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DIMETAPP DM PAEDIATRIC DROPS & DIMETAPP DM COLOUR FREE PAEDIATRIC DROPS*

What is in this leaflet

This leaflet answers some common questions about Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops. ^. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops* are used for

Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops have been developed specifically for children. For adults there are other Dimetapp preparations which can be used.

Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops temporarily relieve some of the symptoms of the common cold. Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops can be used for the temporary relief of blocked nose or sinuses, runny nose, itchy watery eyes and sneezing associated with common colds. Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops also temporarily relieve cough due to minor throat and bronchial irritation as may occur with a cold.

Phenylephrine Hydrochloride is a nasal decongestant which assists in drying a running nose or reducing sinus and nasal congestion. Brompheniramine Maleate is an antihistamine which reduces the allergic response, thereby providing relief of itchy watery eyes and sneezing.

Dextromethorphan Hydrobromide helps to suppress the cough.

Before you use Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops*

Before you start to use it

Tell your doctor or pharmacist if:

1. Your child has any allergies to:
   • any other medicines
   • any other substances, such as foods, preservatives or dyes, or ingredients listed at the end of this leaflet.
2. Your child has or has had any medical conditions, especially the following:
   • treatment for thyroid conditions
   • treatment for depression
   • diabetes
   • difficulty in breathing
   • high blood pressure or heart problems
   • persistent cough
   • asthma
   • glaucoma
   • difficulty in passing urine
3. Your child is scheduled for surgery

If you forget to use it

If it is almost time for your child's next dose, skip the dose you missed and give the next dose when you are meant to. Otherwise, use it as soon as you remember and then go back to using Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops as you would normally.

Do not use a double dose to make up for the dose that you missed.

If you use too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (New Zealand telephone 0800 764 766) or go to casualty at your nearest hospital, if you think that you or anyone else may have used too much Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops. Do this even if there are no signs of discomfort or poisoning. Keep telephone numbers of these handy.

While you are using Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops*

Things you must do

If anyone in the family becomes pregnant and happens to use Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops, tell your doctor or pharmacist immediately.

If your child is about to be started on any new medicine tell your doctor, dentist or pharmacist that you are using Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops.

Things to be careful of

If adults happen to use Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops be careful driving or operating machinery until you know how the medication affects you.

Side Effects

Tell your doctor or pharmacist as soon as possible if your child does not feel well whilst using Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops.

Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops may have unwanted side effects in a few children. All medicines can have side effects. Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of using this medicine.

Tell your doctor or pharmacist if you notice any of the following side effects:

• nausea (feeling sick),
• skin rash which may be itchy
• weariness
• drowsiness
• dilated pupils of the eye
• high or low blood pressure
• irritability or excitement
• giddiness
• dryness of the mouth

Some children may experience other side effects while using Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops.

Do not be alarmed by this list of possible side effects. Your child may not experience any of them.

Taking other medicines

Tell your doctor or pharmacist if you are giving any other medicines to your child, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. In particular, you should tell your doctor or pharmacist :

if you are using:

• any medicine which contains antihistamines
• nasal decongestants from other cough, cold or allergy products
• medicines used to treat high blood pressure;

if you are using or have recently used:

• medicine used to treat depression or Parkinson's disease.

Your doctor and pharmacist has more information on medicines to be careful with or avoid whilst using Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops.

How to use Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops*

How much to use

For infants between 1 and 2 years the dosage shown below should be used only on your doctor's advice.

1 to 2 years:

1.6 to 2.0 mL every 4 hours orally.

 

Do not administer to children under 2 years of age without advice from your doctor or pharmacist.

For older children of average weight recommended dosage is:

2 to 6 years:

2.5 mL every 4 hours orally.

Paediatric Use

Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops are not recommended for infants up to 12 months.

Do not exceed 6 doses in a 24-hour period.

A persistent cough may be a sign of a serious condition. If symptoms do not improve within 7 days (or within 48 hours in the case of children), tend to recur, or are accompanied by fever, rash or persistent headache, patients should consult a doctor.

Always rinse the dropper well with hot water after use before returning it to the container.

After using Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops*

Storage

Keep Dimetapp DM Paediatric Drops & Dimetapp DM Colour Free Paediatric Drops in a cool dry place where the temperature stays below 25°C.

Do not leave it in the car or on window sills.
Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

Disposal

After the expiry date has passed, any unused Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops should be returned to your pharmacist so that it can be disposed of safely.

Product description

What it looks like

Dimetapp DM Paediatric Drops is a clear red-coloured liquid.

Dimetapp DM Colour Free Paediatric Drops is a clear colourless liquid.

Ingredients

Dimetapp DM Paediatric Drops or Dimetapp DM Colour Free Paediatric Drops is a combination of the following medicines per 1mL:

Brompheniramine Maleate - 0.4mg
Phenylephrine Hydrochloride - 1.0 mg
Dextromethorphan Hydrobromide - 2.0 mg

Dimetapp DM Paediatric Drops also contains Saccharin Sodium, Sodium Benzoate, Ethanol, Citric Acid - Anhydrous, Glycerol, Propylene Glycol, Sorbitol, Water-purified, Brilliant Blue FCF CI42090, Allura Red AC CI16035 and Flavour (Grape).

Dimetapp DM Colour Free Paediatric Drops also contains Saccharin Sodium, Sodium Benzoate, Ethanol, Citric Acid - Anhydrous, Glycerol, Propylene Glycol, Sorbitol, Water-purified, and Flavour (Grape).

Both products are Sugar-free (contains Sorbitol).

Supplier

Wyeth Consumer Healthcare
15B Vestey Drive, Mt. Wellington
Auckland, New Zealand

P.O. Box 12736 Penrose
Auckland New Zealand

Wyeth Consumer Healthcare Pty Ltd
17-19 Solent Circuit
Norwest Business Park
Baulkham Hills NSW 2153
Australia

Dimetapp DM Paediatric Drops - AUST R 43578.

Dimetapp DM Colour Free Paediatric Drops - AUST R 60799

Date of Preparation: 1 March 2001

Date of Revision: 31 Jan 2007

*Dimetapp DM Colour Free Paediatric Drops is currently not marketed in New Zealand.