10 mm

8 mm

GB 726-8535-APIL 31021618

Ui SOVEREIGN

medical

Baclofen 5 mg/5 mL Oral Solution

Baclofen

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.

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

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.

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.

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.

Pregnancy and breast-feeding:

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

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.

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.

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

8 mm

Date of preparation of leaflet: November 2012

31021618