Lisinopril/hydrochlorothiazide Teva 20 mg/12.5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lisinopril/Hydrochlorothiazide Teva 20 mg/12.5 mg Tablets EFG

lisinopril and hydrochlorothiazide

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4

Contents of the leaflet

1. What Lisinopril/Hydrochlorothiazide Teva is and what it is used for
2. What you need to know before taking Lisinopril/Hydrochlorothiazide Teva
3. How to take Lisinopril/Hydrochlorothiazide Teva
4. Possible side effects
5. How to store Lisinopril/Hydrochlorothiazide Teva
6. Contents of the pack and other information

1. What Lisinopril/Hydrochlorothiazide Teva is and what it is used for

Lisinopril/Hydrochlorothiazide Teva contains lisinopril and hydrochlorothiazide.

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).

Hydrochlorothiazide belongs to a group of medicines called diuretics or "water pills." Diuretic medicines increase the amount of water you lose in your urine, thereby reducing the amount of fluid in your blood vessels.

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

2. What you need to know before taking Lisinopril/Hydrochlorothiazide Teva

Do not take Lisinopril/Hydrochlorothiazide Teva

• if you are allergic to lisinopril or hydrochlorothiazide, or to any of the other components of this medicine (listed in section 6)

• if you are allergic to sulfonamides (e.g. trimethoprim)

• if you have previously experienced an unexplained allergic reaction or allergic reaction to other ACE inhibitors, e.g. captopril, enalapril, causing swelling 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 (sudden severe swelling of the skin in a particular area, frequently affecting eyes, lips, nose, tongue, throat (larynx), hands or intestines)

• if you have severe liver or kidney problems

• if you are more than 3 months pregnant. (Lisinopril/Hydrochlorothiazide should also be avoided during early pregnancy – see section “Pregnancy and breastfeeding”).

• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren

• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is increased

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• if you think you are (or might become) pregnant. Lisinopril/Hydrochlorothiazide tablets are not recommended during early pregnancy and may cause serious harm to the unborn baby if you are more than three months pregnant (see section “Pregnancy and breastfeeding”).

• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Lisinopril/Hydrochlorothiazide Teva, seek medical attention immediately.

• if you are at risk of high potassium levels in your blood, e.g. due to taking potassium-containing salt substitutes or potassium supplements

• if you have been on 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 thickening of the heart muscle

• if you have liver disease

• if you have kidney problems, require 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 suffer from gout

• if you are taking a diuretic

• if you have blood vessel disorders (collagen vascular disease)

• if you have low blood pressure. You may feel dizzy or lightheaded, especially when standing up

• if you have poor blood circulation to the heart or brain, as a sudden drop in blood pressure could lead to a heart attack or stroke

• if you have a history of allergies, bronchial asthma, or systemic lupus erythematosus (SLE – an autoimmune disease causing joint pain, skin rashes, and fever)

• if you require blood separation treatment (apheresis) or desensitization therapy, e.g. after a wasp or bee sting; your doctor may temporarily stop this medicine to prevent a possible allergic reaction

• if you are undergoing surgery or general anesthesia. Inform your doctor, dentist, or hospital staff that you are taking this medicine, as your blood pressure may drop suddenly

• if you are taking lithium (a mood-stabilizing medicine)

• if you participate in competitive sports, as hydrochlorothiazide is a banned substance and may result in a positive anti-doping test

• if you have had skin cancer or 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 and lip cancer. Protect your skin from sun and UV exposure while taking Lisinopril/Hydrochlorothiazide Teva.

• if you are of Black or Afro-Caribbean origin: ACE inhibitors may be less effective at lowering blood pressure in this patient group, and a higher dose of this medicine may be needed

• if you are taking any of the following medicines for high blood pressure:

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes

• aliskiren

• if you are taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea

• medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus)

• vildagliptin, a medicine used to treat diabetes

• medicines containing tissue plasminogen activator

• if you experience vision loss or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Lisinopril/Hydrochlorothiazide Teva. This may lead to permanent vision loss if untreated. If you previously had an allergy to penicillin or sulfonamide, your risk may be higher.

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).

