Zolmitriptan Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

ZOLMITRIPTAN DOC Generici 2.5 mg orodispersible 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 they have the same symptoms as yours, because it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ZOLMITRIPTAN DOC Generici is and what it is used for
2. What you need to know before taking ZOLMITRIPTAN DOC Generici
3. How to take ZOLMITRIPTAN DOC Generici
4. Possible side effects
5. How to store ZOLMITRIPTAN DOC Generici
6. Package contents and other information

1. What ZOLMITRIPTAN DOC Generici is and what it is used for

ZOLMITRIPTAN DOC Generici contains the active substance zolmitriptan and belongs to a group of medicines called triptans.
ZOLMITRIPTAN DOC Generici is used to treat migraine attacks.
The symptoms of migraine may be caused by the dilation of blood vessels in the head. ZOLMITRIPTAN DOC Generici is thought to reduce this dilation of blood vessels, thereby helping to relieve headache and other symptoms of migraine attacks, such as nausea or vomiting and sensitivity to light and sound. ZOLMITRIPTAN DOC Generici works only once a migraine attack has started. It does not prevent migraine attacks.

2. What you need to know before taking ZOLMITRIPTAN DOC Generici

Do not take ZOLMITRIPTAN DOC Generici

• 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 ever had heart problems, including heart attack, angina (chest pain triggered by physical exertion or stress), Prinzmetal's angina (chest pain occurring at rest), or if you have experienced symptoms related to heart problems 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 currently taking certain other migraine medications (e.g. ergotamine or ergot-like medicines such as dihydroergotamine and methysergide) or other triptan-based migraine medications. For further information, see "Other medicines and ZOLMITRIPTAN DOC Generici"

If you are unsure whether you fall into any of the above categories, consult your doctor or pharmacist.
Warnings and precautions Talk to your doctor or pharmacist before taking ZOLMITRIPTAN DOC Generici if:

• you are at risk of cardiac ischemia (reduced blood flow in the heart arteries). Your risk is higher if you smoke, have high blood pressure, high cholesterol, diabetes, or if someone in your family has cardiac ischemia
• you have been diagnosed with Wolff-Parkinson-White syndrome (a type of heart rhythm abnormality)
• you have ever had liver problems
• your headache is different from your usual migraine
• you are taking another medicine for depression (see "Taking with other medicines" below)

If you are admitted to hospital, inform the medical staff that you are taking ZOLMITRIPTAN DOC Generici.
ZOLMITRIPTAN DOC Generici is not recommended for people under 18 years of age or over 65.
Like other migraine treatments, excessive use of ZOLMITRIPTAN DOC Generici may cause daily headaches or may worsen your migraines. Ask your doctor if you think this may apply to you. You may need to stop using ZOLMITRIPTAN DOC Generici to resolve the problem.
Taking ZOLMITRIPTAN DOC Generici during the aura phase (the period preceding headache) to prevent migraine development is not recommended. You should take the medicine once the migraine headache has started.
Other medicines and ZOLMITRIPTAN DOC Generici
Inform 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 besides ZOLMITRIPTAN DOC Generici, wait 24 hours before taking ZOLMITRIPTAN DOC Generici
• after taking ZOLMITRIPTAN DOC Generici, wait 24 hours before taking other triptans different from ZOLMITRIPTAN DOC Generici
• if you are taking medicines containing ergotamine or ergot-like medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking ZOLMITRIPTAN DOC Generici
• after taking ZOLMITRIPTAN DOC Generici, wait 6 hours before taking ergotamine or ergot-like medicines

Medicines for depression

• 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 take herbal remedies containing St. John's wort (Hypericum perforatum), you may be more likely to experience side effects from ZOLMITRIPTAN DOC Generici.
ZOLMITRIPTAN DOC Generici with food and drinks
You may take ZOLMITRIPTAN DOC Generici with or without food. It does not affect the efficacy of ZOLMITRIPTAN DOC Generici.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
It is not known whether using ZOLMITRIPTAN DOC Generici during pregnancy is harmful.
Do not breastfeed within 24 hours after taking ZOLMITRIPTAN DOC Generici.
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.
ZOLMITRIPTAN DOC Generici is unlikely to affect your ability to drive or use tools or machinery. However, it is advisable to check how ZOLMITRIPTAN DOC Generici affects you before attempting these activities.
ZOLMITRIPTAN DOC Generici contains aspartame
ZOLMITRIPTAN DOC Generici orodispersible tablets contain aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.

