PATIENT INFORMATION LEAFLET

Lisinopril/Hidroclorotiazida Teva-ratiopharm belongs to the group of anti-hypertensive medications that contain an ACE inhibitor (angiotensin-converting enzyme inhibitor).

Lisinopril/Hidroclorotiazida Teva-ratiopharm contains two active substances, lisinopril and hidroclorotiazida, which lower blood pressure through different mechanisms. Lisinopril prevents the formation of hypertensive agents in the body, and hidroclorotiazida reduces blood pressure by increasing the elimination of water and salts from the body.

Lisinopril/Hidroclorotiazida Teva-ratiopharm is indicated for the treatment of hypertensionwhen the desired result has not been achieved with monotherapy alone.

Do not take Lisinopril/Hidroclorotiazida Teva-ratiopharm

• If you are allergic to lisinopril dihydrate, other ACE inhibitors, hydrochlorothiazide, thiazides, sulfonamide derivatives, or any of the other components of this medication (listed in section 6).
• If you have previously been treated with an ACE inhibitor and have experienced hypersensitivity reactions that manifested, for example, as swelling of the face, lips, tongue, and/or throat and were accompanied by difficulty swallowing or breathing, or if you have experienced similar reactions for any other reason.
• If you have a family history of angioedema or have experienced angioedema in any other circumstance.
• If you are more than three months pregnant (it is better to avoid Lisinopril/Hidroclorotiazida Teva-ratiopharm in the early stages of pregnancy - see the Pregnancy section).
• If you have severe kidney or liver problems.
• If your kidneys produce very little urine or no urine.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you have taken or are currently taking sacubitrilo/valsartan, a medication used to treat a type of chronic heart failure in adults, the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lisinopril/Hidroclorotiazida ratiopharm

• 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 Lisinopril/Hidroclorotiazida ratiopharm, seek medical attention immediately.
• If you are using diuretics, your diet contains little or no salt, or if you are currently experiencing or have experienced severe diarrhea or vomiting.
• If you are taking any of the following medications used to treat high blood pressure:

• 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 renal function, blood pressure, and electrolyte levels in your blood (such as potassium) at regular intervals.

• See also the information under the heading “Do not use Lisinopril/Hidroclorotiazida ratiopharm”

• If you have coronary artery disease or cerebrovascular disease,
• If you have a narrowing of the main artery (aortic stenosis) that exits the left side of the heart or a narrowing of a heart valve (mitral stenosis)
• If you have hypertrophic cardiomyopathy
• If you have low blood pressure. Symptoms of low blood pressure include dizziness or lightheadedness, especially when standing up
• If you have kidney insufficiency or are receiving dialysis,
• If you have recently had a kidney transplant
• If you have bilateral renal artery stenosis or stenosis of the artery of the single functioning kidney,
• If you have diabetes or vascular collagen disease,
• If you have gout
• If you have recently had diarrhea or vomiting (nausea)
• If your doctor has advised you to control the amount of salt in your diet
• If you are taking potassium tablets or salt substitutes containing potassium
• If you have liver insufficiency or other liver disease,
• If you are receiving desensitization treatment for insect venom,
• If you have persistent dry cough for a long time.
• If you have high cholesterol and are receiving a treatment called “LDL apheresis”
• If you are taking lithium (a medication for depression) at the same time
• Due to your ethnic origin (particularly in black patients), the effect of lisinopril/hydrochlorothiazide may be reduced. You may also be more likely to have an allergic reaction (angioedema)
• If you are taking any of the following medications, the risk of angioedema may increase:
• • Racecadotrilo, a medication used to treat diarrhea;
  • Medications used to prevent organ transplant rejection and for cancer (for example, temsirolimus, sirolimus, everolimus);
  • Vildagliptina, a medication used to treat diabetes.
  • Medications containing a tissue plasminogen activator

The symptoms of angioedema include swelling of the face, lips, tongue, and/or throat with difficulty swallowing and breathing

• IfYou 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 cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Lisinopril/Hidroclorotiazida Teva-ratiopharm.
• If you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, and may occur within a few hours to a week after taking Lisinopril/Hidroclorotiazida Teva-ratiopharm. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing it.

