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Focus Mnimao

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Baclofen 5mg/5ml Oral Liquid

Baclofen

Read all of this leaflet carefully before you, or your child, start taking this medicine.

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 Baclofen Oral Liquid is and what it is used for

2.    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.    Further information

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I.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 freat 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. Before you take Baclofen Oral Liquid

Do not take Baclofen Oral Liquid if you:

are allergic (hypersensitive) to baclofen or any of the other ingredients of Baclofen Oral Liquid (see section 6, Further Information);

•    have, or have had, a stomach ulcer.

Talk to your doctor if any of the following apply to you:

•    if you are pregnant, may become pregnant, or are breast-feeding;

if you have problems wi1h 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 caused by muscle weakness.

Using other medicines

Make sure your doctor knows if you are taking a medicine listed here:

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

Tell your doctor or pharmacist if you are taking or

have recently taken any other medicines, including

medicines obtained without a prescription

Taking 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, thinking of becoming pregnant, or breast-feeding, ask your doctor or pharmacist for advice before taking Baclofen Oral Liquid

Driving and using machines

•    Baclofen Oral Liquid does not generally affecl 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.

Important information about some of the othei

ingredients in Baclofen Oral Liquid

•    Baclofen Oral Liquid contains sorbitol. If you have been told by your doctor that you have an intolerance to certain sugars, speak to your doctor before taking this medicine.

•    Baclofen Oral Liquid contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions; these reactions may not happen immediately.

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3.How to take Baclofen Oral Liquid

Always take Baclofen Oral Liquid exactly as your doctor has told you. Check with your doctor if you are not sure.

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 the 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 (lOOmg) per day,

•    If you are in hospital, your doctor may give you a dose higher than the maximum stated here.

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Children (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 suns 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. 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 double the amount to make up for a forgotten dose.

If you stop taking Baclofen Oral Liquid Do not slop taking Baclofen Oral Liquid suddenly.

•    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 effecls. If you have any further questions on the use of this oroduct, ask your doctor or pharmacist.

•    sense of taste is altered

•    stomach ache or pain in the abdomen

•    problems with your liver

•    difficulty passing urine

•    impotence

Very rare (less than 1 person in 10,000):

•    very low body temperature (hypothermia) Unknown

•    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 and increased muscle spasms

•    increased blood sugar levels

See Section 2 of this leaflet for side effects that may be caused by some of the ingredients in your medicine ('Important information about some of the ingredients in Baclofen Oral Liquid').

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 at: www.mhra.gov.uk/yellowcard. 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 out of the reach and sight of children.

Baclofen Oral Liquid does not require any special storage conditions. Do not use after the expiry date stated on the carton or bottle. The expiry date refers to the last day of that month.

Once opened, use within 28 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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4. Possible side effects

Like all medicines. Baclofen Oral Liquid 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 nigh, but they can occur at other times.

Very common (more than 1 person in 10): feeling sleepy or drowsy feeling sick

Common (more than 1 in 100 but less 1han 1 in 10 people): hallucinations (seeing or hearing things which are not there) trouble breathing

tow blood pressure making you feel light-headed or dizzy feeling weak and exhausted feeling confused headaches

unable to sleep or having nightmares euphoria (a feeing of exceptional well being) or depression blurred or double vision, rapid eye movements dry mouth

mild stomach ache, retching or being sick,

constipation or diarrhoea

slow heart rate

excessive sweating

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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 and difficulty on passing urine, unable to control urine flow or bed wetting. Rare (more than 1 in 10,000 but less than 1 in 1,000 oeople):

• numbness or tingling in hands or feet difficulty speaking, slurred speech increased muscle spasms

6. Further information

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What Baclofen Oral Liquid contains

-    The active substance is baclofen. Each 5m 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 ol the pack

-    Baclofen Oral Liquid is a dear, raspberry flavoured [quid.

-    Each amber glass bottle of Baclofen Ora Liquid contains 300ml.

Marketing Authorisation Holder

Focus Pharmaceuticals Limited, Capital House,

85 King William Street, London EC4N 7BL, UK.

Tel:    01283 495 280

Fax:    01283 495 290

Email: medinfo@focuspharma.co.uk

Manufacturer

Dales Pharmaceuticals Ltd, Skipton, N. Yorkshire, BD23 2RW, UK

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please telephone 01283 495 280 or email medinfo@focuspharma.co.uk.

This leaflet was last revised in March 2016.

103446/LF/035/03 FI 273

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