Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules Paracetamol 500 mg Pholcodine 5 mg Pseudoephedrine Hydrochloride 30 mg

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Paracetamol; Pseudoephedrine hydrochloride; Pholcodine

Disponible depuis:

The Boots Company Plc

Code ATC:

N02BE; N02BE51

DCI (Dénomination commune internationale):

Paracetamol; Pseudoephedrine hydrochloride; Pholcodine

Dosage:

500/5/30 milligram(s)

forme pharmaceutique:

Capsule, hard

Type d'ordonnance:

Product not subject to medical prescription

Domaine thérapeutique:

Anilides; paracetamol, combinations excl. psycholeptics

Statut de autorisation:

Not marketed

Date de l'autorisation:

2003-11-04

Notice patient

INFORMATION FOR THE USER
DAY COLD & FLU RELIEF HARD CAPSULES
(Paracetamol 500 mg, Pholcodine 5 mg, Pseudoephedrine Hydrochloride 30
mg)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription to treat minor
conditions. However, you still need to
take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice
WHAT THIS MEDICINE IS FOR
This medicine contains Paracetamol, an analgesic, which relieves pain
and reduces fever,
Pseudoephedrine, a decongestant to relieve a blocked nose and
Pholcodine, a cough suppressant to
relieve coughing.
It can be used to relieve the major symptoms of colds and flu
including aches and pains, fever,
blocked nose and dry, tickly coughs. Dry coughs do not produce phlegm
or mucus on the chest.
For children, simple treatments should be tried first before you give
this medicine. Further
information on “TREATING COUGHS AND COLDS IN CHILDREN” is provided
at the end of this leaflet.
BEFORE YOU TAKE THIS MEDICINE
This medicine can be taken by adults and children of 16 years and
over. However, some people
should not take this medicine or should seek the advice of their
pharmacist or doctor first.

DO NOT TAKE:

IF YOU ARE ALLERGIC to any of the ingredients in this medicine (see
“What is in this medicine”)

IF YOU ARE ALLERGIC TO OTHER DECONGESTANTS

IF YOU HAVE SEVERE KIDNEY PROBLEMS OR LIVER FAILURE

IF YOU HAVE HEART OR BLOOD VESSEL DISEASE

IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near
your kidneys)

IF YOU HAVE DIFFICULTY BREATHING

IF YOU HAVE LONG-TERM LUNG PROBLEMS OR AN INFECTION which produces
lots of phlegm on the chest

IF YOU HAVE DIABETES

IF YOU HAVE AN OVERACTIVE THYROID

IF YOU HAVE RAISED PRESSURE IN THE EYE (glaucoma)

IF YOU ARE HYPERACTIVE

IF YOU HAVE DIFFICULTY IN PASSING URINE

IF YOU ARE TAKING ANY OF THESE MEDICIN

Résumé des caractéristiques du produit

Health Products Regulatory Authority
10 July 2020
CRN009S05
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Pharmaceuticals Day Cold & Flu Relief Hard Capsules Paracetamol
500 mg Pholcodine 5 mg Pseudoephedrine
Hydrochloride 30 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
Quantity mg/capsule
Paracetamol
500
Pseudoephedrine hydrochloride
30
Pholcodine
5
Excipients:
Allura Red (E129) 0.53 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
The capsule has an orange cap and yellow body, printed axially in
black ink ‘BOOTS’ on the cap and ‘0580’ on the body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of the major symptoms of colds and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Take during the day.
For oral administration.
Adults and children over 16 years: Two capsules every four hours, up
to a maximum of 4 doses in 24 hours if needed.
Elderly: There is no specific requirement for dosage reduction in the
elderly.
Warning: Do not exceed the stated dose.
Keep all medicines out of the sight and reach of children.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients.
Severe renal impairment.
Cardiovascular disease including hypertension and ischaemic heart
disease
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
Avoid in patients with hyperexcitability or liver failure.
Prostatic enlargement (patients with prostatic hypertrophy may have
increased difficulty in micturation)
Urinary retention
Health Products Regulatory Authority
10 July 2020
CRN009S05
Page 2 of 7
Pholcodine should not be given to subjects in, or at risk of
developing respiratory failure.
Patients with chronic bronchitis, COPD, bronchiolitis or
bronchiectasis due to sputum retention.
Use in patients who are currently receiving other sympathomimetic
drugs (such as other decongestants).
Patients taking monoamine oxidase inhibitors (MAOIs) or within 14 days
of stopping