ZOLMITRIPTAN FLAS SANDOZ 2.5 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Zolmitriptan Flas Sandoz 2.5 mg Oral Lyophilisates EFG

Zolmitriptan Flas Sandoz 5 mg Oral Lyophilisates EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Zolmitriptan Flas Sandoz and what is it used for

Zolmitriptan Flas Sandoz contains the active substance zolmitriptan and belongs to a group of medicines called triptans.

Zolmitriptanis used to treat migraine headaches in adults over 18 years of age.

• The symptoms of migraine can be caused by the dilation of blood vessels in the head. It is believed that zolmitriptan decreases the dilation of these blood vessels. This helps to alleviate the headache and other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.
• Zolmitriptan only works when a migraine attack has started. It will not prevent you from having a migraine attack.

2. What you need to know before you take Zolmitriptan Flas Sandoz

Do not take Zolmitriptan Flas Sandoz if:

• you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6),
• you have severe kidney problems,
• you have had a stroke (cerebrovascular accident or CVA) or symptoms of short duration similar to those of a stroke (transient ischaemic attack or TIA),
• you have moderate or severe high blood pressure, or mild high blood pressure that is not controlled with medication,
• you have had heart problems, including heart attack, angina (chest pain caused by exercise or exertion), or a special type of chest pain known as Prinzmetal's angina, or have experienced symptoms related to the heart such as shortness of breath or pressure on the chest,
• you have had problems with blood flow to the legs (peripheral vascular disease),
• you are taking another medicine for migraine, such as ergotamine, ergotamine-type medications (dihydroergotamine, methysergide), or another medicine from the same group as zolmitriptan (i.e., 5-HT1B/1D receptor agonist or triptan, such as sumatriptan, naratriptan, or rizatriptan) (see section "Other medicines and Zolmitriptan Flas Sandoz").

Warnings and precautions

Consult your doctor or pharmacist before taking zolmitriptan if you have:

• any risk factor for ischaemic heart disease (reduced blood flow in the arteries of the heart):
• • high blood pressure or diabetes,
  • high levels of cholesterol in the blood,
  • smoking,
  • family history of heart disease or stroke,
  • you are a man over 40 years old or a post-menopausal woman,
• a type of abnormal heartbeat (Wolff-Parkinson-White syndrome) or any other type of heart rhythm disorder,
• liver or kidney problems,
• headache accompanied by dizziness, difficulty walking, lack of coordination, or weakness in the arms or legs.

Tell your doctor if you are taking any medicine for depression or herbal remedies such as St. John's Wort (Hypericum perforatum) (for more information, see section "Other medicines and Zolmitriptan Flas Sandoz").

Zolmitriptan may increase blood pressure. If blood pressure rises too high, you may experience symptoms such as headache, dizziness, or ringing in the ears. If this happens, contact your doctor.

If you take zolmitriptan too frequently, you may experience chronic headache. In this case, you should contact your doctor, as it may be necessary to stop taking this medication.

Tell your doctor about the symptoms you have. Your doctor will tell you if you have migraine. You should only take zolmitriptan for a migraine attack. Do not use zolmitriptan to treat headaches that may be caused by other, more serious conditions.

Zolmitriptan Flas Sandoz is not recommended for people over 65 years old. If you are over 65, your doctor will tell you if you can take these tablets.

Children and adolescents

Zolmitriptan Flas Sandoz is not recommended for people under 18 years old.

Other medicines and Zolmitriptan Flas Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Zolmitriptan Flas Sandoz with other medicines for migraine, such as:

• other medicines from the same group as zolmitriptan (e.g., 5-HT1B/1D receptor agonists or triptans, e.g., sumatriptan, naratriptan, or rizatriptan).

If you take other triptans different from zolmitriptan, wait 24 hours before taking Zolmitriptan Flas Sandoz.

After taking zolmitriptan, wait 24 hours before taking other triptans different from Zolmitriptan Flas Sandoz,

• ergotamine-derived medicines, dihydroergotamine, and methysergide. After taking zolmitriptan, wait at least 6 hours before taking this type of medicine, and if you are taking ergotamine-derived medicines, wait at least 24 hours before taking zolmitriptan.

Consult your doctor about the instructions for taking the medicine and the risks of taking these tablets with:

• medicines for depression:

• monoamine oxidase inhibitors (MAOIs), such as moclobemide,
• medicines called selective serotonin reuptake inhibitors (SSRIs), such as sertraline, escitalopram, fluoxetine, and fluvoxamine,
• medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine,

Serotonin syndrome is a rare but potentially life-threatening disorder that has been reported in some patients who took zolmitriptan in combination with serotonergic medicines (e.g., certain medicines for depression). The symptoms of serotonin syndrome can be, for example, agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle rigidity, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor can provide you with more information.

• cimetidine (for indigestion or stomach ulcers),
• quinolone-type antibiotics (such as ciprofloxacin),
• herbal remedies such as St. John's Wort (Hypericum perforatum), as taking it with zolmitriptan increases the likelihood of side effects. It is not recommended to take zolmitriptan and St. John's Wort at the same time.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking any other medicine. If you are pregnant, you should only take zolmitriptan if your doctor decides it is necessary.

If you are breastfeeding, consult your doctor before taking this medicine. You should avoid breastfeeding for 24 hours after taking zolmitriptan.

