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BACLOFEN 5MG/5ML ORAL SOLUTION

Active substance(s): BACLOFEN

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Size 148 x 500 mm

Patients with kidney pro
You will probably be given

GB 724-9634-APIL
Package leaflet: Information for the user
Received Date:
CDL JOB No. :
Required By :

Baclofen 5 mg/5 ml Oral Solution

If you feel sick after takin

Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

PRODUCT NAME:
PIP CODE:
COMPONENT:
SIZE:
MARKET:
PRODUCT SITE:
SCALE:
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DATE:
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What is in this leaflet
1. What Baclofen Oral Solution is and what it is used for
2. What you need to know before you take Baclofen Oral Solution
3. How to take Baclofen Oral Solution
4. Possible side effects
5. How to store Baclofen Oral Solution
6. Contents of the pack and other information

If you stop taking Baclof
You should not stop takin
If the doctor decides to st
to prevent withdrawal sym
Baclofenfever,
5 mg/5
ml
confusion,
hallucina
Oral Solution
convulsions (fits).

GB 724-9634-APIL
Carton If you take more Baclofe
148x500Ifmm
you realize you have tak
Great Britain
Baclofen Oral Solution), t
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hospital casualty departm
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20/03/2017
If you forget to take a dos
9 pt
for the forgotten dose.
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4. Possible side effe
Sovereign Medical

Like all medicines, this m

These occur mainly at the
elderly patients. Effects o
are not usually severe eno
REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Serious side effects

1. What Baclofen Oral Solution is and what it is used for
The name of your medicine is Baclofen 5 mg/5 ml Oral Solution (referred to as Baclofen Oral Solution in
this leaflet). Baclofen Oral Solution contains the active ingredient baclofen, which is a muscle-relaxant.
Baclofen Oral Solution is used to reduce and relieve the excessive tension in your muscles (spasms)
occurring in various illnesses such as cerebral palsy, multiple sclerosis, cerebrovascular accidents, spinal
cord diseases and other nervous system disorders.

Confirmation that this artwork has been approved by
If you notice any of the fo
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade•Plc Convulsions
have license
(fits), par
approval to distribute this component for sale in the
• Breathing difficulties,
relevent market.

2. What you need to know before you take Baclofen Oral Solution

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• Difficulties

Do not take Baclofen Oral Solution
• if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).
• if you have or have ever had a stomach ulcer.

The other side
Reject Artwork ..................................................................

• Excessive weakness o
in passing

effects lis
Very common: (may affe
• Tiredness, sleepiness,
Signature ..........................................................................

Common (may affect up
• Aching muscles
• Headache, dizziness o
Date ...................................................................................
• Sleeplessness
• Mood changes, confu
• Dry mouth
• Eye problems (blurred
• Unsteadiness, trembli
• Low blood pressure (f
• Stomach problems inc
• Excessive sweating, ra
• Increased need to pas

If any of the above apply to you, tell your doctor or pharmacist immediately, as Baclofen Oral Solution may
not be suitable for you.

XXXX

19/03/2018
If you are not sure about
65136
21/03/2018
Shake the bottle well befo

Name .................................................................................

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Baclofen Oral Solution
• if you suffer from epilepsy
• if you have difficulties in passing water
• if you suffer from any liver, kidney or lung disease
• if you suffer from mental illness
• if you are being treated for high blood pressure
• if you have diabetes
• if you have Parkinson’s disease
• if you are pregnant or are breast-feeding (see section “Pregnancy and breast-feeding”)
• if you have had a stroke
• if you have an intolerance to some sugars. This is because Baclofen Oral Solution contains sorbitol,
which is a type of sugar.

PAGE 1 OF 2

Rare (may affect up to 1
• Numbness or tingling
• Increased muscle spa
• Disturbed sense of tas
• Slurred or slow speec
• Stomach ache
• Liver problems
• Sexual problems in m

If any of the above apply to you or if you are not sure, tell your doctor or pharmacist.
Other medicines and Baclofen Oral Solution
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines. This includes any medicines obtained without prescription.

