Patient Information Leaflet: Information for the Patient

Doneka Plus 20 mg/12.5 mg Tablets

lisinopril/hydrochlorothiazide

Read this leaflet carefully before you start taking 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. Do not give it to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

Table of Contents

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

Doneka Plus contains two medications, lisinopril and hydrochlorothiazide. Each one reduces blood pressure through a different mechanism. Lisinopril belongs to a group of medications called ACE inhibitors. Lisinopril acts by dilating blood vessels, helping to reduce blood pressure to facilitate the heart's ability to pump blood throughout the body. Hydrochlorothiazide is a diuretic that increases the amount of urine produced by the kidneys.

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

No take Doneka Plus

• If you are allergic to lisinopril, hydrochlorothiazide, or any of the other components of this medication (listed in section 6).
• If you have previously received a medication from the same group of drugs as lisinopril (angiotensin-converting enzyme inhibitors) and have experienced an allergic reaction that caused hives, 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 medication used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

-If a family member has had a severe allergic reaction (angioedema) to an angiotensin-converting enzyme inhibitor or if you have had a severe allergic reaction (angioedema) of unknown cause.

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

• If you are more than 3 months pregnant. It is also best to avoid this medication at the beginning of pregnancy - see section on pregnancy.
• If you have kidney function impairment.
• If you have recently undergone a kidney transplant.
• If you have decreased urine output or are unable to urinate (anuria).
• If you have liver function impairment.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.

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

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 that are in the heart) or the mitral valve (one of the valves that are 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 notice it as dizziness, especially when standing up. In these cases, lying down may help).

-You have heart failure (heart problem to pump enough blood to the body) and normal or low blood pressure.

• You have kidney problems or if you are on dialysis.

-You have liver problems.

• You have diabetes and are being treated with oral antidiabetic medications or insulin.
• You are taking any of the following medications used to treat high blood pressure (hypertension):
• An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in your blood (such as potassium), at regular intervals.

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

• If you are taking any medication that may increase the risk of angioedema, see “Taking Doneka Plus with other medications”:
• • Medications used to prevent organ rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

-Vildagliptin, a medication used to treat diabetes.

-You have gout.

• You have recently had diarrhea or vomiting.
• You are following a low-sodium diet, taking potassium supplements, or taking salt substitutes containing potassium.
• You are being treated with potassium-sparing diuretics or medications that may increase potassium levels in the blood, such as heparin.

-You have high cholesterol levels and are receiving a treatment called “LDL apheresis”.

• You are of black race, as this medication may be less effective. You are also more likely to develop the adverse effect “angioedema” (a severe allergic reaction).
• You have persistent dry cough.
• You have persistent low potassium levels in the blood.
• You have persistent high calcium levels in the blood.
• You are undergoing tests to detect thyroid or parathyroid gland abnormalities.
• Inform your doctor if you think you are (or plan to become) pregnant. Lisinopril/hydrochlorothiazide is not recommended at the beginning 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 section on pregnancy).
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Doneka Plus.
• If you experience a decrease in vision or eye pain, it may be a symptom of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to a week after taking Doneka Plus.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Doneka Plus, seek medical attention immediately.

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

Stop taking Doneka Plus and seek medical attention immediately if:

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

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

Allergic reactions such as insect bites

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

Surgery

If you are undergoing surgery (including dental surgery), inform your doctor or dentist that you are taking this medication. This is because you may experience low blood pressure (hypotension) if you are given certain local or general anesthetics while taking lisinopril/hydrochlorothiazide.

Be especially careful with the initial dose of this medication, as it may cause a more pronounced decrease in blood pressure than the usual treatment, which can be noticeable as dizziness or vertigo, in which case lying down may help. However, if you are concerned, consult your doctor.

Taking Doneka Plus with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This is because this medication may affect the way some medications work, and some medications may have an effect on this medication. Your doctor may need to adjust your dose and/or take other precautions.

Especially, inform your doctor or pharmacist if you are taking any of the following medications:

• Medications that cause a decrease in potassium levels in the blood, such as amphotericin (for fungal infections), carbenoxolone (for esophageal disease or oral ulcers), corticosteroids (e.g., prednisone), pituitary hormone (ACTH), or some laxatives, other diuretics (medications used to increase urine output, including potassium-sparing diuretics), and salicylate derivatives.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections: cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medication used to prevent blood clotting).
• Medications that cause arrhythmias.
• Medications for depression and mental disorders, including lithium.
• Medications, barbiturates, or alcohol that may exacerbate low blood pressure (you may notice it as dizziness, especially when standing up).
• Nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and indomethacin, for pain and arthritis treatment.
• Injectable medications for rheumatoid arthritis that contain gold salts (e.g., aurothiomalate sodium).
• Medications to control heart rhythm (antiarrhythmic agents) such as digoxin and beta-blockers (sotalol).
• Other medications for high blood pressure treatment (anti-hypertensives, including angiotensin II receptor antagonists or aliskiren (see “Do not take Doneka Plus”).
• Medications derived from nitrate (for heart problems).
• Medications for diabetes treatment (such as insulin and oral antidiabetic medications like sulfonylureas). You may need to adjust your antidiabetic medication dose while taking diuretics.
• • Diuretics tiazídicos.
• Medications that cause an increase in potassium levels in the blood, such as heparin (to prevent blood clotting).
• Potassium supplements or vitamin D.
• Medications to lower cholesterol, such as cholestyramine or colestipol or lovastatin.
• Muscle relaxants such as tubocurarine.
• Trimethoprim (an antibiotic).
• Alopurinol (for gout).
• Ciclosporina (medication to prevent organ rejection and other immune system disorders).
• Medications for cancer treatment, such as cyclophosphamide or methotrexate.

