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TELFORT 80 mg. / 5 mg. 28 tablets

Product Code: TELFORT 80 mg. / 5 mg. 28 tablets
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What Telfort and what it is used
Telfort contains two active substances called telmisartan and amlodipine. Both substances help to control your high blood pressure:
- Telmisartan belongs to a group of medicines called "angiotensin receptor antagonists II" Angiotensin II is a substance produced in the body which causes constriction of blood vessels, thereby increasing blood pressure. Telmisartan works by blocking the effect of angiotensin II.
- Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine stops entry of calcium into the blood vessel wall, which prevents the blood vessels to narrow.
This means that both substances prevent the narrowing of the blood vessels. As a result, blood vessels relax and blood pressure is lowered
2. What you need to know before taking Telfort
Do not take Telfort
• If you are allergic to amlodipine or to dihydropyridine derivatives to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant after the third month (better to avoid the use of telephones in early pregnancy - see pregnancy section.)
• If you have severe liver problems or biliary obstruction (problems with the broadcast of bile from the liver and gall bladder).
• If you have very low blood pressure (hypotension), including shock (a condition where your heart can not supply enough blood to the body).
• If you suffer from reduced cardiac stroke volume because of a serious heart problem
• If you have diabetes or impaired kidney function and you are treated with medication to lower blood pressure containing aliskiren
If any of these apply to you, tell your doctor or pharmacist before taking Telfort.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Telfort. Tell your doctor if you suffer or have ever suffered from any of the following conditions or illnesses:
• Kidney disease or kidney transplant
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• Liver disease
• Increased levels of aldosterone (retention of water and salt in the body, accompanied by disturbed levels of various minerals in the blood)
• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or low salt due to treatment with diuretics ( "water pills"), a diet low in salt, diarrhea or vomiting
• Increased levels of potassium in the blood
• Diabetes
• narrowed aorta (aortic stenosis)
• Heart attack (within the past four weeks)
• Heart failure
• steep and rapid increase in blood pressure (hypertensive crisis)
• You are elderly and your dose should be increased
Talk to your doctor before taking Telfort:
• If you are taking any of these medicines used to treat high blood pressure:
? ACE - inhibitor (such as enalapril, lisinopril, ramipril), especially if you have kidney problems associated with diabetes.
? aliskiren.
Your doctor may regularly monitor kidney function, blood pressure and levels of electrolytes (eg. Potassium) in the blood.
See also the information titled "Do not take Telfort."
• If you take digoxin.
Tell your doctor if you are pregnant or are planned. Telfort 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).
In case of surgery or anesthesia, you should tell your doctor that you are taking Telfort.
Telfort may be less effective in lowering blood pressure in black patients.
Children and adolescents
There is no experience in the use of Telfort in children (under 18 years). So do not give this medicine to children and adolescents.
Other medicines and Telfort
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
You may need your doctor may change your dose and / 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 Telfort:
• Lithium (a medicine for mental illness)
• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in the blood)
• NSAIDs (nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen)
• Corticosteroids
• Heparin (a medicine for blood clotting)
• Immunosuppressants (such as cyclosporine or tacrolimus)
• Diuretics ( "water pills")
• ACE inhibitor or aliskiren (used to treat high blood pressure) (see also the information titled "Do not take Telfort" and "Warnings and Precautions")

You should tell your doctor if you think you are (or might become) pregnant.
Usually, your doctor will advise you to stop taking Telfor and before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telfort. Telfort is not recommended in early pregnancy and must not be taken if you are pregnant after the third month, as it may cause serious harm to your baby after the third month of pregnancy.
Tell your doctor if you are breastfeeding or planning to breastfeed. Telfort is not recommended for mothers who are breastfeeding and your doctor may prescribe another treatment if you want to breastfeed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Telfort can affect your ability to drive and use machines. If Telfort makes you feel sick, dizzy or tired, or cause you headaches, do not drive or operate machinery and contact your doctor immediately.
Telfort contains sorbitol.
If your doctor has told you that you have an intolerance to some sugars, consult your doctor before you start taking this medicine.
3. How to take Telfort
Always take this medicine exactly as you told your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
Telfort recommended dose is one tablet daily. Try to take the tablet at the same time each day. You can take Telfort with or without food. The tablets should be swallowed with some water or soft drink.
If your liver is not working properly, the usual dose should not exceed 40 mg / 10 mg once daily.
If you take more than the amount Telfort
Taking too many tablets may cause a decrease in blood pressure or even lower the blood pressure to a dangerously low level. You may feel dizziness, vertigo, fatigue or weakness. If the drop in blood pressure is very severe, may occur shock.
You may feel your skin cold and damp and lose consciousness. If you take too many tablets, seek medical advice immediately.
If you forget to take Telfort
If you forget to take a tablet, take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you stop taking Telfort
Your doctor will advise you how long to take your medicine. Your condition may return if you stop taking your medicine before you are advised to do so.
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.
Visit your doctor immediately if you experience any of these side effects while taking this medicine:
• swelling of the eyelids, face or lips
• Swelling of the tongue and throat, causing difficulty in breathing
• Sudden wheezing, chest pain, shortness of breath or difficulty breathing, low blood pressure
• Severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson) or other allergic reactions
• Heart attack, abnormal heart rhythm
• Inflammation of the pancreas, which can cause severe pain in the abdomen or back, accompanied by a serious ailment
• Sepsis * (often called "blood poisoning" - severe infection with inflammation throughout the body)

