Baclofen Doc Generici

Patient Information Leaflet

BACLOFENE DOC 25 mg Tablets

Equivalent medicine
Please read all of this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 BACLOFENE DOC is and what it is used for

BACLOFENE DOC contains the active substance baclofen, which belongs to a class of medicines known as "centrally acting muscle relaxants". Baclofen works by relaxing the muscles.

Adults
BACLOFENE DOC is indicated for the treatment of conditions characterised by increased muscle tone and muscle contractions (spastic hypertonia):

• in multiple sclerosis
• in spinal cord diseases of infectious, degenerative, traumatic, tumour-related or unknown origin, for example:
  o spastic spinal paralysis
  o amyotrophic lateral sclerosis
  o syringomyelia
  o transverse myelitis
  o paraplegia
  o traumatic paraparesis
  o spinal cord compression states
• following brain damage, particularly in cases of:
  o childhood-onset disease (infantile encephalopathy)
  o cerebral vascular diseases (cerebral vasculopathy)
  o brain diseases due to tumours or degeneration.

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

• following brain damage, particularly in cases of:
  o cerebral palsy
  o stroke
  o transient ischaemic attack
  o brain diseases due to tumours or degeneration
• in spinal cord diseases of infectious, degenerative, traumatic, tumour-related or 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 spinal cord compression states.

2. What you need to know before taking BACLOFENE DOC

Do not use BACLOFENE DOC

• if you/your child are allergic to baclofen or to any of the other ingredients of this medicine (listed in section 6).
• if you/your child have or have had a stomach or first part of the intestine 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 monitoring, if you/your child:

• suffer from mood disorders (e.g. psychosis, schizophrenia, depressive or manic disorders)
• suffer from confusion
• have Parkinson's disease
• have epilepsy
• have cerebrovascular disorders
• have breathing problems
• have liver problems
• have kidney problems
• have difficulty urinating due to increased tone of the muscles controlling urine release (vesical sphincter hypertonia)
• are pregnant: after delivery, your baby may experience seizures and other symptoms related to sudden discontinuation of treatment (see "If you/your child stop taking BACLOFENE DOC")
• have a history of alcoholism, excessive alcohol use, or a history of drug abuse or dependence.

If you undergo certain laboratory tests during treatment with BACLOFENE DOC to assess liver function (levels of aspartate aminotransferase and alkaline phosphatase) or blood glucose levels, please be aware that these values may be altered. Your doctor will perform periodic check-ups on you or your child, especially if you have liver problems or suffer from diabetes.
Some patients treated with baclofen have developed suicidal or self-harming thoughts or have attempted suicide. Almost all of these patients also suffered from depression, excessive alcohol use, or were prone to suicidal thoughts. If at any time you develop thoughts of self-harm or suicide, speak immediately with your doctor or go to hospital. Additionally, ask a relative or close friend to alert you if they notice any changes in your behaviour, and encourage 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 evaluate the use of this medicine in these patients.

Other medicines and BACLOFENE DOC
Inform 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 reduce the activity of the Central Nervous System, for example: other muscle relaxants such as tizanidine or synthetic opioids
• morphine
• antidepressants of the tricyclic class
• lithium (a medicine for mood disorders)
• antihypertensives (medicines for high blood pressure)
• medicines that reduce kidney function.

Your doctor will keep you/your child under close monitoring and will assess whether to adjust the dose of BACLOFENE DOC or of the other medicine.

BACLOFENE DOC and alcohol
Taking BACLOFENE DOC with alcohol may increase the sedative effect and the risk of breathing difficulties.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
There are no adequate studies in pregnant women. Baclofen crosses the placenta; therefore, it will be prescribed during pregnancy only if clearly needed and under direct medical supervision.
If you take BACLOFENE DOC during pregnancy, your baby may experience seizures and other symptoms related to sudden discontinuation of treatment after delivery (see "If you/your child stop taking BACLOFENE DOC" and "Warnings and precautions").

Breastfeeding
Baclofen passes into breast milk in small amounts; therefore, adverse effects in the breastfed infant are not expected.

Fertility
There are no available data on the effect of baclofen on male fertility, nor data supporting specific recommendations for women of childbearing potential.

Driving and using machines
BACLOFENE DOC may cause dizziness, sedation, drowsiness and impaired vision.
Therefore, patients experiencing these symptoms should not drive vehicles (including bicycles) or operate machinery.

3. How to take BACLOFENE DOC

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will initially prescribe the lowest possible effective dose of BACLOFENE DOC for you or your child, which may then be gradually increased.
If no therapeutic benefit is evident 6–8 weeks after reaching the maximum dose, your doctor will decide whether to continue or discontinue treatment with BACLOFENE DOC.
BACLOFENE DOC tablets should be taken during meals with some liquid.
The tablet can be divided into two equal doses using the cross-shaped break line. Further division into four parts is intended only to facilitate breaking the tablet for easier swallowing, and not to divide it into four equal doses.
If a dosage lower than 12.5 mg of baclofen is prescribed, other baclofen-containing medicines should be used.

Use in adults
The daily dose should preferably be divided into three doses.
Please note that your doctor will:

• start treatment with an initial dose of 5 mg, taken three times a day
• increase the daily dose by 15 mg every 3 days (divided into three doses) until the effective dose is reached. The optimal dose is generally between 30 and 80 mg per day, up to 100–120 mg per day in hospitalized patients under close supervision.

