DepoCyte - patient leaflet, side effects, dosage

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects may occur after each injection, usually within the first five days.

Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.

The frequency of possible side effects listed below is defined using the following convention: 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).

The severity of adverse events of DepoCyte may be increased when DepoCyte is given in combination with other chemotherapeutic agents.

Tell the medical staff monitoring you during this time, if you suffer from:

Very common (experienced in more than 1 in 10 patients)

• Nausea and/or vomiting
• Weakness
• Confusion
• Fever
• Headaches
• Dizziness
• Shaking

Common (experienced in less than 1 in 10

• Back pain
• Convulsion
• Neck pain
• A stiff or rigid neck
• Infection of the meninges
• Fatigue
• Pain, numbness or tingling (feeling of sensation of pins and needles)
• Blindness and other visual disturbances
• Hearing loss
• Persistent or extreme sleepiness
• Partial paralysis

5. How to store DepoCyte

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 on the vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

DepoCyte should be used as soon as possible after first opening, and should normally be used within 4 hours (stored at 18–22°C).

DepoCyte is a sterile white to off-white-suspension. Do not use this medicine if you notice severe discolouration, a changed appearance or a defective container.

Do not throw away any medicines via wastewater. DepoCyte contains cytarabine, and shoul disposed of in a manner consistent with local requirements.

6. Contents of the pack and other information

What DepoCyte contains

The active substance is cytarabine. One ml of suspension contains 10 mg cytarabine. Each 5 ml

vial contains 50 mg cytarabine

The other ingredients are cholesterol, triolein, dioleoylph dipalmitoylphos­phatidylglyce­rol, sodium chloride, an

What DepoCyte looks like and contents of the pack

DepoCyte is a white to off-white-suspension for injection supplied in a glass vial.

Each vial contains 5 ml of suspension for a single injection.

Each pack contains a single vial.

Marketing Authorisation Holder

w Road, Bourne End, Buckinghamshire, SL8 5SP, United

Manufacturer

Almac Pharma Services Limited, 20 Seagoe Industrial Estate, Craigavon, Co Armagh, BT63 5QD, United Kingdom.

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

Detailed information on this medicine is available on the European Medicines Agency web site:.

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