MAXOLON

Tablets and oral solution

What is in this leaflet

This leaflet answers some of the common questions about Maxolon. It does not
contain all the available information. It does not take the place of talking to
your doctor or pharmacist.

All medicines have risks and benefits. The doctor has weighed the possible risks
of taking Maxolon against the expected benefits. Use Maxolon as instructed. If
you have any concerns about using this medication, talk to the doctor or
pharmacist.

Keep this leaflet until treatment with Maxolon is finished. You may want to read
it again.

What Maxolon is used for

Maxolon contains metoclopramide as the active ingredient.

Maxolon helps control nausea and vomiting caused by infectious diseases,
migraine, kidney disease, childbirth, other medications, cancer, or following
surgery, chemotherapy or radiation treatment.

Maxolon is also used to activate stomach contractions in conditions where there
is a need to encourage normal passage of food through the stomach and
intestines.

Maxolon is used together with X-rays to help diagnose problems of the stomach
and/or intestine. It is also used to assist with passing a tube into the
intestine.

Maxolon works by blocking the action of a chemical in the brain which causes
nausea and vomiting. Maxolon also acts in the stomach and upper intestine to
increase muscle contractions.

The doctor may have prescribed Maxolon for another reason. Ask the doctor if you
have any questions about why Maxolon has been prescribed for you (or your
child).

There is no evidence that Maxolon is addictive.

Before using Maxolon

Do not use Maxolon if:

  • you (or your child) have had an allergic reaction to metoclopramide or any
    of the other ingredients contained in this medicine. The ingredients are
    listed at the end of this leaflet. Signs of an allergic reaction may include
    itchy skin rash, shortness of breath and swelling of the face or tongue.

    If you (or your child) have taken metoclopramide before and became unwell,
    tell your doctor before taking any Maxolon.
  • If you (or your child) have any of the following conditions:
    • active bleeding from the stomach and/or digestive tract
    • blockage of the stomach and/or digestive tract
    • recent surgery on the stomach and/or digestive tract
    • phaeochromocytoma (an adrenaline-producing tumour of the adrenal gland).
  • the expiry date (EXP) printed on the pack has passed or if the package is
    torn or shows signs of tampering.

Do not use this medicine to treat any other complaints unless the doctor says
it is safe.

Do not give this medicine to anyone else; the doctor has prescribed it
specifically for you (or your child).

Before starting Maxolon tell the doctor if:

  • you (or your child) have ever had an allergic reaction (such as a rash) to
    metoclopramide in the past.
  • you (or your child) have epilepsy. Maxolon may increase the risk of having
    a fit.
  • you have Parkinson's disease. Maxolon may make this condition worse.
  • you are or think you may be pregnant or if you intend to become pregnant.
    The doctor will discuss with you the possible risks and benefits of using
    Maxolon during pregnancy.
  • you are breastfeeding. Your baby can absorb metoclopramide from breast
    milk if you are breastfeeding. Maxolon can also have an effect on the flow of
    milk.
  • you (or your child) have liver or kidney problems. The dosage of Maxolon
    may need to be changed or you may need to be given an alternative medicine.

Taking other medicines with Maxolon:

Tell your doctor if you (or your child) are taking any other medicines or
have taken other medicines until recently. This includes those medicines that
you buy without a prescription. In particular mention if you are taking any of
the following:

  • tranquillizers or anti-anxiety medications
  • strong pain relievers (eg codeine, morphine)
  • sedatives or sleeping medications
  • atropine-like medications (eg. some cold preparations, travel sickness
    medicines)
  • tetracycline antibiotics, paracetamol, levodopa. Maxolon may increase the
    absorption of these medicines.
  • digoxin. Maxolon may decrease the absorption of digoxin from the stomach.

Some medicines may affect the way other medicines work. The doctor or
pharmacist will be able to tell you which medicines are safe to work with
Maxolon.

If you have not told the doctor about any of these things, tell them before
you use any Maxolon.

How to use Maxolon

Follow the doctor's instructions about how and when to use Maxolon. The
doctor will advise how many doses are needed each day, and for how long you (or
your child) will need to use Maxolon. Read the direction label carefully. If you
have any concerns about how to use Maxolon, talk to the doctor or pharmacist.

How much to use

Follow the doctor's instructions about how much Maxolon to use. The dose of
Maxolon varies with the age of the patient and with the reason for use. The
total daily dosage of Maxolon, especially for children and young adults, should
not normally exceed 0.5mg/kg bodyweight. Space the doses as evenly as possible
throughout the day.

The usual dose of Maxolon is:

  Tablets (10mg) Oral Solution (1mg/mL)
Adults 20 yrs and over 1 tablet every 8 hrs 10mL every 8 hrs
Young adults 15 to 20 yrs 1/2 to 1 tablet every 8 hrs 5 to 10mL every 8 hrs
Children 5 to 14 yrs Use oral solution only 2.5 to 5mL every 8 hrs
Children 3 to 5 yrs Use oral solution only 2mL every 8 to 12 hrs
Children 1 to 3 yrs Use oral solution only 1mL every 8 to 12 hrs
Children under 1 yr Use oral solution only 1mL every 12 hrs

 

Children and young adults are very sensitive to the effects of Maxolon. The
doctor will normally start treatment at the lower dose. Do not exceed the
prescribed dose in these age groups.

