LISINOPRIL AND HYDROCHLOROTHIAZIDE 20 MG/12.5 MG TABLETS

Active substance: LISINOPRIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Lisinopril and Hydrochlorothiazide 10mg/12.5mg and 20mg/12.5mg Tablets
(lisinopril and hydrochlorothiazide)

Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Lisinopril and Hydrochlorothiazide Tablets are and what they are used for
2.
Before you take Lisinopril and Hydrochlorothiazide Tablets
3.
How to take Lisinopril and Hydrochlorothiazide Tablets
4.
Possible side effects
5.
How to store Lisinopril and Hydrochlorothiazide Tablets
6.
Further information

1.

WHAT LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS ARE AND WHAT
THEY ARE USED FOR

Your tablets contain two medicines, lisinopril an ACE (angiotensin converting enzyme) inhibitor and
hydrochlorothiazide a thiazide diuretic, which work together to lower your blood pressure. You have
been given Lisinopril and Hydrochlorothiazide Tablets because your high blood pressure was not
being adequately treated using lisinopril or hydrochlorothiazide alone.

2.

BEFORE YOU TAKE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS

Do not take Lisinopril and Hydrochlorothiazide Tablets if








you are allergic (hypersensitive) to lisinopril, other ACE inhibitors or any of the other
ingredients of this medicine (see section 6 ‘Further information’)
you are allergic (hypersensitive) to hydrochlorothiazide or other sulphonamides (medicines
chemically related to hydrochlorothiazide)
you have previously been treated with an ACE inhibitor and have suffered an allergic reaction
called angioedema. Symptoms may include swelling of the face, lips, tongue or hands and feet,
or breathing difficulties
you or one of your family have ever suffered from the allergic reaction called angioedema for
any reason
you have severe kidney disease or cannot pass urine.
you are more than 3 months pregnant. (It is also better to avoid Lisinopril and
Hydrochlorothiazide Tablets in early pregnancy – see pregnancy section.)
you have severe liver disease.

Ask your doctor if you are not sure.
Take special care with Lisinopril and Hydrochlorothiazide Tablets
You should tell your doctor before taking this medicine if:

you feel dehydrated due to treatment with diuretics, dialysis, a low salt diet, vomiting or
diarrhoea. You may be more likely to suffer from a large drop in your blood pressure when you
















start taking your tablets and may feel faint or light-headed. Your doctor will monitor you closely
at the start of treatment and if your dose is adjusted.
you think that you are (or might become) pregnant. Lisinopril and Hydrochlorothiazide Tablets
are 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 section)
you are at risk of high levels of potassium in your blood eg. from taking potassium-containing
salt substitutes or supplements
you have heart or blood vessel disease
you have heart (aortic) valve disease or an enlarged heart
you have liver disease or liver problems
you have kidney problems, need dialysis treatment or have had a kidney transplant
you suffer from narrowing of the blood vessels to the kidney
you have diabetes. As you may need a different dose of your antidiabetic medicine (including
insulin)
you suffer from gout
you have a history of allergy, bronchial asthma or SLE (system lupus erythematosus is an
allergic condition causing joint pain, rashes and fever)
you need blood separation treatment (apheresis) or desensitisation treatment eg. following a
wasp or bee sting; your doctor may wish to interrupt treatment with this medicine to prevent a
possible allergic reaction
you need to have surgery or a general anaesthetic. Tell the doctor, dentist or hospital staff you
are taking this medicine
you play competitive sports as hydrochlorothiazide is a banned substance and may give a
positive result in anti-doping tests.
Use in Afro-Caribbean patients: ACE inhibitors may be less effective in lowering blood pressure
in black Afro-Caribbean patients and a higher dose of this medicine may be needed.

While taking Lisinopril and Hydrochlorothiazide Tablets
If you develop any of the following symptoms let your doctor know immediately:

you feel dizzy after your first dose. A few people react to their first dose or when the dose is
increased by feeling dizzy, weak, faint and sick. Lie down if your blood pressure drops too low.

