PACKAGE LEAFLET: INFORMATION FOR THE USER

Baclofen 10 mg/20 ml solution for infusion

Baclofen

In this leaflet:

1.    What Baclofen is and what it is used for

2.    Before you use Baclofen

3.    How to use Baclofen

4.    Possible side effects

5.    How to store Baclofen

6.    Further information

1. WHAT BACLOFEN IS AND WHAT IT IS USED FOR

Baclofen is a medicine to relieve severe muscle spasms (antispastic).

Your doctor has decided that you or your child needs this medicine to help treat your condition.

Baclofen is intended for adults and children of 4 years and above and is used to reduce and relieve the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple sclerosis, spinal cord diseases, cerebrovascular accidents, and other nervous system disorders.

For this purpose a special infusion pump is implanted under your skin which allows continuous delivery of small quantities of Baclofen 10 mg/20 ml solution for infusion or Baclofen 10 mg/5 ml solution for infusion into the spinal cord.

2. BEFORE YOU USE BACLOFEN Do not use Baclofen

-    if you are allergic (hypersensitive) to baclofen or any of the other ingredients of Baclofen.

-    if you have epilepsy that is untreatable.

Take special care with Baclofen

-    if you have abnormal flow of cerebral spinal fluid (liquor) as a result of obstructed passage,

-    epilepsy or other cerebral seizures,

-    bulbar paralytic symptoms or partial paralysis (pareses) of the respiratory muscles (neurological syndromes caused by damage to the motor cranial nerves in the elongated spine),

-    acute or chronic confusional states,

-    psychotic disorders, schizophrenia or Parkinson's disease,

-    history of abnormal autonomic nervous system reflexes,

-    inadequate blood flow in the brain and difficulty breathing (cerebrovascular and respiratory insufficiency),

-    pre-existing overactivity of the bladder sphincter muscle,

-    cardiac problems,

-    impaired renal function,

-    stomach and intestinal ulcers (peptic ulcers),

-    severely impaired hepatic function.

For patients with spasticity due to head injury, it is recommended not to proceed to long-term Baclofen therapy until the symptoms of spasticity are stable and can be reliably assessed.

Children and adolescents

Baclofen intrathecal formulation is intended for children of 4 years and above.

Children should be of sufficient body mass to accommodate the implantable pump. There is very limited clinical data in children under the age of six.

Elderly patients

Several patients over the age of 65 years have been treated with Baclofen during the clinical trials without specific problems. Experience with Baclofen tablets shows however that this patient group may be more susceptible to side effects. Elderly patients should therefore be carefully monitored for the occurrence of side effects.

Using Baclofen with other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

No specific studies have been carried out on interactions with other medicines.

Experience so far does not allow any predictions to be made about combination of Baclofen with other medications.

The following medicines may interact with Baclofen or Baclofen may interact with them:

-    Medicines to relieve severe muscle spasms (antispastics).

-    Medicines that have depressant effects on the functions of the central nervous system.

-    Medicines to treat depression (tricyclic antidepressants).

-    Medicines used to treat high blood pressure.

It may be necessary for the doctor to adjust the dose of Baclofen or one of your other medicines.

Using Baclofen with food and drink

Drinking alcohol while using Baclofen should be avoided as this may lead to an undesirable intensification or unpredictable change in the effect of the medicine.

Pregnancy and breast-feeding

There is no experience on the use of Baclofen during pregnancy or while breast-feeding. Baclofen should not be used during pregnancy or while breast-feeding unless the potential benefit to the mother outweighs the potential risk to the child. Baclofen passes into breast milk. As so far there are no adequate studies available the concentration cannot be predicted.

Driving and using machines

During treatment with Baclofen your ability to drive or operate machines may be considerably impaired. Do not drive, operate machines or participate in any other hazardous activities.

In particular it should be noted that drinking alcohol at the same time further intensifies this decreased alertness.

Important information about some of the ingredients of Baclofen

Baclofen 10 mg/20 ml solution for infusion contains less than 1 mmol sodium (23 mg) per maximum dose of 4 ml (corresponding to 2 mg baclofen).

3. HOW TO USE BACLOFEN

Always use Baclofen exactly as your doctor has told you.

At a first stage the doctor will find out by single injections of Baclofen 0.05 mg/l ml if this improves your muscular spasms. If this is the case a special pump will be implanted under your skin, which permits continuous delivery of small quantities of Baclofen.

