NeuroBloc 5000 U/ml solution for injection

NeuroBloc injection works by reducing or stopping muscle contractions. It contains the active ingredient ?Botulinum Toxin Type B?.

NeuroBloc is used to treat an illness called cervical dystonia (torticollis). This is where you have contractions of your neck or shoulder muscles that you cannot control.

You must not be given NeuroBloc:

• if you are allergic (hypersensitive) to Botulinum Toxin Type B or any of the other ingredients ofNeuroBloc (listed in section 6 ?Further information?)
• if you have other problems with your nerves or muscles, such as amyotrophic lateral sclerosis(Lou Gehrig's disease), peripheral neuropathy, myasthenia gravis or Lambert-Eaton syndrome (muscle weakness or numbness or pain)

You must not be given NeuroBloc if any of the above applies to you. If you are not sure talk to your doctor or pharmacist.

Take special care withNeuroBloc
Check with your doctor or pharmacist before you are given NeuroBloc:

• if you have a bleeding problem such as haemophilia
• if you have lung problems
• if you have difficulty swallowing. This is because swallowing problems could make you breathefood or liquids into your lungs, which could then cause very serious pneumonia

Use in children

NeuroBloc is not to be used in children aged 0-18 years.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because NeuroBloc can affect the way some medicines work and other medicines can also affect the way NeuroBloc works.

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

• aminoglycoside antibiotics for an infection
• medicines to stop blood clotting, such as warfarin

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before you are given NeuroBloc.

Before having an operation

If you are going to have an operation, please tell your doctor that you have been given NeuroBloc. This is because NeuroBloc can affect the medicines you may be given before a general anaesthetic.

Pregnancy and breast feeding

• you will not normally be given NeuroBloc if you are pregnant or breast-feeding. This is because it is not known how NeuroBloc affects patients who are pregnant and it is not known if NeuroBloc passes into a nursing mother?s breast milk
• ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding

Driving and using machines

You may have muscle weakness or eye problems such as blurred vision or eyelid drooping after being given NeuroBloc. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of NeuroBloc

NeuroBloc contains less than 1 mmol sodium (23 mg) per 10,000 units of NeuroBloc. This means it is essentially ?sodium free?.

NeuroBloc will be given to you by a doctorwith specialist experience in the treatment of cervical dystonia and in the use of botulinum toxins.

How much will be given

• your doctor will decide how much NeuroBloc to give you
• the usual dose is 10,000 units, however, it can be higher or lower
• if you have had NeuroBloc injections before, your doctor will take into account how well itworked the other times

How NeuroBloc is given

• NeuroBloc will be injected into your neck or shoulder muscles, depending on which ones arecausing the problem
• your doctor may inject part of the dose into different places in your muscles

Having more injections of NeuroBloc

• the effects of NeuroBloc will usually last about 12 to 16 weeks
• your doctor will decide if you need another injection and how much to give you

If you think that the effect of NeuroBloc is too strong or too weak, talk to your doctor.

If you are given too much NeuroBloc

• if you have been given more NeuroBloc than you need, some of your muscles that were not injected may feel weak or you may develop symptoms away from the injected muscles, like difficulty in swallowing or breathing. This may occur when higher doses of up to 15,000 units are given
• if you have difficulty breathing or you are worried by any symptoms you develop away from the place of the injection, talk to your doctor immediately. If he/she is unavailable seek emergency assistance. You may need urgent medical treatment

A serious condition called ?botulism? which causes paralysis of muscles and respiratory failure could occur if too much of the active ingredient (botulinum toxin) is injected into the body. If your doctor suspects that botulism may have occurred, you will be admitted to hospital and your breathing (respiratory function) will be monitored. Recovery usually takes place over a period of time.

Like all medicines, NeuroBloc can cause side effects, although not everybody gets them. They may happen days to weeks after you have had the injection. You may feel pain at the place where you had the injection, but this should wear off after a few minutes.

You may get a dry mouth and it might become difficult to swallow. In rare cases difficulty in swallowing may be severe and choking is possible. If your swallowing difficulty gets worse or you have choking or breathing problems, see a doctor immediately. You may need urgent medical treatment.

Aspiration pneumonia caused by food particles or vomit entering into the lungs, and respiratory disease, have been reported after treatment with botulinum toxins (Type A and Type B). These side effects have sometimes resulted in death and are possibly related to the spread of botulinum toxin to body parts away from the place where the injection is given.

Other side effects include:
Very common (affects more than 1 user in 10)

• dry mouth
• difficulty swallowing
• headache

Common (affects 1 to 10 users in 100)

• blurred vision or drooping of your upper eyelid
• indigestion or being sick (vomiting)
• constipation
• neck pain
• feeling weak, pain or stiff muscles around your body
• loss of strength or energy
• changes in the taste of your food and drink
• changes in the sound of your voice
• flu-like symptoms

Skin allergies such as rash with or without paleness, redness, patches, severe itching; and skin eruptions such as welts or hives have also been reported after receiving NeuroBloc. The frequency of these side effects is not known.

It is possible that cervical dystonia could become worse after you have had your injection.

