Skip to Content

UK Edition. Click here for US version.

LISINOPRIL + HCT 20/12.5MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / LISINOPRIL DIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
Lisinopril Hydrochlorothiazide 10/12.5 mg and 20/12.5 mg Tablets
Active substances: Lisinopril and Hydrochlorothiazide

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 belongs to a group of medicines called angiotensin converting enzyme inhibitors (ACE
inhibitors) and lowers blood pressure by widening the blood vessels.
Hydrochlorothiazide belongs to a group of drugs called diuretics (“water tablets”) and lowers blood
pressure by increasing urine output.
Lisinopril + Hydrochlorothiazide contains a combination of lisinopril and hydrochlorothiazide and is
used as a treatment for high blood pressure when treatment with lisinopril as a single agent on its own
has proven insufficient.
Your doctor may also prescribe Lisinopril + Hydrochlorothiazide instead of separate tablets of the
same doses of lisinopril and hydrochlorothiazide. This fixed dose combination is not suitable for initial
therapy.

2.

BEFORE YOU TAKE LISINOPRIL + HYDROCHLOROTHIAZIDE

Do NOT take Lisinopril + Hydrochlorothiazide:
if you are allergic (hypersensitive) to lisinopril, hydrochlorothiazide or any of the other
ingredients of this medicine.
if you are allergic (hypersensitive) to other ACE inhibitors e.g. ramipril or to sulphonamidederived medicines (mostly antibiotics e.g. sulphamethoxazole)
if you have previously suffered from swelling of the extremities, face, lips, throat, mouth or
tongue (angioedema) when treated with other medicines belonging to a group of drugs called
ACE inhibitors (angiotensin-converting enzyme inhibitors) such as ramipril
if you have previously suffered from swelling of the extremities, face, lips, throat, mouth or
tongue (angioedema) under any other circumstances
if anyone among your blood relatives has previously suffered from swelling of the extremities,
face, lips, throat, mouth or tongue (angioedema)
2/10

-

if you have severe kidney problems
if you have severe liver problems
if you suffer from an inability to pass water (anuria)
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 diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Lisinopril + Hydrochlorothiazide

if you have narrowing of the arteries (atherosclerosis), cerebrovascular problems such as a
stroke or transient ischaemic attack (TIA, a “mini-stroke”)

if you have heart failure

if you have low blood pressure, are on a salt restricted diet or are taking diuretics (“water
tablets”)

if you have abnormal levels of water and minerals in your body (fluid/electrolyte imbalance)

have heart muscle disease (hypertrophic cardiomyopathy), a narrowing of the main artery
carrying blood away from the heart, the aorta (aortic stenosis), or other forms of a heart problem
called outflow obstruction

if you undergo LDL apheresis (removal of cholesterol from the blood by a machine)

if you undergo desensitisation therapy to some insect venoms, such as bee or wasp stings

if you have diabetes

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 + Hydrochlorothiazide”.

if you suffer from gout, have high levels of uric acid in your blood or are being treated with
allopurinol

if you need to have an anaesthetic

if you have recently suffered from prolonged, violent vomiting and/or serious diarrhoea

if you are going to have tests to check your parathyroid function

if you have or have had liver or kidney problems, or you have narrow arteries to your kidneys
(renal artery stenosis) or only have one functioning kidney, or you are undergoing
haemodialysis

if you have collagen vascular disease such as systemic lupus erythematosus (SLE) or
scleroderma, which may be associated with skin rashes, joint pain and fever

if you have allergy problems or asthma.

if you are taking lithium, used for the treatment of some psychiatric illness

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).

if you are being treated with other water tablets (diuretics). To other treatment should be
stopped 2-3 days before starting treatment with Lisinopril + Hydrochlorothiazide.
Lisinopril + Hydrochlorothiazide is not generally recommended if the following apply, so talk to your
doctor before starting to take this medicine:
if you have recently had a kidney transplant.
if you have high levels of potassium in your blood.
Please refer also to “Other medicines and Lisinopril + Hydrochlorothiazide” below.
3/10

Talk to your doctor if you are an athlete taking a doping test, as Lisinopril + Hydrochlorothiazide
contains an active ingredient that can cause positive results in a doping test.
Elderly or malnourished patients should be particularly careful when using Lisinopril +
Hydrochlorothiazide
Lisinopril + Hydrochlorothiazide may be less effective in Black people.
This medicine is not recommended for use in children.
While taking Lisinopril + Hydrochlorothiazide:
If you develop any of the following symptoms you should let your doctor know immediately:
-

