Lisinopril hydrochlorothiazide Teva

Package leaflet: Information for the user

Lisinopril Hydrochlorothiazide Teva 20 mg/12.5 mg, tablets

Generic medicine
lisinopril and hydrochlorothiazide
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 vasodilator medicines (they 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 "medicines that help you urinate". Diuretic medicines increase the amount of water lost in the urine and therefore reduce the amount of fluid in the blood vessels.
Since each of these medicines lowers blood pressure in a different way, Lisinopril Hydrochlorothiazide Teva may be used together for the treatment of high blood pressure when taking either of these medicines alone does not adequately control blood pressure.

2. What you should 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 excipients listed in section 6
• if you are allergic to ACE inhibitors
• if you are allergic to sulfonamides (e.g. trimethoprim)
• if you have experienced an unexplained allergic reaction or an allergic reaction to other ACE inhibitors, such as captopril or enalapril, which caused 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 (a sudden, severe swelling of the skin in a specific area, commonly affecting the eyes, lips, nose, tongue, larynx, hands, or intestines)
• if you have severe kidney or liver problems
• if you are more than 3 months pregnant. (It is best to avoid use of Lisinopril Hydrochlorothiazide Teva even in early pregnancy - see section Pregnancy and breastfeeding.)
• if you have diabetes or impaired kidney function 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 this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Warnings and precautions
Inform your doctor or pharmacist before taking Lisinopril Hydrochlorothiazide Teva:

• if you think you are (or might become) pregnant. Lisinopril Hydrochlorothiazide Teva tablets are not recommended during early pregnancy and may cause serious harm to the unborn baby after three months of pregnancy (see section 'Pregnancy and breastfeeding')
• if you are at risk of high potassium levels in the blood, for example due to taking potassium-containing salt substitutes or supplements
• if you are on a low-sodium diet
• if you have diarrhea or vomiting
• if you have an imbalance of salts in your blood
• if you have heart valve disorders (aortic or mitral) or cardiomyopathy (enlarged heart)
• if you have liver disease or liver problems
• 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 have a history of allergies, bronchial asthma, or SLE (systemic lupus erythematosus, an autoimmune condition causing joint pain, skin rashes, and fever)
• if you require blood separation treatment (apheresis) or desensitization therapy, for example following a wasp or bee sting, your doctor may decide to stop treatment with this medicine to avoid a possible allergic reaction
• if you need surgery or general anesthesia. Inform your doctor, dentist, or hospital staff that you are taking this medicine, as it may cause a sudden drop in blood pressure
• if you are taking lithium (a mood-stabilizing medicine)
• if you participate in competitive sports, since hydrochlorothiazide is a banned substance and may lead to a positive doping test
• if you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer 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 in lowering blood pressure in this patient group, and a higher dose of this medicine may be required
• if you are taking any of the following medicines used to treat high blood pressure:
  • an "angiotensin II receptor antagonist" (AIIRA), 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 be increased:
  • racecadotril, a medicine used to treat diarrhea;
  • medicines used to prevent rejection of transplanted organs or to treat cancer (such as temsirolimus, sirolimus, everolimus);
  • vildagliptin, a medicine used to treat diabetes.
• if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking Lisinopril Hydrochlorothiazide Teva. This may lead to permanent vision loss if untreated. If you have recently had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this symptom.

Your doctor may regularly monitor your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood.
See also the section "Do not take Lisinopril Hydrochlorothiazide Teva".

During treatment with Lisinopril Hydrochlorothiazide Teva tablets
Your doctor will closely monitor your condition, prescribe blood tests, and check your kidney function and blood 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, or hoarseness, these are signs of a serious allergic reaction called angioedema. This may occur at any time during treatment. The risk is higher in patients of Black or Afro-Caribbean origin. In this case, stop taking the tablets immediately and contact your doctor right away or go to the nearest hospital emergency department.

Children and adolescents
Lisinopril Hydrochlorothiazide Teva must not be given to children, as the safety and efficacy of lisinopril/hydrochlorothiazide have not been established in this age group.