Children and adolescents

Do not administer Lisinopril/Hidroclorotiazida ratiopharm to children under 18 years of age. There is limited information on the safety and efficacy of Lisinopril/Hidroclorotiazida in children.

Older adults

In patients over 65 years of age, blood pressure, certain laboratory values, electrolytes, creatinine, blood sugar, and hemoglobin should be monitored, especially at the beginning of treatment. Dosage should be adjusted with special care in elderly patients.

Kidney

If you have kidney insufficiency, it is essential not to take potassium supplements or potassium-sparing diuretics during treatment with lisinopril/hydrochlorothiazide, as it may increase potassium levels in your body excessively.

Surgery

Inform your doctor that you are using Lisinopril/Hidroclorotiazida Teva-ratiopharm if you need to undergo surgery (including dental surgery) during treatment, as some anesthetic agents used during surgery may cause excessive blood pressure decrease in combination with Lisinopril/Hidroclorotiazida Teva-ratiopharm.

Pregnancy

Inform your doctor if you think you are (or may be) pregnant. Lisinopril/hydrochlorothiazide is not recommended in the early stages of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period (see the Pregnancy section).

While taking Lisinopril/Hidroclorotiazida Teva-ratiopharm

If you develop any of the following symptoms, inform your doctor immediately:

• If you feel dizzy after the first dose. Some people react to Lisinopril/Hidroclorotiazida Teva-ratiopharm with the first dose or when it is increased, with dizziness, weakness, fainting, and vomiting,
• Sudden swelling of the lips and face, neck, and possibly hands and feet, or breathing difficulties. This condition is called angioedema. ACE inhibitors have a higher rate of angioedema in black patients than in white patients,
• High temperature, sore throat, or mouth ulcers (these may be symptoms of an infection caused by reduced white blood cell count),
• Yellowing of the skin and eyes (jaundice) may be signs of liver disease.

At the beginning of treatment and/or during the dosage adjustment period, it may be necessary to increase the frequency of medical check-ups. Do not skip these visits even if you feel well. Your doctor will determine the frequency of medical check-ups.

Taking Lisinopril/Hidroclorotiazida with other medications

The concomitant use of other medications may affect the efficacy and safety of this medication. On the other hand, Lisinopril/Hidroclorotiazida Teva-ratiopharm may affect the safety and efficacy of other medications. Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, herbal products, and natural remedies. Remember to tell your doctor that you are taking Lisinopril/Hidroclorotiazida Teva-ratiopharm if they prescribe another medication during treatment or shortly after.

It is especially important to inform your doctor if you are taking:

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (for example, trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ transplant rejection and for cancer; heparin, a medication used to dilute blood to prevent clots).
• Other antihypertensive agents,

Your doctor may need to adjust your dosage and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not use Lisinopril/Hidroclorotiazida Teva-ratiopharm” and “Warnings and precautions”).

• Other diuretics
• Alopurol (a medication for gout), procainamide (an antiarrhythmic medication), oral corticosteroids, cytostatic agents (cancer medications) or medications that affect the body's immune system (such as ciclosporin),
• Lithium (a medication used in bipolar affective disorder),
• Antipsychotic medications or central nervous system stimulants,
• Nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin
• Certain anesthetics
• Vitamin D preparations
• Insulin or oral antidiabetic medications,
• Lovastatin, cholestyramine, or colestipol (to reduce cholesterol),
• Digoxin (for heart disease),
• Antiarrhythmic medications
• Sotalol (an antiarrhythmic medication),
• Anfotericin B (an antifungal medication),
• Carbenoloxolone (for ulcers),
• Certain pituitary gland hormones (ACTH)
• Laxatives (medications that help with bowel movements),
• Racecadotrilo (used to treat diarrhea)
• Sacubitrilo/valsartan (used to treat high blood pressure)
• Vildagliptina (used to treat diabetes)
• Certain medications used to treat asthma
• Medications for nasal congestion or sinusitis or other cold medications (including those you can buy without a prescription at pharmacies)
• Tubocurarina (a muscle relaxant),
• Gold
• Diazoxide (used, for example, to treat hypoglycemia)
• Amantadina (used to treat Parkinson's disease or to treat severe viral infections)
• Barbiturates (a type of sedative also used to treat epilepsy)
• Alcohol
• Adrenergic amines such as noradrenaline (substances that increase blood pressure)
• Tissue plasminogen activator (a medication used to dissolve blood clots)
• Medications that are more often used to prevent organ transplant rejection (sirolimus, everolimus, and other medications belonging to the mTOR inhibitor class). See the section “Warnings and precautions”