3. How to take ZOLMITRIPTAN DOC Generici

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You may take ZOLMITRIPTAN DOC Generici as soon as your migraine attack starts. You may also take it while the attack is ongoing.
The usual dose is one 2.5 mg tablet (2.5 mg of zolmitriptan) or two 2.5 mg tablets (5 mg of zolmitriptan).
You may take another tablet if the migraine is still present after two hours or if it returns within 24 hours.
Inform your doctor if the tablets have not provided sufficient relief from your migraine. Your doctor may increase the dose to 5 mg of zolmitriptan or change your treatment.
Do not take a higher dose than the one prescribed for you.
Do not take more than two doses in one 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).

Instructions for use

1. Open the blister by peeling it. Do not push the tablet through the foil.
2. Place the tablet on your tongue, where it will dissolve and be swallowed with saliva. It is not necessary to take a sip of water to swallow the tablet.

If you take more ZOLMITRIPTAN DOC Generici than you should
If you have taken more ZOLMITRIPTAN DOC Generici than prescribed by your doctor, inform your doctor or go immediately to the nearest hospital. Take the pack of ZOLMITRIPTAN DOC Generici with you.
If you have any further questions about the use of 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 manifestations of the migraine attack itself.

Common side effects (may affect up to 1 in 10 people):
• Altered sensation such as tingling in the fingers of the hands and feet or skin sensitivity to touch
• Drowsiness, dizziness or feeling warm
• Headache
• Irregular heartbeat
• Nausea, vomiting
• Stomach ache
• Dry mouth
• Muscle weakness or muscle pain
• Feeling weak
• Heaviness, tightness, pain or pressure in the throat, neck, arms, legs or chest
• Difficulty swallowing

Uncommon side effects (may affect up to 1 in 100 people):
• Very rapid heartbeat
• Slight increase in blood pressure
• Increased amount of urine produced or increased frequency of urination

Rare side effects (may affect up to 1 in 1,000 people):
• Allergic/hypersensitivity reactions including hives and swelling of the face, lips, mouth, tongue and throat. If you think ZOLMITRIPTAN DOC Generici is causing you an allergic reaction, stop taking it and contact your doctor immediately.

Very rare side effects (may affect up to 1 in 10,000 people):
• Angina (chest pain, often occurring during exertion), heart attack or spasm of the blood vessels of the heart. If you experience chest pain or shortness of breath after taking ZOLMITRIPTAN DOC Generici, contact your doctor and do not take any further doses of ZOLMITRIPTAN DOC Generici.
• Spasms of the blood vessels of the intestine, which may damage the intestine. You may experience stomach pain or bloody diarrhoea. If this occurs, contact your doctor and do not take any further doses of ZOLMITRIPTAN DOC Generici.

Reporting of side effects
If you get any side effects, including ones 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging 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 any medicine 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 DOC Generici contains

• The active substance is zolmitriptan. ZOLMITRIPTAN DOC Generici orodispersible tablets contain 2.5 mg of zolmitriptan.
• The other components are: mannitol (E421), magnesium aluminium metasilicate, low-substituted hydroxypropyl cellulose, aspartame (E951), sodium lauryl sulfate, butyl methacrylate copolymer, talc, anhydrous colloidal silica, magnesium stearate, mint flavour (containing, for example, maltodextrin, natural flavours, modified starch).