Very rare (may affect up
• Hypothermia (low bod

In particular, tell your doctor if you are taking any of the following:
• other medicines to relax muscles e.g. tizanidine
• medicines to treat mood disorders such as lithium or, tricyclic antidepressants such as amitriptyline
• medicines for high blood pressure e.g. diltiazem
• other medicines which also affect the kidney, e.g. ibuprofen
• medicines which slow down the nervous system, e.g. antihistamines such as promethazine, sedatives
such as temazepam, opiates for pain relief such as morphine and anti-convulsants (medicines for
epilepsy such as carbamazepine)
• medicines for Parkinson’s disease e.g. levodopa or carbidopa
Baclofen Oral Solution and alcohol
Be careful when drinking alcohol - it may affect you more than usual.
Other special warnings
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 Oral Solution if you are going to have an operation of any
kind.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice
before taking this medicine.
You should not take this medicine during pregnancy unless your doctor advises you to do so.
If you have to take Baclofen Oral Solution during pregnancy, your unborn baby will also be exposed to
Baclofen Oral Solution. After birth, your baby may develop withdrawal symptoms such as convulsions
(symptoms of withdrawal are described in Section 3 “If you stop taking Baclofen Oral Solution”).

Not known (frequency ca
• Raised itchy rash (urti
• Slow heart beat.
• Increase in blood suga
• Symptoms caused by
Solution’).

XXXX

Reporting of side effects
If you get any side effects
listed in this leaflet. You c
(www.mhra.gov.uk/yellow
By reporting side effects

5. How to store Bac

Keep this medicine out of
Do not use after the expir
refers to the last day of th
Once opened, the solution
Store the solution so that
Do not throw away any m
away medicines you no lo

6. Contents of the pa

Only a very small amount of baclofen passes into breast milk. You doctor will discuss with you whether
you should breast-feed while taking Baclofen Oral Solution.

What Baclofen Solution
The active substance is b

Driving and using machines
This medicine can make you feel drowsy and/or dizzy or cause blurred vision. Do not drive or operate
machinery if you are affected.

The other ingredients are:
raspberry flavour, hydrox
hydroxide and purified wa

Baclofen Oral Solution contains methyl and propyl parahydroxybenzoate and sorbitol
This medicinal product contains:
• Small amounts of the preservatives methyl and parapropyl hydroxybenzoate. These can sometimes
cause allergic reactions which might appear sometime after first taking the medicine.
• Sorbitol. This can have a mild laxative effect and you might be affected if you take more than 25 ml of
Baclofen Oral Solution per day. Calorific value 2.6 kcal/g sorbitol.

What Baclofen Oral Solu
Baclofen Oral Solution is
available in amber glass b
Each bottle contains 300
Each bottle is packed in a

3. How to take Baclofen Oral Solution
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
Recommended dose
In all patients the dose is increased gradually, usually every 3 days, starting with doses of 5-15 mg (5-15
ml) per day. Each dose should be taken during meals with a little liquid. The final dose depends on how
you respond. If the starting dose is too high, or if the dose is increased too quickly, you may experience
side effects, particularly if you are elderly, have kidney problems or have had a stroke.
The usual doses of Baclofen 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.
Elderly patients
The dose may be reduced for elderly patients.
Use in children and adolescents (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 over 8 years of age a maximum daily dose of 60 mg/day may be given.

Marketing Authorisation
Marketing Authorisation
Sovereign Medical, Sover

Manufacturer
Waymade Plc, Josselin R

This leaflet was last revi
PL 06464/2354

Bacl

To request a c
audio format, c
address or tele
Medical Inform

Patients with kidney problems
You will probably be given a much lower dose. The doctor will decide what the dose should be.
Received Date:
CDL JOB No. :
Required By :

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.

19/03/2018
65136
21/03/2018

If you feel sick after taking this medicine, you may find it helps to take it with food or a milk drink.
If you stop taking Baclofen Oral Solution
You should not stop taking your medicine suddenly.
If the doctor decides to stop your treatment with Baclofen Oral Solution, the dose will be reduced gradually
to prevent withdrawal symptoms 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).

