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BACLOFEN 5MG|5ML ORAL LIQUID

Active substance(s): BACLOFEN

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Package leaflet: Information for the patient
Baclofen 5mg/5ml Oral Liquid
Baclofen
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.
What is in this leaflet
1. What Baclofen Oral Liquid is and what it is used for
2. What you need to know before you take Baclofen Oral Liquid
3. How to take Baclofen Oral Liquid
4. Possible side effects
5. How to store Baclofen Oral Liquid
6. Contents of the pack and other information
1. What Baclofen Oral Liquid is and what it is used for
Baclofen Oral Liquid is one of a group of medicines called muscle relaxants.
Your doctor has decided that you or your child needs this medicine to help treat your condition. Baclofen
Oral Liquid is used to reduce and relieve muscle spasms, which may occur during certain illnesses affecting
the nervous system, such as cerebral palsy, multiple sclerosis, motor neurone disease or following a disease
or injury which has affected your head, brain or spine.
2. What you need to know before you take Baclofen Oral Liquid
Do not take Baclofen Oral Liquid:
 If you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6)
 If you have or have had a stomach ulcer.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Baclofen Oral Liquid
 If you are pregnant, may become pregnant, or are breast-feeding
 If you have problems with your kidneys or passing water
 If you have problems with your liver
 If you have breathing difficulties or lung disease
 If you have epilepsy
 If you have diabetes
 If you have a mental illness
 If you suffer from Parkinson’s disease
 If you have a problem with the circulation of blood in your brain such as a stroke
 If you suffer with posture problems caused by muscle weakness.
Other medicines and Baclofen Oral Liquid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.


Tricyclic antidepressants (for depression), e.g. amitryptyline: if taken with baclofen your muscles may
become weak
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Lithium (for mood disorders): if taken with baclofen it may worsen symptoms associated with disorders,
such as ADHD (Attention Deficit Hyperactivity Disorder), that affect your attention and ability to
control movement
Antihypertensive medicines (for high blood pressure): if taken with baclofen your blood pressure may
fall too low. Your doctor will adjust your dose of antihypertensive medicine
Medicines for arthritis or pain e.g. Ibuprofen: if taken with baclofen you may have more serious side
effects
Medicines which slow down your nervous system, e.g. antihistamines (for allergies), sedatives,
opiates such as Morphine for pain relief, antidepressants and drugs for epilepsy as well as
medicines that relax your muscles e.g. tizanidine: if taken with baclofen you may feel sleepy or sedated,
or your muscles may feel weak
Levodopa and carbidopa (for Parkinson’s Disease): if both of these drugs are taken together with
baclofen, you may become more confused, hallucinate (see and hear things that are not there), feel sick
or become agitated.

Baclofen Oral Liquid with food, drink and alcohol
 Baclofen Oral Liquid can be taken with food or a milky drink
 Seek advice from your doctor before drinking alcohol. If you drink alcohol when taking Baclofen Oral
Liquid the alcohol may affect you more than usual.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
 Baclofen Oral Liquid does not generally affect people’s ability to drive or use machines
 Do not drive or use machines if you feel dizzy, sleepy, drowsy or if your eye sight is affected.
Baclofen Oral Liquid contains sorbitol, methyl parahydroxybenzoate and propyl
parahydroxybenzoate



Baclofen Oral Liquid contains sorbitol. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicinal product
Baclofen Oral Liquid contains methyl parahydroxybenzoate and propyl parahydroxybenzoate,
which may cause allergic reactions; these reactions may not happen immediately.

3. How to take Baclofen Oral Liquid
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose is:
In all patients, the dosage is increased gradually, usually every 3 days in adults and once a week in children.
Your doctor will decide your final dose, depending upon how you respond.
Baclofen Oral Liquid is usually taken three times a day during meals with a small drink. However, some
patients take it only at night; others about an hour before doing a task such as washing, dressing or shaving.
If after taking your medicine, you still have problems with muscle control, speak to your doctor (see also
Section 4 – Possible side effects).

Adults and elderly
 The starting dose is one 5ml spoonful (5mg) three times a day which normally increases to a final dose
of four 5ml spoonfuls (20mg) three times a day. The final dose is normally reached over a period of two
weeks
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The maximum daily dose is 100ml (100mg) per day
If you are in hospital, your doctor may give you a dose higher than the maximum stated here.

