Prospect: information for the patient

Zolmitriptán Flas Sandoz 2.5 mg buccal dispersible tablets EFG

Zolmitriptán Flas Sandoz 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 doubts, consult your doctor or pharmacist.

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

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Zolmitriptán Flas Sandoz

3.How to take Zolmitriptán Flas Sandoz

4.Possible adverse effects

5.Storage of Zolmitriptán Flas Sandoz

6.Contents of the package and additional information

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

Zolmitriptanis used to treat migraine headache in adults aged 18 years and older.

• The symptoms of migraine may be caused by a widening of the blood vessels in the head. It is believed that zolmitriptan reduces the widening of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as a feeling of discomfort (nausea or vomiting) and sensitivity to light and noise.
• Zolmitriptan acts only when a migraine attack has started. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Flas Sandoz if:

• You are allergic to zolmitriptán or any of the other components of this medication (listed in section 6),
• You have severe kidney problems,
• You have had a stroke (cerebrovascular accident or CVA) or symptoms of a short duration similar to those of a stroke (transient ischemic attack or TIA),
• You have moderate or severe hypertension, or mild hypertension that is not controlled with medication,
• You have had any heart problems, including heart attack, angina (chest pain caused by exercise or effort), or a 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 lower limbs (peripheral vascular disease),
• You are taking another medication for migraine, such as ergotamine, ergotamine-type medications (dihydroergotamine, methysergide), or another medication in the same group as zolmitriptán (5-HT 1B/1D receptor agonists or triptans, such as sumatriptan, naratriptan, or rizatriptan) (see section “Other medications and Zolmitriptán Flas Sandoz”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take zolmitriptán if you have:

• Any risk factor for ischemic heart disease (insufficient blood flow to the heart):
• High blood pressure or diabetes,
• High cholesterol levels in the blood,
• You smoke,
• You have a family history of ischemic heart disease,
• You are a man over 40 years old or a postmenopausal woman,
• A type of abnormal heart rhythm (Wolff-Parkinson-White syndrome) or any other type of heart rhythm disorder,
• Problems with the liver or kidneys,
• Headache accompanied by dizziness, difficulty walking, lack of coordination, or weakness in the arms or legs.

Inform your doctor if you are taking any medication for depression or herbal remedies such as St. John's Wort (Hypericum perforatum) (for more information, see section “Other medications and Zolmitriptán Flas Sandoz”.

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

If you take zolmitriptán too frequently, you may experience chronic headache. In this case, contact your doctor, as it may be necessary to discontinue this medication.

Inform your doctor or pharmacist of your symptoms. Your doctor will indicate if you have migraine.You should only take zolmitriptán for a migraine attack.Do not use zolmitriptán to treat headaches that may be caused by other more serious diseases.

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

Children and adolescents

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

Other medications and Zolmitriptán Flas Sandoz

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

Do not take Zolmitriptán Flas Sandoz with other medications for migraine,such as:

• Other medications in the same group as zolmitriptán (e.g., 5-HT 1B/1D receptor agonists or triptans, e.g., sumatriptan, naratriptan, or rizatriptan).

If you take other triptans different from zolmitriptán, leave 24 hours before taking Zolmitriptán Flas Sandoz.

After taking zolmitriptán, leave 24 hours before taking other triptans different from Zolmitriptán Flas Sandoz,

• Ergotamine-derived medications, dihydroergotamine, and methysergide. After taking zolmitriptán, wait at least 6 hours to take this type of medication, and if you are taking ergotamine derivatives, wait at least 24 hours to take zolmitriptán.

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

• Depression medications:

• Monamine oxidase inhibitors (MAOIs), such as moclobemide,
• Medications known as selective serotonin reuptake inhibitors (SSRIs), such as sertraline, escitalopram, fluoxetine, and fluvoxamine,
• Medications known as serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine,

The serotonin syndrome is a rare but potentially fatal condition that has been reported in some patients who took zolmitriptán in combination with certain serotonin-related medications (e.g., some medications for depression). Symptoms of serotonin syndrome may include, for example, agitation, tremors, restlessness, fever, excessive sweating, spasms, muscle rigidity, uncoordinated movements of the limbs or eyes, and involuntary muscle contractions. Your doctor may provide additional information.

• Cimetidine (for indigestion or stomach ulcers),
• Quinolone antibiotics (such as ciprofloxacin),
• Herbal remedies such as St. John's Wort (Hypericum perforatum), as taking this with zolmitriptán may increase the risk of side effects. It is not recommended to take zolmitriptán and St. John's Wort at the same time.