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you are (or may be) 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 advise you to take another medication instead of Lisinopril/Hidroclorotiazida Teva-ratiopharm. Lisinopril/Hidroclorotiazida Teva-ratiopharm is not recommended in the early stages of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Lisinopril/Hidroclorotiazida Teva-ratiopharm is not recommended in breastfeeding mothers, and your doctor should choose another treatment if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

At the beginning of treatment, when the dosage is changed, or in combination with alcohol, Lisinopril/Hidroclorotiazida Teva-ratiopharm may have mild to moderate effects on your ability to drive or operate machinery that requires special attention. You should be aware that when driving vehicles or operating machinery, dizziness or fatigue may occur.

Athletes

Warning to athletes: This medication contains an active substance (hydrochlorothiazide) that may result in a positive test in a doping control.

Lisinopril/Hidroclorotiazida Teva-ratiopharm contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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.

The recommended dose is one or two tablets per day. Your doctor will decide the dose you should take based on previous treatment with the separate medications lisinopril and hidroclorotiazida.

Renal Insufficiency

The dose depends on the degree of insufficiency. Follow your doctor's instructions.

Before Diuretic Treatment

Diuretic treatment should be suspended from 2 to 3 days before starting treatment with Lisinopril/Hidroclorotiazida Teva-ratiopharm. Follow your doctor's instructions.

Dose Change

Do not change the dose or stop taking the medication without consulting your doctor first.

If You Take More Lisinopril / Hidroclorotiazida Teva-ratiopharm Than You Should

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

Immediately consult your doctor or the nearest hospital if you have taken more doses than you should (overdose). An overdose may cause a significant drop in blood pressure, which can lead to dizziness and mild headache. Symptoms may include shortness of breath, acceleration or slowing of the heart, palpitations, anxiety, or cough.

If You Forget to Take Lisinopril/Hidroclorotiazida Teva-ratiopharm

Do not take a double dose to compensate for the missed doses.

Resume the usual schedule.

If You Interrupt Treatment with Lisinopril/Hidroclorotiazida Teva-ratiopharm

Do not stop taking the medication without consulting your doctor first.

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.

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

Unknown: the frequency cannot be estimated from available data

If you notice any of the following side effects, stop taking lisinopril/hydrochlorothiazide and contact a doctor immediately:

• Severe allergic reactions (uncommon), which may include the following symptoms that may appear suddenly:
• • Swelling of the face, lips, tongue, or throat. This may cause difficulty swallowing
  • Severe or sudden swelling of the hands, feet, and ankles
  • Difficulty breathing
  • Intense itching of the skin (with blisters)
• Severe skin conditions, such as a sudden and unexpected rash or a sensation of burning, redness, or peeling of the skin (very rare)
• A severe infection with fever and a significant deterioration in your general condition, or fever with signs of a local infection such as sore throat, tonsillitis, or urinary problems (very rare)

Lisinopril

Common

Dizziness, headache, fainting, hypotension associated with symptoms (dizziness, weakness, blurred vision), dry cough, vomiting, diarrhea, renal dysfunction.

