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BACLOFEN 5MG/5ML ORAL SOLUTION

Active substance(s): BACLOFEN

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10 mm

10 mm

8 mm

over 8 years of age a maximum daily dose of 60 m

GB 726-8535-APIL
31021618

If you have kidney problems
A lower dose of 5 mg (5 mL) daily may be used.

Baclofen 5 mg/5 mL Oral Solution

If you are not sure about how much medicine to tak

60 mm

Baclofen

Shake the bottle well before you take your medicine

Read all of this leaflet carefully before you start taking this medicine.
- Please 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 becomes severe, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

If you feel sick after taking this medicine, you may f

Do not stop taking your medicine suddenly; unwan
rigidity, fast heart rate, fever, confusion, hallucinatio
persecuted or convulsions (fits) may occur. Ask yo

If you take more solution than you should
If you accidentally take too much of your medicine,
casualty department. Take your medicine with you.

In this leaflet:
1. What Baclofen 5 mg/5 mL Oral Solution is and what it is used for
2. Before you take Baclofen 5 mg/5 mL Oral Solution
3. How to take Baclofen 5 mg/5 mL Oral Solution
4. Possible side effects
5. How to store Baclofen 5 mg/5 mL Oral Solution
6. Further information

If you forget to take your medicine
If you forget to take a dose, just take the next dose

4. POSSIBLE SIDE EFFECTS
Like all medicines, Baclofen 5 mg/5 mL Oral Solutio
You are unlikely to get any of the following, but if yo
• Skin reddening, itching, difficulty in breathing or
might be due to some of the ingredients. These
• Excessive weakness of the limbs or feeling tired
• Difficulty in passing water
• Hallucinations (seeing or hearing things which a
• Fits
• Blurred or double vision, difficulty in focussing,
• Symptoms similar to the effects of alcohol
• Fainting
• Breathing difficulties
• Mood changes
• Skin rash
If you notice any side effects mentioned above, plea

1. WHAT BACLOFEN 5 MG/5 ML ORAL SOLUTION IS AND WHAT IT IS USED FOR
The name of your medicine is Baclofen 5 mg/5 mL Oral Solution. The active ingredient is baclofen.
Baclofen 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) occurring in various
illnesses such as cerebral palsy, multiple sclerosis, head injuries, spinal cord diseases and other nervous
system disorders.
2. BEFORE YOU TAKE BACLOFEN 5 MG/5 ML ORAL SOLUTION
Do not take this medicine if:
• you have ever had an allergic reaction to any of the ingredients of Baclofen 5 mg/5 mL Oral Solution or any
other medicines that you may have taken to relieve muscle spasms. The signs of an allergic reaction may
have been itching, reddening of the skin or difficulty in breathing
• you have or have ever had a stomach ulcer.

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Take special care with this medicine and tell your doctor or pharmacist if:
• you suffer from epilepsy
• you have difficulties in passing water
• you suffer from any serious liver, kidney or lung disease
• you suffer from mental illness, for example: depression, manic disorders, schizophrenia, psychotic disorders
or confused states
• you suffer from diabetes
• you suffer from Parkinson’s disease
• you are pregnant, trying to become pregnant or are breast-feeding
• you have breathing problems
• you have had a stroke, a “mini stroke” (transient ischaemic attack) or have been told you may be at risk of
these.
Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars.
This is because Baclofen 5 mg/5 mL Oral Solution contains sorbitol, a type of sugar.
Taking other medicines:
Tell your doctor if you are taking any other medicines, especially the following:
• medicines for depression, e.g. tricyclic antidepressants
• medicines for high blood pressure
• medicines for arthritis or pain, e.g. ibuprofen
• medicines which slow down the nervous system, e.g. antihistamines
• sedatives or sleeping tablets e.g. diazepam
• medicines for pain relief e.g. morphine or codeine
• medicines for epilepsy e.g. phenytoin or carbamazepine
• medicines for Parkinson’s disease e.g. levodopa or carbidopa
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without prescription.

If any of the side effects becomes severe, or if you
your doctor or pharmacist immediately.

5. HOW TO STORE BACLOFEN 5 MG/5 ML ORAL
Do not use after the expiry date that is stated on the
Once opened, the solution should be used within 60
Store the solution so that it is protected from light. D

KEEP OUT OF THE REACH AND SIGHT
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION

Other special warnings:
• Be careful when drinking alcohol - it may affect you more than usual.
• Whilst you are taking this medicine, your doctor may want to give you a check up from time to time.
• Tell your doctor that you are taking Baclofen 5 mg/5 mL Oral Solution if you are going to have an operation
of any kind.

What Baclofen 5 mg/5 mL Oral Solution contains:
Each 5 mL of solution contains 5 mg of the active s
The other ingredients are: methylparahydroxybenzo
flavour; hydroxyethylcellulose (E1525); propylene g
purified water.

Pregnancy and breast-feeding:
Tell your doctor if you become pregnant, or if you are breast-feeding.

What Baclofen 5 mg/5 mL Oral Solution looks like
Baclofen 5 mg/5 mL Oral Solution is a clear, colour
bottles with tamper-evident caps.
Each bottle contains 300 mL oral solution.
Each bottle is packed singly in a carton.

Driving and using machines:
This medicine can make you feel drowsy or cause blurred vision. Do not drive or operate machinery if you are
affected.
3. HOW TO TAKE BACLOFEN 5 MG/5 ML ORAL SOLUTION
Always take your medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. In all patients the dose is increased gradually, usually every 3 days, starting
with doses of 5-15 mg (5-15 mL) per day. The final dose depends on how you respond.

