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TELMISARTAN/HYDROCHLOROTHIAZIDE 80MG/25MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / TELMISARTAN

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Package leaflet: Information for the patient

Telmisartan/Hydrochlorot
hiazide 40 mg/12.5 mg
tablets
Telmisartan/Hydrochlorot
hiazide 80 mg/12.5 mg
tablets
Telmisartan/Hydrochlorot
hiazide 80 mg/25 mg
tablets
telmisartan/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 Telmisartan/Hydrochlorothiazide is and
what it is used for
2. What you need to know before you take
Telmisartan/Hydrochlorothiazide
3. How to take Telmisartan/Hydrochlorothiazide
4. Possible side effects
5. How to store Telmisartan/Hydrochlorothiazide
6. Contents of the pack and other information

1. What
Telmisartan/Hydrochlorothiazi
de is and what it is used for
Telmisartan/Hydrochlorothiazide is 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 (40 mg/12.5
mg, 80 mg/12.5 mg) is used to treat high blood
pressure (essential hypertension) in adults whose
blood pressure is not controlled enough when
telmisartan is used alone.
Telmisartan/Hydrochlorothiazide (80 mg/25
mg) is used to treat high blood pressure
(essential hypertension) in adults whose blood
pressure is not adequately controlled by
Telmisartan/Hydrochlorothiazide 80 mg/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
Do not take Telmisartan/Hydrochlorothiazide :
- 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 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 liver and the 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 or impaired kidney function
and you are treated with a blood pressure
lowering medicine containing aliskiren.
If any of the above applies to you, tell your doctor
or pharmacist before taking
Telmisartan/Hydrochlorothiazide .
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. This
can lead to permanent vision impairment, if not
treated.
Talk to your doctor before taking
Telmisartan/Hydrochlorothiazide :
- if you are taking digoxin.
- if you are taking any of the following medicines
used to treat high blood pressure:
o an ACE-inhibitor (for example enalapril,
lisinopril, ramipril), in particular if you have

diabetes-related kidney problems.
o 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
Telmisartan/Hydrochlorothiazide”.
You must tell your doctor if you think you are (or
might become) pregnant.
Telmisartan/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).
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.
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
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 :
- 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.
- If you are taking an ACE-inhibitor or aliskiren
(see also information under the headings “Do
not take Telmisartan/Hydrochlorothiazide ” and
“Warnings and precautions”).
- Digoxin.
Telmisartan/Hydrochlorothiazide 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.
The effect of Telmisartan/Hydrochlorothiazide
may be reduced when you take NSAIDs (non
steroidal anti-inflammatory medicines, e.g. aspirin
or ibuprofen).
Pregnancy and breast-feeding
Pregnancy
If you are pregnant or breast feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine. Your doctor will normally
advise you to stop taking
Telmisartan/Hydrochlorothiazide 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 .
Telmisartan/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.
Telmisartan/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.
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
lactose monohydrate
If you have been told by your doctor that you
have an intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. How to take
Telmisartan/Hydrochlorothiazide
Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose of
Telmisartan/Hydrochlorothiazide is one tablet a
day. Try to take a tablet at the same time each
day. You can take
Telmisartan/Hydrochlorothiazide 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
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.

decreased blood volume, increased levels of
glucose, or fat in the blood.

If you take more
Telmisartan/Hydrochlorothiazide than you
should
If you accidentally take too many tablets contact
your doctor, pharmacist, or your nearest hospital
emergency department immediately.

