Baclofen Mylan Generics

Package leaflet: Information for the patient

Baclofene Mylan Generics 10 mg tablets, 25 mg tablets

baclofen
Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 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

1. What Baclofene Mylan Generics is and what it is used for

Baclofene Mylan Generics belongs to a class of medicines known as "centrally acting muscle relaxants". Baclofen works by relaxing the muscles.
Adults
Baclofene Mylan Generics is indicated for the treatment of conditions characterised by increased muscle tone and muscle contractions (spastic hypertonia):

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

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

• following brain damage, particularly in cases of:
  - cerebral palsy
  - stroke
  - transient ischaemic attack
  - brain diseases due to tumours or degeneration
• in diseases of the spinal cord of infectious, degenerative, traumatic, tumour-related or unknown origin, for example:
  - multiple sclerosis
  - spastic spinal paralysis
  - amyotrophic lateral sclerosis
  - syringomyelia
  - transverse myelitis
  - paraplegia
  - traumatic paraparesis
  - states of spinal cord compression.

2. What you need to know before taking Baclofen Mylan Generics

Do not take Baclofen Mylan Generics

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Baclofen Mylan Generics.
Inform your doctor, who will pay particular attention when prescribing Baclofen Mylan Generics 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 confusional states
• have Parkinson’s disease
• have epilepsy
• have cerebrovascular disorders
• have breathing difficulties
• have liver problems
• have kidney problems
• have difficulty urinating due to increased muscle tone in the muscles controlling urine release (vesical sphincter hypertonia)
• are pregnant (see section “Pregnancy” and “If you/your child stop treatment with Baclofen Mylan Generics”)
• consume excessive amounts of alcohol or have a history of drug abuse or dependence.

Some patients treated with baclofen have experienced suicidal or self-harming thoughts or have attempted suicide. Almost all of these patients also suffered from depression, consumed excessive amounts of alcohol, or were prone to suicidal thoughts. If at any time you experience thoughts of self-harm or suicide, speak to your doctor immediately or go to hospital. In addition, ask a relative or close friend to inform you if they notice any changes in your behaviour, and encourage them to read this leaflet.
If you undergo laboratory tests during treatment with Baclofen Mylan Generics to assess liver function (levels of aspartate aminotransferase and alkaline phosphatase) or blood glucose levels, be aware that these values may be altered. Your doctor will carry out periodic checks on you or your child, especially if you have liver problems or suffer from diabetes.
Cases of reduced brain function (encephalopathy) have been reported in some patients treated with Baclofen Mylan Generics at prescribed doses, which resolved after discontinuation of the medicine. Symptoms include increased drowsiness or onset of drowsiness, confusion, muscle contractions, or coma. If any of these symptoms occur, consult your doctor immediately. Your doctor will decide whether to discontinue baclofen treatment.
Children
Clinical data on the use of Baclofen Mylan Generics in children under one year of age are limited; therefore, your doctor will carefully evaluate the use of this medicine in these patients.
Other medicines and Baclofen Mylan Generics
Inform your doctor or pharmacist if you 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, synthetic opioids or morphine
• antidepressants of the tricyclic class
• lithium (a medicine for mood disorders)
• medicines that lower blood pressure, including antihypertensives (medicines for high blood pressure)
• medicines that reduce kidney function.

Your doctor will keep you/your child under close supervision and will assess whether the dose of Baclofen Mylan Generics or of the other medicine needs to be adjusted.
Baclofen Mylan Generics and alcohol
Taking Baclofen Mylan Generics with alcohol may increase the sedative effect and the risk of breathing difficulties.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 only when clearly needed and under direct medical supervision.
If you take Baclofen Mylan Generics during pregnancy, your newborn may experience seizures and other symptoms related to sudden withdrawal after birth (see “If you/your child stop treatment with Baclofen Mylan Generics” 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
Baclofen Mylan Generics may cause dizziness, drowsiness and visual disturbances. Therefore, patients experiencing these symptoms should not drive or operate machinery.

3. How to take Baclofene Mylan Generics

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 Mylan Generics for you/your child, which may then be gradually increased.

