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Baclofen 10mg Tablets

Document: leaflet MAH GENERIC_PL 00289-0243 change

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BACLOFEN 10 mg TABLETS

baclofen

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking this

medicine.

•    Keep this leaflet.You may need to read it again.

•    If you have any further questions, askyour doctor or pharmacist.

•    This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this listed. See section 4.

INTHIS LEAFLET:

1.    What Baclofen is and what it is used for

2.    Before you take Baclofen

3.    How to take Baclofen

4.    Possible side effects

5.    How to store Baclofen

6.    Further information

OWHAT BACLOFEN IS AND WHAT IT IS USED FOR

Please read this product information carefully before you oryour child is given Baclofen since it contains important information

Your doctor has decided that you or your child needs this medicine to help treat your condition.

Baclofen is a muscle relaxant that acts on the central nervous system.

BaclofenTablets are used:

• to treat muscle rigidity caused by brain injury • to reduce and relieve cramping, muscle rigidity, the excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple scelrosis, cerebrovascular accidents, spinal cord diseases, injuries to the spinal cord and other nervous system disorders.

Your doctor may sometimes prescribe these tablets for other reasons. If you have any questions askyour doctor or pharmacist for information.

BEFOREYOUTAKE BACLOFEN Do NOT take Baclofen if you:

• are allergic (hypersensitive) to baclofen or any of the other ingredients of this medicine.These are listed at the end of the leaflet.)

• suffer from stomach ulcers.

Children and adolescents:

Baclofen tablets are not suitable for use in children under 33 kg body weight.

Take special care with Baclofen

Talk to your doctor before you start to take this medicine if you:

• suffer from schizophrenia, psychotic, depressive or manic disorders (any mental illness)

• suffer from Parkinson's disease • suffer from confusion • suffer from epilepsy • have had a stroke • suffer from liver or kidney problems • have Diabetes Mellitus

• suffer from heart problems or have breathing difficulties due to weak muscles.Your doctorwill want to carefully monitor yourtreatment • suffer from porphyria

• have problems with your bladder muscles (difficulty urinating)

• are pregnant or breast-feeding (see section 2: Pregnancy and breast-feeding).

Taking other medicines

Talk to your doctor if you are taking any of the following:

•    drugs to loweryour blood pressure, including ACE inhibitors e.g. captopril

•    tricyclic antidepressants e.g. amitriptyline, clomipramine, dothiepin or dosulepin

•    drugs which also affect the kidney such as ibuprofen

•    lithium

•    ievodopa plus carbidopa, for Parkinson's Disease

•    synthetic opiates e.g. dihydrocodeine ortramadol.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Baclofen with food and drink

You should be aware that taking alcohol with Baclofen

may cause drowsiness.

Pregnancy and breast-feeding

Askyour doctor or pharmacist for advice before taking any medicine.

You should not use Baclofen during pregnancy unless your doctor advises you to do so.Tell your doctor if you are pregnant, or planning to become pregnant.

Only a very small amount of Baclofen passes into breast milk.Your doctor will discuss with you whether you should breast-feed whilst taking Baclofen.

Driving and using machines

Baclofen may cause drowsiness, decreased alertness, dizziness, incoordination, and shaking. If you are affected, do not drive or operate machinery.

Important information about some of the ingredients of Baclofen

Patients who are intolerant to lactose should note that Baclofen tablets contain a small amount of lactose. If you have been told by your doctorthat you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

© HOWTO TAKE BACLOFEN

Always take Baclofen exactly as your doctor has told you. Your doctor will tell you exactly how long you should take this medicine.You should checkwith your doctor or pharmacist if you are not sure

The tablets should be swallowed preferably with a drink of water.The timing and usual range of doses is:

•    Use in children (0 to <18 years)

Children's treatment is adjusted to their body weight. Children's treatment usually starts with very low dose (approximately 0.3 mg/kg/day), in 2-4 divided doses (preferably in 4 doses).The dosage is then gradually increased until it becomes sufficient forthe child's individual requirements, this may be between 0.75 and 2 mg/kg body weight.The total daily dose should not exceed a maximum of 40 mg/day in children below 8 years of age. In children over 8 years of age a maximum daily dose of 60 mg/day may be given. Baclofen tablets are not suitable for use in children below 33 kg body weight.

