Exforge 5 mg/80 mg film-coated tablets Amlodipine,Valsartan - United Kingdom[英国药品]

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Exforge 5 mg/80 mg film-coated tablets Amlodipine,Valsartan

2013-11-02 17:08:47 来源: 作者: 【大中小】浏览:445次评论:0条

For doctors

What is it and how is it used?

Exforge tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure.

Exforge is used to treat high blood pressure in patients whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.

What do you have to consider before using it?

Do not take Exforge

Take special care with Exforge

You must tell your doctor if you think that you are ( or might become) pregnant. Exforge is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see section Pregnancy).

The use of Exforge in children and adolescents is not recommended.

Also tell your doctor if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor may need to change the dose or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below:

Taking Exforge with food and drink
You can take Exforge with or without food.

Exforge and older people
Caution is required when increasing the dosage.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are ( or might become) pregnant. Your doctor will normally advise you to stop taking Exforge before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge. Exforge is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Exforge is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine may make you feel dizzy. This can affect how well you can concentrate. So, if you are not sure how this medicine will affect you, do not drive, use machinery, or do other activities that you need to concentrate on.

How is it used?

Always take this medicine exactly as your doctor has told you. You should check with your doctor if you are not sure. This will help you get the best results and lower the risk of side effects.

The usual dose of Exforge is one tablet per day.

Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you take more Exforge than you should
If you have taken too many tablets of Exforge, or if someone else has taken your tablets, consult a doctor immediately.

If you forget to take Exforge
If you forget to take this medicine, take it as soon as you remember. Then take your next dose at its usual time. However, if it is almost time for your next dose, skip the dose you missed. Do not take a double dose to make up for a forgotten tablet.

What are possible side effects?

Like all medicines, Exforge can cause side effects, although not everybody gets them.

Some side effects can be serious:
A few patients have experienced these serious side effects (affecting less than 1 in 1,000 patients). If any of the following happen, tell your doctor straight away:
Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, light-headedness).

Other possible side effects:
Common (affecting less than 1 in 10 patients): Influenza; blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; redness and warm feeling of the face and/or neck.
Uncommon (affecting less than 1 in 100 patients): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Rare (affecting less than 1 in 1,000 patients): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light-headedness; excessive sweating; skin rash all over your body; itching; muscle spasm. If any of these affect you severely, tell your doctor.

Side effects with amlodipine or valsartan alone which can be serious:
These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data

Amlodipine Common: Vomiting.
Uncommon: Hair loss; change in bowel habits, feeling bloated, indigestion, stomach discomfort after meal; stomach pain, nausea; bleeding, tender or enlarged gums; breathlessness; breast enlargement in men; runny or stuffy nose, sneezing; yellow skin and eyes, nausea, loss of appetite, light-coloured urine; high level of sugar in the blood; inability to achieve or maintain an erection; increased need to pass urine; fever, sore throat or mouth ulcers due to infections; mood swings; muscle pain; sensation of numbness or tingling in fingers and toes; severe upper stomach pain; spontaneous bleeding or bruising; rash, purplish-red spots, fever, itching; swelling mainly of the face and throat; skin reddening, blistering of lips, eyes or mouth, skin peeling.
Rare: Crushing chest pain, irregular heart beat, angina pain.
Very rare: Yellowing of the skin and eyes, changes in the results of some liver function tests; purple skin patches, rash and itching, stiff limbs, trembling hands

Valsartan Not known: Decrease in red blood cells, fever, sore throat or mouth sores due to infections, spontaneous bleeding or bruising, high level of potassium in the blood, abnormal liver test results, decreased renal functions and severely decreased renal functions, swelling mainly of the face and the throat, muscle pain, rash, purplish-red spots, fever, itching, allergic reaction.

If you experience any of these, tell your doctor straight away.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.
Do not use Exforge after the expiry date stated on the carton and blister.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use any Exforge pack that is damaged or shows signs of tampering.

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For doctors

What is it?

Exforge is a medicine that contains two active substances, amlodipine and valsartan. It is available as tablets (dark yellow and round: 5 mg amlodipine and 80 mg valsartan; dark yellow and oval: 5 mg amlodipine and 160 mg valsartan; light yellow and oval: 10 mg amlodipine and 160 mg valsartan).

What is it used for?

Exforge is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone. ‘Essential’ means that the hypertension has no obvious cause. Exforge is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group. The medicine can only be obtained with a prescription.

How is it used?

Exforge is taken by mouth as one tablet once a day with some water, with or without food. The dose of Exforge to be used depends on the doses of amlodipine or valsartan that the patient was taking before. The patient may need to take separate tablets or capsules before switching to the combination tablet. Exforge should be used with caution in patients who have problems with their liver or biliary obstructive disorders (problems with the elimination of bile).

How does it work?

Exforge contains two active substances, amlodipine and valsartan. Both are anti-hypertensives that have been available separately in the European Union (EU) since the mid-1990s. They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced. Amlodipine is a calcium channel blocker. It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells. When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax. Valsartan is an ‘angiotensin II receptor antagonist’, which means that it blocks the action of a hormone in the body called angiotensin II. Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels). By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen.

How has it been studied?

Because amlodipine and valsartan have been used for many years, the company presented information on the two substances from earlier studies and the scientific literature, as well as new studies that used a combination of the two active substances.
Five main studies involving nearly 5,200 patients, mostly with mild to moderate hypertension, were carried out. Two studies (involving almost 3,200 patients) compared the effectiveness of amlodipine, valsartan or a combination of both substances with the effectiveness of placebo (a dummy treatment). Two studies (involving 1,891 patients) compared the effects of the combination in patients whose hypertension was not adequately controlled with either 10 mg amlodipine or 160 mg valsartan. The fifth, smaller study compared the effectiveness of the combination with that of lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension. In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats). The blood pressure was measured in ‘millimetres of mercury’ (mmHg).
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Exforge and people taking the separate medicines.

What benefits has it shown during the studies?

The combination of amlodipine and valsartan was more effective at reducing blood pressure than placebo or either valsartan or amlodipine taken alone. In the studies comparing the effectiveness of the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively. Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.

What is the risk associated?

The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes. For the full list of all side effects reported with Exforge, see the Package Leaflet.
Exforge should not be used in patients who may be hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives’ class, to valsartan, or to any of the other ingredients. It must not be used in women who are more than three months pregnant. Its use during the first three months of pregnancy is not recommended. Exforge must also not be used in patients who have severe liver, kidney or bile problems, or in patients undergoing dialysis (a blood clearance technique).

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Exforge’s benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy. The Committee recommended that Exforge be given marketing authorisation.