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ZOLMITRIPTAN RENANTOS 5 MG ORODISPERSIBLE FILMS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zolmitriptan Renantos 5 mg orodispersible films
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.
What is in this leaflet
1.
What Zolmitriptan Renantos is and what it is used for
2.
What you need to know before you take Zolmitriptan Renantos
3.
How to take Zolmitriptan Renantos
4.
Possible side effects
5.
How to store Zolmitriptan Renantos
6.
Contents of the pack and other information

1.

WHAT ZOLMITRIPTAN RENANTOS IS AND WHAT IT IS USED FOR

Zolmitriptan Renantos contains zolmitriptan and belongs to a group of medicines called triptans.
Zolmitriptan Renantos is used to treat migraine headaches.




2.

Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan
Renantos 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 Renantos works only when a migraine attack has started. It is not a treatment to
prevent migraine attacks.
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE ZOLMITRIPTAN RENANTOS

Do not take:

 if you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section
6)
 if you 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 are at the same time taking certain other medicines for migraine (e.g. ergotamine or ergottype medicines like dihydroergotamine and methysergide) or other triptan medicines for migraine.
See section below: ‘Taking other medicines’ for further information.
 if you have severe kidney problems
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 Renantos:
 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).
If you go into hospital tell the medical staff you are taking Zolmitriptan Renantos
Zolmitriptan Renantos is not recommended for people aged under 18 years or over 65.
As with other migraine treatments, using too much Zolmitriptan Renantos 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 Renantos to correct the problem.
Other medicines and Zolmitriptan Renantos
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 Renantos (such as sumatriptan or naratriptan) wait for
24 hours before taking Zolmitriptan Renantos After taking Zolmitriptan Renantos wait for 24 hours
before taking triptans other than Zolmitriptan Renantos .
 If you take medicines containing ergotamine or ergot-type medicines (such as dihydroergotamine
or methysergide), wait for 24 hours before taking Zolmitriptan Renantos
After taking Zolmitriptan Renantos wait for 6 hours before taking ergotamine or ergot-type
medicines.
Medicines for depression
 Mono-Amine Oxidase Inhibitors, also known as MAOIs (such as moclobemide)
 medicines called SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine,
fluvoxamine or sertraline
 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 Zolmitriptan Renantos may be more likely to happen. You should not take the herbal remedy St.
John's Wort at the same time as this medicine. If you already take a St. John's Wort preparation,
stop taking it and mention this to your doctor at your next visit.

Zolmitriptan Renantos with food and drink
You can take Zolmitriptan Renantos with or without food. It does not affect the way that Zolmitriptan
Renantos works.
Pregnancy and breast-feeding
 It is not known if taking Zolmitriptan Renantos during pregnancy is harmful. Before taking
Zolmitriptan Renantos , tell your doctor if you are pregnant or trying to become pregnant.
 Before taking Zolmitriptan Renantos tell your doctor if you are breast-feeding.
 Do not breast-feed within 24 hours of taking Zolmitriptan Renantos.

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.
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 Renantos is unlikely to affect driving or using tools or machines. However, it is best
to wait to see how Zolmitriptan Renantos affects you before you try these activities.
3.

HOW TO TAKE ZOLMITRIPTAN RENANTOS

Always take Zolmitriptan Renantos exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
You can take Zolmitriptan Renantos as soon as a migraine headache starts. You can also take
Zolmitriptan Renantos once an attack is underway.
 The usual dose is 5 mg .You can take another tablet if the migraine is still present after two hours
or if it returns within 24 hours.
If Zolmitriptan Renantos does not give you enough help with your migraine, tell your doctor. Your doctor
may change your treatment.
Do not use more than two doses in one day. The maximum daily dose is 10 mg zolmitriptan.
Zolmitriptan Renantos is recommended for patients who may have difficulties to swallow tablets.
Remove Zolmitriptan Renantos orodispersible film from its individual sachet in the following way:
1. Do not cut the sachet
2. Open very carefully
3. Open only at the tear tag
4. Tear off slowly
5. Check the film for damage
6. Use only undamaged films
7. Take immediately after opening the sachet.
Your mouth should be empty before placing Zolmitriptan Renantos on the tongue with a dry finger. In a
few seconds the film disintegrates in the mouth and can be swallowed without fluids.
Use only undamaged sachet.

If you take more Zolmitriptan Renantos than you should
If you have taken more Zolmitriptan Renantos than prescribed by your doctor, tell your doctor or go to
the nearest hospital straight away. Take Zolmitriptan Renantos 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, Zolmitriptan Renantos 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 (affect 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 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

Uncommon side effects (affect 1 to 10 users in 1000):




Very fast heart beat
Slightly higher blood pressure
Increase in the amount of urine you pass or in how often you need to urinate

Rare side effects (affect 1 to 10 users in 10 000):
 Allergic/hypersensitivity reactions including lumpy rash (hives) and swelling of the face, lips,
mouth, tongue and throat. If you think that Zolmitriptan Renantos is causing an allergic reaction,
stop using it and contact your doctor straight away.
Very rare side effects (affect less than 1 user in 10,000):



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
Renantos, contact your doctor and do not take any more Zolmitriptan Renantos .
Spasm of the blood vessels of the intestines, which can cause damage to your intestines. You may
notice stomach pain or bloody diarrhoea. If this happens, contact your doctor and do not take
any more Zolmitriptan Renantos

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet.
5.

HOW TO STORE ZOLMITRIPTAN RENANTOS
 Keep this medicine out of the reach and sight of children.
 Do not use Zolmitriptan Renantos after the expiry date which is stated on the carton and on the
sachet after EXP. The expiry date refers to the last day of that month.
 This medicinal product doesn’t require any special storage conditions.

 Do not use Zolmitriptan Renantos if you notice that it is damaged.
 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 Renantos contains
The active substance is zolmitriptan.
Each 5 mg orodispersible film contains 5 mg zolmitriptan.
The other ingredients are: polyvinyl alcohol, macrogol 4000, macrogol 400, rice starch, acesulfame
potassium, orange flavour (containing Flavouring, Butylated Hydroxy Anisole E320), titanium dioxide
(E171), glutathione.
What Zolmitriptan Renantos 5 mg looks like and contents of the pack
Zolmitriptan Renantos 5 mg are white and rectangular (size 6 cm2) orodispersible films.
Each orodispersible film is placed into a sachet. The sachet material is of two foils made of paper-PEAluminium-Ionomer.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Renantos Pharmavertriebsges. mbH
Beethovenstraße 10
89340 Leipheim
Germany
Labtec GmbH
Raiffeisenstr. 4,
40764 Langenfeld
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
DE
Zolmitriptan Renantos 5 mg Schmelzfilm
AT
Zolmitriptan Renantos 5 mg Schmelzfilme
BE
Zolmitriptan Renantos 5 mg orodispergeerbare film/ film orodispersible/schmelzfilm
DK
Zolmitriptan Renantos
ES
Zolmitriptan Renantos 5 mg comprimidos bucodispersables
FI
Zolmitriptan Renantos 5 mg kalvo suussa hajoava
IE
Zolmitriptan Renantos 5 mg orodispersible film
IT
Zolmitriptan Renantos
NL
Zolmitriptan Renantos 5 mg orodispergeerbare film
NO
Zolmitriptan Renantos 5 mg munnsmeltende film
PL
Zolmitryptan Renantos
PT
Zolmitriptano Renantos 5 mg pelìcula orodispersìvel
SE
Zolmitriptan Renantos 5 mg munsönderfallande film
UK
Zolmitriptan Renantos 5 mg orodispersible film
This leaflet was last revised in 03/2012

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.

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