Summary of product characteristic
TELBLOCK
Telmisartan Tablets 40 mg
Prescription drug
Read the leaflet carefully before using.
Keep this medicine out of the sight and reach of children.
Immediately notify your doctor or pharmacist of adverse reactions encountered when using medicine.
INGREDIENTS AND CONTENT
Each tablets contains
Active ingredientst
TELBLOCK (Telmisartan Tablets 40 mg): Telmisartan .....................40 mg
Excipients just enough: Sodium hydroxide, mannitol 160C, microcrystalline cellulose 101, crospovidone XL, Silica K200, magnesium stearate, talc.
DESCRIPTION ABOUT PRODUCT
TELBLOCK (Telmisartan Tablets 40 mg):
Tablets are white, rounded, beleved, 2 flat surfaces, one surface with “H” word, the other with grooves, intact edge and walls.
PACKAGING
TELBLOCK (Telmisartan Tablets 40 mg): Box of 10 blisters x 10 Tablets.
WHAT IS THE MEDICINE USED FOR
Telblock belongs to the group of angiotensin II receptor. Angiotensin II is a compound produced in the body that narrows the blood vessels, thus increasing the pressure. Telblock prevent the action of angiotensin II, so blood vessels dilate, and finally blood pressure drops.
Telblock is used to treat primary hypertension in adults. Primary means that blood pressure increases without any reason.
Hypertension, it left untreated, can cause damage to blood vessels in many organs, which can lead to heart attack, heart failure or kidney failure, stroke or bindless. There are usually no symptoms of hypertension before the appearance of lesions. Therefore, regular blood pressure measurement is very important to determine blood pressure within the normal range.
Telblock also used to reduce cardiovascular problems (as heart attack or strokes) in adults who are at the risk for reduced blood supply to heart or leg or blocked or have had a stroke or high risk diabetes. Your doctor may tell you if you are at high risk for these disease.
HOW TO TAKE THIS MEDICINE AND DOSAGE
How to use:
Always take the medication exactly as the doctor told you. See your doctor or pharmacist if you unsure about the dosage and how to use.
Telblock tablets are taken once daily, trying to drink at the same time each day. Drink until your doctor tell you to stop. Should drink with water or non-alcoholic drinks, can drink when hungry or full.
Only take the medicine out of the blister when started drinking because of the moisute absorption of the tablet.
Dosage:
- In treatment of high blood pressure, Telblock doses for most patients are 40 mg once daily to control blood pressure for 24 hours. Doctor may recommend lower doses of 20 mg once a day or higher than 80mg once a day, depending on your level of response. If you notice that the impact of Telblock is too strong or too weak, tell your doctor immediately.
Telblock also used to combination with diuretics such as hydrochlorothiazide can significantly reduce blood pressure.
- In prevention of cardiovascular disease, the usual dose is 80 mg once a day. At the start of treatment with Telblock, blood pressre should be checked. If your liver is not working effectively, the usual dose should not be up to 40 mg once a day.
WHEN SHOULD NOT TAKE THIS MEDICINE
- If you allergic with Telmisartan or any of ingredients of the medicine.
- If you are pregnant more than 3 months.
- If you have a serious about liver such as cholestasis or bile duct obstruction or any severe liver disease.
- If you are diabetes or impaired renal fuction and you are being treated with an antihypertensive drug that contains aliskiren.
If any of the above applies to you, inform for you doctor or pharmacist before using Telblock.
UNDESIRABLE EFFECTS
Like other drug, Telblock can cause some undesirable effects, although not all patients will experientce it.
Some side effects may be serious and need immediate medical intervention is required:
You should meet a doctor immediately if you have any signs:
Sepsis is a seriuous infection with a general inflammatory reaction, swelling of the skin and the mucous membranes is rapid, these side effects are rare (may affect 1 in 1000 people) but extremely dangerous, patients should stop the drug and see the doctor immediately. If these side effects are not treated promptly, the patient may be die.
Undesirable effects of Telblock:
Common (affects 1 in 10 people):
- Low blood pressure in patients taking Telblock to prevent cardiovascular disease.
Less common (1 in 100 people)
- Urinary tract infections, upper respriatory tract infections (such as sore throat, swollen sinusitis, colds, red blood deficiency (anemia), high blood potassium levels, difficulty falling asleep, depression, dizziness, bradycardia, low blood pressure, abdominal pain, diarrhea, vomiting, itching, sweating, back pain, muscle cramps, kidney failure including acute kidney failure, chest pain, weakness, increased creatinin blood.
Rare (1 in 1 000 people):
- Sepsis, increased leukocytes, decreased platelet count, severe allergic reactions, allergic reactions (such as redness, itching, difficulty breathing, swelling of the face, low pressure blood) hypoglycaemia, felling anxious, sleepiness, decreased vision, tachycardia, dry mouth, dyspepsia, decreased taste, abnormal liver function (high jananese ability to appear undesirable effects), swelling skin, mucous membranes can lead to death, eczema, redness, hives, pain in the ligaments, pain as the flu, decreased haemoglobin, elevated uric acid levels, evelated liver enzymes, or creatinin phosphokinase in blood.
