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ANECTINE 50 MG/ML INJECTION

Active substance(s): SUXAMETHONIUM

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10000000132023

GSK-ITA-Parma-ITPAR

United Kingdom-GBR

Anectine

N/A

D03000LEA

N/A

N/A

K

1

0

0

3

8 pt

9 pt
8 pt

FRONT PAGE
10000000132023

The following information is intended for medical
or healthcare professionals only

Anectine® 50 mg / ml
Injection
suxamethonium chloride
Product Summary
1. NAME OF THE MEDICINAL PRODUCT
Anectine 50 mg/ml Injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Suxamethonium chloride Injection BP 100 mg in 2 ml.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
.
Solution for injection.
. .
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Used in anaesthesia as a muscle relaxant to facilitate endotracheal
intubation, mechanical ventilation and a wide range of surgical and
obstetric procedures.
It is also used to reduce the intensity of muscular contractions
associated with pharmacologically or electrically-induced convulsions.
4.2 Posology and method of administration
Usually by bolus intravenous injection.
Adults: The dose is dependent on body weight, the degree of
muscular relaxation required, the route of administration, and the
response of individual patients.
To achieve endotracheal intubation Anectine is usually administered
intravenously in a dose of 1 mg/kg. This dose will usually produce
muscular relaxation in about 30 to 60 seconds and has a duration
of action of about 2 to 6 minutes. Larger doses will produce more
prolonged muscular relaxation, but doubling the dose does not
necessarily double the duration of relaxation. Supplementary doses
of Anectine of 50% to 100% of the initial dose administered at 5 to
10 minute intervals will maintain muscle relaxation during short
surgical procedures performed under general anaesthesia.
For prolonged surgical procedures Anectine may be given by
intravenous infusion as a 0.1% to 0.2% solution, diluted in
5% glucose solution or sterile isotonic saline solution, at a rate
of 2.5 to 4 mg per minute. The infusion rate should be adjusted
according to the response of individual patients.
The total dose of Anectine given by repeated intravenous injection or
continuous infusion should not exceed 500 mg per hour.
Children: Infants and young children are more resistant to Anectine
compared with adults.
The recommended intravenous dose of Anectine for neonates
and infants is 2 mg/kg. A dose of 1 mg/kg in older children is
recommended.
When Anectine is given as intravenous infusion in children, the
dosage is as for adults with a proportionately lower initial infusion
rate based on body weight.
Anectine may be given intramuscularly to infants at doses
up to 4 to 5 mg/kg and in older children up to 4 mg/kg. These
doses produce muscular relaxation within about 3 minutes.
A total dose of 150 mg should not be exceeded.
Use in the elderly: Dosage requirements of Anectine in the
elderly are comparable to those for younger adults.
The elderly may be more susceptible to cardiac
arrhythmias, especially if digitalis‑like drugs are also being
taken. (see section 4.4).
Use in renal impairment: A normal single dose of
suxamethonium injection may be administered to patients with
renal insufficiency in the absence of hyperkalaemia. Multiples
or larger doses may cause clinically significant rises in serum
potassium and should not be used (see section 4.3 and 4.4).
Use in hepatic impairment: Termination of the action of
suxamethonium is dependent on plasma cholinesterase,
which is synthesised in the liver. Although plasma
cholinesterase levels often fall in patients with liver
disease, with the exception of severe hepatic failure,
levels are seldom low enough to significantly prolong
suxamethonium-induced apnoea (see section 4.4).
Use in patients with reduced plasma cholinesterase: Patients with
reduced plasma cholinesterase activity may experience prolonged
and intensified neuromuscular blockade following administration of
suxamethonium. In these patients it may be advisable to administer
reduced doses of suxamethonium injection (see section 4.3, 4.4 and 4.5).
Monitoring advice: Monitoring of neuromuscular function is
recommended during infusion of suxamethonium injection or if
suxamethonium injection is to be administered in relatively large
cumulative doses over a relatively short period of time in order to
individualise dosage requirements (see section 4.4).
Instructions to open the ampoule: See section 6.6 Special precautions
for disposal and other handling for further information.
4.3 Contra‑indications
Anectine has no effect on the level of consciousness and should not
be administered to a patient who is not fully anaesthetised.
Hypersensitivity to suxamethonium may exist in rare instances,
and Anectine should not be administered to patients known to be
hypersensitive to the drug.
As suxamethonium can act as a trigger of sustained myofibrillar
contraction in susceptible individuals, Anectine is contraindicated in
patients with a personal or family history of malignant hyperthermia.
If this condition occurs unexpectedly, all anaesthetic agents known
to be associated with its development (including Anectine) must be
immediately discontinued, and full supportive measures must be
immediately instituted. Intravenous dantrolene sodium is the primary
specific therapeutic drug and is recommended as soon as possible
after the diagnosis is made.
Anectine is contraindicated in patients known to have an inherited
atypical plasma cholinesterase activity.

Package Leaflet: Information for the
patient

Anectine® 50 mg / ml
Injection
suxamethonium chloride
Read all of this leaflet carefully before
you are given 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, nurse or member of the
operating theatre staff.
- If you get any side effects, talk to your
doctor, nurse, or member of the operating
theatre staff. This includes any possible
side effects not listed in this leaflet. See
section 4.
What is in this leaflet:
1. What Anectine is and what it is used for
2. What you need to know before you are
given Anectine
3. How Anectine is given
4. Possible side effects
5. How to store Anectine
6. Contents of the pack and other
information
1. What Anectine is and what it
is used for
Anectine contains a medicine called
suxamethonium chloride. This belongs to a
group of medicines called muscle relaxants.
Anectine is used:
• to relax muscles during operations on
adults and children
• to help insert a tube into the windpipe
(endotracheal intubation), if a person
needs help to breathe
• to reduce how strongly your muscles
contract
Ask your doctor if you would like more
explanation about this medicine.

You should not be given Anectine if:
• you are allergic to suxamethonium
chloride, any other muscle relaxants or
any of the other ingredients of Anectine
Injection (listed in section 6)
• you or your family have reacted badly to an
anaesthetic before such as a very high body
temperature (malignant hyperthermia)
• you have an inherited enzyme abnormality,
pseudocholinesterase which breaks down
suxamethonium in the body
• you have had a major accident, operation
or severe burns within the last three
months
• you have not been able to move for a
long time such as to allow a broken bone
to mend or a long period of bed rest
• you have high levels of potassium in your
blood (hyperkalaemia)
• you have recently had an eye injury
• you suffer from a problem caused by too
much pressure in your eye called ‘glaucoma’
• you or any of your family have a disease
of the muscles or nerves, such as a
muscle wasting disease, paralysis, motor
neurone disease, muscular dystrophy or
cerebral palsy.
If any of the above apply to you or if you
are not sure, talk to your doctor, nurse
or member of the operating theatre staff
before you are given Anectine.
Warnings and precautions
Talk to your doctor, nurse or member of the
operating theatre staff before having this
medicine if you have:
• tetanus, an infection which occurs
through wound contamination
• tuberculosis or other severe or
long-standing infection
• had any long-standing illness which has
left you weak
• cancer
.
• anaemia
. .
• malnutrition
• liver or kidney problems
• auto-immune diseases, for example,
multiple sclerosis
• an underactive thyroid gland, a condition
known as myxoedema
• muscle disease, for example, myasthenia
gravis

No

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An acute transient rise in serum potassium often occurs following
the administration of Anectine in normal individuals; the magnitude
of this rise is of the order of 0.5 mmol/litre. In certain pathological
states or conditions this increase in serum potassium following
Anectine administration may be excessive and cause serious cardiac
arrhythmias and cardiac arrest. For this reason the use of Anectine is
contraindicated in:
• patients recovering from major trauma or severe burns; the period
of greatest risk of hyperkalaemia is from about 5 to 70 days
after the injury and may be further prolonged if there is delayed
healing due to persistent infection.
• patients with neurological deficits involving acute major muscle
wasting (upper and/or lower motor neurone lesions); the
potential for potassium release occurs within the first 6 months
after the acute onset of the neurological deficit and correlates
with the degree and extent of muscle paralysis. Patients who
have been immobilised for prolonged periods of time may be at
similar risk.
• patients with pre-existing hyperkalaemia. In the absence
of hyperkalaemia and neuropathy, renal failure is not a
contra-indication to the administration of a normal single dose of
Anectine Injection, but multiple or large doses may cause clinically
significant rises in serum potassium and should not be used.
Suxamethonium causes a significant transient rise in intra‑ocular
pressure, and should therefore not be used in the presence of
open eye injuries or where an increase in intra‑ocular pressure is
undesirable unless the potential benefit of its use outweighs the
potential risk to the eye.
Anectine should be avoided in patients with a personal or family
history of congenital myotonic diseases such as myotonia congenita
and dystrophia myotonica since its administration may on occasion
be associated with severe myotonic spasms and rigidity.
Anectine should not be used in patients with skeletal muscle
myopathies e.g. Duchenne muscular dystrophy since its
administration may be associated with malignant hyperthermia,
ventricular dysrhythmias and cardiac arrest secondary to acute
rhabdomyolysis with hyperkalaemia.
4.4 Special warnings and precautions for use
Anectine paralyses the respiratory muscles as well as other skeletal
muscles but has no effect on consciousness.
Anectine should be administered only by or under close supervision
of an anaesthetist familiar with its action, characteristics and
hazards, who is skilled in the management of artificial respiration
and only where there are adequate facilities for immediate
endotracheal intubation with administration of oxygen by
intermittent positive pressure ventilation.
High rates of cross‑sensitivity (greater than 50%) between
neuromuscular blocking agents have been reported. Therefore,
where possible, before administering suxamethonium,
hypersensitivity to other neuromuscular blocking agents should be
excluded. Suxamethonium, should only be used when absolutely
essential in susceptible patients. Patients who experience a
hypersensitivity reaction under general anaesthesia should be tested
subsequently for hypersensitivity to other neuromuscular blockers.
Suxamethonium injection should not be mixed with any other drug
prior to its administration.
Suxamethonium injection is acidic and should not be mixed with
highly alkaline solutions, e.g. barbiturates.
During prolonged administration of Anectine, it is recommended
that the patient is fully monitored with a peripheral nerve stimulator
in order to avoid overdosage.
Anectine is rapidly hydrolysed by plasma cholinesterase which
thereby limits the intensity and duration of the neuromuscular
blockade.
Individuals with decreased plasma cholinesterase activity exhibit a
prolonged response to suxamethonium. Approximately 0.05% of the
population has an inherited cause of reduced cholinesterase activity.
Prolonged and intensified neuromuscular blockade following
Anectine Injection may occur secondary to reduced plasma
cholinesterase activity in the following states or pathological
conditions:
• physiological variation as in pregnancy and the puerperium
(see section 4.6)
• genetically determined abnormal plasma cholinesterase (see
section 4.3)
• severe generalised tetanus, tuberculosis, other severe or chronic
infections
• following severe burns (see section 4.3)
• chronic debilitating disease, malignancy, chronic anaemia and
malnutrition
• end-stage hepatic failure, acute or chronic renal failure (see
section 4.2)
• auto-immune diseases: myxoedema, collagen diseases
• iatrogenic: following plasma exchange, plasmapheresis,
cardiopulmonary bypass, and as a result of concomitant drug
therapy (see section 4.5).
If Anectine is given over a prolonged period, the characteristic
depolarising neuromuscular (or Phase I) block may change to
one with characteristics of a non‑depolarising (or Phase II) block.
Although the characteristics of a developing Phase II block resemble
those of a true non‑depolarising block, the former cannot always be
fully or permanently reversed by anticholinesterase agents. When a
Phase II block is fully established, its effects will then usually be fully
reversible with standard doses of neostigmine accompanied by an
anticholinergic agent.
Tachyphylaxis occurs after repeated administration of Anectine.
Muscle pains are frequently experienced after administration of
suxamethonium and most commonly occur in ambulatory patients
undergoing short surgical procedures under general
anaesthesia. There appears to be no direct connection
between the degree of visible muscle fasciculation after
Anectine administration and the incidence or severity
of pain. The use of small doses of non‑depolarising
muscle relaxants given minutes before suxamethonium
administration has been advocated for the reduction
of incidence and severity of suxamethonium‑associated
muscle pains. This technique may require the use of
doses of suxamethonium in excess of 1 mg/kg to achieve
satisfactory conditions for endotracheal intubation.

2. What you need to know before
you are given Anectine

85%

• recently had a blood transfusion or a
heart-lung bypass
• been in contact with insecticides
• ever had an allergic reaction to any
muscle relaxant which was given as part
of an operation.
Other medicines and Anectine
Tell your doctor, nurse or other relevant
hospital staff member if you are taking or
have recently taken any other medicines. This
includes any herbal products or medicines
bought without a prescription. This is
because these medicines can affect how well
Anectine works or can cause side effects.
In particular tell your doctor, nurse or
member of the operating theatre staff if
you are taking any of the following:
• anaesthetics, or other medicines used
during surgery such as painkillers
• medicines for raised pressure in the eye
(glaucoma) such as ecothiophate eye drops
• medicines for coughs, cold, sleeping or
tablets for allergies
• medicines used to treat malaria,
containing chloroquine or quinine
• oral contraceptives
• medicines for treating asthma and other
breathing conditions
• medicines containing metoclopramide, used
to treat and prevent feeling or being sick
• m
 edicines for treating cancer (cytotoxic drugs)
• medicines for mental problems
• medicines containing magnesium
• medicines containing oestrogens
• medicines containing steroids
• antibiotics
• medicines used to treat
disturbances in heartbeat rhythm
(antiarrhythmic drugs)
• medicines used to treat myasthenia gravis
• medicines used to control your heart
• medicines used to control your blood
pressure during surgery
• medicines that can affect the way your
body fights disease (immunosuppressants)
such as azathioprine. These can be used
to stop your body rejecting a transplanted
organ or for ‘auto-immune’ diseases such
as rheumatoid arthritis.
• medicines used to treat depression
and/or anxiety SSRIs (selective serotonin
reuptake inhibitors) including fluoxetine,
paroxetine, sertraline, fluvoxamine,
citalopram, escitalopram.

Caution should be exercised when using suxamethonium in
children, since paediatric patients are more likely to have an
undiagnosed myopathy or an unknown predisposition to malignant
hyperthermia and rhabdomyolysis, which places them at increased
risk of serious adverse events following suxamethonium (see
section 4.3 and section 4.8).
In patients with severe sepsis, the potential for hyperkalaemia seems
to be related to the severity and duration of infection.
It is inadvisable to administer Anectine to patients with advanced
myasthenia gravis. Although these patients are resistant to
suxamethonium they develop a state of Phase II block which can
result in delayed recovery. Patients with myasthenic Eaton‑Lambert
syndrome are more sensitive than normal to Anectine, necessitating
dosage reduction.
In healthy adults, Anectine occasionally causes a mild transient
slowing of the heart rate on initial administration. Bradycardias are
more commonly observed in children and on repeated administration
of suxamethonium in both children and adults. Pre‑treatment with
intravenous atropine or glycopyrrolate significantly reduces the
incidence and severity of suxamethonium‑related bradycardia.
In the absence of pre‑existing or evoked hyperkalaemia,
ventricular arrhythmias are rarely seen following suxamethonium
administration. Patients taking digitalis‑like drugs are however more
susceptible to such arrhythmias. The action of suxamethonium on the
heart may cause changes in cardiac rhythm including cardiac arrest.
4.5 Interactions with other medicinal products and other forms of
interaction
Certain drugs or chemicals are known to reduce normal plasma
cholinesterase activity and may therefore prolong the neuromuscular
blocking effects of Anectine. These include:
• organophosphorous insecticides and metriphonate
• ecothiopate eye drops
• trimetaphan
• specific anticholinesterase agents: neostigmine, pyridostigmine,
physostigmine, edrophonium; tacrine hydrochloride
• cytotoxic compounds: cyclophosphamide, mechlorethamine,
triethylene-melamine, and thiotepa
• psychiatric drugs: phenelzine, promazine and chlorpromazine
• anaesthetic agents and drugs: ketamine, morphine and morphine
antagonists, pethidine, pancuronium, propanidid
• selective serotonin reuptake inhibitors (SSRI).
Other drugs with potentially deleterious effects on plasma
cholinesterase activity include aprotinin, diphenhydramine,
promethazine, oestrogens, oxytocin, high‑dose steroids, and oral
contraceptives, terbutaline and metoclopramide.
Certain drugs or substances may enhance or prolong the
neuromuscular effects of Anectine by mechanisms unrelated to
plasma cholinesterase activity. These include:
• magnesium salts
• lithium carbonate
• azathioprine
• quinine and chloroquine
• antibiotics such as the aminoglycosides, clindamycin and
polymyxins
• antiarrhythmic drugs: quinidine, procainamide, verapamil,
beta-blockers, lidocaine and procaine
• volatile inhalational anaesthetic agents: halothane, enflurane,
desflurane, isoflurane, diethylether and methoxyflurane have
little effect on the Phase I block of Anectine Injection but will
accelerate the onset and enhance the intensity of a Phase II
suxamethonium-induced block.
Patients receiving digitalis‑like drugs are more susceptible to the
effects of suxamethonium‑exacerbated hyperkalaemia.
4.6 Fertility, pregnancy and lactation
No studies of the effect of suxamethonium on female fertility or
pregnancy have been performed.
Suxamethonium has no direct action on the uterus or other smooth
muscle structures. In normal therapeutic doses it does not cross the
placental barrier in sufficient amounts to affect the respiration of
the infant.
The benefits of the use of suxamethonium as part of a rapid
sequence induction for general anaesthesia normally outweigh the
possible risk to the foetus.
Plasma cholinesterase levels fall during the first trimester of
pregnancy to about 70 to 80% of their pre‑pregnancy values; a
further fall to about 60 to 70% of the pre‑pregnancy levels occurs
within 2 to 4 days after delivery. Plasma cholinesterase levels then
increase to reach normal over the next 6 weeks. Consequently, a high
proportion of pregnant and puerperal patients may exhibit mildly
prolonged neuromuscular blockade following Anectine Injection.
It is not known whether suxamethonium or its metabolites are
excreted in human milk.
4.7 Effects on ability to drive and use machines
This precaution is not relevant to the use of suxamethonium
injection. Suxamethonium will always be used in combination with a
general anaesthetic and therefore the usual precautions relating to
performance of tasks following general anaesthesia apply.
4.8 Undesirable effects
Adverse reactions are listed below by system organ class and
frequency. Estimated frequencies were determined from
published data. Frequencies are defined as follows: very common
(≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100);
rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Immune system disorders
Very rare Anaphylactic reactions.
Eye disorders
Common Increased intraocular pressure.
Cardiac disorders
Common Bradycardia, tachycardia.
Rare
Arrhythmias (including ventricular
arrhythmias), cardiac arrest.
There are case reports of hyperkalaemia‑related cardiac
arrests following the administration of suxamethonium to
patients with congenital cerebral palsy, tetanus, Duchenne
muscular dystrophy, and closed head injury. Such events
have also been reported rarely in children with hitherto
undiagnosed muscular disorders.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think
you may be pregnant, are planning to have
a baby or have given birth in the last six
weeks, ask your doctor for advice before
taking this medicine.
Driving and using machines
It can be dangerous to drive or operate
machinery too soon after having had an
operation. Your doctor will tell you how long to
wait before you can drive and use machinery.
3. How Anectine is given
How your injection is given
You will never be expected to give yourself
this medicine. It will always be given to you
by a person who is qualified to do so.
Anectine can be given:
• as a single injection into your vein
(intravenous bolus injection)
• as a continuous infusion into your vein.
This is where the drug is slowly given to
you over a long period of time.
Your doctor will decide the way you are
given the drug and the dose you will
receive. It will depend on:
• your body weight
• the amount of muscle relaxation you
require
• your expected response to the medicine.
If you receive more Anectine than you
should
Anectine will always be given under carefully
controlled conditions. However, if you think
that you have been given more than you
should tell your doctor or nurse immediately.
If you have any further questions on the use
of this medicine, ask your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you get any side effects, talk to your
doctor, nurse or other relevant hospital staff
member. This includes any possible side
effects not listed in this leaflet.
Very rarely, a sudden and severe allergic
reaction to Anectine can occur. If you get
any of the following symptoms tell your
doctor or nurse immediately:
• shortness of breath, wheezing or trouble
breathing
• swelling of your eyelids, face, lips, tongue
or other parts of the body
• rash, itching or hives on the skin
• a collapse.

Vascular disorders
.
Common Skin flushing.
. .
Hypertension and hypotension have also been reported.
Respiratory, thoracic and mediastinal disorders
Rare
Bronchospasm, prolonged respiratory depression†,
apnoea†.
† Individuals with decreased plasma cholinesterase activity exhibit a
prolonged response to suxamethonium. Approximately 0.05% of the
population has an inherited cause of reduced cholinesterase activity
(please refer to section 4.4).
Gastrointestinal disorders
Very common Increased intragastric pressure.
Excessive salivation has also been reported
Skin and subcutaneous tissue disorders
Common
Rash.
Musculoskeletal and connective tissue disorders
Very common Muscle fasciculation, post‑operative muscle pains
(please refer to section 4.4).
Common Myoglobinaemia#, myoglobinuria#.
Rare
Trismus
# Rhabdomyolysis has also been reported (see section 4.3 and
section 4.4).
General disorders and administration site conditions
Very rare Malignant hyperthermia (please refer to section 4.4).
Investigations
Common Transient blood potassium increase
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows continued monitoring
of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Apnoea and prolonged muscle paralysis are the main serious effects
of overdosage. It is essential, therefore, to maintain the airway and
adequate ventilation until spontaneous respiration occurs.
The decision to use neostigmine to reverse a Phase II
suxamethonium‑induced block depends on the judgement of the
clinician in the individual case. Valuable information in regard to
this decision will be gained by monitoring neuromuscular function.
If neostigmine is used its administration should be accompanied by
appropriate doses of an anticholinergic agent such as atropine.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Peripherally acting muscle relaxants,
choline derivatives, ATC code: M03AB01.
Short‑acting depolarising neuromuscular blocking agent.
5.2 Pharmacokinetic properties
None stated.
5.3 Preclinical safety data
Genotoxicity:‑
No bacterial mutation assays have been conducted.
There are some data to suggest a weak clastogenic effect in mice, but
not in patients who had received suxamethonium chloride.
Carcinogenicity:‑
Carcinogenicity studies have not been performed.
Embryo‑foetal Development:‑
Animal reproduction studies have not been conducted
with suxamethonium. It is also not known whether
suxamethonium can affect reproductive capacity or cause
foetal harm when administered to a pregnant woman.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections EP.
6.2 Incompatibilities
None known.
Suxamethonium injection should not be mixed with any
other drug prior to its administration.
6.3 Shelf life
18 months.
6.4 Special precautions for storage
Store between 2 and 8°C. Do not freeze. Keep in the outer carton to
protect from light.
6.5 Nature and contents of container
Neutral glass. 2ml ampoules.
6.6 Special precautions for disposal and other handling
For intravenous injection under medical direction.
Instructions to open the ampoule
Ampoules are equipped with the OPC (One Point Cut) opening
system and must be opened using the following instructions:
• h
 old with the hand the bottom part of
the ampoule as indicated in picture 1
• put the other hand on the top of
the ampoule positioning the thumb
above the coloured point and press as
Picture 1
indicated in picture 2

Picture 2

7. MARKETING AUTHORISATION HOLDER
The Wellcome Foundation Limited
980 Great West Road, Brentford, Middlesex TW8 9GS,
United Kingdom
trading as GlaxoSmithKline UK,
Stockley Park West, Uxbridge, Middlesex UB11 1BT
8. MARKETING AUTHORISATION NUMBER
PL 00003/5203R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30 August 1985/16 May 2008
This leaflet was last revised in July 2015

There are other serious side effects that
you and your doctor must look out for. You
must tell your doctor or nurse straight
away if you have any of the following:
Common (may affect up to 1 in 10 people)
• raised pressure of fluid in the eye which
may cause headache or blurred vision
• speeding up or slowing down of your
heart rate
• protein in the blood or urine due to
muscle damage
• muscle damage which may make your
muscles ache or feel tender, stiff and
weak. Your urine may also look dark or
be red or cola coloured.
Rare (may affect up to 1 in 1,000 people)
• abnormal heart rhythm
• heart problems including changes in the
way in which your heart beats or your
heart stopping beating
• difficulty in breathing or temporary loss
of breath.
Very rare (may affect up to 1 in 10,000 people)
• high body temperature.
Other side effects include:
Very common (may affect more than 1 in
10 people)
• abdominal cramps or pain and a feeling
of nausea or “fullness”
• visible twitching of muscle under the skin
• excessive production of saliva
• muscle pain after the operation your doctor will monitor you for this.
Common (may affect up to 1 in 10 people)
• skin flushing
• skin rash
• high level of potassium in your blood
• high/low blood pressure
Rare (may affect up to 1 in 1,000 people)
• difficulty in opening your mouth.
Reporting of side effects
If you get any side effects, talk to your
doctor, nurse 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.
By reporting side effects you can help
provide more information on the safety of
this medicine.
5. How to store Anectine
• 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 pack after
“EXP”. The expiry date refers to the last
day of that month

• Store in a refrigerator, between 2 and
8°C. Do not freeze
• Store in the original package to protect
from light
• Do not throw away any medicines via
wastewater or household waste. Your
doctor or nurse will throw away any
medicine that is no longer required. This
will help protect the environment.
6. Contents of the pack and other
information
What Anectine contains
• The active substance is 50 mg / ml
suxamethonium chloride
• The other ingredient is water for injection.
What Anectine looks like and contents
of the pack
Anectine Injection is supplied as a clear,
colourless solution in a neutral glass, 2 ml
ampoule.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
The Wellcome Foundation Limited,
Stockley Park West, Uxbridge,
Middlesex UB11 1BT
Manufacturer:
GlaxoSmithKline Manufacturing S.p.A.,
Strada Provinciale Asolana 90,
43056 San Polo di Torrile, Parma, Italy
Other formats
To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:
0800 198 5000 (UK Only).
Please be ready to give the following
information:
Product name:
Anectine 50 mg / ml

Injection
Reference number: 00003/5203R
This is a service provided by the Royal
National Institute of Blind People.
The Information provided applies only to
Anectine 50 mg / ml Injection.
This leaflet was last revised in July 2015
Anectine is a registered trade mark of the
GSK group of companies.
© 2015 GSK group of companies.
All rights reserved.
.
. .
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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