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TELMISARTAN/HYDROCHLOROTHIZIDE 80 MG/12.5 MG TABLETS

Active substance(s): HYDROCHLOROTHIAZIDE / TELMISARTAN

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-PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan/Hydrochlorothiazide 40 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 doctoror 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 doctoror pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4..
What is in this leaflet
1.
2.
3.
4.
5.
6.

What Telmisartan/Hydrochlorothiazide is and what it is used for
What you need to know before you ake Telmisartan/Hydrochlorothiazide
How to take Telmisartan/Hydrochlorothiazide
Possible side effects
How to store Telmisartan/Hydrochlorothiazide
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 patients
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 (hypersensitive) to telmisartan or any other ingredients of this medicine (listed in
section 6)

if you are allergic (hypersensitive) 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.
-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.
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 adolescentsThe 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,
including medicines obtained without a prescription. 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.


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 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 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.
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.
Important information about some of the ingredients of Telmisartan/Hydrochlorothiazide
Telmisartan/Hydrochlorothiazide contains milk sugar (lactose) If you are intolerant to some sugars, consult
your doctor before taking Telmisartan/Hydrochlorothiazide.

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 usual 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.
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"), 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 can not 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 1000 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 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 to 10 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", 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.
Hydrochlorothiazide
In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Side effects of unknown frequency (frequency cannon 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
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 national reporting system listed in Appendix
V*. 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 (sealed) package in order to protect the tablets from moisture
and light
Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets.
You do not need to take any action if this happens.
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.
The other ingredients are Mannitol, Povidone (Povidone K 25), Crospovidone, Magnesium Stearate,
Meglumine, Sodium Hydroxide, Lactose Monohydrate, Cellulose Microcrystalline, Hypromellose
(Hydroxipropylmethylcellulose), Sodium Starch Glycolate Type A, Magnesium Stearate,and Ferric Oxide
Yellow (10E 172).
What Telmisartan/Hydrochlorothiazide looks like and contents of the pack

Telmisartan/Hydrochlorothiazide 40 mg/12.5 mg tablets are round bilayer tablets with white and yellow color.
Telmisartan/Hydrochlorothiazide is available in blisters packs containing 7, 10, 14, 28, 28x1, 30, 30x1, 50,
56, 84, 90, 90x1, 98, 100, 112, 126, 140, 154, 168, 182, 196 tablets.
Not all pack sizes may be available in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Liconsa, S.A.
Gran Vía Carlos III, 98
7th floor - 08028 – Barcelona
Spain
Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, no 7
Poligono Industrial Miralcampo
19200 AZUQUECA DE HENARES (Guadalajara)
Spain
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
This leaflet was last revised in January 2014
Detailed information on t his m edicine i s a vailable on the E uropean
Medicines Agency (EMA) web site: http://www.ema.europa.eu/

PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
2.
3.
4.
5.
6.

What Telmisartan/Hydrochlorothiazide is and what it is used for
What you need to know before you take Telmisartan/Hydrochlorothiazide.
How to take Telmisartan/Hydrochlorothiazide
Possible side effects
How to store Telmisartan/Hydrochlorothiazide
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 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 patients
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 (hypersensitive) to telmisartan or any other ingredients of this medicine (listed in
section 6) if you are allergic (hypersensitive) 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.
-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.
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,
including medicines obtained without a prescription. 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.

