Sumatriptan 100mg tablets

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Sumatriptan succinate

Dostupné s:

Milpharm Ltd

ATC kód:

N02CC01

INN (Mezinárodní Name):

Sumatriptan succinate

Dávkování:

100mg

Léková forma:

Tablet

Podání:

Oral

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04070401; GTIN: 8901175000142

Informace pro uživatele

READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to
read it again.
-
If you have any further questions,
ask your doctor or pharmacist.
-
This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as
yours.
-
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 Sumatriptan is and what it is
used for
2.
What you need to know before you
take Sumatriptan
3.
How to take Sumatriptan
4.
Possible side effects
5.
How to store Sumatriptan
6.
Contents of the pack and other
information
1.
WHAT SUMATRIPTAN IS AND WHAT IT
IS USED FOR
Sumatriptan belongs to a group of
medicines called triptanes, which are
used to treat migraine headache.
Migraine symptoms may be caused
by the temporary widening of blood
vessels in the head. Sumatriptan is
believed to reduce the widening of
these blood vessels. This in turn helps
to take away the headache and relieve
other symptoms of a migraine attack,
such as feeling or being sick (nausea
or vomiting) and sensitivity to light and
sound.
Sumatriptan works only when a migraine
attack has started. It will not stop you
from getting an attack.
You must not use sumatriptan to prevent
a migraine attack.
2.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE SUMATRIPTAN
Do not take Sumatriptan
-
if you are allergic to sumatriptan or
any of the other ingredients of this
medicine (listed in section 6).
-
if you have a heart
problem such as
narrowing of the
arteries (Ischaemic
heart disease)
or chest pains
(angina), or have
already had a heart
attack.
-
if you have
circulation
problems in
your legs that
cause cramp-like
pains when you
walk (peripheral
vascular disease).
-
if you have had a stroke or a mini-
stroke (also called a transient
ischaemic attack or TIA).
-
if you have high blood pressure. You
may be

Charakteristika produktu

OBJECT 1
SUMATRIPTAN 100MG TABLETS
Summary of Product Characteristics Updated 04-Dec-2018 | Aurobindo
Pharma - Milpharm Ltd.
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Sumatriptan 100 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 100 mg sumatriptan (as sumatriptan succinate).
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet.
White to off – white, capsule shaped, biconvex, uncoated tablets,
debossed with 'C' on one side and '34'
on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Sumatriptan is indicated for the acute treatment of migraine attacks
with or without aura.
4.2 Posology and method of administration
General recommendations with regard to use and administration:
Sumatriptan should not be used prophylactically.
Sumatriptan is recommended as monotherapy for the acute treatment of a
migraine attack and should not
be given concomitantly with ergotamine or derivatives of ergotamine