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Baclofen 5mg/5ml Oral Solution

Document: leaflet MAH GENERIC_PL 06464-2354 change

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8 mm


GB 726-8535-APIL 31021618


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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



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over 8 years of age a maximum daily dose of 60 mg/day may be given.

If you have kidney problems

A lower dose of 5 mg (5 mL) daily may be used.

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.

If you feel sick after taking this medicine, you may find it helps to take it with food or a milk drink.

Do not stop taking your medicine suddenly; unwanted effects 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) may occur. Ask your doctor how to reduce the dose gradually.

If you take more solution than you should

If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.


If you forget to take your medicine

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Baclofen 5 mg/5 mL Oral Solution can cause side effects, although not everybody gets them. You are unlikely to get any of the following, but if you do, tell your doctor immediately:

•    Skin reddening, itching, difficulty in breathing or swelling. These could be signs of an allergic reaction and might be due to some of the ingredients. These might not happen immediately - they can be delayed. Excessive weakness of the limbs or feeling tired and exhausted Difficulty in passing water

Hallucinations (seeing or hearing things which are not there)

Fits

Blurred or double vision, difficulty in focussing, trembling or flicking of the eyes Symptoms similar to the effects of alcohol Fainting

Breathing difficulties Mood changes Skin rash

If you notice any side effects mentioned above, please tell your doctor or pharmacist.

Other side effects may include:

•    Feeling sleepy, dizzy, light-headed or slightly confused

•    Feeling or being sick, retching, constipation or diarrhoea

•    Headache or sleeplessness

•    Unsteadiness, trembling or other problems with muscle control

•    Pain in your muscles or abdomen

•    Numbness or tingling in hands or feet; increased muscle spasm

•    Sexual problems in men, e.g. impotence

•    Increased sweating

•    Dry mouth or changes in the way things taste, slurred speech

•    Increased need to pass water

•    Nightmares

•    Changes in blood sugar or blood levels of certain liver enzymes

•    Slow heart rate.

These effects are often mild and may wear off after a few days' treatment. If they are severe or last for more than a few days, tell your doctor. Older people may be at more risk of these effects, particularly at the start of treatment.

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 immediately.

5.    HOW TO STORE BACLOFEN 5 MG/5 ML ORAL SOLUTION

Do not use after the expiry date that is stated on the carton and bottle labels.

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.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Baclofen 5 mg/5 mL Oral Solution contains:

Each 5 mL of solution contains 5 mg of the active substance, 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 5 mg/5 mL Oral Solution looks like and the contents of the pack:


Baclofen 5 mg/5 mL Oral Solution is a clear, colourless to pale yellow solution, which is available in amber glass bottles with tamper-evident caps.

Each bottle contains 300 mL oral solution.

Each bottle is packed singly in a carton.

Marketing Authorisation Holder and Manufacturer

Waymade Plc trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR.

This leaflet does not contain all the available information about your medicine.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet applies only to Baclofen 5 mg/5 mL Oral Solution.

Date of preparation of leaflet: November 2012

31021618


Ui SOVEREIGN

MEDICAL

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