Prospecto: information for the user

Lisinopril/Hidroclorotiazida Teva 20 mg/12,5 mg Tablets EFG

lisinopril and hydrochlorothiazide

Read this prospect carefully before starting to take this medicine, as it contains important information for you

• Keep this prospect, as you may need to read it again
• If you have any doubts, consult your doctor or pharmacist
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4

1. What is Lisinopril/Hidroclorotiazida Teva and how it is used

2. What you need to know before starting to take Lisinopril/Hidroclorotiazida Teva

3. How to take Lisinopril/Hidroclorotiazida Teva

4. Possible adverse effects.

5. Storage of Lisinopril/Hidroclorotiazida Teva

6. Contents of the package and additional information

Lisinopril/Hidroclorotiazida Teva contains lisinopril and hidroclorotiazida.

Lisinopril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. ACE inhibitors are vasodilators (medicines that widen blood vessels, making it easier for the heart to pump blood throughout the body)

Hidroclorotiazida belongs to a group of medicines called diuretics or "water pills". Diuretics increase the amount of water you lose in your urine and therefore reduce the amount of fluid in your blood vessels.

Since each of these medicines lowers blood pressure in a different way, Lisinopril/Hidroclorotiazida Teva can be used together to treat high blood pressure when taking these medicines alone does not control blood pressure sufficiently.

Do not take Lisinopril/Hidroclorotiazida Teva

• If you are allergic to lisinopril or hidroclorotiazida, or to any of the other components of this medication (listed in section 6)
• If you are allergic to sulfonamides (e.g. trimetoprim)
• If you have had an inexplicable allergic reaction or an allergic reaction to other ACE inhibitors, e.g. captopril, enalapril, that caused inflammation of the face, lips, tongue, and/or throat.
• If you have been diagnosed with a condition known as hereditary angioedema or have a history of angioedema (a sudden severe swelling of the skin in a particular area that often affects the eyes, lips, nose, tongue, larynx, hands, or intestines)
• If you have severe liver or kidney problems

• If you are more than 3 months pregnant. (It is also best to avoid Lisinopril/Hidroclorotiazida in the early months of pregnancy – see section “Pregnancy and breastfeeding”)
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you have taken or are currently taking sacubitrilo/valsartán, 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 taking this medication:

• If you think you are (or may become) pregnant. Lisinopril/Hidroclorotiazida tablets are not recommended in the early months of pregnancy, and may cause serious harm to the baby if taken after the third month of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience shortness of breath or severe difficulty breathing after taking Lisinopril/Hidroclorotiazida Teva, seek medical attention immediately.
• If you have a risk of high potassium levels in your blood, e.g. by taking salt substitutes or supplements containing potassium.
• If you have a low-sodium diet
• If you have diarrhea or vomiting
• If you have an electrolyte imbalance in your blood
• If you have heart valve disease (aortic or mitral) or an increase in cardiac muscle thickness
• If you have liver disease or problems;
• If you have kidney problems, need dialysis, or have had a kidney transplant.
• If you have diabetes. You may need a different dose of your antidiabetic medication (including insulin)
• If you have gout;
• If you are being treated with a diuretic.
• If you have vascular problems (collagen vascular disease).
• If you have low blood pressure. You may feel dizzy or lightheaded, especially when standing up.
• If you have circulation problems in the heart or brain, as a sudden drop in blood pressure can cause a heart attack or stroke.
• If you have a history of allergy, asthma, or systemic lupus erythematosus (a type of allergic disease that causes joint pain, skin rashes, and fever)
• If you need blood separation treatment (apheresis) or desensitization treatment, e.g. after a bee or wasp sting; your doctor may interrupt treatment with this medication to prevent a possible allergic reaction
• If you need surgery or general anesthesia. Consult your doctor, dentist, or hospital staff while taking this medication, as your blood pressure may drop suddenly.
• If you are taking lithium (a medication for mood stabilization)
• If you engage in competitive sports, as hidroclorotiazida is a banned substance and may give a positive result in anti-doping tests
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The treatment with hidroclorotiazida, 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 the sun and UV rays while taking Lisinopril/Hidroclorotiazida Teva.
• If you are of black or Afro-Caribbean descent: ACE inhibitors may be less effective in reducing blood pressure in this group of patients, and a higher dose of this medication may be needed.
• If you are taking any of the following medications used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) (also known as “sartanes” – e.g. valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes
• Aliskirén

• 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 (e.g. temsirolimus, sirolimus, everolimus);
• Vildagliptina, a medication used to treat diabetes.
• Medications containing a tissue plasminogen activator

• If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which can occur within a few hours to weeks after taking Lisinopril/Hidroclorotiazida Teva. This can 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.

