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TELMISARTAN/HYDROCHLOROTHIAZIDE MYLAN 40 MG/12.5 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / TELMISARTAN

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Transcript
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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 40 mg/12.5 mg
and 80 mg/12.5 mg Tablets are 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 Tablets are
used to treat high blood pressure (essential hypertension)
in adults whose blood pressure is either not controlled
enough by treatment with Telmisartan/Hydrochlorothiazide
80 mg/12.5 mg or has been previously controlled by taking
telmisartan and hydrochlorothiazide separately.
2. What you need to know before you take
Telmisartan/Hydrochlorothiazide
Do not take Telmisartan/Hydrochlorothiazide:
• if you are allergic to telmisartan, hydrochlorothiazide, any
other sulfonamide-derived medicines or any of the other
ingredients of this medicine (listed in section 6).
• 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
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 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 this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Telmisartan/Hydrochlorothiazide:
• 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
• 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
* Allergy or asthma
* 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

See also information under the heading 'Do not take
Telmisartan/Hydrochlorothiazide'

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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.

Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g. potassium) in
your blood at regular intervals.

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.
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 signs of fluid or electrolyte
imbalance include dry mouth, weakness, lethargy,
drowsiness, restlessness, muscle pain or cramps, nausea
(feeling sick), vomiting, tired muscles, passing less urine
than is normal, 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 signs of
sunburn (such as redness, itching, swelling, blistering)
occurring more quickly than normal.
In case of surgery or anaesthetics, you should tell your
doctor or medical staff 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 your dose and/or to 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:
• An ACE-inhibitor or aliskiren (see also information
under the headings 'Do not take Telmisartan/
Hydrochlorothiazide' and 'Warnings and Precautions').
• 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), salicylic acid
and derivatives.
• Potassium-sparing diuretics, potassium supplements, salt
substitutes containing potassium.
• 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.
• 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 antiinflammatory medicines, e.g. aspirin or ibuprofen).
Telmisartan/Hydrochlorothiazide with alcohol
Alcohol should be avoided during treatment with this
medicine as it may increase some side effects.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might
become) pregnant or if you are planning to have a baby.
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 whentaking Telmisartan/
Hydrochlorothiazide. If you feel dizzy or tired, do not drive
or operate machinery.
Telmisartan/Hydrochlorothiazide contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

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Package leaflet: Information for the user

Telmisartan/Hydrochlorothiazide
40 mg/12.5 mg tablets
Telmisartan/Hydrochlorothiazide
80 mg/12.5 mg tablets
Telmisartan/Hydrochlorothiazide
80 mg/25 mg tablets

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.
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 recommended
maximum dose is 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 a
forgotten dose.
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.
Some side effects can be serious and need immediate
medical attention:
You should see your doctor or go to your nearest hospital
emergency department immediately if you notice 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/Hydrochlorothizide.
Possible side effects of Telmisartan/Hydrochlorothiazide:
Common (may affect up to 1 in 10 people):
• Dizziness
Uncommon (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 • 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 (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 • Flulike-illness • Pain • Increased levels of uric acid • Low levels
of sodium • Increased levels of creatinine, hepatic enzymes
or creatine phosphokinase in the blood
Side effects reported with one of the individual
components may be potential side effects with
Telmisartan/Hydrochlorothiazide.
Telmisartan
In patients taking telmisartan alone the following
additional side effects have been reported:
Uncommon (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
Rare (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 (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:

Not known (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 • Lightheadedness • Blurred or yellowing of vision • Decrease in
vision and eye pain (possible signs of acute myopia or acuteangle 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.
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
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.
This medicine does not require any special storage conditions.
After opening the bottle use within 3 months.
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 either 40 mg or 80 mg telmisartan
and 12.5 mg or 25 mg hydrochlorothiazide.
The other ingredients are: lactose monohydrate (see
section 2, 'Telmisartan/Hydrochlorothiazide contains
lactose'), magnesium stearate, maize starch, mannitol,
meglumine, microcrystalline cellulose, povidone (K30),
sodium hydroxide, sodium starch glycolate (Type A).
The 40 mg/12.5 mg and 80 mg/12.5 mg tablets also contain
red iron oxide (E172).
The 80 mg/25 mg tablets also contain yellow iron
oxide (E172).
What Telmisartan/Hydrochlorothiazide looks like and
contents of the pack
Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg Tablets
are red and white to off-white, oval shaped, uncoated,
biconvex, bilayered tablets, marked with 'TH1M' on the
red side and plain on the other side. The white to off white
layer may occasionally contain red tinge/specks. The tablet
dimensions are approximately 7 mm by 14 mm.
Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg Tablets
are red and white to off-white, oblong shaped, uncoated,
biconvex, bilayered tablets, marked with 'TH2M' on the
red side and plain on the other side. The white to off white
layer may occasionally contain red tinge/specks. The tablet
dimensions are approximately 8 mm by 16 mm.
Telmisartan/Hydrochlorothiazide 80 mg/25 mg Tablets are
yellow and white to off-white, oblong shaped, uncoated,
biconvex, bilayered tablets, marked with 'TH3M' on the
yellow side and plain on the other side. The white to off
white layer may occasionally contain yellow tinge/specks.
The tablet dimensions are approximately 8 mm by 16 mm.
Telmisartan/Hydrochlorothiazide is packed as cardboard
cartons containing either blister packs of 14, 28, 30, 56, 90,
98 and 100 tablets or unit dose blister packs of (28 x 1),
(30 x 1), (56 x 1), (90 x 1) and (98 x 1) tablets and cardboard
cartons containing bottles of 14, 28, 56 and 98 and
500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, UK
Manufacturer
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Generics [UK] Ltd, Potters Bar, EN6 1TL, United Kingdom
Mylan Hungary Kft, H-2900 Komárom,
Mylan útca 1, Hungary
This leaflet was last revised in July 2014.
CODE No.: MH/DRUGS/25/NKD/89

463367

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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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