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

While taking Lisinopril/HCTZ Tablets

Your doctor will closely monitor your condition, perform blood tests, check your kidney function, and periodically monitor electrolyte levels in your body.

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

Children and adolescents

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

Taking Lisinopril/HCTZ with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, especially if you are taking any of the following:

• diuretics ("water pills") such as furosemide, torasemide, amiloride

• non-steroidal anti-inflammatory drugs (NSAIDs), a type of painkiller, e.g. aspirin or ibuprofen

• gold preparations

• other medicines to lower blood pressure, as your blood pressure may become too low

• your doctor may need to adjust your dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Lisinopril/Hydrochlorothiazide Teva” and “Warnings and precautions”)

• tricyclic antidepressants (e.g. amitriptyline), as these may further lower your blood pressure

• antipsychotics, e.g. chlorpromazine (used to treat mental disorders), which may cause low blood pressure

• sympathomimetic medicines, e.g. adrenaline, noradrenaline, or ephedrine, as the effectiveness of lisinopril may be reduced. Ephedrine may be present in cold and nasal congestion medicines

• insulin or oral tablets for diabetes, as the risk of hypoglycemia may be increased

• allopurinol (for treatment of gout), as there is an increased risk of a blood disorder called leucopenia (a reduction in white blood cells) and kidney failure

• cyclosporine (used after organ transplant), as the risk of kidney failure may be increased

• lovastatin (a medicine that lowers blood fat levels)

• procainamide (used to treat abnormal heart rhythms), as there is an increased risk of leucopenia (a reduction in white blood cells)

• cytostatic drugs (cancer treatments) and immunosuppressants

• amphotericin B (used to treat serious fungal infections)

• carbenoxolone (used to treat stomach and duodenal ulcers)

• corticosteroids, e.g. prednisolone

• a hormone called corticotropin (ACTH)

• laxatives, e.g. lactulose

• racecadotril (for treatment of diarrhea)

• calcium/vitamin D supplements

• cardiac glycosides, e.g. digoxin

• medicines that reduce blood fat levels such as cholestyramine or colestipol, as they may affect the absorption of hydrochlorothiazide. Lisinopril/HCTZ should be taken at least one hour before or four to six hours after these medicines

• sotalol (a beta-blocker), as there is an increased risk of heart rhythm abnormalities

• potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g. trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to prevent blood clots)

• lithium, as lithium levels may increase

• medicines more commonly used to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitors). See section “Warnings and precautions”

• certain medicines for asthma

• non-depolarizing muscle relaxants (e.g. tubocurarine chloride)

• diazoxide (used to treat hypoglycemia, among other things)

• amantadine (for treatment of Parkinson’s disease or serious 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 medicine used to dissolve blood clots)

Lisinopril/Hydrochlorothiazide Teva with alcohol

Drinking alcohol while taking Lisinopril/Hydrochlorothiazide may have additive effects and cause dizziness or fainting.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you think you are (or might 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. Lisinopril/Hydrochlorothiazide is not recommended during pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Lisinopril/Hydrochlorothiazide is not recommended for use in breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

3. How to take Lisinopril/Hydrochlorothiazide Teva

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

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

Your doctor will monitor you during treatment, which may include blood or urine tests.

Adults (including elderly people):

Lisinopril/HCTZ should be taken once daily. The tablets should be taken with water. Your doctor will decide your dose, depending on your response to treatment.

The maximum daily dose must not exceed 40 mg of Lisinopril / 25 mg of Hydrochlorothiazide.

The score line is only intended to help you split the tablet if you have difficulty swallowing it whole.

If you take more Lisinopril/Hydrochlorothiazide Teva than you should

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

Take this leaflet, any remaining tablets, and the packaging with you to the hospital or doctor so they can see which tablets have been taken.

If you forget to take Lisinopril/Hydrochlorothiazide Teva

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

If you stop taking Lisinopril/HCTZ

You must continue taking these tablets for as long as your doctor tells you to. Do not stop taking your medicine without first talking to your doctor, even if you feel better.

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

4. Possible adverse effects

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

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

• an allergic reaction (swelling of the lips, face or neck leading to severe breathing difficulty; skin rash or hives).

