J?ozoL

ORAL SOLUTION

Paracetamol and Diphenhydramine Hydrochloride

Please read all of this leaflet carefully before you give this medicine to a child.

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

•    If you need more information or advice, please ask your doctor or pharmacist

•    You must contact your doctor if your child’s symptoms get worse or do not improve

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Dozol is and what is it used for

2.    Before you give Dozol to your child

3.    How to give Dozol

4.    Possible side effects

5.    How to store Dozol

6.    Further information.

1. What Dozol is and what it is used for

Dozol is a caramel flavoured sugar free oral solution. Dozol contains the active ingredients paracetamol and diphenhydramine hydrochloride. Paracetamol is a pain killer and can be used to treat mild to moderate pain, including headache, sore throat, aches and pains. It also lowers high temperatures and brings down fever. Diphenhydramine hydrochloride is a mild antihistamine, which provides relief of a runny nose and sneezing.

Together these active ingredients relieve the symptoms of colds and flu when simple measures have failed to provide adequate relief. It is suitable for children aged from 6 to 12 years.

Treating colds in children

It’s normal for children to get 8 or more colds in a year. Gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Because colds are caused by viruses and not bacteria, antibiotics do not help. Here are simple steps to help your child who has a cold.

1.    If they are hot/ feverish: Increase the amount of fluid your child normally drinks. Lower their temperature with a paracetamol or ibuprofen medicine which has doses for children (paracetamol is not for children under 2 months. Ibuprofen is not for children under 3 months).

2.    To help with breathing: Plain saline nose drops available from your pharmacy can help babies with blocked noses who are having trouble feeding.

2. Before you give Dozol to your child

Do not give Dozol to your child if:

•    Your child is allergic to paracetamol or diphenhydramine hydrochloride or to any of the other ingredients listed (see ingredients in section 6)

•    Your child is under 6 years of age

•    Your child has epilepsy (large doses of antihistamines may bring on epileptic fits)

•    Your child is taking any other cough and cold medicines

•    Your child is taking any other paracetamol containing products

•    Your child is taking or has recently taken (in the last 14 days) antidepressants called monoamine oxidase inhibitors (MAOIs).

You must be especially careful. Speak to your doctor or pharmacist before giving Dozol if:

•    Your child has kidney or liver problems

•    Your child has an intolerance to some sugars

•    Your child has prostate problems

•    Your child has problems passing water

•    Your child suffers from an eye condition called angle closure glaucoma.

If any of the above applies, please talk to a doctor or pharmacist before giving this medicine.

Other special warnings:

•    Dozol may cause drowsiness. Children receiving this medicine should be kept under supervision

•    This product should not be used to sedate a child

•    Contains Paracetamol. Do not give with any other paracetamol containing products.

If adults take this medicine:

The following warnings also apply if you are an adult taking this medicine:

•    If you drink large amounts of alcohol, you may be more prone to the side effects of paracetamol, and the dangerous effects of a paracetamol overdose

•    Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, think you might be pregnant or are breast feeding

•    May cause drowsiness, if affected do not drive or operate machinery.

Taking other medicines:

The following advice is included in case older children or adults are taking this medicine.

Dozol can affect some other medicines you or your child may be taking. Always tell your doctor or pharmacist about all the medicines you are taking or giving to your child. This means medicines you have bought yourself as well as those you have on prescription from your doctor.

•    Some medicines must not be taken with Dozol, if you or your child is taking or has recently taken (in the last 14 days) antidepressants called monoamine oxidase inhibitors (MAOIs) such as phenelzine, do not take or give Dozol.

Make sure your pharmacist knows if you or your child is taking or has recently taken any other medicines including:

•    other antidepressants called tricyclic antidepressants such as imipramine

•    metoclopramide and domperidone used to treat feeling and being sick (nausea and vomiting)

•    colestyramine, used to treat high cholesterol

•    drugs that thin the blood (anticoagulants) such as warfarin

•    drugs to treat epilepsy (anticonvulsants)

•    drugs that help you sleep (sedatives) such as nitrazepam

•    drugs to treat anxiety such as diazepam

•    medicines to treat mental illness (psychosis), such as chlorpromazine

•    painkillers (opioid analgesics) such as morphine or codeine

•    drugs such as atropine (antimuscarinics) which can be used for digestive problems

•    other paracetamol containing medicines

•    other cough and cold medicines

•    the effects of alcohol may also be increased.

continued, please turn over.

