Zolmitriptan Aurobindo

Package leaflet: Information for the patient

Zolmitriptan Aurobindo 2.5 mg and 5 mg film-coated tablets

Generic medicine
Please read 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, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Zolmitriptan Aurobindo contains zolmitriptan and belongs to a group of medicines called triptans.
Zolmitriptan Aurobindo is used to treat migraine headache.
Migraine symptoms may be caused by the widening of blood vessels in the head.
Zolmitriptan Aurobindo is thought to reduce this dilation of blood vessels. This helps relieve headache and other symptoms of a migraine attack, such as discomfort (nausea or vomiting) and sensitivity to light and sound.
Zolmitriptan Aurobindo works only once a migraine attack has started. It does not help prevent an attack.

2. Before taking Zolmitriptan Aurobindo

Do not take Zolmitriptan Aurobindo

• 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 brief stroke-like symptoms (transient ischaemic attack or TIA)
• If you have severe kidney problems
• If you are currently taking certain other medicines for migraine (e.g. ergotamine or ergot derivatives such as dihydroergotamine and methysergide) or other triptan medicines for migraine. For further information, see the next section: “Other medicines and Zolmitriptan Aurobindo”. 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 if:

• You are at risk of developing ischaemic 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 ischaemic 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 the section “Other medicines and Zolmitriptan Aurobindo” below in this section).

When Zolmitriptan Aurobindo is taken together with other medicines of the SSRI or SNRI type used to treat depression, there is a risk of developing so-called serotonin syndrome. Symptoms may 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 the dose 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.

Children and adolescents
The use of Zolmitriptan Aurobindo is not recommended in individuals under 18 years of age.

Elderly patients
The use of Zolmitriptan Aurobindo is not recommended in individuals over 65 years of age.

As with other migraine treatments, excessive use of Zolmitriptan Aurobindo may cause daily headaches or worsen migraine headaches. If you think this may apply to you, discuss it with your doctor. Resolving the problem may require you to stop taking Zolmitriptan Aurobindo.

Other medicines and Zolmitriptan Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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. After taking Zolmitriptan Aurobindo, 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. After taking Zolmitriptan Aurobindo, wait 6 hours before taking ergotamine or ergot derivatives.

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

• Moclobemide or fluvoxamine
• Medicines called SSRIs (selective serotonin reuptake inhibitors)
• 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 such as St John's wort (Hypericum perforatum), you may have an increased risk of experiencing side effects from Zolmitriptan Aurobindo.

Zolmitriptan Aurobindo with food and drink

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

It is not known whether taking Zolmitriptan Aurobindo during pregnancy could be harmful.

Do not breastfeed for 24 hours after taking Zolmitriptan Aurobindo.

Driving and using machines

During a migraine attack, your reactions may be slowed. You should bear this in mind when driving or using tools or machinery.

It is unlikely that Zolmitriptan Aurobindo will affect your ability to drive or use machines. However, it is advisable to wait and see how Zolmitriptan Aurobindo affects you before engaging in such activities.

Zolmitriptan Aurobindo contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Zolmitriptan Aurobindo

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 as soon as your migraine attack starts. You may also take it some time
after the attack has begun.
The recommended dose is one tablet (2.5 or 5 mg).
If your migraine is still present after two hours or if it returns within 24 hours, you may take another
tablet.
If the tablets do not provide sufficient relief for your migraine, inform your doctor. Your doctor
may decide to increase the dose to 5 mg or change your 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 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 your 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 do not provide sufficient relief for your migraine, inform your doctor. Your doctor
may decide to increase the zolmitriptan dose to 5 mg or change your 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 one 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 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 your migraine is still present after two hours or if it returns within 24 hours, you may take another
tablet.
If the tablet does not provide sufficient relief for your migraine, inform your doctor. Your doctor
may change your 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 the 5 mg tablet (5 mg of zolmitriptan), the maximum daily dose is two 5 mg tablets (10 mg of zolmitriptan).

Swallow the tablet with a glass of water.

If you take more Zolmitriptan Aurobindo than you should
If you have taken more Zolmitriptan Aurobindo than prescribed, inform your doctor immediately
or go to the nearest hospital. Take Zolmitriptan Aurobindo with you.
Taking too many tablets may cause symptoms such as sedation.

If you have any doubts about how to use 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 (affect 1 to 10 users in 100):

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

Uncommon side effects (affect 1 to 10 users in 1,000):

• Very fast heartbeat
• Slight increase in blood pressure
• Increased amount of urine produced or increased need to urinate

Rare side effects (affect 1 to 10 users in 10,000):

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

Very rare side effects (affect less than 1 user in 10,000):

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

Reporting of side effects
If you get any side effects, 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 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 Zolmitriptan Aurobindo

Keep out of the sight and reach of children.
Do not use Zolmitriptan Aurobindo after the expiry date stated on the carton after “Exp”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zolmitriptan Aurobindo contains

• The active substance is zolmitriptan. Zolmitriptan Aurobindo film-coated tablets contain 2.5 mg or 5 mg of zolmitriptan.
• The other components are: tablet core: lactose (anhydrous), microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate; tablet coating: hypromellose (E464), titanium dioxide (E171), polydextrose, talc, maltodextrin, medium-chain triglycerides, yellow iron oxide (E172) and black iron oxide (E172) (only for 2.5 mg) or red iron oxide (E172) (only for 5 mg).

Description of the appearance of Zolmitriptan Aurobindo and pack sizes
Zolmitriptan Aurobindo 2.5 mg film-coated tablets are light yellow, round, biconvex tablets with the imprint ‘ZL 2.5’ on one side.
Zolmitriptan Aurobindo 5 mg film-coated tablets are light pink, round, biconvex tablets with the imprint ‘ZL 5’ on one side.
Zolmitriptan Aurobindo 2.5 mg and 5 mg are supplied in blister packs containing 3, 6, 12 or 18 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l. – via S. Giuseppe 102, Saronno (VA) - 21047 Italy

Manufacturer
Aurobindo Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium Zolmitriptan Actavis 2.5 mg filmomhulde tabletten
Zolmitriptan Actavis 5 mg filmomhulde tabletten
Denmark Zolmitriptan Actavis
Finland Zolmitriptan Actavis 2.5 mg tabletti, kalvopäällysteinen
Zolmitriptan Actavis 5 mg tabletti, kalvopäällysteinen
Italy Zolmitriptan Actavis
Norway Zolmitriptan Actavis
Portugal Zolmitriptano Actavis
Sweden Zolmitriptan Actavis
United Kingdom Zolmitriptan 2.5 mg Film coated tablets
Zolmitriptan 5 mg Film coated tablets

This patient information leaflet was last approved on