These are uncommon but very serious adverse effects. You may require urgent medical attention or hospitalization.

Contact 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 uncommon adverse effects (may affect up to 1 in 100 people).

• a serious illness with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson Syndrome), or severe blistering and peeling of large areas of skin (toxic epidermal necrolysis)
• jaundice (yellowing of the skin and whites of the eyes); this may be a sign of liver inflammation (hepatitis) or liver failure
• acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion)

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

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

• you feel dizzy after your first dose. A few people react to their first dose or when the dose is increased by feeling dizzy, weak, faint, or unwell. Lie down if your blood pressure drops too low. This is a common adverse effect (may affect up to 1 in 10 people).
• you develop a persistent dry cough. This is a common adverse 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 urinating less. These are signs of a fluid or mineral imbalance in the body. This is a rare adverse effect (may affect up to 1 in 1,000 people).
• you develop a high temperature, sore throat, and mouth ulcers, which are signs of a low white blood cell count in the blood. This is a very rare adverse effect (may affect up to 1 in 10,000 people).

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

Common: may affect up to 1 in 10 people

• tiredness, lethargy (a feeling of tiredness, sluggishness, or lack of energy)
• headache
• kidney problems
• diarrhoea or vomiting

Uncommon: may affect up to 1 in 100 people

• nausea
• feeling weak
• sensation of spinning (dizziness)
• changes in taste
• 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 heartbeat
• poor circulation, coldness in fingers and toes
• muscle spasms and/or weakness, tingling, pins and needles, or numbness (usually in hands, arms, legs, or feet)
• impotence (difficulty achieving or maintaining an erection)
• mood changes, depressive symptoms, hallucinations
• difficulty sleeping
• runny and itchy nose
• change in color of 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 bruising, sore throat, mouth or throat ulcers, fever or chills; these may be signs of anaemia
• inappropriate secretion of ADH (antidiuretic hormone)
• psoriasis (thick or inflamed patches, red skin covered with silvery scales)
• breast enlargement in men
• mental confusion, changes in sense of smell
• itchy skin rash (urticaria)
• hair loss (alopecia)
• kidney failure

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

• reduced number of platelets in your blood
• swollen glands (lymph nodes)
• increased immune response (autoimmune disease)
• difficulty breathing
• blocked or congested nose with headache (sinusitis)
• inflammation of the lungs (allergic alveolitis, eosinophilic pneumonia)
• inflammation of the intestinal lining
• difficulty urinating or inability to urinate at all
• blistering, peeling, and other skin problems
• excessive sweating
• low blood sugar levels (symptoms may include headache, feeling faint, mental confusion, aggressive or abnormal behaviour, incoherent speech)

Not known: frequency cannot be estimated from available data

• skin and lip cancer (non-melanoma skin cancer)
• loss of appetite
• feeling restless
• flushing
• blurred vision, or visual changes causing you to see things as yellow, 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)
• abnormal heart rhythm or heart rate
• constipation
• inflammation of the salivary glands
• damage to blood vessels causing red or purple spots on the skin
• cutaneous lupus erythematosus, systemic lupus erythematosus, lupus erythematosus-like skin reactions, reactivation of cutaneous lupus erythematosus

Test results show:

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lisinopril/Hydrochlorothiazide Teva

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lisinopril/Hydrochlorothiazide Teva 20 mg/12.5 mg tablets

• The active substances in this medicine are 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.
• The other components (excipients) are calcium hydrogen phosphate, magnesium stearate, pregelatinized starch, mannitol and maize starch.

Appearance of the product and contents of the pack

Each Lisinopril/Hydrochlorothiazide Teva 20 mg/12.5 mg tablet is oval-shaped, white, slightly biconvex, marked with “LZ 20” on one side and a score line on the other side.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid, Spain.

Manufacturer responsible for production

Teva Pharmaceutical Works Private Limited Company

Pallagi Street 13

H-4042 Debrecen

Hungary

Pharmachemie BV

Swegsweg 5, PO Box 552, 2003 RN Haarlem

The Netherlands

Date of the most recent review of this leaflet: February 2022

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