Lyflex 5mg/5ml Oral Solution
CHEMIDEX GENERICS
61B/L/h/6
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
Baclofen 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 activities.
Pregnancy and breast-feeding
Baclofen can be passed to your unborn or breast-fed baby.
If you need to take Baclofen, 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
Baclofen 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 Baclofen Sugar Free Oral Solution
• sorbitol
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 Baclofen 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).
Do NOT take Baclofen 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 Baclofen 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 Baclofen or they may affect how well Baclofen 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.
Always take Baclofen 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).
• Baclofen may increase the effect of alcohol. Drinking alcohol while taking Baclofen 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 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.
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Although Baclofen 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 Baclofen Solution long term
Continue taking Baclofen for as long as the doctor tells you to.
Do not stop taking Baclofen, 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 Baclofen 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.
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):
• 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.
Reporting of side effects
If you get any side effect, 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.
• 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.
Like all medicines, Baclofen 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:
What Baclofen Sugar Free 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 Baclofen Sugar Free Oral Solution looks like and contents of the pack
Baclofen Sugar Free 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., trading as Chemidex Generics,
7 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 June 2015
^^CHEMIDEX GENERICS
‘Chemidex' is a registered trade mark
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