Zolmitriptan 5 Mg Orodispersible Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zolmitriptan 2.5 mg Orodispersible Tablets Zolmitriptan 5 mg Orodispersible Tablets
zolmitriptan
Read all of this leaflet carefully before you start taking
this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Zolmitriptan Orodispersible Tablets is and what it is used for
2. Before you take Zolmitriptan Orodispersible Tablets
3. How to take Zolmitriptan Orodispersible Tablets
4. Possible side effects
5. How to store Zolmitriptan Orodispersible Tablets
6. Further information
1. WHAT Zolmitriptan Orodispersible Tablets IS AND WHAT IT IS USED FOR
Zolmitriptan Orodispersible Tablets contains zolmitriptan and belongs to a group of medicines called triptans.
Zolmitriptan Orodispersible Tablets is used to treat migraine headache.
• Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan Orodispersible Tablets 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.
• Zolmitriptan Orodispersible Tablets works only when a migraine attack has started. Do not use it to prevent an attack.
2. BEFORE YOU TAKE Zolmitriptan Orodispersible Tablets
Do not take Zolmitriptan Orodispersible Tablets:
- if you are allergic (hypersensitive) to zolmitriptan or any of the other ingredients of Zolmitriptan Orodispersible Tablets (see Section 6: Further Information)
- 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 you have severe kidney problems
- if you are at the same time taking some other medicines for migraine (e.g. ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine. See section below: ‘Taking other medicines’ for further information.
If you are not sure if any of these apply to you, talk to
your doctor or pharmacist
Take special care with Zolmitriptan Orodispersible
Tablets
Before you take Zolmitriptan Orodispersible Tablets, tell
your doctor if:
- you are at risk of getting ischaemic heart disease (poor blood flow in the arteries of the heart). Your risk is greater if you smoke, have high blood pressure, high levels of cholesterol, diabetes or if anyone in your family has ischeamic heart disease
- you have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat)
- you have ever had liver problems
- you have headaches which are not like your usual migraine headache
- you are taking any other medicine for treatment of depression (see ‘Taking other medicines’ later in this section).
If you go into hospital, tell the medical staff you are taking Zolmitriptan Orodispersible Tablets.
Zolmitriptan Orodispersible Tablets is not recommended for people aged under 18 years or over 65.
As with other migraine treatments, using too much Zolmitriptan Orodispersible Tablets can cause daily headaches or can make your migraine headaches worse. Ask your doctor if you think that this is the case for you. You may need to stop using Zolmitriptan Orodispersible Tablets to correct the problem.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines and herbal medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following medicines:
Medicines for migraine
• If you take triptans other than Zolmitriptan Orodispersible Tablets, leave 24 hours before taking Zolmitriptan Orodispersible Tablets.
• After taking Zolmitriptan Orodispersible Tablets, leave 24 hours before taking triptans other than Zolmitriptan Orodispersible Tablets.
• If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmitriptan Orodispersible Tablets.
• After taking Zolmitriptan Orodispersible Tablets, leave 6 hours before taking ergotamine or ergot-type medicines.
Medicines for depression
• moclobemide or fluvoxamine
• medicines called SSRIs (selective serotonin reuptake inhibitors)
• medicines called SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine, duloxetine
Other medicines
• cimetidine (for indigestion or stomach ulcers)
• a quinolone antibiotic (such as ciprofloxacin)
If you are using herbal remedies containing St John’s Wort (Hypericum perforatum), side effects of Zolmitriptan Orodispersible Tablets may be more likely to happen. Taking Zolmitriptan Orodispersible Tablets with food and drink
You can take Zolmitriptan Orodispersible Tablets with or without food. It does not affect the way that Zolmitriptan Orodispersible Tablets works.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
• It is not known if taking Zolmitriptan Orodispersible Tablets during pregnancy is harmful. Before taking Zolmitriptan Orodispersible Tablets, tell your doctor if you are pregnant or trying to become pregnant.
• Do not breast-feed within 24 hours of taking Zolmitriptan Orodispersible Tablets.
Driving and using machines
• During a migraine attack your reactions may be slower than usual. Bear this in mind when you drive or use any tools or machines.
• Zolmitriptan Orodispersible Tablets is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how Zolmitriptan Orodispersible Tablets affects you before you try these activities.
Important information about some of the ingredients of Zolmitriptan Orodispersible Tablets Zolmitriptan Orodispersible Tablets contains aspartame (E951). Aspartame contains a source of phenylalanine and may be harmful for people with phenylketonuria.
3. HOW TO TAKE Zolmitriptan Orodispersible Tablets
Always take Zolmitriptan Orodispersible Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
|
G GLENMARK GENERICS LTD. |
14.03.2014 |
Black | |
|
Zolmitriptan ODT (UK) Ins (Front) VFRSinN- |
PKG. DEV.: |
Item code, Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | |
|
RA |
Regulatory Text | ||
|
QA: |
Entire Text | ||
|
Goa 33 x 170 mm | |||
|
PRODUCTION: |
Machine Suitability | ||
|
330 x 170 mm | |||
|
40 gsm Bible Paper | |||
The usual dose is 2.5 mg. Zolmitriptan Orodispersible Tablets is used to treat migraine attacks. Take Zolmitriptan Orodispersible Tablets as soon as possible after your migraine headache has started. You can also take it once an attack is underway.
