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ZOLTZICS 2.5 MG FILM-COATED TABLETS

Active substance(s): ZOLMITRIPTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoltzics 2.5 mg film-coated 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.
2.
3.
4.
5.
6.

What Zoltzics is and what it is used for
Before you take Zoltzics
How to take Zoltzics
Possible side effects
How to store Zoltzics
Further information

1. WHAT ZOLTZICSIS AND WHAT IT IS USED FOR
Zoltzics contain zolmitriptan and belongs to a group of medicines called triptans.
Zoltzicsare used to treat migraine headache with or without aura.


Migraine symptoms may be caused by the widening of blood vessels in the head. Zoltzics are
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.



Zoltzics work only when a migraine attack has started. It will not prevent attacks.

2. BEFORE YOU TAKE ZOLTZICS
Do not take Zoltzicsif you:
- are allergic (hypersensitive) to the active substance zolmitriptan or any of the other ingredients of
Zoltzics (see Section 6: ‘Further Information’)
- have high blood pressure
- have a type of abnormal heart beat called symptomatic Wolff-Parkinson-White syndrome or a type of
irregular heart beat
- have ever had heart problems, including a heart attack, chest pain caused by exercise or effort (angina),
a type of chest pain called Prinzmetal’s angina or have experienced heart related symptoms such as
shortness of breath or pressure over the chest
- have had a stroke or short-lasting symptoms similar to stroke (transient ischaemic attack or TIA)
- have blood circulation problems in your legs that cause cramp like pains when you walk (called
peripheral vascular disease)

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- have severe kidney problems
- are at the same time taking some other medicines for migraine (e.g. ergotamine or ergot-type medicines
like 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
Before you take Zoltzics, tell your doctor if you:
- smoke, have high blood pressure, high levels of cholesterol in the blood, diabetes or if anyone in your
family has ischaemic heart disease . These factors put you at risk of developing ischaemic heart disease
(poor blood flow in the arteries of the heart). Especially postmenopausal women and men over 40 years
of age should consider these risk factors.
- have ever had liver problems
- have headaches which are not like your usual migraine headache
- 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 Zoltzics.
Chest pain (angina pectoris):
You may feel sensations of heaviness, pressure or tightness in the chest area after treatment with Zoltzics.
If you develop chest pain you should:




stop taking Zoltzics
contact your doctor

As with other migraine treatments, long-term use of Zoltzics can cause daily headaches or can make your
migraine headaches worse. Tell your doctor if you think that this is the case for you. Your doctor may
advise that you stop using to correct the problem.
Children and elderly people
Zoltzics should not be used by 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 and herbal medicines.
This is because some medicines affect how Zoltzics work and Zoltzics affect how some other medicines
work.
In particular, tell your doctor if you are taking any of the following medicines:
Medicines for migraine
• triptans other than Zoltzics must not be taken at the same time as Zoltzics
• ergotamine or ergot-type medicines (such as methysergide) must not be taken at the same time as
Zoltzics. Make sure there is a time-gap between taking these medicines and Zoltzics:
- If you have just taken ergotamine or ergot-type medicines you must wait at least 24 hours before
taking Zoltzics.

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- If you have just taken Zoltzics you must wait at least 6 hours before taking ergotamine or ergottype medicines.
Medicines for depression
• medicines called MAO-A inhibitors (monoaminooxidase-A inhibitor) such as moclobemide
• medicines called SSRIs (selective serotonin reuptake inhibitors) such as fluvoxamine or fluoxetine
• 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 (Hypericum perforatum), side effects of
Zoltzics may be more likely to happen.
Using Zoltzics with food and drink
You can take Zoltzics with or without food. It does not affect the way that Zoltzics work.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.



It is not known if taking Zoltzics during pregnancy is harmful. Before taking Zoltzics, tell your
doctor if you are pregnant or trying to become pregnant.
Before taking Zoltzics while you are breast-feeding talk to your doctor. To minimize the risk of
exposing your baby to your medicine you should not breast-feed for 24 hours after taking
Zoltzics.

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.
• Zoltzics are unlikely to affect driving or using tools or machines. However, it is best to wait to see
how Zoltzics affect you before trying these activities. This medicine may make you sleepy and
dizzy. You should not drive or use machines if you are affected.
Important information about some of the ingredients of Zoltzics
Zoltzics contain 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.
3. HOW TO TAKE ZOLTZICS
Always take Zoltzics exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. Your doctor will decide on your dose, which will depend on how bad your
migraines are.
You should take Zoltzics as soon as a migraine headache starts. Although it can be taken once a migraine
attack is underway.
Dosage
• The usual dose is 2.5mg (1 tablet).