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in your blood at regular intervals.

See also the information under the heading “Do not take Lisinopril/Hidroclorotiazida Teva”

While taking Lisinopril/HCTZ Tablets

Your doctor will closely monitor your condition, perform blood tests, check your renal function, and monitor your body's electrolyte levels from time to time.

If you experience sudden swelling of the lips, face, neck, and possibly hands and feet, skin rash, difficulty swallowing or breathing, hoarseness, these are signs of a severe allergic reaction called angioedema. This can occur at any time during treatment. There is a higher risk in patients of black or Afro-Caribbean descent. If this occurs, stop taking the tablets and consult your doctor immediately or go to the emergency department of your nearest hospital.

Children and adolescents

Lisinopril/HCTZ is not recommended for use in children and adolescents because the safety and efficacy of Lisinopril/HCTZ in children have not been established.

Taking Lisinopril/HCTZ with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, especially if you are taking any of the following:

• Diuretics ("water pills") such as furosemide, torasemide, amilorida
• Nonsteroidal anti-inflammatory drugs (NSAIDs) that are a type of analgesic, e.g. aspirin or ibuprofen
• Gold preparations

• Other medications to lower blood pressure, as your blood pressure may become too low
• Your doctor may need to modify your dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Lisinopril/Hidroclorotiazida Teva” and “Warnings and precautions”).
• Tricyclic antidepressants (e.g. amitriptilina), as these will lower your blood pressure further
• Antipsychotics, e.g. clorpromazina (used to treat mental disorders), which can cause low blood pressure
• Sympathomimetics, e.g. adrenaline, noradrenalina, or efedrina, as the effectiveness of lisinopril may be reduced. Ephedrine may be present in cold and nasal congestion medications.
• Insulin or tablets for diabetes treatment, as the risk of hypoglycemia may be increased
• Allopurinol for gout treatment, as there is an increased risk of a blood disorder called leucopenia (a reduction in the number of white blood cells) and kidney failure
• Ciclosporina (used after an organ transplant), as the risk of kidney failure may be increased
• Lovastatina (a medication that reduces cholesterol levels in your blood)
• Procainamida, used to treat abnormal heart rhythms, as there is an increased risk of a blood disorder called leucopenia (a reduction in the number of white blood cells)
• Cytostatics (cancer medications) and immunosuppressants
• Amfotericina B (used to treat serious fungal infections)
• Carbenoxolona (used to treat stomach and duodenal ulcers)
• Corticosteroids, e.g. prednisolona
• A hormone called corticotropina (ACTH)
• Laxatives, e.g. lactulosa
• Racecadotrilo (for diarrhea treatment)
• Calcium/vitamin D supplements
• Cardiac glycosides, e.g. digoxina
• Medications that reduce cholesterol levels in your blood, such as colestiramina or colestipol, as they may affect the absorption of hidroclorotiazida. Lisinopril/HCTZ can be taken at least one hour before or four to six hours after these medications.
• Sotalol (beta-blocker), as there is an increased risk of abnormal heart rhythms
• Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medications that may increase potassium levels in the blood (e.g. trimetoprim and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection and heparina, a medication used to dilute blood to prevent clots).
• Lithium, as lithium levels may be increased
• Medications that are more often used to prevent organ transplant rejection (sirolimus, everolimus, and other medications in the mTOR inhibitor group). See section “Warnings and precautions”
• Certain medications for asthma treatment,
• Non-depolarizing muscle relaxants (e.g. tubocurarina chloride),
• Diazóxido (used to treat hypoglycemia, among other things),
• Amantadina (for Parkinson's disease treatment or serious viral infections),
• Barbiturates (a type of sedative that is also used to treat epilepsy),
• Alcohol,
• Adrenergic amines such as noradrenalina (substances that increase blood pressure),
• Tissue plasminogen activator (a medication used to dissolve blood clots).

