Zolmiless 2.5 Mg Orodispersible Tablets
Package leaflet: information for the user
Zolmiless 2.5 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.
What is in this leaflet:
1. What Zolmiless is and what it is used for
2. What you need to know before you take Zolmiless
3. How to take Zolmiless
4. Possible side effects
5. How to store Zolmiless
6. Contents of the pack and other information
1. What Zolmiless is and what it is used for
Zolmiless contains active substance zolmitriptan and belongs to a group of medicines called triptans.
Zolmiless is used to treat migraine attacks (headache and nausea).
Migraine symptoms may be caused by swollen blood vessels in the head. Zolmiless reduces 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.
Zolmiless 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 Zolmiless
Do not take Zolmiless if you
• are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6).
• have high blood pressure.
• 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.
• have circulatory problem (restricted blood flow in your legs or arms).
• have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA).
• have severe kidney problem.
• 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 (see section below: 'Other medicines and Zolmiless').
Do not take Zolmiless if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Zolmiless.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zolmiless 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.
• have ever had liver problems.
• have headaches which are not like your usual migraine headache.
• have been told that you have Wolff-Parkinson-White Syndrome (a type of abnormal heart beat).
• are taking any medicine for treatment of depression or herbal remedy called St. John’s wort (see section below: 'Other medicines and Zolmiless').
Zolmiless is not recommended for patients under 18 years or over 65.
As with other migraine treatments, using too much Zolmiless 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 taking Zolmiless to correct the problem.
Other medicines and Zolmiless
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 a triptan other than Zolmiless (such as sumatriptan or naratriptan) leave 24 hours before taking Zolmiless.
- After taking Zolmiless leave 24 hours before taking another triptan.
- If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmiless.
- After taking Zolmiless leave 6 hours before taking ergotamine or ergot-type medicines.
> Medicines for depression
- Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobemide).
- SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine or sertraline.
- SNRIs (serotonin norepinephrine reuptake inhibitors) such as venlafaxine or duloxetine.
> Other medicines
- Cimetidine (for indigestion or stomach ulcers).
- A quinolone antibiotic (such as ciprofloxacin).
- You should not take the herbal remedy St. John's wort (Hypericumperforatum) at the same time as this medicine because side effects of Zolmiless may be more likely to
happen. If you already take a St. John's wort preparation, stop taking it and mention this to your doctor at your next visit.
Zolmiless with food and drink
You can take Zolmiless with or without food. It does not affect the way that Zolmiless works. Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or for advice before taking this medicine.
It is not known if taking Zolmiless during pregnancy is harmful.
Therefore it should be used during the pregnancy only if the potential benefit to the mother outweighs the potential risk to the unborn child and no other appropriate treatment option is available.
No data exist on the excretion of zolmitriptan into breast milk. Therefore, as a precautionary measure, breast-feeding should be avoided for 24 hours after treatment.
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.
Zolmiless is unlikely to affect driving or using tools or machines. However, it may make you feel sleepy. Wait to see how Zolmiless affects you before you try these activities.
Zolmiless contains aspartame
Aspartame (951) contains a source of phenylalanine. May be harmful for people with phenylketonuria.
3. How to take Zolmiless
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Zolmiless is used to treat migraine attacks. Take Zolmiless as soon as possible after your migraine headache has started. You can also take it once an attack is underway. Do not use it to prevent an attack.
How much to take
Do not use more than the dose prescribed for you.
Adults (aged over 18 years and under 65 years)
The usual starting dose is 2.5 mg zolmitriptan.
If 2.5 mg zolmitriptan did not give you enough help with your migraine, tell your doctor. Your doctor may change your treatment and recommend you 5 mg zolmitriptan for next attack.
Occurrence of side effects is more likely with higher doses.
The maximum daily dose is 10 mg zolmitriptan.
Special patient groups
Patients aged over 65 years
Zolmiless should not be given to patients over 65 years.
Patients with liver problems
If you have liver problems, the recommended maximum daily dose is lowered to 5 mg.
