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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 patient
Lisinopril and Hydrochlorothiazide 10mg/12.5mg Tablets
Lisinopril and Hydrochlorothiazide 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 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.
What is in this leaflet
1.
What Lisinopril and Hydrochlorothiazide is and what it 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 Lisinopr il and Hydr ochlor othiazide is and what it is used for

Your Lisinopril and Hydrochlorothiazide contains the active substance lisinopril, which belongs to a
group pf medicines known as ACE (angiotensin converting enzyme) inhibitors and
hydrochlorothiazide, which belongs to a group of medicines known as thiazide diuretics, 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 Lisinopr il and Hydr ochlorothiazide

Do not take Lisinopril and Hydrochlorothiazide:








if you are allergic to lisinopril, hydrochlorothiazide or any of the other ingredients of this
medicine (listed in section 6)
if you are allergic to other ACE inhibitors hydrochlorothiazide or other sulphonamides
(medicines chemically related to hydrochlorothiazide such as some antibiotics)
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 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril and Hydrochlorothiazide:

if you feel dehydrated due to treatment with diuretics (water tablets), 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 e.g. from taking potassiumcontaining salt substitutes or supplements

if you have heart or blood vessel disease(e.g. angina) or problems with blood supply to the brain

if you have 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

if you have other liver problems

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

if you suffer from narrowing of the blood vessels to one or both kidneys

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

if you suffer from gout or increased uric acid levels in your blood

if you suffer from increased levels of cholesterol or blood fats

if you have a history of allergy, bronchial asthma or a collagen vascular disease e.g.
scleroderma, SLE (system lupus erythematosus is an allergic condition causing joint pain,
rashes and fever)

if you need blood separation treatment (apheresis, to help remove cholesterol) or desensitisation
treatment e.g. following a wasp or bee sting; your doctor may wish to interrupt treatment with
this medicine to prevent a possible allergic reaction

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
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, weakness, lethargy, muscle weakness, 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.
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 Afro-Caribbean patients.
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, which 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.
If you need surgery or any blood tests:
Tell the doctor, nurse, dentist or hospital staff that you are taking this medicine if:

you are undergoing tests to check your parathyroid function, as this medicine may alter your
test results.

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

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)

other medicines to treat high blood pressure e.g. a beta blocker such as sotalol, or a nitrate
(which may also be used for chest pain e.g. angina)

medicines known as cardiac glycosides (e.g. digoxin used for a heart condition)

medicines 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)

medicines used to treat blood clots (usually given in hospitals)

medicines known to cause a serious type of heart rhythm disorder called torsades de pointes
(e.g. certain medicines used to treat rhythm disorders or mental illness), this is more likely if
potassium levels in the body are low.

medicine containing calcium salts

anti-inflammatory medicine called NSAIDs e.g. ibuprofen or COX-2 inhibitors e.g. celecoxib
(to treat arthritis or muscle pain)

aspirin (in doses used to treat disorders)

lithium (medicine for depression).

anaesthetics (e.g. lidocaine, bupivacaine) and medicines for mental disorders or depression, to
treat psychoses (e.g. haloperidol, chlorpromazine), tricyclic antidepressants (e.g. amitriptyline,
clomipramine, imipramine), or sedatives (e.g. lorazepam, alprazolam).

antidiabetic medicine e.g. insulin, gliclazide; your blood glucose should be monitored closely in
the first few weeks of treatment

allopurinol (for gout)

medicines used after organ transplantation which supress your immune system e.g. ciclosporin

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)

procainamide (for an irregular heart rhythm)

carbenoxolone (for throat ulcers)

corticosteroids (such as hydrocortisone used as anti-inflammatory medicines)









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 e.g. ephedrine or pseudoephedrine, often
found in cough and cold remedies
muscle relaxants such as tubocurarine.
medicines that contain gold, such as sodium aurothiomalate, which may be given to you as an
injection

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”).
Lisinopril and Hydrochlorothiazide with alcohol
You should not drink alcohol while being treated with this medicine, because it will further worsen
your ability to drive and use machines.
Pr egnancy and br east-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.
Breast-feeding
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 lisinopr il and hydr ochlor othiazide

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended dose is:
Adults (including elderly)
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.

Patients with kidney problems
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
(see section 2, Do not take Lisinopril and Hydrochlorothiazide).
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.

