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DepoCyte - Patient leaflet, side effects, dosage

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ATC code:

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Patient leaflet - DepoCyte

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

dylcholine, or injections.


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

Pacira Limited, Wessex House, Kingdom.


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.

België/Belgiqu­e/Belgien Mundipharma Comm VA. Tél/Tel: +32 (0) 15 45 11 80


Lietuva

KBM Pharma OÜ

Tel. +372 733 8080


Etnrapun


Tn MyHgu^apMa MeguKM OOfl Ten. +359 2 962 13 56/54


Luxembourg/Lu­xemburg


Mundipharma Comm VA. Tél: +32 (0) 15 45 11 80


Česká republika

Mundipharma Ges.m.b.H. Austria

Organizační složka ČR

Tel : +420 222 318 221


Magyarország

Medis Hungary Kft

Információsvonal: +36 2 380 10


Danmark

Mundipharma A/S

Tlf: +45 45 17 48 00



Malta

Pacira Limited

Wessex House, Marlow Road

Bourne End kinghamshire


SL8 5

Tel: +4


u Unit

628 530554


Deutschland

Mundipharma GmbH

Tel: + 49 (0) 64 31 701–0


Eesti

KBM Pharma OÜ

Tel: +372 733 8080

kbmpharma@kbmpha


Nederland

Mundipharma Pharmaceuticals B.V.

Tel: +31 (0) 33 450 8270


Norge

Mundipharma AS

Tlf: +47 67 51 89 00


EXXaSa

Pacira Limited

Wessex House, Marlow Road

Bourne End, Buckinghamshire


Österreich

Mundipharma Gesellschaft.m.b.H.

Tel: + 43 (0) 1 523 25 05



aoiXeio

4 (0) 1628 530554


Espana

Mundipharma Pharmaceuticals, S.L.

Tel: +34 91 3821870


Polska

Mundipharma Polska Sp.z o.o.

Tel: +48(0) 22 866 87 12


France

Mundipharma

Tel: +33 (0) 1 40 65 29 29


Portugal

Companhia Portuguesa Higiene Pharma -Produtos Farmacéuticos, S.A.

Tel: +351 214 449 600


Hrvatska


România


Medis Adria d.o.o.

Kolarova 7,


Mundipharma Gesellschaft m.b.H., Austria

Tel: +40 751 121 222


10000 Zagreb


Tel.: +385 1 2303 446



Ireland

Mundipharma Pharmaceuticals Limited

Tel: +353 1 2063800


Slovenija

Medis, d.o.o.

Tel: +386 158969 00



Ísland

Mundipharma A/S

Tel: +45 45 17 48 00

mundipharma@ mundipharma.dk


Slovenská republika

Mundipharma Ges.m.b.H. – o.z

Tel: +421 2 63811611


Italia

Mundipharma Pharmaceuticals Srl

Tel: + 39.02.318288216


Suomi


Oy

Puh/Tel: +358 (0)9 8520 2065


Kùnpoç

Mundipharma Pharmaceuticals Ltd

Tql: +357 22 81 56 56

info@mundiphar­ma.com.c


Sverige

Mundipharma AB

Tel: + 46 (0)31 773 75 30


Latvija

Institute of Innovative Biomedical Technology

Tel: +371 7 800810


last revised in MM/YYYY

This lea


United Kingdom

Napp Pharmaceuticals Limited

Tel: +44 (0) 1223 424444


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

26

The drug is classified in the ATC tree:

Frequently Asked Questions

What is DepoCyte used for?

DepoCyte is primarily used to treat certain types of cancer, specifically lymphomatous meningitis.

How does DepoCyte work?

DepoCyte contains cytarabine, which works by stopping the growth of cancer cells in the body.

How is DepoCyte administered?

DepoCyte is given as an injection into the spinal canal by a healthcare professional.

What should I tell my doctor before using DepoCyte?

Inform your doctor about any allergies, current medications, or any health conditions you have.

Are there any common side effects of DepoCyte?

Yes, common side effects may include headache, nausea, vomiting, and fatigue.

Can I drink alcohol while using DepoCyte?

It's best to avoid alcohol while receiving treatment with DepoCyte as it may increase side effects.

How often will I need to receive DepoCyte injections?

The frequency of injections depends on your specific treatment plan developed by your healthcare provider.

What should I do if I miss a dose of DepoCyte?

Contact your healthcare provider immediately if you miss a dose for guidance on rescheduling.

Is it safe to use DepoCyte during pregnancy?

DepoCyte is not recommended during pregnancy; discuss with your doctor if you're pregnant or planning to become pregnant.

Can I get vaccinations while on DepoCyte treatment?

Check with your doctor before getting any vaccines during or after treatment with DepoCyte.

What precautions should I take when using DepoCyte?

Avoid contact with sick individuals and report signs of infection like fever or chills to your doctor.

Will using DepoCyte affect my fertility?

Cytarabine may impact fertility; consult your healthcare provider if you have concerns about future pregnancies.

How should I store unused DepoCyte medication?

Store unused medication at room temperature away from light and moisture, and keep it out of reach of children.

Can I drive after receiving a DepoCyte injection?

You may experience side effects that affect your ability to drive; consult your doctor about when it's safe to drive again.

What happens if I experience severe side effects from DepoCyte?

If you experience severe side effects like pronounced fatigue or breathing difficulties, seek medical attention immediately.

How long does it take for DepoCyte to start working?

The effectiveness varies per individual; your healthcare provider will monitor progress during treatment.

Are there alternative treatments to DepoCyte for lymphomatous meningitis?

Yes, there are other treatments available; discuss options with your healthcare provider based on your condition.

Can I continue taking my other medications while using DepoCyte?

Always inform your doctor about all medications you are taking to avoid potential interactions with DepoCyte.

Is there any dietary restriction while on DepoCyte?

While no specific diet is required, maintaining a healthy diet may help manage side effects; consult your doctor for personalized advice.

Where can I find more information about clinical trials involving DepoCyte?

You can visit clinical trial registries online or consult with your healthcare provider for ongoing studies related to DepoCyte.