ZOLMITRIPTAN 2.5 MG Orodispersible tablet

Зміст інструкції

1. ZOLMITRIPTAN DOC Generici 2.5 mg orodispersible tablets
   1. What is ZOLMITRIPTAN DOC Generici 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
2. ZOLMITRIPTAN DOC Generici 2.5 mg coated tablets
   1. What is ZOLMITRIPTAN DOC Generici 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

ZOLMITRIPTAN DOC Generici 2.5 mg orodispersible tablets

Generic medicine
Read this leaflet carefully before 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 they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell 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 you take 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

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

ZOLMITRIPTAN DOC Generici contains zolmitriptan and belongs to a group of medicines called
triptans.
ZOLMITRIPTAN DOC Generici is used for the treatment of migraine.
The symptoms of migraine may be caused by the dilation of blood vessels in the head. It is believed
that ZOLMITRIPTAN DOC Generici reduces the dilation of these blood vessels. This helps to eliminate
the headache and other symptoms of a migraine attack, such as nausea or vomiting and hypersensitivity to
light and noise. ZOLMITRIPTAN DOC Generici only works at the beginning of a migraine attack. It does
not prevent the attack.

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 caused by exercise or exertion), Prinzmetal's angina (chest pain that occurs at rest) or if you have had symptoms related to the heart such as shortness of breath or a feeling of oppression in the chest
• if you have had a stroke or symptoms of short duration similar to a stroke (transient ischemic attack or TIA)
• if you have severe kidney problems
• if you are taking certain other medicines for migraine at the same time (e.g. ergotamine or medicines similar to ergot such as dihydroergotamine and methysergide) or other triptan-based medicines for migraine. For more information, see “Other medicines and ZOLMITRIPTAN DOC Generici”

If you are not sure if you are in any of the conditions described above, ask your doctor or pharmacist.

Warnings and precautionsTalk to your doctor or pharmacist before taking ZOLMITRIPTAN DOC
Generici if:

• you are at risk of heart ischemia (poor blood flow in the arteries of the heart). The risk for you is greater if you smoke, if you have high blood pressure, if you have high cholesterol, diabetes or if someone in your family has heart ischemia
• you have been told you have 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 the treatment of depression (see “Taking with other medicines” below).

If you are hospitalized, tell 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.
As with other migraine treatments, excessive use of ZOLMITRIPTAN DOC Generici can cause daily
headaches or can worsen your migraines. Ask your doctor if you think this is your
case. 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 development of migraine is not recommended. You should take the medicine when
the migraine headache has started.

Other medicines and ZOLMITRIPTAN DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine. 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 DOC Generici, allow 24 hours to pass before taking ZOLMITRIPTAN DOC Generici
• After taking ZOLMITRIPTAN DOC Generici allow 24 hours to pass before taking other triptans other than 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 use herbal remedies based on St. John's wort ( Hypericum perforatum), you are more likely to
experience side effects of ZOLMITRIPTAN DOC Generici.

ZOLMITRIPTAN DOC Generici with food and drink
You can take ZOLMITRIPTAN DOC Generici with or without food. It has no influence on the effectiveness of
ZOLMITRIPTAN DOC Generici.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
It is not known whether the use of ZOLMITRIPTAN DOC Generici during pregnancy is harmful.
Do not breastfeed for 24 hours after taking ZOLMITRIPTAN DOC Generici.

Driving and operating machinery
During a migraine attack your reactions may be slower than usual. Keep this in mind
when driving or using any kind of tool or machinery.
It is unlikely that ZOLMITRIPTAN DOC Generici will affect your ability to drive or
operate tools or machinery. However, it is best to check how ZOLMITRIPTAN DOC Generici affects
you, before you attempt to perform these activities.

ZOLMITRIPTAN DOC Generici contains aspartame
ZOLMITRIPTAN DOC Generici orodispersible tablets contains aspartame, a source of phenylalanine.
This may be harmful to people with phenylketonuria.

3. How to take ZOLMITRIPTAN DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
You can take ZOLMITRIPTAN DOC Generici as soon as the migraine attack starts. You can also take it
when the attack is in progress.
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 can take another tablet if the migraine is still present after two hours orif it recurs within 24
hours.
Tell your doctor if the tablets have not helped you sufficiently with the migraine. The doctor may
increase the dose to 5 mg of zolmitriptan or change your therapy.
Do not take a dose higher than the one prescribed to you.
Do not take more than two doses in a 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).

