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DOZOL

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / PARACETAMOL

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Dozol
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.

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

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).

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

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

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

6. Further information.

• 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

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).

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

• 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.

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:

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.

Child’s Age

How Much

How often
(in 24 hours)

6 – 8 years

Two x 5ml

3 times

Keep out of the reach and sight of children.

8 – 10 years

Three x 5ml

3 times

10 – 12 years

Four x 5ml

3 times

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

• 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.

5. How to store Dozol

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.

Product licence holder and manufacturer
The product licence holder is
Ricesteele Manufacturing Limited,
Tallaght, Dublin 24, Ireland.

PL 01648/0004
Leaflet revision date: August 2011
06609/P/02
If you would like this leaflet in a different format, please contact the licence holder at the above address.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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