Zolmitriptan 2.5 Mg Orodispersible Tablets
1st Fold : 86 mm
|
^- |
-w | |
|
30 mm |
30 mm |
50 mm
xxxx
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 foryou.
- Keepthis leaflet. You may need to read itagain.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even iftheir signs of illness arethesameasyours.
- 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 mg orodispersible tablets or Zolmitriptan 5 mg orodispersible tablets” but will be referred to as “Zolmitriptan” throughout the restofthisleaflet.
What is in this leaflet:
1. What Zolmitriptan is and what it is usedfor
2. Whatyou need to know before you take Zolmitriptan
3. HowtotakeZolmitriptan
4. Possible side effects
5. Howto store Zolmitriptan
6. Contents ofthe packand other information
1. What Zolmitriptan is and what it is used for Zolmitriptan contains zolmitriptan and belongs to a group of medicinescalledtriptans.
Zolmitriptan is used totreat 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 lightand sound.
Zolmitriptan works only when a migraine attack has started. It willnot stopyou 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).
- ifyouhavehighbloodpressure.
- 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 overthe chest.
- if you have had a stroke or short-lasting symptoms similarto stroke (transient ischaemic attack or TIA).
- if you havesevere 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 medicinesandZolmitriptan’forfurther information.
Ifyou are not sure if any of these apply to you, talkto your doctor or pharmacist.
Warnings and precautions
Talkto your doctororpharmacistbefore taking Zolmitriptan if:
- you are at risk ofgetting 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.
- if you have been told that you have Wolff-Parkinson-White Syndrome (atype of abnormal heart beat).
- youhave 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.
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 ofthe 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 aretakingany of thefollowing medicines:
Medicinesformigraine
- if you take triptans other than Zolmitriptan, leave 24 hours before taking Zolmitriptan.
- after taking Zolmitriptan leave 24 hours before taking triptans otherthan 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.
Medicinesfordepression
- moclobemideorfluvoxamine.
- medicines called SSRIs (selective serotonin reuptake inhibitors).
- medicines called SNRIs (serotonin norepinephrine reuptake inhibitors) such asvenlafaxine, duloxetine.
Other medicines
- cimetidine (for indigestion or stomach ulcers).
- aquinoloneantibiotic (such as ciprofloxacin).
If you are using herbal remedies containing St John's Wort (Hypericum perforatum), side effects of Zolmitriptan may be morelikelytohappen.
Zolmitriptan with food and drink
You can take Zolmitriptan with orwithoutfood. It does not affect theywaythatZolmitriptan 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 pharmacistforadvicebeforetakingthismedicine.
It is not known if taking Zolmitriptan during pregnancy is harmful.
Do not breast-feed within 24 hours oftaking 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 trythese activities.
Zolmitriptan contains aspartame Zolmitriptan orodispersible tablets contain aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.
3. HowtotakeZolmitriptan
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist ifyou are not sure.
Q
You can take Zolmitriptan as soon as a migraine headache starts. You can also take itonce an attack is underway.
The usual dose is onetablet (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. You are more likely to get side effects with the higher dose (5 mg).
Do not use more than the dose prescribed foryou.
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 doseis10mg.
Instruction foruse
1. Peel the blister pack open. Do not push the tabletthrough 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 orderto swallowyourtablet.
Ifyou 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. Takethe Zolmitriptan medicine with you.
If you have any further questions on the use of this medicine, askyourdoctoror 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, dizzyorwarm.
• Headache.
• Uneven heartbeat.
• Feeling sick, vomiting.
• Stomach pain.
• Drymouth.
• 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 upto 1in100 people):
• Very fast heartbeat.
• Slightly higherbloodpressure.
• Increase in the amount of water you pass (urine) or in how often you need to pass water.
Rare side effects (may affect upto 1in1,000 people):
• Allergic/hypersensitivity reactions including lumpy rash (hives) and swelling of the face, lips, mouth, tongue and throat. Ifyou thinkthat 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 anymoreZolmitriptan.
Reportingofsideeffects
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/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HowtostoreZolmitriptan
Keep this medicineoutofthesightand reachofchildren.
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 ofthatmonth.
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 characteristicflavour.
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 18tablets.
Notall packsizes may be marketed.
Marketing Authorisation Holder Jubilant Pharmaceuticals nv AxxesBusinessPark Guldensporenpark 22 - Block C 9820 Merelbeke Belgium Manufacturer PSI supply nv AxxesBusinessPark Guldensporenpark 22 - Block C 9820 Merelbeke Belgium or
Rafarm SA
8 Kapodistriou & 12 Korinthou str
GR-15451 Neo Psihico
Athens Greece
Distributed by
Lupin (Europe) Limited
VictoriaCourtBexton Road
Knutsford Cheshire, WA16 0PF 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.