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Samsca (tolvaptan) – Package leaflet - C03XA01

Updated on site: 10-Oct-2017

Medication nameSamsca
ATC CodeC03XA01
Substancetolvaptan
ManufacturerOtsuka Pharmaceutical Europe Ltd.

Package leaflet: Information for the user

Samsca 15 mg tablets Samsca 30 mg tablets tolvaptan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet. You may need to read it again.

-If you have any further questions, please ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.What Samsca is and what it is used for

2.What you need to know before you take Samsca

3.How to take Samsca

4.Possible side effects

5.How to store Samsca

6.Contents of the pack and other information

1.What Samsca is and what it is used for

Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists. Vasopression is a hormone that helps prevent the loss of water from the body by reducing urine output. Antagonist 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 or concentration of sodium in your blood.

Samsca is used to treat low serum sodium levels in adults. You have been prescribed Samsca because you have a lowered sodium level in your blood as a result of a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH) where the kidneys retain too much water. 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.

2. What you need to know before you take Samsca

Do not take Samsca

if you are allergic to tolvaptan or any of the other ingredients of this medicine (listed in section 6)

if your kidneys do not work (no urine production)

if you have a condition which increases the salt in your blood (“hypernatraemia”)

if you have a condition which is associated with a very low blood volume

if you do not realise when you are thirsty

if you are pregnant

if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Samsca:

if you cannot drink enough water or if you are fluid restricted

if you have difficulties in urination or have an enlarged prostate

if you suffer from liver disease

if you have diabetes.

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 or even more severe side effects like kidney problems (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 and adolescents

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

Other medicines and Samsca

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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.

Other products which increase the salt in your blood or which contain large amounts of salt may increase the effects of Samsca. Medicines which also increase your urine production (diuretics) may further increase the risk of water loss related side effects (see “Drinking enough water” above). Therefore, please tell your doctor about all medicines you are receiving or have recently received, including medicines obtained without a prescription.

Samsca may reduce the effect of desmopressin (used to increase blood clotting factors).

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.

Samsca with food and drink

Avoid drinking grapefruit juice when taking Samsca.

Pregnancy and breastfeeding

Pregnant women must not take this medicine.

Breastfeeding women must not take this medicine.

Women of childbearing potential should use adequate contraceptive measures during use of this medicine.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Samsca is unlikely to adversely affect your ability to drive a car or to operate machinery. However, you may occasionally feel dizzy or weak or you may faint for a short period.

Samsca contains lactose.

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

3.How to take Samsca

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Treatment with Samsca will be initiated in hospital

For treatment of your low sodium (hyponatraemia), the dose can be from 15 mg to 60 mg once a day. Your doctor will start with a dose of 15 mg and may then increase it to a maximum of 60 mg to achieve the desired level of serum sodium. To monitor the effects of Samsca your doctor will do regular blood tests.

Swallow the tablet without chewing, with a glass of water.

Take the tablets once a day preferably in the morning with or without food.

If you take more Samsca than you should

If you have taken more tablets thanyour 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 a forgotten dose.

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 medicine, ask your doctor or pharmacist.

4.Possible side effects

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

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

find it difficult to urinate

find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).

Consult your doctor if symptoms of fatigue, loss of appetite, right upper abdominal discomfort, dark urine or jaundice (yellowing of skin or eyes) occur.

Other side effects

Very common (may affect more than 1 in 10 people)

thirst

nausea

Common (may affect up to 1 in 10 people)

raised levels of liver enzymes in the blood

dry mouth

excessive drinking of water

increased need to urinate, or to urinate more frequently

water loss

tiredness, general weakness

decreased appetite

constipation

dizziness

low blood pressure when standing up

fainting

patchy bleeding in the skin

itching

fever

high levels of sodium, potassium, creatinine, uric acid and blood sugar

rapid rise in level of sodium

decrease in level of blood sugar

headache

general feeling of being unwell

diarrhoea

blood in urine

Uncommon (may affect up to 1 in 100 people)

increase of bilirubin in the blood

kidney problems

sense of taste altered

itchy rash

Not known

Other side effects have occurred in a very small number of people but their exact frequency is unknown.

allergic reactions (see above)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Samsca

Keep this medicine out of the sight and reach of children.

