BACLOFENE 10 mg Tablet

Зміст інструкції

1. BACLOFENE MYLAN GENERICS 10 mg COMPRESSE, 25 mg COMPRESSE
   1. What is BACLOFENE MYLAN GENERICS and what it is used for
   2. What you need to know before taking BACLOFENE MYLAN GENERICS
   3. How to take BACLOFENE MYLAN GENERICS
   4. Possible side effects
   5. How to store BACLOFENE MYLAN GENERICS
   6. Contents of the pack and other information

BACLOFENE MYLAN GENERICS 10 mg COMPRESSE, 25 mg COMPRESSE

baclofene

Generic medicine

Read this leaflet carefully before taking this medicine because 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 MYLAN GENERICS is and what it is used for
• 2. What you need to know before you take BACLOFENE MYLAN GENERICS
• 3. How to take BACLOFENE MYLAN GENERICS
• 4. Possible side effects
• 5. How to store BACLOFENE MYLAN GENERICS
• 6. Contents of the pack and other information

1. What is BACLOFENE MYLAN GENERICS and what it is used for

BACLOFENE MYLAN GENERICS belongs to a group of medicines called centrally acting muscle relaxants which work by relieving excessive muscle tension (spasms) that occurs in various diseases.
This medicine is indicated in adults to treat excessive muscle tension caused by the following diseases:

• multiple sclerosis, a disease that affects the nervous system and is also known as disseminated sclerosis;
• spinal cord diseases following infections, trauma, tumors, degeneration or of unknown cause;
• infantile encephalopathy, a type of disease that affects the brain;
• brain diseases due to circulatory problems (cerebrovascular diseases), tumors or degeneration.

This medicine is indicated in children (from 0 to 18 years) to treat excessive muscle tension caused
by diseases such as:

• cerebral palsy, a disease that causes a persistent disorder in posture and movement;
• stroke, caused by serious problems with blood circulation to the brain;
• brain diseases caused by tumors or degeneration;
• spinal cord diseases following infections, trauma, tumors, degeneration or of unknown cause.

2. What you need to know before taking BACLOFENE MYLAN GENERICS

Do not take BACLOFENE MYLAN GENERICS

• if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking BACLOFENE MYLAN GENERICS.
Use this medicine with caution and under the direct supervision of your doctor if any of the following circumstances
applies to you:

• if you have mental disorders, schizophrenia (a serious illness affecting the brain), depressive disorders (mood disorders) or mania, states of confusion;
• if you suffer from Parkinson's disease;
• if you suffer from epileptic seizures;
• if you have problems with injuries to the stomach or intestines (peptic ulcer);
• if you have problems with blood circulation to the brain (cerebrovascular disorders);
• if you have problems breathing (respiratory failure);
• if you have serious kidney problems or are taking medicines that can affect kidney function (see section 3);
• if you suffer from urinary tract problems such as overactive bladder;
• if you have severe liver function problems and suffer from diabetes; in these cases, periodically check the levels of transaminases (SGOT) and blood sugar;
• if you have a history of alcoholism, excessively use alcohol or have a history of drug abuse or dependence.

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, excessively used
alcohol 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 changes in your
behavior and invite them to read this leaflet.

Children and adolescents
In infants under one year of age, the use of the medicine requires a careful assessment of the risk/benefit ratio
by the doctor. Do not give this medicine if the child's weight is less
than 33 kg.

Other medicines and BACLOFENE MYLAN GENERICS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Pay particular attention and consult your doctor if you are taking:

• medicines that cause depression of the Central Nervous System, including those similar to BACLOFENE MYLAN GENERICS (muscle relaxants), such as tizanidine and medicines used for the treatment of pain (opioids), because the sedative effect and the risk of respiratory depression may be intensified;
• tricyclic antidepressants (medicines used to treat depression), as there is a greater reduction in muscle tone;
• lithium, used for mental health problems;
• antihypertensives (used to treat high blood pressure); in this case, a further lowering of blood pressure may occur;
• carbidopa and levodopa, medicines used in the treatment of Parkinson's disease;
• medicines that can have adverse effects on the kidneys.

