Clofen

contains the active ingredient baclofen
CONSUMER MEDICINE INFORMATION
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Clofen. It does not contain all the information that is known about Clofen. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Clofen is used for

Clofen is used to control muscle spasms in conditions such as:
multiple sclerosis
spinal cord damage resulting from disease or physical injury.
Clofen belongs to a group of medicine called muscle relaxants.
This medicine works by reducing excess muscle tension, thereby reducing pain and stiffness. This can help improve mobility and the management of daily activities.
Clofen may be used alone, or in combination with other medicines, to treat your condition.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.

Before you take Clofen

When you must not take it

Do not take Clofen if you have an allergy to:
medicines containing baclofen (e.g. Lioresal)
any of the ingredients listed at the end of this leaflet
any other similar medicines (such as medicines of the same class or with a similar structure, as per PI).
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not give this medicine to a child under the age of 16 years.
Safety and effectiveness in children younger than 16 years have not been established.
Clofen tablets are not suitable for use in children below 33 kg body weight.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you are pregnant or plan to become pregnant, or are breastfeeding or wish to breastfeed.
There is very little information on the use of this medicine in pregnancy or breastfeeding.
Your doctor will discuss the risks and benefits of taking Clofen in pregnancy or when breastfeeding.
Tell your doctor if you have or have had any of the following medical conditions:
mental disorders such as schizophrenia or depression
epilepsy or any other condition that causes convulsions, fits or seizures
stomach or duodenal ulcers
stroke or other brain blood vessel problems
heart problems
liver problems
kidney problems
lung or breathing problems
porphyria, a disorder which can affect the liver and blood cell formation
alcohol dependence
diabetes
high blood pressure
Parkinson's disease
cerebral palsy
rheumatoid disorders.
If you have not told your doctor about any of the above, tell him/her before you start taking Clofen.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Clofen may interfere with each other. These include:
medicines that can cause sedation (makes you sleepy) such as some pain relievers; medicines for anxiety, travel sickness, hay fever or allergy, cough and cold, blocked nose; sleeping tablets or sedatives
some medicines used for depression such as tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs)
lithium (eg. Lithicarb), a medicine used to treat mood swings and some types of depressions
levodopa and carbidopa combinations (eg. Sinemet, Kinson), medicines used for Parkinson's disease
medicines used for high blood pressure
insulin and medicines used to treat diabetes.
These medicines may be affected by Clofen or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Clofen

Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

How much to take

Treatment with Clofen is usually started in hospital using low doses.
The dose varies from person to person.
The usual starting dose is 5 mg three times a day (15 mg per day).
Your doctor may increase this dose slowly depending on how you respond to Clofen. Doses can range from 30 mg to 75 mg per day. The maximum dose is 100 mg per day.
Your doctor will tell you how many tablets you need to take each day and when to take them.
People over 65 or below 16 years of age and those with kidney problems may need smaller doses.

How to take it

Swallow the tablets with a glass of water.

When to take it

Take Clofen during meals.
This will lessen the chance of a stomach upset.
Clofen is usually taken as 3 divided doses throughout the day. However, your doctor may advise you differently depending on your situation.

How long to take it

Keep taking Clofen for as long as your doctor recommends.
Your doctor will discuss with you how long treatment with Clofen should continue for, especially if you do not respond after 6 to 8 weeks of treatment at the maximum dosage.
Do not stop taking Clofen suddenly, even if you feel better after a few days, unless advised by your doctor.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do or have any questions, ask your doctor or pharmacist for help.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Clofen.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too much Clofen, you may feel drowsy, have problems breathing or lose consciousness.
You may also feel confused, hallucinate, have blurred vision, feel sick (nausea), vomit, faint, have diarrhoea, increased saliva, a slow or irregular heart beat, muscle weakness or seizures (fits).

While you are taking Clofen

Things you must do

If you become pregnant while taking Clofen, tell your doctor immediately.
Before starting any new medicine, tell your doctor or pharmacist that you are taking Clofen.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Clofen.
If you plan to have surgery that needs a general anaesthetic, including dental surgery, tell your doctor or dentist that you are taking Clofen.
Visit your doctor regularly so they can check on your progress.
Your doctor may order some blood tests to prevent unwanted side effects, especially for people with liver problems or diabetes.

