Informations for option: Lisinopril And Hydrochlorothiazide 20mg/12.5mg Tablets, show other option

Select option:

1. Lisinopril And Hydrochlorothiazide 20mg/12.5mg Tablets
2. Lisinopril And Hydrochlorothiazide 20mg/12.5mg Tablets

Document: document 0 change

• document 0
• document 1
• document 2

---

TEVA UK Ref: 231-30-63238-Y LEA LISINOPRIL/HCTZ 10/12.5mg TAB 28 TUK <DEB	Version: 5	05 February 2014

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

Lisinopril and Hydrochlorothiazide

PACKAGE LEAFLET: INFORMATION FORTHE USER

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

» Keep this leaflet. You may need to read it again.

» Ifyou have any further questions, askyour 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.

» Ifyou get any side effects, talkto yourdoctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

Lisinopril and Hydrochlorothiazide will be referred to as "Lisinopril/HCTZ" throughout this leaflet.

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

Ol What Lisinopril/HCTZ is and what it is used for

.isinopril belongs to a group ofdrugs called angiotensin-converting enzyme (ACE) inhibitors. ACE inhibitors are vasodilators (drugs which widen the blood vessels) making it easierfor the heart to pump blood around the body. Hydrochlorothiazide belongs to a group of drugs called diuretics or "water tablets') Diuretic medicines increase the amount ofwateryou ose in your urine and therefore reduce the amount of fluid in your blood vessels.

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

What you need to know before you take Lisinopril/HCTZ

Do not take Lisinopril/HCTZ:

» if you are allergic to lisinopril or

hydrochlorothiazide, any other ACE-inhibitors or any of the other ingredients ofthis medicine (listed in section 6)

» if you are more than 3 months pregnant. (It is also better to avoid Lisinopril/HCTZ in early pregnancy - see section 2: Pregnancy and breast-feeding.)

» if you are allergic to sulphonamide derived drugs, e.g. trimethoprim » if you have suffered an unexplained allergic reaction oran allergic reaction to any other ACE inhibitors, e.g. captopril, enalapril, which has led to swelling ofthe 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 ofthe skin in a particular area which commonly affects the eyes, lips, nose, tongue, voice box (larynx), hands, or bowel)

» if you have severe liveror kidney problems.

» if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking

this medicine:

» if you have diabetes (as your insulin requirements may change)

» ifyou have severe high blood pressure » ifyou have hypertrophiccardiomyopathy (disorderofthe heart muscle)

» ifyou have heartfailure » ifyou have narrowing ofthe aortic or mitral valve

» if you have insufficient blood supply to your heart (ischaemic heart disease)

» if you have insufficient blood supply to your brain (cerebrovascular disease)

» ifyou have narrowing ofthe arteries leading to the kidneys, any other kidney problems, are undergoing dialysis or have had a kidney transplant

» ifyou have impaired liverfunction » if you have a collagen vasculardisease (a

affectthe structure oftendons, bones, and connective tissues) such as: rheumatoid arthritis, systemic iupus erythematosus or scleroderma

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 are up to 3 months of pregnant if you are undergoing haemodialysis or having LDL apheresis (removal of cholesterol from the blood by machine), if you are taking any ofthe following medicines used to treat high blood pressure:

♦    an angiotensin II receptor blocker (ARBs) (also known as sartans - forexample valsartan,telmisartan, irbesartan), in particular ifyou have diabetes-related kidney problems.

♦    aliskiren

Yourdoctor may checkyour kidney function, alood pressure, and the amount of electrolytes e.g. potassium) in your blood at regular ntervals.

See also information underthe heading 'Do not take Lisinopril/HCTZ'.

fany ofthe above applies to you,or if you are not sure, please talkto yourdoctoror aharmacist before taking this medicine.

You must tell yourdoctor ifyou thinkyou are (or might become) pregnant. Lisinopril/HCTZ is not recommended in early pregnancy, and must not be taken ifyou are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section 2: ³regnancyand breast-feeding).

Tell your doctor you are taking Lisinopril/HCTZ if you:

have to undergo a desensitisation treatment for an allergy e.g. bee or wasp stings are to have an operation and/oranaesthetic (including at the dentist): tell the doctor or dentist that you are taking Lisinopril/HCTZ Tablets

are to have a liver function test or other blood tests, as Lisinopril/HCTZ may affect the results

are to take an anti-doping test, as Lisinopril/HCTZ may produce a positive result.

Other medicines and Lisinopril/HCTZ

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

otherdrugs to reduce blood pressure such as

diuretics ("water tablets”) e.g. amiloride,

vasodilators or nitrates

anti-psychotics e.g. chlorpromazine (forthe

treatment of mental disorders)

tricyclic antidepressants (e.g. amitriptyline)

lithium

insulin, or tablets forthe treatment of diabetes such as metformin or gliclazide muscle-relaxing drugs such as tubocurarine (given sometimes during a general anaesthetic) laxatives e.g. lactulose carbenoxolone (used to treat stomach and duodenal ulcers)

Amphotericin B (used in the treatment of fungal infections) calcium salts

cardiacglycosides e.g. digoxin medicines used to treat abnormal heart rhythms such as sotalol (a beta-blocker), procainamide

non-steroidal anti-inflammatory drugs (NSAIDs) which are a type of pain killer, e.g. diflunisal or ibuprofen sympathomimeticdrugs e.g. adrenaline, noradrenaline, or ephedrine. Ephedrine may be present in medicines for colds and nasal stuffiness.

drugs that reduce fat levels in your blood such as lovastatin (a cholesterol lowering agent), colestyramine orcolestipol potassium supplements, potassium-sparing agents or potassium-containing salt substitutes

ciclosporin (used following organ transplant) trimethoprim (used to treat urinary and respiratorytract infections) allopurinol forthe treatment of gout medicines to treat cancer, or immunosuppressive drugs (used following an organ transplant)

corticosteroids, e.g. prednisolone and ACTH (to treat inflammation in diseases such as rheumatoid arthritis).

your doctor may need to change yourdose 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').