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. You do not need 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 your doctor has prescribed, tell your doctor or
go immediately to the nearest hospital. Bring the ZOLMITRIPTAN DOC Generici package with you.
If you have further questions about the use of this medicine, ask 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
pins and needles in the fingers of hands and feet or skin sensitivity to touch.

• Feeling of drowsiness, dizziness or heat
• Headache
• Irregular heartbeat
• Feeling of nausea, vomiting
• Stomach pain
• Dry mouth
• Muscle weakness or muscle pain
• Feeling of weakness
• Heaviness, tightness, pain or pressure in the throat, neck, arms and legs or chest
• Difficulty swallowing

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

• Very fast heartbeat
• Slightly increased blood pressure
• Increased amount of urine produced or 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 andtell 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 heart's blood vessels. If you notice chest pain or shortness of breath after taking ZOLMITRIPTAN DOC Generici, tellyour doctor and do not take any more doses of ZOLMITRIPTAN DOC Generici.
• Spasms of the blood vessels of the intestine, which can damage the intestine. You may notice stomach pain or bloody diarrhea. If this happens, tell your doctor and do not take any more doses ofZOLMITRIPTAN DOC Generici.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 which is reported on the packaging after EXP. The date
of expiry refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What ZOLMITRIPTAN DOC Generici contains

• The active ingredient is zolmitriptan. ZOLMITRIPTAN DOC Generici orodispersible tablets contain 2.5 mg of zolmitriptan.
• The other ingredients are: mannitol (E421), aluminium magnesium metasilicate, low substituted hydroxypropyl cellulose, aspartame (E951), sodium lauryl sulfate, butyl methacrylate basic copolymer, talc, anhydrous colloidal silica, magnesium stearate, mint flavour (containing e.g. maltodextrin, natural flavourings, 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” embossed on one side, with a characteristic aroma.
ZOLMITRIPTAN DOC Generici 2.5 mg orodispersible tablets are in peelable blisters containing 2, 3, 6
or 9 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milano

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 authorised in the Member States of the European Economic Area with the following
names:
Sweden: Zolmitriptan Jubilant
United Kingdom: Zolmitriptan
Netherlands: Zolmitriptan Jubilant
Italy: ZOLMITRIPTAN DOC Generici

ZOLMITRIPTAN DOC Generici 2.5 mg coated tablets

Generic medicine
Read this leaflet carefully before 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 7. What ZOLMITRIPTAN DOC Generici is and what it is used for
• 8. What you need to know before you take ZOLMITRIPTAN DOC Generici
• 9. How to take ZOLMITRIPTAN DOC Generici
• 10. Possible side effects
• 11. How to store ZOLMITRIPTAN DOC Generici
• 12. Contents of the pack and other information

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

ZOLMITRIPTAN DOC Generici contains zolmitriptan and belongs to a group of drugs called
triptans.
ZOLMITRIPTAN DOC Generici is used for the treatment of migraine.
The symptoms of migraine may be caused by the dilation of blood vessels in the head. It is believed
that ZOLMITRIPTAN DOC Generici reduces the dilation of these blood vessels. This helps to eliminate
the headache and other symptoms of a migraine attack, such as nausea or vomiting and hypersensitivity to
light and noise. ZOLMITRIPTAN DOC Generici only works at the beginning of a migraine attack. 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 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 caused by exercise or exertion), Prinzmetal's angina (chest pain that occurs at rest) or if you have had symptoms related to the heart such as shortness of breath or a feeling of tightness in the chest
• if you have had a stroke or symptoms of a short-term stroke-like condition (transient ischemic attack or TIA)
• if you have severe kidney problems
• if you are taking certain other medicines for migraine at the same time (e.g. ergotamine or medicines similar to ergot such as dihydroergotamine and methysergide) or other triptan-based medicines for migraine. For more information, see “Other medicines and ZOLMITRIPTAN DOC Generici”.

If you are not sure if any of the above conditions apply to you, ask 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 (poor blood flow to the arteries of the heart). The risk for you is greater if you smoke, if you have high blood pressure, if you have high cholesterol, diabetes or if someone in your family has heart ischemia
• you have been told you have 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 to treat depression (see “Taking with other medicines” below).