-

You feel dizzy after your first dose. A few people react to their first dose or when their dose is
increased by feeling dizzy, weak, faint and sick.
Sudden swelling of the lips and face neck, possibly also hands and feet, or wheezing or
hoarseness. This condition is called angioedema. This may occur at any time during treatment.
ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
High temperature, sore throat or mouth ulcers (these may be symptoms of infection caused by
the lowering of the number of white blood cells).
Yellowing of the skin and whites of eyes (jaundice) that may be sign of liver disease.
A dry cough which is persistent for a long time. Cough has been reported with the use of ACE
inhibitors but may be also a symptom of other upper respiratory track disease.

Other medicines and Lisinopril + Hydrochlorothiazide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This particularly applies to:



















potassium supplements, or potassium-containing salt substitutes and potassium-sparing diuretics
other medicines used to treat high blood pressure
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”).
anaestetics and medicines for mental disorders or depressions, medicines to treat psychoses,
tricyclic antidepressants, or sedatives
lithium (medicines for depression)
painkillers and anti-inflammatory medicines, such as acetylsalicylic acid (> 3000 mg/day) or
indomethacin
Sodiumaurothiomalat (gold), a medicine to injection against rheumatic arthritis
sympathomimetics, drugs such as ephedrine, noradrenaline or adrenaline used for the treatment
of hypotension, shock, cardiac failure, asthma or allergies.
blood sugar lowering medicines, such as insulin or those taken orally.
colestyramine resin and colestipol, active substances for lowering blood lipid values
corticosteroids, anti-inflammatory hormone-like substances
ACTH, used to test whether your adrenal glands are working properly
muscle relaxants (e.g .tubocurarine chloride, medicines for relaxing muscles that are used in
operations)
allopurinol, medicinal products used to treat gout
medicines to treat cancer, such as cyclophoshamide or methotrexate
medicines that inhibit your body’s immune system, medicines to prevent rejection reactions
after organ or bone marrow transplants
ciclosporin medicines to prevent rejection reactions after organ or bone marrow transplants
cardiac glycosides (e.g. digoxin, medicines for strengthening the heart)

4/10










medicines that as a side effect cause abnormalities in the stimulus conduction in the heart such
as medicines for disturbances for heart rhythm, some medicines for psychosis and other
medicines such as drugs used to treat bacterial infections
calcium salts, elevated calcium levels in the blood.
amphotericin B, medicines against fungal infections
laxatives, medicines to promote defection
carbenoxolone active substance for the treatment of gastrointestinal diseases
trimethoprim medicines against bacterial infections
lovastatin medicine against high cholesterol
Sotalol (a beta-blocker), the risk for arrhythmias is increased

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, herbal or natural products.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think that you are (or might become) pregnant. Your doctor will
normally advise you to stop taking Lisinopril + 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 + Hydrochlorothiazide. Lisinopril + Hydrochlorothiazide is not recommended in early
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 of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril +
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
Dizziness and tiredness have been reported by people taking Lisinopril + Hydrochlorothiazide. If you
experience either of these do not drive a car and do not operate machinery (see also “4. Possible side
effects”).

3.
HOW TO TAKE LISINOPRIL + HYDROCHLOROTHIAZIDE
Always take Lisinopril + Hydrochlorothiazide exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Adults
The usual dose is one tablet taken once a day.
The maximum daily dose is 40 mg lisinopril and 25 mg hydrochlorothiazide.
Children
Safety and effectiveness in children and adolescents have not been established.
Elderly
No special dosage adjustment is necessary.
Kidney problems
Use of Lisinopril + Hydrochlorothiazide is contraindicated if you have severely impaired kidney
function.

