Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.


PDF options:  View Fullscreen   Download PDF

PDF Transcript

PL 15773/0727
Version 1

Draft 1

Onzir 2.5 mg orodispersible tablets

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 Onzir 2.5 mg orodispersible tablets are and what they are used for
2. Before you take Onzir 2.5 mg orodispersible tablets
3. How to take Onzir 2.5 mg orodispersible tablets
4. Possible side effects
5. How to store Onzir 2.5 mg orodispersible tablets
6. Further information


Onzir 2.5 mg belongs to a group of medicines called 5HT1 agonists.
Onzir 2.5 mg is used to treat migraine attacks.


Do not take this medicine if
• you are allergic (hypersensitive) to zolmitriptan or any of the other ingredients of Onzir 2.5 mg
orodispersible tablets (see section 6. Further information).
• you suffer from high blood pressure which is difficult to treat or have poorly controlled blood pressure.
Speak to your doctor if unsure.
• you have poor blood flow in the arteries of the heart (ischaemic or coronary heart disease) or have other
circulatory problems or suffer from a particular type of chest pain known as Prinzmetal’s angina.
• you suffer from a condition called Wolff-Parkinson-White Syndrome which is characterised by an
abnormal heart rhythm
• you have had a stroke or symptoms similar to a stroke which wear off after a day or two (transient
ischaemic attack).
• you are taking any medicines for migraine, including others of this type (5HT1 agonists) and ergotamine
or ergot-type products. Onzir 2.5 mg should not be taken at the same time as these medicines (see section
“Taking other medicines”).
• you suffer from kidney failure
Take special care with this medicine
Your doctor will decide if your headache is caused by migraine. You should take this medicine only for a
migraine attack, not for other types of headache.
Before taking your tablets, tell your doctor if:
• You have ever had problems with your heart, including angina, heart attack or high blood pressure.
• You have ever been told that you may have an increased risk of heart disease.

PL 15773/0727
Version 1

Draft 1

• You have ever had any problems with your liver. Your dose may have to be reduced.
• Your migraine attack comes along with dizziness, double vision, impaired consciousness, slurred speech,
incoordination, palsy (basiliar migraine) or paralysis on one side of the body (hemiplegic migraine).
• you are taking a herbal remedy called St. John’s wort.
If you take this medicine too often this may result in you getting a chronic headache. In such cases you
should contact your doctor as you may have to stop taking this medicine.
If you get chest pain, stop taking this medicine until you have discussed the pain with your doctor.
Children and elderly patients
Onzir 2.5 mg is not recommended for people aged under 18 years or over 65.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
This particularly applies if you are also taking any of the following medicines during treatment with Onzir
2.5 mg:
• any other medicine for your migraine such as other 5HT1 agonists.
• medicines containing ergotamine or ergot-type medicines (like dihydroergotamine or methysergide). Do
not take Onzir 2.5 mg within 24 hours after taking these drugs and do not take ergotamine or ergot-type
medicines within 6 hours after taking Onzir 2.5 mg.
• any medicine for the treatment of depression; including medicines called monoaminooxidase inhibitors
(MAOI) like moclobemide, serotonin reuptake inhibitors (SSRIs) like fluoxetine, paroxetine,
fluvoxamine or sertraline, or serotonin noradrenaline reuptake inhibitors (SNRIs) like venlafaxine or
• cimetidine (for stomach ulcers) or a quinolone antibiotic such as ciprofloxacin (ask your doctor if you are
not sure).
• the herbal remedy St. John’s wort. If you already take a St. John’s wort preparation, stop taking it and
mention this to your doctor at your next visit.
Pregnancy and breast-feeding
Ask your doctor for advice if you are pregnant, trying to get pregnant, or breast-feeding.
It is not known whether this medicine is harmful to an unborn baby when taken by a pregnant woman.
Breast-feeding should be avoided for 24 hours after taking this medicine.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machinery. But you should wait to see how it
affects you before you try these activities.
Important information about some of the ingredients of Onzir 2.5 MG
Each tablet contains 53 mg lactose.If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Each tablet contains 2.3 mg aspartame which is a source of phenylalanine. Aspartame may be harmful for
people with phenylketonuria.


Always take your medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

PL 15773/0727
Version 1

Draft 1

The usual dose is one tablet or two tablets (2.5 mg or 5 mg Onzir) as soon as you feel your migraine start.
If you take a higher dose (5 mg) you are more likely to suffer side effects.

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 your migraine has not gone after two hours, or it comes back within 24 hours, take another tablet.
Do not take Onzir 2.5 mg more than 2 times within 24 hours.
If these tablets do not work, tell your doctor. Your doctor may want to change your treatment.
If you take more Onzir 2.5 mg than you should
If you take more tablets than your doctor told you to take, contact your doctor or nearest hospital. Remember
to take your tablets with you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.


Like all medicines, Onzir 2.5 mg can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking your medicine and seek immediate medical
● Hypersensitivity reactions including itchy rash, swelling of the mouth, tongue and neck, with fluid in the
tissues (angioedema) and anaphylaxis or anaphylactoid reactions (serious allergic-type reactions).
● Pains in the chest (Angina), spasm of the blood vessels of the heart, heart attack.
● Bloody diarrhoea or other serious complication with gut and stomach.
Side effects are usually mild to moderate.
Common (affects 1 to 10 users in 100):
● Feeling or being sick. Feeling dizzy, sleepy, warm or weak.
● Dry mouth.
● Stomach pain.
● Headache (overuse of this type of medicine may cause an increased number of headaches, tell your doctor
if this happens).
● An uneven heart beat.
● Feelings of heaviness, tightness, pain or pressure in your throat, neck, chest, arms or legs.
● Aches and pains in your muscles, or muscle weakness.
● Tingling in your fingers and toes, a loss of sense of touch, or skin that is sensitive to touch.
Uncommon (affects 1 to 10 users in 1,000):
● Very fast heart beat, slightly higher blood pressure
● Increase in the amount of water (urine) you pass, or in how often you need to pass water.
Very rare (affectts less than 1 user in 10,000):
● Urge to urinate
People who get migraines may be at risk of certain problems of the blood circulation in the brain, such as
cerebral bleeding (bleeding in the brain) or strokes. As with other drugs of this type, these problems have
been reported in very rare cases.
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.

PL 15773/0727
Version 1


Draft 1


Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date
refers to the last day of that month.
Do not store above 30 °C
Store in the original package (blisters) in order to protect from light and moisture.
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.


What Onzir 2.5 mg contains
The active substance is zolmitriptan.
Each orodispersible tablet contains 2.5 mg zolmitritpan.
The other ingredients are
calcium silicate
crospovidone type B
maize starch
lactose monohydrate
sodium hydrogen carbonate
citric acid monohydrate
aspartame (E951)
orange flavour
magnesium stearate (vegetal)
What Onzir 2.5 mg looks like and contents of the pack
White to off-white round, flat faced tablets marked “Z31” on one side.
Onzir 2.5 mg is available in packs containing 2, 3, 6, 10, 12 and 18 orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ratiopharm GmbH, Graf-Arco-Strasse 3, 89079 Ulm, Germany
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany

This leaflet was last revised in January 2011
PL 15773/0727

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.