TOLUCOMBI 80 mg. 30 tablets
Tolucombi 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 belongs to 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 to verify if it is within normal limits.
Tolucombi is used to treat hypertension (essential hypertension) in adults whose blood pressure is not adequately controlled, if telmisartan is used alone.
Tolucombi used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled Tolucombi 80 mg / 12.5 mg or in patients who have already been stabilized by the independent use of telmisartan and hydrochlorothiazide.
2. What you need to know before you take Tolucombi
Do not take Tolucombi:
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 Tolucombi 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 the blood, which do not respond to treatment.
Tell your doctor or pharmacist before taking Tolucombi, 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);
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;
active ingredient hydrochlorothiazide may cause atypical reactions, resulting in reduced vision and eye pain. These may be symptoms of increased pressure in your eye can occur from a few hours to weeks of taking Tolucombi. If left untreated, it can cause permanent vision loss.
You should tell your doctor if you think you are (or might become) pregnant. Tolucombi 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 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, muscle fatigue and palpitations (more than 100 beats per minute). You should tell your doctor if you experience any of these symptoms.
You should tell your doctor if you experience an increased sensitivity of the skin to sun exposure, with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more frequently than usual.
In case of surgery or anesthesia, you should tell your doctor that you are taking Tolucombi.
Tolucombi may be less effective in lowering blood pressure in black patients.
Children and adolescents
Not recommended for use Tolucombi in children and adolescents up to 18 years.
Other medicines and Tolucombi
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 Tolucombi:
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.
Tolucombi 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 Tolucombi.
The effect of Tolucombi may be reduced when administered with an NSAID (nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen).
Pregnancy and lactation
You should tell your doctor if you think you are (or might become) pregnant. Usually, your doctor will advise you to stop taking Tolucombi before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Tolucombi. Tolucombi 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.
Tell your doctor if you are breastfeeding or plan to breastfeed. Tolucombi not recommended for mothers who are breastfeeding, and your doctor may prescribe other treatments if you want to breastfeed.
Driving and using machines
Some people feel dizzy or tired when taking Tolucombi. If you feel dizzy or tired, do not drive or operate machinery.
Tolucombi contains lactose and sorbitol.
If you have an intolerance to some sugars, consult your doctor before you start taking Tolucombi.
3. How to take Tolucombi
Always take Tolucombi exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Tolucombi recommended dose is one tablet daily. Try to take the tablet at the same time each day. You can take Tolucombi with or without food. The tablets should be swallowed with some water or other soft drink. It is important to take Tolucombi 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 dose Tolucombi
If you accidentally take too many tablets, contact your doctor, pharmacist or nearest emergency center.
If you forget to take Tolucombi
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 product, 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 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 Tolucoinbi.
Possible side effects of Tolucombi
Common side effects (may affect up to 1 in 10 people):
Uncommon side effects (may affect up to 1 in 100 people):
Decreased levels of potassium in the blood, anxiety, fainting (syncope), sensation of tingling and numbness in the extremities (paraesthesia), dizziness (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when standing, 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 up to 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) , insomnia, visual disturbances, 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 response), rapid swelling of the skin and mucous membranes, which can lead to death (angioedema also with fatal outcome), redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), 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.
Side effects reported for each component may be potential adverse reactions Tolucombi, even if not observed in clinical trials for this product.
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 upper respiratory tract infections (eg sore throat, inflamed sinuses, common cold), urinary tract infection, reduced number of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute renal failure, weakness, cough.
Rare side effects (may affect up to 1 in 1000 people):
Sepsis * (often called "blood poisoning" is a severe infection with an inflammatory process in the whole 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, eczema (a skin disorder), 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. However, it is not known whether the cause is telmisartan.
The following adverse reactions were reported in patients taking only hydrochlorothiazide.
Side effects with unknown frequency (from the available data can not be made assessment of 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), 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), a syndrome similar to lupus (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 with your doctor or pharmacist. This includes any possible effects not listed in this leaflet.
5. How to store Tolucombi
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton after "EXP:" The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. Store in the original package in order to protect from light.