Cymevene 500mg powder for concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Cymevene is and what it is used for
2. What you need to know before you use Cymevene
3. How to use Cymevene
4. Possible side effects
5. How to store Cymevene
6. Contents of the pack and other information

Cymevene contains the active substance ganciclovir. This belongs to a group called antiviral medicines.

Cymevene is used to treat diseases caused by a virus called cytomegalovirus (CMV) in adults and adolescent patients 12 years and older who have a weak immune system. It is also used to prevent CMV infection after an organ transplant or during chemotherapy in adults and children from birth.

• The virus can affect any part of the body. This includes the retina at the back of the eye – this means the virus can cause problems with eye sight.
• The virus can affect anyone, but it is a particular problem in people with a weak immune system. In these people the CMV virus can lead to a serious disease. A weak immune system may be caused by other diseases (such as AIDS) or by medicines (such as chemotherapy or immunosuppressants).

• you are allergic to ganciclovir, valganciclovir or any of the other ingredients of this medicine (listed in section 6).
• you are breastfeeding (see Breastfeeding subsection).

Do not use Cymevene if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before using Cymevene.

Talk to your doctor, pharmacist or nurse before using Cymevene if:

• you are allergic to aciclovir, valaciclovir, penciclovir or famciclovir – these are other medicines used for viral infections.
• you have low white blood cell, red blood cell or platelet counts – your doctor will do blood tests before you start and during your treatment.
• you have had problems with your blood cell counts caused by medicines in the past.
• you have kidney problems – your doctor will need to give you a lower dose and check your blood cell counts more often during treatment.
• you are having radiotherapy.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using Cymevene.

Look out for side effects

Cymevene can cause some serious side effects that you need to tell your doctor about straight away. Look out for the serious side effects listed in Section 4 and tell your doctor if you notice any of these while you are taking Cymevene - your doctor may tell you to stop taking Cymevene and you may need urgent medical treatment.

Tests and checks

While you are using Cymevene your doctor will do regular blood tests. This is to check the dose you are having is right for you. For the first 2 weeks these blood tests will be done often. After that the tests will be done less often.

There is limited information on how safe or effective Cymevene is as a treatment for CMV disease in children under 12 years. Babies and infants given Cymevene for prevention of CMV disease, will undergo regular blood tests.

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• imipenem/cilastatin – used for bacterial infections,
• pentamidine – used for parasite or lung infections,
• flucytosine, amphotericin B – used for fungal infections,
• trimethoprim, trimethoprim/sulfamethoxazole, dapsone – used for bacterial infections,
• probenecid – used for gout,
• mycophenolate mofetil, ciclosporin, tacrolimus – used after an organ transplant,
• vincristine, vinblastine, doxorubicin – used for cancer,
• hydroxyurea – used for a problem called polycythemia, sickle cell disease and cancer,
• didanosine, stavudine, zidovudine, tenofovir or any other medicines used for HIV,
• adefovir or any other medicines used to treat Hepatitis B.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Cymevene.

Pregnancy

Cymevene should not be used by pregnant women unless the benefits to the mother outweigh the possible risks to the unborn baby.

If you are pregnant or think you might be pregnant, do not use this medicine unless your doctor tells you to. This is because Cymevene may harm the unborn baby.

Contraception

You should not become pregnant while using this medicine. This is because it may affect the unborn baby.

Women

If you are a woman who could get pregnant – use contraception while you are using Cymevene.

Also do this for at least 30 days after Cymevene has been stopped.

Men

If you are a man whose female partner could get pregnant – use a barrier method of contraception (such as condoms) while you are using Cymevene. Also do this for at least 90 days after Cymevene has been stopped.

If you or your partner becomes pregnant while using Cymevene, talk to your doctor straight away.

Breastfeeding

Do not use Cymevene if you are breastfeeding. If your doctor wants you to start using Cymevene you must stop breastfeeding before you start using the medicine. This is because Cymevene may pass into breast milk.

