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TELMISARTAN/HYDROCHLOROTHIAZIDE 80 MG/25 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / TELMISARTAN

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Package leaflet: Information for the user

Telmisartan/
Hydrochlorothiazide
80 mg/25 mg Tablets
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 Telmisartan/Hydrochlorothiazide
Tablets is and what it is used for
2. What you need to know before you take
Telmisartan/Hydrochlorothiazide Tablets
3. How to take Telmisartan/Hydrochlorothiazide
Tablets
4. Possible side effects
5. How to store Telmisartan/Hydrochlorothiazide
Tablets
6. Contents of the pack and other information

1.

What Telmisartan/Hydrochlorothiazide Tablets
are and what they are used for

Telmisartan/Hydrochlorothiazide Tablets are a combination
of two active substances, telmisartan and hydrochlorothiazide
in one tablet. Both of these substances help to control high
blood pressure.
• Telmisartan belongs to a group of medicines called
angiotensin II receptor antagonists. Angiotensin-II is a
substance produced in your body which causes your
blood vessels to narrow thus increasing your blood
pressure. Telmisartan blocks the effect of angiotensin II
so that the blood vessels relax, and your blood pressure
is lowered.
• Hydrochlorothiazide belongs to a group of medicines
called thiazide diuretics, which cause your urine output
to increase, leading to a lowering of your blood pressure.
High blood pressure, if not treated, can damage blood
vessels in several organs, which could lead sometimes to
heart attack, heart or kidney failure, stroke, or blindness.
There are usually no symptoms of high blood pressure before
damage occurs. Thus it is important to regularly measure
blood pressure to verify if it is within the normal range.
Telmisartan/Hydrochlorothiazide Tablets are used to
treat high blood pressure (essential hypertension) in adults
whose blood pressure is not adequately controlled by
Telmisartan/Hydrochlorothiazide 80/12.5 mg or in patients
who have been previously stabilised by telmisartan and
hydrochlorothiazide given separately.

2.

What you need to know before you take
Telmisartan/Hydrochlorothiazide Tablets

Do not take Telmisartan/Hydrochlorothiazide Tablets
• if you are allergic to telmisartan or any other ingredients
of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to any other
sulfonamide-derived medicines
• if you are more than 3 months pregnant. (It is also better
to avoid Telmisartan/Hydrochlorothiazide Tablets in early
pregnancy – see pregnancy section.)
• if you have severe liver problems such as cholestasis or
biliary obstruction (problems with drainage of the bile
from the liver and gall bladder) or any other severe liver
disease
• if you have severe kidney disease
• if your doctor determines that you have low potassium
levels or high calcium levels in your blood that do not get
better with treatment
• if you have diabetes mellitus or impaired kidney function
and you are treated with Rasilez.
If any of the above applies to you, tell your doctor or
pharmacist before taking Telmisartan/Hydrochlorothiazide
Tablets.
Warnings and precautions
Talk to your doctor if you are suffering or have ever suffered
from any of the following conditions or illnesses:
• low blood pressure (hypotension), likely to occur if you
are dehydrated (excessive loss of body water) or have
salt deficiency due to diuretic therapy (water tablets),
low-salt diet, diarrhoea, vomiting, or haemodialysis
• kidney disease or kidney transplant
• renal artery stenosis (narrowing of the blood vessels to
one or both kidneys)
• liver disease
• heart trouble

• diabetes
• gout
• raised aldosterone levels (water and salt retention in the
body along with imbalance of various blood minerals)
• systemic lupus erythematosus (also called “lupus” or
“SLE”) a disease where the body’s immune system
attacks the body
• the active ingredient hydrochlorothiazide can cause an
unusual reaction, resulting in a decrease in vision and
eye pain. These could be symptoms of an increase of
pressure in your eye and can happen within hours to
weeks of taking Telmisartan/Hydrochlorothiazide
Tablets. This can lead to permanent vision impairment, if
not treated.
Talk to your doctor before taking
Telmisartan/Hydrochlorothiazide Tablets:
• if you are taking Rasilez, a medicine used to treat high
blood pressure.
• if you are taking digoxin.
You must tell your doctor if you think you are (or might
become) pregnant. Telmisartan/Hydrochlorothiazide Tablets
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).
Treatment with hydrochlorothiazide may cause electrolyte
imbalance in your body. Typical symptoms of fluid or
electrolyte imbalance include dry mouth, weakness,
lethargy, drowsiness, restlessness, muscle pain or cramps,
nausea (feeling sick), vomiting, tired muscles, and an
abnormally fast heart rate (faster than 100 beats per
minute). If you experience any of these you should tell your
doctor.

