Paracetamol Plus tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Caffeine

Available from:

Zentiva Pharma UK Ltd

ATC code:

N02BE51

INN (International Name):

Paracetamol; Caffeine

Dosage:

500mg ; 65mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 04070100

Patient Information leaflet

Please turn over
➥
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 or
pharmacist has 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 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 this medicine is and what it is used for
2. What you need to know before you take
this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. What this medicine is and
what it is used for
This medicine contains
• paracetamol which is a pain reliever
(analgesic) and helps reduce your
temperature when you have a fever
• caffeine which helps to increase the pain
relief from paracetamol and makes you
more alert.
These tablets are for the relief of mild to
moderate pain including headache, migraine,
toothache, nerve pain, sore throat and period
pains. They are also for symptomatic relief of
sprains, strains, rheumatic pain, sciatica,
lumbago, fibrositis, muscular aches and
pains, joint swelling and stiffness, flu,
feverishness and feverish colds.
2. What you need to know
before you take this medicine
Do not take this medicine if you
• are allergic to paracetamol, caffeine or
any of the other ingredients (as listed in
section 6)
• have high blood pressure or are taking any
medication for high blood pressure, such
as beta blockers
• your heart beat is too fast, too slow or
irregular
• are recovering from alcoholism and are
taking the medicine disulfiram
• are taking any medication to treat anxiety,
this includes antidepressants (e.g. lithium
carbonate or monoamine oxidase inhibitors),
anxiolytics or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Max Remedies Paracetamol Plus Caplets
Max Remedies Paracetamol and Caffeine Caplets
Paracetamol & Caffeine Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol
500.0 mg
Caffeine
50.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
White film coated capsule-shaped tablet with a break line
The score line is only to facilitate breaking for ease of swallowing
and not to
divide into equal doses
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the effective treatment of mild to moderate pain such as headache,
migraine, neuralgia, backache, rheumatic and muscular pain, period
pain and
toothache. For the relief of the symptoms of coughs, colds and sore
throats.
For the reduction of fever in influenza.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pos
olo
gy:
Ora
l.
Adults and children of 16 years and over: 1-2 tablets every 4-6 hours
when
necessary to a maximum of 4 doses in 24 hours. The tablets should be
taken
with a glass of water.
Children 12 to 15 years: 1 tablet every 4-6 hours when necessary to a
maximum
of 4 doses in 24 hours. The tablets should be taken with a glass of
water.
Elderly: No special dosage regimen required, but care should be taken
to
observe
the
contraindications,
precautions
and
warnings,
which
may be
particularly applicable to elderly persons.
Children: Not recommended for children less than 12 years old except
under
medical supervision.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol and/or other constituents.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Precautions: paracetamol should be used with caution in patients with
severe
renal disease or liver dysfunction. The hazards of overdose are
greater in
those with non-cirrhotic alcoholic liver disease.
Excessive intake of caffeine from coffee and tea should be avoided.
Keep out of the reach of children.
Warning: Do not exceed the stated dose.
If symptoms persist consult your doctor.
THE LABEL WILL SAY: Conta