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• keep out of the reach and sight of children
• do not use after the expiry date which is stated on the carton and on the vial after EXP.
• store in a refrigerator (2°C-8°C). Do not freeze
• keep the vial in the outer carton in order to protect from light
• Within its shelf-life, NeuroBloc may be removed from the refrigerator for a single period of up to 3 months at a temperature not above 25 oC. At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
• The date at which the medicine was taken out from the refrigerator will be put on the outer carton.
• if the medicine is diluted, the doctor will use it immediately
• before using the medicine the doctor will check that the solution is clear and colourless/light yellow. If there are any visible signs of deterioration, the medicine should not be used, but discarded.
• any unused solution should be discarded
• due to the special nature of NeuroBloc, the doctor will ensure that all used vials, needles and syringes must be processed as Medical Biohazardous Waste in accordance with local requirements

What NeuroBloc contains
The active substance is Botulinum Toxin Type B. One millilitre (ml) contains 5000 U.

One vial of 0.5 ml contains 2500 U of Botulinum Toxin Type B.
One vial of 1 ml contains 5000 U of Botulinum Toxin Type B.
One vial of 2 ml contains 10,000 U of Botulinum Toxin Type B.

The other ingredients are disodium succinate, sodium chloride, human serum albumin solution, hydrochloric acid (for pH adjustment) and water for injections

What NeuroBloc looks like and contents of the pack
NeuroBloc is presented as a solution for injection in a vial that contains 0.5 ml (2500 Units), 1.0 ml (5000 Units) or 2.0 ml (10,000 Units). The solution is clear and colourless to pale yellow.

Pack size of 1.

Marketing Authorisation holder:
Eisai Limited
Mosquito Way
Hatfield
Herts
AL10 9SN
United Kingdom

Manufacturer
Eisai Manufacturing Limited
Mosquito Way
Hatfield
Herts

AL10 9SN
United Kingdom

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

LuxembourgLuxemburg Eisai Ltd. TélTel 44 0 600 1400 Royaume-UniVerenigd Koninkrijk BelgiëBelgiqueBelgien Eisai Ltd. TélTel 44 0 208 600 1400 Royaume-UniVerenigd KoninkrijkVereinigtes Königreich

Magyarország Eisai GesmbH Tel. 36 1 230 43 20 Eisai Ltd. Te. 44 0 208 600 1400

eská republika Eisai GesmbH organizaní sloka Tel 420 242 485 839 Malta Associated Drug Company Ltd Tel 356 2277 8000

Danmark Eisai AB Tlf 46 0 8 501 01 600 Sverige Nederland Eisai Ltd. Tel 44 0 208 600 1400 Verenigd Koninkrijk

Deutschland Eisai GmbH Tel 49 0 696 65 85-0 Norge Eisai AB Tlf 46 0 8 501 01 600 Sverige

Österreich Eisai GesmbH Tel 43 0 1 535 1980-0 Eesti Eisai Ltd. Tel 44 0 208 600 1400 Ühendkuningriik

Arriani Pharmaceuticals S.A. 30 210 668 3000 Polska Eisai Ltd. Tel. 44 0 208 600 1400 Wielka Brytania

España Eisai Farmacéutica, S.A. Tel 34 91 455 94 55 Portugal Eisai Farmacêutica, Unipessoal Lda Tel 351 214 875 540

France Eisai SAS Tél 33 1 47 67 00 05 România Eisai Ltd. Tel 44 0 208 600 1400 Marea Britanie

Ireland Eisai Ltd. Tel 44 0 208 600 1400 United Kingdom Slovenija Eisai Ltd. Tel 44 0 208 600 1400 Velika Britanija

Ísland Vistor hf. Hörgatún 2 SímiTel 354 535 7000 Slovenská republika Eisai GesmbH organizaní sloka Tel 420 242 485 839 eská republika

Italia Eisai S.r.l. Tel 39 02 5181401 SuomiFinland Eisai AB PuhTel 46 0 8 501 01 600 RuotsiSverige

Arriani Pharmaceuticals S.A. 30 210 668 3000 Sverige Eisai AB Tel 46 0 8 501 01 600

United Kingdom Eisai Ltd. Tel 44 0 208 600 1400 Latvija Eisai Ltd. Tel 44 0 208 600 1400 Lielbritnija

Lietuva
Eisai Ltd.
Tel. + 44 (0) 208 600 1400
(Jungtin- Karalyst-)

This leaflet was last approved in

------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only

INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL

NeuroBloc is provided in vials for single use only.

The medicinal product is ready to use and no reconstitution is required. Do not shake.

To allow division of the total dose between several injections, NeuroBloc may be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection (see section 4.2). Such dilutions with sodium chloride should be done in a syringe, pulling out the desired amount of Neurobloc into the syringe first, and then adding sodium chloride to the syringe. In non clinical experiments, NeuroBloc solution has been diluted up to 6-fold without any resulting change in potency. Once diluted, the medicinal product must be used immediately as the formulation does not contain a preservative.

Any unused solution, all vials of expired NeuroBloc and equipment used in the administration of the medicinal product should be carefully discarded as Medical Bioharzardous Waste in accordance with local requirements. Vials should be visually inspected prior to use. If the NeuroBloc solution is not clear and colourless/light yellow or if the vial appears damaged, the product should not be used, but discarded as Medical Biohazardous Waste in accordance with local requirements.

Decontaminate any spill with 10% caustic solution, or sodium hypochlorite (household chlorine bleach ?2 ml (0.5%): 1 litre water) solution. Wear waterproof gloves and soak up the liquid with an appropriate absorbent. Place the absorbed toxin in an autoclave bag, seal it and process as Medical Biohazardous Waste in accordance with local requirements.

Do not use after the expiration date stamped on the vial.