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

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Paracetamol; BROMPHENIRAMINE MALEATE; Caffeine

Fáanlegur frá:

Seven Seas Ltd

ATC númer:

R06AB; R06AB51

INN (Alþjóðlegt nafn):

Paracetamol; BROMPHENIRAMINE MALEATE; Caffeine

Skammtar:

325 / 30 / 3 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Substituted alkylamines; brompheniramine, combinations

Leyfisstaða:

Marketed

Leyfisdagur:

2010-11-05

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
Ilvico Cold and Flu film-coated tablets will be referred to as Ilvico
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 Ilvico is and what it is used for
2. What you need to know before you take Ilvico
3. How to take Ilvico
4. Possible side effects
5. How to store Ilvico
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. Ilvico 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 ILVICO IF
• You are allergic (hypersensitive) to paracetamol, caffeine or
brompheniramine, or any of the other ingredients of Ilvico.
• You suffer from severe liver diseases (with or without liver
insufficiency), viral hepatitis (increases the risk of liver toxicity)
• You suffer from peptic ulcers
• Your 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 (fast heart rate)
• You suffer from narrow-angle g

Vara einkenni

Health Products Regulatory Authority
17 April 2019
CRN008QXT
Page 1 of 11
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.
The elderly:
Health Products Regulatory Authority
17 April 2019
CRN008QXT
Page 2 of 11
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