Dozol Oral Solution Paracetamol 120mg/5ml Diphenhydramine Hydrochloride 12.5mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diphenhydramine hydrochloride; Paracetamol

Available from:

Ricesteele Manufacturing Ltd

ATC code:

N02BE; N02BE51

INN (International Name):

Diphenhydramine hydrochloride; Paracetamol

Dosage:

120 mg/5ml

Pharmaceutical form:

Oral solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

1978-04-01

Patient Information leaflet

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.
ORAL SOLUTION
DOZOL
PARACETAMOL 120MG/5ML
DIPHENHYDRAMINE HYDROCHLORIDE 12.5MG/5ML
•
Your child is taking or has recently taken (in the
last 14 days) antidepressants called monoamine
oxidase inhibitors (MAOIs)
•
Your child has porphyria.
YOU MUST NOT GIVE DOZOL IF ANY OF THE ABOVE APPLIES.
IF YOU ARE UNSURE ABOUT WHETHER YOU CAN GIVE THIS
MEDICINE SPEAK TO YOUR DOCTOR OR PHARMACIST.
SPECIAL WARNINGS:
•
Dozol may cause drowsiness. Children receiving
this medicine should be kept under supervision
•
Dozol should be given with caution to children
with known liver or renal impairment.
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:
Dozol can affect some other medicines your child may
be taking. Always tell your doctor or pharmacist about
all the medicines you are giving to your child. This
means medicines you have bought yourself as well as
those you have on prescription from your doctor.
Dozol should not be taken if your child is taking any
other medicines, without the advice of a
doctor / pharmacist.
IMPORTANT INFORMATION ABOUT SOME OF THE
INGREDIENTS
•
Contains propylene glycol which may
cause alcohol-like effects
•
C

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2020
CRN009SWX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dozol Oral Solution Paracetamol 120mg/5ml Diphenhydramine
Hydrochloride 12.5mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains: Paracetamol 120 mg and Diphenhydramine
Hydrochloride 12.5 mg.
Excipients: Also contains:
Propylene glycol 500mg/5ml
Sorbitol liquid (non-crystallising) (E420) 1.5g/5ml
Maltitol liquid (E965) 250mg/5ml
Ponceau 4R (E124) 16.7micrograms/5ml
E218 1.825mg/5ml
E214 0.4mg/5ml
and E216 0.275mg/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear amber coloured oral solution with caramel odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dozol Oral Solution is indicated in children aged over 2 years in the
relief of teething pains, irritability associated with injections
or feverishness, aches or pains, sleeplessness associated with the
above conditions. Not recommended for routine use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Age
How Much
How Often (in 24 hours)
2 years – 4 years
5 mL
3 times
4 years – 6 years
7.5 mL
3 times
6 years – 8 years
10 mL
3 times
8 years – 10 years
15 mL
3 times
10 years – 12 years
20 mL
3 times
Maximum of 3 doses per 24 hours.
Do not exceed the stated dose.
Carefully administer the correct volume to the child using the
measuring device provided in order to minimise the risk of
overdose.
Parents should consult a pharmacist or other healthcare professional
before use in children under 6 years of age.
For short-term use only. Not recommended for routine use (See sections
4.4/4.1).
Dozol is contraindicated in children under 2 years (see section 4.3).
Dozol should be administered with caution to patients with known liver
or renal impairment. (see section 4.4).
4.3 CONTRAINDICATIONS
1. Large doses of antihistamines may precipitate fits in epileptics.
2. Patients with rare hereditary problems of fructose intolerance
should not take this medicine.
3. This medic