Zolmitriptan Aurobindo Pharma Italia

Package leaflet: Information for the patient

Zolmitriptan Aurobindo Pharma Italia 2.5 mg and 5 mg orodispersible tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to 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 taking 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 Zolmitriptan Aurobindo Pharma Italia is and what it is used for

Zolmitriptan Aurobindo Pharma Italia contains the active substance zolmitriptan and belongs to a group of medicines called triptans.
Zolmitriptan Aurobindo Pharma Italia is used to treat migraine headache.
Migraine symptoms may be caused by the widening of blood vessels in the head. Zolmitriptan Aurobindo Pharma Italia is thought to reduce this widening of blood vessels, thereby helping to relieve headache and other symptoms of a migraine attack, such as discomfort (nausea or vomiting) and sensitivity to light and sound.
Zolmitriptan Aurobindo Pharma Italia works only once a migraine attack has 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 to 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 occurring at rest), or have experienced heart-related symptoms such as shortness of breath or chest tightness
• If you have had a stroke or transient stroke-like symptoms (transient ischemic attack or TIA)
• If you have severe kidney problems
• If you are simultaneously taking certain other medicines for migraine (e.g. ergotamine or ergot derivatives such as dihydroergotamine and methysergide) or other triptan migraine medicines. For further information, see the next section: “Other medicines and Zolmitriptan Aurobindo Pharma Italia”. If you are unsure whether any of these conditions apply to you, consult 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 (reduced blood flow in the heart arteries). Your risk is higher if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has ischemic heart disease
• You have been diagnosed with Wolff-Parkinson-White syndrome (a type of heart rhythm abnormality)
• You have had liver problems
• You experience headaches different from your usual migraine headache
• You are taking other medicines for depression (see “Other medicines and Zolmitriptan Aurobindo Pharma Italia” later in this section).

When Zolmitriptan Aurobindo Pharma Italia is taken together with other medicines of the
SSRI or SNRI type, used to treat depression, there is a risk of developing the so-called
serotonin syndrome. Symptoms may be severe and include chills, hyperactive 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
the dosage needs to be increased, or when another serotoninergic medicine is added. If you
experience any of these symptoms, contact your doctor as soon as possible.
If you go to hospital, inform the medical staff that you are taking Zolmitriptan Aurobindo Pharma Italia.
Children and adolescents
The use of Zolmitriptan Aurobindo Pharma Italia is not recommended in individuals under 18 years of age.
Elderly patients
The use of Zolmitriptan Aurobindo Pharma Italia is not recommended in individuals over 65 years of age.
As with other migraine treatments, excessive use of Zolmitriptan Aurobindo Pharma Italia may
cause daily headaches or worsen migraine headaches. If you think this applies to you, discuss it with your doctor.
To resolve the problem, you may need to stop taking Zolmitriptan Aurobindo Pharma Italia.
Other medicines and Zolmitriptan Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicine. In particular, inform your doctor if you are taking any of the following medicines:
Migraine medicines

• If you are taking other triptans different from zolmitriptan, wait 24 hours before taking Zolmitriptan Aurobindo Pharma Italia, and after taking Zolmitriptan Aurobindo Pharma Italia, wait 24 hours before taking any other triptan.
• If you are taking medicines containing ergotamine or ergot derivatives (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptan Aurobindo Pharma Italia, and after taking Zolmitriptan Aurobindo Pharma Italia, wait 6 hours 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 (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 containing St. John’s wort (Hypericum perforatum),
the likelihood of experiencing side effects from Zolmitriptan Aurobindo Pharma Italia increases.
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, planning to become pregnant, or 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 24 hours after taking Zolmitriptan Aurobindo Pharma Italia.
Driving and using machines
During a migraine attack, your reactions may be slower than usual. Keep this in mind
when driving or operating tools or machinery.
It is unlikely that Zolmitriptan Aurobindo Pharma Italia will impair your ability to drive or operate machinery.
Nevertheless, it is advisable to wait and see how Zolmitriptan Aurobindo Pharma Italia affects you
before engaging in these activities.
Zolmitriptan Aurobindo Pharma Italia contains aspartame
Zolmitriptan Aurobindo Pharma Italia orodispersible tablets contain aspartame, a source of
phenylalanine. This may be harmful if you have phenylketonuria.