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

Use in children and adolescents (aged 0 to 18 years)
The maximum total daily dose is 40 mg per day in children under 8 years of age and 60 mg per day in children over 8 years of age.
Do not use BACLOFENE DOC tablets in children weighing less than 33 kg. Please note that your doctor will:

• start treatment with a very low dose (approximately 0.3 mg/kg body weight per day), divided into 2–4 doses (preferably four doses)
• increase the dose cautiously at intervals of about one week until the effective dose is reached. The usual daily dose for maintenance therapy ranges between 0.75 and 2 mg/kg body weight.

Use in patients with kidney problems
If you or your child have kidney problems, your doctor will prescribe a lower dose of BACLOFENE DOC. If you or your child are undergoing chronic hemodialysis, your doctor will determine the optimal dose, usually about 5 mg per day.
If you or your child have end-stage renal failure, your doctor will prescribe BACLOFENE DOC only when strictly necessary and will keep you or your child under close monitoring to detect early signs and symptoms of toxicity (e.g. drowsiness, lethargy).

Use in patients with liver problems
Your doctor will exercise particular caution when prescribing BACLOFENE DOC.

Use in elderly patients (age ≥ 65 years)
Your doctor will exercise particular caution when prescribing BACLOFENE DOC and will monitor you closely for any adverse effects.

Use in patients with spastic states due to brain damage
Your doctor will exercise particular caution when prescribing BACLOFENE DOC and will monitor you or your child for any adverse effects.

If you take more BACLOFENE DOC than you should
In case of accidental overdose of BACLOFENE DOC, contact your doctor immediately or go to the nearest hospital.
If you or your child take more BACLOFENE DOC than prescribed, the following may occur:

• drowsiness
• decreased level of consciousness
• reduced respiratory activity
• coma
• confusion
• hallucinations
• agitation
• seizures
• abnormalities in electroencephalogram (EEG)
• visual disturbances
• ringing in the ears
• generalized decrease in muscle tone
• brief and sudden contractions of one or more muscles (myoclonus)
• reduction or absence of reflexes
• dilation of veins and arteries in the limbs
• increased or decreased blood pressure
• slowed or accelerated heart rate
• heart rhythm disturbances
• decreased body temperature
• nausea, vomiting, diarrhea
• increased salivation
• increased blood levels of certain liver enzymes.

If you or your child have kidney problems, the above effects may occur even at low doses.
Concurrent use of substances or medicines acting on the Central Nervous System (e.g. alcohol, diazepam, tricyclic antidepressants) may worsen the syndrome associated with overdose of BACLOFENE DOC.

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

If you stop taking BACLOFENE DOC
You or your child must not stop treatment with BACLOFENE DOC abruptly, except if serious adverse reactions occur or in case of overdose. Treatment with BACLOFENE DOC should always be discontinued gradually, by progressively reducing the dose over a period of about 1–2 weeks.
If treatment with BACLOFENE DOC is stopped abruptly, symptoms such as anxiety, confusion, delirium, hallucinations, psychotic, manic or paranoid states, seizures, involuntary movements of the tongue, mouth, trunk and extremities, increased heart rate, elevated body temperature, and a temporary worsening of spasticity known as "rebound phenomenon" may occur.

If you have any questions 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 mainly at the beginning of treatment (e.g. sedation, drowsiness), when the dose is increased too rapidly, when high doses are used, or in elderly patients.
However, these effects are often temporary and can be eliminated or reduced by lowering the dose. Rarely are they so severe as to require discontinuation of treatment.
Side effects may be more severe in patients with a history of psychiatric disorders or cerebrovascular diseases (e.g. stroke), and in elderly patients.
Patients with epilepsy may experience seizures more easily. Some patients have shown increased muscle spasticity as a reaction to treatment.
Many of the reported side effects may also be related 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)

• reduced respiratory activity
• fatigue
• confusion
• dizziness
• headache
• insomnia
• euphoria
• depression
• muscle weakness
• loss of coordination of movement (ataxia)
• tremor
• hallucinations
• nightmares
• muscle pain (myalgia)
• nystagmus (involuntary rhythmic oscillations of the eyes)
• dry mouth
• visual disturbances
• decreased blood volume
• low blood pressure
• gastrointestinal discomfort
• nausea, vomiting
• constipation
• diarrhoea
• excessive sweating
• skin rash
• frequent passage 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 sensations (paraesthesia)
• speech disorders in which words are spoken slowly and imperfectly (dysarthria)
• altered taste (dysgeusia)
• abdominal pain
• alteration of liver function
• urinary retention
• erectile dysfunction

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

• decreased body temperature

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

• slowing of heart rate
• urticaria
• withdrawal syndrome due to discontinuation of treatment
• increased blood sugar levels
• breathing difficulties during sleep (sleep apnoea syndrome)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 stated on the blister and on the carton after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BACLOFENE DOC contains

• The active substance is baclofen. Each tablet contains 25 mg of baclofen.
• The other components are microcrystalline cellulose, maize 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 break line on one side.
This medicinal product is available in packs of 50 tablets in blister packs.

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