What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 00031/0465.

Cymevene 500 mg powder for concentrate for solution for Infusion

Package leaflet: Information for the user

Cymevene 500 mg powder for concentrate for solution for infusion

ganciclovir

Read all of this leaflet carefully before you start using 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, 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.

What is in this leaflet

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

1. What Cymevene is and what it is used for

What Cymevene is

Cymevene contains the active substance ganciclovir. This belongs to a group called anti-viral medicines.

What Cymevene is used for

Cymevene is used to treat diseases caused by a virus called cytomegalovirus (CMV) in patients who have a weak immune system. It is also used to prevent CMV infection after an organ transplant or during chemotherapy.

It is used in adults and adolescents 12 years and older.

  • 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).

2. What you need to know before you use Cymevene

Do not use Cymevene if:

  • you are allergic to ganciclovir, valganciclovir or any of the other ingredients of this medicine (listed in section 6)
  • you are breast-feeding (see Breast-feeding 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.

Warnings and precautions

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.

Children and adolescents

There is limited information on how safe or effective Cymevene is in children under 12 years.

Other medicines and Cymevene

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, breast-feeding and fertility

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.

Breast-feeding

Do not use Cymevene if you are breast-feeding. If your doctor wants you to start using Cymevene you must stop breast-feeding 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.

Driving and using machines

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.

Cymevene contains sodium

Cymevene contains 43 mg of sodium in each 500mg dose. This should be taken into consideration by patients on a controlled sodium diet.

3. How to use Cymevene

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

Using this medicine

Cymevene will be given to you by a doctor or nurse. It will be given through a tube into your vein. This is called an intravenous infusion and it will usually take one hour.

The dose of Cymevene varies from one patient to another. Your doctor will work out how much you need. It will depend on:

  • your weight
  • your age
  • how well your kidneys are working
  • your blood counts
  • what you are using the medicine for.

How often you will have Cymevene and how long you keep using it will also vary.

  • You will usually start by having one or two infusions every day.
  • If you have two infusions a day, this will continue for up to 21 days.
  • After that the doctor may prescribe the infusion once a day.

People with kidney or blood problems

If you have any kidney or blood problems your doctor might suggest a smaller dose of Cymevene and check your blood cell counts more often during treatment.

If you use more Cymevene than you should

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.

If you stop using Cymevene

Do not stop using Cymevene without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Serious side effects

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 1000 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.

Other side effects

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

Side effects in children and adolescents

The following side effects are more likely in children:

  • fever
  • stomach pain
  • low white blood cell counts.

Reporting of side effects

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

Yellow Card Scheme
Website:www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Cymevene

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

Powder: Does not require any special storage conditions. It should not be used after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

After reconstitution:

Chemical and physical in-use stability has been demonstrated for the reconstituted product for 12 hours at 25°C after dissolving with water for injections. Do not refrigerate or freeze.

From a microbiological point of view, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

After dilution in infusion solutions (sodium chloride 0.9%, dextrose 5%, Ringer’s or lactated Ringer’s solution for injection) :

Chemical and physical in-use stability has been demonstrated for 24 hours at 2 – 8°C (do not freeze).

From a microbiological point of view, the Cymevene infusion solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C to 8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.

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 Cymevene contains

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

What Cymevene looks like and contents of the pack

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.

Marketing Authorisation Holder

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturer

Roche Pharma AG
Emil-Barell-Str.1
D-79639 Grenzach-Wyhlen
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Cymevene: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Ireland, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Spain, Sweden, United Kingdom

Cymeven i.v.: Germany

Cymevan : France

Citovirax: Italy

This leaflet was last revised in October 2017.

Other sources of information

Detailed information on this medicine is available on the Medicines and Healthcare Products Regulatory Agency (MHRA) website : http://www.mhra.gov.uk

uk-pil-Cymevene-clean-171006-500mg-inf