ZOLMITRIPTAN 2.5 mg Orodispersible tablet

Зміст інструкції

1. Zolmitriptan Aurobindo Pharma Italia 2.5 mg and 5 mg orodispersible tablets
   1. What is Zolmitriptan Aurobindo Pharma Italia and what it is used for
   2. What you need to know before taking Zolmitriptan Aurobindo Pharma Italia
   3. Possible side effects
   4. Contents of the pack and other information

Zolmitriptan Aurobindo Pharma Italia 2.5 mg and 5 mg orodispersible tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Zolmitriptan Aurobindo Pharma Italia is and what it is used for
• 2. What you need to know before you take Zolmitriptan Aurobindo Pharma Italia
• 3. How to take Zolmitriptan Aurobindo Pharma Italia
• 4. Possible side effects
• 5. How to store Zolmitriptan Aurobindo Pharma Italia
• 6. Contents of the pack and other information

1. What is Zolmitriptan Aurobindo Pharma Italia and what it is used for

Zolmitriptan Aurobindo Pharma Italia contains zolmitriptan and belongs to a group of medicines called
triptans.
Zolmitriptan Aurobindo Pharma Italia is used to treat migraine headache.
The symptoms of migraine can be caused by the widening of blood vessels in the head. It is believed that
Zolmitriptan Aurobindo Pharma Italia reduces the widening of these blood vessels. In this way it helps to
relieve the headache and other symptoms of the migraine attack, such as feeling unwell (nausea or vomiting) and
sensitivity to light and sounds.
Zolmitriptan Aurobindo Pharma Italia only works on a migraine attack that has already started. It does not help to prevent
an attack.

2. What you need to know before taking Zolmitriptan Aurobindo Pharma Italia

Do not take Zolmitriptan Aurobindo Pharma Italia

• 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 had heart problems, including heart attack, angina (chest pain caused by physical activity or exertion), Prinzmetal's angina (chest pain that occurs at rest) or have experienced heart-related symptoms, such as shortness of breath or a feeling of tightness in the chest
• If you have had a stroke or symptoms of a stroke-like transient duration (transient ischemic attack or TIA)
• If you have severe kidney problems
• If you are taking certain other medicines to treat migraine at the same time (e.g. ergotamine or ergot derivatives such as dihydroergotamine and methysergide) or other triptan medicines for migraine. For more information, see the following section: “Other medicines and Zolmitriptan Aurobindo Pharma Italia”. If you are not sure if any of these conditions apply to you, talk to your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zolmitriptan Aurobindo Pharma Italia if:

• You are at risk of developing ischemic heart disease (poor blood flow in the arteries of the heart). Your risk is higher if you smoke, have high blood pressure, high cholesterol levels, if you have diabetes, or if a family member has ischemic heart disease
• You have been told you have Wolff-Parkinson-White syndrome (a type of heart rhythm abnormality)
• You have had liver problems
• You experience headaches that are different from your usual migraine headache
• You are taking other medicines to treat depression (see “Other medicines and Zolmitriptan Aurobindo Pharma Italia” later in this section).

When Zolmitriptan Aurobindo Pharma Italia is taken at the same time as other medicines of the
type SSRI or SNRI, used to treat depression, there is a risk of developing so-called
serotonin syndrome. Symptoms can be severe and include chills, overactive reflexes, nausea,
fever, sweating, delirium, mental confusion and coma. If you are taking this combination of
medicines, your doctor must monitor you closely, especially at the beginning of treatment, when it is
necessary to increase the dosage, or if another serotonergic medicine is added. If you should
experience any of these symptoms, contact your doctor as soon as possible.
If you go to hospital, tell the medical staff that you are taking Zolmitriptan Aurobindo Pharma Italia
.

Children and adolescents
The use of Zolmitriptan Aurobindo Pharma Italiais not recommended in people under the age of 18 years.

Elderly patients
The use of Zolmitriptan Aurobindo Pharma Italiais not recommended in people over the age of 65.
As with other treatments for migraine, overuse of Zolmitriptan Aurobindo Pharma Italia can
cause daily headaches or worsen migraine headaches. If you think this is the case, talk to your
doctor. To solve the problem, you may need to stop taking Zolmitriptan Aurobindo
Pharma Italia .

Other medicines and Zolmitriptan Aurobindo Pharma Italia
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 are taking other triptans other than zolmitriptan, allow 24 hours to pass before taking Zolmitriptan Aurobindo Pharma Italia, and after taking Zolmitriptan Aurobindo Pharma Italia, allow 24 hours to pass before taking any other triptan.
• If you are taking medicines containing ergotamine or ergot derivatives (such as dihydroergotamine or methysergide), allow 24 hours to pass before taking Zolmitriptan Aurobindo Pharma Italia and after taking Zolmitriptan Aurobindo Pharma Italia, allow 6 hours to pass before taking ergotamine or ergot derivatives.