Description of the appearance of ZOLMITRIPTAN DOC Generici and package contents
ZOLMITRIPTAN DOC Generici 2.5 mg orodispersible tablets are flat, white to off-white, round tablets, 5.5 mm in diameter, with "2.5" engraved on one side and a characteristic mint flavour.
ZOLMITRIPTAN DOC Generici 2.5 mg orodispersible tablets are supplied in peelable blisters containing 2, 3, 6 or 9 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy

Manufacturer responsible for batch release
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
or
Rafarm SA
8 Kapodistriou & 12 Korinthou str
GR-154 51 Neo Psihico
Athens
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Sweden: Zolmitriptan Jubilant
United Kingdom: Zolmitriptan
Netherlands: Zolmitriptan Jubilant
Italy: ZOLMITRIPTAN DOC Generici

PATIENT INFORMATION LEAFLET

ZOLMITRIPTAN DOC Generici 2.5 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

4. What ZOLMITRIPTAN DOC Generici is and what it is used for

ZOLMITRIPTAN DOC Generici contains zolmitriptan and belongs to a group of medicines known as triptans.
ZOLMITRIPTAN DOC Generici is used to treat migraine attacks.
The symptoms of migraine may be caused by the dilation of blood vessels in the head. ZOLMITRIPTAN DOC Generici is thought to reduce the dilation of these blood vessels. This helps relieve headache and other symptoms of migraine attacks, such as nausea or vomiting and sensitivity to light and sound. ZOLMITRIPTAN DOC Generici works only once a migraine attack has started. It does not prevent the attack.

5. What you need to know before taking ZOLMITRIPTAN DOC Generici

Do not take ZOLMITRIPTAN DOC Generici

• 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 ever had heart problems, including heart attack, angina (chest pain brought on by physical exertion or stress), Prinzmetal's angina (chest pain occurring at rest), or if you have experienced symptoms related to heart problems such as shortness of breath or chest tightness
• if you have had a stroke or brief stroke-like symptoms (transient ischemic attack or TIA)
• if you have severe kidney problems
• if you are currently taking certain other migraine medications (e.g. ergotamine or ergot-like medicines such as dihydroergotamine and methysergide) or other triptan-based migraine medications. For further information, see "Other medicines and ZOLMITRIPTAN DOC Generici".

If you are unsure whether you fall into any of the above categories, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking ZOLMITRIPTAN DOC Generici if:

• you are at risk of heart ischemia (reduced blood flow in the heart arteries). Your risk is higher if you smoke, have high blood pressure, high cholesterol, diabetes, or if someone in your family has heart ischemia
• you have been diagnosed with Wolff-Parkinson-White syndrome (a type of heart rhythm abnormality)
• you have ever had liver problems
• your headache is different from your usual migraine
• you are taking another medicine for depression (see "Taking with other medicines" below).

If you are admitted to hospital, inform medical staff that you are taking ZOLMITRIPTAN DOC Generici.
ZOLMITRIPTAN DOC Generici is not recommended for people under 18 years of age or over 65.
Like other migraine treatments, excessive use of ZOLMITRIPTAN DOC Generici may cause daily headaches or may worsen your migraines. Ask your doctor if you think this may apply to you. You may need to stop using ZOLMITRIPTAN DOC Generici to resolve the problem.
Taking ZOLMITRIPTAN DOC Generici during the aura phase (the period preceding the headache) to prevent the onset of migraine is not recommended. You should take the medicine once the migraine headache has started.
Other medicines and ZOLMITRIPTAN DOC Generici
Inform 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 medications

• if you are taking other triptans different from ZOLMITRIPTAN DOC Generici, wait 24 hours before taking ZOLMITRIPTAN DOC Generici
• after taking ZOLMITRIPTAN DOC Generici, wait 24 hours before taking other triptans different from ZOLMITRIPTAN DOC Generici
• if you are taking medicines containing ergotamine or ergot-like medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking ZOLMITRIPTAN DOC Generici
• after taking ZOLMITRIPTAN DOC Generici, wait 6 hours before taking ergotamine or ergot-like medicines.

