TANYDON HCT 80 mg. / 12.5 mg. 30 tablets

What is Tanydon HCT and what it is used
Tanydon HCT is a combination of two active substances in one tablet - telmisartan and hydrochlorothiazide. Both substances help to control high blood pressure.
Telmisartan belongs to a group of medicines called receptor antagonists of angiotensin II. Angiotensin II is a substance produced in your body which causes blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax and blood pressure is lowered.
Hydrochlorothiazide is a group of medicines called thiazide diuretics, which cause an increase in urine output, leading to a lowering of your blood pressure.
If left untreated, high blood pressure can damage blood vessels in several organs, which can sometimes lead to heart attacks, heart or kidney failure, stroke and blindness. Symptoms due to high blood pressure, are not usually observed before damage occurs. It is therefore important to regularly measure blood pressure in order to check the date it was within normal limits.
Tanydon HCT is used to treat hypertension (essential hypertension) in adults whose blood pressure is not adequately controlled, if telmisartan is used alone.

2. What you need to know before taking Tanydon HCT
Do not take Tanydon HCT:
if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6);
if you are allergic to hydrochlorothiazide or other medicines derived from sulfonamides;
if you are pregnant after the third month (better to avoid the use of Tanidon HCT in early pregnancy - see "Pregnancy");
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 suffer from severe kidney disease;
if your doctor determines that you have low potassium levels or high calcium levels in the blood, which do not improve with treatment.
Tell your doctor or pharmacist before taking Tanydon HCT if any of the above applies to you.

Warnings and Precautions
Talk to your doctor if you have 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), a diet low in salt, diarrhea, vomiting or hemodialysis;
kidney disease or kidney transplant;
renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
liver disease;
heart problems;
diabetes;
gout;
elevated levels of aldosterone (retention of water and salt in the body, accompanied by imbalance of other minerals in the blood);
systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the immune system attacks its own body.
You should tell your doctor if you think you are (or might become) pregnant.
Tanidon HCT is not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to your baby if used at that stage (see "Pregnancy").
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, muscle fatigue and palpitations (more than 100 beats per minute). You should tell your doctor if you experience any of these symptoms.
You should also tell your doctor if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (eg. Redness, itching, swelling, blistering) occurring more frequently than usual.
In case of surgery or anesthesia, you should tell your doctor that you are taking Tanidon HCT.
Tanidon HCT may be less effective in lowering blood pressure in black patients.

Children and adolescents
Not recommended for use Tanydon HCT in children and adolescents up to 18 years.

Other medicines and Tanydon HCT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. May be necessary for your doctor to change the dose of these medicines or take other precautions. In some cases it may be necessary to stop taking one of the medicines. This is particularly true for the drugs listed below, when used simultaneously with Tanidon NBT:
drugs containing lithium used to treat certain types of depression;
Medicines associated with low blood potassium (hypokalaemia) such as other diuretics (water tablets), laxatives (eg castor oil), corticosteroids (such as prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treatment of mouth ulcers), penicillin G sodium (an antibiotic), salicylic acid and its derivatives;
potassium-sparing diuretics, potassium supplements, potassium containing salt substitutes, ACE inhibitors that may increase the level of potassium in the blood;
heart drugs (e.g. digoxin) or medicines to control heart rhythm (e.g., quinidine, disopyramide);
drugs used in mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine);
other drugs used to treat high blood pressure, steroids, analgesics, drugs for treating cancer, arthritis and gout or supplements with vitamin D.
Tanidon HCT may increase the effect of lowering blood pressure other medicines and you should consult with your doctor if you need to adjust the dose of the other medicine while taking Tanidon HCT.
The effect of Tanidon HCT may be reduced when administered with an NSAID (nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen).

Pregnancy and lactation
Pregnancy
You should tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Tanidon HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Tanidon HCT. Tanidon HCT is not recommended during pregnancy and should not be taken if you are pregnant after the third month, 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 plan to breastfeed. Tanidon HCT is not recommended for use by mothers who are breastfeeding, and your doctor may prescribe other treatments if you want to breast-feed, especially if your baby is newborn, or born prematurely.

