BACLOFENE 25 mg Coated Tablet

Содержание инструкции

1. BACLOFENE DOC 25 mg tablets
   1. What is BACLOFENE DOC and what is it used for
   2. What you need to know before you take BACLOFENE DOC
   3. How to take BACLOFENE DOC
   4. Possible side effects
   5. How to store BACLOFENE DOC
   6. Contents of the pack and other information

BACLOFENE DOC 25 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is BACLOFENE DOC and what is it used for

BACLOFENE DOC contains the active ingredient baclofen which belongs to the class of medicines
known as “centrally acting muscle relaxants”. Baclofen works by relaxing the muscles.

Adults
BACLOFENE DOC is indicated for the treatment of manifestations characterized by increased
muscle tone and contraction (spastic hypertonia):

• in multiple sclerosis
• in diseases of the spinal cord of infectious, degenerative, traumatic, tumorous, unknown origin for example: o spastic spinal paralysis o amyotrophic lateral sclerosis o syringomyelia o transverse myelitis o paraplegia o traumatic paraparesis o states of spinal cord compression
• following damage to the brain, in particular in cases of: o disease occurring in childhood (childhood encephalopathy) o diseases of the cerebral blood vessels (cerebrovascular disease) o diseases of the brain due to tumors or degeneration.

Children and adolescents (from 0 to 18 years of age)
BACLOFENE DOC is indicated for the treatment of symptoms of increased muscle tone and
muscle contraction (spastic hypertonia):

• following damage to the brain, in particular in cases of: o infantile cerebral palsy

o stroke o transient ischemic attack
o diseases of the brain due to tumors or degeneration

• in diseases of the spinal cord of infectious, degenerative, traumatic, tumorous, unknown origin for example: o multiple sclerosis o spastic spinal paralysis o amyotrophic lateral sclerosis o syringomyelia o transverse myelitis o paraplegia o traumatic paraparesis o states of spinal cord compression.

2. What you need to know before you take BACLOFENE DOC

Do not use BACLOFENE DOC

• if you/your child are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).
• if you/your child have or have had a stomach or duodenal ulcer (peptic ulcer).

Warnings and precautions
Talk to your doctor or pharmacist before taking BACLOFENE DOC.
Inform your doctor, who will pay particular attention when prescribing BACLOFENE DOC and will keep
you/your child under close supervision, if you/your child:

• suffer from mood disorders (e.g. psychosis, schizophrenia, depressive or manic disorders)
• suffer from states of confusion
• have Parkinson's disease
• have epilepsy
• have disorders of the blood vessels of the brain
• have breathing problems
• have liver problems
• have kidney problems
• have difficulty urinating due to an increase in the tone of the muscles that control the passage of urine (vesical sphincter hypertonia)
• are pregnant: immediately after childbirth your baby may have convulsions and other symptoms related to the abrupt interruption of treatment (see “If you/your child stop taking BACLOFENE DOC”)
• have a history of alcoholism, excessively consume alcohol or have a history of drug abuse or dependence.

If during treatment with BACLOFENE DOC you undergo some laboratory tests to
evaluate liver function (levels of aspartate aminotransferase and alkaline phosphatase) or blood sugar levels, be aware that these values may be altered. The doctor
will subject you or your child to periodic checks, especially if you have liver problems or suffer from
diabetes.
Some people treated with baclofen have developed thoughts of self-harm or suicide
or have attempted suicide. Almost all of these people were also suffering from depression,
were excessive alcohol users or were prone to suicidal thoughts. If at any time you should
develop thoughts of self-harm or suicide, tell your doctor immediately or go to
hospital. Also, ask a relative or close friend to warn you if they should notice
any change in your behavior and invite them to read this leaflet.

Children
Clinical data on the use of baclofen in children under one year of age are limited, therefore the
doctor will carefully assess the use of this medicine in these patients.

Other medicines and BACLOFENE DOC
Tell your doctor or pharmacist if you/your child are taking, have recently taken or might take
any other medicines.
Inform your doctor if you/your child are taking:

• medicines for Parkinson's disease (e.g. levodopa, carbidopa)
• medicines that cause a reduction in the activity of the Central Nervous System, for example: or other medicines to relax muscles, for example tizanidine or synthetic opioids
• morphine
• medicines against depression of the tricyclic class
• lithium (medicine for mood disorders)
• antihypertensives (medicines for high blood pressure)
• medicines that reduce kidney function.