Fertility

Cymevene may affect fertility. Cymevene may temporarily or permanently stop men from producing sperm. If you are planning to have a baby, talk to your doctor or pharmacist before using Cymevene.

You may feel sleepy, dizzy, confused or shaky, or you may lose your balance or have fits while using Cymevene. If this happens, do not drive or use any tools or machines.

This medicine contains 43 mg sodium (main component of cooking/table salt) in each 500 mg vial.

This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.

If you think you have been given too much Cymevene talk to your doctor or go to hospital straight away. You may get the following symptoms if you have too much:

• stomach pain, diarrhoea or being sick
• shaking or fits
• blood in your urine
• kidney or liver problems
• changes in blood cell counts.

Do not stop using Cymevene without talking to your doctor.

Tell your doctor straight away if you notice any of the following serious side effects – your doctor may tell you to stop taking Cymevene and you may need urgent medical treatment:

Very common: may affect more than 1 in 10 people

• low white blood cell counts – with signs of infection such as sore throat, mouth ulcers or a fever
• low red blood cell counts – signs include feeling short of breath or tired, palpitations or pale skin.

Common: may affect up to 1 in 10 people

• blood infection (sepsis) – signs include fever, chills, palpitations, confusion and slurred speech
• low level of platelets – signs include bleeding or bruising more easily than usual, blood in urine or stools or bleeding from gums, the bleeding could be severe
• severely low blood cell count
• pancreatitis – signs are severe stomach pain which spreads into your back
• fits.

Uncommon: may affect up to 1 in 100 people

• failure of the bone marrow to produce blood cells
• hallucinations – hearing or seeing things that are not real
• abnormal thoughts or feelings, losing contact with reality
• failure of kidney function.

Rare: may affect up to 1 in 1,000 people

• severe allergic reaction – the signs may include, red itchy skin, swelling of the throat, face, lips or mouth, difficulty swallowing or breathing.

Tell your doctor straight away if you notice any of the side effects above.

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• thrush and oral thrush
• upper respiratory tract infection (e.g. sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• feeling short of breath
• diarrhoea
• feeling or being sick
• abdominal pain
• eczema
• feeling tired
• fever.

Common: may affect up to 1 in 10 people

• influenza
• urine infection – signs include fever, passing urine more often, pain when passing urine
• infection of the skin and the tissues under the skin
• mild allergic reaction – the signs may include red, itchy skin
• weight loss
• feeling depressed, anxious or confused
• trouble sleeping
• hands or feet feeling weak or numb, which may affect your balance
• changes to your sense of touch, tingling, tickling, pricking or burning feeling
• changes to the way things taste
• chills
• eye inflammation (conjunctivitis), eye pain or sight problems
• ear pain
• low blood pressure, which may make you feel dizzy or faint
• problems swallowing
• constipation, wind, indigestion, stomach pain, swelling of the abdomen
• mouth ulcers
• abnormal results of liver and kidney laboratory tests
• night sweats
• itching, rash
• hair loss
• back pain, muscle or joint pain, muscle spasms
• feeling dizzy, weak or generally unwell
• a skin reaction where the medicine was injected – such as inflammation, pain and swelling.

Uncommon: may affect up to 1 in 100 people

• feeling agitated
• tremor, shaking
• deafness
• uneven heartbeat
• hives, dry skin
• blood in urine
• infertility in men – see ‘Fertility’ section
• chest pain.

Low blood cell counts are more likely in children, especially babies and infants.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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• The active substance is ganciclovir. Each glass vial contains 500 mg ganciclovir as ganciclovir sodium. Following reconstitution of the powder, 1 mL solution contains 50 mg ganciclovir.
• The other ingredients are sodium hydroxide and hydrochloric acid.

Cymevene is a white to off white powder for concentrate for solution for infusion, supplied in a single-dose glass vial, with a rubber stopper and aluminium closure with flip-off cap. Reconstituted solutions of Cymevene range in colour from colourless to light yellow.

Vials of Cymevene are supplied in packs of 1 or 5. Not all pack sizes may be marketed.

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