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LISINOPRIL/HYDROCHLOROTHIAZIDE 20/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LISINOPRIL DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SZ00000LT000

Lisinopril/Hydrochlorothiazide 10/12.5 mg Tablets
Lisinopril/Hydrochlorothiazide 20/12.5 mg Tablets
used at that stage (see pregnancy section).
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 signs of
illness 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.

Lisinopril/Hydrochlorothiazide can cause cough or serious side
effects which require immediate medical attention. It is essential
that you read section 4 (“Possible side effects”) and follow the
instructions carefully if you get any of the symptoms described.
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking this medicine.
Other medicines and Lisinopril/Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Tell your doctor or pharmacist if you are taking any of the
following:

What is in this leaflet
1. What Lisinopril/Hydrochlorothiazide is and what it is used for
2. What you need to know before you take
Lisinopril/Hydrochlorothiazide
3. How to take Lisinopril/Hydrochlorothiazide
4. Possible side effects
5. How to store Lisinopril/Hydrochlorothiazide
6. Contents of the pack and further information

Medicines that increase the effect of
Lisinopril/Hydrochlorothiazide
• water tablets (diuretics) and other blood pressure lowering
medicines. They can also sometimes change the levels of salts
in your blood
• antidepressants and antipsychotics (medicines for depression
and other mental problems).
Medicines that lower the effect of Lisinopril/Hydrochlorothiazide
• sympathomimetics such as ephedrine or adrenaline (medicines
usually used to treat asthma, heart conditions, eye problems, or
blocked noses)
• NSAIDs or ‘Non-Steroidal Anti-Inflammatory Drugs’ such as
aspirin, ibuprofen and diclofenac (medicines for pain). They can
also reduce the amount of urine you produce.

1. What Lisinopril/Hydrochlorothiazide is and
what it is used for
Lisinopril/Hydrochlorothiazide contains two different active
substances: Lisinopril and Hydrochlorothiazide.
Lisinopril belongs to the ‘ACE inhibitor’ (Angiotensin-Converting
Enzyme inhibitor) group of medicines. It stops your body making a
blood pressure increasing substance so your blood pressure falls.
Hydrochlorothiazide is a water tablet (diuretic). It increases the
amount of salt and water you lose in your urine. This also results in
a fall in your blood pressure.
Lisinopril/Hydrochlorothiazide is used to lower high blood pressure.

2. What you need to know before you take
Lisinopril/Hydrochlorothiazide
Do not take Lisinopril/Hydrochlorothiazide:
• if you are allergic to:
- lisinopril, any other ACE inhibitor, hydrochlorothiazide or any of
the other ingredients of this medicine (listed in section 6).
- other medicines known as ACE inhibitors.
- any medicine which contains a ‘sulphonamide’, such as
co-trimoxazole (used for water infections).
• if you have ever had swelling of your face, lips, mouth, tongue or
throat which caused difficulty in swallowing or breathing
(angioedema). This may be inherited or from an unknown cause.
• if you have severe liver or kidney problems.
• if you are more than 3 months pregnant (It is also better to avoid
Lisinopril/Hydrochlorothiazide in early pregnancy - see
pregnancy section.).
• if you have an inability to produce urine.
• if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.

Medicines which may have an effect on your blood
• allopurinol (a medicine for gout)
• procainamide (a medicine for disturbances in your heart rhythm)
• cytotoxics (medicines used to treat cancer)
• steroids or ‘corticosteroids’ such as prednisolone. There is also a
risk of low potassium in your blood
• immunosuppressants (medicines to stop rejection after organ or
bone marrow transplants). There is also a greater risk of you
having too much potassium in your blood. This can cause
muscle cramps, diarrhoea, feeling sick, dizziness, or headache
Taking these medicines together with
Lisinopril/Hydrochlorothiazide may cause serious infections. Your
doctor will monitor your blood.
Other medicines which change the levels of salts in your blood
An example of this would be the lowering of potassium in your
blood. Medicines include:
• amphotericin B (for fungal infections)
• carbenoxolone (for ulcers and inflammation in your oesophagus)
• ACTH, used to test whether your adrenal glands are working
properly
• laxatives
• potassium-containing supplements and potassium-containing
salt substitutes
• calcium salts and vitamin D.
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/Hydrochlorothiazide” and “Warnings and precautions”).