BACLOFENE MYLAN GENERICS with alcohol
Pay particular attention to alcohol consumption during treatment with this medicine as its
effect may be more pronounced than usual.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be 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.
Do not take this medicine if you are pregnant. The use of this medicine during pregnancy is
recommended only if the benefits to the mother outweigh the risks to the fetus.

Driving and using machines
If you take this medicine, you may experience side effects such as dizziness, drowsiness and visual disturbances. If
this happens to you, avoid driving and using machines.

3. How to take BACLOFENE MYLAN GENERICS

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor will recommend that you start treatment with this medicine starting from low doses and will
gradually increase the dose based on your sensitivity to this medicine in order to find the
optimal dose. It is recommended to use the minimum effective dose.
This medicine should be used with caution to maintain a certain degree of muscle tone, to prevent
falls, excessive muscle weakness and to allow some occasional spasms useful for
circulatory functionality.
The total daily dose should be divided, preferably into 3 administrations in adults and 4
in children.
If after 6-8 weeks from reaching the maximum dosage you do not find an evident therapeutic
benefit, the doctor will decide whether you should continue the administration of baclofen.
You can divide the tablets of BACLOFENE MYLAN GENERICS. Take them during meals with some
water.

Adults
The recommended starting dose is 5 mg, 3 times a day. This dose should be increased by 5 mg every
3 days, until reaching the optimal daily dose which will depend on your clinical conditions.
In some cases it may be necessary to start treatment with a lower dose (5 or 10 mg per day) and
reach the ideal dose gradually. The recommended ideal dose is between 30 and 80 mg per day.
Higher doses, from 100 to 120 mg per day, can be administered to patients hospitalized and
strictly monitored.

Use in children and adolescents (from 0 to 18 years of age)
Treatment should be started with a very low dosage (about 0.3 mg per kg per day), in 2-4 separate doses
(preferably 4 separate doses).
The dosage should be increased cautiously, at intervals of about 1 week, until it proves
sufficient to meet the individual needs of the child. The recommended daily dose for maintenance therapy is between 0.75 and 2 mg per kg of body weight.
In children under 8 years of age, the maximum dose should not exceed 40 mg per day.
In children over 8 years of age, the maximum dose is 60 mg per day.
Do not administer this medicine if the child's weight is less than 33 kg.

Use in patients with kidney problems
If you have kidney problems, use this medicine with caution and at lower doses.
If you are undergoing hemodialysis sessions, the recommended dose per day is about 5 mg.
If you have end-stage renal failure, this medicine should only be administered if absolutely
necessary and under strict medical supervision.

Use in patients with liver problems
Use this medicine with caution as it may alter liver function, measured by the levels of
enzymes produced (transaminases).

Use in the elderly (age ≥ 65 years)
Consult your doctor who will tell you what dose is recommended for you and will monitor you during
treatment.

Use in people with spastic conditions of cerebral origin
The doctor will tell you what dose is recommended for you and will monitor you during treatment.

If you take more BACLOFENE MYLAN GENERICS than you should
The symptoms of an overdose of this medicine are:

• drowsiness;
• altered state of consciousness;
• insufficient breathing (respiratory depression) and coma;
• confusion, hallucinations and agitation;
• convulsions;
• alterations of the heartbeat visible on the electrocardiogram (burst suppression pattern and trifasic waves), slowed heartbeat (bradycardia), accelerated heartbeat (tachycardia) or irregular heartbeat (cardiac arrhythmias);
• visual disturbances (accommodation disorders, absence of pupillary reflex);
• muscle disorders (muscle weakness, myoclonus, hyporeflexia or areflexia);
• alterations of blood circulation (vasodilation, increase or decrease in pressure);
• decreased body temperature (hypothermia);
• nausea, vomiting, diarrhea;
• increased amount of saliva produced (hypersalivation);
• elevated levels of liver enzymes. If you take medicines such as diazepam (used for the treatment of seizures), tricyclic antidepressants (used for the treatment of depression) or consume alcohol, the symptoms of an overdose may worsen. In case of ingestion of an excessive dose of the drug, contact your doctor immediately or go to the nearest hospital.

