotericin (used to treat fungal infections), carbenoxolone (used to treat esophageal disease or oral ulcers), corticosteroids (e.g., prednisone), pituitary hormone (ACTH), or certain laxatives, other diuretics (medicines used to increase urine elimination, including potassium-sparing diuretics), and salicylic acid derivatives.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clots).
• Medicines that may cause arrhythmias.
• Medicines for depression and mental disorders, including lithium.
• Anesthetic medicines, barbiturates, or alcohol, which may worsen the drop in blood pressure (you may notice this as dizziness, especially when standing up).
• Non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, ibuprofen, and indomethacin, used to treat pain and arthritis.
• Injectable medicines for rheumatoid arthritis containing gold salts (e.g., sodium aurothiomalate).
• Medicines to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers (e.g., sotalol).
• Other medicines used to treat high blood pressure (antihypertensives, including angiotensin II receptor antagonists (ARBs) or aliskiren (see “Do not take Doneka Plus”).
• Nitrate-derived medicines (for heart problems).
• Medicines for the treatment of diabetes (such as insulin and oral antidiabetics like sulfonylureas). It may be necessary to adjust the dose of your antidiabetic medicine while taking
  • thiazide diuretics.
• Medicines that increase blood potassium levels, such as heparin (used to prevent blood clot formation).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol, cholestyramine, or lovastatin.
• Muscle relaxants such as tubocurarine.
• Trimethoprim (an antibiotic).
• Allopurinol (for gout).
• Cyclosporine (a medicine used to prevent organ transplant rejection and for other immune system disorders).
• Medicines for the treatment of cancer, such as cyclophosphamide or methotrexate.

If you are taking any of the following medicines, your risk of developing angioedema may increase (signs of angioedema include swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing):

• Medicines used to dissolve blood clots (tissue plasminogen activator), usually administered in hospital.
• Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Racecadotril, a medicine used to treat diarrhoea.
• Vildagliptin, a medicine used to treat diabetes.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you think you are (or plan to become) pregnant. Your doctor will usually advise you to stop taking lisinopril/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of this one. Lisinopril/hydrochlorothiazide is not recommended during early pregnancy, and must not be taken after the first trimester, as it may cause serious harm to the baby if used beyond the third month of pregnancy.

Lisinopril/hydrochlorothiazide should normally be replaced with an appropriate antihypertensive treatment before starting pregnancy. This medicine must not be used during the 2nd and 3rd trimesters of pregnancy.

Your doctor will usually advise you to stop taking lisinopril/hydrochlorothiazide as soon as you find out you are pregnant.

If you become pregnant while taking this medicine, inform your doctor and seek medical advice immediately.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Hydrochlorothiazide (one of the components of this medicine) is excreted in small amounts in breast milk and, at high doses, may inhibit milk production. The use of this medicine is not recommended in breastfeeding mothers, and your doctor may choose an alternative treatment for you if you plan to breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and operating machinery

• It is unlikely that Doneka Plus will affect the ability to drive or operate machinery. However, like other medicines used to treat high blood pressure, Doneka Plus may cause dizziness or drowsiness in some people, especially at the beginning of treatment, when changing doses, or if alcohol is consumed. If you experience dizziness or drowsiness, consult your doctor before engaging in such activities.
• You should wait to see how the medicine affects you before attempting these activities.

Use in athletes:

This medicine contains hydrochlorothiazide, which may produce a positive result in doping control tests.

3. How to use Doneka Plus

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Taking the medicine

• Swallow the tablet with water.
• Try to take your tablets at the same time every day, preferably in the morning. It does not matter whether you take this medicine before or after meals.
• Do not stop taking your tablets if you feel well, unless your doctor has instructed you otherwise.
• If you think that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

Taking the First Dose

• Exercise special caution when taking the first dose of this medicine or if your dose is increased.

It may cause a greater decrease in blood pressure than subsequent doses.

• This effect may make you feel dizzy or lightheaded. If this occurs, lying down may help.

If you are concerned, consult your doctor as soon as possible.

Adults

• The usual dose is one or two tablets once daily.

Use in children and adolescents:

The use of lisinopril/hydrochlorothiazide is not recommended in children and adolescents, as information on safety and efficacy in this age group is limited.

If you take more Doneka Plus than you should

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Doneka Plus

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.
• Do not stop treatment before your doctor tells you to.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you experience any of the following reactions, stop taking Doneka Plus immediately and contact your doctor right away.

• Severe allergic reactions (uncommon, may affect up to 1 in 100 people). Signs may include sudden onset of:
• Swelling of the face, lips, tongue, or throat. This may make swallowing difficult.
• Severe or sudden swelling of the hands, feet, or ankles.
• Difficulty breathing.
• Severe skin itching (with hives).
• Serious skin disorders, such as an unexpected and sudden rash, redness, or skin peeling (very rare, may affect up to 1 in 10,000 people).
• An infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth irritation or urinary disorders (very rare, may affect up to 1 in 10,000 people).
• Acute pain with redness in the eye, as without treatment, permanent vision loss may occur.

Other possible adverse effects due to lisinopril:

Common (may affect up to 1 in 10 people):

• Dizziness, especially when standing up quickly.
• Headache.
• Persistent dry cough.
• Fatigue.
• Diarrhea.
• Nausea.
• Kidney disorders (detected by blood tests).
• Fainting.

