EQUASYNT 5MG. 10MG or 20MG TABLETS

Methylphenidate hydrochloride

PATIENT INFORMATION LEAFLET

Your doctor has prescribed Equasym $mg,10mg.or 20mg Tablets for your child. This leaflet contains important information about the tablets. Please read it carefully BEFORE your child starts taking them. If you have any questions or you want to know more about this medicine, please ask your doctor (or pharmacist).

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YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NQT THROW IT AWAY UNTIL YOU HAVE FINISHED GIVING ALL THE MEDICINE.

What is the medicine?

Equasym Tablets contain methylphenidate hydrochloride which enhances the activity of certain underactive pans of the brain. Each tablet contains 5mg. 10mg or 20mg of methylphenidate

hydrochloride.

The tablets also contain the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycollate.

Equasym Tablets come in blister packs containing 30 tablets.

Who makes it?

The Marketing Authorisation Holder is;

Shire Pharmaceuticals Ireland Limited, 5 Riverwalk. Citywest Business Campus, Dublin 24. Ireland It is made by:

Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, OL7 9RR. UK.

What is this medicine used for?

Methylphenidate is used to treat a behavioural disorder in children known a? attention-deficit hyper-activity disorder (adhd). It should be given under the supervision of a specialist in this condition. ADHD is also known as attention-deficit disorder (ADD) "or just hyperactivity or hyperkinetic disorder. Children with ADHD tend to be restless or oyer active and find it difficult to concentrate. Methylphenidate is often used together with other forms of treatment in ADHD.

Before you give this medicine” ~

Equasym Tablets should not be used in children under 6 years of age.

Talk to your doctor before giving your child Eguasym Tablets if your child:

•    Is very anxious or agitated or depressed

•    Suffers from nervous motor tics (also tell your doctor if any other family members suffer from tics)

•    Suffers from Tourette's syndrome or if any f ;-nily member has been diagnosed with this condition or other movement

disorders    .

•    Suffers from any heart or thyroid problems

•    Is allergic to methylphenidate or to any of the other ingredients in this medicine

•    Suffers from glaucoma (increased pressure in the eye)

•    Is dependent on firugs or alcohol (or has been in the past)

•    Suffers from schizophrenia, anorexia nervosa, personality disorders, aggression or suicidal tendencies

•    Suffers from galactose intolerance, Lapp lactase deficiency or glucose - galactose malabsorption

Also tell your doctor if your child:

•    Has high blood pressure

•    Suffers from epilepsy (fits)

•    Is or could be pregnant

Is taking:

•    Any medicines for depression, for example amitriptyline or imipramine

•    Any medicine from a group of drugs known as monoamine-oxidase inhibitors, of which phenezine IS an example. Of tricyclic antidepressants (or has taken them recently)

•    Any medicines for epilepsy (anticonvulsants), for example phenobarbitone. phenytoin, carbimazepirte and primidone

•    Any medicines affecting blood pressure, for example guanethidine, verapamil and propranolol. In addition, some couch and cold remedies may also contain ingredients which can affect blood pressure, so it Is important to check with your pharmacist when you buy any of these products.

•    Anticoagulants (blood thinning tablets, like warfarin)

•    Phenylbutazone

This drug may produce abnormalities in the unborn baby. Therefore Equasym should not be taken by sexually active females unless clearly necessary.

Other special warnings

•    Whilst your child is taking Equasym Tablets, your doctor will probably want to carry out blood tests and monitor your chiid's height, weight and blood pressure from time to time.

•    When your child first starts to take methylphenidate. they may feel slightly dizzy or sleepy, if so, make sure they avoid activities wnere this could be dangerous, for example, working machinery, until these effects wear off.

•    Your child should not drink alcohol whilst taking this medicine.

•    These tablets contain lactose and may be unsuitable for some people.

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How do I give EQUASYM TABLETS?

Equasym Tablet* can be used in children aged 6 years and over.

It is important that your child takes the tablets at the right times. They must be taken as instructed by your doctor. Your doctor will usualiy start treatment with a low dose, for example, 5mg once or twice a day (for example at breakfast and lunch), and Increase it gradually as required. The maximum daily dose is 60mg.

If you are not sure how many tablets your child should take, ask your doctor or pharmacist.

•    The tablets should be swallowed with a drink of water

•    Do not stop the tablets suddenly. Ask your doctor first.

What if I givs too much?

If your child, or anyone else, accidentally takes too many Equasym Tablets, tell your doctor at once or contact your nearest hospital casualty department.

What if I miss a dose?

If your child forgets to take a dose, they should take the next dose at the usual time. They should NO^taJce a double dose.

After using EQUASYM TABLETS

Those tablets sometimes cause unwanted effects in some people. Nervousness and sleeplessness sometimes occur at the start of treatment. If they do not go away, your doctor may decide to reduce the dose or change the times at which your child takes the tablets.

Common side effects include:

•    Skin rash which may be accompanied with skin peeling or purplish red patches.

•    Itching.

•    Increased heart rate or palpitations or chest pain.

•    Increased hair loss.

•    Headache, sleepiness, dizziness or uncontrolled movements,

•    Dry rtvouth.

•    Reduced appetite, stomach pain or sickness, Taking the tablets with food may help,

These effects are often mild and may wear off after a few days' treatment. If they are severe or last for more than a few

days, toll your doctor.

Rare side effects include:

•    Some children taking mothylphomdate for a long time may have slower than normal growth but they usually catch up when methylphenidate is stopped.

•    Blurred vision.

Very rare side effects indude:

•    Persistent sore throat, high temperature, joint pain or muscle cramps.

•    Uncontrolled movements or fits.

•    Severe or unusual mood changes, delusions and hallucinations.

•    Hyperactivity.

•    Increased susceptibility to infections, tiredness, bruising or unusual bleeding.

•    Inflammation of blood vessels to the brain.

•    Liver blood tests may be altered.

If the tablets upset your child in any other way, tell your doctor.

How to store this medicine

The expiry date for these tablets is given on the carton and on the foil- The tablets must not be taken after this date.

Do not store above 2S*C. Store in the original package.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF CHILDREN.

Return any unused tablets to your pharmacist.

Further information

REMEM8ER: This medicine is for your child. Only a doctor can prescribe it. Never give it to someone else. It may harm them even if they have the same symptoms as your child.

This leaflet'docs not coTitain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor (or pharmacist) who will have access to further information.

This leaflet only applies to the product Equasym 5mg, 10mg or 20mg Tablets for which it has been prepared. Equasym is a trade mark.

Date of preparation of leaflet: 06/2009    p_106SO S0M2M27-42Hmt2

i SO26674_P1065D_P1.indd 2    26/8/09 11:47:38