PACKAGE LEAFLET: INFORMATION FOR THE USER_

LISORETIC 10MG/12.5MG TABLETS _LISORETIC 20MG/12.5MG TABLETS_

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 it again.

•    If you have any 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 symptoms 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.

What is in this leaflet:

1.    What Lisoretic Tablets are and what they are used for

2.    What you need to know before you take Lisoretic Tablets

3.    How to Take Lisoretic Tablets

4.    Possible side effects

5.    How to store Lisoretic Tablets

6.    Contents of the pack and other information

_1. What Lisoretic Tablets are and what they are used for_

Lisoretic is used to treat high blood pressure (hypertension). It contains two medicines called lisinopril (as dihydrate) and hydrochlorothiazide.

•    Lisinopril belongs to a group of medicines called ACE inhibitors. It works by making your blood vessels widen.

•    Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine.

These medicines work together to lower your blood pressure.

|    2. What you need to know before you take Lisoretic Tablets |

Do not take Lisoretic Tablets if:

•    You are allergic (hypersensitive) to lisinopril or hydrochlorothiazide or any of the other ingredients of Lisoretic (listed in Section 6: Further information).

•    You are allergic to ACE inhibitor or sulphonamide medicines. If you are not sure if this applies to you, please ask your doctor.

•    You have ever had sudden swelling of the hands, feet, ankles, face, lips, tongue or throat, especially if this followed treatment with an ACE inhibitor. It may also have been difficult to swallow or breathe.

•    You have hereditary angioedema (a condition that makes you more prone to the swelling described above). If you are not sure if this applies to you, please ask your doctor.

•    You have severe kidney problems.

•    You are having kidney dialysis or you have had a kidney transplant.

•    You have stopped passing water (urine).

•    You have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

•    You have severe liver problems.

•    You are more than 3 months pregnant. (It is also better to avoid Lisoretic in early pregnancy - see pregnancy section).

Do not take Lisoretic if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Lisoretic.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lisoretic if:

•    You have a narrowing (stenosis) of the aorta (an artery in your heart) or the kidney artery.

•    You have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy).

•    You have problems with your blood vessels (collagen vascular disease).

•    You have low blood pressure. You may notice this as feeling dizzy or lightheaded, especially when standing up.

•    You have kidney problems.

•    You have liver problems or liver failure associated with hypotension.

•    You have diabetes.

•    You have recently had diarrhoea or vomiting (being sick).

•    Your doctor has told you to control the amount of salt in your diet.

•    You have high levels of cholesterol and you are having a treatment called 'LDL apheresis'.

•    You have ever had a condition called systemic lupus erythematosus (SLE).

•    You are of black origin as Lisoretic may be less effective. You may also more readily get the side effect 'angioedema' (a severe allergic reaction with swelling of the hands, feet, ankles, face, lips, tongue or throat).

•    You have increased serum potassium salts

•    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

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 Lisoretic tablets”

You must tell your doctor if you think you are (or might become) pregnant. Lisoretic is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy, breast-feeding and fertility section).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Lisoretic.

Treatment for allergies such as insect stings

Tell your doctor if you are having or are going to have treatment to lower the effects of an allergy such as insect stings (desensitisation treatment).

If you take Lisoretic while you are having this treatment, it may cause a severe allergic reaction.

Operations

If you are going to have an operation (including dental surgery) tell the doctor or dentist that you are taking Lisoretic. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking Lisoretic.

Other medicines and Lisoretic Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    Other medicines to help lower your blood pressure.

•    Water tablets (diuretic medicines).

•    Non-steroidal anti inflammatory drugs (NSAIDs) such as indomethacin, used to treat pain and arthritis.

•    Medicines for depression (tricyclic and tetracyclic antidepressants).

•    Medicines for mental problems, including lithium.

•    Aspirin (acetylsalicylic acid), if you are taking more than 3 grams each day.

•    Medicines that can increase the amount of potassium in the blood such as potassium tablets, potassium sparing diuretics or salt substitutes that have potassium in them.

•    Calcium salts.

•    Insulin or medicines that you take by mouth for diabetes.

•    Medicines to treat asthma.

•    Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).

•    Medicines to suppress the body's immune response (immuno suppressants, such as ciclosporin).

•    Allopurinol (for gout).

•    Medicines for uneven heart beat problems (such as procainamide).

•    Cardiac glycosides (to treat heart failure).

•    Medicines that contain gold, such as sodium aurothiomalate, which may be given to you as an injection.

•    Amphotericin B injection (to treat fungal infections).

•    Carbenoxolone (to treat ulcers or inflammation in the gullet or in and around the mouth).

•    Corticosteroids (steroid medicines).

•    Corticotropin (a hormone).

•    Medicines to treat constipation (stimulant laxatives).

