Leaflet: Information for the user

Rizatriptan Stada 10 mg orally disintegrating tablets EFG

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

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

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

-This medicine has been prescribedonlyfor you. Do not give it to others, even if they havethe same symptoms as you, as it may harm them.

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

1.What Rizatriptan Stada is and what it is used for

2.What you need to know before you start taking Rizatriptan Stada

3.How to take Rizatriptan Stada

4.Possible side effects

5.Storage of Rizatriptan Stada

6.Contents of the pack and additional information

Rizatriptán STADA belongs to a group of medicines called selective 5-HT 1B/1D receptor agonists.

Your doctor has prescribed rizatriptán to treat the headaches of migraine attacks. Rizatriptán should not be used for preventive purposes.

Treatment with rizatriptán reduces the swelling of blood vessels surrounding the brain. This swelling causes the headache of a migraine attack.

Do not take Rizatriptán Stada

• If you are allergic to rizatriptan benzoate, menthol, or any of the other components of this medication (listed in section 6).
• If you have moderately severe, severe, or mild high blood pressure that is not controlled with medication.
• If you have or have had any heart problems, including myocardial infarction or chest pain (angina) or have experienced symptoms related to heart disease.
• If you have or have had severe liver or kidney problems.
• If you have had a stroke or a transient ischemic attack (TIA).
• If you have peripheral vascular disease (blockage in your arteries).
• If you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (depression medications) or linezolid (an antibiotic), or if it has been less than two weeks since you stopped taking an MAOI.
• If you are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for your migraine or methysergide to prevent a migraine attack.

• If you are taking any other medication in the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine (See "Taking Rizatriptán Stada with other medications").

If you are unsure if any of the above applies to you, talk to your doctor or pharmacist before taking rizatriptan.

Warnings and precautions

Consult your doctor or pharmacist before starting to take rizatriptan if:

• You have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or taking nicotine substitutes, a family history of heart disease, being a man over 40 years old or a postmenopausal woman.
• You have kidney or liver problems.
• You have a specific problem with the way your heart beats (left branch block).
• You have or have had any allergies.
• Your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm.
• You use herbal preparations containing St. John's Wort.
• You have had allergic reactions such as swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (angioedema).
• You are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, or fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• You have had transient symptoms including chest pain and pressure.

If you take rizatriptan frequently, this may cause you to develop chronic headache. In such cases, contact your doctor and stop taking Rizatriptán STADA.

Please inform your doctor or pharmacist of all your symptoms. Your doctor will decide if you have migraines. You should only take rizatriptan for a migraine attack. Rizatriptan should not be used to treat other headaches that may be caused by more serious underlying diseases.

Taking Rizatriptán Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.This is because rizatriptan may affect the way some medications work. Other medications may also affect rizatriptan.

Do not take rizatriptan concomitantly

• If you are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.
• If you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if it has been less than two weeks since you stopped taking an MAOI.
• If you are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for your migraine.
• If you are taking methysergide to prevent a migraine attack.

The medications mentioned above, when taken with rizatriptan, may increase the risk of adverse reactions.

After taking rizatriptan, you should wait at least 6 hours before taking ergotamine-type medications such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medications, you should wait at least 24 hours before taking rizatriptan.

Ask your doctor for instructions and risks on how to take Rizatriptán Stada

• If you are currently taking propranolol (see "How to take Rizatriptán Stada").
• If you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, or fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Taking Rizatriptán Stada with food and drinks

Rizatriptan may take longer to work if taken after meals. Although it is better to take it on an empty stomach, you can still take it even if you have eaten.

Pregnancy and breastfeeding

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

The available data on the safety of rizatriptan when used during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown if rizatriptan is harmful to the fetus when taken by a pregnant woman after the first three months of pregnancy.

If you are breastfeeding, you can postpone breastfeeding for 12 hours after treatment to avoid exposing your baby.

Use in children

Rizatriptan is not recommended for use in children under 18 years of age.

Older patients

There are no completed studies to evaluate the safety and efficacy of rizatriptan in patients over 65 years of age.

Driving and operating machinery

When taking rizatriptan, you may feel drowsiness or dizziness. If this occurs, do not drive or use tools or machinery.

Rizatriptan Stada contains sodium

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

Rizatriptán is used to treat migraine attacks. Take rizatriptán as soon as possible once your migraine headache has started. Do not use it to prevent an attack.

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

The recommended doseis 10 mg.

If you are currently taking propanolol or have kidney or liver problems, you must use a dose of 5 mg of rizatriptán. You must wait at least 2 hours between the intake of propanolol and rizatriptán up to a maximum of 2 doses in a 24-hour period.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine reappears, you can take an additional dose of rizatriptán. You must always wait at least 2 hours between doses.