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

If you stop taking BACLOFENE MYLAN GENERICS
If you suddenly stop treatment with this medicine, especially if it is long-lasting, you may
experience symptoms such as:

• anxiety and confusion (delirium), hallucinations, altered states of consciousness (psychotic, manic or paranoid states);
• convulsions (status epilepticus), and involuntary movement disorders (dyskinesia);
• accelerated heartbeat (tachycardia);
• increased body temperature (hyperthermia);
• temporary worsening of muscle tension (spasm), also known as “rebound phenomenon”.

Do not stop treatment immediately. In the event that the doctor decides to stop
treatment, the dosage must be reduced gradually decreasing the dose progressively in a
period of about 1-2 weeks. Do not stop treatment with this medicine unless serious side effects have occurred or in case of overdose.
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.
You are more likely to experience these side effects at the start of treatment (for example, sedation,
drowsiness), when your dose is increased too quickly, when you are prescribed high doses of medicine or if
you are an elderly person. In most cases they are transient and decrease by reducing the dose. Rarely are side
effects so severe that they require discontinuation of treatment.
If you have suffered in the past from mental disorders (psychiatric illnesses) or from disorders of blood
circulation in the brain (for example, a stroke) and if you are an elderly person, side effects may be more
serious.
If you suffer from epilepsy, a decrease in the convulsive threshold and seizures may be observed.
Some patients have shown increased muscle spasticity as a paradoxical reaction to treatment.

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

• sedation and drowsiness;
• nausea. Common(may affect up to 1 in 10 people)
• severe breathing difficulty (respiratory depression);
• feeling of emptiness in the head and fatigue (apathy), marked weakness (asthenia);
• confusional state;
• dizziness, headache;
• insomnia;
• euphoria;
• depression;
• muscle weakness, difficult movements (ataxia) and tremor;
• hallucinations, nightmares;
• muscle pain (myalgia);
• involuntary eye movements (nystagmus);
• dry mouth;
• vision disorders;
• decrease in blood volume;
• low blood pressure (hypotension);
• gastrointestinal discomfort, vomiting, diarrhea, constipation;
• increased sweating (hyperhidrosis);
• skin irritation (rash);
• frequent urge to urinate (pollakiuria), involuntary and complete loss of urine during sleep (enuresis), difficult
  urination (dysuria). Rare(may affect up to 1 in 100 people)
• altered sensitivity in hands and feet or other parts of the human body (paresthesia);
• difficulty speaking (dysarthria);
• altered taste (dysgeusia);
• abdominal pain;
• altered liver activity;
• decreased urine production (urinary retention);
• impotence (erectile dysfunction). Very rare(may affect up to 1 in 10,000 people)
• decreased body temperature (hypothermia). Not known(frequency cannot be estimated from available data)
• slowed heartbeat (bradycardia);
• skin irritation (urticaria);
• withdrawal syndrome;
• increased blood sugar levels;
• breathing difficulties during sleep (sleep apnea syndrome).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through the Italian Medicines Agency - Website:
https://www.aifa.gov.it/web/guest/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 MYLAN GENERICS

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store this medicine in its packaging to protect it from light and humidity.
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 MYLAN GENERICS 10 mg tablets contains

• The active ingredient is baclofen. Each tablet contains 10 mg of baclofen.
• The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone K30, corn starch.

What BACLOFENE MYLAN GENERICS 25 mg tablets contains

• The active ingredient is baclofen. Each tablet contains 25 mg of baclofen.
• The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, povidone K30, corn starch.

Description of the appearance of BACLOFENE MYLAN GENERICS and contents of the pack
BACLOFENE MYLAN GENERICS 10 mg tablets
The tablets are round, white in colour, marked with “10” and have a break line that
allows the tablet to be divided into two equal halves.
Pack of 50 divisible 10 mg tablets.
BACLOFENE MYLAN GENERICS 25 mg tablets
The tablets are round, white in colour and have a break line that allows the tablet to be divided into
two equal halves.
Pack of 50 divisible 25 mg tablets.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturer
Edmond Pharma S.r.l., Via dei Giovi 131, Paderno Dugnano (MI)
ABC Farmaceutici S.p.A., Canton Moretti 29, 10090 S. Bernardo d’Ivrea (TO)