Complaints such as a dry mouth, thirst, lethargy, muscle pain or cramps, a racing heart,
dizziness, feeling or being sick, and passing less urine, are signs of a fluid or mineral imbalance
in the body.

Sudden swelling of the lips, face, neck, and possibly hands and feet, a rash, difficulty
swallowing or breathing, hoarseness, are signs of angioedema. This may occur at any time
during treatment. There is a higher risk in black patients.

High temperature, sore throat and mouth ulcers, are signs of a low white cell count in the blood

Yellowing of the skin or whites of the eyes, may be a sign of liver problems.
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 to time.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, or the following:

other diuretic (‘water’ tablets)

medicine to treat high blood pressure eg. a beta blocker such as sotalol, or a nitrate

digoxin (for a heart condition)

medicine that can increase the amount of potassium in the blood such as potassium-containing
supplements, salt substitutes, heparin (given by injection to treat blood clots)

medicine known to cause a serious type of heart rhythm disorder called torsades de pointes, this
is more likely if potassium levels in the body are low.

medicine containing calcium






















anti-inflammatory medicine called NSAIDs eg. ibuprofen (to treat arthritis or muscle pain)
aspirin
lithium (medicine for depression)..
anaesthetics and medicines for mental disorders or depressions, medicines to treat psychoses,
tricyclic antidepressants, or sedatives.
antidepressants such as amitriptyline
antidiabetic medicine eg. insulin, gliclazide; your blood glucose should be monitored closely in
the first few weeks of treatment
allopurinol (for gout)
medicines used after organ transplantation eg.ciclosporin
anti-cancer medicines
colestyramine, colestipol, (help reduce blood fat levels); take Lisinopril and
Hydrochlorothiazide dose at least one hour before or four to six hours after these medicines.
lovastatin (helps reduce cholesterol)
procainamide (for an irregular heart rhythm)
carbenoxolone (for throat ulcers)
corticosteroids (anti-inflammatory)
corticotropin (for rheumatoid arthritis or Crohn’s disease)
laxatives such as senna
amphotericin B by injection (for fungal infections)
trimethoprim (antibiotic)
medicines used to stimulate the central nervous system eg. ephedrine or pseudoephedrine, often
found in cough and cold remedies
anaesthetic medicines or muscle relaxants such as tubocurarine.

Please Notice:
If you are going to have an operation or need an anaesthetic, tell your doctor or dentist that you are
taking Lisinopril and Hydrochlorothiazide Tablets.
Your doctor may want to do some blood or urine tests while you are taking Lisinopril and
Hydrochlorothiazide Tablets to check that there are no problems with your blood, liver or kidneys.
Taking Lisinopril and Hydrochlorothiazide Tablets with alcohol
You should not drink alcohol while being treated with this medicine, because in some cases alcohol
can make the side effects worse.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally
advise you to stop taking Lisinopril and Hydrochlorothiazide Tablets before you become pregnant or
as soon as you know you are pregnant and will advise you to take another medicine instead of
Lisinopril and Hydrochlorothiazide Tablets. Lisinopril and Hydrochlorothiazide Tablets 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.
Breastfeeding
Tell your doctor if you are breastfeeding or about to start breastfeeding. Lisinopril and
Hydrochlorothiazide Tablets is not recommended for mothers who are breastfeeding, and your doctor
may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or
was born prematurely.
Driving and using machines

This medicine can sometimes make people feel faint or dizzy. This may especially be the case at the
start of treatment or when changing the dose. If you are affected, you should not drive a car or operate
machinery. These side effects may be worse if you drink alcohol at the same time.

3.