•    Adults

The dosage you receive will gradually be increased until your condition is under adequate control.The dosage schedule given below is only a guide and may vary from person to person.

•    Start with 5 mg three times a day for three days

• Then 10 mg three times a day for the next three days

• Then 15 mg three times a day for the next three days

•    Finally 20 mg three times a day for three days.

The usual maintenance dose is 20 mg three times a day (60 mg a day).The maximum dose is 100 mg a day.

•    Elderly

You may be more likely to suffer from side effects, especially at the start of treatment.Therefore, your doctor may start you on a lower dose than the usual adult dosage.

•    Patients with kidney problems

You may be started on a lower dose of Baclofen e.g. 5 mg a day.The doctor will decide what the dose should be.

If you take more Baclofen than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

An overdose is likely to cause coma, drowsiness, loss of consciousness and breathing problems.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Baclofen If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do NOT take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Baclofen

Do NOT stop taking Baclofen without talking to your doctor first even if you feel better.

Do NOT stop taking your tablets suddenly because unwanted effects such as muscle spasms and increased muscle rigidity, difficulty in controlling movement, fast heart rate, fever, confusion, hallucinations, changes in mood and emotion, mental disorders, anxiety, manic or paranoid state, orfits may occur.Your doctor will reduce your dose gradually.

If you have any further questions on the use of this product, askyour doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Baclofen can cause side effects, although not everybody gets them. Side effects may be more serious in patients with a history of psychiatric illness, stroke and in the elderly.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect.You may need urgent medical attention or hospitalisation.

You may notice the following side effects when you first start taking Baclofen, but they may lessen as you get used to your medicine or if the dose is reduced:

•    daytime drowsiness

•    feeling sick.

If the feeling of sickness continues after your dosage has been decreased, it may be lessened by taking Baclofen with food or milk. Discuss this with your doctor.

The following side effects have been reported at the approximate frequencies shown:

Very common (affecting more than one person in 10):

•    drowsiness and sleepiness

•    feeling sick (nausea).

Common (affecting less than one person in 10 but more than one person in 100):

•    nightmares

•    light-headedness

•    shallow breathing

•    exhaustion or lack of energy

•    dizziness

•    headache

•    reduced heart function

•    low blood pressure

•    confusion

•    difficulty in sleeping

•    changes in mood

•    muscle weakness and pain

•    hallucinations

•    dry mouth

•    loss of co-ordination

•    shaking

•    difficulty focusing and controlling eye movements

•    skin rash

•    excessive sweating

•    retching, being sick, constipation, diarrhoea or stomach problems.

•    needing to pass water often

•    pain or difficulty passing water

•    incontinence.

Uncommon (affecting less than one person in 100 but more than one person in 1,000):

•    speech disorder

•    pins-and-needles

•    fits (particularly in epileptics)

•    unusual taste sensations

•    abdominal pain

•    impotence (inability to get or maintain an erection)

•    inability to pass water

•    abnormal liver function leading to changes in blood sugar or blood levels of certain liver enzymes.

Very rare (less than 1 person in 10,000; includes isolated reports)

•    hypothermia (low body temperature).

Not known (cannot be estimated from available data)

•    nettle rash.

Some patients have experienced an unexpected (paradoxical) increase in involuntary muscle stiffness (spasticity).

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 via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOWTO STORE BACLOFEN

Keep out of the reach and sight of children. Store in a dry place at or below 25°C in the package or container supplied. Do not transfer them to another container.

Do not use Baclofen after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist howto dispose of medicines no longer required.These measures will help to protect the environment.

FURTHER INFORMATION

What Baclofen tablets contain:

•    The active ingredient is baclofen

•    The other ingredients are lactose, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.

What Baclofen tablets look like and contents of the pack:

•    Baclofen 10 mgTablets are white, plain, flat bevel-edged tablets.They are marked breakline and '3K2'

•    Baclofen 10 mgTablets are available in pack sizes of 10, 28, 30, 50, 56, 60, 84, 100, 250, 500, or 1000.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture:TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: June 2015 PL 00289/0243

TFWTI

83914-X


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