If you are admitted to hospital, tell the medical staff that you are taking ZOLMITRIPTAN DOC
Generici.
ZOLMITRIPTAN DOC Generici is not recommended for people under the age of 18 or over 65.
As with other migraine treatments, excessive use of ZOLMITRIPTAN DOC Generici can cause daily
headaches or may worsen your migraines. Ask your doctor if you think this is the case. 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 development of a migraine is not recommended. You should take the medicine when
the migraine headache has started.

Other medicines and ZOLMITRIPTAN DOC Generici
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 DOC Generici, allow 24 hours to pass before taking ZOLMITRIPTAN DOC Generici
• After taking ZOLMITRIPTAN DOC Generici, allow 24 hours to pass before taking other triptans other than 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 are more likely to
experience side effects of ZOLMITRIPTAN DOC Generici.

ZOLMITRIPTAN DOC Generici with food and drink
You can take ZOLMITRIPTAN DOC Generici with or without food. It has no influence on the effectiveness of
ZOLMITRIPTAN DOC Generici.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
It is not known whether the use of ZOLMITRIPTAN DOC Generici during pregnancy is harmful.
Do not breastfeed for 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 using any kind of tool or machinery.
It is unlikely that ZOLMITRIPTAN DOC Generici will affect your ability to drive or
use tools or machinery. However, it is best to check how ZOLMITRIPTAN DOC Generici affects
you before you attempt to perform these activities.

ZOLMITRIPTAN DOC Generici contains lactoseIf your doctor has told you that you have an intolerance to
certain sugars, contact your doctor before taking this medicine.

6. How to take ZOLMITRIPTAN DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
You can take ZOLMITRIPTAN DOC Generici as soon as the migraine attack begins. You can also take it
when the attack is in progress.

• The usual dose is one 2.5 mg tablet (2.5 mg of zolmitriptan) or two 2.5 mg tablets (5 mg of zolmitriptan).
• Swallow the tablet whole with a sip of water
• You can take another tablet if the migraine is still present after two hours orif it recurs within 24 hours.

Inform your doctor if the tablets have not helped you sufficiently with the migraine. The doctor may
increase the dose to 5 mg of zolmitriptan or change your therapy.
Do not take a dose higher than the one prescribed to you.
Do not take more than two doses in a 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).

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. Bring the ZOLMITRIPTAN DOC Generici package with you.
If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 hands and feet or skin sensitivity to touch.
• Feeling of drowsiness, dizziness or warmth
• Headache
• Irregular heartbeat
• Feeling of nausea, vomiting
• Stomach pain
• Dry mouth
• Muscle weakness or muscle pain
• Feeling of weakness
• Heaviness, constriction, pain or pressure in the throat, neck, arms and legs or chest
• Difficulty swallowing

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

• Very rapid heartbeat
• Slightly increased blood pressure
• Increased amount of urine produced or 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 that ZOLMITRIPTAN DOC Generici is causing you an allergic reaction, stop taking it andtell 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 heart's blood vessels. If you experience chest pain or shortness of breath after taking ZOLMITRIPTAN DOC Generici, tellyour doctor and do not take any more doses of ZOLMITRIPTAN DOC Generici.
• Spasms of the blood vessels in the intestine, which can damage the intestine. You may notice stomach pain or bloody diarrhea. If this happens, tell your doctor and do not take any more doses ofZOLMITRIPTAN DOC Generici.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through
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 sight and reach of children
Do not use this medicine after the expiry date which is stated on the package and on the blister after SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ZOLMITRIPTAN DOC Generici contains

• The active ingredient is zolmitriptan. ZOLMITRIPTAN DOC Generici film-coated tablets contain 2.5 mg of zolmitriptan.
• The other ingredients 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 contents of the pack
ZOLMITRIPTAN DOC Generici 2.5 mg film-coated tablets are film-coated tablets, of
pale pink colour, round, with a diameter of 7.1 mm with ‘2.5’ imprinted on one side and smooth on the other side.
ZOLMITRIPTAN DOC Generici 2.5 mg is packaged in blisters of 2, 3, 6 or 9 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milano

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 authorised in the Member States of the European Economic Area with the following
names:
Sweden: Zolmitriptan Jubilant
United Kingdom: Zolmitriptan
Netherlands: Zolmitriptan Jubilant
Italy: ZOLMITRIPTAN DOC Generici