Panmigran 250 mg /250 mg /65 mg film-coated tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

제공처:

Haleon Hellas Single Member Societe Anonyme, under the distinctive title of Haleon Hellas, 274, Kifissias Ave, 15232 chalandri, Athens, Greece

ATC 코드:

N02BA51

INN (International Name):

ACETYLSALICYLIC ACID 250 mg PARACETAMOL 250 mg CAFFEINE 65 mg

약제 형태:

FILM-COATED TABLET

구성:

ACETYLSALICYLIC ACID 250 mg PARACETAMOL 250 mg CAFFEINE 65 mg

처방전 유형:

OTC

치료 영역:

ANALGESICS

제품 요약:

Licence number in the source country: NOT APPLICAPABLE

승인 상태:

Authorised

승인 날짜:

2023-06-16

환자 정보 전단

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Panmigran 250mg /250mg /65mg film-coated tablets
Acetylsalicylic acid / Paracetamol / Caffeine
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.
•
You must talk to a doctor if you do not feel better or your symptoms
worsen or do not improve after 3 days
for migraine and 4 days for headache.
•
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.
WHAT IS IN THIS LEAFLET
:
1.
What Panmigran is and what it is used for
2.
What you need to know before you take Panmigran
3.
How to take Panmigran
4.
Possible side effects
5.
How to store Panmigran
6.
Contents of the pack and other
information
1.
WHAT PANMIGRAN IS AND WHAT IT IS USED FOR
Each tablet of Panmigran contains three active substances:
acetylsalicylic acid, paracetamol and caffeine.
•
Acetylsalicylic acid
and paracetamol reduce pain and
fever,
and
acetylsalicylic
acid also
reduces
inflammation.
•
Caffeine is a mild stimulant and increases the effect of
acetylsalicylic acid and paracetamol.
Panmigran is used for the acute treatment of headache and migraine
attacks (symptoms such as headache,
nausea, sensitivity to light and sound, and functional disability)
with or without aura.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANMIGRAN
DO NOT TAKE PANMIGRAN IF YOU:
•
ARE ALLERGIC
(hypersensitive)
TO ACETYLSALICYLIC ACID, PARACETAMOL, CAFFEINE OR
any of the
OTHER
INGREDIENTS
OF PANMIGRAN
listed in section 6.
•
EVER HAD AN ALLERGIC REACTION
to other MEDICINES USED TO TREAT PAIN, INFLAMMATION OR FEVER
, such as
acetylsalicylic acid and salicylates, or any other anti-inflammatory
medicines known as NSAIDs such as
d

제품 특성 요약

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Panmigran 250 mg /250 mg /65 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 250 mg acetylsalicylic acid, 250 mg
paracetamol and 65 mg caffeine.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong-shaped, film-coated tablet with the letter “E”
debossed on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Panmigran is indicated in adults for the acute treatment of headache
and of migraine attacks with or
without aura.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults (18 years and older)
FOR HEADACHE:
The usual recommended dosage is 1 tablet; an additional tablet can be
taken, with 4 to 6 hours between
doses. In case of more intense pain, it is possible to take 2 tablets.
If needed, additional 2 tablets can be
taken, with 4 to 6 hours between doses.
Panmigran is intended for episodic use, up to 4 days for headache.
FOR MIGRAINE:
Take 2 tablets when symptoms appear. If needed additional 2 tablets
can be taken, with 4 to 6 hours
between doses.
Panmigran is intended for episodic use, up to 3 days for migraine.
For both headache and migraine, intake must be limited to 6 tablets in
24 hours. The medicinal product
must not be used for a longer period or at a higher dosage without
first consulting a doctor (see
section 4.4).
Drink a full glass of water with each dose.
Page 2 of 19
Children and adolescents (under 18 years of age)
Safety and efficacy of Panmigran in children and adolescents have not
been evaluated. Use of
Panmigran in children and adolescents is therefore not recommended
(see section 4.4).
Elderly
Based on general medical considerations, caution should be exercised
in the elderly, particularly in
elderly patients with low body weight.
Hepatic and renal impairment
The
effect
of
hepatic
or
renal
disease
on
the
pharmacokinetics
of
Panmigran
has
not
been
evaluated. Due to the mechanism of action of acetylsali