LISINOPRIL/HYDROCHLOROTHIAZIDE 20/12.5MG TABLETS

Active substance: 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 and take aliskiren (a medicine which treats
high blood pressure).

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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.

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

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.

• 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
Kidney problems
• a complex side effect has also been reported which may include
If you have a kidney problem, your doctor will prescribe a lower
some or all of the following: high temperature, inflammation of
dose and monitor your kidney function. Lisinopril/Hydrochlorothiazide
your blood vessels, pain and inflammation in your muscles and
should not be used if you have severe kidney problems.
joints, blood problems found by blood tests, rash,
Dividing the 20/12.5 mg tablets:
hypersensitivity to sunlight and other effects on your skin.
Place the tablet on a hard, flat surface with the breaking-line facing
Not known (frequency cannot be estimated from the available data)
upwards. Press with a finger on the middle of the tablet and the
• depression
tablet breaks into two parts.
• flushing (e.g. in the face)
If you take more Lisinopril/Hydrochlorothiazide than you should:
Other side effects of hydrochlorothiazide include (not known,
If you take more Lisinopril/Hydrochlorothiazide than you should, talk
frequency cannot be estimated from the available data):
to your doctor or go to hospital immediately. The most common
• loss of appetite, weight loss, fever, weakness
signs of an overdose are a feeling of light-headedness or dizziness
• restlessness, depression, sleep disturbances, muscle spasms or
(this is because your blood pressure is falling) and changes in your
muscle weakness
salt balance.
• dizziness, tingling or numbness in your hands and feet, feeling of
In case of a severe fall in blood pressure, the patient should be
light-headedness
placed in the shock position (lying flat on the back with legs elevated).
• dizziness and fainting on standing up
If you forget to take Lisinopril/Hydrochlorothiazide:
• inflammation of a salivary gland, gastric irritation, diarrhoea,
• If you have forgotten to take a dose, you can take it when you
constipation
remember unless it is almost time for your next dose. In that
• temporary blurred vision and visual changes which can make a
case, skip the missed dose and take your next tablet as normal.
colourless object look tinged with yellow
• Do not take a double dose to make up for a forgotten dose.
• high temperature, coughing, difficulty breathing, wheezing
caused by inflammation of the lungs, fluid on your lungs
If you have any further questions on the use of this medicine, ask
• inflammation of your blood vessels, often with skin rash
your doctor or pharmacist.
• hypersensitivity to light, rash, rash with pink-red blotches, itching,
nettle-rash or hives
4. Possible side effects
• kidney problems
• low levels of potassium in your blood, which can cause muscle
weakness, twitching or changes in your heart rhythm
Like all medicines, this medicine can cause side effects, although
• low levels of sodium in your blood, which can cause weakness,
not everybody gets them.
tiredness, headache, feeling sick, being sick (vomiting),
Serious side effects
confusion, muscle twitching, fits loss of consciousness or coma,
Stop taking this medicine and see your doctor or go to hospital
• decreased level of magnesia and chlorine in the blood
immediately, if any of the following serious side effects happen:
• high levels of sugar, cholesterol, triglycerides or uric acid in your blood.
The following side effects are uncommon (may affect up to 1 in 100 • presence of sugar in the urine
• gout
people):
• decrease in the number of red blood cells and blood platelets
• 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.
• 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
sick (vomiting), due to a blockage in your small bowel.
• sudden difficulty breathing with wheezing or coughing

If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.

5. How to store Lisinopril/Hydrochlorothiazide

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 04/2014.

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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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