Pregnancy and breast-feeding Pregnancy

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

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril/HCTZ is not recommended for mothers who are breast-feeding, and your doctor may choose anothertreatment foryou ifyou wish to breast-feed, especially ifyou baby is newborn,orwas born prematurely.

Driving and using machines

Lisinopril/HCTZ may reduce your ability to drive and use machines at the start of treatment orwhen the dose is modified, especially when taken in combination with alcohol. Ifyou are affected, DO NOT drive or operate machinery.

How to take Lisinopril/HCTZ

Always take this medicine exactly as your

doctor has told you. Checkwith yourdoctor or

oharmacist ifyou are not sure.

fyou are already taking diuretics yourdoctor

may reduce your dose ofthese, or even tell you

to stop taking them before you start to take

.isinopril/HCTZ.

Yourdoctor will monitor you during treatment and this may include blood or urine tests.

*    Adults (including older people):

Lisinopril/HCTZ should be taken once a day. The tablets should be swallowed preferably with a glass ofwater.

Your dose will be decided by yourdoctor, depending on your response to treatment. The maximum daily dose of40 mg lisinopril/25 mg hydrochlorothiazide should not be exceeded.

*    Children and adolescents under 18 years of age.

Lisinopril/HCTZ is not recommended in children and adolescents under 18 years of age.

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

If you take more Lisinopril/HCTZ than you should

Ifyou (or someone else) swallow a lot ofthe tablets all togetheror ifyou think a child has swallowed any ofthe tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause faintness or dizziness (due to a drop in blood pressure), rapid breathing, anxiety and a cough.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Lisinopril/HCTZ Do not take a double dose to make up for a forgotten dose, take one as soon as you remember, unless it is nearly time to take the next one.Take the remaining doses at the correct time.

If you stop taking Lisinopril/HCTZ You should continue to take these tablets foras long as your doctortells you to. Do not stop taking your medicine without talking to your doctorfirst even ifyoufeel better.

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

^ Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the tablets and tell your doctor immediately orgo to the casualty department at your nearest hospital if any ofthe following happen:

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

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if you experience any ofthe following effects:

» heart attackorstroke in susceptible patients » symptoms including feeling or being sick, abdominal and back pain; these may be signs of pancreatitis (inflammation of the pancreas).

These are serious but uncommon (may affect up to 1 in 100 people) side effects.

» a serious illness with blistering ofthe skin, mouth eyes and genitals (Stevens-Johnson Syndrome), or severe blistering and peeling of large areas ofthe skin (toxic epidermal necrolysis)

» jaundice (yellowing of the skin and whites of the eyes); this may be a sign of inflammation of the liver (hepatitis).

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

Ifyou are taking Lisinopril/HCTZ tablets for the first time, you may feel dizzy or light-headed for a short time afterwards.This is unlikely to happen when you are taking the tablets regularly.Tell your doctor ifyou continue to experience these effects and are worried about them.

The following side effects have been reported at the approximate frequencies shown: Common (may affect uptol in10 people ):

» dizziness or light-headedness (including feeling faint on standing)

» low blood pressure (which may make you feel dizzy or faint)

» drycough

» tiredness, lethargy (a feeling of tiredness, drowsiness, or lack ofenergy)

» headache » kidney problems » diarrhoea or being sick.

Uncommon (may affect up to 1 in 100 people):

» feeling sick

» a sensation that your surroundings are spinning (vertigo)

» changes in your sensation oftaste » dry mouth » indigestion » abdominal pain

rash, itching

gout (sudden, unexpected, burning pain, as

well as swelling, redness, warmth, and

stiffness in the affected joint)

chest pain, awareness ofyour heart beating

(palpitations), fast heart rate

poor circulation, coldness in the fingers and

toes

muscle spasms and/orweakness,

Very rare (may affect up to 1 in10,000 people):

» breathing difficulties » blocked orstuffy nose with a headache » difficulty in passing urine or not passing any at all

» blistering, peeling and other problems of the skin

» excessive sweating

» low levels of blood sugar (symptoms of this may include headache, feeling faint, mental confusion, aggressive or abnormal behaviour, slurred speech).

Results of tests 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, increase in cholesterol and other fats in the blood, increased levels of liver enzyme, bone marrow depression and other blood disorders.

Reporting of side effects

Ifyou get anyside effects, talkto your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

How to store Lisinopril/HCTZ

Keep this medicine out of the sight and reach of children.

Do not use this medicine afterthe expiry date, which is stated on the outer packaging.The expiry date refers to the last day of that month.

Contents of the pack and other information

What Lisinopril/HCTZ contains:

» The active substances are eitherlO mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide, or 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.

» The other ingredients are pregelatinised starch, maize starch, calcium hydrogen phosphate anhydrous, mannitol and magnesium stearate.

What Lisinopril/HCTZ looks like and contents

of the pack:

» Each Lisinopril/HCTZ 10mg/12.5mg tablet is white oval shaped slightly arched, indented "LZ10" on one side and a breakline on the other.

» Each Lisinopril/HCTZ20mg/12.5mgtablet is white oval shaped slightly arched, indented "LZ20" on one side and a breakline on the other.

» The product is available in packs of 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 Authorisation Holder and

Manufacturer

Marketing Authorisation holder:TEVA UK

Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: January 2015

PL 00289/0453-0454

the hands arms, legs orfeet)

» impotence (difficulty getting or maintaining an erection)

» mood swings » sleep difficulties » runny and itchy nose.

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 orother skin problems