Night Nurse Capsules Paracetamol 500 mg Promethazine Hydrochloride 10 mg Dextromethorphan Hydrobromide 7.5 mg

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide

Saadav alates:

Haleon Ireland Limited

ATC kood:

N02BE; N02BE51

INN (Rahvusvaheline Nimetus):

Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide

Annus:

500 mg/10 mg/7.5 milligram(s)

Ravimvorm:

Capsule, hard

Retsepti tüüp:

Product not subject to medical prescription

Terapeutiline ala:

Anilides; paracetamol, combinations excl. psycholeptics

Volitamisolek:

Marketed

Loa andmise kuupäev:

1990-02-08

Infovoldik

PACKAGE LEAFLET: Information for the user
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 have 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, pharmacist or
nurse. 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.
WHAT IS IN THIS LEAFLET:
1.
What Night Nurse Capsules are and what they are used for
2. What you need to know before you take Night Nurse Capsules
3.
How to take Night Nurse Capsules
4.
Possible side effects
5.
How to store Night Nurse Capsules
6.
Contents of the pack and other information
1.
What Night Nurse Capsules are and what
they are used for
NIGHT NURSE CAPSULES ARE USED FOR THE NIGHT TIME RELIEF OF THE
SYMPTOMS OF CHILLS, COLD AND ‘FLU INCLUDING HEADACHE, SHIVERS,
ACHES AND PAINS, SORE THROAT, RUNNY NOSE AND DRY TICKLY COUGH.
Night Nurse Capsules contain three active ingredients. Paracetamol
is a painkiller and reduces your temperature when you have a
fever. Promethazine hydrochloride is an antihistamine which dries
up a runny nose to allow easy breathing and aids restful sleep.
Dextromethorphan hydrobromide is a cough suppressant that helps
relieve dry or tickly coughs.
2.
What you need to know before you take
Night Nurse Capsules
CONTAINS PARACETAMOL.
TAKING TOO MUCH PARACETAMOL CAN CAUSE SERIOUS HARM TO
YOUR LIVER. DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL
WITHIN FOUR HOURS OF TAKING THIS PRODUCT. DO NOT TAKE WITH
OTHER COUGH OR COLD MEDICINES, OR ANY OTHER PRODUCTS
CONTAINING ANTIHISTAMINES, INCLUDING THOSE USE ON YOUR SKIN.
DO NOT TAKE NIGHT NURSE
CAPSULES
• IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol,
promethazine hydrochloride, dextromethorphan hydro

Toote omadused

Health Products Regulatory Authority
20 June 2023
CRN00DJMJ
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Night Nurse Capsules Paracetamol 500 mg Promethazine Hydrochloride 10
mg Dextromethorphan Hydrobromide 7.5 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Paracetamol 500.0 mg
Promethazine Hydrochloride 10.0 mg
Dextromethorphan Hydrobromide 7.5 mg
Excipients:
Lactose 60.04 mg per capsule
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsule
No. 0 hard gelatin capsule with an opaque bright green cap and opaque
white body, printed ‘night nurse’ in black on both
halves and containing a white free-flowing powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the night-time relief of the symptoms of colds, chills and
influenza, including cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Adults aged 16 years and over:
Take two capsules just before bedtime.
Only one dose (two capsules) should be taken per night.
Elderly
The normal adult dose can be taken by the elderly.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used.
Other products containing paracetamol may be taken during the day but
the total daily dose of paracetamol must not exceed
4000mg (including this product) in any 24 hour period.
Allow at least four hours between taking any paracetamol-containing
product and this product.
Maximum duration of continued use without medical advice: 7 days
Should not be used at the same time or within a 4 hour period of
taking other cough or cold medicines, or any other
antihistamine containing products, including those used on the skin.
If symptoms persist, consult a doctor.
Health Products Regulatory Authority
20 June 2023
CRN00DJMJ
Page 2 of 9
4.3 CONTRAINDICATIONS

Known hypersensitivity to the active ingredients or to any of the
excipients.

Use in children under 16 years of age.

Hepatic or renal impairment.

Patients who are taking or have t