LYFLEX 5MG/5ML ORAL SOLUTION

Active substance: BACLOFEN

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Lyflex
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.

Baclofen

61A/L/h/5

Read all of this leaflet carefully before you or your child starts using this medicine since it contains important information.
iKeep this leaflet. You may need to read it again.
iIf you have any further questions, ask your doctor or pharmacist.
iThis 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.
iIf 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 disease 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:
iare allergic to baclofen or to any of the other ingredients (see
Section 6)
ihave 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:
imental illness (e.g. schizophrenia, depression)
iParkinson's disease
iepilepsy
ihigh blood pressure or if you take any blood pressure medication
iblood vessel disease or stroke
ilung problems which make breathing difficult
iliver or kidney problems
idiabetes
idifficulty 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:
iany 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
imedicines used to treat depression, such as tricyclic antidepressants
imedicines for high blood pressure
ianti-inflammatory medicines for arthritis or pain, such as ibuprofen
imedicines 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
Solution
isorbitol
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.
imethyl 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.
iTake the solution with food or a milk drink if you find that taking it
makes you nauseous (sick).
iLyflex 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.

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 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
holidays.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

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):
idaytime sleepiness, lack of energy
ifeeling nauseous (sick)
iincreased need to pass urine which can be painful.
Common side effects (in up to 1 in 10 people):
iheadaches
ivomiting, retching, constipation or diarrhoea
iunsteadiness, trembling or other problems with muscle control
iincreased muscle spasm
imuscle pain or weakness
idry mouth
iincreased sweating
inightmares or sleeplessness.
Uncommon side effects (in up to 1 in 100 people):
iabdominal pain
iyellowing of your skin or eyes, pale faeces and dark urine,
unexplained persistent nausea, stomach problems, loss of appetite
or unusual tiredness
isexual problems in men, e.g. impotence
itaste disturbances
inumbness or tingling in the hands or feet.
If any of the side effects get troublesome, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store
iKeep out of the reach and sight of children.
iDo 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.
iDo not use after eight weeks from the date of first opening.
iDo not store above 25°C. Store in the original package.
iDo 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.

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:
idifficulty breathing or swallowing, swelling of the face, lips, tongue or
throat
isevere itching of the skin, with a red rash or raised lumps.
Seek immediate medical attention if you have any of the following
symptoms:
iexcessive weakness of the limbs or feeling tired and exhausted
ifeeling dizzy, light-headed, or fainting
ihallucinations, confusion
imood changes (e.g. excitement or depression)
iblurred or double vision
islow or difficult breathing
iskin rash
idifficulty in passing urine
iseizures (fits)
islurred speech
ilow body temperature (less than 35°C), feeling cold with pale-looking
skin.

6. Further information
What Lyflex Oral Solution contains
iThe active ingredient is baclofen (5 mg per 5 ml).
iThe 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

05/2011

'Lyflex' and 'Chemidex' are registered trade marks.

61A/L/h/5

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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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