Zolmitriptan 5mg Orodispersible Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zolmitriptan 2.5 mg and 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 is and what it is used for
2. Before you take Zolmitriptan
3. How to take Zolmitriptan
4. Possible side effects
5. How to store Zolmitriptan
6. Further information
1. WHAT ZOLMITRIPTAN IS AND WHAT IT IS USED FOR
Zolmitriptan orodispersible tablets contain zolmitriptan and belong to a group of medicines called triptans.
Zolmitriptan is used to treat migraine headache.
Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan 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 works only when a migraine attack has started. It will not stop you from getting an attack.
2. BEFORE YOU TAKE ZOLMITRIPTAN Do not take Zolmitriptan
- if you are allergic (hypersensitive) to zolmitriptan or any of the other ingredients of this medicine (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
Before you take Zolmitriptan, 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).
When Zolmitriptan is taken at the same time as medicines of the type SSRI or SNRI, which are used for the treatment of depression, there is a risk of development of so called serotonin syndrome. The symptoms can be severe and include shivering, over-reactive reflexes, nausea, fever, sweating, delirium, mental confusion and coma. In case you are taking this combination your doctor should monitor you carefully, especially in the beginning of treatment, when doses are increased or if another serotonergic medication is added. If you experience any of these symptoms contact a doctor as soon as possible
If you go into hospital tell the medical staff you are taking Zolmitriptan.
Zolmitriptan is not recommended for people aged under 18 years or over 65.
As with other migraine treatments, using too much Zolmitriptan 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 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 obtained without prescription and herbal medicines. In particular, tell your doctor if you are taking any of the following medicines:
Medicines for migraine
- other triptans than zolmitriptan
- if you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmitriptan.
- after taking Zolmitriptan leave 6 hours before taking ergotamine or ergot-type medicines.
Medicines for depression (see also section ‘Take special care with Zolmitriptan above)
- moclobemide or fluvoxamine
- medicines called SSRIs (selective serotonin reuptake inhibitors)
- medicines called SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine or 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 (Hypericumperforatum), side effects of Zolmitriptan may be more likely to happen.
Taking Zolmitriptan orodispersible tablets with food and drink
You can take Zolmitriptan with or without food. It does not affect the way that Zolmitriptan works. Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
It is not known if taking Zolmitriptan during pregnancy is harmful. Before taking Zolmitriptan, tell your doctor if you are pregnant or trying to become pregnant.
Do not breast-feed within 24 hours of taking Zolmitriptan.
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 is unlikely to affect driving or using tools or machines. However, it is best to wait to see how Zolmitriptan affects you before you try these activities.
Important information about some of the ingredients of Zolmitriptan
Zolmitriptan orodispersible tablets contain source of phenylalanine. May be harmful for people with phenylketonuria.
3. HOW TO TAKE ZOLMITRIPTAN
Always take Zolmitriptan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You can take Zolmitriptan as soon as a migraine headache starts. You can also take it once an attack is underway.
The usual dose is one tablet (either 2.5 mg or 5 mg).
You can take another tablet if the migraine is still present after two hours or if it returns within 24 hours.
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 the dose prescribed for you.
Do not use more than two doses in one day. If you have been prescribed the 2.5 mg tablet, the maximum daily dose is 5 mg. If you have been prescribed the 5 mg tablet, the maximum daily dose is 10 mg.
Instruction for use
1. Peel the blister pack open. Do not push the tablet through the foil.
2. 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 than you should
If you have taken more Zolmitriptan than prescribed by your doctor, tell your doctor or go to the nearest hospital straight away. Take the Zolmitriptan medicine with you.
When too many orodispersible tablets are taken the symptoms may possible include sedation.
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 can cause side effects, although not everybody gets them. Some of the symptoms below could be part of the migraine attack itself.
Common side effects (affects 1to 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, vomiting
• Stomach pain
• Dry mouth
• Muscle weakness or muscle pain
• Feeling weak
• Heaviness, tightness, pain or pressure in throat, neck, arms and legs, or chest
Uncommon side effects (affects 1to 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
Rare side effects (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 that Zolmitriptan is causing an allergic reaction, stop using it and contact your doctor straight away.
Very rare side effects (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, contact your doctor and do not take any more Zolmitriptan.
• 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.
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.
5. HOW TO STORE ZOLMITRIPTAN
Keep out of the reach and sight of children.
Do not use Zolmitriptan after the expiry date which is stated on the blister and the carton after EXP. The 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 contains
The active substance is zolmitriptan. Zolmitriptan orodispersible tablets contain either 2.5 mg or 5 mg of zolmitriptan.
The other ingredients are mannitol (E421), calcium silicate, microcrystalline cellulose, aspartame (E951), sodium starch glycolate type A, crospovidone, colloidal anhydrous silica, magnesium stearate and orange cream flavour (containing e.g. maltodextrin (maize), acacia (E414), ascorbic acid (E300), butylhydroxyanisole (E320)) .
What Zolmitriptan looks like and contents of the pack
Zolmitriptan 2.5 mg orodispersible tablets are white and round flat tablets with the diameter 7.5 mm.
Zolmitriptan 5 mg orodispersible tablets are white and round flat tablets with the diameter 9.5 mm.
Zolmitriptan orodispersible tablets 2.5 mg and 5 mg come in peelable aluminium laminate blister packs containing 2, 3, 6 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer:
Actavis Limited
BLB016, Bulebel Industrial Estate
ZTN3000
Malta