Zolmitriptan 2.5 Mg Orodispersible Tablets
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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 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.
The name of your medicine is “Zolmitriptan 2.5 orodispersible tablets or Zolmitriptan 5 mg orodispersible tablets” but will be referred to as “Zolmitriptan” throughout the rest of this leaflet.
What is in this leaflet:
1. What Zolmitriptan is and what it is used for
2. What you need to know before you take Zolmitriptan
3. How to take Zolmitriptan
4. Possible side effects
5. How to store Zolmitriptan
6. Contents of the pack and other information
1. What Zolmitriptan is and what it is used for
Zolmitriptan contains zolmitriptan and belongs 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. What you need to know before you take Zolmitriptan Do not take Zolmitriptan
- if you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6).
- ifyou 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: 'Other medicines and Zolmitriptan' for further information.
If you are not sure if any of these apply to you, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zolmitriptan 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 ischaemic 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).
Ifyou 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.
It is not recommended to take Zolmitriptan during the aura phase (period that precedes the head pain) to prevent migraine headaches from developing. You should take your medicine during the headache phase of the migraine.
Other medicines and Zolmitriptan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking any of the following medicines:
Medicines for migraine
- if you take triptans other than Zolmitriptan, leave 24 hours before taking Zolmitriptan.
- after taking Zolmitriptan leave 24 hours before taking triptans other 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
- 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 (Hypericumperforatum), side effects of Zolmitriptan may be more likely to happen.
Zolmitriptan with food and drink
You can take Zolmitriptan with or without food. It does not affect they way that Zolmitriptan works.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if taking Zolmitriptan during pregnancy is harmful.
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.
Zolmitriptan contains aspartame
Zolmitriptan orodispersible tablets contain aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.
3. How to take Zolmitriptan
Always take this medicine 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).
PSI supply nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
or
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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. You are more likely to get side effects with the higher dose (5 mg).
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 (may affect up to 1 in 10 people):
• 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.
• Difficulty in swallowing.
Uncommon side effects (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1,000 people):
• 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 (may affect up to 1 in 10,000 people):
• 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - Website: www.mhra.gov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zolmitriptan
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other 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), Magnesium Aluminometasilicate, Low substituted Hydroxy Propyl Cellulose, Aspartame (E951), Sodium Lauril Sulfate, Basic Butylated Methacrylate Copolymer, Talc, Colloidal anhydrous silica, Magnesium stearate, Peppermint Flavour (containing e.g. maltodextrin, natural flavours, modified corn starch).
What Zolmitriptan looks like and contents of the pack
Zolmitriptan 2.5 mg orodispersible tablets are white to off-white round flat tablets of 5.5 mm diameter, debossed with “2.5” on one side, having a characteristic flavour.
Zolmitriptan 5 mg orodispersible tablets are white to off-white round flat tablets of 7.0 mm diameter, debossed with “5” on one side, having a characteristic flavour.
Zolmitriptan 2.5 mg orodispersible tablets comes in peelable blister packs containing 2, 3, 6 or 9 tablets.
Zolmitriptan 5 mg orodispersible tablets comes in peelable blister packs containing 2, 3, 6, 9, 12 or 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Manufacturer
Jubilant Pharmaceuticals nv Axxes Business Park Guldensporenpark 22 - Block C 9820 Merelbeke Belgium
Distributed by
Aspire Pharma Ltd Antrobus House 18 College Street Petersfield, Hampshire GU31 4AD United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Sweden: Zolmitriptan Jubilant
United Kingdom: Zolmitriptan
The Netherlands: Zolmitriptan Jubilant
Italy: ZOLMITRIPTAN DOC Generici
This leaflet was last revised in 11/2014.