Baclofen

Baclofen

Read all of this page carefully before you start using this medicinal product because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any doubt, please ask your doctor or nurse.
  • If you manifest any side effects, including those that are not listed in this leaflet, please inform your doctor or nurse.

1.  What is BACLOFENE Bioindustria L.I.M. and what it is used for
2.  What you need to know before using BACLOFENE Bioindustria L.I.M.
3.  How to use BACLOFENE Bioindustria L.I.M.
4.  Possible side effects
5.  How to store BACLOFENE Bioindustria L.I.M.
6.  Package contents and other information
1.  What is BACLOFENE Bioindustria L.I.M. and what it is used for
BACLOFENE Bioindustria L.I.M. contains the active substance baclofen that belongs to a group of medicinal products called muscle relaxants, used to relax the muscles.
This medicine is indicated in the case of:

  • Severe muscular problems (severe chronic spasticity), associated with multiple sclerosis, lesions or other bone marrow diseases, that do not respond to oral antispasticity therapies (antispasmodics, including baclofen) or cannot use them because of unacceptable side-effects;
  • Brain problems (cerebral spasticity), as in the case of cerebral palsy, skull lesions or cerebral infarction;
  • Infectious disease called tetanus, that affects the muscles and nerves, to reduce tendons reflexes (hyperreflexia), involuntary muscle contractions (myoclonus) and painful contractions of the masticatory muscles (lockjaw).

BACLOFENE Bioindustria L.I.M. is indicated for children from 4 to <18 years of age with severe problems of the nervous system (chronic spasticity of cerebral or spinal origin) associated with trauma or bone marrow diseases such as multiple sclerosis, who do not respond to oral administration of antispasticity drugs (antispasmodics, including baclofen) or cannot use them because of unacceptable side-effects.
2.  What you need to know before using BACLOFENE Bioindustria L.I.M.
Do not use BACLOFENE Bioindustria L.I.M.

  • If you are allergic to baclofen or any of the other components of this medicinal product (listed in paragraph 6);
  • For administration into a vein (intravenous), into a muscle (intramuscular), for subcutaneous or epidural administration.

Warnings and precautions
Talk to your doctor or nurse before you are administered BACLOFENE Bioindustria L.I.M.
Before you are given this medicinal product you should stop gradually and under medical control the use of oral antispasticity drugs (antispasmodics), to avoid the possibility of an overdose or interactions between drugs.
This medicinal product should be administered with caution and under strict medical supervision in the following cases:

  • If you suffer from anomalies in cephalorachidian fluid circulation;
  • If you suffer from mental disorders such as schizophrenia, confusion or Parkinson's Disease;
  • If you suffer from epilepsy;
  • If you suffer from alterations of the autonomic nervous system (autonomic dysreflexia);
  • If you suffer from cerebrovascular or respiratory failure, because these conditions may worsen;
  • If you have suffered from a stomach or intestine problem (peptic ulcer, previously existing hypertonic sphincter);
  • If you suffer from kidney problems (renal insufficiency).

Before starting chronic intrathecal infusion of this medicinal product using an implantable pump, your doctor will need to submit you to an initial test (screening phase), during which this medicine is administered with an intrathecal bolus, and check that there are no symptoms of an infection. Furthermore, during the administration of the initial test dose your doctor will monitor your respiratory function and your heart function, especially if you have heart problems, lung problems, respiratory muscle weakness or if you are taking drugs that may increase the risk of respiratory problems (respiratory depression) like benzodiazepines and opiates.
The sudden suspension of this medicine may lead to:

  • An increase in muscle disorders (spasticity), itching, disorder of the sensitivity of legs and arms or other parts of the body (paraesthesia) and reduction of blood pressure (hypotension) with consequent excessive increase in motor activity (hyperactive state), rapid and uncontrolled contractions of muscles, strong increase in body temperature (hyperthermia) and symptoms related to the neuroleptic malignant syndrome such as altered mental status and muscle stiffness;
  • In some rare cases, seizure episodes, convulsion/epilepsy, damage to skeletal muscles  (rhabdomyolysis), bleeding disorders (coagulopathy), multi-organ failure and death;
  • Alterations of the autonomic nervous system (autonomic dysreflexia), infection (sepsis), pharmacogenetic disease of the skeletal muscles (malignant hyperthermia) and excessive increase of energy consumption (neuroleptic malignant syndrome associated with hypermetabolic status).

