Bupivacaine Alternova

Document: Bupivacaine Alternova Solution for injection ENG PL change

Package leaflet: Information for the user

Bupivacaine Alternova 2.5 mg/ml solution for injection

Bupivacaine Alternova 5 mg/ml solution for injection

Bupivacaine hydrochloride

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 or pharmacist.
If you get any 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 Bupivacaine Alternova is and what it is used for

2. What you need to know before you use Bupivacaine Alternova

3. How to use Bupivacaine Alternova

4. Possible side effects

5. How to store Bupivacaine Alternova

6. Contents of the pack and other information

What Bupivacaine Alternova is and what it is used for

Bupivacaine Alternova is a local anaesthetic. It belongs to a group of medicines called amide-type local anaesthetics. It works by blocking the transmission of pain signals through nerves in or near the spinal cord. It is used to numb or make parts of the body free from pain.

Bupivacaine Alternova can be used to:

numb parts of the body during surgery in adults and adolescents above 12 years
relieve of acute pain in adults, infants and children above 1 year of age

It is used for example in surgical operations and as relief of pain after an operation.

What you need to know before you use Bupivacaine Alternova

You should not be given Bupivacaine Alternova:

if you are allergic to bupivacaine hydrochloride or local anaesthetics of the amide type or to any of the other ingredients of this medicine (listed in section 6).
to numb an area by injecting Bupivacine Alternova into a vein
to produce epidural anaesthesia in case you have:

very low blood pressure or low blood volume
a disease in the central nervous system, e.g. meningitis, polio, tumours, increased pressure or bleedings into your brain
a disease in the backbone (e.g. spondylitis, tuberculosis, tumores, recent traumas), spinal stenosis (an abnormal narrowing of spaces in the backbone which causes pressure on the spinal cord and nerves)
blood-poisoning
problems with your spinal cord due to anaemia
an infection near to where the injection will be given
heart problems
problems with blood clotting or if you have been given medicines to reduce blood clotting (with the exception of medicines containing the substance heparin)

Warnings and precautions

Talk to your doctor or nurse before you are given Bupivacaine Alternova if you have any of the diseases or conditions below

if you are elderly and

have any liver disorder
have any kidney disorder
are in a generally impaired condition

very low or very high blood pressure
heart disease

Children
Bupivacaine Alternova is not recommended in children less than 1 year and only recommended for limited indications in children under 12 years.

Other medicines and Bupivacaine Alternova

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

Taking some medicines together can be harmful. Remember that the doctor at the hospital may not have been informed if you have recently begun a course of treatment for another illness. In particular tell your doctor if you are taking:

other local anaesthetics
medicines to control your irregular heartbeat (such as dronedaron or amiodarone)

Pregnancy and breast-feeding

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 taking this medicine.

Driving and using machines

Depending on dose and method of administration Bupivacaine Alternova may affect your ability to drive and use machines. Ask your doctor or nurse when it could be safe to resume these activities.

Bupivacaine Alternova contains sodium

This medicinal product contains 3.15 mg/ml (0.14 mmol/ml) sodium. This should be taken into consideration by patients on a controlled sodium diet.

How to use Bupivacaine Alternova

Bupivacaine Alternova will be given to you by your doctor by injection. It can be injected subcutaneously (under the skin), intramuscularly (into a muscle), intraarticularly (into a joint) or as an epidural injection (into your back).

Recommended dosage:

Your doctor will decide what doses is right for you. The dose will depend on your size, your state of health, the part of the body that the medicine is injected into and what the medicine is being used for. Smaller doses are used for elderly people, young children and people who are unwell.

You may be given this medicine before minor or major surgery, or during childbirth. For minor surgery, the injection will usually be given near the part of the body to be operated on. The medicine will prevent pain and cause numbness which will gradually wear off once the procedure is over. For major surgery or childbirth, you may be given an injection in your back which will take a few minutes. This will prevent pain and cause numbness in the lower half of your body.

Use in children and adolescents
Depending on the type of required analgesia and on the age and weight of the patient, the dosage will be determined by the doctor.