HOW TO TAKE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS

Always take this medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual dose is:
Adults
The starting dose is one tablet daily. Your doctor will decide which strength of tablet to start you on.
The maximum daily dose is two 20mg/12.5 mg strength tablets once a day.
Reduced kidney function
If you have kidney problems your doctor will check your kidney function. You may be given a lower
dose than stated above. This medicine should not be given to patients with severe kidney problems.
Elderly
As dose stated for adults.
Children and adolescents (under 18 years)
Lisinopril and Hydrochlorothiazide Tablets are not recommended for children and adolescents as the
medicine’s safety and effectiveness in this age group is not known.
How to take

Take the tablets with a glass of water.

Try to take the tablets at the same time each day. Many patients prefer to take Lisinopril and
Hydrochlorothiazide Tablets in the morning so that the effects of the diuretic (passing more
water than usual) occur during the daytime.

If you are taking this medicine for the first time or your dose is increased, you may feel lightheaded or dizzy for a short time and it may help to sit or lie down. This is unlikely to happen
when you are taking the tablets regularly. If you are worried, contact your doctor.
If you have taken more Lisinopril and Hydrochlorothiazide Tablets than you should
Contact your doctor or nearest hospital emergency department immediately. Take this leaflet, the
container and any remaining tablets with you so your doctor will know what you have taken.
Symptoms of overdose may include severe low blood pressure, an unusual amount of salt in the body
and dehydration due to passing a large amount of urine, fast breathing, fast or irregular heart beat,
slow heart beat, dizziness, anxiety, cough and kidney failure.
If you forget to take Lisinopril and Hydrochlorothiazide Tablets
Take your normal dose when it is next due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Lisinopril and Hydrochlorothiazide Tablets
Do not suddenly stop taking this medicine as this may cause serious changes in your blood pressure.
If you want to stop the treatment discuss this with your doctor or pharmacist.
If you have further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Lisinopril and Hydrochlorothiazide Tablets can cause side effects, although not
everybody gets them.
If any of the following happen, stop taking Lisinopril and Hydrochlorothiazide Tablets and tell
your doctor immediately or go to your nearest hospital emergency department:
• allergic reactions causing swelling of the face, lips, tongue and/or throat which may cause
difficulty breathing or swallowing. In some cases, this may also be associated with fever, joint
or muscle pains, skin rashes or sensitivity to sunlight.
• abdominal pain with sickness
• severe skin reactions which can cause blisters, sores and ulceration, skin sensitive to light, and
inflamed blood vessels
• yellowing of your skin or whites of the eyes, dark urine, and pale stools, which can lead to
liver failure.
These are very serious side effects. You may need medical attention.
It is very important that you stop taking Lisinopril and Hydrochlorothiazide Tablets
immediately and see your doctor if you feel very dizziness, light-headed or faint (especially at the
start of treatment or when the dose has increased or when you stand up). These side effects are caused
by a large drop in your blood pressure and could lead to a heart attack (severe chest pain) or stroke.
Tell your doctor if you suffer from any of the following as Lisinopril and Hydrochlorothiazide
Tablets can cause changes to your blood such as:
- raised blood glucose levels causing symptoms such as feeling very thirsty and tired, passing
large amounts of urine, weight loss
- low blood glucose levels which can cause sweating, trembling, a fast pounding heart beat
- change in potassium levels which can cause an abnormal heart rhythm, muscle weakness or
cramps
- low levels of sodium (salt) which can make you feel weak and confused with aching, stiff
muscles
- raised cholesterol or triglyceride (fat) levels
- high urea levels, which can lead to gout (a painful inflammation of the joints)
- reduction in red or white blood cells or platelets which can cause as tiredness, rash, sore
throat, fever, swollen lymph glands, bruising easily or suffering frequent nose bleeds
- problems with the immune system.
Your doctor may occasionally take blood samples to check whether your tablets have had any
effect on your blood.
Other side effects include:
Common side effects (affecting more than 1 in 100 patients but less than 1 in 10 patients):
• dizziness, which generally goes if the dose is reduced
• light-headedness when standing up quickly, low blood pressure (hypotension)
• headache
• dry and persistent cough; tell your doctor he may decide to change your medicine
• tiredness
• being sick, diarrhoea
• problems with kidney function.
Uncommon side effects (affecting more than 1 in 1000 patients but less than 1 in 100 patients):
• a racing or irregular heart beat, missed heartbeats or a pounding heart (palpitations)
• chest pain
• muscle spasms or weakness
• painful, cold and blueish fingers and toes caused by blood circulation problems
• pins and needles in the limbs, feeling weak
• diarrhoea, feeling sick















