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What is Actelsar HCT is and what it is used
Actelsar 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 angiotensin II receptor antagonists. 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 attack, 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.
Actelsar HCT is used to treat hypertension (essential hypertension) in adults whose blood pressure is not adequately controlled when telmisartan is used alone.
2. What you need to know before taking Actelsar HCT
Do not take Actelsar 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 Actelsar HCT 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 Actelsar 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);
elevated levels of aldosterone (retention of water and salts 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;
the active ingredient hydrochlorothiazide may cause an unusual reaction leading to decreased vision and eye pain. These may be symptoms of increased intraocular pressure can occur within hours to weeks after the start of intake of Actelsar HCT. This can lead to permanent vision loss if left untreated.
You should tell your doctor if you think you are (or might become) pregnant. Actelsar HCT is not recommended in early pregnancy, and should 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, 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 when exposed to the sun with symptoms of sunburn (such as redness, itching, swelling, rash) that occur more often than usual.
In case of surgery or anesthesia, you should tell your doctor that you are taking Actelsar HCT.
Actelsar HCT may be less effective in lowering blood pressure in black patients.
Children and adolescents
Not recommended for use Actelsar HCT in children and adolescents up to 18 years.
Other medicines and Actelsar HCT
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. You may need your doctor may change the dose of these medicines or take other precautions. In some cases it may be necessary to stop taking one of the drugs. This applies especially to the medicines listed below, when used simultaneously with Actelsar HCT:
medicines containing lithium used to treat certain types of depression;
medications associated with low levels of potassium in your blood (hypokalemia) 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 medicines (eg digoxin) or medicines to control heart rhythm (eg quinidine, disopyramide);
drugs used in psychiatric disorders (e.g., thioridazine, chlorpromazine, levomepromazine);
other drugs used to treat high blood pressure, steroids, painkillers, drugs for treating cancer, arthritis and gout or additives with vitamin D.
Actelsar 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 Actelsar HCT.
The effect of Actelsar HCT may be reduced when administered with NSAIDs (nonsteroidal anti-inflammatory agents 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 Actelsar HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead Actelsar HCT. Actelsar 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.
Tell your doctor if you are breastfeeding or planning to breastfeed. Actelsar HCT is not recommended for mothers who are breastfeeding and your doctor may prescribe another treatment if you want to breastfeed.
Driving and using machines
Some people feel dizzy or tired when taking Actelsar HCT. If you feel dizzy or tired, do not drive or operate machinery.
3. How to take Actelsar HCT
Always take this medicine exactly as you have been told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
The recommended dose Actelsar HCT is one tablet daily. Try to take the tablet at the same time each day. You can take Actelsar HCT with or without food. The tablets should be swallowed with some water or soft drink. It is important to take Actelsar 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 Actelsar HCT
If you accidentally take too many tablets contact your doctor, pharmacist or nearest emergency center.
If you forget to take Actelsar HCT
If you forget to take a dose, do not worry. Take the dose as soon as you remember and then carry on as before. If you do not take your tablet on one day, take your normal dose 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 untreated, these reactions can be fatal. An increased incidence of sepsis was observed with telmisartan only, but can not be excluded in Actelsar HCT.
Possible side effects of Actelsar HCT:
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 blood potassium levels, 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 spasms, muscle pain, erectile dysfunction (inability to get or maintain 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 in which your 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 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.
Side effects reported for each individual component may be potential adverse reactions Actelsar HCT, even if not observed in clinical studies 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 the upper respiratory tract (eg sore throat, inflamed sinuses, common cold), urinary tract infections, decreased 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), increased number of certain white blood cells (eosinophilia), severe 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) **.
* The event may have accidentally or be associated with unknown mechanism currently.
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether the cause is telmisartan.
The following adverse reactions were reported in patients taking only hydrochlorothiazide:
Adverse reactions known (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 cells, reduced platelet count (thrombocytopenia); serious allergic reactions (eg hypersensitivity, anaphylactic reaction), decreased or loss of appetite; anxiety, dizziness, blurred vision or yellowing of vision, decreased vision and eye pain (possible signs of acute angle-closure glaucoma), inflammation of the blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of skin or eyes (jaundice) syndrome similar to lupus (a condition resembling a disease called systemic lupus erythematosus where the body's own 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, the presence of glucose in the urine (glycosuria) fever, electrolyte imbalance, elevated blood cholesterol levels, 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 Actelsar HCT
Keep out of reach 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.
Al / Al blisters and HDPE packaging for tablets
This medicinal product does not require any special storage conditions.
Al / PVC / PVDC blister
Do not store above 30 ° C.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Actelsar HCT
The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12,5 mg hydrochlorothiazide.
The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).
Actelsar HCT looks like and contents of the pack
Actelsar HCT 80 mg / 12,5 mg tablets are white or almost white, 9,0 x 17,0 mm, capsule-shaped tablets marked "TH 12,5" on both sides.
Blister packs: 14, 28, 56, 84, 90 and 98 tablets.
Tablet: 30, 90 and 250 tablets.
Not all pack sizes may be marketed.
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