Prospect: Information for the user

Zolmitriptan Flas Stada 5 mg buccal dispersible tablets EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• Ifyouexperienceadverse effects, consultyour doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1.What is Zolmitriptan Flas Stada and how is it used

2.What you need to know before starting to take Zolmitriptan Flas Stada

3.How to take Zolmitriptan Flas Stada

4.Adverse effects

5.Storage of Zolmitriptan Flas Stada

6.Contents of the package and additional information

Zolmitriptán Flas Stada contains zolmitriptan and belongs to a group of medicines called triptans.

Zolmitriptan is used totreat migraine headache.

?The symptoms of migraine may be caused by a dilation of blood vessels in the head. It is believed that zolmitriptan reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as nausea or vomiting (nausea or vomiting) and sensitivity to light and sound.

?Zolmitriptan acts only when a migraine attack has started. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Flas Stada if:

• You are allergic to zolmitriptán, mentol or any of the other components of this medication (listed in section 6).
• You have high blood pressure.
• You have had any heart problems, including a heart attack, angina (chest pain caused by exercise or effort), angina of Prinzmetal (chest pain that occurs at rest) or have experienced symptoms related to the heart such as shortness of breath or pressure on the chest.
• You have had a stroke or symptoms similar to a stroke (transient ischemic attack or TIA).
• You have severe kidney problems.
• You are taking other medications for migraine (e.g., ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other medications for migraine in the triptan group. For additional information, see the next section: “Other medications and Zolmitriptán Flas Stada”.

If you are unsure whether any of this applies to you, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor before taking Zolmitriptán Flas Stada if:

• You have a risk of ischemic heart disease (insufficient blood flow to the heart arteries). The 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 told that you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).
• You have had any liver problems.
• You experience headaches other than your usual migraine headache.
• You are taking any other medication for the treatment of depression (see “Other medications and Zolmitriptán Flas Stada” later in this section).

If you are admitted to a hospital, inform the medical staff that you are taking zolmitriptán.

Zolmitriptán is not recommended for people under 18 years or over 65 years.

Like other migraine treatments, excessive use of zolmitriptán may cause daily headaches or worsening of your migraine headaches.

Consult your doctor if you think this is your case. You may need to stop using zolmitriptán to correct the problem.

Other medications and Zolmitriptán Flas Stada

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

Especially, inform your doctor if you are taking any of the following medications:

Migraine medications

• If you take other triptans different from zolmitriptán, wait 24 hours before taking zolmitriptán.
• After taking zolmitriptán, wait 24 hours before taking other triptans different from zolmitriptán.
• If you take medications containing ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), wait 24 hours before taking zolmitriptán.
• After taking zolmitriptán, wait 6 hours before taking ergotamine or ergot-type medications.

Depression medications

• moclobemida or fluvoxamina
• Medications called SSRIs (selective serotonin reuptake inhibitors)
• Medications called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxina, duloxetina

Other medications

• cimetidina (for indigestion or stomach ulcers)
• an antibiotic in the quinolone group (such as ciprofloxacino)

If you are using herbal medicinal preparations containing St. John's Wort (Hypericum perforatum), it may be more likely that zolmitriptán side effects will occur.

Taking Zolmitriptán Flas Stada with food and drinks

You can take zolmitriptán with or without food. This does not affect how zolmitriptán works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

• The safety of taking zolmitriptán during pregnancy is unknown. Before taking zolmitriptán, inform your doctor if you are pregnant or trying to become pregnant.
• Avoid breastfeeding within 24 hours after taking zolmitriptán.

Driving and operating machinery

• During a migraine crisis, your reactions may be slower than usual. Be aware of this when driving or using tools or machinery.
• It is unlikely that zolmitriptán will affect driving or operating tools or machinery. However, it is best to wait and see how zolmitriptán affects you before attempting these activities.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

You can take zolmitriptán as soon as a migraine headache begins. You can also take it once a headache has started.

• The usual dose is one tablet (2.5 mg or 5 mg).
• Place the tablet on your tongue, where it will dissolve and be swallowed with saliva. You do not need to drink water to swallow your tablet.
• You can take another tablet after two hours, if the migraine still persists or if it reappears within 24 hours.or

If the tablets did not provide enough help for your migraine, inform your doctor. Your doctor may increase the dose to 5 mg or change your treatment.

Do not use more than the dose prescribed.

• Do not use more than two doses in a day. If you have been prescribed the 2.5 mg tablet, the maximum daily dose is 5 mg. If you have been prescribed the 5 mg tablet, the maximum daily dose is 10 mg.

If you take more Zolmitriptán Flas Stada than you should

If you have taken morezolmitriptánthan your doctor prescribed, inform your doctor immediately, go to the nearest hospital, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.Remember to bring the packaging and any remaining tablets with you.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Some of the symptoms listed below may be part of the migraine itself.

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

•Abnormal sensations such as tingling in the fingers of the hands and feet or sensitive skin to the touch

• Sensation of drowsiness, dizziness, or heat

•Headache

•Irregular heartbeat

•Nausea. Vomiting

•Stomach pain

•Dry mouth

•Muscle weakness or muscle pain

•Sensation of weakness

•Weight, tension, pain, or pressure in the throat, neck, arms, and legs, or chest

•Difficulty swallowing

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

•Very fast heartbeat.

•Slightly higher blood pressure.

•Increased urine production or the need to urinate more often.

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

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

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

•Angina (chest pain, often caused by exercise), heart attack, or coronary artery spasm. If you experience chest pain or shortness of breath after taking zolmitriptan,contact your doctor and do not take any more zolmitriptan.

•Intestinal blood vessel spasm that may damage your intestine. You may experience stomach pain or bloody diarrhea. If this occurs,contact your doctor and do not take any more zolmitriptan.

•Urgency to urinate

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zolmitriptan Flas Stada

• The active ingredient is zolmitriptan.

Each buccal dispersible tablet of Zolmitriptan Flas Stada contains 5 mg of zolmitriptan.

• The other components are: mannitol (F. Eur.), maltodextrin, microcrystalline cellulose, crospovidone type A, sodium hydrogen carbonate, citric acid, anhydrous colloidal silica, sodium saccharin, magnesium stearate, and peppermint flavor (maltodextrin, natural menthol, modified cornstarch).

Appearance of the product and contents of the package

The buccal dispersible tablets of Zolmitriptan Flas Stada are white, round, flat, and with a beveled edge.

Zolmitriptan Flas Stada 5 mg buccal dispersible tablets are presented in aluminum/aluminum blisters containing 2, 3, 6, 12, or 24 tablets or 2x1, 3x1, 6x1, 12x1, or 24x1 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible manufacturer

Eurogenerics N.V./S.A.

Heizel Esplanade b22,

B-1020 Brussels

Belgium

or

STADA Arzneimittel AG

Stadastr. 2-18,

61118 Bad Vilbel

Germany

or

STADA M&D SRL?

Str. Trascaului nr. 10,?

Municipiul Turda,

Judet Cluj 401135,

Romania?

This medicine is authorized in the EEA member states with the following names:

GermanyZolmitriptan Stada 5 mg Schmelztabletten

BelgiumZolmitriptan Instant EG 5 mg orodispergeerbare tabletten

SpainZolmitriptán Flas Stada 5 mg comprimidos bucodispersables EFG

LuxembourgZolmitriptanInstantEG 5 mg comprimés orodispersible

PortugalZolmitriptano Ciclum

SwedenZolmitriptan Stada 5 mg munsönderfallande tabletter

Last review date of this leaflet:May 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/