5/10

If you suffer from a kidney disorder, the doctor should prescribe the lowest possible dose and monitor
your kidney function.
Previous treatment with a water tablet (diuretic)
If you are being changed from a water tablet to Lisinopril + Hydrochlorothiazide, you should have
stopped taking the water tablet 2-3 days before you start taking this medicine.
Method of administration
Take the tablet or half the tablet with plenty of water.Try to take the medicine at the same time each
day.
Dividing:
Place the tablet on a hard, flat surface with the break-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 (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed
any of the tablets, seek medical advice immediately.
An overdose is likely to cause low blood pressure, circulatory shock, electrolyte disturbances, renal
failure, hyperventilation (rapid breathing, feeling and being sick), an excessively fast or slow heart
beat, palpitations (a feeling of unduly rapid or irregular heart beat), dizziness, anxiety and cough.
Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take a Lisinopril + Hydrochlorothiazide tablet
Do not take a double dose to make up for a forgotten tablet, take your next dose at the normal time.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Lisinopril + Hydrochlorothiazide
The treatment of hypertension is a long term treatment and interruption of treatment must be discussed
with the doctor. Interruption or stopping your treatment could cause your blood pressure to increase.
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.
Side effects can occur with the following frequenties:
Very common
Common
Uncommon
Rare
Very rare
Not known

more than 1 user in 10
1 to 10 users in 100
1 to 10 users in 1,000
1 to 10 users in 10,000
less than 1 user in 10,000
frequency cannot be estimated from available data

I If you experience the following, stop taking Lisinopril + Hydrochlorothiazide and tell your
doctor immediately or go to the emergency department of your nearest hospital:
 A severe allergic reaction called angioedema (rash, itching, swelling of the extremities, face, lips,
mouth or throat that may cause difficulty in swallowing or breathing).
This is a serious and rare side effect. You may need urgent medical attention or hospitalisation.

6/10

 Jaundice (yellowing of the skin and the whites of the eyes).
This is a potentially serious but very rare side effect indicative of inflammation of the liver. You
may need urgent medical attention or hospitalisation.

Lisinopril + Hydrochlorothiazide commonly causes low blood pressure which may be associated with
feelings of light-headedness and weakness. In some patients, this may occur after the first dose or
when the dose is increased. If you experience these symptoms, you should contact your doctor
immediately.
Lisinopril + Hydrochlorothiazide may cause a reduction in the number of white blood cells and your
resistance to infection may be decreased. If you experience an infection with symptoms such as fever
and serious deterioration of your general condition, or fever with local infection symptoms such as
sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test
will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to
inform your doctor about your medicine.
A dry cough, which may persist for a long time, has been reported commonly with the use of
Lisinopril + Hydrochlorothiazide and other ACE inhibitors, but may be also a symptom of other upper
respiratory tract disease. You should contact your doctor if you develop this symptom.

The following side effects have also been reported:
Common

dizziness, headache, sudden loss of consciousness

low blood pressure associated with changes in posture (such as feeling light-headed or weak
when you stand up after lying down)

cough (see beginning of this section)

diarrhoea, vomiting,

kidney problems
Uncommon
 mood changes, depressive symptoms

tingling feeling or numbness, vertigo, taste abnormalities, difficulty in sleeping

heart attack or cerebrovascular accident (“mini-stroke”) (mainly in patients suffering from low
blood pressure)

palpitations (a sensation of a fast or particularly strong or irregular heart beat)

excessively fast heart beat (tachycardia)

raynaud’s syndrome, a blood vessel disorder which may cause your fingers and toes to tingle,
and turn pale, then blueish, then reddish.

inflammation of the lining of the nose causing the nose to run (rhinitis)

nausea, abdominal pain and indigestion

increase in the amount of enzymes and waste products produced by the liver

skin rash and /or itching

impotence

tiredness, general weakness

increase in the amount of urea in the blood

high levels of potassium in the blood, which can cause an abnormal heart rhythm; increase in
the amount of creatinine in the blood
Rare

decrease of the red blood pigment haemoglobin and number of red blood cells (hämatocrit)

mental confusion

dry mouth

7/10






hypersensitivity/angioneurotic oedema (see beginning of the section ), itchy rash, hair loss,
thickened patches of red/silver skin
kidney problems
breast enlargement inclusding in men
low levels of sodium in the blood, which can cause tiredness and confusion, muscle
twitching, fits or coma, also leading to dehydration and low blood pressure that makes you feel
dizzy when you stand up

Very rare

reduction in the number of white blood cells, which makes infection more likely,
reduction in the number of other blood cells, poor production of bone marrow, disease of the
lymph nodes, autoimmune disease, in which the body attacks itself.

reduction in the number of red blood cells, which can make the skin pale and cause weakness or
breathlessness (anaemia)

hypoglycaemia (low blood sugar levels) (see “Take special care with (national completed name”
in section 2)

difficulty breathing, wheezing

inflammation of nasal sinuses,

lung problems including pneumonia

inflammation of the pancreas which causes severe pain in the abdomen and back (pancreatitis)