Baclofen 5 mg/5 ml
PRODUCT NAME:
Oral Solution
PIP CODE: GB 724-9634-APIL
COMPONENT:Carton
148x500 mm Great Britain
SIZE:
TBC
MARKET:
PRODUCT SITE:
100%
SCALE:
COLOURS: Black
20/03/2017
DATE:
9 pt
FONT SIZE:
6
VERSION NO:
KS
AMENDED BY:
Sovereign Medical
PROJECT:

If you take more Baclofen Oral Solution than you should
If you realize you have taken too much of your medicine (or if someone else has taken some of your
Baclofen Oral Solution), tell your doctor at once. If you cannot reach your doctor, contact your nearest
hospital casualty department. Take your medicine with you.
If you forget to take Baclofen Oral Solution
If you forget to take a dose, take the next dose at the usual time. DO NOT take a double dose to make up
for the forgotten dose.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These occur mainly at the start of treatment, if the dose is increased too quickly or is too high, or in
elderly patients. Effects often last only a short time and usually disappear when the dose is reduced. They
are not usually severe enough to stop you taking your medicine.

REGULATORY AUTHORITY
APPROVAL CONFIRMATION

Serious side effects
If you notice any of the following serious side effects, tell your doctor immediately:
• Convulsions (fits), particularly in epileptics,
• Breathing difficulties,
• Excessive weakness of the limbs or feeling tired and exhausted,
• Difficulties in passing urine.

Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................

The other side effects listed below have also been reported:
Very common: (may affect more than 1 in 10 people):
• Tiredness, sleepiness, nausea (feeling sick).

Reject Artwork ..................................................................
Signature ..........................................................................

Common (may affect up to 1 in 10 people):
• Aching muscles
• Headache, dizziness or light-headedness
• Sleeplessness
• Mood changes, confusion, hallucinations or nightmares
• Dry mouth
• Eye problems (blurred or double vision, difficulty focusing, trembling or flickering of the eyes)
• Unsteadiness, trembling or other problems with muscle control
• Low blood pressure (fainting)
• Stomach problems including retching, vomiting, constipation and diarrhoea
• Excessive sweating, rash
• Increased need to pass urine or pain on passing urine.

Name .................................................................................
Date ...................................................................................

PAGE 2 OF 2

Rare (may affect up to 1 in 1,000 people):
• Numbness or tingling in hands or feet
• Increased muscle spasm
XXXX • Disturbed sense of taste
• Slurred or slow speech
• Stomach ache
• Liver problems
• Sexual problems in men, e.g. impotence
Very rare (may affect up to 1 in 10,000 people):
• Hypothermia (low body temperature)
Not known (frequency cannot be estimated from the available data):
• Raised itchy rash (urticaria – also known as nettle rash or hives).
• Slow heart beat.
• Increase in blood sugar.
• Symptoms caused by stopping treatment suddenly (see section 3. ‘How to take Baclofen Oral
Solution’).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard) or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Baclofen Oral Solution
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date that is stated on the carton and bottle labels after EXP. The expiry date
refers to the last day of that month.
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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Baclofen Oral Solution contains
The active substance is baclofen. Each 5 ml of solution contains 5 mg 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 Oral Solution looks like and the contents of the pack
Baclofen Oral Solution is a clear, colourless to pale yellow solution with a raspberry flavour, which is
available in amber glass bottles with tamper-evident caps.
Each bottle contains 300 ml oral solution.
Each bottle is packed in a carton.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder
Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK
Manufacturer
Waymade Plc, Josselin Road, Burnt Mills Industrial Estate, Basildon, Essex, SS13 1QF ,UK
This leaflet was last revised in March 2018
PL 06464/2354

Baclofen 5 mg/5 ml Oral Solution

To request a copy of this leaflet in Braille, large print or
audio format, contact the licence holder at the above
address or telephone: 01268 535200 (select option
Medical Information) / e-mail: info@waymade.co.uk

XXXX

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