Other possible side effects
As Telfort is a combination of two active substances reported adverse reactions may be associated or to amlodipine or telmisartan.
Adverse reactions associated with the use of telmisartan:
Uncommon (may affect up to 1 in 100 patients):
• Urinary tract infections,
• Infections of the upper respiratory tract (eg sore throat, inflamed sinuses, common cold)
• Reduced number of red blood cells (anemia)
• Increased levels of potassium in the blood
• Difficulty falling asleep
• Feelings of sadness (depression)
• Fainting (syncope)
• A feeling of spinning (vertigo)
• Slow heart rate (bradycardia)
• Low blood pressure (hypotension)
• dizziness upon standing (orthostatic hypotension)
• Shortness of breath
• Abdominal pain, diarrhea, stomach discomfort, bloating, vomiting
• Itching, increased sweating, rash
• Back pain
• Muscle cramps, muscle pain (myalgia)
• Renal impairment including acute renal failure
• Feeling weak
• Increased level of creatinine in the blood.
Rare (may affect up to 1 in 1000 patients):
• Increased number of certain white blood cells (eosinophilia), low platelet count, which can cause unusual bruising or bleeding easily.
• low blood sugar levels (in diabetic patients)
• Anxiety
• Sleepiness
• Visual disturbances
• Increased heart rate (tachycardia)
• Dry mouth, upset stomach
• Abnormal liver function (in Japanese patients are more likely to experience this side effect)
• eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash
• Pain in the joints (arthralgia), pain in extremity, tendon pain
• Flu-like illness
• decreased hemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Very rare (may affect up to 1 in 10,000 people):
• Progressive scarring of lung tissue (interstitial lung disease). **
* Event may be a chance finding or related to a mechanism that is not known for the moment.
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan. However, it is not known whether the cause is telmisartan.
Adverse reactions associated with the use of amlodipine:
The following very common and common side effects were reported. Contact your doctor if any of them appear to you or reactions last longer than a week.
Very common (may affect more than 1 in 10 people):
• Swelling (edema)
Common (may affect up to 1 in 10 people):
• headache, dizziness, sleepiness (especially at the beginning of treatment), palpitations (feeling your heartbeat), flushing, abdominal pain, feeling sick (nausea)
• disturbed mode stool, diarrhea, constipation, indigestion, fatigue, weakness
• swollen ankles, muscle cramps, visual disturbances, double vision.
Other reported side effects are:
Uncommon (may affect up to 1 in 100 people):
• mood swings, anxiety, depression, insomnia,
• tremor, taste disturbance, seizures,
• numbness or tingling sensation in the limbs, loss of sensitivity to pain
• ringing in the ears,
• low blood pressure,
• stuffy or runny nose caused by inflammation of the lining of the nose (rhinitis)
• cough
• dry mouth, nausea,
• hair loss, increased sweating, itchy skin, red spots on the skin, change in skin color,
• disorders urinating, the need to urinate during the night, increased urinary frequency,
• inability to obtain an erection (impotence); discomfort or enlargement of breasts in men
• pain, malaise,
• muscle or joint pain, back pain,
• weight gain or weight loss.
Rare (may affect up to 1 in 1000 people):
• confusion.
Very rare (may affect up to 1 in 10,000 people):
• reducing the number of white blood cells, decrease in platelets, which can lead to unusual bruising or bleeding easily (breakdown of red blood cells)
• elevated blood sugar (hyperglycemia)
• nerve disorder that can cause weakness, tingling or numbness,
• swelling of the gums,
• unusual bloating (gastritis)
• impaired liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes, which may affect some medical tests
• increased muscle tone,
• inflammation of blood vessels, often with skin rash (vasculitis)
• sensitivity to light,
• violations including rigidity, tremor (shaking) and / or impaired movement.
How to store Telfort
Keep out of reach of children.
Do not store above 25 "C in the original package to protect from light.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of your medications. These measures will help to protect the environment.
6. Contents of the pack and other information
What Telfort
The active substances are telmisartan and amlodipine. Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate).
The other ingredients are sorbitol (E420), sodium hydroxide, povidone 25, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, meglumine, magnesium stearate.
Telfort looks like and contents of the pack
Telfort of 80 mg / 5 mg tablets are off-white to yellowish, oblong, biconvex tablet size 18,5 x 8,5 mm and an inscription "80" "5" decorative feature on one side. The scoreline is not intended to divide the tablet.
Pack size: 14.28, 30, 56, 90, 98 tablets.
Not all pack sizes may be marketed.

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