LISINOPRIL-HYDROCHLOROTHIAZIDE TEVA 20 mg/12.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lisinopril/Hydrochlorothiazide Teva 20 mg/12.5 mg Tablets EFG

lisinopril and hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, you may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

Contents of the pack

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

1. What is Lisinopril/Hydrochlorothiazide Teva and what is it 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 to all parts of 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, which in turn reduces 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 these medicines alone does not sufficiently control blood pressure.

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

Do not take Lisinopril/Hydrochlorothiazide Teva

• if you are allergic to lisinopril or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to sulfonamides (e.g., trimethoprim)
• if you have had an inexplicable allergic reaction or an allergic reaction to other ACE inhibitors, e.g., captopril, enalapril, which caused swelling of the face, lips, tongue, and/or throat.
• if you have been diagnosed with a disease known as hereditary angioedema or have a history of angioedema (a sudden, severe swelling of the skin in a particular area, which often affects the 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. (It is also best to avoid Lisinopril/Hydrochlorothiazide in the first months of pregnancy – see section “Pregnancy and breastfeeding”).
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 medicine:

• if you think you are (or might become) pregnant. Lisinopril/Hydrochlorothiazide tablets are not recommended in the first months of pregnancy, and may cause serious harm to your baby if you are more than 3 months pregnant (see section “Pregnancy and breastfeeding”).
• 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 Lisinopril/Hydrochlorothiazide Teva, go to your doctor immediately.
• if you are at risk of high potassium levels in your blood, e.g., due to taking salt substitutes or supplements that contain potassium.
• 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 problems (aortic or mitral) or thickening of the heart muscle
• if you have liver 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 diabetes medicine (including insulin)
• if you have gout;
• if you are being treated with a diuretic.
• if you have blood vessel problems (collagen vascular disease).
• if you have low blood pressure. You may feel dizzy or faint, especially when standing up.
• if you have problems with blood circulation in the heart or brain, as a significant drop in blood pressure can cause a heart attack or stroke.
• if you have a history of allergies, bronchial asthma, or systemic lupus erythematosus (SLE, a disease that causes pain in the joints, skin rashes, and fever)
• if you need to undergo blood separation treatment (apheresis) or desensitization treatment, e.g., after a wasp or bee sting; your doctor may stop treatment with this medicine to prevent a possible allergic reaction
• if you need to undergo 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 medicine for mood stabilization)
• if you are involved in competitive sports, as hydrochlorothiazide is a banned substance and may give a positive result in doping tests
• 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 and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Lisinopril/Hydrochlorothiazide Teva.
• if you are of black or Afro-Caribbean origin: ACE inhibitors may be less effective in lowering blood pressure in this group of patients, and a higher dose of this medicine may be needed.
• if you are taking any of the following medicines used to treat high blood pressure:

• 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

• 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 to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.
• medicines that contain a tissue plasminogen activator

• if you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to weeks after taking Lisinopril/Hydrochlorothiazide Teva. This can lead to permanent vision loss if not treated. If you have previously been allergic to penicillin or sulfonamide, you may be at higher risk of developing it.

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 Lisinopril/Hydrochlorothiazide Teva”.

While taking Lisinopril/HCTZ Tablets

Your doctor will closely monitor your condition, perform blood tests, check your kidney function, and monitor the levels of salts in your body from time to time.

If you experience sudden swelling of 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 black or Afro-Caribbean patients. 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 medicines (NSAIDs) that are a type of pain reliever, 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 change your dose 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 take Lisinopril/Hydrochlorothiazide Teva” and “Warnings and precautions”).
• tricyclic antidepressants (e.g., amitriptyline), as they will further lower your blood pressure
• antipsychotics, e.g., chlorpromazine (used to treat mental disorders), which can 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 medicines for colds and nasal congestion.
• insulin or tablets for diabetes, as the risk of hypoglycemia may be increased
• allopurinol for gout, as there is an increased risk of a blood disorder called leucopenia (a reduction in the number of white blood cells) and kidney failure
• cyclosporin (used after organ transplantation), 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 a blood disorder called leucopenia (a reduction in the number of white blood cells)
• cytostatics (cancer medicines) and immunosuppressants
• amphotericin B (used to treat severe 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 the treatment of diarrhea)
• calcium/vitamin D supplements
• cardiac glycosides, e.g., digoxin
• medicines that lower blood fat levels, such as colestyramine or colestipol, as they may affect the absorption of hydrochlorothiazide. Lisinopril/HCTZ can 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 salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection, and heparin, a medicine used to thin blood to prevent clots).
• lithium, as lithium levels may be increased
• medicines that are more often used to prevent organ transplant rejection (sirolimus, everolimus, and other medicines belonging to the group of mTOR inhibitors). See section “Warnings and precautions”
• certain medicines for the treatment of asthma,
• non-depolarizing muscle relaxants (e.g., tubocurarine chloride),
• diazoxide (used to treat hypoglycemia, among other things),
• amantadine (for the treatment of Parkinson's disease or severe viral infections),
• barbiturates (a type of sedative that is 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 addictive effects and cause dizziness or fainting.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Lisinopril/Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisinopril/Hydrochlorothiazide. Lisinopril/Hydrochlorothiazide is not recommended in pregnancy, and must notbe taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

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

Driving and using machines

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

3. How to take Lisinopril/Hydrochlorothiazide Teva

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist.