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Children (under 18 years of age)
Children's treatment is adjusted to their body weight and usually starts with a very low dose (approximately 0.3
mg/kg/day), in 2-4 divided doses (preferably in 4 doses). The dosage is then 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 daily dose should not exceed a maximum of 40 mg/day in children below 8 years of age. In children

148 mm

Marketing Authorisation Holder and Manufacture
Waymade Plc trading as Sovereign Medical, Soverei
This leaflet does not contain all the available inform
If you have any questions or are not sure about any

The information in this leaflet applies only to Baclof
60 mm

The usual doses of Baclofen 5 mg/5 mL Oral Solution are as follows:
Adults
20 mg (20 mL) three times a day. The maximum daily dose is 100 mg (100 mL). However some patients take it
only at night or about one hour before doing a task such as washing, dressing, shaving or having physiotherapy.
If you are in hospital, a higher dose may be used.
The dose may be reduced for elderly patients.

Other side effects may include:
• Feeling sleepy, dizzy, light-headed or slightly co
• Feeling or being sick, retching, constipation or d
• Headache or sleeplessness
• Unsteadiness, trembling or other problems with
• Pain in your muscles or abdomen
• Numbness or tingling in hands or feet; increased
• Sexual problems in men, e.g. impotence
• Increased sweating
• Dry mouth or changes in the way things taste, s
• Increased need to pass water
• Nightmares
• Changes in blood sugar or blood levels of certai
• Slow heart rate.
These effects are often mild and may wear off after
than a few days, tell your doctor. Older people may
treatment.

10 mm

10 mm

8 mm

over 8 years of age a maximum daily dose of 60 mg/day may be given.
If you have kidney problems
A lower dose of 5 mg (5 mL) daily may be used.

60 mm

If you are not sure about how much medicine to take, please speak to your doctor or pharmacist.
Shake the bottle well before you take your medicine.
If you feel sick after taking this medicine, you may find it helps to take it with food or a milk drink.
Do not stop taking your medicine suddenly; unwanted effects such as muscle spasms and increased muscle
rigidity, fast heart rate, fever, confusion, hallucinations, changes in mood and emotion, mental disorders, feeling
persecuted or convulsions (fits) may occur. Ask your doctor how to reduce the dose gradually.
If you take more solution than you should
If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital
casualty department. Take your medicine with you.
If you forget to take your medicine
If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Baclofen 5 mg/5 mL Oral Solution can cause side effects, although not everybody gets them.
You are unlikely to get any of the following, but if you do, tell your doctor immediately:
• Skin reddening, itching, difficulty in breathing or swelling. These could be signs of an allergic reaction and
might be due to some of the ingredients. These might not happen immediately - they can be delayed.
• Excessive weakness of the limbs or feeling tired and exhausted
• Difficulty in passing water
• Hallucinations (seeing or hearing things which are not there)
• Fits
• Blurred or double vision, difficulty in focussing, trembling or flicking of the eyes
• Symptoms similar to the effects of alcohol
• Fainting
• Breathing difficulties
• Mood changes
• Skin rash
If you notice any side effects mentioned above, please tell your doctor or pharmacist.

297 mm

Other side effects may include:
• Feeling sleepy, dizzy, light-headed or slightly confused
• Feeling or being sick, retching, constipation or diarrhoea
• Headache or sleeplessness
• Unsteadiness, trembling or other problems with muscle control
• Pain in your muscles or abdomen
• Numbness or tingling in hands or feet; increased muscle spasm
• Sexual problems in men, e.g. impotence
• Increased sweating
• Dry mouth or changes in the way things taste, slurred speech
• Increased need to pass water
• Nightmares
• Changes in blood sugar or blood levels of certain liver enzymes
• Slow heart rate.
These effects are often mild and may wear off after a few days’ treatment. If they are severe or last for more
than a few days, tell your doctor. Older people may be at more risk of these effects, particularly at the start of
treatment.
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist immediately.
5. HOW TO STORE BACLOFEN 5 MG/5 ML ORAL SOLUTION
Do not use after the expiry date that is stated on the carton and bottle labels.
Once opened, the solution should be used within 60 days.
Store the solution so that it is protected from light. Do not store above 25°C. Do not put it in the fridge.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION
What Baclofen 5 mg/5 mL Oral Solution contains:
Each 5 mL of solution contains 5 mg of the active substance, baclofen.
The other ingredients are: methylparahydroxybenzoate (E218); propylparahydroxybenzoate (E216); raspberry
flavour; hydroxyethylcellulose (E1525); propylene glycol (E490/E1520); sorbitol (E420); sodium hydroxide and
purified water.
What Baclofen 5 mg/5 mL Oral Solution looks like and the contents of the pack:
Baclofen 5 mg/5 mL Oral Solution is a clear, colourless to pale yellow solution, which is available in amber glass
bottles with tamper-evident caps.
Each bottle contains 300 mL oral solution.
Each bottle is packed singly in a carton.
Marketing Authorisation Holder and Manufacturer
Waymade Plc trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.
This leaflet does not contain all the available information about your medicine.
If you have any questions or are not sure about anything, ask your doctor or pharmacist.

60 mm

The information in this leaflet applies only to Baclofen 5 mg/5 mL Oral Solution.

10 mm

Date of preparation of leaflet: November 2012
31021618

148 mm

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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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