Bacentra Intrathecal 0,05 mg/0,5 mg/2 mg Solution

The active ingredient of Bacentra Intrathecal, baclofen, is a muscle-relaxant medicine. Bacentra 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 conditions such as cerebral palsy, multiple sclerosis, spinal cord diseases, cerebrovascular accidents, brain trauma, and other nervous system disorders. This injection is used in people who have not responded to oral medicines or who get unacceptable side effects when they take baclofen by mouth.

You should not be given Bacentra Intrathecal:

• if you are hypersensitive (allergic) to baclofen or any of the other ingredients of Bacentra Intrathecal (listed in section 6).
• if you suffer from epilepsy refractory to therapy.
• if you have porphyria (a genetic condition).
• if you are pregnant and breastfeeding your baby.
• the catheter needed for a continuous infusion should not be inserted if you have any infection in that area.

Bacentra Intrathecal should not be administered by any route other than intrathecal (into the spinal canal).

Warnings and precautions

Tell your doctor or health care provider before you are given Bacentra Intrathecal:

• if you are having any other injections into the spine.
• If you are taking strong pain medication.
• If you are taking any other muscle-relaxing medicines.
• if you are suffering from any infection.
• if you had a head injury within the last year.
• if you have epilepsy.
• if you suffer from any mental illness.
• if you have Parkinson's disease.
• 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 suffer from any liver, kidney or lung disease.
• if you have a stomach ulcer or any other problem with your digestion.
• if you have difficulties in urinating.
• if you are being treated for high blood pressure.

Take special care if you are receiving Bacentra Intrathecal:

• You, your care-givers and family members should be familiar with the symptoms of under- and over dosing, as well as the procedures to be implemented in the event of overdosage (see “If you receive more Bacentra Intrathecal than you should”).
• If you think that Bacentra Intrathecal is not working as well as usual. It is important to make sure that there are no problems with the delivery pump.
• Treatment with Bacentra Intrathecal 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 Bacentra Intrathecal.
• If you are going to have an operation of any kind, make sure that the doctor knows that you are being treated with Bacentra Intrathecal, as certain anaesthetics may increase the risk of side effects.

Children and adolescents

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 Bacentra Intrathecal in children under the age of four years.

Other medicines and Bacentra Intrathecal

Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines). Some medicines can interfere with your treatment. Tell your doctor, nurse or health care provider if you are taking any of the following:

• Other medicines used to treat your spastic condition, including muscle relaxing medicines.
• Medicines used to treat depression or mental illness.
• Medicines to treat high blood pressure.
• Medicines used to treat Parkinson's disease.
• Medicines used to treat epilepsy.
• Strong pain medication called opiates, e.g. morphine.

Bacentra Intrathecal with food, drink and alcohol

Be careful when drinking alcohol whilst receiving Bacentra Intrathecal, as it may affect you more than usual.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine. You should not receive Bacentra Intrathecal if you are pregnant or breastfeeding, as there are no adequate and sufficiently controlled studies in pregnant and lactating women. Baclofen, the active ingredient, crosses the placental barrier, which could lead to exposure of your unborn baby to the medicine. It is not known whether measurable levels of baclofen can be detected in breast milk treated with Bacentra Intrathecal. Orally administered baclofen can pass into breast milk.

You will not be expected to give yourself Bacentra Intrathecal. It will be given to you by a person qualified to do so. Bacentra Intrathecal is administered via 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. Your doctor will decide what dose you need after he/she has tested your response to Bacentra Intrathecal.

Your treatment will start off with your doctor testing to see whether Bacentra Intrathecal is suitable for you by giving you a single intrathecal injection. Usually, this test dose is administered via lumbar puncture or an intrathecal (spinal) catheter into the spinal fluid, in order to see how you respond to Bacentra Intrathecal. During this test period, your heart and lung functions will be closely monitored.

