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

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Diphenhydramine hydrochloride; Paracetamol

থেকে পাওয়া:

Ricesteele Manufacturing Ltd

এটিসি কোড:

N02BE; N02BE51

INN (আন্তর্জাতিক নাম):

Diphenhydramine hydrochloride; Paracetamol

ডোজ:

120 mg/5ml

ফার্মাসিউটিকাল ফর্ম:

Oral solution

প্রেসক্রিপশন টাইপ:

Product not subject to medical prescription

থেরাপিউটিক এলাকা:

Anilides; paracetamol, combinations excl. psycholeptics

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1978-04-01

তথ্য লিফলেট

03309/P/05
Leaflet revision date: May 2020
•
Allergic (hypersensitivity) reactions
including skin rash. Very rare cases of serious
skin reactions have been reported.
REPORTING OF SIDE EFFECTS
If you or your child get any side effects, talk to
your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2
Tel: [phone]; Fax: [phone]
Website: www.hpra.ie
E-mail: [e-mail]
By reporting side effects you can help provide
more information on the safety of this medicine.
2 TO 4 YEARS
5ML
3 TIMES
4 TO 6 YEARS
7.5ML
3 TIMES
6 TO 8 YEARS
10ML
3 TIMES
8 TO 10 YEARS
15ML
3 TIMES
10 TO 12 YEARS
20ML
3 TIMES
3
HOW OFTEN
(IN 24 HOURS)
03309/P/05
Leaflet revision date: May 2020
•
Allergic (hypersensitivity) reactions
including skin rash. Very rare cases of serious
skin reactions have been reported.
REPORTING OF SIDE EFFECTS
If you or your child get any side effects, talk to
your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2
Tel: [phone]; Fax: [phone]
Website: www.hpra.ie
E-mail: [e-mail]
By reporting side effects you can help provide
more information on the safety of this medicine.
2 TO 4 YEARS
5ML
3 TIMES
4 TO 6 YEARS
7.5ML
3 TIMES
6 TO 8 YEARS
10ML
3 TIMES
8 TO 10 YEARS
15ML
3 TIMES
10 TO 12 YEARS
20ML
3 TIMES
3
HOW OFTEN
(IN 24 HOURS)

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
03 November 2020
CRN00C0LK
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teedex Oral Solution Paracetamol 120mg/5ml Diphenhydramine
Hydrochloride 12.5mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains: Paracetamol 120mg and Diphenhydramine hydrochloride
12.5mg.
Excipients: Also contains:
Propylene glycol 500mg/5ml
Sorbitol liquid (non-crystallising) (E420) 1.5g/5ml
Maltitol liquid (E965) 250mg/5ml
Amaranth Red (E123) 180 micrograms/5ml
Raspberry flavour contains Ethanol 1.3mg/5ml
E214 0.4mg/5ml
E218 1.825mg/5ml
and E216 0.275mg/5ml
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
Clear red coloured oral solution with raspberry odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Teedex 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).
Teedex is contraindicated in children under 2 years (see section 4.3).
Teedex 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 intoler