Uncommon

Mood changes, paresthesia, vertigo, taste alterations, sleep disturbances, depressive symptoms, hallucinations, tachycardia, palpitations, myocardial infarction or stroke (in high-risk patients possibly secondary to excessive hypotension), skin color change (pale or blue followed by redness) and/or numbness or tingling in the fingers of the hands and feet (Raynaud's syndrome), rhinitis, nausea, abdominal pain, indigestion, increased liver enzymes and bilirubin, itching with or without rash, skin rash, impotence, fatigue, asthenia, increased urea in the blood, increased serum creatinine, hyperkalemia.

Rare

Anemia, decreased hemoglobin, syndrome of inappropriate antidiuretic hormone secretion (SIADH), confusion, altered sense of smell, dry mouth, urticaria, psoriasis, hair loss, renal function disorders including renal insufficiency, uremia, development of breast tissue in men, hyponatremia.

Very rare

Poor bone marrow production, small number of platelets (thrombocytopenia), decreased white blood cell count (neutropenia, leucopenia), reduced number of white blood cells (agranulocytosis), making infections more likely, lymph node diseases, autoimmune diseases, where the body attacks itself, anemia, hemolytic anemia, bronchospasm, sinusitis, allergic alveolitis/neumonia eosinophilia, pancreatitis, allergic reaction in the small intestine (intestinal angioedema), liver insufficiency and cholestasis (including jaundice), hepatitis including necrosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, erythroderma, pemphigoid reactions, and exfoliative dermatitis, decreased or absent urine excretion, low blood sugar (hypoglycemia).

A complex symptom has been reported that may include one or more of the following: fever, vasculitis, myalgia, arthralgia/arthritis, positive antinuclear antibodies (ANA), elevated erythrocyte sedimentation rate, eosinophilia, and leucocytosis, rash, photosensitivity, and other dermatological manifestations may appear.

Unknown

Severe allergic reaction (anaphylactic/anaphylactoid reaction), flush.

Hydrochlorothiazide

Very rare

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Unknown

Salivary gland inflammation, cancer of the skin and lips (non-melanoma skin cancer),leucopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bone marrow depression, anorexia, hyperglycemia, glucosuria, hyperuricemia, electrolyte imbalance (including hyponatremia, hypocalcemia, hypochloremic alkalosis, and hypomagnesemia), increased cholesterol and triglycerides, gout, restlessness, depression, sleep disturbances, loss of appetite, paresthesia, photosensitivity to light, yellow vision, transient blurred vision, decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma), vertigo, postural hypotension, necrotizing angitis (vasculitis, cutaneous vasculitis), respiratory distress (including pneumonitis and pulmonary edema), gastric irritation, diarrhea, constipation, pancreatitis, jaundice (intrahepatic cholestatic jaundice), photosensitivity reactions, rash, cutaneous lupus erythematosus, systemic lupus erythematosus, cutaneous lupus erythematosus reactions, urticaria, anaphylactic reactions, toxic epidermal necrolysis, muscle spasms, muscle weakness, renal dysfunction, interstitial nephritis, fever, weakness.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, website:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep 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.

This medication does not require special storage conditions.

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

Lisinopril/Hidroclorotiazida Teva-ratiopharm 20/12,5 mg Composition

The active ingredients are: Lisinopril (as lisinopril dihydrate) and hydrochlorothiazide.

Each tablet contains 20 mg of lisinopril (as lisinopril dihydrate) and 12.5 mg of hydrochlorothiazide.

The other components are: mannitol, calcium hydrogen phosphate dihydrate, pregelatinized cornstarch without gluten, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the package

White, round, scored tablets with “LH” marked on the other side.

Lisinopril/Hidroclorotiazida Teva-ratiopharm 20/12,5 mg is available in PVC/PVDC/Aluminum blisters and polypropylene bottles with a low-density polyethylene screw cap and desiccant.

Each package contains blisters of 10, 28, 30, 50, 56, 60, 98, 100, 50 x 1 (perforated single-dose blister), 100 x 1 (perforated single-dose blister), and 500 x 1 (perforated single-dose blister) tablets.

Polypropylene bottles: 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 - Madrid

Responsible manufacturer

Merckle GmbH

Ludwig-Merckle-Street 3

89143 Blaubeuren (Germany)

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: July 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://http://www.aemps.gob.es/