If the symptoms of migraine return within 24 hours, you may take a second dose of zolmitriptan. The second dose should not be taken within 2 hours of your first dose.
If the tablets did not give you enough help with your migraine, tell your doctor. Your doctor may raise the dose to 5 mg or change your treatment.
Do not use more than two doses in one day. The maximum daily dose is 10 mg zolmitriptan.
Method of administration Oral Use.
Peel the blister pack open as shown on the foil. Do not push the tablet through the foil.
Place the tablet on your tongue, where it will dissolve and be swallowed with the saliva. You do not have to take a drink of water in order to swallow your tablet.
If you take more Zolmitriptan Orodispersible Tablets than you should
If you have taken more Zolmitriptan Orodispersible Tablets than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take the Zolmitriptan Orodispersible Tablets medicine with you. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zolmitriptan Orodispersible Tablets can cause side effects, although not everybody gets them. Some of the symptoms below could be part of the migraine attack itself.
Rare (affects 1 to 10 users in 10,000)
• Allergic/hypersensitivity reactions including lumpy rash (hives) and swelling of the face, lips, mouth, tongue and throat. If you think Zolmitriptan Orodispersible Tablets is causing an allergic reaction, stop using it and contact your doctor straight away.
Very rare (affects less than 1 user in 10,000)
• Angina (pain in the chest, often brought on by exercise), heart attack or spasm of the blood vessels of the heart. If you notice chest pain or shortness of breath after taking Zolmitriptan Orodispersible Tablets, contact your doctor and do not take any more Zolmitriptan Orodispersible Tablets.
• Spasm of the blood vessels of the gut, which can cause damage to your gut. You may notice stomach pain or bloody diarrhoea. If this happens, contact your doctor and do not take any more Zolmitriptan Orodispersible Tablets.
Other possible side effects:
Common (affects 1 to 10 users in 100):
• Abnormal sensations such as tingling in your fingers and toes or skin that is sensitive to touch.
• Feeling sleepy, dizzy or warm.
• Headache.
• Uneven heart beat.
• Feeling sick (nausea) or being sick (vomiting).
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain or pressure in the throat, neck, arms and legs, or chest.
Uncommon (affects 1 to 10 users in 1,000):
• Very fast heart beat.
• Slightly higher blood pressure.
• Increase in the amount of water you pass (urine) or in how often you need to pass water.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Zolmitriptan Orodispersible Tablets contains
2.5mg
The active substance i s zolmitriptan. Zolmitriptan 2.5 mg Orodispersible Tablets contain 2.5 mg of zolmitriptan.
The other ingredients are Mannitol (E421), Cellulose microcrystalline, Crospovidone Type A, Aspartame (E951), Silica colloidal anhydrous, Talc, Magnesium Stearate, Peppermint Flavour.
5mg
The active substance i s zolmitriptan. Zolmitriptan 5 mg Orodispersible Tablets contain 5 mg of zolmitriptan.
The other ingredients are Mannitol (E421), Cellulose microcrystalline, Crospovidone Type A, Aspartame (E951), Silica colloidal anhydrous, Talc, Magnesium Stearate, Peppermint Flavour.
What Zolmitriptan Orodispersible Tablets looks like and contents of the pack
Zolmitriptan 2.5 mg Orodispersible Tablets are supplied as:
White to off-white, round tablets debossed ‘F7’ on one side and plain on other side (diameter approximately: 6.5mm).
Zolmitriptan 5 mg Orodispersible Tablets are supplied as: White to off-white, round tablets debossed ‘F11’ on one side and plain on other side (diameter approximately: 8mm).
Zolmitriptan 2.5 mg Orodispersible Tablets are available in Aluminium/Aluminium peelable blisters in cartons containing 2, 3, 4, 5, 6, 12, 18 tablets.
Zolmitriptan 5 mg Orodispersible Tablets are available in Aluminium/Aluminium peelable blisters in cartons containing 2, 3, 4, 5, 6, 12, 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2-B Draycott Avenue,
Kenton, Harrow, Middlesex, HA3 0BU,
United Kingdom
Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143, Vysoke Myto 566 17,
Czech Republic
Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany Zolmitriptan Glenmark 2,5 mg, 5 mg
Schmelztabletten
Spain Zolmitriptan Glenmark
2.5mg, 5 mg Comprimidos bucodispersables
The Netherlands Zolmitriptan Glenmark 2.5mg, 5 mg Orodispergeerbare tabletten
This leaflet was last approved in March 2014.
5. HOW TO STORE Zolmitriptan Orodispersible Tablets
Keep out of the reach and sight of children.
Do not use Zolmitriptan Orodispersible Tablets after the expiry date which is stated on the carton after EXP: The
|
G GLENMARK GENERICS LTD. |
14.03.2014 |
Black | |
|
Zolmitriptan ODT (UK) Ins (Back) VFRSinN- |
PKG. DEV.: |
Item code, Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | |
|
RA |
Regulatory Text | ||
|
QA: |
Entire Text | ||
|
Goa 33 x 170 mm | |||
|
PRODUCTION: |
Machine Suitability | ||
|
330 x 170 mm | |||
|
40 gsm Bible Paper | |||
Temple Packaging Pvt. Ltd. Font: 9 pt Times New Roman Sap code: xxxxxxxxxxx File: xxxxx V.01