Uncommon (may affect up to 1 in 100 people):

• Mood changes.
• Change in skin color of fingers and toes (pale blue followed by redness), or numbness or tingling in fingers or toes.
• Sensation of dizziness.
• Drowsiness.
• Difficulty sleeping.
• Visual and/or auditory hallucinations.
• Rhinitis.
• Nausea.
• Stomach pain or indigestion.
• Changes in blood tests used to monitor proper liver and kidney function.
• Skin rash or itching.
• Inability to achieve an erection (impotence).
• Feeling of tiredness or weakness (lack of strength).
• A significant drop in blood pressure, which may occur in people with the following conditions: coronary heart disease, narrowing of the aorta (a heart artery), renal arteries, or heart valves; thickening of the heart muscle. If this occurs, you may experience dizziness or lightheadedness, especially when standing up quickly.
• Myocardial infarction.
• Stroke.
• Rapid heartbeat.

Rare (may affect up to 1 in 1,000 people):

• Changes in certain blood cells or other blood components. Your doctor may take blood samples from time to time to check whether lisinopril/hydrochlorothiazide is affecting your blood. Signs may include fatigue, pale skin, sore throat, fever, joint and muscle pain, joint or gland swelling, or sensitivity to sunlight.
• Confusion.
• Hives-containing rash.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin condition).
• Breast development in men.
• Sudden kidney failure.
• Change in the sense of smell.
• Decreased sodium levels in blood (hyponatremia) (symptoms may include fatigue, headache, nausea, vomiting).

Very rare (may affect up to 1 in 10,000 people):

• Low blood glucose levels (hypoglycemia). Signs may include feeling hungry or weak, sweating, and rapid heartbeat.
• Sinusitis (feeling of pain and pressure behind the cheeks and eyes).
• Wheezing.
• Lung inflammation. Signs include cough, shortness of breath, and high fever.
• Pancreatitis. This causes moderate to severe stomach pain.
• Intestinal inflammation.
• Yellowing of the skin or whites of the eyes (jaundice).
• Liver inflammation. This may cause loss of appetite, yellowing of the skin and eyes, and dark urine.
• Liver failure.
• Sweating.
• Serious skin disorders. Symptoms include redness, blistering, and peeling.
• Hives.
• Decreased urine output or inability to urinate.

Frequency not known (cannot be estimated from available data):

• Depressive symptoms.
• Flushing (redness).
• Severe allergic reaction.

Other adverse reactions due to hydrochlorothiazide (frequenciesnot known):

Benign, malignant and unspecified neoplasms (including cysts and polyps)

• Skin and lip cancer (non-melanoma skin cancer).

Blood and lymphatic system disorders

• Bone marrow depression.
• Reduction in the number of platelets (thrombocytopenia).
• Reduction in the number of white blood cells (leucopenia).
• Decrease in the number of granulocytes (agranulocytosis).
• Anemia due to destruction of red blood cells (hemolytic anemia).

Metabolism and nutritional disorders

• Anorexia.
• High blood glucose levels (hyperglycemia).
• Presence of glucose in urine.
• High levels of uric acid in urine.
• Low levels of sodium, potassium, chloride, and magnesium in blood.
• Increased levels of cholesterol and triglycerides in blood.
• Gout.

Psychiatric disorders

-Restlessness.

• Depression.
• Sleep disturbances.

Nervous system disorders

-Loss of appetite.

• Tingling sensation in hands and feet.
• Dizziness.

Eye disorders

-Changes in vision causing objects to appear yellowish.

• Severe eye pain accompanied by redness and sudden blurred vision.
• Vision disturbances.
• Decreased vision or eye pain due to elevated pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Ear disorders

-Vertigo.

Cardiac disorders

- Postural hypotension.

Vascular disorders

-Inflammation of blood vessels.

Disorders of the respiratory, thoracic and mediastinal system

-Sensation of breathlessness.

• Pulmonary inflammation.
• Acute respiratory difficulty (signs include severe shortness of breath, fever, weakness, and confusion) (very rare frequency).

Gastrointestinal disorders

-Stomach irritation.

• Diarrhea.
• Constipation.
• Inflammation of the pancreas.

Liver disorders

• Yellowing of the skin (jaundice).

Skin and subcutaneous tissue disorders

• Skin reaction caused by sensitivity to sunlight.
• Rash.
• Urticaria.
• Skin rash with wheals.
• In some patients with lupus, symptoms may be reactivated or worsened.

Musculoskeletal disorders

• Muscle spasms.
• Muscle weakness.

Renal and urinary disorders

• Impaired kidney function.
• Inflammation of the kidney.

General disorders

• Fever.
• Weakness.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it involves possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Conservation of Doneka Plus

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

• Do not store at temperatures above 40°C.

• 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.

• 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 are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Doneka Plus

• The active substances are lisinopril and hydrochlorothiazide. Each tablet contains 21.8 mg of lisinopril dihydrate (equivalent to 20 mg of anhydrous lisinopril) and 12.5 mg of hydrochlorothiazide.
• The other components are: mannitol (E421), calcium hydrogen phosphate dihydrate, corn starch, pregelatinized corn starch, magnesium stearate (E470b), and red iron oxide (E172).

Product appearance and contents of the pack

Doneka Plus is presented as pink, round, biconvex tablets with the imprint “LHZ” on one side and “32.5” on the other.

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 2022

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/