•    Colestyramine and colestipol (to lower cholesterol, prevent diarrhoea or reduce itching)

•    Muscle relaxants such as tubocurarine.

•    Trimethoprim (an antibiotic).

•    Sotalol (a beta-blocker).

•    Lovastatin (to lower cholesterol).

•    Dextran sulphate (used in the treatment called 'LDL apheresis' to lower cholesterol).

•    Chemotherapy for cancer (cytostatics).

•    Other medicines known to have an effect on the heart called Torsades de pointes.

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 Lisoretic tablets” and "Warnings and precautions”)”

Pregnancy, breast-feeding and fertility Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Lisoretic before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lisoretic. Lisoretic is not recommended in early 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. Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisoretic is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

•    Some people feel dizzy or tired when taking this medicine. If this happens to you, do not drive or use any tools or machines

•    You must wait to see how your medicine affects you before trying these activities.

|    3. How to take Lisoretic Tablets    |

Always take Lisoretic exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Once you have started taking Lisoretic your doctor may take blood tests. Your doctor may then adjust your dose so you take the right amount of medicine for you.

Taking your medicine

•    Swallow the tablet with a drink of water.

•    Try to take your tablets at the same time each day. It does not matter if you take Lisoretic before or after food.

•    Keep taking Lisoretic for as long as your doctor tells you to, it is a long term treatment. It is important to keep taking Lisoretic everyday.

Taking your first dose

•    Take special care when you have your first dose of Lisoretic or if your dose is increased. It may cause a greater fall in blood pressure than later doses.

•    This may make you feel dizzy or light-headed. If this happens, it may help to lie down. If you are concerned, please talk to your doctor as soon as possible.

Adults

•    The usual dose is one tablet once a day.    xxxxxxx

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Your doctor will prescribe the tablet that is the right strength for you.

•    If necessary, your doctor may increase your dose to two tablets once a day. Children

•    Lisoretic is not recommended for use in children.

If you take more Lisoretic Tablets than you should

If you take more Lisoretic than prescribed by your doctor, talk to a doctor or go to a hospital immediately. Take the medicine pack with you so that the tablets can be identified.

If you forget to take Lisoretic Tablets

•    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.

•    Do not take a double dose to make up for a forgotten dose.

If you stop taking Lisoretic Tablets

Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you to.

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

|    4. Possible side effects    |

Like all medicines Lisoretic tablets can cause side effects, although not everybody gets them.

Lisoretic contains two medicines: lisinopril and hydrochlorothiazide. The following side effects have been seen with these individual medicines. This means they could also happen with Lisoretic.

Your doctor may take blood samples from time to time to check whether Lisoretic has had any effect on your blood.

Possible side effects with lisinopril

Severe allergic reactions (rare, may affect up to 1 in 1,000 people)

Stop taking Lisoretic, if you have a severe allergic reaction, and see a doctor immediately. The signs may include sudden onset of:

•    Swelling of your face, lips, tongue or throat. This may make it difficult to swallow.

•    Severe or sudden swelling of your hands, feet or ankles.

•    Difficulty breathing.

•    Severe itching of the skin (with raised lumps).

Severe liver problems (very rare, may affect up to 1 in 10,000 people)

The signs may include:

•    Yellowing of your skin or eyes, (jaundice) dark coloured urine or a loss of appetite.

If this happens to you, see a doctor immediately.

Other possible side effects:

Common (may affect up to 1 in 10 people)

•    Headache.

•    Feeling dizzy or light headed, especially if you stand up quickly.

•    Fainting.

•    Diarrhoea, being sick (vomiting).

•    Cough.

•    Kidney problems (shown in a blood test).

Uncommon (may affect up to 1 in 100 people)

•    Mood changes including feeling depressed.

•    Tingling feeling such as 'pins and needles'.

•    Spinning feeling (vertigo).

•    Changes in the way things taste.

•    Difficulty in sleeping.

•    Heart attack or stroke, unusual heart beat.

•    Change of colour in your fingers or toes.

•    Runny nose.

•    Feeling sick (nausea).

•    Stomach pain and indigestion.

•    Changes in blood tests that check how the liver is working.

•    Itchiness, rashes

•    Being unable to get an erection (impotence).

•    Feeling weak or tired

•    Increased levels of certain substances in your blood (urea, creatinine or potassium).

Rare (may affect up to 1 in 1,000 people)

•    Changes to some of the cells or other parts of your blood. The signs may include feeling tired and pale skin.

•    Feeling confused.

•    Changes in the way things smell, dry mouth.

•    Hair loss (alopecia).

•    Psoriasis (a skin problem).

•    Infection of the blood.

•    Kidney failure.

•    Enlarged breasts in men.

