Chirocaine
2.5mg/ml and 5.0mg/ml solution for injection/concentrate for solution for infusion
Levobupivacaine
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or nurse.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Chirocaine is and what it is used for
2. Before you are given Chirocaine
3. How you will be given Chirocaine
4. Possible side effects
5. How to store Chirocaine
6. Further information
What Chirocaine Is And What It Is Used For
Chirocaine belongs to a group of medicines called local anaesthetics. This type of medicine is used to make an area of the body numb or free from pain.
In adults:
Chirocaine is used as a local anaesthetic to numb parts of the body before major surgery (for example as an epidural for caesarean section) and minor surgery (such as on the eye and mouth).
It is also used for pain relief
- after major surgery
- during childbirth
In children:
Chirocaine can also be used with children to numb parts of the body before surgery and for pain relief after minor surgery, such as the repair of a groin hernia.
Before You Are Given Chirocaine
Do not use Chirocaine:
- if you are allergic (hypersensitive) to levobupivacaine, to any similar local anaesthetics or to any of the other ingredients in Chirocaine (see Section 6)
- if you have very low blood pressure
- as a type of pain relief given by injection into the area around the neck of the womb (the cervix) during the early stage of labour (paracervical block)
- to numb an area by injecting Chirocaine into a vein
Take special care with Chirocaine:
Tell your doctor before you are given Chirocaine if you have any of the diseases or conditions below. You may need to be checked more closely or given a smaller dose.
- if you have a heart condition
- if you suffer from diseases of the nervous system
- if you are weak or ill
- if you are elderly
- if you have liver disease.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines you have obtained without a prescription. In particular, tell them if you are taking medicines for:
- irregular heart beats (such as mexiletine)
- fungal infections (such as ketoconazole) since this may affect how long Chirocaine stays in your body
- asthma (such as theophylline) since this may affect how long Chirocaine stays in your body.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, think you may be pregnant or are breast-feeding.
Chirocaine must not be a given for pain relief by injection into the area around the neck of the womb or cervix during childbirth (paracervical block).
The effect of Chirocaine on the child during the early stages of pregnancy is not known. Therefore, Chirocaine should not be used during the first three months of your pregnancy, unless your doctor thinks it is necessary.
It is not known if levobupivacaine passes into breast milk. However from the experience with a similar drug, only small amounts of levobupivacaine are expected to pass into breast milk. Breast-feeding is therefore possible after having a local anaesthesic.
Driving and using machines
The use of Chirocaine can have a considerable effect on the ability to drive or use machines. You must not drive or operate machinery until all the effects of Chirocaine and the immediate effects of surgery have worn off. Make sure you get advice about this matter from the doctor or nurse who is treating you, before leaving hospital.
Important information about some of the ingredients of Chirocaine
This medicinal product contains 3.6 mg/mL sodium in the bag or ampoule solution to be taken into consideration by patients on a controlled sodium diet.
How You Will Be Given Chirocaine
Your doctor will give you Chirocaine by injection through a needle or into a small tube in your back (epidural). Chirocaine can also be injected into other parts of the body to numb the area that you will have treated, such as the eye, arm or leg.
Your doctor and nurse will watch you carefully while you are being given Chirocaine.
Dosage
The amount of Chirocaine you will be given and how often it is given will depend on why it is being used and also on your health, age and weight. The smallest dose that can produce numbness in the required area will be used. The dose will be carefully worked out by your doctor.
When Chirocaine is used for pain relief during labour or for childbirth by caesarean section (an epidural), the dose used should be particularly carefully controlled.
If you get more Chirocaine than you should
If you get more Chirocaine than you should, you may have numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including stopping breathing) and even fits (convulsions). If you notice any of these symptoms, tell your doctor immediately. Sometimes too much Chirocaine may also cause low blood pressure, fast or slow heartbeats and changes in your heart rhythm. Your doctor may need to give you other medicines to help stop these symptoms.
Possible Side Effects
Like all medicines, Chirocaine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you notice any of the following side effects. Some side effects with Chirocaine can be serious.
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data
Very common side effects are:
- feeling tired or weak, short of breath, looking pale (these are all signs of anaemia)
- low blood pressure
- nausea
Common side effects are:
- dizziness
- headache
- vomiting
- problems (distress) for an unborn child
- back pain
- high body temperature (fever)
- pain after surgery
Other side effects (frequently not known) are:
- serious allergic (hypersensitive) reactions which cause severe breathing difficulties, difficulty in swallowing, hives and very low blood pressure.
- allergic (hypersensitive) reactions recognised by red itchy skin, sneezing, sweating a lot, rapid heartbeat, fainting or swelling of the face, lips, mouth, tongue or throat.
- fits (convulsions)
- loss of consciousness
- drowsiness
- blurred vision
- breathing stopping
- localized tingling
- numbness of the tongue
- muscle weakness or twitching
- loss of bladder or bowel control
- paralysis
Fast, slow or irregular heartbeats, and heart rhythm changes that can be seen on an ECG, have also been reported as side effects.
Rarely, some side effects may be permanent.
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 nurse right away.
How To Store Chirocaine
- Keep out of the reach and sight of children.
- Do not use Chirocaine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
- Your doctor will store this medicine for you.
- The solution should be used immediately after opening
- The solution should not be used if there are visible particles in it.
Medicines should not be disposed of through wastewater or household waste. These measures will help to protect the environment.
Further Information
What Chirocaine contains
The active ingredient is levobupivacaine (as hydrochloride).
Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion: One ml contains 2.5 mg levobupivacaine (as hydrochloride). Each ampoule contains 25 mg in 10 ml.
Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion: One ml contains 5 mg levobupivacaine (as hydrochloride). Each ampoule contains 50 mg in 10 ml.
The other ingredients are water for injection, sodium chloride, sodium hydroxide and a small quantity of hydrochloric acid.
What Chirocaine looks like and contents of the pack
Chirocaine Solution for injection / concentrate for solution for infusion is available in strengths containing 2.5 mg or 5.0 mg of levobupivacaine per ml. It is a clear, colourless solution, in polypropylene ampoules. Each ampoule contains 25 mg or 50 mg levobupivacaine in a 10 ml ampoule. It is supplied in packs of 5, 10 or 20 ampoules.
Marketing Authorisation Holder
In the UK:
Berkshire
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Chirocaine: Sweden, Portugal, Switzerland, Latvia, Netherlands, Poland, France, UK, Ireland, Finland, Greece, Slovenia, Austria, Belgium, Hungary, Bulgaria, Czech Republic, Luxembourg
Chirocain: Germany
Chirocane: Spain
This leaflet was last approved in May 2010
131-850-04
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