It may take several days to find out the optimal dose for you. Once the optimum treatment is established, your doctor must check your progress and functioning of the pump at regular intervals.

Intrathecal use.

Baclofen can be administered only by qualified specialist doctors by direct injection or infusion in the back (spinal cord), for which special medical equipment is needed. For this reason hospitalisation will be necessary at the beginning of therapy.

It is extremely important that you keep your appointments with the doctor to refill the pump, otherwise spasms may recur because you are not getting a high enough dose of Baclofen. Your muscle spasms may worsen as a result.

If your muscle spasticity is not improving or if you start having spasms again, either gradually or suddenly, contact your doctor immediately.

If treatment with Baclofen is interrupted

It is very important that you, and those caring for you, are able to recognise signs of Baclofen withdrawal. These may appear suddenly or slowly for example because the pump is not working properly due to battery problems, catheter problems or alarm dysfunction.

The signs of withdrawal are:

-    increased spasticity, too much muscle tone

-    difficulty with muscle movements

-    increase in heart rate or pulse

-    itching, tingling. burning sensation or numbness (paraesthesia) in your hands or feet

-    palpitations

-    anxiety

-    high body temperature

-    low blood pressure

-    altered mental conditions for example agitation, confusion, hallucinations, abnormal thinking and behaviour, convulsions

If you have any of the above signs, tell your doctor straight away. These signs may be followed by more serious side effects unless you are treated immediately.

If you use more Baclofen than you should

It is very important that you, and those caring for you, are able to recognise the signs of overdose. These may appear suddenly or slowly for example because the pump is not working properly.

The signs of overdose are:

-    muscle weakness (too little muscle tone)

-    sleepiness

-    dizziness or light-headedness

-    excessive salivation (hypersalivation)

-    nausea or vomiting

-    difficulty in breathing (respiratory depression), respiratory arrest (apnoea)

-    convulsions

-    clouding or loss of consciousness (coma)

-    abnormal low body temperature

If you have any signs of an overdose of Baclofen, tell your doctor straight away.

If you stop using Baclofen

If this medicine must be stopped, this may only be done by your doctor who will reduce the dose gradually to avoid side effects. Suddenly stopping Baclofen can cause withdrawal symptoms which in some cases have proven fatal.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Baclofen can cause side effects, although not everybody gets them. These occur more often at the start of treatment during your hospital stay, but they may also occur later. Many of these side effects are also known to be associated with the specific medical condition for which you are being treated.

_ The following categories are used as the frequency convention for side effects:

For a description of the signs of withdrawal, see “If treatment with Baclofen is interrupted".

For a description of the signs of overdose, see “If you receive more Baclofen than you should".

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE BACLOFEN

Keep out of the reach and sight of children.

Do not use Baclofen after the expiry date which is stated on the ampoule and the folding box. The expiry date refers to the last day of that month.

Storage conditions

This medicinal product does not require any special storage conditions.

The product should be used immediately after opening the ampoule and dilution (in the pump).

Chemical and physical in-use stability has been demonstrated for 2 months at 37°C.

The solution must be clear and colourless. If particulate matter or discoloration are present the solution must not be used and should be discarded.

Any unrequired fraction must be destroyed.

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.

6. FURTHER INFORMATION What Baclofen contains

The active substance is: baclofen.

Baclofen 10 mg/20 ml solution for infusion:

1 ml solution for infusion contains 0.5 mg baclofen.

1 ampoule with 20 ml solution for infusion contains 10 mg baclofen.

- The other ingredients are: sodium chloride and water for injections.

What Baclofen looks like and contents of the pack

Solution for infusion.

Baclofen is a clear, colourless solution in a clear, colourless ampoule.

Baclofen 10 mg/20 ml, solution for infusion is available in packs containing 1 and 5 ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87 2132 JH Hoofddorp The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany:    Baclofen SUN    10 mg/20    ml Infusionslosung

Spain:    Baclofen SUN    10 mg/20    ml Solucion para perfusion

France:    Baclofene SUN    10 mg/20    ml Solution pour perfusion

IT:    Baclofene SUN    10 mg/20    ml Soluzione per infusione

UK:    Baclofen 10 mg/20 ml Solution for Infusion

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SI

CQ

This leaflet was last approved in 03/2011.