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Active substance(s): BACLOFEN / BACLOFEN / BACLOFEN

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5 mg/5 ml Oral Solution

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.



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 you 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, cerebravacular 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

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
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
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 Oral
If you have been told 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 cildren 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 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 20 ml three
times a day. The maximum daily dose is 100 ml a day, although if you
are in hospital a higher dose may be used.
Continued over page


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
1. Tell your doctor, pharmacist or nearest hospital casualty department
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
Do not use 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
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
severe itching of the skin, with a red rash or raised lumps.
Seek immediate medical attention if you have any of the following
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
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
feeling nauseous (sick)
increased need to pass urine which can be painful.
Common side effects (in up to 1 in 10 people):
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.
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:
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.
Famar Nederland BV, Industrieweg 1, 5531 AD Bladel, The Netherlands.
This leaflet was last revised in June 2015
'Lyflex' and 'Chemidex' are registered trade marks.



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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.