Do not take this medicine if any of the above apply to you. If you are Other medicines to tell your doctor about
not sure, talk to your doctor or pharmacist before taking this medicine. • colestyramine or colestipol resins (medicines used to treat high
cholesterol). These medicines can affect how
Warnings and precautions
hydrochlorothiazide is absorbed into your body. You should take
Talk to your doctor or pharmacist, before taking
Lisinopril/Hydrochlorothiazide 1 hour before or 4 to 6 hours after
Lisinopril/Hydrochlorothiazide:
your colestyramine or colestipol resin
• if you have heart problems, such as a weak heart, problems with
• blood sugar-lowering medicines. Your doctor will monitor your dose
your heart valves or thickening of your heart muscle.
• digoxin (a medicine for disturbances in your heart rhythm, or heart
• if you have kidney problems. There is an increased risk of side
failure). There is a risk of serious effects on your heart rhythm
effects and the dose may have to be adjusted.
• lithium (a medicine used for mental problems). The level of
• if you have a kidney transplant, as experience is limited.
lithium in your blood can increase and cause harmful side effects
• if you are taking ‘water tablets’ (diuretic therapy). Diuretic
• sotalol (a beta-blocker). The risk for arrhythmias is increased
therapy should be stopped 2 to 3 days before taking
• laxatives (medicines to promote defecation)
Lisinopril/Hydrochlorothiazide. If this is not possible, treatment
• medicines that have a side effect which causes abnormalities in
should not be started with Lisinopril/Hydrochlorothiazide but with
the stimulus conduction in the heart such as medicines for
lisinopril alone, in a 5 mg dose.
disturbances of the heart rhythm and some medicines for psychosis
• if you have a condition called ‘collagen vascular disease’,
• lovastatin (a medicine against high blood fats)
especially if you have problems with your kidney.
• trimethoprim (an antibiotic)
• if you have liver problems. There is an increased risk for severe
• tubocurarine (a medicine for anaesthesia). The effect may be
side effects.
enhanced by Lisinopril/Hydrochlorothiazide
• if you have diabetes. You may have to monitor your sugar levels
• injectable gold (for example, sodium aurothiomalate) can lead to
more closely and your dose of antidiabetic medicine may have to
nitritoid reactions (symptoms of vasodilatation including flushing,
be adjusted by your doctor.
nausea, dizziness and hypotension, which can be very severe)
• if you are taking any of the following medicines used to treat high
more frequently in patients taking an ACE inhibitor.
blood pressure:
Tell your doctor or pharmacist if you are taking any of the above.
- an angiotensin II receptor blocker (ARBs) (also known as
sartans – for example valsartan, telmisartan, irbesartan), in
Lisinopril/Hydrochlorothiazide with alcohol
particular if you have diabetes-related kidney problems.
Drinking alcohol while taking this medicine can increase the blood
- aliskiren.
pressure-lowering effect. You may feel dizzy when standing up.
Your doctor may check your kidney function, blood pressure, and
Pregnancy and breast-feeding
the amount of electrolytes (e.g. potassium) in your blood at regular
If you are pregnant or breast-feeding, think you may be pregnant or
intervals. See also information under the heading “Do not take
are planning to have a baby, ask your doctor or pharmacist for
Lisinopril/Hydrochlorothiazide”
advice before taking this medicine.
• if you have a blood vessel problem known as ’collagen vascular
disease’. You may be at risk of severe infections. Your doctor will Pregnancy
check your blood more frequently
You must tell your doctor if you think you are (or might become)
• if you have diarrhoea or are being sick (vomiting) are on a low pregnant. Your doctor will normally advise you to stop taking
salt diet. Your blood pressure may get too low.
Lisinopril/Hydrochlorothiazide before you become pregnant or as
• if you have a disease of the blood vessels in your brain. You
soon as you know you are pregnant and will advise you to take
may be at increased risk for stroke.
another medicine instead of Lisinopril/Hydrochlorothiazide.
• if you are black, this medicine may be less effective and you
Lisinopril/Hydrochlorothiazide is not recommended during
may have a higher risk of allergic reactions called ‘angioedema’
pregnancy, and must not be taken when more than 3 months
(see “Possible side effects”).
pregnant, as it may cause serious harm to your baby if used after
the third month of pregnancy.
If you are about to have any of the following procedures or
investigations, you should tell your doctor who is treating you that
Breast-feeding
you are taking Lisinopril/Hydrochlorothiazide:
Tell your doctor if you are breast-feeding or about to start
• any surgery or receive anaesthetics (even at the dentist)
breast-feeding.
• haemodialysis
• Lisinopril/Hydrochlorothiazide is not recommended for mothers
• desensitisation treatment, to reduce the effect of an allergy
who are breast-feeding, and your doctor may choose another
• a function test of your parathyroid gland
treatment for you if you wish to breast-feed, especially if your
• an anti-doping test. This medicine can produce a positive result.
baby is newborn, or was born prematurely.
You must tell your doctor if you think you are (or might become)
pregnant. Lisinopril/Hydrochlorothiazide 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

Driving and using machines:
You may feel dizzy or tired while taking this medicine. If this
happens, do not drive or operate machines.
Continued on the next page >>

