Lemsip Cold & Flu Headcold 500 mg Powder for Oral Solution

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Paracetamol

Доступна с:

Reckitt Benckiser Ireland Ltd

код АТС:

N02BE; N02BE01

ИНН (Международная Имя):

Paracetamol

дозировка:

500 milligram(s)

Фармацевтическая форма:

Powder for oral solution

Тип рецепта:

Product not subject to medical prescription

Терапевтические области:

Anilides; paracetamol

Статус Авторизация:

Marketed

Дата Авторизация:

1994-11-09

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEMSIP COLD & FLU
Headcold 500mg
Powder for Oral solution
Paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take Lemsip Cold
& Flu Headcold carefully to get the best results from it.
1.
WHAT LEMSIP COLD & FLU HEADCOLD IS AND WHAT IT IS USED
FOR?
Each sachet of Lemsip Cold & Flu Headcold 500mg Powder for Oral
Solution contains
500mg paracetamol. Paracetamol has pain killing (analgesic) and fever
reduction
(antipyretic) properties. Lemsip Cold & Flu Headcold can be used to
relieve the symptoms
of common cold or influenza such as headache, sore throat, fever, body
aches and pains.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEMSIP COLD & FLU
HEADCOLD
DO NOT TAKE LEMSIP COLD & FLU HEADCOLD

If you are allergic (hypersensitive) to paracetamol or any of the
other ingredients
listed in section 6

If you are taking any other paracetamol containing products

If you are less than 12 years of age
TAKE SPECIAL CARE WITH LEMSIP COLD & FLU HEADCOLD

If you have impaired liver or kidney function

If you are underweight (less than 50 kg) or are malnourished

If you use large quantities of alcohol regularly (alcoholism)

If you suffer from severe dehydration

If you are taking other drugs that affect the liver (see Taking other
medicines)

If you are elderly

If you have glutathione deficiency (a metabolic disorder which may
lead to difficulty
in breakdown of paracetamol)

If you have an enzyme deficiency called Glucose-6-phosphate
dehydrogenase
deficiency

If you have haemolytic anaemia (abnormal breakdown of red blood cells)
If any of the above applies to you, you may need to reduce the amount
of paracetamol
that you take or avoid taking this medicinal product altogether.

If you are diabetic, paracetamol contained in this medicine may
falsely elevate
continuous blood glucose monitor readings

Характеристики продукта

Health Products Regulatory Authority
30 May 2023
CRN00DG0J
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Cold & Flu Headcold 500 mg Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVEINGREDIENT MG/SACHET
Paracetamol Ph Eur 500.0
Excipients with known effects: Aspartame - 22.5 mg/sachet
Sodium – 93.77 mg (4 mmol) / sachet
Sucrose - 2.99 g/sachet
Lactose - 9.72 mg per sachet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for oral solution.
Pale cream coloured homogenous powder with an odour of lemon and
menthol and a taste of lemon and menthol intended
for dissolution in water and oral administration to human beings.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an analgesic and antipyretic for the relief of the symptoms
associated with the common cold and influenza.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Paracetamol should be used at the lowest effective dose for the
shortest possible time. The maximum daily dose must not be
exceeded.
POSOLOGY
Adults, the elderly and adolescents aged 16 years and over: 1 sachet
every 4 hours as required. Do not take more than 6
sachets in 24 hours.
In all patients over 16 years of age, the maximum daily dose of
paracetamol should not exceed 60 mg/kg/day (up to a
maximum of 2 g per day) in the following situations, unless directed
by a physician: (see section 4.4)

Weight less than 50kg

Dehydration

Malnutrition

Chronic alcoholism
Renal impairment
Paracetamol should be used with caution in patients with renal
impairment as a reduced dose and/or prolonged dosing
interval may be necessary (see section 4.4).
Hepatic impairment
Paracetamol should be used with caution in patients with hepatic
impairment as a reduced dose or prolonged dosing interval
may be necessary (see section 4.4).
The elderly
Experience has indicated that normal adult dosage of paracetamol is
usually appropriate.
Health Products Regulatory Authority
30 May 2023
CRN00DG0J
Page 2 of 6
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