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

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

Adults (including the elderly):

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 Hydrochlorothiazide.

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

If you take more Lisinopril/Hydrochlorothiazide Teva than you should

If you (or someone else) swallow a lot of tablets all together, or if you think a child has swallowed some, contact your nearest hospital casualty department or your doctor or pharmacist immediately, or call the Poisons Information Service on 91 562 04 20. An overdose is likely to cause fainting or dizziness (due to low 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 what tablets you have taken.

If you forget to take Lisinopril/Hydrochlorothiazide Teva

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

If you stop taking Lisinopril/HCTZ

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

If you have any further questions on 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.

Stop taking the tablets and inform your doctor immediatelyor go to the emergency department of the nearest hospital if you experience the following:

• An allergic reaction (inflammation of the lips, face, or neck leading to severe breathing difficulties; skin rash or hives).

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

Consult your doctor immediatelyif you experience any of the following effects:

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

These are serious but rare adverse 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 the skin on large areas of the body (toxic epidermal necrolysis)
• Jaundice (yellowing of the skin and the whites of the eyes); this may be a sign of liver inflammation (hepatitis), liver failure.
• Acute breathing difficulties (signs include severe breathing difficulties, 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, and sick. Lie down if your blood pressure drops too low. This is a frequent adverse effect (may affect up to 1 in 10 people).
• You develop a persistent and dry cough. This is a frequent adverse effect (may affect up to 1 in 10 people).
• You develop ailments 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:

Frequent: may affect up to 1 in 10 people

• Fatigue, lethargy (a feeling of tiredness, drowsiness, or lack of energy)
• Headache
• Kidney problems
• Diarrhea or vomiting.

Infrequent: may affect up to 1 in 100 people

• Nausea
• Feeling of weakness
• Feeling that everything is spinning (vertigo)
• Changes 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 heartbeat (palpitations), rapid heartbeat
• Poor circulation, coldness in the fingers of the hands and feet
• Muscle spasms and/or weakness, tingling like pins and needles or numbness (usually in the hands, arms, legs, or feet)
• Impotence (difficulty in obtaining or maintaining an erection)

• Mood changes, depressive symptoms, hallucinations
• Difficulty sleeping
• Runny and itchy nose.
• Change in the color of the fingers of the hands and feet (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 anemia.
• Inadequate secretion of ADH (antidiuretic hormone)
• Psoriasis (thick or inflamed patches, red skin covered with silvery scales)
• Increased breast size in men
• Mental confusion, changes in the 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
• Inflamed glands (lymph nodes)
• Increased immune response (autoimmune disease)
• Breathing difficulties
• Stuffy or congested nose with headache (sinusitis)
• Lung inflammation (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 of fainting, mental confusion, aggressive or abnormal behavior, incoherent speech).

Unknown: frequency cannot be estimated from available data

• Skin and lip cancer (non-melanoma skin cancer)
• Loss of appetite
• Feeling of restlessness
• Flushing
• Blurred vision, or changes in vision that make you see things yellow, 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)
• Abnormality of heart rhythm or frequency
• Constipation
• Inflammation of the salivary glands
• Damaged blood vessels causing red or purple spots on the skin
• Cutaneous lupus erythematosus, systemic lupus erythematosus, cutaneous lupus erythematosus-like 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 sugar levels, increased cholesterol and other blood fats, increased liver enzyme levels, bone marrow depression, and other blood disorders.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 Lisinopril/Hydrochlorothiazide Teva

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

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

• The active ingredients of this medicine are 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.
• The other ingredients (excipients) are hydrogenated calcium phosphate, magnesium stearate, pregelatinized starch, mannitol, and cornstarch.

Appearance of the product and package contents

Each Lisinopril/Hydrochlorothiazide Teva 20 mg/12.5 mg tablet is oval, white, slightly curved, marked with "LZ 20" on one side and with 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.

Not all pack sizes may be marketed

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid.

Manufacturer

Teva Pharmaceutical Works Private limited Company

Pallagi Street 13

H-4042 Debrecen

Hungary

Pharmachemie BV

Swegsweg 5, PO Box 552, 2003, RN Haarlem

Netherlands

Date of last revision of this leaflet: February 2022

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