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

• Medications used to dissolve blood clots (tissue plasminogen activator) that are usually administered in the hospital.
• Medications used to prevent organ rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
• Racecadotrilo, a medication used to treat diarrhea.
• Vildagliptin, a medication used to treat diabetes.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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 find out you are pregnant and recommend that you take another medication instead of this medication.

Lisinopril/hydrochlorothiazide is not recommended at the beginning 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.

Usually, lisinopril/hydrochlorothiazide should be replaced with an appropriate antihypertensive treatment before becoming pregnant. The medication should not be used during the 2nd and 3rd trimesters of pregnancy.

Usually, your doctor will advise you to stop taking lisinopril/hydrochlorothiazide as soon as you find out you are pregnant.

If you become pregnant while taking this medication, inform and visit your doctor as soon as possible.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Hydrochlorothiazide (one of the components of the medication) is excreted in small amounts in breast milk, and at high doses, it may inhibit milk production. It is not recommended to use this medication in mothers during breastfeeding, and your doctor may choose another treatment for you if you want to start breastfeeding, especially if your baby is newborn or premature.

Driving and operating machinery

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

Use in athletes:

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Medication Taking

• 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 medication before or after meals.
• Do not stop taking your tablets if you feel well, unless your doctor tells you to.
• If you think the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

First Dose Taking

• Be especially careful when taking the first dose of this medication or if your dose is increased.

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

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

If this concerns you, consult your doctor as soon as possible.

Adults

-The usual dose is one or two tablets once a day.

Use in children and adolescents:

This medication is not recommended for use in children and adolescents as the 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, consult the Toxicological Information Service.Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Doneka Plus

• If you forgot 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 the missed doses.
• 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..

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following reactions,stop taking Doneka Plusand seek medical attention immediately.

• Severe allergic reactions (rare, may affect up to 1 in 100 people).The signs may include sudden onset of:
• Swelling of the face, lips, tongue, or throat. This may make it difficult to swallow.
• Severe or sudden swelling of the hands, feet, or ankles.
• Difficulty breathing.
• Severe skin itching (with hives).
• Severe skin disorders, such as unexpected and sudden rash, redness, or peeling of the skin (very rare, may affect up to 1 in 10,000 people).
• Infection with symptoms such as fever and severe deterioration of your general condition, or fever with local infection symptoms such as throat, pharynx, or mouth irritation or urinary tract disorders
• (very rare, may affect up to 1 in 10,000 people).
• Acute eye pain with redness, as if not treated, it could lead to permanent vision loss.

Other possible side effects due to lisinopril:

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

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

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

• Changes in some blood cells or other components of your blood. Your doctor may take samples from time to time to check if lisinopril/hydrochlorothiazide is affecting your blood. The signs may include fatigue, pale skin, sore throat, fever, joint and muscle pain, inflammation of the joints or glands, or sensitivity to sunlight.
• Confusion.
• Hives.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin condition).
• Development of breasts in men.
• Sudden kidney failure.
• Change in the smell of things
• Decreased sodium levels in the blood (hyponatremia) (the symptoms may be fatigue, headache, nausea, vomiting).

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

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

Unknown frequency(cannot be estimated from available data):

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

Other side effects due to hydrochlorothiazide (unknown frequencies):

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

• Cancer of the skin and lips (non-melanoma skin cancer).

Blood and lymphatic system disorders

• Medullary 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 the destruction of red blood cells (hemolytic anemia).

Metabolic and nutritional disorders

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

Psychiatric disorders

-Anxiety.

• Depression.
• Sleep disturbances.

Nervous system disorders

-Loss of appetite.

• Feeling of tingling in the hands and feet.
• Feeling of dizziness.

Eye disorders

-Changes in vision that make you see objects as yellow.

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

Ear disorders

-Dizziness.

Cardiac disorders

-Postural hypotension.

Vascular disorders

-Phlebitis.

Respiratory, thoracic, and mediastinal disorders

-Shortness of breath.

• Pneumonia.
• Acute respiratory distress (the signs include severe shortness of breath, fever, weakness, and confusion) (very rare).

Digestive disorders

-Stomach irritation.

• Diarrhea.
• Constipation.
• Pancreatitis.

Liver disorders

• Yellowing of the skin (jaundice).

Skin and subcutaneous tissue disorders

• Sunlight sensitivity reaction.
• Rash.
• Hives.
• Urticaria.
• Hives with blisters.
• In some patients with lupus, it may reactivate or worsen their symptoms.

Musculoskeletal disorders

• Muscle spasms.
• Muscle weakness.

Renal and urinary disorders

• Renal function alteration.
• Nephritis.

General disorders

• Fever.
• Weakness.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse reactions, 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 store at a temperature above 40°C.
• 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.

-Medications should not be disposed of through drains or in the trash. Dispose of the 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 the packaging and medications you no longer need. By doing so,

you will help protect the environment.

Composition of Doneka Plus

• The active principles 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 dihydrogen phosphate, cornstarch, pregelatinized cornstarch, magnesium stearate (E470b), and iron oxide red (E172).

Appearance of the product and contents of the packaging

Doneka Plus is presented in the form of pink, round, biconvex tablets with the inscription “LHZ” on one face and “32.5” on the other.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

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

Last review date of this leaflet: September 2022

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