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LISINOPRIL AND HYDROCHLOROTHIAZIDE 20 MG/12.5 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / 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 because it contains
important information for you.
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 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.
What is in this leaflet:
1.
What Lisinopril and Hydrochlorothiazide is and what is used for
2.
What you need to know before you take Lisinopril and Hydrochlorothiazide
3.
How to take Lisinopril and Hydrochlorothiazide
4.
Possible side effects
5.
How to store Lisinopril and Hydrochlorothiazide
6.
Contents of the pack and other information

1.

WHAT LISINOPRIL AND HYDROCHLOROTHIAZIDE IS AND WHAT IT IS 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 because your high blood pressure was not being
adequately treated using lisinopril or hydrochlorothiazide alone.

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL AND
HYDROCHLOROTHIAZIDE

Do not take Lisinopril and Hydrochlorothiazide:









if you are allergic to lisinopril, other ACE inhibitors or any of the other ingredients of this
medicine (listed in section 6 )
if you are allergic to hydrochlorothiazide or other sulphonamides (medicines chemically related
to hydrochlorothiazide)
if 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
if you or one of your family have ever suffered from the allergic reaction called angioedema for
any reason
if you have severe kidney disease or cannot pass urine.
if you are more than 3 months pregnant. (It is also better to avoid Lisinopril and
Hydrochlorothiazide in early pregnancy – see Pregnancy and breast feeding section.)
if you have severe liver disease.
if you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.

Ask your doctor if you are not sure.
Page 1 of 8

Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril and Hydrochlorothiazide:

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.

if you think 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)

if you are at risk of high levels of potassium in your blood eg. from taking potassium-containing
salt substitutes or supplements

if you have heart or blood vessel disease

if you have heart (aortic) valve disease or an enlarged heart

if you have a narrowing (stenosis) of the aorta (an artery in your heart) or mitral valve (a valve
in your heart)

if you are suffering from heart failure and are taking medicines called ACE inhibitors

if you have liver disease or liver problems

if you have kidney problems, need dialysis treatment or have had a kidney transplant

if you suffer from narrowing of the blood vessels to the kidney

if you have diabetes. As you may need a different dose of your antidiabetic medicine (including
insulin)

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 and fever)

if 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

if you need to have surgery or a general anaesthetic. Tell the doctor, dentist or hospital staff you
are taking this medicine

if you play competitive sports as hydrochlorothiazide is a banned substance and may give a
positive result in anti-doping tests.

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 (rapid swelling under
the skin in areas such as the throat) is increased:
- sirolimus, everolimus and other medicines belonging to the class of mTOR inhibitors (used to
avoid rejection of transplanted organs)
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 and Hydrochlorothiazide”
Use in Afro-Caribbean patients: ACE inhibitors 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)
While taking Lisinopril and Hydrochlorothiazide
If you develop any of the following symptoms let your doctor know immediately:

if 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.
Page 2 of 8



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.

Page 3 of 8




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.
Other medicines and Lisinopril and Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines

other diuretic (‘water’ tablets)

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

medicines used for dual blockade of the renin-angiotensin-aldosterone system (RAAS)

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) and cotrimoxazole also known as trimethoprim/sulfamethoxazole (an antibiotic)

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 salts

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
• 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”.

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)

Dextran sulphate (used in the treatment called ‘LDL apheresis’ to lower 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.

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

cardiac glycosides (to treat heart failure)
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 and Hydrochlorothiazide” and “Warnings and precautions”).
Page 4 of 8

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 .

Page 5 of 8

Your doctor may want to do some blood or urine tests while you are taking Lisinopril and
Hydrochlorothiazide to check that there are no problems with your blood, liver or kidneys.
Lisinopril and Hydrochlorothiazide 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 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 . Lisinopril and Hydrochlorothiazide 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 breast-feeding or about to start breast-feeding. Lisinopril and
Hydrochlorothiazide 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
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. Occasionally, dizziness or tiredness may occur when driving vehicles or operating
machinery. These side effects may be worse if you drink alcohol at the same time.

3.

HOW TO TAKE LISINOPRIL AND HYDROCHLOROTHIAZIDE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended 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.
Use in children and adolescents (under 18 years)
Lisinopril and Hydrochlorothiazide is 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.

Page 6 of 8




Try to take the tablets at the same time each day. Many patients prefer to take Lisinopril and
Hydrochlorothiazide 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 take more Lisinopril and Hydrochlorothiazide 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
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
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 any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine 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
• skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and
genitalsyellowing 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 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 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

Page 7 of 8

-

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: may affect up to 1 in 10 people
• 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
• fainting
Uncommon : may affect up to 1 in 100 people
• a racing or irregular heart beat, missed heartbeats or a pounding heart (palpitations)
• chest pain
• muscle spasms or weakness
• painful, cold and bluish fingers and toes caused by blood circulation problems
• pins and needles in the limbs, feeling weak or tired
• 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
• inflammation of the pancreas
• stroke

Rare: : may affect up to 1 in 1, 000 people
• mental confusion
• 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)
• hives (nettle rash)
• changes to some of the cells or other parts of your blood. The signs may include feeling
tired and pale skin.
Page 8 of 8




overproduction of a hormone causing fluid retention, resulting in
weakness, tiredness or confusion
altered liver function tests (increase in albumin in the blood)

Very rare: may effect up to 1 in 10, 000 people
• 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 liver (hepatitis)
• jaundice (yellowing of the skin or whites of the eyes)

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






liver failure
severe condition of the skin that may affect the mouth and other
parts of the body
swelling of the lining of the gut. This may cause sudden stomach pain, diarrhoea or make
you be sick (vomit)
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.

Not known: frequency cannot be estimated from the available data
• flushing
• depressive symptoms
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
• inflammation of the kidney
• high calcium levels in blood
• low level of chloride or magnesium in blood
• disease with painful, swollen joints caused by uric acid crystals (gout)
Page 9 of 8



muscle weakness

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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V*. By reporting side effects you can help provide more information on the safety
of this medicine.
5.

HOW TO STORE LISINOPRIL AND HYDROCHLOROTHIAZIDE

Keep this medicine out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Lisinopril and Hydrochlorothiazide contains
The active substances are:
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 looks 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, UK.
This leaflet was last revised in March 2017

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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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