The doctor will keep you/your child under close supervision and will assess whether to modify the dose of BACLOFENE
DOC or the other medicine.

BACLOFENE DOC with alcohol
The use of BACLOFENE DOC with alcohol can increase the sedative effect and the risk of difficulty
breathing.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate studies in pregnant women. Baclofen crosses the placenta, therefore if you
are pregnant the medicine will be prescribed to you only in cases of actual necessity and under the direct control of
the doctor.
If you have to take BACLOFENE DOC during pregnancy, immediately after childbirth your baby
may have convulsions and other symptoms related to the abrupt interruption of treatment (see
“If you/your child stop taking BACLOFENE DOC” and “Warnings and precautions”).
Breastfeeding
Baclofen passes into breast milk in small amounts, therefore no adverse effects are expected
for the infant.
Fertility
There are no data available regarding the activity of baclofen on human fertility, nor data that
support particular recommendations for women of childbearing potential.

Driving and operating machinery
BACLOFENE DOC can cause dizziness, sedation, drowsiness and impaired vision.
Therefore patients who have experienced these symptoms should not drive vehicles (including
bicycles) and operate machinery.

3. How to take BACLOFENE DOC

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The doctor will initially prescribe you/your child the lowest possible dose of BACLOFENE DOC
effective for treating your condition, which may then be gradually increased.
If 6-8 weeks after reaching the maximum dose no therapeutic benefit is evident, the
doctor will decide whether to continue or discontinue therapy with BACLOFENE DOC.
BACLOFENE DOC tablets should be taken during meals with some liquid.
Through the cross-shaped fracture line, the tablet can be divided into two equal doses. Further
subdivision into four parts serves only to facilitate breaking it in order to swallow the tablet more
easily, and not to divide it into four equal doses.
In the event that a dosage of less than 12.5 mg of baclofen is prescribed, other medicines containing baclofen must be used.

Use in adults
The daily dose should preferably be divided into three administrations.
Keep in mind that the doctor:

• will start treatment with an initial dose of 5 mg, to be taken 3 times a day
• will increase, every 3 days and up to reaching the effective dose, the daily dose of 15 mg divided into 3 administrations. The optimal dose is generally between 30 and 80 mg per day, up to 100 - 120 mg in hospitalized patients under close supervision.

If you are a patient particularly sensitive to medicines, the doctor may prescribe you a lower initial daily dose (5 or 10 mg) and reach the optimal dose more gradually.

Use in children and adolescents (from 0 to 18 years of age)
The maximum total daily dose in children under 8 years of age is 40 mg per day and in
children over 8 years of age is 60 mg per day.
Do not use BACLOFENE DOC tablets in children with a body weight of less than 33 Kg. Keep
in mind that the doctor:

• will start treatment with a very low dose (approximately 0.3 mg/Kg of body weight per day) divided into 2-4 doses (preferably in 4 doses)
• will increase the dose cautiously, at intervals of about 1 week, up to reaching the effective dose. The usual daily dose for maintenance therapy is between 0.75 and 2 mg/Kg of body weight.

Use in patients with kidney problems
If you/your child have kidney problems, the doctor will prescribe a lower dose of BACLOFENE
DOC. If you/your child are undergoing chronic hemodialysis, the doctor will identify the optimal dose,
generally about 5 mg per day.
If you/your child have end-stage kidney failure, the doctor will prescribe BACLOFENE
DOC only in cases of actual necessity and will keep you/your child under close control to identify
early signs and symptoms of toxicity (e.g. drowsiness, lethargy).

Use in patients with liver problems
The doctor will pay particular attention when prescribing you BACLOFENE DOC.

Use in elderly patients (age ≥ 65 years)
The doctor will pay particular attention when prescribing you BACLOFENE DOC and will keep you under control
to monitor any adverse effects.

Use in patients with spastic states due to brain damage
The doctor will pay particular attention when prescribing BACLOFENE DOC and will keep you/your child
under control to monitor any adverse effects.