Medicines for depression (see also the section above “Warnings and precautions”)

• Moclobemide or fluvoxamine
• Medicines called SSRIs (selective serotonin reuptake inhibitors)
• Medicines called SNRIs (selective serotonin and 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 that contain St. John's wort (Hypericum perforatum),
they increase the likelihood that you will experience the side effects of Zolmitriptan Aurobindo Pharma Italia .

Zolmitriptan Aurobindo Pharma Italia with food and drink
Zolmitriptan Aurobindo Pharma Italia can be taken with or without food. This does not affect the effectiveness of
Zolmitriptan Aurobindo Pharma Italia .

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether taking Zolmitriptan Aurobindo Pharma Italia during pregnancy is harmful.
Do not breastfeed for the next 24 hours after taking Zolmitriptan Aurobindo Pharma Italia.

Driving and operating machinery
During a migraine attack, reactions may be slower than usual. You should keep this in mind
when driving or using tools or machinery.
It is unlikely that Zolmitriptan Aurobindo Pharma Italia will impair your ability to drive or operate machinery.
However, it is best to wait to see what effects Zolmitriptan Aurobindo Pharma Italia has on
you before engaging in these activities.

Zolmitriptan Aurobindo Pharma Italia contains aspartame
Zolmitriptan Aurobindo Pharma Italia orodispersible tablets contain aspartame, a source of
phenylalanine. It may be harmful if you have phenylketonuria.

• 3.How to take ZolmitriptanAurobindo Pharma Italia

Always take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, ask your doctor or pharmacist.
You can take Zolmitriptan Aurobindo Pharma Italia as soon as a migraine attack begins. You can
also take it once the attack is in progress. The recommended dose is one tablet (2.5 mg or
5 mg). You can take another tablet if the migraine is still present after 2 hours orif it returns
within 24 hours.
If the tablets are not helping your migraine enough, tell your doctor. The doctor
may decide to increase the dose to 5 mg or change the treatment.
Do not take a dose higher than the one prescribed to you.
Do not take more than two doses in one day. If you have been prescribed a 2.5 mg tablet, the
maximum daily dose is 5 mg. If you have been prescribed a 5 mg tablet, the maximum daily dose is
10 mg.
Zolmitriptan Aurobindo Pharma Italia 2.5 mg
The recommended dose is one 2.5 mg tablet (2.5 mg of zolmitriptan) or two 2.5 mg tablets (5 mg
of zolmitriptan).
If the migraine is still present after two hours orif it returns within 24 hours, you can take another
2.5 mg tablet (2.5 mg of zolmitriptan) or two 2.5 mg tablets (5 mg of zolmitriptan).
If the tablets are not helping your migraine enough, tell your doctor. The doctor
may decide to increase the dose of zolmitriptan to 5 mg or change the treatment.
Do not take a dose higher than the one prescribed to you.
Do not take more than two doses in one day. If you have been prescribed a 2.5 mg tablet (2.5 mg of
zolmitriptan), the maximum daily dose is two 2.5 mg tablets (5 mg of zolmitriptan). If you have been
prescribed two 2.5 mg tablets (5 mg of zolmitriptan), the maximum daily dose is four 2.5 mg tablets
(10 mg of zolmitriptan).
Zolmitriptan Aurobindo Pharma Italia 5 mg
The recommended dose is 2.5 mg of zolmitriptan or one 5 mg tablet (5 mg of zolmitriptan). For the lower
dose of zolmitriptan, 2.5 mg, a formulation with a more appropriate active ingredient content is available.
If the migraine is still present after two hours orif it returns within 24 hours, you can take another
tablet.
If the tablet is not helping your migraine enough, tell your doctor. The doctor
may change the treatment.
Do not take a dose higher than the one prescribed to you.
Do not take more than two doses in one day. If you have been prescribed 2.5 mg of zolmitriptan, the
maximum daily dose is one 5 mg tablet (5 mg of zolmitriptan). If you have been prescribed the 5 mg tablet
(5 mg of zolmitriptan), the maximum daily dose is two 5 mg tablets (10 mg of zolmitriptan).

Instructions for use

• 1. Do not push the tablet out of the foil (figure 1).

Figure 1

• 2. Separate a blister cell from the rest of the strip (figure 2).

Figure 2

• 3. Carefully lift the backing foil starting from the corner, as shown by the arrow (figure 3 and 4).

Figure 3

Figure 4

• 4. With dry hands, remove the tablet from the cell and place it on your tongue (figure 5). It will disintegrate rapidly and can be swallowed without water.

