LISINOPRIL 20 mg /12.5 Mg Tabletka Powlekana

Treść ulotki

1. Lisinopril Idroclorotiazide Teva 20 mg/ 12,5 mg, tablets
2. lisinopril and hydrochlorothiazide
   1. What is Lisinopril Hydrochlorothiazide Teva and what is it 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 Idroclorotiazide Teva
   6. Contents of this leaflet and other information

Lisinopril Idroclorotiazide Teva 20 mg/ 12,5 mg, tablets

Generic medicine

lisinopril and hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lisinopril Idroclorotiazide Teva is and what it is used for
• 2. What you need to know before you take Lisinopril Idroclorotiazide Teva
• 3. How to take Lisinopril Idroclorotiazide Teva
• 4. Possible side effects
• 5. How to store Lisinopril Idroclorotiazide 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 drugs called angiotensin converting enzyme inhibitors
(ACE inhibitors). ACE inhibitors are vasodilating drugs (which widen blood
vessels making it easier for the heart to pump blood throughout the body).
Hydrochlorothiazide belongs to a group of drugs called diuretics or "medicines that help to
urinate". Diuretic drugs increase the amount of water that is lost in the urine and therefore reduce the
amount of fluid in the blood vessels.
Since each of these drugs lowers blood pressure in a different way, Lisinopril
Hydrochlorothiazide Teva can be used together for the treatment of high blood pressure
when taking one of these drugs alone does not control blood pressure
sufficiently.

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 any of the other ingredients 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, for example, captopril, enalapril, which led to 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 particular area which commonly affects the eyes, lips, nose, tongue, larynx, hands, or intestine)
• if you have severe kidney or liver problems
• if you are pregnant for more than 3 months. (It is best to avoid using Lisinopril Hydrochlorothiazide Teva even at the beginning of pregnancy - see section Pregnancy and breastfeeding.)
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Tell 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 at the beginning of pregnancy and can cause serious harm to the baby, after three months of pregnancy (see section 'Pregnancy and breastfeeding')
• if you are at risk of high levels of potassium in your blood e.g. resulting from taking salt substitutes containing potassium or supplements
• if you are following a low-sodium diet
• if you suffer from diarrhoea or vomiting
• if you have an imbalance of salts in your blood
• if you have heart valve disease (aortic or mitral) or an enlarged heart
• if you have a liver disease or liver problems
• if you have kidney problems, need dialysis treatment or have had a kidney transplant
• if you have diabetes. You may need a different dosage of your antidiabetic medicine (including insulin)
• if you suffer from gout
• if you have a history of allergy, bronchial asthma or SLE (systemic lupus erythematosus is an allergic condition that causes joint pain, skin rashes and fever)
• if desensitization treatment (e.g. for insect stings) or allergy testing is needed, your doctor may decide to temporarily interrupt the treatment with this medicine to avoid a possible allergic reaction
• if you need to undergo surgery or general anaesthesia. Tell your doctor, dentist or hospital staff that you are taking this medicine, as it can cause a sudden drop in blood pressure
• if you are taking lithium (a medicine for mood stabilization)
• if you play competitive sports, as hydrochlorothiazide is a prohibited substance and can give a positive result in doping tests
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun 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" (AIIRA) (also known as sartans - for example 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 diarrhoea;
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.
• if you have a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase

in pressure in the eye and can occur within hours to weeks
after taking Lisinopril Hydrochlorothiazide Teva. This can lead to permanent
loss of vision if not treated. If you have recently had an allergy to penicillin or sulfonamides, you
may be at high risk of developing this symptom.
The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Lisinopril Hydrochlorothiazide Teva”.

During treatment with Lisinopril Hydrochlorothiazide Teva tablets
The doctor will carefully monitor your condition, prescribe blood tests, check your
kidney function and blood salt levels from time to time.
If you experience a sudden swelling of the lips, face, neck, and possibly hands and feet, a
skin rash, difficulty swallowing or breathing, hoarseness, these are signs of a
serious allergic reaction called angioedema. This can occur at any time during
treatment. There is a greater risk in patients of Black or Afro-Caribbean origin. In this
case stop taking the tablets and immediately tell your doctoror go to the nearest
hospital emergency room.