Very rare (1 in 10 000 people):
- Development of scar tissue in the lung (interstitial lung disease)
Report on undesirable effects
If you experience any undesirable effects, inform your doctor or pharmacist immediately. Include undesirable effects that appear outside of the signs listed above.
AVOID TAKING MEDICATION OR FOOD WHEN USING MEDICATION
Talk to your doctor or pharmacist if you are taking or have recently taken or may have taken any other medicine. Your doctor may change the dose of these medications or add some notes. In some cases, you may have to stop taking one of them. This is especially applicable to the drugs listed below when used at the same times as Telblock:
- Lithium and other drugs for depression.
- Medications that increase potassium include salt supplements, diuretics that reduce potassium excretion, ACE inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAID) such as aspirin or ibuprofen, heparin, immunosuppressants such as cyclosporin or tacrolimus, trimethoprim antibiotic.
- Diuretics, especially when taken high doses at the same time with Telblock, can lead to loss of water and low blood pressure.
- If you are taking an ACE inhibitor or aliskiren.
- Digoxin.
The effectiveness of Telblock can be reduced by taking NSAID (such as aspirin or ibuprofen) or corticosteroid.
Telblocks can enhance the blood pressure lowering effect of high blood pressure medications or medications with potential for lowering blood pressure (such as baclofen, amifostine). In addition, low blood pressure can be aggravated by alcohol, barbiturat, anesthetic drugs or drugs for depression. You may notice this when you have dizziness when standing up. You should meet doctor and ask for advice if you need to adjust the dose of other medicine while taking Telblock.
Pregnant women
You must tell your doctor if you think you are (or may be) pregnant. Doctor will advise you to stop treatment with Telblock before you become pregnant or as soon as you know you are pregnant and will advise you to take other medicines instead of Telblock. Telblock is not recommended for use in early stages of pregnancy, and is contraindicated during pregnancy for more 3 months because it can adverse effects on the fetus.
Breastfeeding women
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Telblock is not recommended for use in the women who are breastfeeding and the doctor may decide other treatments for you if you want to breastfeed, especially when your baby is young or premature.
Drive or operate machinery
Some people will feel dizzy or tired while taking Telblock. If you feel dizzy or tired, do not drive or operate machinery.
Telblock contains mannitol
If you do not tolerate some sugars, consult your doctor before taking.
WHAT TO DO WHEN ONE TIME FORGETS TO TAKE MEDICINE
If you forget to take a dose, do not worry. Take your medication as soon as you remember and continue as usual. If you forget to take the medicine one day, take the next dose in the next day. Do not take twice dose to make up for the missed dose.
Contact for your doctor or pharmacist if you have any questions.
IF YOU STOP TAKING MEDICINE
Do not stop the drug if not notified to the doctor or pharmacist first.
If you have any questions regarding the use of this medicine, ask your doctor or pharmacist.
STORAGE
Store in sealed, dry place, temperature below 30oC.
SIGNS AND SYMPTOMS OF OVERDOSE
Notify for your doctor or pharmacist immediately if have any abnormal signs.
WHAT TO DO WHEN OVERDOSE IS RECOMMENDED
If you accidentally take too many pills, contact your doctor of pharmacist or contact the nearest hospital emergency department immediately.
CAUTIONS WHEN TAKING THIS MEDICINE
Inform for your doctor if you have had or have any following abnormal signs:
- Kidney disease and kidney transplant.
- Renal artery stenosis
- Liver failure
- Heart problem
- Increased levels of aldosterone (a hormone that have a role in keeping salt and water together with an imbalance of mineral salts in the body).
- Low blood pressure, is likely to occur if you are dehydrated or deficient in salt due to treatment with diuretics, meal lack of salt, diarrhea, or vomiting.
- Increased blood potassium
- Diabetes
Inform for your doctor before taking Telblock:
- If you are taking any of the following medications to treat high blood pressure:
+ ACE inhibitors (eg: enalapril, lisinopril, ramipril), especially if there are kidney problems related to diabetes.
+ Aliskiren. Doctor may check for renal function, blood pressure and electrolyte (eg: otassium) periodically in your blood.
+ If you are taking digoxin
- You must tell your doctor if you think you are or may be pregnant. Telblock is not recommended in the early stages of pregnancy, and do not drink if pregnancy more than 3 months, it may be harmful to the fetus if used in this stage.
- In case of surgery or anesthesia, you should inform your doctor that you are using Telblock.
- Telblock may be less effective in blacks.
WHEN TO CONSULT A DOCTOR, PHARMACIST
When you have any undesirable effects of medicine, no treatment response or symptoms become worse. Consult your doctor or pharmacist for more information.
SHELF LIFE
24 months from manufacturing date.
Manufactured by:
HERA BIOPHARMACRUTICAL CO. LTD.
Lot A17, Tu Ha Industrial zone, Tu Ha Ward, Huong Tra Town, Thua Thien Hue Province, Viet Nam.
© 2016 Hera Biopharm. All Rights Reserved. Designed By Herabiopharm
11.png)
.jpg)
.jpg)
.jpg)
.jpg)