If you take more BACLOFENE DOC than you should
In case of accidental ingestion of an excessive dose of BACLOFENE DOC, immediately
inform your doctor or go to the nearest hospital.
If you/your child take more BACLOFENE DOC than you should, the following may occur:

• drowsiness
• decreased level of consciousness
• reduced respiratory activity
• coma
• confusion
• hallucinations
• agitation
• convulsions
• electroencephalogram (EEG) abnormalities
• visual disturbances
• ringing in the ears
• general reduction of muscle tone
• brief and sudden contractions of one or more muscles (myoclonus)
• decreased or absent reflexes
• dilation of veins and arteries in the limbs
• increased or decreased blood pressure
• slowing or acceleration of the heartbeat
• heart rhythm alterations
• decreased body temperature
• nausea, vomiting, diarrhea
• increased saliva production
• increased levels of some liver enzymes in the blood.

If you/your child have kidney problems, the effects described above may occur even at low
doses.
The simultaneous intake of substances or medicines active on the Central Nervous System (e.g.
alcohol, diazepam, tricyclic antidepressants) may worsen the syndrome associated
with the ingestion of an excessive dose of BACLOFENE DOC.

If you/your child forget to take BACLOFENE DOC
Do not take a double dose to make up for a missed dose.

If you/your child stop taking BACLOFENE DOC
You/your child should not abruptly stop treatment with BACLOFENE DOC, except
if you have experienced severe adverse effects or in case of ingestion of an excessive dose of
BACLOFENE DOC. Treatment with BACLOFENE DOC must always be discontinued gradually, reducing the dose progressively over about 1-2 weeks.
If you stop treatment with BACLOFENE DOC abruptly, you may experience anxiety, confused states, delirium, hallucinations, psychotic, manic or paranoid disorders, convulsions, involuntary movements of tongue, mouth, trunk and limbs, accelerated heartbeat, increased
body temperature and a temporary worsening of spasticity known as "rebound phenomenon".
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects occur especially at the beginning of therapy (e.g. sedation, drowsiness),
when the dose is increased too rapidly, when high doses are used or if the patient
is elderly.
These effects are however often temporary and can be eliminated or reduced by reducing the
dose. Rarely have they been so severe as to require discontinuation of treatment.
Side effects may be more serious in patients with a history of psychiatric illness or with
disorders of the blood vessels of the brain (e.g. stroke) and in elderly patients.
Patients who suffer from epilepsy may be more likely to have seizures. Some patients
have shown increased muscle spasticity as a reaction to treatment.
Many of the reported side effects are attributable to the underlying disease being treated.

Very common side effects (may affect more than 1 in 10 people)

• drowsiness
• sedation
• nausea.

Common side effects (may affect up to 1 in 10 people)

• reduction of respiratory activity
• fatigue
• confusional state
• dizziness
• headache
• insomnia
• euphoria
• depression
• muscle weakness
• loss of coordination of movements (ataxia)
• tremor
• hallucinations
• nightmares
• muscle pain (myalgia)
• nystagmus (rhythmic, undulating and involuntary eye movements)
• dry mouth
• vision disorders
• decrease in blood volume
• low blood pressure
• feeling of discomfort in the stomach and intestines
• retching, vomiting
• constipation
• diarrhea
• excessive sweating
• skin rash
• frequent emission of small amounts of urine (pollakiuria)
• involuntary and complete loss of urine (enuresis)
• difficulty urinating (dysuria).

Rare side effects (may affect up to 1 in 1,000 people)

• tingling (paresthesia)
• speech disorders in which words are pronounced slowly and defectively (dysarthria)
• altered taste (dysgeusia)
• abdominal pain
• impaired liver function
• urinary retention
• erectile dysfunction.

Very rare side effects (may affect up to 1 in 10,000 people)

• decrease in body temperature.

Side effects with unknown frequency (frequency cannot be estimated from available data)

• slowing of the heartbeat
• urticaria
• withdrawal syndrome, due to discontinuation of treatment
• increased blood sugar levels
• difficulty breathing during sleep (sleep apnea syndrome).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store BACLOFENE DOC

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the package after
“Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What BACLOFENE DOC contains

• The active ingredient is baclofen. Each tablet contains 25 mg of baclofen.
• The other ingredients are microcrystalline cellulose, corn starch, povidone, magnesium stearate.

Description of the appearance of BACLOFENE DOC and contents of the pack
BACLOFENE DOC tablets are white, round, flat on both sides, with a cross-shaped fracture line
on one side.
This medicine is available in packs of 50 tablets in blisters.

Marketing authorisation holder and manufacturer
Marketing authorisation holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milano - Italy.
Manufacturer:
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo 1 - 03012 Anagni (Frosinone) – Italy.