If you are given more Bupivacaine Alternova than you should

Serious sideeffects fromgetting toomuch Bupivacaine Alternova areunlikely. Theyneed special treatmentand thedoctor treatingyou istrained todealwith thesesituations.The firstsigns ofbeing giventoo muchBupivacaine Alternova areusuallyasfollows:

feeling dizzy or light-headed
numbness of the lips and around the mouth.
numbness of the tongue.
hearing problems.
problems with your sight (vision).

To reducetherisk ofseriousside effects,your doctorwill stopgiving youBupivacaine Alternovaas soonas thesesigns appear.This meansthat ifany ofthese happento you,or you thinkyou havereceivedtoo muchBupivacaine Alternova,tell yourdoctor immediately.

More seriousside effectsfrom beinggiven toomuch Bupivacaine Alternovaincludetwitching of yourmuscles, fits(seizures),and lossof consciousness.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away if you get the following rare side effect:
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) (may affect up to 1 in 1,000 people).

If you develop any of the following side effects, contact your doctor immediately:

Fits (uncommon side effect, may affect up to 1 in 100 people)
Heart attack (rare side effect, may affect up to 1 in 1,000 people)

The following side effects have also been reported:

Very Common (may affect more than 1 in 10 people)

nausea (feeling sick)
low blood pressure

Common (may affect up to 1 in 10 people)

slow heartbeat
pins and needles
dizziness
vomiting
not being able to urinate
high blood pressure

Uncommon (may affect up to 1 in 100 people)

convulsions
pins and needles around the mouth, numbness of the tongue
sensitivity to sound, ringing in the ears
visual disturbances
loss of consciousness
tremor
light- headedness
speech disorder

Rare (may affect up to 1 in 1,000 people)

nerve disorders or injury
loss of movement, paralysis
double vision
shallow breathing
a condition called arachnoiditis _{(inflammation of the membrane that surrounds the spinal
cord).} _{The signs include a stinging or burning pain in
the lower back or legs and tingling, numbness or weakness in the
legs.}

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

[To be completed nationally]

5. How to store Bupivacaine Alternova

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

Do not use this medicine after the expiry date which is stated on the vial and the carton after “EXP”. The expiry date refers to the last day of the month.

Do not refrigerate or freeze.

After first opening: to be used immediately

Only clear solutions practically free from particles should be used. Do not use if container is damaged.

Any unused solution should be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw awaymedicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Bupivacaine Alternova contains

The active substance is bupivacaine hydrochloride.

For 2.5mg/ml

Each ml contains 2.5 mg of bupivacaine hydrochloride

Each 10 ml glass vial contains 25 mg of bupivacaine hydrochloride.

Each 20 ml glass vial contains 50 mg of bupivacaine hydrochloride.

For 5 mg/ml

Each ml contains 5 mg of bupivacaine hydrochloride

Each 10 ml glass vial contains 50 mg of bupivacaine hydrochloride.

Each 20 ml glass vial contains 100 mg of bupivacaine hydrochloride.

Other ingredients – Sodium chloride, sodium hydroxide, hydrochloric acid and water for injections.

What Bupivacaine Alternova looks like and contents of the pack

Bupivacaine Alternovais a clear, colourless, aqueous, sterile solution for injection supplied in 10 ml and 20 ml glass vial.

Pack sizes:

5 and 10 X 10 ml Solution for Injection

1, 5 and 10 X 20 ml Solution for Injection

Not all packs sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

Svizera Europe BV
Antennestrat 43

1322 AH Almere
Netherlands

This leaflet was last revised in 3 September 2015.

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The following information is intended for healthcare professionals only:

1. Administration

Solution for injection.

The medicinal product is for epidural use, intraarticular use, subcutaneous use or intramuscular use only.

Bupivacaine may precipitate if diluted with alkaline solutions and should not be diluted or co-administered with sodium bicarbonate injections. This medicinal product must not be mixed with other medicinal products.

For dosing instructions please refer to the SmPC section 4.2.

2. Handling Instructions

For single use only.

Only clear solutions practically free from particles should be used. Any unused solution should be discarded.

Do not use Bupivacaine Alternova after the expiry date as indicated on the carton after “EXP”. The expiry date refers to the last day of the month.

Any unused solution should be adequately disposed of, in accordance with local requirements.

3. Storage information

Do not refrigerate or freeze.

After first opening: to be used immediately.