Lisinopril/Hidroclorotiazida Teva with alcohol

Drinking alcohol while taking Lisinopril/Hidoclorotiazida may have addictive effects and cause dizziness or fainting.

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you think you are (or may become) pregnant. Normally, your doctor will advise you to stop taking Lisinopril/Hidroclorotiazida before becoming pregnant or as soon as you know you are pregnant and advise you to take another medication instead of Lisinopril/Hidroclorotiazida. Lisinopril/Hidroclorotiazida is not recommended during pregnancy, and it should not be taken when you are more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.

Lactation

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Lisinopril/Hidroclorotiazida is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed your baby, especially if it is a newborn or premature.

Driving and operating machinery

If you feel tired or dizzy, do not drive or operate machinery, especially at the beginning of your treatment or if you have changed your medication, or if you take it with alcohol.

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

If you are already taking diuretics, your doctor may reduce the dose of these or even tell you to stop taking them before starting to take Lisinopril/HCTZ.

Your doctor will monitor you during treatment and this may include blood or urine tests.

Adults (including elderly people):

Lisinopril/HCTZ should be taken once a day. The tablets should be taken with water. Your dose will be decided by your doctor, depending on your response to treatment.

Do not exceed the maximum daily dose of 40 mg of Lisinopril/ 25 mg of Hidroclorotiazida.

The groove is only to help you break the tablet if you have difficulty swallowing it whole.

If you take more Lisinopril/Hidroclorotiazida Teva than you should

If you (or someone) ingest many tablets together, or if you think a child has swallowed some tablets, contact the emergency department of the nearest hospital immediately or your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20. An overdose is likely to cause dizziness or fainting (due to a drop in blood pressure), rapid breathing, anxiety, or cough.

Take this leaflet, the remaining tablets, and the packaging with you to the hospital or doctor so they can know what tablets you have taken.

If you forgot to take Lisinopril/Hidroclorotiazida Teva

Do not take a double dose to make up for the missed doses. Take it as soon as you remember, unless it is almost time to take the next dose. Take the remaining doses at the correct time.

If you interrupt treatment with Lisinopril/HCTZ

You should continue taking these tablets for the time your doctor tells you. Do not stop taking your medication without first talking to your doctor, even if you feel better.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

Stop taking the tablets and immediately inform your doctor or go to the nearest hospital emergency room if you experience the following:

• a severe allergic reaction (swelling of the lips, face, or neck that leads to severe difficulty breathing; skin rash or urticaria).

These are rare but very serious side effects. You may need urgent medical attention or hospitalization.

Consult your doctor immediately if you experience any of the following:

• heart attack or stroke in susceptible patients
• symptoms including vomiting, abdominal and back pain; these may be signs of pancreatitis (inflammation of the pancreas).

These are serious but rare side effects (may affect up to 1 in 100 people).

• a severe skin disease with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome), or severe blistering and peeling of large areas of the skin (toxic epidermal necrolysis)
• jaundice (yellowing of the skin and white of the eyes); this may be a sign of liver inflammation (hepatitis), liver failure
• acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion)

These are serious but very rare side effects (may affect up to 1 in 10,000 people)

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

• you feel dizzy after your first dose. A few people react to their first dose or when the dose is increased, feeling dizzy, weak, faint, and sick. Lie down if your blood pressure drops too low. This is a common side effect (may affect up to 1 in 10 people).
• you develop a persistent and dry cough. This is a common side effect (may affect up to 1 in 10 people).
• you develop symptoms such as dry mouth, thirst, lethargy, muscle pain or cramps, rapid heartbeat, dizziness, feeling unwell, and decreased urination. These are signs of fluid or mineral imbalance in the body. This is a rare side effect (may affect up to 1 in 1,000 people).
• you develop a high temperature, sore throat, and mouth ulcers, which are signs of low white blood cell count in the blood. This is a very rare side effect (may affect up to 1 in 10,000 people).

