DONEKA PLUS 20/12.5 mg TABLETS

Introduction

Patient Information Leaflet

Doneka Plus 20 mg/12.5 mg tablets

lisinopril/hydrochlorothiazide

Read the entire leaflet carefully before starting to use this medication, 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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

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

Doneka Plus contains two medications, lisinopril and hydrochlorothiazide. Each of them 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).

2. What you need to know before taking Doneka Plus

Do not take Doneka Plus

• If you are allergic to lisinopril, hydrochlorothiazide, or any of the other ingredients of this medication (listed in section 6).
• If you have previously received any medication from the same group of drugs as lisinopril (ACE inhibitors) and have presented an allergic reaction that caused 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 ever had an allergic reaction to diuretics of the hydrochlorothiazide type, which are similar to sulfonamides (a type of antibiotic) or to any other compound in this medication.

• If you are pregnant for more than 3 months. It is also best to avoid this medication at the beginning of pregnancy - see the section on pregnancy.
• If you have kidney function impairment.
• If you have recently undergone a kidney transplant.
• If you have decreased urine production or inability to urinate (anuria).
• If you have liver function impairment.
• If you have diabetes or kidney failure and are being treated with a blood pressure medication 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 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 notice it as dizziness, especially when standing up. In these cases, lying down may help).

-

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

-

• You have diabetes and are being treated with oral antidiabetics or insulin.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., 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":
• • racecadotril, a medication used to treat diarrhea.
  • medications used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).

• vildagliptin, a medication used to treat diabetes.

-

• You have recently had diarrhea or vomiting.
• You are on a low-salt diet, taking potassium supplements, or using salt substitutes containing potassium.
• You are being treated with diuretics (medications used to increase urine production) that spare potassium or medications that can 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 side effect "angioedema" (a severe allergic reaction).
• You have a persistent dry cough.
• You have persistently low potassium levels in the blood.
• You have persistently high calcium levels in the blood.
• You are undergoing tests to detect thyroid or parathyroid disorders.
• You must inform your doctor if you think you are (or plan to become) pregnant. It is not recommended to use lisinopril/hydrochlorothiazide at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to the baby if used during this period (see the 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 skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Doneka Plus.
• If you experience a decrease in vision or eye pain, they could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure, and they can occur within a few hours to a week after taking Doneka Plus.
• If you have had respiratory or lung 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 if 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 swelling of the face, lips, tongue, and/or throat, which can cause difficulty swallowing.
• You experience intense itching of the skin (with hives).

Treatment of allergies such as insect bites

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

Surgery

If you are going to undergo 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 careful with the initial dose of this medication, as it may cause a more pronounced decrease in blood pressure than what is normally achieved with continued treatment. This effect may be noticed as dizziness or a feeling of 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 recently used, or may need to use any other medication. This is because this medication may affect how some medications work and some medications may affect this medication. Your doctor may need to adjust your dose and/or take other precautions.

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

• Medications that decrease 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 certain laxatives, other diuretics (medications used to increase urine production, including potassium-sparing diuretics), and salicylate derivatives.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that can increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medication used to prevent organ rejection; and heparin, a medication used to thin the blood to prevent clots).
• Medications that cause arrhythmias.
• Medications for depression and mental disorders, including lithium.
• Anesthetic medications, barbiturates, or alcohol that can enhance the decrease in blood pressure (you may notice it as dizziness, especially when standing up).
• Non-steroidal anti-inflammatory medications (NSAIDs), including aspirin, ibuprofen, and indomethacin, for pain and arthritis treatment.
• Injectable medications for rheumatoid arthritis that contain gold salts (e.g., sodium aurothiomalate).
• Medications to control heart rate (antiarrhythmic agents) such as digoxin and beta-blockers (sotalol).
• Other medications for high blood pressure treatment (antihypertensives, including angiotensin II receptor antagonists (ARA) or aliskiren (see "Do not take Doneka Plus")).
• Nitrate-derived medications (for heart problems).
• Medications for diabetes treatment (such as insulin and oral antidiabetics like sulfonylureas). It may be necessary to adjust the dose of your antidiabetic medication while taking
• • thiazide diuretics.
• Medications that increase potassium levels in the blood, such as heparin (to prevent blood clot formation).
• Calcium or vitamin D supplements.
• Medications to lower cholesterol, such as colestipol or cholestyramine or lovastatin.
• Muscle relaxants like tubocurarine.
• Trimethoprim (an antibiotic).
• Allopurinol (for gout).
• Cyclosporine (a medication to prevent organ rejection and other immune system diseases).
• Medications for cancer treatment, such as cyclophosphamide or methotrexate.

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

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

Pregnancy, Breastfeeding, and Fertility

Pregnancy

You must inform your doctor if you think you are (or plan to become) pregnant. Normally, your doctor will 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 one. Lisinopril/hydrochlorothiazide is not recommended at the beginning of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to the baby if used during this period.

Normally, lisinopril/hydrochlorothiazide should be replaced with a suitable antihypertensive treatment before starting pregnancy. The medication should not be used during the 2nd and 3rd trimesters of pregnancy.