Use in children and adolescents (0 to 18 years old)
 The dose depends on your child’s weight
 The starting dose is usually very low at 0.3mg per kg of body weight per day, in two to four divided
doses
 The usual daily dose is 0.75 to 2mg per kg of your child’s weight
 The maximum daily dose for children below 8 years of age is 40mg per day
 The maximum daily dose for children over 8 years of age is 60mg per day
 Your doctor will monitor your child and adjust the dose depending on how your child responds
 Make sure your child takes the medicine as the doctor says.
Patients with kidney problems
 The dose is one 5ml spoonful (5mg) a day
 Your doctor will monitor you carefully if your kidneys are failing.
Patients with spasms caused by brain injury
 Your doctor will tell you exactly how much and when to take your medicine
 Increases in dose are very carefully monitored by your doctor to prevent side effects.
If you take more Baclofen Oral Liquid than you should
 If you take more Baclofen Oral Liquid than your doctor has prescribed or you think a child has
accidentally swallowed any, contact the nearest hospital Accident and Emergency Department or a
doctor. Signs of an overdose include drowsiness, breathing difficulties, changes in consciousness or
coma (unarousable unconsciousness). Also, muscle weakness or spasm, confusion, hallucinations,
agitation, fits, reflex problems, vision problem, enlargement of blood vessels, low blood pressure/ high
blood pressure, irregular heartbeat, reduced body temperature, feeling or being sick, diarrhoea, excessive
saliva production, increased blood level of a liver enzyme, muscle injury
 Take this leaflet and any Baclofen Oral Liquid that you still have to show the doctor.
If you forget to take Baclofen Oral Liquid
 If you forget to take a dose, take another as soon as you remember. Then take your next dose at the
normal time
 Do not take a double dose to make up for a forgotten dose.
If you stop taking Baclofen Oral Liquid
 Do not stop taking Baclofen Oral Liquid suddenly. If you stop taking Baclofen Oral Liquid
suddenly, you may experience anxiety, confusion, mental illness, prolonged seizures (more than 5
minutes), uncontrollable muscle movements, increased heart rate, increased temperature and increased
muscle spasms, muscle injury and temporary worsening of the condition being treated
 Speak to your doctor before you stop taking Baclofen Oral Liquid
 Your doctor will tell you how to reduce your dose over a 1-2 week period to stop you having side
effects.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. These side
effects normally occur when you start taking Baclofen Oral Liquid or if your dose is too high, but they can
occur at other times.
Very common (may affect more than 1 in 10 people)
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Feeling sleepy or drowsy
Feeling sick.

Common (may affect up to 1 in 10 people)
 Hallucinations (seeing or hearing things which are not there)
 Trouble breathing
 Low blood pressure making you feel light-headed or dizzy
 Feeling weak and exhausted
 Feeling confused
 Headaches
 Unable to sleep or having nightmares
 Euphoria (a feeling of exceptional well being) or depression
 Blurred or double vision, rapid eye movements
 Dry mouth
 Stomach problems including retching or being sick, constipation or diarrhoea
 Slow heart rate
 Excessive sweating
 Rash
 Problems with muscle control such as tremors, muscle weakness or pain. This can lead to problems
walking or with your ability to feed yourself. These effects can usually be resolved by your doctor
adjusting your dose
 Increased need to pass urine or pain on passing urine, unable to control urine flow or bed wetting.
Rare (may affect up to 1 in 1,000 people)
 Numbness or tingling in hands or feet
 Difficulty speaking, slurred speech
 Increased muscle spasms
 Sense of taste is altered
 Stomach ache or pain in the abdomen
 Problems with your liver
 Difficulty passing urine
 Impotence.
Very rare (may affect up to 1 in 10,000 people)
 Very low body temperature (hypothermia).
Not known (frequency cannot be estimated from the available data)
 Slowing of the heartbeat
 Pale, raised, itchy areas of skin with red edges
 Symptoms of abrupt withdrawal such as: anxiety, confusion, mental illness, prolonged seizures (more
than 5 minutes), uncontrollable muscle movements, increased heart rate, increased temperature,
increased muscle spasms, muscle injury and temporary worsening of the condition being treated
 Increased blood sugar levels
 Trouble breathing during sleep (sleep apnoea syndrome).
See Section 2 of this leaflet for side effects that may be caused by some of the ingredients in your medicine
(‘Baclofen Oral Liquid contains sorbitol, methyl parahydroxybenzoate and propyl parahydroxybenzoate ’).
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:
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.

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5. How to store Baclofen Oral Liquid
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or bottle after Exp:. The expiry date refers
to the last day of that month. Baclofen Oral Liquid does not require any special storage conditions.
Once opened, use within 28 days.
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 protect the environment.
6. Contents of the pack and other information
What Baclofen Oral Liquid contains



The active substance is baclofen. Each 5ml spoonful contains 5mg of baclofen
The other ingredients are sorbitol liquid (non-crystallising), hydroxyethyl cellulose, methyl
parahydroxybenzoate, propyl parahydroxybenzoate, raspberry flavour, propylene glycol and purified
water.

What Baclofen Oral Liquid looks like and contents of the pack



Baclofen Oral Liquid is a clear, raspberry flavoured liquid
Each amber glass bottle of Baclofen Oral Liquid contains 300ml.

Marketing Authorisation Holder
Focus Pharmaceuticals Limited,
Capital House, 85 King William Street, London EC4N 7BL, UK.
Manufacturer
Dales Pharmaceuticals Ltd, Skipton, N. Yorkshire, BD23 2RW, UK
This leaflet was last revised in November 2017.

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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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