Baclofen 0.5mg/ml solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Baclofen Aguettant is and what it is used for
2. What you need to know before you use Baclofen Aguettant
3. How to use Baclofen Aguettant
4. Possible side effects
5. How to store Baclofen Aguettant
6. Contents of the pack and other information

• if you are allergic to baclofen or any of the other ingredients of this medicine. (listed in section 6).
• if you suffer from epilepsy refractory to therapy.
• by any other route of administration than via the spinal canal.

Talk to your doctor or pharmacist before using Baclofen Aguettant

• if you are having any other injections into the spine
• if you are suffering from any infection
• if you had a head injury within the last year
• if you ever had a crisis caused by a condition called autonomic dysreflexia: a reaction of the nervous system to overstimulation, causing sudden severe high blood pressure (Your doctor will be able to explain this to you.)
• if you have had a stroke
• if you have epilepsy
• if you have a stomach ulcer or any other problem with your digestion
• if you suffer from any mental illness
• if you are being treated for high blood pressure
• if you have Parkinson’s disease
• if you suffer from any liver, kidney, heart or breathing difficulties
• if you have diabetes
• if you have difficulties in urinating

If the answer to any of this list of questions is YES, tell your doctor or nurse because Baclofen Aguettant may not be the right medicine for you.

• If you are going to have an operation of any kind, make sure that the doctor knows that you are being treated with Baclofen Aguettant.
• The presence of a PEG tube increases the incidence of infections in children.
• If you have reduced circulation of liquid contained in the brain and spinal cord as a result of obstructed passage, for example caused by inflammation or injuries.
• Contact your doctor immediately if you think that Baclofen Aguettant is not working as well as usual. It is important to make sure that there are no problems with the pump.
• Treatment with Baclofen Aguettant must not stop suddenly because of the risk of withdrawal effects. You must make sure that you do not miss those hospital visits when the pump reservoir is being refilled.
• Your doctor may want to give you a check-up from time to time while you are being treated with Baclofen Aguettant.

Tell your doctor immediately if you get any of these symptoms during treatment with Baclofen Aguettant:

• If you have pain in your back, shoulders, neck and buttock during the treatment (a type of spinal deformity called scoliosis).
• Some patients treated with baclofen have had thoughts of harming or killing themselves or have attempted suicide. Most of these patients also suffered from depression, alcohol abuse, and/or had a history of previous suicide attempts. If you have thoughts of harming or killing yourself, talk to your doctor immediately, or go to a hospital. Also, ask a relative or close friend to tell you if they are concerned about any change in your behaviour and ask them to read this leaflet.

Baclofen Aguettant is not recommended for children under 4 years. Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion. There is very limited clinical data regarding the safety and efficacy of the use of Baclofen Aguettant in children under the age of four year.

In studies, elderly patients treated with Baclofen Aguettant had no specific problems. However, experience with oral baclofen administration shows that this patient group is more likely to experience side effects. Elderly patients should therefore be carefully monitored for the occurrence of side effects.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can interfere with your treatment. Remind your doctor or nurse if you are taking any of the following:

• Other medicines for your spastic condition
• Medicines to treat depression
• Medicines for high blood pressure
• Medicines for Parkinson’s disease
• Strong pain relief medicines, such as morphine
• Medicines which slow down the function of the central nervous system, such as sleep inducing medicines
• Medicines for general anesthesia, such as fentanyl and propofol

Avoid drinking alcohol during treatment with Baclofen Aguettant as this may lead to an undesirable intensification or unpredictable change in the effects of the medicine.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

There is limited experience on the use of intrathecal baclofen during pregnancy. Oral baclofen should not be used during pregnancy unless absolutely necessary, due to cases of malformations (of the central nervous system, bone anomalies, omphalocele (malformation of the abdominal wall)) reported in children of mothers who have received this treatment. If oral baclofen is used until delivery, a withdrawal syndrome may occur in the newborn.

The newborn may experience convulsions and other symptoms associated with abrupt cessation of treatment immediately after delivery (see If treatment with Baclofen Aguettant is interrupted). This syndrome may be delayed for several days after birth. If you take this medicine during pregnancy, you should be monitored and treated accordingly.

Baclofen Aguettant should not be used during pregnancy, unless the doctor finds it necessary and the expected benefit for the mother outweighs the potential risk for the child.

Breast-feeding

Baclofen Aguettant passes into breast milk, but in amounts so small that the infant will probably not experience any undesirable effects. Ask your doctor for advice before using Baclofen Aguettant during breast-feeding.

Some people may feel drowsy and/or dizzy or have problems with their eyes while they are being treated with Baclofen Aguettant. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until these effects have worn off.

This medicine contains 70 mg sodium (main component of cooking/table salt) in each ampoule. This is equivalent to 3.5% of the recommended maximum daily dietary intake of sodium for an adult.

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

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.

It is very important that you, and anyone caring for you, can recognise the signs of overdose. These may appear if the pump is not working properly, and you must tell the doctor straight away.

Signs of overdose are:

• Unusual muscle weakness (too little muscle tone)
• Sleepiness
• Dizziness or light-headedness
• Excessive salivation
• Nausea or vomiting
• Difficulty in breathing
• Convulsions
• Loss of consciousness
• Fast heartbeat (tachycardia)
• Ringing in the ears (tinnitus)

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is baclofen

Baclofen Aguettant 0.5 mg/ml solution for infusion

1 ampoule with 20 ml of solution contains 10 mg of baclofen.

1 ml of solution for infusion contains 0.5 mg of baclofen.

• The other ingredients are sodium chloride (3.5 mg/ml sodium) and water for injections.

Solution for infusion

Clear and colorless solution in ampoules.

Baclofen Aguettant 0.5 mg/ml solution for infusion

Type I clear colorless glass 20 ml ampoules with score-break and red colored ring marker.

Box of 1 ampoule containing 20 ml of solution.

Baclofen Aguettant 0.5 mg/ml solution for infusion

Type I clear colorless glass 20 ml ampoules with score-break and red colored ring marker packaged in sterile plastic blister.

Box of 1 ampoule containing 20 ml of solution.

Not all pack sizes may be marketed.

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