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 are: EU/1/06/341/005, EU/1/06/341/004, EU/1/06/341/003, EU/1/06/341/006, EU/1/06/341/011, EU/1/06/341/008, EU/1/06/341/010, EU/1/06/341/001, EU/1/06/341/007, EU/1/06/341/009, EU/1/06/341/002, EU/1/06/341/012, EU/1/06/341/013.

Zostavax

Package Leaflet: Information for the user

ZOSTAVAX®

Powder and solvent for suspension for injection in a pre-filled syringe

shingles (herpes zoster) vaccine (live)

Read all of this leaflet carefully before you are vaccinated 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 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.

What is in this leaflet:

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

1. What ZOSTAVAX is and what it is used for

ZOSTAVAX is a vaccine used to prevent shingles (zoster) and zoster-related post-herpetic neuralgia (PHN), the long-lasting nerve pain that follows shingles.

ZOSTAVAX is used to vaccinate individuals 50 years of age or older.

ZOSTAVAX cannot be used to treat existing shingles or the pain associated with existing shingles.

Disease information on shingles:

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.

2. What you need to know before you receive ZOSTAVAX

Do not receive ZOSTAVAX

  • if you are allergic (hypersensitive) to any of the components of this vaccine (including neomycin 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).

Warnings and precautions

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 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.

Other medicines and ZOSTAVAX

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.

ZOSTAVAX should not be given at the same time as the 23-valent pneumococcal polysaccharide vaccine. For more information about these vaccines, talk to your doctor or health care provider because it may be better to get these vaccines at least 4 weeks apart.

Pregnancy and breast-feeding

ZOSTAVAX should not be given to pregnant women. Women of child-bearing age 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.

Driving and using machines

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

ZOSTAVAX contains sodium

ZOSTAVAX contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.

3. How to use ZOSTAVAX

ZOSTAVAX should be injected under the skin or into the muscle, preferably in the upper arm.

If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.

ZOSTAVAX is given as a single dose.

Reconstitution instructions intended for healthcare professionals are included at the end of the leaflet.

4. Possible side effects

Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.

Rarely (may affect up to 1 in 1,000 people), allergic reactions may occur. Some of these reactions may be serious and may include difficulty in breathing or swallowing. If you have an allergic reaction, call your doctor right away.

The following side effects have been observed:

  • Very common (may affect more than 1 in 10 people): Redness, pain, swelling and itching at the injection site*
  • Common (may affect up to 1 in 10 people): Warmth, bruising, hard lump, and rash at the injection site*; headache*; pain in the arm or leg*; joint pain, muscle pain; fever; rash
  • Uncommon (may affect up to 1 in 100 people): Nausea; swollen gland (neck, armpit)
  • Rare (may affect up to 1 in 1,000 people): Hives at the injection site
  • Very rare (may affect up to 1 in 10,000 people): Varicella (chicken pox); shingles; damage of retina caused by inflammation resulting in changes in sight (in patients under immunosuppressive therapy).

*These adverse reactions have been observed in clinical trials and through postmarketing surveillance; most of those observed in clinical trials were reported as mild in intensity.

Reporting of side effects

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 (see details below). By reporting side effects you can help provide more information on the safety of this vaccine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie

5. How to store ZOSTAVAX

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

Do not use this vaccine after the expiry date which is stated on the outer carton after EXP. The expiry date refers to the last day of that month.

Store and transport refrigerated (2°C - 8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light.

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 ZOSTAVAX contains

After reconstitution, 1 dose (0.65 ml) contains:

The active substance is:

Varicella-zoster virus1, Oka/Merck strain, (live, attenuated) not less than 19400 PFU (plaque-forming units).

1Produced in human diploid (MRC-5) cells

The other ingredients are:

Powder

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

Solvent

Water for injections

What ZOSTAVAX looks like and contents of the pack

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 solvent is a clear and colourless liquid. Before mixing with the solvent, the powder is a white to off-white compact crystalline plug.

One pack of ZOSTAVAX contains a vial and a prefilled syringe with or without attached needles. One or 2 separate needles may be available in the secondary packaging of the presentation containing the pre-filled syringe without the attached needle

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

MSD VACCINS
162 avenue Jean Jaurès
69007 Lyon
France

Manufacturer:

Merck Sharp and Dohme, B.V.
Waarderweg, 39
2031 BN Haarlem
The Netherlands

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

United Kingdom
Merck Sharp & Dohme Limited
Tel: +44 (0) 1992 467272

This leaflet was last revised in January 2017.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

© Merck Sharp & Dohme Limited, 2017. All rights reserved.

PIL.ZST.PFS.17.UK.5004-IA (MSD Vaccins)