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).
od.
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 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.
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.
Important information about some of the ingredients of Telmisartan/Hydrochlorothiazide
Telmisartan/Hydrochlorothiazide contains milk sugar (lactose). If you are intolerant to some sugars, consult
your doctor before taking Telmisartan/Hydrochlorothiazide.
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 usual dose of Telmisartan/Hydrochlorothiazide is one tablet a day. Try to take the 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.
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"), 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 can not 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 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 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, inflamation 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 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 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, 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 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, 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
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 national reporting system listed in Appendix
V*. 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 (sealed) package in order to protect the tablets from moisture
and light
Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets.
You do not need to take any action if this happens.
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 Mannitol, Povidone (Povidone K 25), Crospovidone, Magnesium Stearate,
Meglumine, Sodium Hydroxide, Lactose Monohydrate, Cellulose Microcrystalline, Hypromellose
(Hydroxipropylmethylcellulose), Sodium Starch Glycolate Type A, Magnesium Stearate, Ferric Oxide Red
(30E 172). and
What Telmisartan/Hydrochlorothiazide looks like and contents of the pack
Telmisartan/Hydrochlorothiazide 80 mg/12.5 mg tablets are round bilayer tablets with white and pink color.
Telmisartan/Hydrochlorothiazide is available in blisters packs containing 7, 10, 14, 28, 28x1, 30, 30x1, 50,
56, 84, 90, 90x1, 98, 100, 112, 126, 140, 154, 168, 182, 196 tablets.
Not all pack sizes may be available in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Liconsa, S.A.
Gran Vía Carlos III, 98
7th floor - 08028 – Barcelona
Spain
Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, no 7
Poligono Industrial Miralcampo
19200 AZUQUECA DE HENARES (Guadalajara)
Spain
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
This leaflet was last revised in January 2014

Detailed information o n this m edicine i s av ailable o n t he E uropean Med icines A gency ( EMA) w eb
site: http://www.ema.europa.eu/

PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan/Hydrochlorothiazide 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.
2.
3.
4.
5.
6.

What Telmisartan/Hydrochlorothiazide is and what it is used for
What you need to know before you take Telmisartan/Hydrochlorothiazide
How to take Telmisartan/Hydrochlorothiazide.
Possible side effects
How to store Telmisartan/Hydrochlorothiazide
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 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 patients
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 (hypersensitive) to telmisartan or any other ingredients of this medicine (listed in
section 6),

if you are allergic (hypersensitive) 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.
-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.
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,
including medicines obtained without a prescription. 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.

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 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 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.
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.
Important information about some of the ingredients of Telmisartan/Hydrochlorothiazide
Telmisartan/Hydrochlorothiazide contains milk sugar (lactose). If you are intolerant to some sugars, consult
your doctor before taking Telmisartan/Hydrochlorothiazide.
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 usual dose of Telmisartan/Hydrochlorothiazide is one tablet a day. Try to take the 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.
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"), 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 in 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 can not be ruled out for Telmisartan/Hydrochlorothiazide.
Possible side effects of Telmisartan/Hydrochlorothiazide:
Common side effects (may affect 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, 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 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 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, 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 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, 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
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 national reporting system listed in Appendix
V*. 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 (sealed) package in order to protect the tablets from moisture
and light
Occasionally, the outer layer of the blister pack separates from the inner layer between the blister pockets.
You do not need to take any action if this happens.
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 25
mg hydrochlorothiazide.
The other ingredients are Mannitol, Povidone (Povidone K 25), Crospovidone, Magnesium Stearate,
Meglumine, Sodium Hydroxide, Lactose Monohydrate, Cellulose Microcrystalline, Hypromellose
(Hydroxipropylmethylcellulose), Sodium Starch Glycolate Type A, Magnesium Stearate and Ferric Oxide
Yellow (10E 172).
What Telmisartan/Hydrochlorothiazide looks like and contents of the pack
Telmisartan/Hydrochlorothiazide 80 mg/25 mg tablets are round bilayer tablets with white and yellow color.
Telmisartan/Hydrochlorothiazide is available in blisters packs containing 7, 10, 14, 28, 28x1, 30, 30x1, 50,
56, 84, 90, 90x1, 98, 100, 112, 126, 140, 154, 168, 182, 196 tablets.
Not all pack sizes may be available in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Liconsa, S.A.
Gran Vía Carlos III, 98
7th floor - 08028 – Barcelona
Spain
Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo, no 7
Poligono Industrial Miralcampo
19200 AZUQUECA DE HENARES (Guadalajara)
Spain
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
This leaflet was last revised in January 2014.
Detailed information o n this m edicine is available o n t he E uropean
Medicines Agency (EMA) web site: http://www.ema.europa.eu/

Expand view ⇕

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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