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TELMISARTAN/HYDROCHLOROTHIAZIDE GLENMARK 80 MG/12.5 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / TELMISARTAN

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SAME SIZE ARTWORK
LEAFLET SIZE: 170 mm X 425 mm

Package leaflet: Information for the patient
Telmisartan/Hydrochlorothiazide 80 mg/12.5 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/Hydrochlorothiazide 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 is used to treat high
blood pressure (essential hypertension) in adults whose
blood pressure is not controlled enough when telmisartan
is used alone.
2. What you need to know before you take
Telmisartan/Hydrochlorothiazide.
Do not take Telmisartan/Hydrochlorothiazide:
• if you are allergic to telmisartan or any of the 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 this medicine 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 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, do not take the tablets
and tell your doctor or pharmacist before taking this
medicine.
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 loss, if not treated.
Talk to your doctor before taking Telmisartan/
Hydrochlorothiazde:
• if you are taking any of the following medicines used
to treat high blood pressure:
• an ACE-inhibitor (for example enalapril, lisinopril,
ramipril), 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 Telmisartan/
Hydrochlorothiazide
•if you are taking digoxin.

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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).
Hydrochlorothiazide may cause 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). Hydrochlorothiazide might also cause decrease
in vision and eye pain (possible signs of acute-angle
closure glaucoma). 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.
If you are going to have an operation tell your doctor that
you are taking this medicine.
These tablets may be less effective in lowering the blood
pressure in black patients.
Children and adolescents
This medicine is not recommended in children and
adolescents up to the age of 18 years.
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
• 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 and 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, breast-feeding and fertility
Pregnancy
You must tell your doctor if you think you are (or might
become) pregnant. Your doctor will normally advise you
to stop taking this medicine before you become pregnant
or as soon as you know you are pregnant and will advise
you to take another medicine instead. These 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start
breast-feeding. These tablets are 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)
If you are intolerant to some sugars, consult your doctor
before taking this medicine.
3. How to take Telmisartan/Hydrochlorothiazide
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Dosage
The recommended dose is one tablet a day.
Try to take a tablet at the same time each day.

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You can take the tablets with or without food. They should
be swallowed with some water or other non-alcoholic
drink.
It is important that you take the 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.
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.
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 think you
have blood poisoning (sepsis).
This is a severe infection with whole-body inflammatory
response, rapid swelling of the skin and mucosa
(angioedema). It is a rare side effect (may affect up to 1 in
1,000 people) but extremely serious and patients should
stop taking the medicine and see their doctor immediately.
If untreated it could be fatal.
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 to 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 or a sudden fall in blood pressure
when you stand up Shortness of breath (dyspnoea)
• Diarrhoea, flatulence
• Dry mouth
• Back pain, muscle spasm, muscle pain, chest pain
• Erectile dysfunction (inability to get or keep an erection)
• 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 this 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, liver enzymes or creatine
phosphokinase in the blood.
Adverse reactions reported with one of the individual
components of this medicine may be potential adverse
reactions with Telmisartan/Hydrochlorothiazide, even if
not observed in clinical trials with this product.
Possible side effects of Telmisartan alone:
In patients taking telmisartan alone the following
additional side effects have been reported:
Uncommon side effects (may affect up to 1 to 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 in blood
• Slow heart rate (bradycardia)
• Kidney impairment including acute kidney failure
• Weakness
• Cough.
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 blood 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)
• Joint pain (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

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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.
Possible side effects of Hydrochlorothiazide alone:
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-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.
If you get any of the side effects, talk to your doctor or
pharmacist. This includes any side effects not listed in this
leaflet.
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 website
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
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 after EXP. The expiry date refers to
the last day of that month.
You should store your medicine in the original package in
order to protect the tablets from moisture.
Do not use this medicine if you notice that the tablets are
discoloured.
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 80 mg telmisartan and 12.5 mg
hydrochlorothiazide.
The other ingredients are crospovidone (type A),
hypromellose, lactose monohydrate, magnesium stearate,
mannitol, meglumine, povidone, colloidal anhydrous
silica, sodium hydroxide, sodium stearyl fumarate, talc,
iron oxide red (E172).
What Telmisartan/Hydrochlorothiazide looks like and
contents of the pack
Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg tablets
are biconvex, two-layered, capsule shaped uncoated
tablets wherein the hydrochlorothiazide layer is white to
off-white, debossed with “424” and the telmisartan layer is
mottled orange to reddish brown, without debossing. The
hydrochlorothiazide layer may contain reddish brown
specks.
Telmisartan/Hydrochlorothiazide Tablets are available in
blisters packs containing 14, 28, 30, 56, 90 or 98 tablets.
Not all pack sizes may be available in your country.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton,
Middlesex, HA3 0BU. United Kingdom
Manufacturer
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park, Croxley Green,
Hertfordshire, WD18 8YA United Kingdom
Glenmark Pharmaceuticals s.r.o.
Fibíchova 143, 566 17 Vysoké Mýto
Czech Republic
Tillomed Laboratories Limited,
3 Howard Road, Eaton Socon, St Neots, Cambridgeshire,
PE19 8ET
United Kingdom
This leaflet was last revised in 10/2014.

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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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