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If you have waited at least 2 hours after taking the first tablet , you may take a second tablet if
your symptoms return within 24 hours. Although, if the first tablet did not help with your
migraine then a second dose is unlikely to make any difference.

If the tablets did not give you enough help with your migraine, tell your doctor. Your doctor may raise the
dose to 2 tablets (5 mg). In this case frequency of undesirable side effects could be higher. Your doctor
may also change your treatment.
Do not use more than the dose prescribed for you.
Do not use more than two doses in one day.
Children, adolescents and the elderly:
Zoltzics should not be used:
• by children
• by adolescents up to 17 years of age, or
• by elderly patients over 65 years of age.
If you have liver problems
Your doctor will assess your liver function. If you have severe liver disease you should not take more than
2 tablets (5 mg) Zoltzics in 24 hours. If you have mild or moderate liver disease your Zoltzics dose does
not need to be adjusted.
Method of administration
Oral use.
The tablet should be swallowed whole (not chewed) and with water.
Duration of treatment
Your doctor will tell you how long you should take Zoltzics for.
If you take more Zoltzics than you should
If you have taken more Zoltzics than prescribed by your doctor, tell your doctor or go to the nearest
hospital straight away. Take the Zoltzics medicine with you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zoltzics can cause side effects, although not everybody gets them. Some of the
symptoms below could be part of the migraine attack itself.

Stop taking Zoltzics and contact your doctor straight away if you notice any of the following:
Rare (affects 1 to 10 users in 10,000):
• Allergic reactions including lumpy rash (hives) and swelling of the face, lips, mouth, tongue and
throat. Serious allergic reactions which cause difficulty in breathing or dizziness.
Very rare (affects less than 1 user in 10,000):

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Angina (pain in the chest, often brought on by exercise), heart attack, spasm of the blood vessels
of the heart, very fast heart beat or life-threatening irregular heartbeat. You may notice chest pain
or shortness of breath or extremely rapid heartbeat eventually together with chest pain or
shortness of breath.
inadequate blood supply to some internal organs (ischaemia), e.g. the intestines. Death of tissue
resulting from a failure of blood supply (infarction), e.g. in the intestines or the spleen. You may
notice stomach pain or bloody diarrhoea.
inadequate blood supply to the kidneys (ischaemia). Death of tissue resulting from a failure of
blood supply in the kidneys (infarction). You may notice pain in your belly, especially the lower
parts or the sides, or bloody urine.

Other possible side effects:
Common (affects 1 to 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 sensations of heat
• 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. If any of these
sensations occur in the chest contact your doctor immediately.
• Sweating
• Disturbances of vision, hearing and occasionally smell
Uncommon (affects 1 to 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
Very rare (affects less than 1 user in 10,000):
• sudden need to urinate (urinary urgency). This may cause some discomfort because you may
frequently feel the need to go to the toilet, but it is a harmless symptom. However if this feeling
persists for more than a day you may need to contact your doctor.
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 ZOLTZICS





Keep out of the reach and sight of children.
Do not use Zoltzics after the expiry date which is stated on the blister and on the carton after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
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.

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6. FURTHER INFORMATION
What Zoltzics contains
The active ingredient is zolmitriptan. Zoltzics contain 2.5 mg of zolmitriptan.
The other ingredients are:
Tablet core:
Lactose anhydrous, microcrystalline cellulose, sodium starch glycolate (Type A), macrogol 8000,
magnesium stearate, silica colloidal anhydrous
Film coat:
Opadry Yellow 03B92520 (containing hypromellose, titanium dioxide (E 171), talc, macrogol 400, yellow
iron oxide (E172))

What Zoltzics looks like and contents of the pack
• Zoltzics 2.5 mg film-coated tablets are yellow, round, biconvex, film-coated tablets, debossed
with “FC” on one side and “2.5” on the other side.
• Zoltzics 2.5 mg film-coated tablets come in blisters containing 2, 3, 6, 12 or 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorization Holder:
Welding GmbH&Co. KG
Esplanade 39
20354 Hamburg
Germany
Manufacturer:
Bluepharma – Industria Farmaceutica, S.A.
Sao Martinho do Bispo
3045 – 016 Coimbra
Portugal
This medicinal product is authorised in the Member States under the following names:
Germany: Zoltizcs 2,5 mg Filmtabletten
France: 2,5 mg comprimé pelliculé
Spain: Zolmitriptan NORMON 2,5 mg comprimidos recubiertos con pelicula EFG
United Kingdom: Zoltzics 2,5 mg film-coated tablet

This leaflet was last approved in 06/2011

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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.

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