Pregnancy and breastfeeding

If you are pregnant, or in the lactation period, consult your doctor before taking any other medication. If you are pregnant, you will only be able to take zolmitriptán if your doctor determines it is necessary.

If you are in the lactation period, consult with your doctor before taking this medication. You should avoid breastfeeding for 24 hours after taking zolmitriptán.

Driving and operating machinery

Migraine itself or treatment with zolmitriptán may cause drowsiness in some patients. There have also been reports of dizziness in some patients treated with this medication. If you experience these effects, you should monitor your ability to drive vehicles or operate machinery.

Zolmitriptán Flas Sandoz contains sodium, sulfites, and aspartame

This medication contains less than 23 mg of sodium (1 mmol) per buccal tablet; it is essentially “sodium-free”.

Sulfites may cause rare but severe allergic reactions and bronchospasm (sudden feeling of suffocation).

Zolmitriptán Flas Sandoz 2.5 mg buccal tablets EFG

This medication contains 2.5 mg of aspartame in each buccal tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Zolmitriptán Flas Sandoz 5 mg buccal tablets EFG

This medication contains 5 mg of aspartame in each buccal tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

You can take Zolmitriptán Flas Sandoz as soon as a migraine headache begins. You can also take it once a headache has started.

The recommended doseis 2.5 mg.

Your doctor will tell you the most suitable dose for your case and it is essential that you take the medication as your doctor has instructed you.

Most migraine attacks are relieved with a single dose (one tablet) of zolmitriptan,but if not, DO NOT take a second tablet to treat that same attack as the likelihood of it being effective is low.

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

If you experience ANOTHER migraine attack within the first 24 hours after the first one, you can take a new tablet of zolmitriptan, but 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 must wait at least 2 hours between doses.

Administration Form

Take the buccal tablets in the following way:

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

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

If you take more Zolmitriptán 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 medication and the amount ingested.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following side 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 may cause difficulty breathing, speaking, or swallowing.

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

• Chest or throat pain, shortness of breath, or other symptoms compatible with a heart attack,
• Spasm of the blood vessels in the digestive tract that may 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,
• Prickling sensation, skin hypersensitivity,
• Numbness, dizziness, or feeling of heat,
• Irregular or rapid heartbeats,
• Nausea (general discomfort), vomiting, stomach pain,
• Dry mouth,
• Muscle weakness or pain,
• Feeling of weakness,
• Weight, pressure, or pain in the throat, neck, arms, and legs, or chest,
• Difficulty swallowing.

Infrequent:may affect up to 1 in 100 people.

• Rapid heartbeats,
• Mildly higher blood pressure or short-term high blood pressure,
• Increased urine production or frequency of urination.

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

• Itchy rash (urticaria).

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

• Urgent and imperative need to urinate.

As with other medicines in this group, there have been rare cases of heart attacks and strokes reported, most of which occurred in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smokers, family history of heart disease or stroke).

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly 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 medicine.

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 and the blister, after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, 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 Sandoz

• The active ingredient is zolmitriptan.

Zolmitriptan Flas Sandoz 2.5 mg orally disintegrating tablets EFG

Each orally disintegrating tablet contains 2.5 mg of zolmitriptan.

Zolmitriptan Flas Sandoz 5 mg orally disintegrating tablets EFG

Each orally disintegrating tablet contains 5 mg of zolmitriptan.

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

Appearance of the product and contents of the package

Zolmitriptan Flas Sandoz 2.5 mg orally disintegrating tablets EFG

Orally disintegrating tablets, white, round, flat, and with the inscription “ZMT 2.5” on one face.

Zolmitriptan Flas Sandoz 5 mg orally disintegrating tablets EFG

Orally disintegrating tablets, white, round, flat, and with the inscription “ZMT 5” on one face.

The orally disintegrating tablets are packaged in Alu/Alu blisters, inserted in a cardboard box.

Zolmitriptan 2.5 mg orally disintegrating tablets

Package sizes:2, 3, 4, 6, 10, 12, 18, or 24 orally disintegrating tablets.

Zolmitriptan 5 mg orally disintegrating tablets

Package sizes:2, 3, 4, 6, 12, 18, or 24 orally disintegrating tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

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 medicine is authorized in the member states of the European Economic Area with the following names:

Date of the last review of this leaflet:October 2021.

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.gob.es/