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LISINOPRIL/HYDROCHLOROTHIAZIDE 10/12.5MG 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
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/Hydrochlorothiazide is and what it is used for
2. Before you take Lisinopril/Hydrochlorothiazide
3. How to take Lisinopril/Hydrochlorothiazide
4. Possible side effects
5. How to store Lisinopril/Hydrochlorothiazide
6. 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. Before you take Lisinopril/Hydrochlorothiazide

Do not take Lisinopril/Hydrochlorothiazide:
• if you are allergic (hypersensitive) to:
- lisinopril, any other ACE inhibitor, hydrochlorothiazide or any
of the other ingredients of this medicine (see section 6 below)
- 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
• during the last 6 months of pregnancy
• if you have an inability to produce urine
Do not take this medicine if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking this
medicine.

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• antidepressants and antipsychotics (medicines for depression
and other mental problems)

Medicines that lower the effect of
Lisinopril/Hydrochlorothiazide
• symphatomimetics 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
• immunosupressants (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)
• medicines that have side effects which cause abnormalities in
the stimulus conduction in the heart such as medicines for
disturbances of the heart rhythm and some medicines for
psychosis
• lovastatin (a medicine against high blood fats)
• trimethoprim (an antibiotic)
• tubocurarine (a medicine for anaesthesia). The effect may be
enhanced by Lisinopril/Hydrochlorothiazide
• injectable gold (for example, sodium aurothiomalate) can lead to
nitritoid reactions (symptoms of vasodilatation including flushing,
nausea, dizziness and hypotension, which can be very severe)
more frequently in patients taking an ACE inhibitor.
Tell your doctor or pharmacist if you are taking any of the
above.

Take special care with Lisinopril/Hydrochlorothiazide:
Talk to your doctor or pharmacist, before taking this medicine:
• if you have heart problems, such as a weak heart, problems
with your heart valves or thickening of your heart muscle
• if you have kidney problems. There is an increased risk of side
effects and the dose may have to be adjusted
• if you have a kidney transplant, as experience is limited
• if you are taking ʻwater tabletsʼ (diuretic therapy). Diuretic
therapy should be stopped 2 to 3 days before taking
Taking Lisinopril/Hydrochlorothiazide with food and drink:
Lisinopril/Hydrochlorothiazide. If this is not possible, treatment
Drinking alcohol while taking this medicine can increase the blood
shoud not be started with Lisinopril/Hydrochlorothiazide but with pressure-lowering effect. You may feel dizzy when standing up.
lisinopril alone, in a 5 mg dose.
Pregnancy and breast-feeding:
• if you have a condtion called ʻcollagen vascular diseaseʼ,
Ask your doctor or pharmacist for advice before taking any
especially if you have problems with your kidney.
• if you have liver problems. There is an increased risk for severe medicine.
side effects
Pregnancy
• if you have diabetes. You may have to monitor your sugar levels • Do not take this medicine if you are pregnant, especially during
more closely and your dose of antidiabetic medicine may have to
the last 6 months of pregnancy.
be adjusted by your doctor
• If you are pregnant or wish to become pregnant you should talk
• if you have a blood vessel problem known as ʼcollagen
to your doctor immediately.
vascular diseaseʼ. You may be at risk of severe infections. Your
It is not known whether the use of this medicine is harmful if it is
doctor will check your blood more frequently
taken during the first 3 months of pregnancy.
• if you have diarrhoea or are being sick (vomiting) are on a
Breast-feeding
low salt diet. Your blood pressure may get too low
• Lisinopril/Hydrochlorothiazide is not recommended for mothers
• if you have a disease of the blood vessels in your brain. You
who are breast-feeding, and your doctor may choose another
may be at increased risk for stroke
treatment for you if you wish to breast-feed, especially if your
• if you are black, this medicine may be less effective and you
baby is newborn, or was born prematurely.
may have a higher risk of allergic reactions called ʻangioedemaʼ
• Both lisinopril and hydrochlorothiazide are excreted into breast
(see “Side effects”)
milk. Hydrochlorothiazide can reduce the amount of milk you
If you are about to have any of the following procedures or
produce and cause other side effects.
investigations, you should tell your doctor who is treating you that
Driving and using machines:
you are taking Lisinopril/Hydrochlorothiazide:
You may feel dizzy or tired while taking this medicine. If this
• any surgery or receive anaesthetics (even at the dentist)
happens, do not drive or operate machines.
• haemodialysis
Important information about some of the ingredients of
• desensitisation treatment, to reduce the effect of an allergy
Lisinopril/Hydrochlorothiazide
• a function test of your parathyroid gland
• an anti-doping test. This medicine can produce a positive result. This medicine contains mannitol. It may have a mild laxative effect.
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.

3. How to take Lisinopril/Hydrochlorothiazide

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking this medicine.

Always take Lisinopril/Hydrochlorothiazide exactly as your doctor
has told you. You should check with your doctor or pharmacist if
you are not sure.

Tell your doctor or pharmacist if you are taking any of the
following:

The usual doses are:
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.

Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription and herbal medicines. This is
because Lisinopril/Hydrochlorothiazide can affect the way some
medicines work. Also some other medicines can affect the way
Lisinopril/Hydrochlorothiazide works.
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

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.

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 and 20/25 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.
• Never take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lisinopril/Hydrochlorothiazide can cause side
effects, although not everybody gets them.
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:

The following side effects are uncommon (affects more that 1 in
1000 but less than 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 (affect more than 1 in 10000 but
less than 1 in 1000 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

The following side effects are very rare (affects less than 1 in 10000
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
• 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.
These are due to a kidney problem
• 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 (affects more that 1 in 100 but less than 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 (affects more that 1 in 1000 but less than 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 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
• depression

Very rare (affects less than 1 in 10000 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 (frequency not
known):
• 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
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.

5. How to store Lisinopril/Hydrochlorothiazide

Keep out of the reach and sight of children.

Lisinopril/Hydrochlorthiazide10/12.5 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.
You should not throw away any medicine through wastewater or
household waste. Ask your pharmacist how to dispose of medicines
that you no longer need. This will help to protect the environment.

6. Further information

What Lisinopril/Hydrochlorothiazide contains
The active substances arelisinopril and hydrochlorothiazide.
Lisinopril/Hydrochlorthiazide10/12.5 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)
Red iron oxide (E 172).

What Lisinopril/Hydrochlorthiazide Tablets look like and
contents of the pack
What this medicine looks like:
• Lisinopril/Hydrochlorthiazide10/12.5 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/Hydrochlorthiazide10/12.5 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/Hydrochlorthiazide10/12.5 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,
Rare (affects more than 1 in 10000 but less than 1 in 1000 people): GU16 7SR, United KIngdom.
• rash with pink-red blotches
Manufacturer:
• dry mouth
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
• nettle-rash or hives, hair loss
or
• confusion
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
• anaemia
39179 Barleben, Germany
• low levels of sodium in your blood
• enlargement of breasts in men
• a complex side effect has also been reported which may include Salutas Pharma GmbH, Dieselstraße 5, D-70839 Gerlingen,
Germany (Applies to Lisinopril/Hct 20/12.5mg Tablet only).
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,
This leaflet was last approved in 03/2011 (to be amended after
hypersensitivity to sunlight and other effects on your skin.
approval).
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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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