TEVA LISINOPRIL AND HYDROCHLOROTHIAZIDE 20 MG / 12.5 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - TEVA LISINOPRIL AND HYDROCHLOROTHIAZIDE 20 MG / 12.5 MG TABLETS

Teva Lisinopril and Hydrochlorothiazide 10 mg/12.5 mg &20 mg/12.5 mg Tablets

lisinopril and hydrochlorothiazide

Package leaflet: Information for the user

183,3mm

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

– Keep this leaflet. You may need to read it again.
– If you have further questions, please 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 asyours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section4.

Teva Lisinopril and Hydrochlorothiazide will be referred to as “Lisinopril/HCTZ” throughout this leaflet.

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What is in this leaflet

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

What Lisinopril/HCTZ is and what it is used for

Lisinopril/HCTZ contains lisinopril and hydrochlorothiazide.

Lisinopril belongs to a group of drugs called angiotensin-converting enzyme (ACE) inhibitors. ACE inhibitors are vasodilators (drugs which widen the blood vessels making it easier for the heart to pump blood around thebody).

Hydrochlorothiazide belongs to a group of drugs called diuretics or “water tablets”.

Diuretic medicines increase the amount of water you lose in your urine and therefore reduce the amount of fluid in your blood vessels.

Because each of these drugs reduces blood pressure in a different way, Lisinopril/HCTZ may be used together to treat high blood pressure when taking either of these drugs alone did not control your blood pressure sufficiently.

What you need to know before you take Lisinopril/HCTZ

Do not take Lisinopril/HCTZ :

if you are allergic to lisinopril or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section6)
if you are allergic to sulphonamides (e.g. trimethoprim)
if you have suffered an unexplained allergic reaction or an allergic reaction to any other ACE inhibitors, e.g. captopril, enalapril, which has led to swelling of the face, lips, tongue and/orthroat
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, voice box (larynx), hands, orbowel)
if you have severe liver or kidney problems.
if you are more than 3months pregnant. (It is also better to avoid Lisinopril/HCTZ in early pregnancy– see section ‚Pregnancy and breast-feeding‘).
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing 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, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lisinopril/HCTZ:

if you think you are (or might become) pregnant. Lisinopril/HCTZ Tablets are not recommended in early pregnancy and may cause serious harm to your baby after three months of pregnancy (see section ‘Pregnancy and breast-feeding’).
if you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Lisinopril/HCTZ, seek medical attention immediately.
if you are at risk of high levels of potassium in your blood e.g. from taking potassium-containing salt substitutes or supplements
if you have been on a low sodium diet
if you are suffering from diarrhoea or vomiting
if you have an imbalance of salts in your blood
if you have heart (aortic or mitral) valve disease or an enlargedheart
if you have 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 dose of your antidiabetic medicine (including insulin)
if you are already being treated with a diuretic (diuretic medicine).
if you have problems with your blood vessels (collagen vascular disease).
if you have low blood pressure. You may feel dizzy or light-headed, especially when you standup.
if you have blood circulation problems in the heart or brain, as an excessive drop in blood pressure can lead to a heart attack or stroke.
if you suffer from gout
if you have a history of allergy, bronchial asthma or SLE (system lupus erythematosus is an allergic condition causing joint pain, rashes andfever)
if you need blood separation treatment (apheresis) or desensitisation treatment e.g. following a wasp or bee sting; your doctor may wish to interrupt treatment with this medicine to prevent a possible allergic reaction
if you need to have surgery or a general anaesthetic. Tell the doctor, dentist or hospital staff you are taking this medicine, as there may be a sudden fall in blood pressure.
if you take lithium (a medicine for mood stabilisation)
if you play competitive sports as hydrochlorothiazide is a banned substance and may give a positive result in anti-dopingtests
if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Lisinopril/HCTZ.
if you are of black race 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 beneeded
if you are taking any of the following medicines used to treat high blood pressure:– an angiotensin II receptor blocker■

(ARBs) (also known as sartans– for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems

– 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 organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus)
– vildagliptin, a medicine used to treat diabetes
– medicines containing 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 an increase of pressure in your eye and can happen within hours to weeks of taking Lisinopril/HCTZ. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulfonamide allergy, you can be at higher risk of developingthis.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading ‘Do not take Lisinopril/HCTZ’.

While taking Lisinopril/HCTZ Tablets

Your doctor will monitor your condition closely, take blood tests, check your kidney function and monitor the level of salts in your blood from time totime.

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

Children and adolescents

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

Other medicines and Lisinopril/HCTZ

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

diuretics („water tablets“) such as furosemide, torasemide, amiloride
non-steroidal anti-inflammatory drugs (NSAIDs) which are a type of pain killer, e.g. aspirin or ibuprofen
gold preparations
other drugs to reduce blood pressure as your blood pressure may become toolow
your doctor may need to change your dose and/or to take other precautions: if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings ‘Do not take Lisinopril/HCTZ’ and ‘Warnings and precautions’)
tricyclic antidepressants (e.g. amitriptyline), as these will further reduced your blood pressure
anti-psychotics e.g. chlorpromazine (used for the treatment of mental disorders), which may 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 medicines for colds and nasal stuffiness.
insulin or tablets for the treatment of diabetes, as the risk of ‘hypos’ may be increased
allopurinol for the treatment of gout, as there is an increased risk of blood disorder called leukopenia (a reduction in the number white blood cells) and of kidney failure
ciclosporin (used following organ transplant), as the risk of kidney failure may be increased
lovastatin (a drug that reduces fat levels in yourblood)
procainamide used to treat abnormal heart rhythms as there is an increased risk of blood disorder called leucopenia (a reduction in the number white bloodcells)
cytostatics (drugs for treatments of cancer) and immunosuppressives
amphotericin B (used for the treatment of serious infections caused byfungi)
carbenoxolone (used in the treatment of stomach and duodenal ulcers)
corticosteroids e.g. prednisolone
hormone called corticotropine (ACTH)
laxatives e.g. lactulose
racecadotril (for the treatment of diarrhoea)
calcium supplements/vitamin D
cardiac glycosides e.g. digoxin
drugs that reduce the fat levels in your blood such as colestyramine or colestipol, as they may impair the absorption of hydrochlorothiazide. Lisinopril/HCTZ must be taken at least one hour before or four to six hours after thesedrugs.
sotalol (beta-blocker), as there is an increased risk of abnormalities of the heartrhythm
potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria; ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to preventclots)
lithium, as lithium levels may be increased
medicines which are most often used to avoid rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors). See section “Warnings and precautions”.
certain medicines for the treatment of asthma,
non-depolarising muscle relaxants (e.g. tubocurarine chloride),
diazoxide (used to treat hypoglycaemia, among other things),
amantadine (for the treatment of Parkinson'sdisease or against severe infections caused by viruses),
barbiturates (a type of sedative also used to treat epilepsy),
alcohol,
adrenergic amines such as noradrenaline (substances that increase blood pressure),
tissue plasminogen activator (medicine used to dissolve blood clots).

How to take Lisinopril/HCTZ

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are notsure.

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

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

TEVA LISINOPRIL AND HYDROCHLOROTHIAZIDE 20 MG / 12.5 MG TABLETS - patient leaflet, side effects, dosage | Patient info (2024)

Patient leaflet - TEVA LISINOPRIL AND HYDROCHLOROTHIAZIDE 20 MG / 12.5 MG TABLETS

6.Contents of the pack and other information