You should also tell your doctor, if you experience an
increased sensitivity of the skin to the sun with symptoms of
sunburn (such as redness, itching, swelling, blistering)
occurring more quickly than normal.
In case of surgery or anaesthetics, you should tell your
doctor that you are taking Telmisartan/Hydrochlorothiazide
Tablets.
Telmisartan/Hydrochlorothiazide may be less effective in
lowering the blood pressure in black patients.
Children and adolescents
The use of Telmisartan/Hydrochlorothiazide in children and
adolescents up to the age of 18 years is not recommended.
Other medicines and Telmisartan/Hydrochlorothiazide
Tablets:
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. Your doctor may
need to change the dose of these other medications or take
other precautions. In some cases you may have to stop
taking one of the medicines. This applies especially to the
medicines listed below taken at the same time with
Telmisartan/Hydrochlorothiazide Tablets:
• lithium containing medicines to treat some types of
depression
• medicines associated with low blood potassium
(hypokalaemia) such as other diuretics, ('water tablets'),
laxatives (e.g. castor oil), corticosteroids (e.g.
prednisone), ACTH (a hormone), amphotericin (an
antifungal medicine), carbenoxolone (used to treat mouth
ulcers), penicillin G sodium (an antibiotic), and salicylic
acid and derivatives
• potassium-sparing diuretics, potassium supplements, salt
substitutes containing potassium, ACE inhibitors that
may increase blood potassium levels

• heart medicines (e.g. digoxin) or medicines to control the
rhythm of your heart (e.g. quinidine, disopyramide)
• medicines used for mental disorders (e.g. thioridazine,
chlorpromazine, levomepromazine)
• other medicines used to treat high blood pressure,
steroids, painkillers, medicines to treat cancer, gout, or
arthritis, and vitamin D supplements
• Rasilez, a medicine used to treat high blood pressure
• digoxin.
Telmisartan/Hydrochlorothiazide Tablets may increase the
blood pressure lowering effect of other medicines used to
treat high blood pressure or of medicines with blood
pressure lowering potential (e.g. baclofen, amifostine).
Furthermore, low blood pressure may be aggravated by
alcohol, barbiturates, narcotics or antidepressants. You may
notice this as dizziness when standing up. You should
consult with your doctor if you need to adjust the dose of
your other medicine while taking
Telmisartan/Hydrochlorothiazide Tablets.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. Telmisartan/Hydrochlorothiazide Tablets is
not recommended for mothers who are breast-feeding, and
your doctor may choose another treatment for you if you
wish to breast-feed.
Driving and using machines
Some people feel dizzy or tired when taking
Telmisartan/Hydrochlorothiazide. If you feel dizzy or tired, do
not drive or operate machinery.
Telmisartan/Hydrochlorothiazide contains milk sugar
(lactose) and sorbitol.
If you are intolerant to some sugars, consult your doctor
before taking Telmisartan/Hydrochlorothiazide.
to take Telmisartan/Hydrochlorothiazide
3. How
Tablets

The effect of Telmisartan/Hydrochlorothiazide Tablets may
be reduced when you take NSAIDs (non steroidal
anti-inflammatory medicines, e.g. aspirin or ibuprofen).

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Pregnancy and breast-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 Telmisartan/Hydrochlorothiazide Tablets before
you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine
instead of Telmisartan/Hydrochlorothiazide Tablets.
Telmisartan/Hydrochlorothiazide Tablets are 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.

The recommended dose of Telmisartan/Hydrochlorothiazide
Tablets is one tablet a day. Try to take a tablet at the same
time each day. You can take Telmisartan/Hydrochlorothiazide
Tablets with or without food. The tablets should be
swallowed with some water or other non-alcoholic drink. It
is important that you take Telmisartan/Hydrochlorothiazide
Tablets every day until your doctor tells you otherwise.
If your liver is not working properly, the usual dose should
not exceed 40 mg/12.5 mg once a day.
The tablet can be divided into equal doses.

If you take more Telmisartan/Hydrochlorothiazide
Tablets than you should
If you accidentally take too many tablets contact your doctor,
pharmacist, or your nearest hospital emergency department
immediately.
If you forget to take Telmisartan/Hydrochlorothiazide
Tablets
If you forget to take a dose, do not worry. Take it as soon as
you remember then carry on as before. If you do not take
your tablet on one day, take your normal dose on the next
day. Do not take a double dose to make up for forgotten
individual doses.
If you have 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.
Some side effects can be serious and need immediate
medical attention:
You should see your doctor immediately if you experience
any of the following symptoms:
Sepsis* (often called "blood poisoning"), is a severe infection
with whole-body inflammatory response, rapid swelling of
the skin and mucosa (angioedema); these side effects are
rare (may affect up to 1 in 1,000 people) but are extremely
serious and patients should stop taking the medicine and
see their doctor immediately. If these effects are not treated
they could be fatal. Increased incidence of sepsis has been
observed with telmisartan only, however cannot be ruled out
for Telmisartan/Hydrochlorothiazide.

