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LISINOPRIL & HYDROCHLOROTHIAZIDE 10MG/12.5MG TABLETS

Active substance: LISINOPRIL DIHYDRATE

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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

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• 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.
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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.

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• 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.

5. How to store Lisoretic Tablets
• 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 25oC. 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
V11 16-10-14 D0
licence holder at the address (or telephone, fax, email) above.
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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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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