Driving and using machines

Migraine itself or treatment with zolmitriptan may cause drowsiness in some patients. There have also been reports of dizziness in some patients treated with this medicine. If you experience these effects, you should be careful when driving or operating machinery.

Zolmitriptan Flas Sandoz contains sodium, sulfites, and aspartame

This medicine contains less than 23 mg of sodium (1 mmol) per oral lyophilisate; this is, essentially, "sodium-free".

Sulfites can rarely cause severe allergic reactions and bronchospasm (sudden feeling of suffocation).

Zolmitriptan Flas Sandoz 2.5 mg Oral Lyophilisates EFG

This medicine contains 2.5 mg of aspartame in each oral lyophilisate. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Zolmitriptan Flas Sandoz 5 mg Oral Lyophilisates EFG

This medicine contains 5 mg of aspartame in each oral lyophilisate. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Zolmitriptan Flas Sandoz

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

You can take Zolmitriptan Flas Sandoz as soon as a migraine headache starts. You can also take it once the attack has started.

The recommended doseis one 2.5 mg tablet.

Your doctor will tell you the most suitable dose for you and it is important that you take the medicine as your doctor has taught you.

Most migraine attacks are relieved with a single dose (one tablet) of zolmitriptan, but if this is not the case, do not take a second tablet to treat the same attackas the likelihood of it working is low.

Consult your doctor if the tablets do not produce sufficient efficacy against your migraine. Your doctor may increase the dose to 5 mg or change the treatment.

If you suffer ANOTHERmigraine attack within the first 24 hours after the first one, you can take another zolmitriptan tablet, but you should never take more than two tablets in 24 hours.

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.

In either case, you should wait at least 2 hours between one dose and another.

Method of administration

Take the oral lyophilisates as follows:

1. Separate the blister along the perforated line.
2. Pull the blister flap carefully from the arrow, as indicated in the drawing.
3. Place the tablet on the tongue to dissolve and swallow it with your saliva. You do not need to drink water to swallow the tablet.

You can take Zolmitriptan Flas Sandoz with or without food. This does not affect how zolmitriptan works.

If you take more Zolmitriptan Flas Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any further questions on 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.

If you experience any of the following effects, stop taking the medicine and consult your doctor immediately.

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

• allergic reactions, sometimes very severe, such as swelling of the face, lips, mouth, tongue, and throat that can cause difficulty breathing, speaking, or swallowing.

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

• chest pain or tightness or throat, shortness of breath, or other symptoms compatible with a heart attack,
• spasm of the blood vessels of the digestive tract that can cause damage to your digestive tract. You may feel stomach pain or have bloody diarrhea,

Other possible side effects

Frequent:may affect up to 1 in 10 people.

• headache,
• tingling sensation, skin hypersensitivity,
• numbness, dizziness, or feeling of warmth,
• irregular or rapid heartbeats,
• nausea (general discomfort), vomiting, stomach pain,
• dry mouth,
• weakness or muscle pain,
• feeling of weakness,
• heaviness, tightness, or pain in the throat, neck, arms, and legs, or chest,
• difficulty swallowing.

Uncommon:may affect up to 1 in 100 people.

• rapid heartbeats,
• mildly increased blood pressure or short-term high blood pressure,
• increased amount of urine or number of times you need to urinate.

Rare:may affect up to 1 in 1,000 people.

• itchy rash (urticaria).

Very rare:may affect up to 1 in 10,000 people.

• sudden and urgent need to urinate.

As with other medicines of this group, very rare cases of heart attack and stroke have been reported, most of them in patients with risk factors for developing heart and blood vessel disease (high blood pressure, diabetes, smoking, family history of heart disease or stroke).

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptan Flas Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Container Content and Additional Information

Composition of Zolmitriptan Flas Sandoz

• The active ingredient is zolmitriptan.

Zolmitriptan Flas Sandoz 2.5 mg oral dispersible tablets EFG

Each oral dispersible tablet contains 2.5 mg of zolmitriptan.

Zolmitriptan Flas Sandoz 5 mg oral dispersible tablets EFG

Each oral dispersible tablet contains 5 mg of zolmitriptan.

• Other components: are silicified microcrystalline cellulose, crospovidone, sodium hydrogen carbonate, anhydrous citric acid, anhydrous colloidal silica, mannitol (E421), sweet orange flavor (contains sodium, sulfites, and propylene glycol), aspartame (E951) (see additional information at the end of section 2), and magnesium stearate.

Product Appearance and Container Content

Zolmitriptan Flas Sandoz 2.5 mg oral dispersible tablets EFG

Oral dispersible tablets, white, round, flat, and with the inscription “ZMT 2.5” on one side.

Zolmitriptan Flas Sandoz 5 mg oral dispersible tablets EFG

Oral dispersible tablets, white, round, flat, and with the inscription “ZMT 5” on one side.

The oral dispersible tablets are packaged in Alu/Alu blisters, inserted in a cardboard box.

Zolmitriptan 2.5 mg oral dispersible tablets

Package sizes: 2, 3, 4, 6, 10, 12, 18, or 24 oral dispersible tablets.

Zolmitriptan 5 mg oral dispersible tablets

Package sizes: 2, 3, 4, 6, 12, 18, or 24 oral dispersible tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben

Germany

Salutas Pharma GmbH

Dieselstrasse 5, 70839 Gerlingen

Germany

or

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava

Slovenia

or

Lek S.A.

Ul. Domaniewska 50 C,

02-672 Warsaw

Poland

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus:October 2021.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/