Important information about some of the

ingredients

•    Contains propylene glycol which may cause alcohol-like effects

•    Contains sorbitol (E420) and maltitol (E965).

If your child has an intolerance to some sugars, contact your doctor before giving this medicinal product

•    Sorbitol may have a mild laxative effect; the calorific value of sorbitol is 2.6Kcal/g

•    Contains the preservatives

ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), colouring agent ponceau 4R (E124), all of which may cause allergic reactions (possibly delayed).

3. How to give Dozol

Read this section carefully to see how much

Dozol to give.

•    Do not give more of this medicine than shown below.

•    Dozol is not recommended for children under 6 years of age.

•    For oral use only.

•    It is important that your child receives the correct dose. The dose needs to be accurately measured using the syringe provided.

•    The syringe should be placed into the bottle, below the level of the liquid, and the plunger pulled gently upwards until it reaches the in-built stop and no further. This corresponds to a 5ml dose.

•    If at the end of the bottle you cannot remove what is left with the syringe provided, you should discard the remaining contents.

•    After use, rinse the syringe several times with warm water, allow to dry.

The usual dose is as follows:
Child’s Age	How Much	How often (in 24 hours)
6 - 8 years	Two x 5ml	3 times
8 - 10 years	Three x 5ml	3 times
10 - 12 years	Four x 5ml	3 times

•    Leave at least 4 hours between doses.

•    Do not give more than 3 doses in any 24 hours.

•    Always use the syringe supplied with the pack.

•    Do not give your child this medicine for more than 3 days, without speaking to your doctor or pharmacist.

•    Do not exceed the stated dose.

If anyone has too much Dozol:

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

Take your medicine or the pack with you so that the doctor knows what you have taken or given.

If you forget to take a dose of Dozol:

If you have missed a dose, don’t worry; give the next dose when needed provided that the last dose was given at least 4 hours ago. Do not give a double dose to make up for a missed dose.

Product licence holder and manufacturer

The product licence holder is

Ricesteele Manufacturing Limited, Tallaght, Dublin 24, Ireland.

If your child’s symptoms do not go away, or, get worse or if you are not sure how to give this medicine and would like further information, then please contact your doctor as soon as possible.

4. Possible side effects

Like all medicines Dozol may sometimes cause side effects. Although these don’t affect everyone and are usually mild.

Stop giving Dozol and seek immediate medical help if you notice the following rare but serious symptoms:

•    Severe allergic (hypersensitivity) reactions including rash; itching; difficulty breathing; tightness in the chest; and swelling of the mouth, face, lips, or tongue

•    Unexpected bruising or bleeding, sore throat, infections or fever, pale skin and weakness or breathlessness. These can be a sign of severe blood disorders (thrombocytopoenia

and agranulocytosis)

•    problems with movement and co-ordination or tremor

•    liver problems which can cause yellowing of the skin or whites of the eyes (jaundice)

Other side effects may include:

Commonly: Drowsiness, headache, dry mouth, nose and throat, blurred vision, upset stomach, difficulty in passing urine, phlegm on the chest.

Rarely: Low blood pressure, dizziness, confusion, increased awareness of the heart beat (palpitations), depression, problems with sleeping, fits (convulsions), excitability in children.

If any of the side effects gets serious, or if you notice any side effects not listed, please tell your doctor or pharmacist.

5. How to store Dozol

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package. Do not refrigerate.

Do not use this medicine after the expiry date shown on the carton or label. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6. Further information

Ingredients

Each 5ml of Dozol contains the active ingredients paracetamol 120mg and diphenhydramine hydrochloride 12.5mg. The other ingredients are macrogol 4000, glycerol, propylene glycol, sorbitol liquid (E420), maltitol liquid (E965), neohesperidin dihydrochalcone, saccharin sodium, ethyl parahydroxybenzoate (E214), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), annatto extract (E160), caramel flavour, ponceau 4R (E124), purified water.

What the medicine looks like

Dozol is a clear amber coloured liquid. This medicine is available in pack sizes of 100ml and 30ml, with a 5ml syringe for measuring the dose. Not all pack sizes may be available.

[P] PL 01648/0004

Leaflet revision date: August 2011 06609/P/02