How to use it

Tablets:

Swallow Maxolon tablets with a glass of water. The tablets can be broken in
half (along the break-line).

Oral Solution:

Measure the dose of Maxolon oral solution using a suitable measure. Make sure
the whole dose is swallowed each time. Do not exceed the prescribed dose.

Maxolon is best taken (or given) 30 minutes before meals.

How long to use it

Follow the doctor's instructions about how long to keep using Maxolon.

If you forget a dose

If you forget a dose of Maxolon, take (or give) it as soon as you remember.
The next dose and all further doses must be taken (or given) at the interval
prescribed by the doctor. Do not take (or give) a double dose to make up for the
dose that has been missed. Using more than the prescribed dose can increase the
chance of unwanted side effects.

Overdose

If you (or someone else) have taken a large amount of Maxolon all at once,
immediately telephone the doctor or Poison Information Centre (telephone 0800
POISON or 0800 764 766) or go to the emergency department at the nearest
hospital.

An overdose of Maxolon may cause drowsiness, confusion, tremor, twitching or
uncontrolled spasm of muscles. Seek medical advice even if there are no signs of
discomfort or poisoning. Be sure to show the doctor the Maxolon pack.

While using Maxolon

Things that must be done:

Tell the doctor if the nausea or vomiting persists.

Tell the doctor or pharmacist if you (or your child) are taking Maxolon before
starting any other prescribed medicine. Some medicines may affect the way other
medicines work.

Tell the doctor or pharmacist if you (or your child) experience any unwanted
effects while taking Maxolon.

Things to be careful of:

Be careful driving or operating machinery until you know how Maxolon affects
you. Maxolon may cause drowsiness, dizziness or light-headedness. Make sure you
know how you react to Maxolon before you drive, operate machinery, or do
anything else that could be dangerous if you are dizzy or not alert.

Avoid alcohol while you are taking Maxolon. It may make you sleepy.

Side effects

Besides their main effect, medicines may have some unwanted effects. Unwanted
effects do not always occur in every person. Most unwanted effects following
Maxolon are mild, and may disappear without stopping Maxolon. However, some side
effects may need medical treatment. Tell the doctor about any effect which is
troublesome or ongoing.

Mild effects

Tell the doctor if you notice any of the following that are troublesome or
ongoing:

  • drowsiness, tiredness, restlessness, sleeplessness, dizziness, headache
  • bowel irregularities.

More serious effects

Tell the doctor immediately if you notice any of the following:

  • mild skin rash, itching or hives
  • a change in heart beat
  • uncontrolled and repeated movements, eg sucking or smacking of the lips,
    darting of the tongue, chewing movements, uncontrolled movements of arms and
    legs.

Stop using Maxolon and contact a doctor immediately or go to the emergency
department of the nearest hospital if any of the following happens:

  • allergic reaction including fainting, swelling of limbs, face, lips, mouth
    or throat which may cause difficulty swallowing or breathing
  • sudden uncontrolled muscle spasm, stiffness of the arms or legs, muscle
    spasm of the face, locked-jaw or upturned eyes
  • shuffling walk, slowing of all movement, muscle tremor.

Serious effects that have been reported very rarely

  • abnormal blood pigment levels
  • neuroleptic malignant syndrome
  • tardive dyskinesia (with long term use).

You should tell the doctor or pharmacist as soon as possible if any of these,
or any other unusual events or problems occur during or after treatment with
Maxolon.

Storage

Keep the medicine in the pack until it is time to use it.

Keep the pack in a cool dry place. Do not leave it in the car on a hot day. Do
not store medicine in the bathroom or near a sink. Heat and dampness can destroy
some medicines.

Store all medicines out of the reach of children, such as in a locked cupboard.

If the doctor tells you to stop using Maxolon, ask the pharmacist what to do
with the doses that are left over.

Product description

What it looks like

Maxolon is available as:

  • round, white tablets containing 10mg of metoclopramide hydrochloride. The
    tablet is marked Maxolon on one side and has a break-line, or
  • oral solution containing metoclopramide hydrochloride 1mg/mL.

Other ingredients:

Maxolon tablets also contain the starch - maize, silica, magnesium stearate,
starch - pregelatinised maize, and lactose.

Maxolon Oral Solution also contains the inactive ingredients
hydroxyethylcellulose, saccharin sodium, propyl hydroxybenzoate, methyl
hydroxybenzoate, citric acid, terpeneless lemon oil, essence of lime (flavour
no. 1 06-3607) and purified water.

Maxolon preparations do not contain sucrose, gluten, tartrazine or any other
azo dyes.

Further information

Maxolon preparations are only available if prescribed by a doctor.


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