Samsca 15 mg tablets

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.

Do not take Samsca

• if you are allergic to tolvaptan or any of the other ingredients of Samsca (see 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.

Take special care with Samsca

Before taking Samsca tell your doctor:

• 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 (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

• Samsca tablets can be taken with or without food.
• Avoid drinking grapefruit juice when taking Samsca.

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.

• Treatment with Samsca will be initiated in hospital
• Always take Samsca exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• 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 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.

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:

• 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.

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:

• find it difficult to urinate
• find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness.

Side effects reported in clinical studies with Samsca were:

Very common

• thirst
• nausea

Common

• 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
• rise in levels of sodium, potassium, creatinine, uric acid and blood sugar
• decrease in level of blood sugar

Uncommon

• sense of taste altered
• itchy rash

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.

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.

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
Hunton House
Highbridge Business Park
Oxford Road
Uxbridge
Middlesex, UB8 1HU
United Kingdom

Manufacturer

Brecon Pharmaceuticals 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:

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Lietuva

Otsuka Pharmaceutical Europe Ltd
Tel: +441895 207 100

This leaflet was last approved in {MM/YYYY} .