Children and adolescents
Lisinopril Hydrochlorothiazide Teva should 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
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 such as furosemide, torasemide, amiloride
• non-steroidal anti-inflammatory drugs (NSAIDs), which are a type of painkiller, for example aspirin or ibuprofen
• gold-containing preparations
• other medicines to lower blood pressure, as your blood pressure may become too low
• The doctor may need to adjust the dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is stated under "Do not take Lisinopril Hydrochlorothiazide Teva " and "Warnings and precautions“)
• tricyclic antidepressants (e.g. amitriptyline), as these will further lower your blood pressure
• antipsychotics e.g. chlorpromazine (used to treat mental disorders), which can cause low blood pressure
• sympathomimetic drugs 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 tablets for the treatment of diabetes, as the risk of 'hypoglycaemic crisis' may be increased
• allopurinol for the treatment of gout, as there is a greater risk of a blood disorder called leucopenia (a reduction in the number of white blood cells) and kidney failure
• cyclosporine (used after organ transplantation), as the risk of kidney failure may be increased
• lovastatin (a medicine that lowers fat levels in the blood)
• procainamide, used to treat heart rhythm abnormalities as there is an increased risk of a blood disease called leucopenia (a reduction in the number of white blood cells)
• cytostatic drugs (cancer treatment drugs) and immunosuppressants
• amphotericin B (used to treat severe infections caused by fungi)
• carbenoxolone (used in the treatment of gastric and duodenal ulcers)
• corticosteroids e.g. prednisolone
• a hormone called corticotropin (ACTH)
• laxatives e.g. lactulose
• calcium supplements
• cardiac glycosides e.g. digoxin
• medicines that lower fat levels in the blood such as colestyramine or colestipol, as they may impair 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 the amount of potassium in the blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots)
• lithium, as lithium levels may be increased
• medicines commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.

Lisinopril Hydrochlorothiazide Teva with alcohol
Drinking alcohol while taking Lisinopril Hydrochlorothiazide Teva may have additive effects and
cause dizziness or lightheadedness.
For athletes: the use of the medicine without therapeutic need constitutes doping and may
still result in a positive doping test.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or planning to become pregnant). The
doctor will normally advise you to stop taking Lisinopril Hydrochlorothiazide Teva
before becoming pregnant or as soon as you find out you are pregnant and will suggest taking another
medicine instead of Lisinopril Hydrochlorothiazide Teva. Lisinopril Hydrochlorothiazide Teva is
not recommended at the beginning of pregnancy, and must not be taken if you are pregnant for more than 3
months, as it can cause serious harm to the baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Lisinopril Hydrochlorothiazide
Teva is not recommended for mothers who are breastfeeding, and your doctor will choose another treatment if
you wish to breastfeed, especially if your baby is 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
or if you have changed medicine, or if you have taken alcohol.

3. How to take Lisinopril Hydrochlorothiazide Teva

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask 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 starting to take lisinopril/hydrochlorothiazide.
Your doctor will monitor you during treatment and this may include blood or urine tests.

Adults (including the elderly):
Lisinopril Hydrochlorothiazide Teva should be taken once a day. The tablets should be
swallowed with a glass of water. The dose will be decided by your doctor, depending on your response to
treatment.
The maximum daily dose of 40 mg of lisinopril /25 mg hydrochlorothiazide should not be exceeded.
The break line is present 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) swallows many tablets together or if you think a child has swallowed
any of the tablets, contact the nearest emergency room 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, the remaining tablets and the container with you to hospital or to the 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 a forgotten dose. Take one dose as soon as you
remember, unless it is almost time to take the next one. Take the remaining doses at the
right time.