During treatment with BACLOFENE Bioindustria L.I.M an inflammatory mass may appear at the tip of the implanted catheter, that can lead to severe neurological impairment, including lesions of the motor nerves (paralysis), especially when this medicine is administered at high doses and in association with intrathecal opioids.
Pay the highest attention and inform your doctor immediately if you experience the following symptoms: Worsening or resurgence of muscular problems (spasticity), poor response following administration of increasing doses or frequent or large dosages; pain, neurological disorders (deficit/neurological dysfunction). In this case the doctor will perform specific controls to confirm or exclude the presence of an inflammatory mass.
Children
Data on the safety and efficacy of BACLOFENE Bioindustria L.I.M. to treat children under 4 years of age are very limited
The Elderly
If you are over 65, this medicine should be administered to you with great caution.
Other medicinal products and BACLOFENE Bioindustria L.I.M.
Tell your doctor or nurse if you are using, have recently used or may use any other medicinal product.
This medicinal product should be administered with great caution if you are using any of the following medicinal products:

  • Drugs used for Parkinson's Disease (levodopa, DOPA-decarboxylase inhibitors);
  • Drugs used to reduce pain during surgical operations (general anaesthetics) such as fentanyl and propofol;
  • Morphine, a drug used to reduce severe pain;
  • Drugs that act on the Central Nervous System (analgesics, neuroleptics, barbiturates, benzodiazepines, anxiolytics);
  • Drugs for the treatment of mood disorders (tricyclic antidepressants);
  • Drugs used for the control of blood pressure (antihypertensive drugs).

Baclofen Bioindustria L.I.M. with alcohol
Avoid drinking alcohol during treatment with this medicinal product, because it may increase the effect of the medicinal product.
Pregnancy and lactation
If you are pregnant, if you think you might be or are planning to become pregnant, or if you are breastfeeding, ask your doctor or nurse for advice before this medicinal product is administered to you. If you are pregnant or if you are breastfeeding, use this medicine only in cases of absolute necessity and under direct medical supervision.
Effects on the ability to drive and use machinery
The use of BACLOFENE Bioindustria L.I.M.may cause drowsiness, sedation, movement disorders (ataxia), hallucinations, double vision (diplopia) and withdrawal symptoms, which may impair the ability to drive and use machines. In this case avoid driving and using machines.
BACLOFENE Bioindustria L.I.M. contains sodium
BACLOFENE Bioindustria L.I.M. 10 mg/20 ml contains up 73.9 mg (3.08 mmol) of sodium for 20 millilitres. To be taken into consideration by people with reduced renal function or that are following a low sodium diet.
BACLOFENE Bioindustria L.I.M. 10 mg/5 ml and BACLOFENE Bioindustria L.I.M. 0.05 mg/1 ml contain less than 23 mg (1 mmol) of sodium per dose, i.e. they are practically “sodium free”.
3.   How to use BACLOFENE Bioindustria L.I.M.
Always follow the instructions of your doctor when using this medicinal product. If you have any doubts consult your doctor.
This medicinal product will be administered by a trained physician, by means of an infusion in the liquid that surrounds the vertebral column (intrathecal) using a delivery device implanted in a subcutaneous pocket, generally in the abdomen.
If you use more BACLOFENE Bioindustria L.I.M. than you should
In the event of overdose, the following reactions may occur: excessive muscle tone reduction (hypotonia), drowsiness, light-headedness, dizziness, seizures, blackouts, reduction of body temperature (hypothermia), increased production of saliva (hypersalivation), nausea and vomiting and after excessive doses respiratory problems (respiratory depression), absence of breath (apnoea) and coma. Your doctor will determine the appropriate therapy.
If you experience these effects immediately notify your doctor or contact the nearest hospital.
If you forget to use BACLOFENE Bioindustria L.I.M.
This medicine will be administered by a physician, so it is unlikely that a dose would be forgotten.
If you suspend the treatment with BACLOFENE Bioindustria L.I.M.
The treatment with this medicinal product should not be suspended abruptly. In case of sudden suspension of this medicinal product your doctor will reduce the dosage gradually and will determine the appropriate therapy.
If you have any doubt about the use of this medicinal product, please ask your doctor or nurse.
4.  Possible side effects
Like all drugs, this medicinal product may cause side effects although not all patients present them. The following side effects may occur:
Very common (which may affect more than 1 in 10 people):

  • Drowsiness, feeling of unsteadiness;
  • Muscle tone reduction (hypotonia).