indigestion, stomach pain, dry mouth
taste changes
mood changes
sleep problems
skin rash, itchy skin
gout
impotence
feeling of spinning (vertigo)
a runny itchy nose
raised creatinine levels in the blood (which may indicate kidney problems)
altered liver enzyme levels in the blood.
heart attack
stroke.

Rare side effects (affecting more than 1 in 10, 000 patients but less than 1 in 1,000 patients):
• mental confusion
• dry mouth, hair loss
• swollen skin
• psoriasis, a skin condition, red scaly patches on the skin
• changes in urine function which may be serious, uraemia (a toxic condition caused by kidney
failure and a build up of urea in the blood)
• swollen breasts (in men)
• altered liver function tests (increase in albumin in the blood).
Very rare side effects (affecting less than 1 in 10, 000 patients):
• swollen inflamed intestine (gut)
• difficulty or unable to pass urine
• wheezing, breathlessness
• lung problems such as infection or inflammation in the lungs caused by allergy
• inflamed and swollen sinuses causing pain, high temperature and tenderness
• sweating.
• bone marrow depression
• enlargement of the lymph nodes
• inflammation of the pancreas
• inflammation of the liver (hepatitis)
• jaundice (yellowing of the skin or whites of the eyes)
• liver failure
Other side effects reported with hydrochlorothiazide alone are:
• loss of appetite
• eyesight changes such as blurred vision, yellowing of colour vision
• infection in the salivary glands
• fever
• glucose in the urine
• depression,
• restlessness.
• constipation.
• inflammation of the blood vessels
• upset stomach
• hives (nettle rash)
• inflammation of the kidney
Other side effects reported with lisinopril (or other ACE inhibitors) alone are:
• itching blisters




decrease in haemoglobin
a combination of one or more of the following symptoms may appear together: fever,
inflammation of blood vessels, muscle pain, joint pain, rash, sensitivity to sunlight, changes in
red and white blood cell count

If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

5.

HOW TO STORE LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Lisinopril and Hydrochlorothiazide Tablets contain
Each Lisinopril and Hydrochlorothiazide 10mg/12.5mg Tablet contains 10mg of lisinopril (as the
dihydrate) and 12.5mg of hydrochlorothiazide.
Each Lisinopril and Hydrochlorothiazide 20mg/12.5mg Tablet contains 20mg of lisinopril (as the
dihydrate) and 12.5mg of hydrochlorothiazide.
The other ingredients are calcium hydrogen phosphate dihydrate, mannitol, maize starch,
pregelatinized starch and magnesium stearate. The 20mg/12.5mg strength tablets also contain iron
oxide (E172).
What Lisinopril and Hydrochlorothiazide Tablets look like and contents of the pack
Lisinopril and Hydrochlorothiazide 10mg/12.5mg Tablets come as white, round, biconvex tablets
marked LHZ on one side and 22.5 on the other side.
Lisinopril and Hydrochlorothiazide 20mg/12.5mg Tablets come as pink, round tablets marked LHZ on
one side and 32.5 on the other side.
Lisinopril and Hydrochlorothiazide Tablets are available in blister packs of 10, 14, 28, 30, 50, 56 and
100. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts EN6 1TL, U.K.
Revision date:
This leaflet was last revised in October 2012.

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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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