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

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

4. Possible side effects

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

Stop taking the tablets and immediately inform your doctoror go to the nearest hospital emergency room if you experience any of the following conditions:

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

Immediately inform your doctorif any of the following occur:

• heart attack or stroke in sensitive 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 severe illness with the appearance of blisters on the skin, eyes, mouth 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 whites of the eyes), this could be a sign of liver inflammation (hepatitis), 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, inform your doctor if:

• you feel dizzy after the first dose. Some people react to their first dose or when the dose is increased with a feeling of dizziness, weakness and unwellness. 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 cough, which is persistent and dry. This is a common side effect (may affect up to 1 in 10 people).
• you develop disorders such as a dry mouth, thirst, lethargy, muscle pain or cramps, rapid heartbeat, dizziness, nausea or vomiting, and decreased urination. These are signs of an imbalance of fluids or minerals in the body. This is a rare side effect (may affect up to 1 in 1000 people).
• you develop a high temperature, sore throat and mouth ulcers, which are signs of a low number of white blood cells in the blood. This is a very rare side effect (may affect up to 1 in 10,000 people). The following undesirable effects have been reported with the approximate frequencies:

Common:may affect up to 1 in 10 people

• fatigue, 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 surrounding environment is spinning (vertigo)
• changes in your sense of taste
• dry mouth
• indigestion
• abdominal pain
• skin rash, itching
• gout (sudden, unexpected, burning pain, as well as swelling, redness, heat and stiffness of the affected joint)
• chest pain, awareness of your heart beating (palpitations), rapid heartbeat
• poor circulation, coldness in the hands and feet
• muscle spasms and/or weakness, tingling or numbness (usually in the hands arms, legs or feet)
• impotence (difficulty in achieving or maintaining an erection)
• mood swings
• sleep disorders
• runny nose and itching
• change of colour in the fingers of the hands or feet (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

• a complex of symptoms including, fever, muscle and joint pains, redness, pain and inflammation of the blood vessels, sensitivity to light or other skin problems
• unusual bleeding, unexplained bruising, sore throat, ulcers in the mouth or throat, fever or chills, these may be signs of anaemia
• psoriasis (thick, inflamed, red skin covered with silvery scales)
• increase in volume of male breast
• mental confusion
• itchy skin rash (urticaria)
• hair loss (alopecia)
• kidney failure

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

• reduced number of platelets in the blood
• swollen glands (lymph nodes)
• increased immune response (autoimmune disease)
• difficulty breathing
• blocked or congested nose with a headache (sinusitis)
• inflammation of the lungs (allergic alveolitis, eosinophilic pneumonia)
• swelling of the mucous membrane of the intestine
• difficulty urinating or not being able to urinate at all
• blisters, dryness and other skin problems
• excessive sweating
• low blood sugar levels (symptoms of this may include headache, feeling faint, confusion, aggressive or abnormal behaviour, difficulty speaking).

Not known:the frequency cannot be estimated based on the available data

• skin and lip cancer (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 the rhythm or rate of the heartbeat
• 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 levels of potassium, low levels of sodium, high levels of uric acid, high levels of sugar, increased cholesterol and other fats in the blood, increased levels of liver enzymes, depression of the bone marrow and other blood diseases.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through 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 Idroclorotiazide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after
“Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 ° C.
Do not dispose of any medicine in waste water. Ask your pharmacist how to dispose of medicines that
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 ingredients are 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.
The other ingredients are pregelatinized starch, corn starch, calcium hydrogen phosphate,
mannitol and magnesium stearate.

Description of the appearance of Lisinopril Hydrochlorothiazide Teva and contents of the pack
Each Lisinopril Hydrochlorothiazide 20 mg/12.5mg tablet is oval, white, slightly
convex, with "LZ20" imprinted 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: hospital unit dose pack), and 100.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva Italia Srl – Piazzale Luigi Cadorna, 4 – 20123 Milan

Manufacturer
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 (Netherlands)