3. How to take Zolmitriptan Aurobindo Pharma Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
You may take Zolmitriptan Aurobindo Pharma Italia as soon as your migraine attack begins. You may
also take it once the attack has already started. The recommended dose is one tablet (2.5 mg or 5 mg). You may take another tablet if the migraine is still present after 2 hours or if it returns within 24 hours.
If the tablets are not sufficiently effective for your migraine, inform your doctor. Your doctor
may decide to increase the dose to 5 mg or change the treatment.
Do not use a higher dose than the one prescribed for you.
Do not take more than two doses in a single 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 or if it returns within 24 hours, you may 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 sufficiently effective for your migraine, inform your doctor. Your doctor
may decide to increase the zolmitriptan dose to 5 mg or change the treatment.
Do not use a higher dose than the one prescribed for you.
Do not take more than two doses in a single 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
zolmitriptan dose of 2.5 mg, a formulation with a more suitable active ingredient content is available.
If the migraine is still present after two hours or if it returns within 24 hours, you may take another
tablet.
If the tablet is not sufficiently effective for your migraine, inform your doctor. Your doctor
may change the treatment.
Do not use a higher dose than the one prescribed for you.
Do not take more than two doses in a single 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 a 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 one blister cavity from the rest of the strip (Figure 2).

Figure 2

3. Carefully lift the foil backing starting from the corner, as indicated by the arrow (Figure 3 and 4).

Figure 3

Figure 4

4. With dry hands, remove the tablet from the blister and place it on the 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, inform
your doctor immediately or go to the nearest hospital. Take Zolmitriptan Aurobindo Pharma Italia
with you.
When too many orodispersible tablets are taken, possible symptoms include drowsiness.
If you have any doubts about using this medicine, consult 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 (occur in 1 to 10 users out of 100):

• Abnormal sensations such as tingling in the fingers or toes or skin sensitivity to touch
• Drowsiness, dizziness, or feeling warm
• Headache
• Irregular heartbeat
• Nausea and vomiting
• Stomach ache
• Dry mouth
• Difficulty swallowing
• Muscle weakness or muscle pain
• Feeling weak
• Sensation of heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest.

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

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

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

• Angina (chest pain, often triggered by physical activity), heart attack, or spasm of blood vessels in the heart. If you experience chest pain or shortness of breath after taking Zolmitriptan Aurobindo Pharma Italia, contact your doctor and do not take any further tablets of Zolmitriptan Aurobindo Pharma Italia.
• Spasm of blood vessels in the intestine, which may cause intestinal damage. You may experience stomach pain or diarrhoea with blood. If this occurs, contact your doctor and do not take any further tablets of Zolmitriptan Aurobindo Pharma Italia.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Zolmitriptan Aurobindo Pharma Italia

Keep out of the sight and reach of children.
Do not use Zolmitriptan Aurobindo Pharma Italia after the expiry date stated on the blister and carton after "Exp". The expiry date refers to the last day of the month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zolmitriptan Aurobindo Pharma Italia contains

• The active substance 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 cream-orange flavour (containing, for example, maltodextrin (maize), acacia (E414), ascorbic acid (E300), butylated hydroxyanisole (E320)).

Description of the appearance of Zolmitriptan Aurobindo Pharma Italia and contents of the pack

Zolmitriptan Aurobindo Pharma Italia 2.5 mg orodispersible tablets are white, flat, round tablets with a diameter of 7.5 mm.
Zolmitriptan Aurobindo Pharma Italia 5 mg orodispersible tablets are white, flat, 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 an aluminium peelable lid, 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 European Economic Area Member States under the following names:

Belgium
Zolmitriptan-instant Actavis 2.5 mg orodispergeerbare tabletten
Zolmitriptan-instant Actavis 5 mg orodispergeerbare tabletten

Denmark
Zolmitriptan Smelt Actavis

Finland
Zolmitriptan Actavis 2.5 mg tabletti, suussa hajoava
Zolmitriptan Actavis 5 mg tabletti, suussa hajoava

Greece
Zolmitriptan ODT / Actavis 2.5 mg
Zolmitriptan ODT / Actavis 5 mg

Italy
ZOLMITRIPTAN AUROBINDO PHARMA ITALIA 2.5 mg orodispersible tablets
ZOLMITRIPTAN AUROBINDO PHARMA ITALIA 5 mg orodispersible tablets

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 2.5 mg Orodispersible Tablets
Zolmitriptan 5 mg Orodispersible Tablets