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

If you become pregnant during treatment with this medication, inform and consult 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, may inhibit milk production. It is not recommended to use this medication in breastfeeding mothers, and your doctor may choose another treatment for you if you wish to start breastfeeding, especially if your baby is newborn or premature.

Driving and Using Machines

• It is unlikely that Doneka Plus will affect your ability to drive or use machines. However, like other medications 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 you consume alcohol. If you experience dizziness or drowsiness, consult your doctor before performing these activities.
• You should wait to see how the medication affects you before attempting to perform these activities.

Use in Athletes:

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

3. How to Use Doneka Plus

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Taking the Medication

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

Taking the First Dose

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

It may cause a greater decrease in blood pressure than what will occur with subsequent doses.

• This effect may make you feel dizzy or lightheaded. If this happens, 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 a day.

Use in Children and Adolescents:

The use of lisinopril/hydrochlorothiazide is not recommended 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 Toxicology Information Service. Phone 91 562 04 20, indicating the medication and the amount taken.

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 the missed doses.
• Do not stop treatment before your doctor tells you to do so.

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 all people suffer from them.

If you experience any of the following reactions, stop taking Doneka Plusand consult your doctor immediately.

• Severe allergic reactions (uncommon, may affect up to 1 in 100 people). The signs may include the sudden appearance of:
• Swelling of the face, lips, tongue, or throat. This can make swallowing difficult.
• Severe or sudden swelling of the hands, feet, or ankles.
• Difficulty breathing.
• Severe skin itching (with hives).
• Severe 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 of your general condition, or fever with symptoms of local infection such as 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 if left untreated, it could lead to permanent vision loss.

Other possible adverse 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.
• Kidney disorders (detected by blood tests).
• Fainting.

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

• Mood changes.
• Change in finger and toe color (pale blue followed by redness) or numbness or tingling in the fingers or toes.
• Feeling of dizziness.
• Drowsiness.
• Difficulty sleeping.
• Seeing and/or hearing hallucinations.
• Rhinitis.
• Nausea.
• Stomach pain or indigestion.
• Changes in blood tests to determine liver and kidney function.
• Skin rash or itching.
• Inability to have an erection (impotence).
• Feeling of fatigue or weakness (lack of strength).
• A significant decrease in blood pressure that can occur in people in the following situations: coronary artery disease, aortic stenosis (a heart artery), renal arteries, or heart valves; thickening of the heart muscle. If this happens to you, you may feel
• 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 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, throat irritation, fever, joint and muscle pain, inflammation of the joints or glands, or sensitivity to sunlight.
• Confusion.
• Rash with hives.
• Dry mouth.
• Hair loss.
• Psoriasis (a skin problem).
• Development of breast tissue in men.
• Sudden kidney failure.
• Change in the smell of things
• Decrease in sodium levels in the blood (hyponatremia) (symptoms may be fatigue, headache, nausea, vomiting).

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

• Low blood sugar levels (hypoglycemia). The signs may include a feeling of hunger or weakness, sweating, and rapid heartbeat.
• Sinusitis (feeling of pain and pressure behind the cheeks and eyes).
• Shortness of breath.
• Lung inflammation. 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 the whites of the eyes (jaundice).
• Liver inflammation. This can 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.

Frequency Not Known(cannot be estimated from the available data):

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

Other Adverse Effects Due to Hydrochlorothiazide (Frequencies NotKnown):

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 platelet count (thrombocytopenia).
• Reduction in white blood cell count (leukopenia).
• Decrease in granulocyte count (agranulocytosis).
• Anemia due to red blood cell destruction (hemolytic anemia).

Metabolic and nutritional disorders

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

Psychiatric disorders

-

• Depression.
• Sleep disturbances.

Nervous system disorders

-

• Tingling sensation in hands and feet.
• Feeling of dizziness.

Eye disorders

-Changes in vision that make you see objects yellowish.

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

Hearing disorders

-

Cardiac disorders

-

Vascular disorders

-

Respiratory, thoracic, and mediastinal disorders

-

• Lung inflammation.
• Acute breathing difficulties (symptoms include severe breathing difficulties, fever, weakness, and confusion) (very rare frequency).

Gastrointestinal disorders

-

• Diarrhea.
• Constipation.
• Pancreatitis.

Liver disorders

• Yellowing of the skin (jaundice).

Disorders of the skin and subcutaneous tissue

• Skin reaction caused by sensitivity to sunlight.
• Rash.
• Urticaria.
• Skin rash with hives.
• In some patients with lupus, it can reactivate or worsen their symptoms.

Musculoskeletal disorders

• Muscle spasms.
• Muscle weakness.

Renal and urinary disorders

• Kidney function impairment.
• Kidney inflammation.

General disorders

• Fever.
• Weakness.

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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Doneka Plus

-

• Do not store above 40°C.
• Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

• Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Doneka Plus

• The active ingredients 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 ingredients are: mannitol (E421), calcium hydrogen phosphate dihydrate, corn starch, pregelatinized corn starch, magnesium stearate (E470b), and red iron oxide (E172).

Appearance of the Product and Package Contents

Doneka Plus is presented in the form of pink, round, biconvex tablets with the inscription "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 Last Revision of this Leaflet: September 2022

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