If no therapeutic benefit is evident within 6–8 weeks after reaching the maximum dose, your doctor will decide whether to continue or discontinue treatment with Baclofene Mylan Generics.

You may split the Baclofene Mylan Generics tablets. Take them during meals with a glass of water.

Use in adults
The daily dose should preferably be divided into three administrations.

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 reaching the effective dose.

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 (from 0 to 18 years of age)
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 Mylan Generics 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 4 doses)
• increase the dose cautiously, at intervals of about one week, until reaching the effective dose.

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/your child have kidney problems, your doctor will prescribe a lower dose of Baclofene Mylan Generics.

If you/your child are undergoing chronic haemodialysis, your doctor will determine the optimal dose, generally about 5 mg per day.

If you/your child have end-stage renal failure, your doctor will prescribe Baclofene Mylan Generics only if strictly necessary and will keep you/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 Mylan Generics.

Use in elderly patients (age ≥ 65 years)
Your doctor will exercise particular caution when prescribing Baclofene Mylan Generics and will monitor you/your child for any adverse effects.

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

If you take more Baclofene Mylan Generics than you should
In case of accidental overdose of Baclofene Mylan Generics, contact your doctor immediately or go to the nearest hospital.

If you/your child take more Baclofene Mylan Generics 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
• general decrease in muscle tone
• brief and sudden contractions of one or more muscles (myoclonus)
• reduced or absent 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, diarrhoea
• increased salivation
• increased blood levels of certain liver enzymes
• tinnitus (ringing in the ears)

If you/your child have kidney problems, the above effects may occur even at low doses.

Concomitant 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 Mylan Generics.

If you/your child forget to take Baclofene Mylan Generics
Do not take a double dose to make up for the missed dose.

If you/your child stop taking Baclofene Mylan Generics
You/your child must not stop treatment with Baclofene Mylan Generics abruptly, except if you/your child have experienced severe adverse effects or have taken an overdose of Baclofene Mylan Generics. Treatment with Baclofene Mylan Generics should always be discontinued gradually, by progressively reducing the dose over a period of approximately 1–2 weeks.

If you stop treatment with Baclofene Mylan Generics abruptly, you may experience 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, excessive muscle tone, and a temporary worsening of spasticity known as the "rebound phenomenon".

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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.
These effects are however often temporary and can be eliminated or reduced by lowering the dose.
Rarely, they have been so severe as to require discontinuation of treatment.
Side effects may be more serious in patients with a history of psychiatric disorders or cerebrovascular disease (e.g. stroke), and in elderly patients.
Patients suffering from 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 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 (rhythmic, wavelike, involuntary eye movements)
• dry mouth
• visual disturbances
• decreased blood volume
• low blood pressure
• gastrointestinal discomfort
• nausea, vomiting
• constipation
• diarrhoea
• excessive sweating
• skin rash
• frequent passage of small volumes 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 with slow and defective pronunciation of words (dysarthria)
• altered taste sensation (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 (frequency cannot be estimated from the available data)

• slowed heartbeat
• urticaria
• withdrawal syndrome due to discontinuation of treatment
• increased blood sugar levels
• breathing difficulties during sleep (sleep apnoea syndrome)
• swelling of the ankles, feet or lower legs
• facial swelling
• allergic reaction (hypersensitivity)
• hair loss
• sexual difficulties
• reduced brain function (encephalopathy)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://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 Baclofen Mylan Generics

Protect the medicine from moisture and heat.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via 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 contain

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

What Baclofene Mylan Generics 25 mg tablets contain

• The active substance is baclofen. Each tablet contains 25 mg of baclofen.
• The other components are anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, povidone K30, maize 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 score line allowing the tablet to be divided into two equal parts.
Pack size: 50 divisible tablets of 10 mg.
Baclofene Mylan Generics 25 mg tablets
The tablets are round, white in colour and have a score line allowing the tablet to be divided into two equal parts.
Pack size: 50 divisible tablets of 25 mg.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
Edmond Pharma S.r.l., Via dei Giovi 131, Paderno Dugnano (MI)
ABC Farmaceutici S.p.A., Canton Moretti 29, 10015 S. Bernardo d’Ivrea (TO)