Other medicines and Lisinopril Hydrochlorothiazide Teva
Inform 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 such as furosemide, torasemide, amiloride
• non-steroidal anti-inflammatory drugs (NSAIDs), which are a type of painkiller, for example 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 (AIIRA) or aliskiren (see also sections "Do not take Lisinopril Hydrochlorothiazide Teva" and "Warnings and precautions")
• tricyclic antidepressants (e.g. amitriptyline), as these may further lower your blood pressure
• antipsychotics such as chlorpromazine (used to treat mental disorders), which may cause low blood pressure
• sympathomimetic drugs such as adrenaline, noradrenaline, or ephedrine, as the effectiveness of lisinopril may be reduced. Ephedrine may be present in cold and nasal decongestant medicines
• insulin or oral antidiabetic medicines, as the risk of hypoglycemic crisis may increase
• allopurinol for the treatment of gout, as there is an increased risk of blood disorders such as leucopenia (reduction in white blood cell count) and kidney failure
• cyclosporine (used after organ transplantation), as the risk of kidney failure may increase
• lovastatin (a medicine that reduces blood fat levels)
• procainamide, used to treat heart rhythm disorders, as there is an increased risk of blood disorders such as leucopenia (reduction in white blood cell count)
• cytostatic agents (cancer treatment medicines) and immunosuppressants
• amphotericin B (used to treat serious fungal infections)
• carbenoxolone (used in the treatment of gastric and duodenal ulcers)
• corticosteroids such as prednisolone
• a hormone called corticotropin (ACTH)
• laxatives such as lactulose
• calcium supplements
• cardiac glycosides such as digoxin
• medicines that reduce blood fat levels such as cholestyramine or colestipol, as they may interfere with the absorption of hydrochlorothiazide. Lisinopril/hydrochlorothiazide should be taken at least one hour before or 4–6 hours after these medicines
• sotalol (beta-blockers), 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 (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting)
• lithium, as lithium levels may increase
• medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors). See section "Warnings and precautions".

Lisinopril Hydrochlorothiazide Teva and alcohol
Drinking alcohol while taking Lisinopril Hydrochlorothiazide Teva may have additive effects and cause dizziness or a feeling of lightheadedness.
For athletes: using this medicine without medical need constitutes doping and may result in a positive anti-doping test.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Lisinopril Hydrochlorothiazide Teva before pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine. Lisinopril Hydrochlorothiazide Teva is not recommended during early 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 gestation.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Lisinopril Hydrochlorothiazide Teva is not recommended for breastfeeding mothers, and your doctor will choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines
If you feel tired or dizzy, do not drive or operate machinery, especially at the beginning of treatment, after changing medication, or if you have consumed alcohol.

3. How to take Lisinopril Hydrochlorothiazide Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
If you are already taking diuretics, your doctor may reduce the dose of these, or may even tell you to stop taking them before starting lisinopril/hydrochlorothiazide.
Your doctor will monitor you during treatment, which may include blood or urine tests.

Adults (including elderly):
Lisinopril Hydrochlorothiazide Teva should be taken once daily. The tablets should be swallowed with a glass of water. Your doctor will decide the dose based on your response to treatment.
The maximum daily dose of 40 mg lisinopril / 25 mg hydrochlorothiazide must not be exceeded.
The break line is present only 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 else) swallow many tablets at once, or if you think a child has taken any of the tablets, contact your nearest emergency department or doctor immediately.
An overdose may cause weakness or dizziness (due to a drop in blood pressure), rapid breathing, anxiety, or cough.
Take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so they know which tablets have been taken.

If you forget to take Lisinopril Hydrochlorothiazide Teva
Do not take a double dose to make up for the forgotten dose. Take a dose as soon as you remember, unless it is almost time for your next dose. Then take the remaining doses at the usual times.

If you stop taking Lisinopril Hydrochlorothiazide Teva
You should continue taking these tablets for as long as your doctor tells you to. Do not stop taking the medicine without first consulting your doctor, even if you feel better.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the following:

• an allergic reaction (swelling of the lips, face or throat leading to severe breathing difficulties, skin rash or hives). This is a very serious, but rare, side effect. You may need urgent medical treatment or hospitalisation.

