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TELMISARTAN/HYDROCHLOROTHIAZIDE DR REDDYS 80 MG/12.5 MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg, 80 mg/12.5 mg, 80 mg/25 mg Tablets
Telmisartan and 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.
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 either telmisartan or hydrochlorothiazide 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 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 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 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.
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
vitamin D supplements.

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).
Telmisartan/Hydrochlorothiazide with food and drink
You can take Telmisartan/Hydrochlorothiazide with or without food. Swallow the tablets with some
water or other non-alcoholic drink.
Pregnancy and breastfeeding
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 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 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 month of pregnancy.
Breastfeeding:
Tell your doctor if you are breastfeeding or about to start breastfeeding.
Telmisartan/Hydrochlorothiazide is not recommended for mothers who are breastfeeding, and your
doctor may choose another treatment for you if you wish to breastfeed.
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
If you are intolerant to some sugars, consult your doctor before taking
Telmisartan/Hydrochlorothiazide.
3. How to take Telmisartan/Hydrochlorothiazide
Always take Telmisartan/Hydrochlorothiazide 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 this medicine 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 experience any of the following symptoms:
 sepsis* (often called "blood poisoning", which is a severe infection with whole-body inflammatory
response). Signs are: rapid breathing and fast heart rate, fever or low body temperature, confusion,
disorientation, agitation and low blood pressure
 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:
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
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 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, 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:
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.
Rare side effects (may affect up to 1 in 1,000 people):
 sepsis* (often called "blood poisoning", which is a severe infection with whole-body inflammatory
response, which can lead to death). Signs are: rapid breathing and fast heart rate, fever or low body
temperature, confusion, disorientation, agitation and low blood pressure
 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.
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
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 (see
section 2), 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 (symptoms 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))
high blood cholesterol levels, decreased blood volume
increased levels of glucose, or fat in the blood.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
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.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Telmisartan/Hydrochlorothiazide tablets contain
The active substances are telmisartan and hydrochlorothiazide. Each 40 mg/12.5 mg tablet contains
40 mg telmisartan and 12.5 mg hydrochlorothiazide. Each 80 mg/12.5 mg tablet contains 80 mg
telmisartan and 12.5 mg hydrochlorothiazide. Each 80 mg/25 mg tablet contains 80 mg telmisartan
and 25 mg hydrochlorothiazide.
The other ingredients are meglumine, sodium hydroxide, povidone, polysorbate, mannitol (E421),
magnesium stearate, lactose monohydrate, yellow iron oxide (80 mg/25 mg tablet only), red iron oxide
(40 mg/12.5 mg and 80 mg/12.5 mg tablets only).
What Telmisartan/Hydrochlorothiazide tablets look like and contents of the pack
Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg tablets are oblong-shaped, uncoated bilayered
tablets, with a light pink to pink layer on one side and a white to off-white layer on the other side, with
‘T’ and ‘1’ debossed on either side of a break line.
Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg tablets are oblong-shaped, uncoated bilayered
tablets, with a light pink to pink layer on one side and a white to off-white layer on the other side, with
‘T’ and ‘2’ debossed on either side of a break line.
Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets are oblong-shaped, uncoated bilayered tablets,
with a light yellow to yellow layer on one side and a white to off-white layer on the other side, with
‘T’ and ‘3’ debossed on either side of a break line.

The break line is only to help break the tablet for ease of swallowing and not to divide into equal
doses.
Telmisartan/Hydrochlorothiazide is available in blisters packs containing 28, 56, or 98 tablets.
Not all pack sizes may be available in your country.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United
Kingdom
This leaflet was last revised in 04/2013

Expand Transcript

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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