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anaemia
low levels of sodium in your blood
enlargement of breasts in men
a complex side effect has also been reported which may include
some or all of the following: high temperature, inflammation of
your blood vessels, pain and inflammation in your muscles and
joints, blood problems found by blood tests, rash,
hypersensitivity to sunlight and other effects on your skin.
Very rare (may affect up to 1 in 10,000 people):
• pain in and around your stomach area (the abdomen) and being
sick (vomiting), due to a blockage in your small bowel
• sore throat and hoarseness, difficulty breathing with wheezing or
coughing, sinusitis
• excessive sweating
• low levels of sugar in your blood, which can make you feel sick
(nausea), weak, dizzy, sweat, tremble, have a headache
• changes in your lymph glands and lower numbers of blood cells
usually seen in blood tests
• sore mouth and tongue, runny or stuffy nose, sneezing
• lung problems with breathlessness, or pneumonia
• reduction in the amount of urine produced per day.
Other side effects of hydrochlorothiazide include (not known,
frequency cannot be estimated from the available data):
• loss of appetite, weight loss, fever, weakness
• restlessness, depression, sleep disturbances, muscle spasms
• dizziness, tingling or numbness in your hands and feet, feeling of
light-headedness
• dizziness and fainting on standing up
• inflammation of a salivary gland, gastric irritation, diarrhoea,
constipation
• temporary blurred vision and visual changes which can make a
colourless object look tinged with yellow
• high temperature, coughing, difficulty breathing, wheezing
caused by inflammation of the lungs, fluid on your lungs
• inflammation of your blood vessels, often with skin rash
• hypersensitivity to light, rash, rash with pink-red blotches, itching,
nettle-rash or hives
• kidney problems
• low levels of potassium in your blood, which can cause muscle
weakness, twitching or changes in your heart rhythm
• low levels of sodium in your blood, which can cause tiredness,
confusion, muscle twitching, fits or coma
• high levels of sugar, cholesterol, triglycerides or uric acid in your blood
• gout
• decrease in the number of red blood cells and blood platelets.
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 Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects you can
help provide more information on the safety of this medicine.






3. How to take Lisinopril/Hydrochlorothiazide
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
How to take the tablet
• Take the tablet with plenty of water
• Take the tablet once a day, approximately at the same time
every day
• If you feel that the effect of Lisinopril/Hydrochlorothiazide is too
strong or too weak, ask your doctor or pharmacist for advice.
The recommended dose is:
Adults - 1 tablet a day. The maximum dose is 40 mg lisinopril and
25 mg hydrochlorothiazide per day.
Children -The use in children is not recommended as safety and
effectiveness have not been established.
Elderly - No special dose is required. If you have kidney problems,
you will usually get a lower dose.
Previous treatment with a water tablet (diuretic)
If you are being changed from a water tablet to
Lisinopril/Hydrochlorothiazide, your doctor may tell you to stop taking
the water tablet 2 to 3 days before you start taking this medicine.
Kidney problems
If you have a kidney problem, your doctor will prescribe a lower
dose and monitor your kidney function. Lisinopril/Hydrochlorothiazide
should not be used if you have severe kidney problems.
Dividing the 20/12.5 mg tablets:
Place the tablet on a hard, flat surface with the breaking-line facing
upwards. Press with a finger on the middle of the tablet and the
tablet breaks into two parts.
If you take more Lisinopril/Hydrochlorothiazide than you should
If you take more Lisinopril/Hydrochlorothiazide than you should, talk
to your doctor or go to hospital immediately. The most common
signs of an overdose are a feeling of light-headedness or dizziness
(this is because your blood pressure is falling) and changes in your
salt balance.
In case of a severe fall in blood pressure, the patient should be
placed in the shock position (lying flat on the back with legs elevated).
If you forget to take Lisinopril/Hydrochlorothiazide
• If you have forgotten to take a dose, you can take it when you
remember unless it is almost time for your next dose. In that
case, skip the missed dose and take your next tablet as normal.
• Do not take a double dose to make up for a forgotten dose.
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.

5. How to store Lisinopril/Hydrochlorothiazide

Serious side effects
Stop taking this medicine and see your doctor or go to hospital
immediately, if any of the following serious side effects happen:

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

The following side effects are uncommon (may affect up to 1 in 100
people):
• heart attack which can cause crushing chest pain
• stroke which can cause weakness or paralysis of your limbs or
face or difficulty speaking.
The following side effects are rare (may affect up to 1 in 1,000 people):
• if you develop a red and lumpy skin rash, swelling of your
eyelids, lips and face, mouth, tongue or throat, start to itch or
have difficulty in breathing or swallowing or dizziness, this
may be a serious allergic reaction.
• not going to the toilet (low urine output) which can also occur
with a high temperature (fever), nausea, tiredness, pain in your
sides, swelling of your legs, ankles, feet, face and hands or
blood in your urine. These are due to kidney problems.
The following side effects are very rare (may affect up to 1 in
10,000 people):
• severe or itchy skin rash, especially if your skin blisters or your
eyes, mouth or genital organs become sore
• severe pain in your abdomen and back caused by
inflammation of the pancreas
• yellowing of your skin and the whites of your eyes (jaundice)
caused by liver problems
• constant or frequent colds, bruising and prolonged
bleeding, pale skin, weakness, or breathlessness. These
can all occur if you have a very low number of blood cells.
These are serious side effects which require immediate medical
attention.
Other side effects of lisinopril include:
Common (may affect up to 1 in 10 people):
• low blood pressure, dizziness and fainting on standing up, loss
of consciousness
• dizziness
• cough. Talk to your doctor if you have a dry cough for a long time
• diarrhoea, being sick (vomiting)
• headache
• kidney problems.
Uncommon (may affect up to 1 in 100 people):
• weakness, feeling sick (nausea)
• fast or irregular heart beat
• abdominal pain, indigestion, disturbed sense of taste, fatigue,
mood alterations
• skin rash
• high levels of potassium in your blood, which can cause changes
in your heart rhythm
• An increase in your level of creatinine. This will be seen during
tests to see how your kidneys are working called ‘kidney function
tests’
• runny nose
• tingling or numbness in your hands and feet, spinning sensation
• itching
• inability to achieve or maintain erection in men (impotence)
• poor blood circulation which makes the toes and fingers numb
and pale
• liver problems, shown by blood tests called ‘liver function tests’
• sleep disturbance
• depression.
Rare (may affect up to 1 in 1,000 people):
• rash with pink-red blotches
• dry mouth
• nettle-rash or hives, hair loss
• confusion

Lisinopril/Hydrochlorthiazide 10/12.5 mg: Do not store above 25°C.
Lisinopril/Hydrochlorthiazide 20/12.5 mg: Do not store above 30°C.
Do not use this medicine after the expiry date which is stated on the
label and carton after EXP. The expiry date refers to the last day of
that month.
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 protect the environment.

6. Contents of the pack and further information
What Lisinopril/Hydrochlorothiazide contains
The active substances are lisinopril and hydrochlorothiazide.
Lisinopril/Hydrochlorthiazide 10/12.5 mg: Each tablet contains
lisinopril dihydrate equivalent to 10 mg anhydrous lisinopril and
hydrochlorothiazide 12.5 mg
Lisinopril/Hydrochlorthiazide 20/12.5 mg: Each tablet contains
lisinopril dihydrate equivalent to 20 mg anhydrous lisinopril and
hydrochlorothiazide 12.5 mg
The other ingredients are:
Mannitol
Calcium hydrogen phosphate dihydrate
Pregelatinized maize starch
Croscarmellose sodium
Magnesium stearate
Lisinopril/Hydrochlorothiazide 10/12.5 mg Tablets also contain:
Yellow iron oxide (E 172)
Red iron oxide (E 172)
What Lisinopril/Hydrochlorthiazide Tablets look like and
contents of the pack
What this medicine looks like:
• Lisinopril/Hydrochlorthiazide 10/12.5 mg:
Peach-coloured, round tablets (diameter 6 mm), LH embossed
on one side.
• Lisinopril/Hydrochlorthiazide 20/12.5 mg:
White, round tablets (diameter 8 mm) with break-line, LH
embossed on one side.
Contents of the pack:
Blisters:
• Lisinopril/Hydrochlorthiazide 10/12.5 mg: 10, 28, 30, 50, 98, 100,
50x1, (perforated unit dose blisters) and 100x1 (perforated unit
dose blisters) tablets.
• Lisinopril/Hydrochlorthiazide 20/12.5 mg: 10, 28, 30, 50, 56, 60,
98, 100, 50x1 (perforated unit dose blisters), 100x1 (perforated
unit dose blisters) and 500x1 (perforated unit dose blisters) tablets.
PP-container:
• Lisinopril/Hydrochlorthiazide 10/12.5 mg and 20/12.5 mg:
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, UK.
Manufacturer:
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana Slovenia
or Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179
Barleben, Germany.
Salutas Pharma GmbH, Dieselstraße 5, D-70839 Gerlingen,
Germany (Applies to Lisinopril/HCT 20/12.5mg Tablet only).
Leaflet was last revised in 08/2015

Artwork Proof Box
Ref: V047: Updated in line with QRD + responses
Proof no.
010.1

Date prepared:
04/08/2015

Colours:
Black
Dimensions: 170 x 380 mm

Font size:
7pt
Fonts:
Helvetica

SZ00000LT000

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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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