Common (which may affect up to 1 in 10 people):

  • Mood disturbance (depression), feeling of worry or fear (anxiety), restlessness;
  • confusion, sedation, dizziness/light-headedness, disorder of the sensitivity of legs and arms or other parts of the body (paraesthesia), disorder of the speech muscles (dysarthria), deep sleep (lethargy), reduced coordination, sleep disorders (insomnia), disorientation; convulsion and headache especially in patients with muscle disorders (spasticity) of cerebral origin rather than in patients with spasticity of spinal origin;
  • Difficulties for the eyes to focus objects (accommodation disorder), blurred vision, double vision (diplopia);
  • Blood pressure reduction (hypotension);
  • Respiratory disorders (respiratory depression), inflammation of the lungs (pneumonia), difficulty in breathing (dyspnoea);
  • Nausea, vomiting, most often in patients with motor disorders (spasticity) of cerebral origin rather than in patients with spasticity of spinal origin ;
  • Constipation, dry mouth, diarrhoea, loss of appetite, increased salivation;
  • Skin irritation (hives), itching, swelling of the face and/or legs and feet (facial and/or peripheral oedema);
  • Excessive muscle tone increase (hypertonia);
  • Involuntary loss of urine (urinary incontinence), bladder disorders; inability of the bladder to empty (urinary retention), most often in patients with motor disorders (spasticity) of cerebral origin rather than in patients with spasticity of spinal origin ;
  • Sexual disorders (sexual dysfunction);
  • Reduction of muscular force (asthenia), fever (pyrexia), pain, chills.

Not common (which may affect up to 1 in 100 people):

  • Lack of water in the body (dehydration);
  • Suicidal ideation, attempted suicide, hallucinations, paranoia, euphoria;
  • Muscle coordination disorders (ataxia), memory impairment, rapid and oscillatory movements of the
  • eyes (nystagmus);
  • Heartbeat reduction (bradycardia);
  • Cardiac problems (hypertension), formation of blood clots in a deep vein (deep venous thrombosis),
  • reddening of the skin, lightness of skin colour (paleness);
  • Intestinal occlusion, difficulty swallowing (dysphagia), diminished sense of taste (hypogeusia);
  • Hair loss (alopecia), excessive sweating (hyperhidrosis);
  • Reduction of body temperature (hypothermia).

Rare (which may affect up to 1 in 1000 people):

  • Life-threatening suspension symptoms due to poor infusion function of the medicinal product (see the paragraph "Warnings and Precautions").

Not known (whose frequency can not be established on the basis of the available data):

  • Identity disorders (dysphoria);
  • Reduction of the number of breaths (bradipnea).

The following side effects associated with the device that delivers the medicinal product may also occur:

  • Inflammation at the tip of the implanted catheter, displacement of the catheter with potential

complications, infection of the subcutaneous pocket, infection of the central nervous system
(meningitis), overdose due to incorrect handling of the device.
Reporting side effects
If you manifest any side effects, including those that are not listed in this leaflet, please inform your doctor or
pharmacist. You can also report the side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more
information on the safety of this medicinal product.
5.  How to store BACLOFENE Bioindustria L.I.M.
The medical staff knows how to store this medicinal product.
Keep this medicinal product out of the reach and sight of children.
Do not use this medicinal product after the expiry date which is written on the packaging. The expiry date
refers to the last day of that month.
Do not freeze the ampoules. Store below 30°C.
Do not throw any medicinal product in the waste water or in the household waste. Ask your pharmacist how to eliminate medicinal products which you no longer use. This will help to protect the environment.
6.  Package contents and other information
What does BACLOFENE Bioindustria L.I.M. 10 mg/20 ml injectable solution for intrathecal use contain

  • The active substance is baclofen: 1 ampoule with 20 ml of solution contains 10 mg of baclofen.
  • The other ingredients are sodium chloride, water for injections.

What does BACLOFENE Bioindustria L.I.M. 10 mg/5 ml injectable solution for intrathecal use contain

  • The active substance is baclofen: 1 ampoule with 5 ml of solution contains 10 mg of baclofen.
  • The other ingredients are sodium chloride, water for injections.

What does BACLOFENE Bioindustria L.I.M. 0.05 mg/1 ml injectable solution for intrathecal use contain

  • The active substance is baclofen: 1 ampoule with 1 ml of solution contains 0.05 mg of baclofen.
  • The other ingredients are sodium chloride, water for injections.

Description of the appearance of BACLOFENE Bioindustria L.I.M. and package contents

  • BACLOFENE Bioindustria L.I.M. 10 mg/20 ml: 1 ampoule of 10 mg/20ml
  • BACLOFENE Bioindustria L.I.M. 10 mg/5 ml: 5 ampoules of 10 mg/5ml
  • BACLOFENE Bioindustria L.I.M. 0.05 mg/1 ml: 10 ampoules of 0.05 mg/1ml