Patient leaflet - Baclofen 5 mg|5 ml oral liquid
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 (see section “Pregnancy and breast-feeding”)
- If you have problems with your kidneys or passing water
- If you have high blood pressure
- 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 an intolerance to some sugars (Baclofen oral liquid contains sorbitol)
- 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.
- If you have a history of alcoholism, you drink alcohol to excess or you have a history of drug abuse or dependence
There have been reports of reduction in brain function (encephalopathy) in some patients taking Baclofen Oral Liquid at prescribed doses, which resolved after stopping the medication. Symptoms include increased sleepiness, new onset of drowsiness, confusion, muscle jerks or coma. If you experience any of these symptoms, seek medical attention immediately. Your physician will decide whether baclofen has to be discontinued.
Other special warnings
Some people being treated with baclofen have had thoughts of harming or killing themselves or have tried to kill themselves. Most of these people also had depression, had been using alcohol excessively or were prone to having thoughts of killing themselves. If you have thoughts of harming or killing yourself at any time, speak to your doctor straightaway or go to a hospital. Also, ask a relative or close friend to tell you if they are worried about any changes in your behaviour and ask them to read this leaflet.
Your doctor may want to give you a check up from time to time while you are taking Baclofen Oral Liquid. If you are going to have an operation of any kind, make sure that the doctor knows that you are taking Baclofen Oral Liquid.
Other medicines and Baclofen Oral Liquid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- Tricyclic antidepressants (for depression), e.g. amitryptyline: if taken with baclofen your muscles may become weak
- 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 and breast-feeding
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.
You should not use Baclofen Oral Liquid during pregnancy unless your doctor advises you to do so. If you have to take Baclofen Oral Liquid during pregnancy, your unborn baby will also be exposed to Baclofen. After birth your baby may develop withdrawal symptoms such as convulsions (symptoms of withdrawal are described in the section “If you stop taking Baclofen Oral Liquid”).
Only a very small amount of baclofen passes into breast milk. Your doctor will discuss with you whether you should breast-feed whilst taking baclofen.
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 and propylene glycol
Sorbitol. This medicine contains 1400 mg sorbitol in each 5ml of liquid. Sorbitol is a source of fructose.
If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions
(possibly delayed).
- Propylene glycol - This medicine contains 150 mg propylene glycol in each 5 ml of solution which is equivalent to 30 mg per ml of solution. If your baby is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.
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
- 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
- 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, ringing in the ears
- 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
- 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 problem in 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
- Convulsions (particularly in epileptics)
- 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)
- Reduction in brain function (encephalopathy).
If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to adjust the dose or give you a different medicine.
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 website: 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 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,
Dashwood House, 69 Old Broad Street,London, EC2M 1QS, United Kingdom.
Manufacturer
Farmasierra Manufacturing, S.L.
Ctra. Irún, Km. 26,200, San Sebastián de los Reyes, Madrid, 28709, Spain.