Figure 5
If you take more Zolmitriptan Aurobindo Pharma Italia than you should
If you have taken more Zolmitriptan Aurobindo Pharma Italia than prescribed by your doctor, tell
your doctor immediately or go to the nearest hospital. Bring Zolmitriptan Aurobindo Pharma
Italia with you.
When taking too many orodispersible tablets, sedation is among the possible symptoms.
If you have any questions about using this medicine, talk to 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 listed below may be part of the migraine attack itself.

Common side effects (which occur in 1-10 users out of 100):

• Abnormal sensations, such as tingling in the fingers or toes or skin sensitive to touch
• Drowsiness, dizziness or feeling of warmth
• Headache
• Irregular heartbeat
• Feeling of nausea and vomiting
• Stomach pain
• Dry mouth
• Difficulty swallowing
• Muscle weakness or muscle pain
• Feeling of weakness
• Feeling of heaviness, oppression, pain or pressure in the throat, neck, arms or legs, or in the chest.

Uncommon side effects (which occur in 1-10 users out of 1,000):

• Very fast heartbeat
• Slightly high blood pressure
• Increased amount of urine produced or increased frequency of needing to urinate.

Rare side effects (which occur in 1-10 users out of 10,000):

• Allergic/hypersensitivity reactions, including nodular skin reaction (urticaria) and swelling of the face, lips, mouth, tongue and throat. If you think that Zolmitriptan Aurobindo Pharma Italia is causing you an allergic reaction, stop using it and see a doctor immediately.

Very rare side effects (which occur in less than 1 user out of 10,000):

• Angina (chest pain, often triggered by physical activity), heart attack or spasm of the heart's blood vessels. If you experience chest pain or shortness of breath after taking Zolmitriptan Aurobindo Pharma Italia, see a doctor and do not take any more ZolmitriptanAurobindo Pharma Italia .
• Spasm of the blood vessels of the intestine, which can cause damage to the intestine. You may experience stomach pain or diarrhea with blood. If this happens, see a doctor and do not takeany more ZolmitriptanAurobindo Pharma Italia .

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

• 5.How to store ZolmitriptanAurobindo Pharma Italia

Keep out of the sight and reach of children.
Do not use Zolmitriptan Aurobindo Pharma Italia 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 the month.
Do not store above 30°C.
Do not dispose of any medicine in water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ZolmitriptanAurobindo Pharma Italia contains

• The active ingredient is zolmitriptan. Zolmitriptan Aurobindo Pharma Italia orodispersible tablets contain 2.5 mg or 5 mg of zolmitriptan.
• The excipients are: mannitol (E421), calcium silicate, microcrystalline cellulose, aspartame (E951), sodium starch glycolate type A, crospovidone type B, anhydrous colloidal silica, magnesium stearate and orange cream flavour (containing e.g. maltodextrin (corn), acacia (E414), ascorbic acid (E300), butylated hydroxyanisole (E320)). Description of the appearance of Zolmitriptan Aurobindo Pharma Italia and contents of the packZolmitriptan Aurobindo Pharma Italia 2.5 mg orodispersible tablets are white, flat and round tablets, with a diameter of 7.5 mm. Zolmitriptan Aurobindo Pharma Italia 5 mg orodispersible tablets are white, flat and round tablets, with a diameter of 9.5 mm. Zolmitriptan Aurobindo Pharma Italia 2.5 mg and 5 mg orodispersible tablets are supplied in blister packs with a detachable aluminium foil cover, containing 2, 3, 6 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) – Via San Giuseppe 102 – 21047 Saronno (Varese)

Manufacturer
Actavis Ltd. – BLB016 Bulebel Industrial Estate – Zejtun ZTN 3000 Malta

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Belgium Zolmitriptan-instant Actavis 2.5 mg orodispersible tablets
Zolmitriptan-instant Actavis 5 mg orodispersible tablets
Denmark Zolmitriptan Smelt Actavis
Finland Zolmitriptan Actavis 2.5 mg tablet, orally disintegrating
Zolmitriptan Actavis 5 mg tablet, orally disintegrating
Greece Zolmitriptan ODT / Actavis 2.5 mg
Zolmitriptan ODT / Actavis 5 mg
Italy ZOLMITRIPTAN AUROBINDO PHARMA ITALIA 2.5 mg tablets
orodispersible
ZOLMITRIPTAN AUROBINDO PHARMA ITALIA 5 mg tablets
orodispersible
Ireland Zolmilestriptan Actavis 2.5 mg Orodispersible Tablets
Netherlands Zolmitriptan Actavis Disper 2.5 mg
Zolmitriptan Actavis Disper 5 mg
Norway Zolmitriptan Actavis smeltetabletter
Portugal Zolmitriptano Actavis
Sweden Zolmitriptan Actavis
United Kingdom Zolmitriptan 2.5mg Orodispersible Tablets
Zolmitriptan 5mg Orodispersible Tablets