If after 2 hours you still have a migraine

If you do not respond to the first dose of rizatriptánduring an attack, do not take a second dose of rizatriptánfor the treatment of the same attack. However, you are still likely to respond to rizatriptán during the next attack.

Do not take more than 2 doses of rizatriptánin a 24-hour period (for example, do not take more than two buccal tablets of 10 mg or 5 mg in a 24-hour period). You must always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Administration

Rizatriptán buccal tabletsdissolve in the mouth and can be swallowed with liquid.

Buccal tablets can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids. Place the buccal tablet on the tongue, let it dissolve, and swallow with saliva.

If you take more Rizatriptán Stada than you should

If you take more rizatriptánthan you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. Bring the medication packaging with you.

The signs of overdose may include dizziness, numbness, vomiting, fainting, and slow heart rate.

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

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

Inform your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, a heart attack, or a stroke.

Also, inform your doctor if you experience any symptoms that suggest an allergic reaction (such as hives or itching) after taking rizatriptan.

The following side effects may occur with this medicine.

In adult studies, the most commonly reported side effects were dizziness, drowsiness, and fatigue.

Frequent(may affect up to 1 in 10 people)

tingling sensation (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, tremor

• rapid or irregular heart rate (palpitation), very rapid heart rate (tachycardia)
• flushing (brief facial redness), hot flashes, sweating
• throat discomfort, difficulty breathing (dyspnea)
• uncomfortable feeling (nausea), dry mouth, vomiting, diarrhea
• discomfort or heaviness in parts of the body
• stomach or chest pain

Rare(may affect up to 1 in 100 people)

• bad taste in the mouth
• unsteadiness when walking (ataxia), dizziness, vertigo (sensation of movement), blurred vision
• confusion, insomnia, nervousness
• high blood pressure (hypertension); thirst, indigestion (dyspepsia)
• eruption, itching (pruritus), and hives (urticaria) facial swelling, lips, tongue, and/or throat that may cause difficulty breathing and/or swallowing (angioedema)
• neck pain, feeling of stiffness in parts of the body, numbness, muscle weakness
• abnormalities in heart rhythm (arrhythmia); abnormalities in electrocardiogram (test that records the heart's electrical activity).
• facial pain, muscle pain

Very rare

• syncope (fainting),
• abnormal breathing sounds
• allergic reaction (hypersensitivity); severe and sudden allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, and a specific problem with the way their heart beats (left branch block))).
• slow heart rate (bradycardia).

Frequency not known (cannot be estimated from available data)

• myocardial infarction, coronary artery spasms, stroke. (These usually occurred in patients with risk factors for heart disease or blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, postmenopausal women, and a specific problem with the way their heart beats (left branch block))).
• Syndrome called "serotonin syndrome" that can cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination problems, agitation, and hallucinations
• severe skin peeling even accompanied by fever (toxic epidermal necrolysis)
• seizures (seizures/attacks)
• spasms of blood vessels in the extremities, including coldness and numbness of the hands or feet.

• spasm of the colon (large intestine) blood vessels, which can cause abdominal pain.

Reporting of 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 leaflet. You can also report them through the Spanish System for the Vigilance 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 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 trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Rizatriptan Stada

The active ingredient is rizatriptan.

A Rizatriptan Stada 10 mg buccal dispersible tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

The other components are mannitol, maltodextrin, microcrystalline cellulose, crospovidone type A, sodium saccharin, anhydrous colloidal silica, magnesium stearate, menthol aroma (maltodextrin, natural menthol, modified cornstarch).

Appearance of the product and contents of the package

Rizatriptan Stada 10 mg buccal dispersible tablets are round, flat, white or almost white, 10 mm in diameter, and have a beveled edge.

Rizatriptan Stada 10 mg buccal dispersible tablets are presented in aluminum/aluminum blister packs containing 1, 2, 3, 6, 12, or 18 buccal dispersible tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Laboratorio Stada, S.L.

Frederic Mompou 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

Responsible manufacturer

STADA Arzneimittel AG

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

or

LAMP SAN PROSPERO S.p.A.

Via della Pace, 25/A

41030 San Prospero (Modena)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the EEA member states with the following

names:

Germany:Rizatriptan STADA 10 mg Schmelztabletten

Denmark:Rizasmelt10 mg Smeltetabletter

Spain:Rizatriptán Stada 10 mg comprimidos bucodispersables EFG

Finland:Rizastad 10 mg tabletti, suussa hajoava

France:Rizatriptan 10 mg, comprimé orodispersible

Sweden:Rizasmelt 10 mg munsönderfallande tabletter

Last review date of this leaflet:June 2024.

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/