Driving and using machines
Some people feel dizzy or tired when taking Tanydon HCT. If you feel dizzy or tired, do not drive or operate machinery.

3. How to take Tanydon HCT
Always take Tanidon HCT exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Tanidon HCT is one tablet daily. Try to take the tablet at the same time each day. You can take Tanidon HCT with or without food.
The tablets should be swallowed with some water or other soft drink. It is important to take Tanidon HCT 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 daily.

If you take more than the amount of HCT Tanidon
If you accidentally take too many tablets, contact your doctor, pharmacist or nearest emergency center.

If you forget to take Tanydon HCT
If you forget to take a dose, do not worry. Take it as soon as you remember and then carry on as usual. 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 the missed 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 require immediate medical attention.
Tell your doctor if you experience any of the following symptoms:
Sepsis * (often called "blood poisoning", is a severe infection with inflammation throughout the body), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1000 people) but very serious. Patients should stop taking the drug immediately and consult a doctor. If not treated, these reactions can be fatal. Increased incidence of sepsis was observed with telmisartan only, but can not be excluded in Tanidon HCT.
Possible side effects to Tanidon HCT:
Common side effects (may affect up to 1 in 10 people): Vertigo.

Uncommon side effects (may affect up to 1 in 100 people): Decreased blood potassium levels, anxiety, fainting (syncope), sensation of tingling and numbness (paresthesia), dizziness (vertigo), fast heart beat (tachycardia) heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when standing up, shortness of breath (dyspnoea), diarrhea, dry mouth, flatulence, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to get or keep an erection ), chest pain, increased levels of uric acid in the blood.

Rare side effects (may affect less than 1 in 1000 people): inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body's own immune system attacks the body, which causes joint pain, skin rash and fever), sore throat, inflamed sinuses, feeling sad (depression), difficulty sleeping (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), nausea, inflammation of the stomach (gastritis) , abnormal liver function (in Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucous membranes, which can lead to death (angioedema also with fatal outcome), redness 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 sodium , increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.

Adverse reactions reported for each component may be potential adverse reactions Tanidon HCT even if not observed in clinical trials for this product.
Telmisartan
The following additional adverse reactions were reported in patients taking telmisartan alone:
Uncommon side effects (may affect up to 1 in 100 people): infection of the upper respiratory tract infection (eg sore throat, inflamed sinuses, common cold), urinary tract infection, reduced number of red blood cells (anemia), high levels of potassium, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.

Rare side effects (may affect less than 1 in 1000 people): sepsis * (often called "blood poisoning", is a severe infection with inflammation throughout the body, which can lead to death), low platelet count ( thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reactions (eg hypersensitivity, anaphylactic reaction, drug rash), reduced blood sugar levels (in diabetic patients), upset stomach, skin disorders (including eczema, medicinal rash, toxic skin eruption), arthrosis, inflammation of the tendons, decreased hemoglobin (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). **
* Event may be a chance or could be related to a mechanism currently unknown.
** Cases of progressive scarring of lung tissue have been reported during administration of telmisartan. It is unknown, however, whether the cause is telmisartan.

Hydrochlorothiazide
The following additional adverse reactions have been reported in patients receiving hydrochlorothiazide only:
Side effects with unknown frequency (based on available data can not assess the frequency): inflammation of the salivary glands, low blood counts, including low red and white blood cell count, low platelet count (thrombocytopenia); serious allergic reactions (eg hypersensitivity, anaphylactic reaction), varying levels of blood sugar - if you suffer from diabetes, 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 in which the immune system attacks its own 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, the presence of glucose in the urine (glycosuria) fever, electrolyte imbalance, increased levels of cholesterol in the blood, decreased blood volume, increased levels of glucose or lipids in the blood.

If you get any side effects, tell your doctor or pharmacist. This includes any possible effects not listed in this leaflet.

5. How to store Tanydon HCT
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton, blister or bottle label after "EXP". The expiry date refers to the last day of that month.