Possible side effects of
Telmisartan/Hydrochlorothiazide Tablets:
Common side effects (may affect up to 1 in 10 people):
Dizziness
Uncommon side effects (may affect up to 1 in 100 people):
Decreased blood potassium levels, anxiety, fainting
(syncope), sensation of tingling, pins and needles
(paraesthesia), feeling of spinning (vertigo), fast heart beat
(tachycardia), heart rhythm disorders, low blood pressure, a
sudden fall in blood pressure when you stand up, shortness
of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back
pain, muscle spasm, muscle pain, erectile dysfunction
(inability to get or keep an erection), chest pain, increased
blood uric acid levels.
Rare side effects (may affect up to 1 in 1,000 people):
Inflammation of the lung (bronchitis), activation or worsening
of systemic lupus erythematosus (a disease where the body’s
immune system attacks the body, which causes joint pain, skin
rashes and fever); sore throat, inflamed sinuses, feeling sad
(depression), difficulty falling asleep (insomnia), impaired
vision, difficulty breathing, abdominal pain, constipation,
bloating (dyspepsia), feeling sick, inflammation of the stomach
(gastritis), abnormal liver function (Japanese patients are more
likely to experience these side effect), rapid swelling of the
skin and mucosa which can also lead to death (angioedema
also with fatal outcome), redness of the skin (erythema),
allergic reactions such as itching or rash, increased sweating,
hives (urticaria), joint pain (arthralgia) and pain in extremities,
muscle cramps, flu-like-illness, pain, increased levels of uric
acid, low levels of sodium, increased levels of creatinine,
hepatic enzymes or creatine phosphokinase in the blood.
Adverse reactions reported with one of the individual
components may be potential adverse reactions with
Telmisartan/Hydrochlorothiazide, even if not observed in
clinical trials with this product.

Telmisartan
In patients taking telmisartan alone the following additional
side effects have been reported:

Hydrochlorothiazide
In patients taking hydrochlorothiazide alone the following
additional side effects have been reported:

Uncommon side effects (may affect up to 1 in 100 people):
Upper respiratory tract infection (e.g. sore throat, inflamed
sinuses, common cold), urinary tract infections, deficiency in
red blood cells (anaemia), high potassium levels, slow heart
rate (bradycardia), kidney impairment including acute kidney
failure, weakness, cough.

Side effects of unknown frequency (frequency cannot be
estimated from the available data):
Inflammation of the salivary gland, decreases in the number
of cells in the blood, including low red and white blood cell
count, low platelet count (thrombocytopenia), serious
allergic reactions (e.g. hypersensitivity, anaphylactic
reaction), decreased or loss of appetite, restlessness,
light-headedness, blurred or yellowing of vision, decrease in
vision and eye pain (possible signs of acute myopia or
acute-angle closure glaucoma), inflammation of blood
vessels (vasculitis necrotising), inflamed pancreas, upset
stomach, yellowing of the skin or eyes (jaundice), lupus-like
syndrome (a condition mimicking a disease called systemic
lupus erythematosus where the body’s immune system
attacks the body); skin disorders such as inflamed blood
vessels in the skin, increased sensitivity to sunlight, or
blistering and peeling of the top layer of skin (toxic
epidermal necrolysis), weakness, kidney inflammation or
impaired kidney function, glucose in the urine (glycosuria),
fever, impaired electrolyte balance, high blood cholesterol
levels, decreased blood volume, increased levels of glucose,
or fat in the blood.

Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called "blood poisoning", is a severe infection
with whole-body inflammatory response which can lead to
death), low platelet count (thrombocytopenia), increase in
certain white blood cells (eosinophilia), serious allergic
reaction (e.g. hypersensitivity, anaphylactic reaction, drug
rash), low blood sugar levels (in diabetic patients), upset
stomach, eczema (a skin disorder), arthrosis, inflammation of
the tendons, decreased haemoglobin (a blood protein),
somnolence.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung
disease)**
* The event may have happened by chance or could be
related to a mechanism currently not known.
** Cases of progressive scarring of lung tissue have been
reported during intake of telmisartan. However, it is not
known whether telmisartan was the cause.

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 the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5.

How to store Telmisartan/Hydrochlorothiazide
Tablets

Telmisartan/Hydrochlorothiazide Tablets are available in
blister packs containing 7, 10, 14, 28, 28x1, 30, 30x1, 50x1,
56, 60, 84, 90, 90x1, 98, 100, 112, 120, 156 or 300 tablets.

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

Not all pack sizes may be marketed.

Do not use this medicine after the expiry date which is
stated on the carton after “EXP”. The expiry date refers to
the last day of that month.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK

This medicinal product 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.

Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna
Filipovica 25, 10000 Zagreb, Croatia
This leaflet was last revised in 01/2014.
PL 00289/1771

6. Contents of the pack and other information
What Telmisartan/Hydrochlorothiazide Tablets contains
The active substances are telmisartan and
hydrochlorothiazide. Each tablet contains 80 mg telmisartan
and 25 mg hydrochlorothiazide.
The other ingredients are
Sodium Hydroxide, Hypromellose, Sorbitol (E420),
Meglumine, Mannitol (E421), Talc, Magnesium Stearate,
Lactose Monohydrate, Hydroxypropylcellulose, Yellow Iron
Oxide (E172)
What Telmisartan/Hydrochlorothiazide Tablets look
like and contents of the pack
Yellow and white to off white coloured capsule shaped
bilayer tablet with a breakline on the yellow coloured side
(dimension: approx. 18.0 x 8.0 mm).
The tablet can be divided into equal doses.

10058-A

600 x 180

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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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