•    Low levels of sodium in the blood, which may cause weakness, tiredness, headache, feeling sick, being sick (vomiting) and cramps.

Very rare (may affect up to 1 in 10,000 people)

•    Problems with your bone marrow or a reduced number of blood cells and/or platelets in your blood. You may notice tiredness, an infection (which may be serious), fever, feeling breathless or that you bruise or bleed more easily.

•    Swollen glands (lymph nodes).

•    Increased immune response (autoimmune disease).

•    Low levels of sugar in your blood (hypoglycaemia). The signs may include feeling hungry or weak, sweating and a fast heart beat.

•    Suddenly feeling wheezy or short of breath (bronchospasm).

• Lung inflammation (which may make you feel breathless).

• Sinusitis (a feeling of pain and fullness behind your cheeks and eyes).

•    Eosinophilic pneumonia. The signs include a combination of the following:

•    sinusitis

•    feeling like you have flu

•    feeling more and more breathless

•    pain in the area of your stomach or gut

•    skin rash

•    a feeling of 'pins and needles' or numbness of your arms or legs.

•    Inflammation of the pancreas. This causes moderate to severe pain in the stomach.

•    Swelling of the lining of the gut. This may cause sudden stomach pain, diarrhoea or make you be sick (vomit).

•    Sweating.

•    Severe skin disorder or rash. The symptoms include redness, blistering and peeling of the skin which may develop quickly and may include blistering in the mouth and nose.

•    Passing less water (urine) than normal or passing no water.

Possible side effects with hydrochlorothiazide

Not known (frequency cannot be estimated from the available data)

•    Inflammation of a salivary gland.

•    A reduced number of blood cells and/or platelets in your blood. You may notice tiredness, an infection (which may be serious), fever, feeling breathless or that you bruise or bleed more easily.

•    Loss of appetite.

•    An increase in the amount of sugar (glucose) in your blood.

•    Sugar in your urine.

•    An increase in the amount of uric acid in your blood.

•    Altered levels of substances in your blood (low sodium, low potassium, low magnesium, low chlorides). You may notice muscle weakness, thirst, 'pins and needles', cramps or feeling sick.

•    Raised or high levels of fats in your blood (including cholesterol).

•    Feeling restless, depression.

•    Difficulty sleeping.

•    Tingling feelings such as 'pins and needles'.

•    Feeling light headed.

•    Feeling faint (especially when standing up).

•    Damage to blood vessels causing red or purple spots in the skin.

•    Difficulty breathing. You may feel breathless if your lungs get inflamed or have fluid on them.

•    Stomach irritation, diarrhoea or constipation

•    Inflammation of the pancreas. This causes moderate to severe pain in the stomach.

•    Yellowing of your skin or the whites of your eyes (jaundice).

•    Skin problems including rash caused by sensitivity to sunlight, rash, severe rash that develops quickly with blistering or peeling of the skin and possibly blistering in the mouth, worsening of existing lupus erythematosus-like reactions or appearance of unusual skin reactions.

•    Allergic reactions

•    Muscle cramps and muscle weakness.

•    Kidney problems which may be severe (shown in blood tests).

•    Fever.

•    Redness of skin (flushing)

•    Weakness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

I    5. How to store Lisoretic Tablets    I

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

•    Do not use this medicine after expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

•    Do not store above 25^oC. Store in the original package.

•    Do not throw away any medicines via waste water or house hold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

|    6. Contents of the pack and other information    |

What Lisoretic tablets contain

•    The active substances are Lisinopril (as dihydrate) and Hydrochlorothiazide.

•    Lisoretic tablets come in two strengths, 10mg/12.5mg and 20mg/12.5mg. Each tablet contains either 10mg of lisinopril (as dihydrate) and 12.5mg of hydrochlorothiazide or 20mg lisinopril (as dihydrate) and 12.5mg of hydrochlorothiazide.

The other ingredients of the tablets calcium hydrogen phosphate, mannitol, maize starch, pregelatinised starch and magnesium stearate. Lisoretic 10mg/12.5mg tablets also contain ferric oxide red (E172) and ferric oxide yellow (E172).

What Lisoretic tablets looks like and contents of the pack

•    Lisoretic 10mg/12.5mg tablets are light pink, circular, biconvex uncoated tablets.

•    Lisoretic 20mg/12.5mg tablets are white to off white circular, biconvex uncoated tablets.

•    Lisoretic tablets come in packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer

Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Lisoretic 10mg/12.5mg Tablets; PL 17907/0073    „

Lisoretic 20mg/12.5mg Tablets; PL 17907/0074    |

This leaflet was last revised in October 2014    §

To request a copy of this leaflet in Braille, large print or audio, please contact the licence holder at the address (or telephone, fax, email) above. V11 16-10-14 D0

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