The following side effects have been reported at the approximate frequencies shown:

Common:may affect up to 1 in 10 people

• fatigue, lethargy (a feeling of tiredness, drowsiness, or lack of energy)
• headache
• renal problems
• diarrhea or vomiting.

Rare: may affect up to 1 in 100 people

• nausea
• feeling weak
• feeling like everything is spinning (dizziness)
• change in the taste of food
• dry mouth
• indigestion
• abdominal pain
• skin rash, itching
• gout (sudden, unexpected, burning pain, as well as swelling, redness, heat, and stiffness in the affected joint)
• chest pain, awareness of your heartbeat (palpitations), rapid heart rate
• poor circulation, coldness in the hands and feet
• muscle spasms and/or weakness, tingling like pinpricks or numbness (usually in the hands, arms, legs, or feet)
• impotence (difficulty obtaining or maintaining an erection)

• changes in mood, depressive symptoms, hallucinations
• difficulty sleeping
• runny nose and itching.
• change in color of the fingers and toes (Raynaud's phenomenon)
• increased levels of certain substances in your blood (urea, creatinine, potassium, liver enzymes)

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

• a complex of symptoms including fever, muscle and joint pain, redness, pain, and inflammation of blood vessels, sensitivity to light, or other skin problems
• unusual bleeding, unexplained petechiae, sore throat, mouth or throat ulcers, fever, or chills; these may be signs of anemia
• inadequate secretion of ADH (antidiuretic hormone)
• psoriasis (thick, inflamed patches, red skin covered with silvery scales)
• enlargement of the breasts in men
• confusion, changes in sense of smell
• skin rash with itching (urticaria)
• hair loss (alopecia)
• renal insufficiency.

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

• reduced platelet count in your blood
• inflamed lymph nodes
• increased immune response (autoimmune disease)
• difficulty breathing
• stuffy or congested nose with headache (sinusitis)
• inflammation of the lungs (allergic alveolitis, eosinophilic pneumonia)
• inflammation of the intestinal lining
• difficulty urinating or not urinating at all
• blistering, peeling, and other skin problems
• excessive sweating
• low blood sugar levels (symptoms may include headache, feeling faint, confusion, aggressive or abnormal behavior, incoherent speech).

Unknown: the frequency cannot be estimated from available data

• skin and lip cancer (non-melanoma skin cancer)
• loss of appetite
• feeling anxious
• flushing
• blurred vision, or changes in vision that make things appear yellow, 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)
• abnormal heart rhythm or frequency
• constipation
• inflammation of the salivary glands
• damage to blood vessels causing red or purple spots on the skin
• lupus erythematosus, lupus erythematosus, cutaneous lupus erythematosus, reactivation of cutaneous lupus erythematosus.

The test results show:

• urine sugar
• high or low potassium levels, low sodium levels, high uric acid levels, high sugar levels, increased cholesterol and other fats in the blood, elevated liver enzyme levels, bone marrow depression, and other blood disorders.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above30°C.

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

Composition of Lisinopril/Hidroclorotiazida Teva 20mg/12,5mg tablets

• The active principles of this medication are 20mg of lisinopril (as dihydrate) and 12,5mg of hidroclorotiazida.
• The other components (excipients) are calcium hydrogen phosphate, magnesium stearate, pregelatinized starch, mannitol, and cornstarch.

Appearance of the product and contents of the packaging

Each tablet ofLisinopril/Hidroclorotiazida Teva 20mg/12,5mg is, oval, white, slightly arched, marked with “LZ20”on one side and with a groove on the other side.

The product is available in sizes of 28, 30, 50, 98, and 100 tablets and in hospital packs of 50 and 100.

You may not be marketed all the sizes of packaging

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid.

Responsible for manufacturing

Teva Pharmaceutical Works Private limited Company

Pallagi Street 13

H-4042 Debrecen

Hungary

Pharmachemie BV

Swegsweg 5, PO Box 552, 2003, RN Haarlem

Netherlands

Last review date of this leaflet: February 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/