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 heartbeat, slow
heartbeat, dizziness, reduced consciousness (which may even lead to coma), impaired movement, fits,
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:
Uncommon (may affect up to 1 in 100 people):
• inflammation of the pancreas, which may cause severe abdominal pain with sickness
• severe chest pain which may spread to the neck and shoulders (heart attack) or stroke. These
are more likely to occur if you have severe dizziness, light-headedness etc. when you stand up
after taking the medicine at the start of treatment or when the dose has increased and you also
have other health problems. Your doctor should monitor you closely to help reduce the risk
Rare (may affect up to 1 in 1,000 people):





feeling unwell, confused and/or weak, feeling sick (nausea), loss of appetite, feeling irritable.
This could be something called a syndrome of inappropriate antidiuretic hormone secretion
(SIADH).
allergic reactions causing swelling of the face, lips, tongue and/or throat, hands or feet which
may cause difficulty breathing or swallowing.
kidney problems or failure (with signs such as pain in the back, swelling of the legs, feet,
hands and face, tiredness, difficulty passing urine) which may cause a build-up of urea in the
blood (a condition known as uraemia)

Very rare (may affect up to 1 in 10,000 people):

lung problems such as infection or inflammation in the lungs caused by allergy

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.
• swelling of the lining of the gut. This may cause sudden stomach pain, diarrhoea or make
you be sick (vomit)
• yellowing of your skin or whites of the eyes, pale stools, dark urine or stomach pain (these
may be signs of liver problems such as inflammation of the liver or blockage in the bile duct),
which can lead to liver failure.
• severe skin reactions such as blistering of the skin, mouth, eyes and genitals or sores which
may also include fever, joint or muscle pains, inflamed blood vessels, sensitivity to sunlight,
increase in white blood cells (which may be seen in blood tests), immune system disorders.
• severe condition of the skin which causes red, often itchy spots, which start on the limbs and
sometimes on the face and the rest of the body. The spots may blister or may progress to form
raised, red, pale-centred marks. Those affected may have fever, joint pain, sore throat,
headache and/or diarrhoea.
• an increase in infections or fever e.g. sore throat, mouth ulcers that you get (this is more likely
in patients with kidney problems and a collagen vascular disease e.g. scleroderma or SLE, or
those on immunosuppressant treatment, allopurinol or procainamide), or if you notice that
you bruise or bleed more easily or without explanation or yellowing of the skin or eyes, feel
tired, pale or weak. These may be signs of changes, some serious, in the number or type of
blood cells, which may be due to a reduction in the activity of bone marrow (where blood
cells are produced).
• problems with the immune system which may include when the immune system attacks
normal body cells.
• changes in kidney function, passing less urine than usual or no production of urine.
Not known (frequency cannot be estimated from the available data):
• infection or inflammation of the salivary gland
• irregular heart beat (cardiac arrhythmia)
• increased pressure in your eyes which may cause reduced vision
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 as they 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 , increased heartbeats or a pounding heart (palpitations)
• 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
• feeling sick
• indigestion, stomach pain, dry mouth
• taste changes
• mood changes
• sleep problems
• skin rash, itchy skin
• painful, swollen joints (gout)
• impotence
• feeling of spinning (vertigo)
• a runny itchy nose
• increase in potassium levels which if severe can cause an abnormal heart rhythm, muscle
weakness or cramps
• depressive symptoms
• raised creatinine levels in the blood (which may indicate kidney problems)
• elevated liver enzyme and bilirubin levels the blood.
Rare (may affect up to 1 in 1, 000 people):
• mental confusion
• hair loss
• psoriasis, a skin condition, red scaly patches on the skin
• swollen breasts (in men)
• changes in sense of smell
• hives (nettle rash)
• changes to some of the red blood cells of your blood, which may be seen in blood tests. low
levels of sodium (salt) which can make you feel weak and confused with aching, stiff muscles
Very rare (may effect up to 1 in 10, 000 people):
• inflamed and swollen sinuses causing pain, high temperature and tenderness
• sweating
• enlargement of the lymph nodes
• low blood glucose levels which can cause sweating, feeling excessively hungry, trembling, a
fast pounding heart beat
Not known: frequency cannot be estimated from the available data
• Seeing hearing or feeling things that are not there (hallucinations)
• flushing
Other side effects reported with hydrochlorothiazide alone are:
• loss of appetite
• eyesight changes such as blurred vision, yellowing of colour vision, short sightedness
• fever
• glucose in the urine
• restlessness










constipation
inflammation of the blood vessels
upset stomach
high calcium levels in blood
low level of chloride, potassium or magnesium in blood
raised blood glucose levels causing symptoms such as feeling very thirsty and tired, passing
large amounts of urine, weight loss
raised cholesterol or triglyceride (blood fat) levels
raised blood levels of uric acid (which may be associated with gout)

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 www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to stor e lisinopr il and hydr ochlor othiazide

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 medicine 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 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 February 2016

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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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