Zomig 2.5mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Zolmitriptan

Fáanlegur frá:

Grunenthal Ltd

ATC númer:

N02CC03

INN (Alþjóðlegt nafn):

Zolmitriptan

Skammtar:

2.5mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04070401; GTIN: 5000455007062 5000455007468

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOMIG 2.5 MG TABLETS
zolmitriptan
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 Zomig is and what it is used for
2.
What you need to know before you take Zomig
3.
How to take Zomig
4.
Possible side effects
5.
How to store Zomig
6.
Contents of the pack and other information
1.
WHAT ZOMIG IS AND WHAT IT IS USED FOR
Zomig 2.5 mg tablets contain zolmitriptan and belongs to a group of
medicines called triptans.
Zomig is used to treat migraine headache.
•
Migraine symptoms may be caused by swollen blood vessels in the head.
Zomig is thought to
reduce the widening of these blood vessels. This helps to take away
the headache and other
symptoms of a migraine attack, such as feeling or being sick (nausea
or vomiting) and being
sensitive to light and sound.
•
Zomig works only when a migraine attack has started. It will not stop
you from getting an
attack.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOMIG
DO NOT TAKE ZOMIG:
•
If you are allergic to zolmitriptan or any of the other ingredients of
this medicine (listed in
Section 6).
•
If you have high blood pressure.
•
If you have ever had heart problems, including a heart attack, angina
(chest pain caused by
exercise or effort), Prinzmetal’s angina (chest pain which happens
at rest) or have experienced
heart related symptoms such as shortness of breath or pressure over
the chest.
•
If you have had a stroke or short-lasting symptoms similar to stroke
(transient ischaemic attack
or TIA).
•
If

Vara einkenni

OBJECT 1
Zomig Tablets 2.5mg
Summary of Product Characteristics Updated 10-Mar-2022 | Grunenthal
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
Zomig 2.5 mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 2.5 mg of zolmitriptan.
Excipient(s) with known effect
Each tablet contains 100 mg lactose anhydrous.
For the full list of excipients, see Section 6.1.
3. Pharmaceutical form
Tablets.
4. Clinical particulars
4.1 Therapeutic indications
Zomig is indicated for the acute treatment of migraine with or without
aura.
4.2 Posology and method of administration
Posology
The recommended dose of Zomig to treat a migraine attack is 2.5 mg.
If symptoms persist or return within 24 hours, a second dose has been
shown to be effective. If a second
dose is required, it should not be taken within 2 hours of the initial
dose.
If a patient does not achieve satisfactory relief with 2.5 mg doses,
subsequent attacks can be treated with
5 mg doses of Zomig.
In thos