1.     What Baclofen Sintetica is and what it is used for

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

Baclofen Intrathecal 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.

This injection is used in people who haven't responded to oral medicines or who get unacceptable side effects when they take baclofen by mouth.

2.     What you need to know before Baclofen Sintetica is given to you

Children and adolescents:

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

You must not be given  Baclofen Sintetica

-        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.

-        Baclofen Sintetica should not be administered by any route other than intrathecal (into the spinal canal).

Warnings and precautions

Talk to your doctor or pharmacist before using Baclofen Sintetica

• 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 (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 or lung disease

• 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 Sintetica 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 Sintetica.

• The presence of a PEG tube increases the incidence of infections in children.

• If you have a slowed cerebrospinal fluid circulation the effect of Baclofen Intrathecal may be reduced.

• Contact your doctor immediately if you think that Baclofen Sintetica is not working as well as usual. It is important to make sure that there are no problems with the pump.

• Treatment with Baclofen Sintetica 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 Sintetica.

Precautions in paediatric patients:

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 Sintetica in children under the age of four year.

Other medicines and Baclofen Sintetica

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

•     Antidepressants

•     Medicines for high blood pressure

•     Other drugs which also affect the kidney, e.g. ibuprofen

•     Medicines for Parkinson's disease

•     Medicines for epilepsy

•     Opiates for pain relief

•     Medicines which slow down the nervous system, e.g. anti-histamines and sedatives. (Some of these can be bought over-the-counter.)

Baclofen Sintetica with food and drink

•  Be careful when drinking alcohol - it may affect you more than usual.

Pregnancy, breast-feeding and fertility

Ask your doctor or nurse for advice before taking any medicine.

There are no adequate and sufficiently controlled studies in pregnant women. Baclofen crosses the placental barrier. Baclofen Sintetica must not be used during pregnancy, unless the potential benefits outweigh the possible risks to the foetus.

Breast-feeding

It is not known whether measurable levels of the product can be detected in the maternal milk of lactating mothers treated with Baclofen Sintetica. At oral therapeutic doses, the active substance passes into breast milk, but in amounts so small that the infant will probably not experience any undesirable effects.

Driving and using machines

Some people may feel drowsy and/or dizzy or have problems with their eyes while they are being treated with Baclofen Sintetica. 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.

Important information about some of the ingredients of Baclofen Sintetica

This medicinal product contains less than 1 mmol sodium (23 mg) per maximum daily dose, so it is essentially “sodium-free”.

1.      How to use Baclofen Sintetica

Baclofen Sintetica is administered by intrathecal injection. This means that the medicine is injected directly into the spinal fluid. The dose needed varies from person to person depending on their condition, and the doctor will decide what dose you need after he/she has tested your response to the drug.

First of all the doctor will find out, by giving you single doses of Baclofen Sintetica, whether it is suitable for you. Usually, this test dose is administered via lumbar puncture or an intrathecal (spinal) catheter, in order to provoke a response. During this period your heart and lung functions will be closely monitored. If your symptoms improve, a special pump which can deliver the drug continuously will be implanted into your chest or abdominal wall. The doctor will give you all of the information you need to use the pump and to get the correct dosage. Make sure that you understand everything.

The final dose of Baclofen Sintetica depends on how each person responds to the drug. You will be started on a low dose, and this will be increased gradually over a few days, under the supervision of the doctor, until you are having the dose which is right for you. If the starting dose is too high, or if the dose is increased too quickly, you are more likely to experience side effects.

To avoid unpleasant side effects which may be serious and even life-threatening, it is important that your pump does not run out. The pump must always be filled by a doctor or nurse, and you must make sure that you do not miss your clinic appointments.

During long-term treatment some patients find that Baclofen Sintetica becomes less effective. You may require occasional breaks in treatment. Your doctor will advise you what to do.

Baclofen Sintetica is not suitable for all children. The doctor will decide.

Efficacy of baclofen intrathecal has been demonstrated in controlled randomized studies with infusion systems. EU certified pumps can be used as implantable administration system: a refillable reservoir is implanted beneath the skin, mostly into the abdominal wall. This system is connected to an intrathecal (spinal) catheter that passes subcutaneously into the subarachnoid space. Other pumps, known to be suitable for intrathecal baclofen administration based on experience, may be used.

If you have been given too much Baclofen Sintetica

It is very important that you, and anyone caring for you, can recognize 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

Abnormally low body temperature

If you stop using Baclofen Sintetica

You should not stop treatment suddenly. If the doctor decides to stop your treatment, the dose will be reduced gradually to prevent withdrawal symptoms 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). On rare occasions these symptoms could be life-threatening. If you or your caregivers notice any of these symptoms, contact your doctor immediately just in case something has gone wrong with the pump or delivery system.

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 Sintetica can cause side effects, although not everybody gets them.

The side effects listed below have been reported:

Very common: may affect more than 1 in 10 people

Feeling tired, drowsy or weak.

Common: may affect up to 1 in 10 people

Feeling lethargic (having no energy)

Headache, dizziness or light-headedness

Pain, fever or chills

Seizures

Tingling hands or feet

Problems with eyesight

Slurred speech Insomnia

Breathing difficulties, pneumonia

Feeling confused, anxious, agitated or depressed

Low blood pressure (fainting)

Feeling or being sick, constipation and diarrhoea

Loss of appetite, dry mouth or excessive saliva

Rash and itching, swelling of the face or hands and feet

Urinary incontinence, or problems when urinating

Cramps

Sexual problems in men, e.g. impotence.

Uncommon: may affect up to 1 in 100 people

Feeling abnormally cold

Memory loss

Mood swings and hallucinations, feeling suicidal

Stomach ache, difficulty in swallowing, loss of taste, dehydration

Loss of muscle control

Raised blood pressure

Slow heart beat

Deep vein thrombosis

Flushed or pale skin, excessive sweating

Hair loss.

Other side effects (how often they happen is not known)

Restlessness

Abnormally slow breathing rate.

There have been rare reports of problems associated with the pump and delivery system. There are sometimes adverse events associated with the delivery system e.g. infections, a collection of immune cells at the tip of delivery tube or meningitis, in particular the presence of a PEG tube increased the incidence of deep infections in children.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system. 

To Report any side effect(s):

• Saudi Arabia:

• Other GCC States

By reporting side effects you can help provide more information on the safety of this medicine.

5.       How to store Baclofen Sintetica

Keep this medicine out of the sight and reach of children.

Do not use Baclofen Sintetica after the expiry date {month/year} which is stated on the outer carton and on the ampoule.The expiry date refers to the last day of that month.

Do not refrigerate or freeze.

Store in the original package in order to protect from light.

From a microbiological point of view, unless the method of opening and dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not use Baclofen Sintetica if you notice that the solution is not clear and free from particles.

As it is limited to hospital use the waste drug elimination is carried out directly by the hospital. These measures will help to protect the environment.