Ilvico Cold and Flu film-coated tablets Paracetamol 325 mg Caffeine 30 mg Brompheniramine maleate 3 mg

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Paracetamol; BROMPHENIRAMINE MALEATE; Caffeine

Предлага се от:

P&G Health Germany GmbH

АТС код:

R06AB; R06AB51

INN (Международно Name):

Paracetamol; BROMPHENIRAMINE MALEATE; Caffeine

дозиране:

325 / 30 / 3 milligram(s)

Лекарствена форма:

Film-coated tablet

Терапевтична област:

Substituted alkylamines; brompheniramine, combinations

Статус Оторизация:

Marketed

Дата Оторизация:

2010-11-05

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
ILVICO
® COLD AND FLU FILM-COATED TABLETS
Paracetamol 325mg, Caffeine 30mg, Brompheniramine maleate 3mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to use Ilvico
carefully to get the best results from it. llvico Cold and Flu
film-coated tablets will be
referred to as llvico throughout the leaflet.
•
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.
WHAT IS IN THIS LEAFLET
1.
What llvico is and what it is used for
2.
What you need to know before you take llvico
3.
How to take llvico
4.
Possible side effects
5.
How to store llvico
6.
Contents of the pack and other information
1. WHAT ILVICO IS AND WHAT IT IS USED FOR
Ilvico Cold and Flu film-coated tablets contain paracetamol, caffeine
and brompheniramine.
llvico Cold and Flu film-coated tablets are used for the relief of
symptoms associated with
the common cold, influenza, and upper respiratory tract infections.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ILVICO TABLETS
DO NOT TAKE LLVICO IF:
•
You are allergic (hypersensitive) to paracetamol, caffeine or
brompheniramine, or any of
the other ingredients of llvico.
•
You suffer from severe liver diseases (with or without liver
insufficiency), viral hepatitis
(increases the risk of liver toxicity).
•
You suffer from peptic ulcers.
•
You suffer from severe kidney impairment.
•
You suffer from haemophilia (a disorder that affects blood clotting).
•
You are less than 12 years old.
•
You are pregnant or are breast-feeding.
•
You have tachyarrhythmia (fa

Данни за продукта

Health Products Regulatory Authority
09 June 2022
CRN00CY54
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ilvico Cold and Flu film-coated tablets Paracetamol 325 mg Caffeine 30
mg Brompheniramine maleate 3 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Paracetamol 325mg
Caffeine 30mg
Brompheniramine maleate 3mg
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White, biconvex round, smooth on both sides, film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with the common cold, influenza
and upper respiratory tract infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
ADULTS AND CHILDREN OLDER THAN 12 YEARS
One or two tablets taken orally with water three times daily and the
maximum dose of 6 tablets daily should not be exceeded.
Not recommended for children under the age of 12 years.
Renal impairment:
It is recommended, when giving paracetamol to patients with renal
impairment, to reduce the dose and to increase the
minimum interval between each administration to at least 6 hours
unless directed otherwise by a physician. The table below is
provided for guidance only, noting that a 500mg dose cannot be
achieved with this product:
Adults:
Glomerular filtration rate
Dose
10-50 ml/min
500mg every 6 hours*
<10ml/min
500mg every 8 hours*
Hepatic impairment:
In patients with hepatic impairment or Gilbert's Syndrome, the dose
should be reduced or the dosing interval prolonged.
The daily dose should not exceed 2g/day unless directed by a
physician.
Health Products Regulatory Authority
09 June 2022
CRN00CY54
Page 2 of 13
The elderly:
Experience has indicated that normal adult dosage is usually
appropriate. However in frail, immobile, elderly subjects or in
elderly patients with renal or hepatic impairment, a reduction in the
amount or frequency of dosing may be appropriate.
The maximum daily dose should not exceed 60mg/kg/day (up to a maximum
of 2