If it has been established that you responded well to the Bacentra Intrathecal test dose, and that Bacentra Intrathecal is suitable to treat your condition, a special refillable delivery pump, which will be filled with Bacentra Intrathecal, will be implanted beneath your skin into your chest or abdominal wall. This delivery system is connected to an intrathecal (spinal) catheter that passes under the skin into the subarachnoid space, which contains your spinal fluid. Your 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.

During the initial treatment with the delivery pump, your doctor will continually adjust the dose of Bacentra Intrathecal delivered to you by the delivery pump. You will be started on a low dose, which will be increased gradually over a few days under the supervision of your doctor, until the correct dose has been established for you. The final dose of Bacentra Intrathecal will depend on how you respond to the medicine. To avoid unpleasant side effects which may be serious and even life-threatening, it is important that your pump does not run out of medicine. The pump must always be filled by a doctor or suitable qualified healthcare professional. You must make sure that you do not miss your hospital appointments to have your pump refilled.

Bacentra Intrathecal can have side effects. Not all side effects reported for Bacentra Intrathecal are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving this medicine, please consult your doctor, pharmacist or other health care provider for advice.

If any of the following happens, tell your doctor, nurse or healthcare professional immediately or go to the casualty department of your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting;
• yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to Bacentra Intrathecal. You may need urgent medical attention.

The following frequent side effects have been observed:

• Breathing difficulties, chest tightness, pneumonia
• Epileptic seizures (fits)
• Feeling confused/disorientated, anxious, agitated or depressed
• Headache, dizziness or light-headedness
• Feeling tired, drowsy or weak
• Feeling lethargic (having no energy)
• Insomnia (difficulty to sleep)
• Finding it difficult to concentrate
• Tingling hands or feet
• Slurred speech
• Problems with eyesight
• Low blood pressure
• Vomiting, nausea (feeling like vomiting)
• Constipation or diarrhoea
• Loss of appetite
• Dry mouth or excessive saliva
• Rash and itching of the skin
• Swelling of the face or hands and feet (facial or peripheral oedema)
• Unusual muscle weakness (too little muscle tone)
• Uncontrollable shock-like jerks of muscles or groups of muscles
• Difficulty to maintain balance
• Urinary incontinence (not being able to control when you urinate) or being unable to urinate
• Sexual problems in men, e.g. impotence.
• Pain, fever or chills

The following less frequent side effects have been observed:

• Dehydration
• Mood swings and hallucinations, feeling suicidal
• Loss of coordination (ataxia)
• Memory loss
• Uncontrollable eye movements (nystagmus)
• Slow heart rate (bradycardia)
• Raised blood pressure
• Deep vein thrombosis (the forming of a blood clot in a deep vein in the body)
• Flushed or pale skin
• Cerebrovascular disorder (a conditions that affects the blood vessels in the brain)
• Ileus (a condition which makes it difficult to empty your bowel)
• Difficulty in swallowing
• Loss of taste
• Hair loss
• Excessive sweating
• Feeling abnormally cold
• Septicaemia (an infection in which a large amount of bacteria is present in the blood)
• Subdural haemorrhage (bleeding between the skull and brain)
• Accidental injury
• Weight loss
• Potentially life-threatening withdrawal symptoms (as a result of sudden interruption of medicine delivery)

The following side effects have been observed, but their frequency is unknown (how often they happen is not known):

• Restlessness (dysphoria)
• Scoliosis (a condition where the spine curves sideways)
• Erectile dysfunction

There have been rare reports of problems associated with the pump and delivery system, which include infections, a collection of immune cells at the tip of delivery tube, dislodgement/kink/rupture of the delivery tube, meningitis, seroma (blood plasma that has leaked out of small blood vessels), bleeding, pump malfunction, cerebrospinal fluid leakage, skin ulcers and overdosage or underdosage. In one report, the presence of a polyethylene glycol (PEG) tube increased the incidence of deep infections in children. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of sight and reach of children. Store at or below 30 °C. 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 Bacentra Intrathecal if you notice that the solution is not clear and free from particles.

Every ampoule is for single-use only. Any remaining product must be disposed of. Bacentra Intrathecal must not be resterilized.