Samsca 15 mg tablets Tolvaptan - United Kingdom[英国药品]

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Samsca 15 mg tablets Tolvaptan

2015-05-21 18:31:09 来源: 作者: 【大中小】浏览:390次评论:0条

For doctors

What is it and how is it used?

Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists. This means that it prevents vasopressin having its effect on water retention. This leads to a reduction in the amount of water in the body by increasing urine production and as a result it increases the level of sodium in your blood.

You have been prescribed Samsca because you have a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH). This disease causes an inappropriate production of the hormone vasopressin which has caused the sodium levels in your blood to get too low (hyponatraemia). That can lead to difficulties in concentration and memory, or in keeping your balance.

What do you have to consider before using it?

Do not take Samsca

Take special care with Samsca

Before taking Samsca tell your doctor:

Drinking enough water
Samsca causes water loss because it increases your urine production. This water loss may result in side effects such as dry mouth and thirst (see section 4). It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty.

Children
Samsca is not suitable for children and adolescents (under age 18).

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.

Products containing ketoconazole (against fungal infections), macrolide antibiotics, or diltiazem (treatment for high blood pressure and chest pain) may increase the effects of Samsca. Samsca may increase the effect of digoxin (used for treatment of irregularities of heart beat and heart failure). Barbiturates (used to treat epilepsy/seizures and some sleep disorders) or rifampicin (against tuberculosis) may decrease the effects of Samsca.

It may still be alright for you to take these medicines and Samsca together. Your doctor will be able to decide what is suitable for you.

Taking Samsca with food and drink

Pregnancy and breastfeeding

Pregnant women must not take this medicine.
Before taking Samsca you must tell your doctor if you are pregnant, if you think you are pregnant, or if you intend to become pregnant.
Breastfeeding women must not take this medicine.

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

Driving and using machines

Samsca may occasionally make you feel dizzy or weak or you may faint for a short period.

Important information about some of the ingredients of Samsca

This medicine contains lactose.If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How is it used?

60 mg to achieve the desired level of serum sodium. To monitor the effects of Samsca your doctor will do regular blood tests..

If you take more Samsca than you should

If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately. Remember to take the medicine pack with you so that it is clear what you have taken.

If you forget to take Samsca

If you forget to take your medicine you should take the dose as soon as you remember on the same day. 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 for forgotten individual doses.

If you stop taking Samsca

If you stop taking Samsca this may lead to reoccurrence of your low sodium. Therefore, you should only stop taking Samsca if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.

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

What are possible side effects?

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

These side effects may occur with certain frequencies, which are defined as follows:

If you notice any of the following side effects, you may need urgent medical attention. Stop taking Samsca and immediately contact a doctor or go to the nearest hospital if you:

Side effects reported in clinical studies with Samsca were:

Very common

Common

Uncommon

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 Samsca after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Samsca is a medicine that contains the active substance tolvaptan. It is available as blue tablets (triangular: 15 mg; round: 30 mg).

What is it used for?

Samsca is used to treat adults with hyponatraemia (abnormally low levels of sodium in the blood) caused by a condition called ‘syndrome of inappropriate antidiuretic hormone secretion’ (SIADH). SIADH occurs when there is an excessive amount of a hormone called ‘antidiuretic hormone’ or ‘vasopressin’, which reduces urine output by retaining water in the blood. This results in the blood becoming diluted, lowering the level of sodium.
The medicine can only be obtained with a prescription.

How is it used?

Treatment with Samsca should be started in hospital so that healthcare professionals can determine the most appropriate dose and monitor the patient’s level of blood sodium and blood volume. The starting dose is 15 mg once a day. This may be increased to a maximum of 60 mg once a day to achieve an appropriate level of blood sodium and blood volume.
The tablets should be swallowed whole with a glass of water. They should not be taken with grapefruit juice.

How does it work?

People with SIADH have an amount of vasopressin, leading to decreased urine production and dilution of the blood. The active substance in Samsca, tolvaptan, is a ‘vasopressin-2 receptor antagonist’. This means that it blocks one type of receptor (a protein) to which the hormone vasopressin normally attaches itself. By blocking this receptor, Samsca prevents vasopressin from having its effect. This leads to an increase in urine production, decreasing the amount of water in the blood and increasing the blood sodium level.

How has it been studied?

The effects of Samsca were first tested in experimental models before being studied in humans. Samsca was compared with placebo (a dummy treatment) in two main studies involving 424 adults with low sodium levels caused by SIADH and other conditions such as liver and heart problems. The main measure of effectiveness was based on the change in the amount of sodium in the blood over the first 30 days of treatment. The study also looked specifically at effect of treatment in the different disease groups.

What benefits has it shown during the studies?

Samsca was more effective than placebo at increasing sodium levels in the blood in all diseases, but Samsca was more effective in patients with SIADH than with liver or heart problems. Sodium levels were around 129 mmol/l at the start of the study. In patients with SIADH, the levels had increased by an average of 4.8 mmol/l by day 4 in those who took Samsca, compared with 0.2 mmol/l in those who took placebo. By day 30, sodium had increased by an average of 7.4 mmol/l in patients who took Samsca, compared with 1.5 mmol/l in patients receiving placebo.

What is the risk associated?

The most common side effects with Samsca (seen in more than 1 patient in 10) are thirst and nausea (feeling sick). For the full list of all side effects reported with Samsca, see the Package Leaflet. Samsca should not be used in people who may be hypersensitive (allergic) to tolvaptan or any of the other ingredients. It must not be used in patients with anuria (an inability to pass urine), very low blood volume, low blood sodium levels with low blood volume, hypernatremia (abnormally high levels of sodium in the blood) or in patients who cannot perceive thirst. It must also not be used in women who are pregnant or breast-feeding.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Samsca’s benefits are greater than its risks for the treatment of adult patients with hyponatraemia secondary to SIADH. The Committee recommended that Samsca be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Samsca to Otsuka Pharmaceutical Europe Ltd on 3 August 2009.

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