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
United kingdom
The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

If you forget to take
Telmisartan/Hydrochlorothiazide
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:
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:

Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store
Telmisartan/Hydrochlorothiazide
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 or blister after
“EXP”. The expiry date refers to the last day of
that month.
This medicine does not require any special
temperature storage conditions. Store in the
original package in order to protect from
moisture.
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 Telmisartan/Hydrochlorothiazide
contains
The active substances are telmisartan and
hydrochlorothiazide.
Each tablet contains 40 mg telmisartan and 12.5
mg hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 12.5
mg hydrochlorothiazide.
Each tablet contains 80 mg telmisartan and 25
mg hydrochlorothiazide.
The other ingredients are:
Cellulose, microcrystalline, lactose monohydrate,
mannitol, sodium hydroxide, meglumine,
povidone (K30), magnesium stearate, sodium
stearyl fumarate, red ferric oxide (E172) [for 40
mg/12.5 mg and 80 mg/12.5 mg tablets] and
yellow ferric oxide (E172) [for 80 mg/25 mg
tablets].
What Telmisartan/Hydrochlorothiazide looks
like and contents of the pack
40 mg/12.5 mg tablets: White to off white on one
side and red, possibly mottled, on other side,
biconvex, bilayer, oblong shaped, uncoated
tablets, approximately 13 mm in length and 6.2
mm in width, debossed with “T1” on red side and
plain on other side.
80 mg/12.5 mg tablets: White to off white on one
side and red, possibly mottled, on other side,
biconvex, bilayer, oblong shaped, uncoated
tablets, approximately 16.2 mm in length and 7.9
mm in width, debossed with “T2” on red side and
plain on other side.
80 mg/25 mg tablets: White to off white on one
side and yellow, possibly mottled, on other side,
biconvex, bilayer, oblong shaped, uncoated
tablets, approximately 16.2 mm in length and 7.9
mm in width, debossed with “T2” on yellow side
and plain on other side.
Available in Aluminium/ Aluminium blisters packs
containing 14, 28, 30, 56, 60, 84, 90, 98 or 100
tablets.
Not all pack sizes may be marketed.

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.

Marketing Authorisation Holder and
Manufacturer

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.

Manufacturer
Accord Healthcare Limited,
Sage house, 319 Pinner road, North Harrow,
Middlesex, HA1 4HF, United Kingdom

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

Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom

Wessling Hungary Kft.,
Fóti út 56., Budapest 1047,
Hungary
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Austria
Telmisartan/Hydrochlorothiazid
Accord 40 mg/12,5 mg,
80 mg/12,5 mg, 80 mg/25 mg
Tabletten
Germany Telmisartan/Hydrochlorothiazid
Accord 40 mg/12,5 mg,
80 mg/12,5 mg, 80 mg/25 mg
Tabletten
Estonia
Telmisartan/Hydrochlorothiazide
Accord
Finland
Telmisartan/Hydrochlorothiazide
Accord 40 mg/12.5 mg,
80 mg/12.5 mg, 80 mg/25 mg
tabletit/tabletter
Ireland
Telmisartan/Hydrochlorothiazide
40 mg/12.5 mg, 80 mg/12.5 mg,
80 mg/25 mg tablets
Italy
Telmisartan e Idroclorotiazide Accord
Latvia
Telmisartan/Hydrochlorothiazide
Accord 40 mg/12,5 mg,
80 mg/12,5 mg, 80 mg/25 mg
tabletes
Lithuania Telmisartan/Hydrochlorothiazide
Accord 40 mg/12,5 mg,
80 mg/12,5 mg, 80 mg/25 mg
tabletės
The
Telmisartan/Hydrochloorthiazide
Netherland Accord 40 mg/12,5 mg,
80 mg/12,5 mg, 80 mg/25 mg
tabletten
Poland
Telmidon
Slovakia
Telmisartan/Hydrochlorotiazid
Accord 40 mg/12.5 mg,
80 mg/12.5 mg, 80 mg/25 mg tablety
United
Telmisartan/Hydrochlorothiazide
Kingdom 40 mg/12.5 mg, 80 mg/12.5 mg,
80 mg/25 mg tablets
TELMISARTAN/HYDROCHLOROTHIAZIDE
France
ACCORD 40 mg/12,5 mg,
80 mg/12,5 mg, 80 mg/25 mg
comprimés
This leaflet was last approved in 02/2016

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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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