Patients with kidney problems
Your dosage can be the same as in adults.
Children and adolescents under 18 years of age
Zolmiless should not be given to children or adolescents under 18 years of age.
Taking this medicine
• Oral use
• 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.
• You can take Zolmiless with or without food. It does not affect the way that Zolmiless works.
If after 2 hours after taking Zolmiless you still have a migraine or the migraine returns within 24 hours
You can take another dose if the migraine is still present after two hours or if it returns within 24 hours.
Do not take more than 2 doses of Zolmiless in a 24-hour period.
Always wait at least 2 hours between doses.
If Zolmiless did not give you enough help with your migraine, tell your doctor. Your doctor may change your treatment.
If your condition worsens, seek medical attention.
If you take more Zolmiless than you should
If you take more than you should or someone accidentally swallows some, contact your doctor or go to the nearest hospital straight away. Take the medicine pack and any remaining tablets with you so that the doctor knows what has been taken.
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.
If you experience any of the side effects listed below stop taking the medication and seek the doctor immediately
> Rare: may affect up to 1 in 1,000 people
- Allergic reactions including itchy rash (urticaria) and swelling of the face, lips, mouth, tongue and throat.
> Very rare: 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. The signs include chest pain and shortness of breath.
- Spasm of the blood vessels of the gut, which can cause damage to your gut. The signs include stomach pain or bloody diarrhoea.
- Bleeding in the brain (cerebral bleeding) or stroke.
In the course of the treatment with the active substance of the product Zolmiless the following adverse effects have also been observed
> Common: may affect up to 1 in 10 people
These side effects are usually mild and go away after a short time.
- Abnormal sensations such as tingling in your fingers and toes or skin that is sensitive to touch.
- Feeling sleepy, dizzy or warm.
- Headache.
- Uneven heartbeat.
- 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.
- Difficulty in swallowing.
> Uncommon: may affect up to 1 in 100 people
- Very fast heartbeat.
- Slightly higher blood pressure.
- Increase in the amount of water you pass (urine) or in how often you need to pass water.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zolmiless
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 package. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
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 Zolmiless contains
The active substance is zolmitriptan.
Each orodispersible tablet contains 2.5 mg zolmitriptan.
The other ingredients are mannitol (E421), cellulose microcrystalline, aspartame (E951), croscarmellose sodium, sillica colloidal anhydrous, magnesium stearate (E470b), orange flavor (containing nature-identical flavouring substance(s), flavouring preparation, natural flavouring substance(s), maltodextrin, acacia gum (E414), ascorbic acid (E300), butylated hydroxyanisole (E320)).
What Zolmiless looks like and contents of the pack
Zolmiless is a white to off-white, round, flat faced beveled edge uncoated tablet of 6.4 ± 0.3 mm diameter and with ‘2.5’ debossed on one side and plain on other side.
Size of packaging: 2 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GUI 4YS
UK
Manufacturer
S.C Zentiva SA
Bulevardul Theodor Pallady 50, Sector 3,
Bucharest
RO-032266
Romania
This medicinal product is authorised in the Member States of the EEA under the following name
|
Germany |
Zolmiless 2,5 mg Schmelztabletten |
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Bulgaria |
3onMmpunTaH 3eHTUBa 2,5 mg TaGneTKu, gucneprupa^u ce b ycTaTa |
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Lithuania |
Zolmitriptan Zentiva 2,5 mg burnoje disperguojamosios tabletes |
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Romania |
Zolmitriptan sanofi-aventis 2,5 mg comprimate orodispersabile |
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Sweden |
Zolmitriptan sanofi-aventis, 2,5 mg munsonderfallande tablett |
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United Kingdom |
Zolmiless 2.5mg Orodispersible Tablet |
This leaflet was last revised in 01/2014.
Reference: 92613 1.3.1.3 - Leaflet Text - PIL - 2.5mg - 2014-02-12 - 000000 - MAA 1.1