Things you must not do

Do not stop taking Clofen, or change the dose, without checking with your doctor. Do not let yourself run out of your medicine over weekends or during holidays.
Stopping Clofen suddenly may cause unwanted effects such as mood changes or mental disturbances, seizures (fits), a fast heart beat and worsening of muscle spasms.
Your doctor will tell you how to gradually reduce the amount of Clofen you are taking before stopping completely. This may take a few weeks.
Do not use Clofen to treat any other conditions unless your doctor tells you to.
Do not give Clofen to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Clofen affects you.
Clofen may cause drowsiness, especially at the start of treatment, dizziness or lightheadedness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while taking Clofen.
Combining Clofen and alcohol can make you feel more sleepy, dizzy or lightheaded. Your doctor may suggest you avoid alcohol while you are taking Clofen.
Be careful taking other medicines that can cause drowsiness while you are taking Clofen.
Combining Clofen with medicines that can cause sedation (make you sleepy) can make you more drowsy or dizzy. Your doctor and pharmacist can give you more information.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Clofen.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of these side effects.
Side effects to Clofen are usually short-lived and mainly occur at the start of treatment or if the dose of Clofen is too high or increased too quickly.
Do not suddenly stop taking Clofen. If unwanted side effects do occur, tell your doctor.
Your doctor may lower the dose to relieve any side effects.
If you are over 65 years of age or have brain blood vessel problems (eg. stroke) or a history of mental disorders, the chance of side effects may be increased.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
daytime sleepiness or drowsiness
tiredness, lack of energy
dizziness, lightheadedness, spinning sensation (vertigo)
headache
nausea (feeling sick), vomiting, retching
dry mouth
change in sense of taste
stuffy or blocked nose
constipation, diarrhoea, stomach pain
weight gain
loss of appetite
difficulty sleeping, nightmares
excessive sweating
impotence or inability to ejaculate
blurred vision.
The above list includes the milder side effects of Clofen.
Tell your doctor as soon as possible if you notice any of the following:
confusion, depression or hallucinations (seeing or hearing things that are not there)
ringing in the ears
muscle weakness, spasms or pain
unsteadiness when walking, shaking
tingling or numbness of the hands or feet
swelling of ankles due to fluid buildup
difficulty or pain when urinating
frequent urination or bed-wetting
blood in the urine.
The above list includes serious side effects, which may require medical attention.
Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:
signs of an allergic reaction such as skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath
difficulty in breathing
uncontrollable severe muscle spasms of the body or eyes
fainting
seizures (fits)
fast or irregular heart beat
chest pain.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything that is making you feel unwell.
This is not a complete list of all possible side effects. Other side effects not listed above may also occur in some people.

After taking Clofen

Storage

Keep Clofen where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store Clofen or any other medicine in the bathroom or near a sink.
Do not leave Clofen in the car or on window sills.
Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking Clofen, or your tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Clofen tablets are available in 2 strengths:
Clofen 10 - round, white, scored tablet, marked "BN" over "10" on one side and "G" on the other.
Clofen 25 - round, white, scored tablet, marked "BN" over "25" on one side and "G" on the other.
Each bottle contains 100 tablets.

Ingredients

The active ingredient in Clofen is baclofen.
Each Clofen 10 contains 10 mg of baclofen.
Each Clofen 25 contains 25 mg of baclofen.
The tablets also contain the following inactive ingredients:
lactose
microcrystalline cellulose
calcium hydrogen phosphate anhydrous
sodium starch glycollate
colloidal anhydrous silica
magnesium stearate.
The tablets are gluten free.

Manufacturer

Clofen is made in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30 - 34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au
Medical Information
Phone: 1800 028 365
Australian registration numbers:
Australian registration numbers:
Clofen 10 - AUST R 42146
Clofen 25 - AUST R 42147
This leaflet was prepared on
30th April 2013.