Swelling in the intestines

liver problems *

excessive sweating (diaphoresis), severe skin disorders including Stevens-Johnson Syndrome
and aggregate of mature or abnormal looking lymphocytes in the dermis (cutaneous
pseudolymphoma)**

reduced urine production
* Very rarely, it has been reported that in some patients the undesirable development of hepatitis has
progressed to hepatic failure. Patients receiving lisinopril/hydrochloro-thiazide combination who
develop jaundice or marked elevations of hepatic enzymes should discontinue lisinoprilhydrochlorothiazide combination and receive appropriate medical follow up.
** A symptom complex has been reported which may include one or more of the following: fever,
inflammation of a blood vessel (vasculitis), muscle pains (myalgia), pains in the joints (arthralgia) and
inflammation of the joints (arthritis), increased quantity of antibodies (ANA), increased blood
sedimentation rate, rash and increase in the number of white blood cells (eosinophilia and
leukocytosis), rash, photosensitive to light or other skin reactions can occur.
Not known











inflammation of a salivary gland
increased blood sugar, fat or uric acid levels, glucose in the urine; low levels of potassium in the
blood, which can cause muscle weakness, twitching or abnormal heart rhythm; high levels of
calcium in the blood causing abdominal pain, feeling sick and being sick, constipation, loss of
appetite, excessive thirst, excessive urinating, tiredness, weakness and weight loss, painful and
swollen joints
restlessness
vision disturbances
necrotising vasculitis (inflammatory condition of blood vessels)
sensitivity of the skin to light, skin conditions with red scaly patches over the nose and cheeks
(lupus erythematosus) – this condition may be worsened in patients who already have it, severe
allergic reactions
muscle spasms, muscle weakness
inflammation in the kidneys (interstitial nephritis)
fever
8/10

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.
Do not use Lisinopril + Hydrochlorothiazide after the expiry date which is stated on the blister and the
carton after “EXP”. The expiry date refers to the last day of that month.
Storage conditions
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Lisinopril + Hydrochlorothiazide contains:
The active substances are: lisinopril and hydrochlorothiazide
Each tablet contains lisinopril dihydrate equivalent to 10 mg lisinopril and 12.5 mg
hydrochlorothiazide.
Lisinopril/Hydrochlorothiazid 20 mg/12.5 mg, Tablets:
Each tablet contains lisinopril dihydrate equivalent to 20 mg lisinopril and 12.5 mg
hydrochlorothiazide.
The other ingredients are: calcium hydrogenphosphate dihydrate, croscarmellose sodium, mannitol,
maize starch, magnesium stearate and red iron oxide (E 172).
What Lisinopril + Hydrochlorothiazide looks like and contents of the pack
The tabltes are pink, round, biconvex and scored on one side.
The tablet can be divided into equal halves.
The tablets are packed in PVC/aluminium blisters and inserted into a carton.
Lisinopril + Hydrochlorothiazide are available in pack sizes of 14, 28, 30, 50, 56, 98, 100 and 400
tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St Neots
Cambs PE19 8ET
United Kingdom
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
9/10

39179 Barleben
Germany
Product Licence Number:
Lisinopril + Hydrochlorothiazide 10/12.5mg Tablets: PL 11311/0235
Lisinopril + Hydrochlorothiazide 20/12.5mg Tablets: PL 11311/0236
This medical product is authorised in the Member States of the EEA under the following names:
BE:

Co-Lisinopril Sandoz 10/12.5 mg tabletten
Co-Lisinopril Sandoz 20/12.5 mg tabletten
IE: Lispril-hydrochlorothiazide 10 mg/12.5 mg Tablets
Lispril-hydrochlorothiazide 20 mg/12.5 mg Tablets
IT: Lisinopril idrochlorothiazide Sandoz 20 mg + 12,5 mg compresse
PT: Lisinopril + Hidroclorotiazida Sandoz 20 mg + 12,5 mg comprimidos
ES: Lisinoprilo Hidroclorotiazida Bexal 20/12,5 mg comprimidos EFG
UK: Lisinopril + HCT 10/12.5 mg Tablets
Lisinopril + HCT 20/12.5 mg Tablets

This package leaflet was last approved in May 2016.

10/10

Expand view ⇕

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.

Hide