Zostavax vaccine

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for you only. Do not pass it on to others.
• If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

What is shingles?

Shingles is a painful, blistering rash. It usually occurs in one part of the body and can last for several weeks. It may lead to severe and long-lasting pain and scarring. Less commonly, bacterial skin infections, weakness, muscle paralysis, loss of hearing or vision can occur. Shingles is caused by the same virus that causes chickenpox. After you have had chickenpox, the virus that caused it stays in your body in nerve cells. Sometimes, after many years, the virus becomes active again and causes shingles.

What is PHN?

After the shingles blisters heal, pain can last for months or years and may be severe. This long-lasting nerve pain is called post-herpetic neuralgia or PHN.

• if you are allergic to any of the components of this vaccine (including neomycin (which may be present as trace residue) or any of the other ingredients listed in section 6)
• if you have a blood disorder or any type of cancer that weakens your immune system
• if you have been told by your doctor that you have a weakened immune system as a result of a disease, medicines, or other treatment
• if you have active untreated tuberculosis
• if you are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breast-feeding).

If you have experienced any of the following, talk to your doctor or pharmacist before receiving ZOSTAVAX:

• if you have or have had any medical problems or any allergies
• if you have a fever
• if you have HIV infection

Tell your doctor if you have ever had an allergic reaction to any of the ingredients (including neomycin (which may be present as trace residue) or any of the ingredients listed under section 6) before you receive this vaccine.

As with many vaccines, ZOSTAVAX may not completely protect all persons who are vaccinated.

If you have a blood clotting disorder or low levels of platelets, the vaccine should be given under the skin because bleeding may occur following administration into the muscle.

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

ZOSTAVAX can be administered at the same time as inactivated influenza vaccine. The two vaccines should be given as separate injections at different body sites.

For information about the administration of ZOSTAVAX and pneumococcal polysaccharide vaccine at the same time, talk to your doctor or health care provider.

ZOSTAVAX should not be given to pregnant women. Women of child-bearing potential should take the necessary precautions to avoid pregnancy for 1 month following vaccination.

Inform your doctor if you are breast-feeding or intending to breast-feed. Your doctor will decide if ZOSTAVAX should be given.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.

There is no information to suggest that ZOSTAVAX affects the ability to drive or use machines.

This medicine contains less than 1 mmol sodium (23 milligrams) per dose, that is to say essentially ‘sodium-free'.

This medicine contains less than 1 mmol potassium (39 milligrams) per dose, that is to say essentially ‘potassium-free’.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this vaccine.

After reconstitution, one dose (0.65 mL) contains:

The active substance is:

Varicella-zoster virus¹, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU (plaque-forming units).

¹Produced in human diploid (MRC-5) cells

The other ingredients are:

Powder

Sucrose, hydrolysed gelatin, sodium chloride (NaCl), potassium dihydrogen phosphate, potassium chloride (KCl), monosodium L-glutamate monohydrate, disodium phosphate, sodium hydroxide (NaOH) (to adjust pH) and urea.

Solvent

Water for injections

The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be reconstituted with the solvent provided with the vial of powder.

The powder is a white to off-white compact crystalline plug. The solvent is a clear and colourless liquid.

One pack of ZOSTAVAX contains a vial and a pre-filled syringe without needle or with one or 2 separate needles.

ZOSTAVAX is available in packs of 1, 10 or 20 with or without needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder in Great Britain:

Marketing Authorisation Holder in UK (Northern Ireland):

Manufacturer:

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: