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LYFLEX 5MG/5ML ORAL SOLUTION

Active substance(s): BACLOFEN

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Lyflex
5 mg/5 ml Oral Solution
Baclofen

61A/L/h/7

Read all of this leaflet carefully before you or your child starts using this medicine since it contains important
information.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as
yours.
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.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

1. What this medicine is and what it is used for
Lyflex Solution contains baclofen which is a muscle relaxant.
Your doctor has decided that you or your child needs this
medicine to help treat your condition.
Baclofen is used to reduce and relieve the excessive tension in
your muscles (spasms) occuring in various illnesses such as
cerebral palsy, multiple sclerosis, cerebrovacular accidents,
spinal cord diseases and other nervous system disorders.
Because baclofen reduces spasms and the pain that goes with
them, it helps to make you more mobile and better able to
manage your daily activities.

2. Before you take
Do NOT take Lyflex Solution if you:
are allergic to baclofen or to any of the other ingredients (see
Section 6)
have or have ever had stomach ulcers.
If any of the above apply to you, speak to your doctor or
pharmacist.
Take special care with Lyflex Solution
Before taking the solution, tell your doctor if you have:
mental illness (e.g. schizophrenia, depression)
Parkinson's disease
epilepsy
high blood pressure or if you take any blood pressure
medication
blood vessel disease or stroke
lung problems which make breathing difficult
liver or kidney problems
diabetes
difficulty in passing urine.
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, and herbal preparations.
Some medicines may be affected by Lyflex or they may affect
how well Lyflex will work. Tell your doctor or pharmacist if you are
taking:
any medicines that tend to make you sleepy, such as
medication used to help you sleep or calm you down, pain
relievers, medicines for colds or allergies, or medicines
containing alcohol
medicines used to treat depression, such as tricyclic
antidepressants
medicines for high blood pressure
anti-inflammatory medicines for arthritis or pain, such as
ibuprofen
medicines for Parkinson's disease.

Pregnancy and breast-feeding
Lyflex can be passed to your unborn or breast-fed baby.
If you need to take Lyflex, your doctor can help you decide
whether or not to take it during pregnancy and while
breast-feeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Lyflex may cause drowsiness. If this occurs do not drive, use
machinery, or perform any tasks that may require you to be alert.
Important information about some of the ingredients of
Lyflex Solution
sorbitol
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicine.
Sorbitol may have a mild laxative effect and can cause an
upset stomach and diarrhoea.
Each 5 ml of Lyflex Solution contains 2.2 g sorbitol.
Calorific value 2.6 kcal/g sorbitol.
methyl hydroxybenzoate and propyl hydroxybenzoate
These may cause allergic reactions (possibly delayed).

3. How to take
Always take Lyflex Solution exactly as your doctor has told you
and always read the label. Your doctor will decide on the
appropriate dose to suit your condition. Ask your doctor or
pharmacist if you are not sure.
Take the solution with food or a milk drink if you find that
taking it makes you nauseous (sick).
Lyflex may increase the effect of alcohol. Drinking alcohol
while taking Lyflex may cause you to feel sleepy. If you feel
that the alcohol is affecting you more than usual, do not drink
alcoholic drinks.
Starting doses
Children (infants and children up to 18 years): the
treatment is adjusted to their body weight. Children’s
treatment usually starts with very low dose (approximately
0.3 mg/kg/day), in 2-4 divided doses (preferably 4 doses).
Adults: the usual starting dose is 5 ml three times a day.
Elderly and those with spasms from brain injury: are
more likely to get side effects, particularly at the start of
treatment. Your doctor may lower the dose.
Increasing and final dose
Children (infants and children up to 18 years): the dosage
should be gradually increased until it becomes sufficient for
the child’s individual requirements, this may be between 0.75
and 2 mg/kg body weight. The total dose should not exceed
a maximum of 40 ml a day in children below 8 years of age.
In children over 8 years of age a maximum dose of 60 ml a
day may be given.
Adults: your doctor may advise you to increase the dose
gradually - i.e. every 3 days, until the appropriate final dose is
reached. Your doctor will decide on the final dose, this will
usually be up to 20 ml three times a day. The maximum dose
is 100 ml a day, although if you are in hospital a higher dose
may be used.

feeling nauseous (sick)
increased need to pass urine which can be painful.
Common side effects (in up to 1 in 10 people):
headaches
vomiting, retching, constipation or diarrhoea
unsteadiness, trembling or other problems with muscle
control
increased muscle spasm
muscle pain or weakness
dry mouth
increased sweating
nightmares or sleeplessness.
Uncommon side effects (in up to 1 in 100 people):
abdominal pain
yellowing of your skin or eyes, pale faeces and dark urine,
unexplained persistent nausea, stomach problems, loss of
appetite or unusual tiredness
sexual problems in men, e.g. impotence
taste disturbances
numbness or tingling in the hands or feet.

Although Lyflex Solution is usually taken three times a day, some
patients may take it only at night or an hour before doing a task,
such as washing, dressing, shaving, etc.
Patients with kidney problems: a lower dose of 5 ml daily is
used.
Blood tests may be carried out during treatment, especially in
those with diabetes or liver diseases.
Taking Lyflex Solution long term
Continue taking Lyflex for as long as the doctor tells you to.
Do not stop taking Lyflex, or lower the dose, without first
checking with your doctor.
If you take more than you should
If you take more solution than you should you may feel very
drowsy or confused.
1. Tell your doctor, pharmacist or nearest hospital casualty
department immediately.
2. Take the bottle and any remaining solution with you so that
people can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but
if it is almost time for your next dose, skip the missed dose and
continue as usual.
Do not take a double dose to make up for a missed dose.
If you stop taking
Stopping this medicine suddenly may cause unwanted effects
such as muscle spasms and increased muscle rigidity, feeling
anxious or confused, changes in mood and emotion, mental
disorders, hallucinations, fast heart rate, fever or convulsions.
Talk to your doctor if you want to stop taking Lyflex Solution. Your
doctor will advise you how to stop the medicine gradually.
Do not let yourself run out of medicine especially over the
weekend or on holidays.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Lyflex Solution can cause side effects,
although not everybody gets them. Do not be alarmed by this list
of possible side effects. You may not experience any of them.
STOP taking the solution and seek medical help immediately
if you have any of the following allergic reactions:
difficulty breathing or swallowing, swelling of the face, lips,
tongue or throat
severe itching of the skin, with a red rash or raised lumps.
Seek immediate medical attention if you have any of the
following symptoms:
excessive weakness of the limbs or feeling tired and
exhausted
feeling dizzy, light-headed, or fainting
hallucinations, confusion
mood changes (e.g. excitement or depression)
blurred or double vision
slow or difficult breathing
skin rash
difficulty in passing urine
seizures (fits)
slurred speech
low body temperature (less than 35°C), feeling cold with
pale-looking skin.
The following side effects are usually mild and settle without
changing the dose. If they are severe or last for more than a few
days, tell your doctor:
Very common side effects (in more than 1 in 10 people):
daytime sleepiness, lack of energy

Not known: frequency cannot be estimated from the
available data
Trouble breathing during sleep (sleep apnoea syndrome).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. 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
Keep out of the reach and sight of children.
Do not take after the expiry date which is stated on the bottle
label and on the carton. The expiry date refers to the last day
of that month.
Do not use after eight weeks from the date of first opening.
Do not store above 25°C. Store in the original package.
Do not throw it away with your household waste or in water.
Return all the unwanted medicine to your pharmacist. This will
help to protect the environment.

6. Further information
What Lyflex Oral Solution contains
The active ingredient is baclofen (5 mg per 5 ml).
The other ingredients are:
sorbitol (E420), methyl hydroxybenzoate (E218), propyl
hydroxybenzoate (E216), carmellose sodium, raspberry
flavour (containing propylene glycol) and water.
(See end of Section 2 for further information on sorbitol,
methyl hydroxybenzoate, and propyl hydroxybenzoate).
What Lyflex Oral Solution looks like and contents of the
pack
Lyflex Oral Solution is a clear, slightly yellow liquid with the smell
and flavour of raspberry.
It is available in amber glass bottles of 300 ml.
Marketing Authorisation Holder
Chemidex Pharma Ltd., Chemidex House, Egham Business
Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Famar Nederland BV, Industrieweg 1, 5531 AD Bladel, the
Netherlands.
This leaflet was last revised in August 2017
'Lyflex' and 'Chemidex' are registered trade marks.

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