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

• heart attack or stroke in susceptible patients.
• symptoms including nausea or vomiting, abdominal pain and back pain. These may be symptoms of pancreatitis (inflammation of the pancreas). These are serious but uncommon side effects (may affect up to 1 in 100 people).
• a serious illness with blistering of the skin, eyes, mouth and genitals (Stevens-Johnson syndrome), or blistering and severe peeling of large areas of the skin (toxic epidermal necrolysis).
• jaundice (yellowing of the skin and whites of the eyes), which could be a sign of liver inflammation (hepatitis) or liver failure. 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, tell your doctor:

• you feel dizzy after the first dose. Some people react to their first dose or when the dose is increased with dizziness, weakness and feeling unwell. Lie down if your blood pressure drops too low. This is a common side effect (may affect up to 1 in 10 people).
• you have a persistent, 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, nausea or vomiting, and reduced urine output. These are signs of a fluid or mineral imbalance in the body. This is a rare side effect (may affect up to 1 in 1,000 people).
• you develop symptoms such as high temperature, sore throat and mouth ulcers, which are signs of a low white blood cell count. This is a very rare side effect (may affect up to 1 in 10,000 people).

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

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• feeling unwell
• feeling weak
• a sensation that the surroundings are spinning (dizziness)
• changes in taste sensation
• dry mouth
• indigestion
• abdominal pain
• skin rash, itching
• gout (sudden, unexpected, burning pain, as well as swelling, redness, warmth and stiffness in the affected joint)
• chest pain, awareness of your heartbeat (palpitations), tachycardia
• poor circulation, coldness in fingers of hands and feet
• muscle spasms and/or weakness, tingling or numbness (usually in hands, arms, legs or feet)
• impotence (difficulty achieving or maintaining an erection)
• mood swings
• sleep disorders
• runny nose and itching
• colour changes in fingers or toes (Raynaud’s phenomenon)
• increased levels of certain substances in the blood (urea, creatinine, potassium, liver enzymes)

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

• a group of symptoms including fever, muscle and joint pain, redness, pain and inflammation of blood vessels, light sensitivity or other skin problems
• unusual bleeding, unexplained bruising, sore throat, mouth or throat ulcers, fever or chills, which may be signs of anaemia
• psoriasis (inflamed, thick red patches of skin covered with silvery scales)
• enlargement of the male breast
• mental confusion
• 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 the blood
• swollen glands (lymph nodes)
• increased immune response (autoimmune disease)
• difficulty breathing
• blocked or stuffy nose with headache (sinusitis)
• inflammation of the lungs (allergic alveolitis, eosinophilic pneumonia)
• swelling of the intestinal mucosa
• difficulty passing urine or inability to pass urine at all
• blisters, dryness and other skin problems
• excessive sweating
• low blood sugar levels (symptoms may include headache, feeling faint, mental confusion, aggressive or abnormal behaviour, difficulty speaking)

Not known: frequency cannot be estimated from the available data

• cancer of the skin and lips (non-melanoma skin cancer)
• loss of appetite
• restlessness, depression
• hot flushes
• blurred vision, or a yellow tinge to your vision, 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)
• abnormalities in heart rhythm or heart rate
• constipation
• inflammation of the salivary glands
• damage to blood vessels causing reddish or purplish spots on the skin

Test results may show:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lisinopril Hydrochlorothiazide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of this leaflet and other information

What Lisinopril Hydrochlorothiazide Teva contains
The active substances are 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.
The other components are pregelatinized starch, maize starch, calcium hydrogen phosphate,
mannitol and magnesium stearate.
Description of the appearance of Lisinopril Hydrochlorothiazide Teva and pack contents
Each Lisinopril Hydrochlorothiazide 20 mg/12.5 mg tablet is oval, white, slightly biconvex, with "LZ20" engraved on one side and a break line on the other.
The product is available in packs of 14, 28, 30, 50, 98 and 100 tablets, and in hospital packs of 50 (EAV: unit dose hospital pack) and 100.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Teva Italia Srl – Piazzale Luigi Cadorna, 4 – 20123 Milan
Manufacturers
Teva Pharmaceutical Works Private Limited Company – Pallagi st. 13 - H-4042 Debrecen (Hungary)
Teva UK Ltd. - Brampton Road - Hampden Park – BN22 9AG Eastbourne – East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 – P.O. Box 552 - 2003 RN Haarlem (The Netherlands)