Medicines for depression

• 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), you may be more likely to experience side effects from ZOLMITRIPTAN DOC Generici.
ZOLMITRIPTAN DOC Generici with food and drink
You may take ZOLMITRIPTAN DOC Generici with or without food. It does not affect the effectiveness of ZOLMITRIPTAN DOC Generici.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
It is not known whether the use of ZOLMITRIPTAN DOC Generici during pregnancy is harmful.
Do not breastfeed within 24 hours after taking ZOLMITRIPTAN DOC Generici.
Driving and using machines
During a migraine attack, your reactions may be slower than usual. Keep this in mind when driving or operating machinery or tools.
ZOLMITRIPTAN DOC Generici is unlikely to affect your ability to drive or use tools or machinery. However, it is advisable to assess how ZOLMITRIPTAN DOC Generici affects you before attempting these activities.
ZOLMITRIPTAN DOC Generici contains lactose If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

6. How to take ZOLMITRIPTAN DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

You may take ZOLMITRIPTAN DOC Generici as soon as your migraine attack starts, or while the attack is ongoing.

• The usual dose is one tablet of 2.5 mg (2.5 mg of zolmitriptan) or two tablets of 2.5 mg (5 mg of zolmitriptan).
• Swallow the tablet whole with a glass of water.
• You may take another tablet if the migraine persists after two hours or if it returns within 24 hours.

Inform your doctor if the tablets have not provided sufficient relief during your migraine attack. Your doctor may increase the dose to 5 mg of zolmitriptan or change your treatment.

Do not take a higher dose than the one prescribed for you.
Do not take more than two doses in one day.
If you have been prescribed one tablet of 2.5 mg (2.5 mg of zolmitriptan), the maximum daily dose is two tablets of 2.5 mg (5 mg of zolmitriptan).
If you have been prescribed two tablets of 2.5 mg (5 mg of zolmitriptan), the maximum daily dose is four tablets of 2.5 mg (10 mg of zolmitriptan).

If you take more ZOLMITRIPTAN DOC Generici than you should
If you have taken more ZOLMITRIPTAN DOC Generici than your doctor has prescribed, inform your doctor or go immediately to the nearest hospital. Take the pack of ZOLMITRIPTAN DOC Generici with you.

If you have any further questions about the use of 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 related to the migraine attack itself.

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

• Very fast heartbeat
• Slight increase in blood pressure
• Increased amount of urine produced or increased frequency of urination

Rare side effects (may affect up to 1 in 1,000 people):

• Allergic/hypersensitivity reactions including hives and swelling of the face, lips, mouth, tongue and throat. If you think ZOLMITRIPTAN DOC Generici is causing you an allergic reaction, stop taking it and contact your doctor immediately.

Very rare side effects (may affect up to 1 in 10,000 people):

• Angina (chest pain, often occurring during exertion), heart attack or spasm of the blood vessels of the heart. If you experience chest pain or shortness of breath after taking ZOLMITRIPTAN DOC Generici, contact your doctor and do not take any further doses of ZOLMITRIPTAN DOC Generici.
• Spasms of the intestinal blood vessels, which may damage the intestine. You may experience stomach pain or bloody diarrhoea. If this occurs, contact your doctor and do not take any further doses of ZOLMITRIPTAN DOC Generici.

Reporting of side effects
If you experience 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 DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 any medicine 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 DOC Generici contains

• The active substance is zolmitriptan. ZOLMITRIPTAN DOC Generici film-coated tablets contain 2.5 mg of zolmitriptan.
• The other components are: lactose (anhydrous), microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol, and red iron oxide (E172).

Description of the appearance of ZOLMITRIPTAN DOC Generici and pack sizes
ZOLMITRIPTAN DOC Generici 2.5 mg film-coated tablets are film-coated, pale pink, round tablets, 7.1 mm in diameter, with '2.5' engraved on one side and smooth on the other.
ZOLMITRIPTAN DOC Generici 2.5 mg is supplied in blisters containing 2, 3, 6 or 9 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy

Manufacturer responsible for batch release
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
or
Rafarm SA
8 Kapodistriou & 12 Korinthou str
GR-154 51 Neo Psihico
Athens
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Sweden: Zolmitriptan Jubilant
United Kingdom: Zolmitriptan
Netherlands: Zolmitriptan Jubilant
Italy: ZOLMITRIPTAN DOC Generici