Do not use this medicine 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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Samsca contains

The active substance is tolvaptan.

Each Samsca 15 mg tablet contains 15 mg tolvaptan.

Each Samsca 30 mg tablet contains 30 mg tolvaptan.

The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine (E 132) aluminium lake.

What Samsca looks like and contents of the pack

Samsca 15 mg is a blue, triangular, convex tablet, with “OTSUKA” and “15” on one side. Samsca 30 mg is a blue, round, convex tablet, with “OTSUKA” and “30” on one side.

Your medicine is supplied in perforated unit dose blisters of 10 x 1 tablets. One pack with 10 Samsca tablets contains one blister of 10 tablets and one pack with 30 Samsca tablets contains three blisters of 10 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs

Framewood Road

Wexham, SL3 6PJ

United Kingdom

Manufacturer

AndersonBrecon (UK) Ltd.

Wye Valley Business Park

Brecon Road

Hay-on-Wye

Hereford, HR3 5PG

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharmaceutical Europe Ltd

Tél/Tel: +44 (0)203 747 5000

Tel: +44 (0)203 747 5000

България

Luxembourg/Luxemburg

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharmaceutical Europe Ltd

Teл: +44 (0)203 747 5000

Tel/ Tél: +44 (0)203 747 5000

Česká republika

Magyarország

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharmaceutical Europe Ltd

Tel: +44 (0)203 747 5000

Tel: +44 (0)203 747 5000

Danmark

Malta

Otsuka Pharma Scandinavia AB

Otsuka Pharmaceutical Europe Ltd

Tlf: +46854 528 660

Tel: +44 (0)203 747 5000

Deutschland

Nederland

Otsuka Pharma GmbH

Otsuka Pharmaceutical Europe Ltd

Tel: +49691 700 860

Tel: +44 (0)203 747 5000

Eesti

Norge

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharma Scandinavia AB

Tel: +44 (0)203 747 5000

Tlf: +46854 528 660

Ελλάδα

Österreich

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharmaceutical Europe Ltd

Thλ: +44 (0)203 747 5000

Tel: +44 (0)203 747 5000

España

Polska

Otsuka Pharmaceutical S.A

Otsuka Pharmaceutical Europe Ltd

Tel: +3493 2081 020

Tel: +44 (0)203 747 5000

France

Portugal

Otsuka Pharmaceutical France SAS

Otsuka Pharmaceutical Europe Ltd

Tél: +33147 080 000

Tel: +44 (0)203 747 5000

Hrvatska

România

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharmaceutical Europe Ltd

Tel: +44 (0)203 747 5000

Tel: +44 (0)203 747 5000

Ireland

Slovenija

Otsuka Pharmaceuticals (UK) Ltd

Otsuka Pharmaceutical Europe Ltd

Tel: +44 (0)203 747 5300

Tel: +44 (0)203 747 5000

Ísland

Slovenská republika

Otsuka Pharma Scandinavia AB

Otsuka Pharmaceutical Europe Ltd

Tlf: +46854 528 660

Tel: +44 (0)203 747 5000

Italia

Suomi/Finland

Otsuka Pharmaceutical Italy S.r.l.

Otsuka Pharma Scandinavia AB

Tel: +39 02 00 63 27 10

Tel/ Puh: +46854 528 660

Κύπρος

Sverige

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharma Scandinavia AB

Thλ: +44 (0)203 747 5000

Tel: +46854 528 660

Latvija

United Kingdom

Otsuka Pharmaceutical Europe Ltd

Otsuka Pharmaceuticals (UK) Ltd

Tel: +44 (0)203 747 5000

Tel: +44 (0)203 747 5300

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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