Diphenhydramine 25mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Diphenhydramine hydrochloride

Dostopno od:

Ennogen Healthcare Ltd

Koda artikla:

R06AA02

INN (mednarodno ime):

Diphenhydramine hydrochloride

Odmerek:

25mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 03040100

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Paracetamol and diphenhydramine hydrochloride 500 mg/25 mg Film-coated
Tablets
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist, or nurse
has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
WHAT PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE IS AND WHAT IT IS
USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL AND DIPHENHYDRAMINE
HYDROCHLORIDE
3.
HOW TO TAKE USE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE IS AND WHAT IT IS
USED FOR
Paracetamol and diphenhydramine hydrochloride is used to provide fast
and effective relief of the
fever, aches and pains associated with colds and flu, headaches,
backache, rheumatic and muscle
pains, period pains and toothache which is causing difficulty in
getting to sleep.
The active ingredients are paracetamol and diphenhydramine
hydrochloride.
Paracetamol is a painkiller and diphenhydramine hydrochloride is an
antihistamine that causes
sleepiness or drowsiness making it useful when pain is keeping you
awake.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL AND DIPHENHYDRAMINE
HYDROCHLORIDE
DO NOT TAKE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE IF YOU:

are allergic to paracetamol or diphenhydramine or any of the other
ingredients of this me

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol and diphenhydramine hydrochloride 500mg/25mg Film-coated
Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains Paracetamol 500 mg and
Diphenhydramine
hydrochloride 25 mg
Excipients with known effect:
Each tablet contains:
0.0426 mg of Brilliant blue FCF (E133)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Blue, capsule shaped, biconvex, film coated tablet, 17.6 mm x 7.5 mm,
engraved with
“A163” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short term treatment of bedtime symptoms of pain, for example
arising from
colds and flu, rheumatic and muscle pain, backache, toothache,
headache and period
pain which is causing difficulty in getting to sleep.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Do not exceed the stated dose or frequency of dosing
Children: Not recommended for children under 12 years of age except on
medical
advice.
ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS 16 YEARS AND OVER:
2 tablets to be taken 20 minutes before bedtime. Other products
containing
paracetamol may be taken during the day but the total daily dose of
paracetamol must
not exceed 4000 mg (including this product) in any 24 hour period.
Allow at least
four hours between taking any paracetamol-containing product and this
product.
MAXIMUM DAILY DOSE OF PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE
500
MG/25MG FILM-COATED TABLETS: Two tablets (1000mg paracetamol, 50mg
diphenhydramine) in 24 hours.
ADOLESCENTS 12 TO 15 YEARS:
1 tablet to be taken 20 minutes before bedtime. Other products
containing
paracetamol may be taken during the day but the total daily dose of
paracetamol must
not exceed 3000 mg (including this product) in any 24 hour period.
Allow at least
four to six hours between taking any paracetamol-containing product
and this
product.
MAXIMUM DAILY DOSE OF PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE
500
MG/25MG FILM-COATED TABLETS: One t