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LISINOPRIL/HYDROCHLOROTHIAZIDE 10/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LISINOPRIL DIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lisinopril/Hydrochlorothiazide 10/12.5 mg Tablets
Lisinopril/Hydrochlorothiazide 20/12.5 mg Tablets
Lisinopril/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 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.

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

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 ʻACE inhibitorʼ (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 ʻsulphonamideʼ, 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

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instructions carefully if you get any of the symptoms described.
Lisinopril/Hydrochlorothiazide can cause short sightedness or glaucoma.
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:

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 ʻNon-Steroidal Anti-Inflammatory Drugsʼ such as
aspirin, ibuprofen and diclofenac (medicines for pain). They can
also reduce the amount of urine you produce.

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 ʻcorticosteroidsʼ 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”).

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

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

Important information about some of the ingredients of
Lisinopril/Hydrochlorothiazide
This medicine contains mannitol. It may have a mild laxative effect.

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.












sick (vomiting), due to a blockage in your small bowel.
sudden difficulty breathing with wheezing or coughing
feeling of pain and fullness behind your check and eyes (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
increased immune response (autoimmune disease)
runny or stuffy nose, sneezing
cough, feeling short of breath and high temperature (fever) due
to inflammation of the lungs
reduction in the amount of urine produced per day or not going
to the toilet
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.

Kidney problems
If you have a kidney problem, your doctor will prescribe a lower
dose and monitor your kidney function. Lisinopril/Hydrochlorothiazide
Not known (frequency cannot be estimated from the available data)
should not be used if you have severe kidney problems.
• depression
Dividing the 20/12.5 mg tablets:
Place the tablet on a hard, flat surface with the breaking-line facing • flushing (e.g. in the face)

Other side effects of hydrochlorothiazide include (not known,
frequency cannot be estimated from the available data):
If you take more Lisinopril/Hydrochlorothiazide than you should: • loss of appetite, weight loss, fever, weakness
If you take more Lisinopril/Hydrochlorothiazide than you should, talk • restlessness, depression, sleep disturbances, muscle spasms or
muscle weakness
to your doctor or go to hospital immediately. The most common
signs of an overdose are a feeling of light-headedness or dizziness • dizziness, tingling or numbness in your hands and feet, feeling of
light-headedness
(this is because your blood pressure is falling) and changes in your
• dizziness and fainting on standing up
salt balance.
• inflammation of a salivary gland, gastric irritation, diarrhoea,
In case of a severe fall in blood pressure, the patient should be
constipation
placed in the shock position (lying flat on the back with legs elevated).
• temporary blurred vision and visual changes which can make a
If you forget to take Lisinopril/Hydrochlorothiazide:
colourless object look tinged with yellow
• If you have forgotten to take a dose, you can take it when you
• high temperature, coughing, difficulty breathing, wheezing
remember unless it is almost time for your next dose. In that
caused by inflammation of the lungs, fluid on your lungs
case, skip the missed dose and take your next tablet as normal. • inflammation of your blood vessels, often with skin rash
• Do not take a double dose to make up for a forgotten dose.
• hypersensitivity to light, rash, rash with pink-red blotches, itching,
nettle-rash or hives
If you have any further questions on the use of this medicine, ask
• kidney problems
your doctor or pharmacist.
• low levels of potassium in your blood, which can cause muscle
weakness, twitching or changes in your heart rhythm
4. Possible side effects
• low levels of sodium in your blood, which can cause weakness,
tiredness, headache, feeling sick, being sick (vomiting),
confusion, muscle twitching, fits loss of consciousness or coma,
Like all medicines, this medicine can cause side effects, although
• decreased level of magnesia and chlorine in the blood
not everybody gets them.
• high levels of sugar, cholesterol, triglycerides or uric acid in your blood.
Serious side effects
• presence of sugar in the urine
Stop taking this medicine and see your doctor or go to hospital
• gout
immediately, if any of the following serious side effects happen:
• decrease in the number of red blood cells and blood platelets
The following side effects are uncommon (may affect up to 1 in 100
If you get any side effects, talk to your doctor or pharmacist. This
people):
includes any side effects not listed in this leaflet.
• heart attack which can cause crushing chest pain
• stroke which can cause weakness or paralysis of your limbs or
face or difficulty speaking.
5. How to store Lisinopril/Hydrochlorothiazide
upwards. Press with a finger on the middle of the tablet and the
tablet breaks into two parts.

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.
• kidney problems that are noticed with the following symptoms:
not going to the toilet (low urine output) or going to the toilet
more often (high urine output) which can also occur with a high
temperature (fever), pain in your sides or blood in your urine.

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 is peeling or
blistering 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, sore throat, fever, 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 urea and creatinine. This will be
seen during tests to see how your kidneys are working called
ʻkidney function testsʼ.
• 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 ʻliver function testsʼ
• sleep disturbance.
Rare (may affect up to 1 in 1,000 people):
• itchy scaly pink patches on the elbows, knees, scalp and other
parts of the body (psoriasis)
• dry mouth
• nettle-rash or hives, hair loss
• confusion
• low levels of sodium in your blood, which can cause weakness,
tiredness, headache, feeling sick, being sick (vomiting),
confusion, muscle twitching, fits, loss of consciousness or coma
• enlargement of breasts in men
• alterations in some laboratory blood tests.

Very rare (may affect up to 1 in 10,000 people):
• pain in and around your stomach area (the abdomen) and being

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

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. The expiry date refers to the last day of that
month. Do not use the medicine after the expiry date.
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.
Yellow iron oxide (E 172) [only for 10/12.5 mg].
Red iron oxide (E 172) [only for 10/12.5 mg].

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).
This leaflet was last revised in 08/2014.
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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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