RIZATRIPTAN STADA 10 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Rizatriptan Stada

Do not take Rizatriptan Stada

• If you are allergic to rizatriptan benzoate, menthol, or any of the other ingredients of this medication (listed in section 6).
• If you have moderately severe, severe, or uncontrolled mild high blood pressure.
• If you have or have ever had heart problems, including heart attack or chest pain (angina) or have experienced signs related to heart disease.
• If you have had severe liver or kidney problems.
• If you have had a stroke (CVA) or a transient ischemic attack (TIA).
• If you have problems with obstruction in your arteries (peripheral vascular disease).
• If you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (medicines for depression) 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 to treat your migraine or methysergide to prevent a migraine attack.

• If you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see "Taking Rizatriptan Stada with other medications").

If you are not sure 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, you are a smoker or are taking nicotine substitutes, your family has a history of heart disease, you are 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 bundle branch block).
• you have or have had any allergy.
• 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).
• if you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have had transient symptoms including pain and pressure in the chest.

If you take rizatriptan too frequently, it may produce chronic headache. In such cases, you should contact your doctor and stop taking Rizatriptan 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 types of headaches that may be caused by more serious conditions.

Taking Rizatriptan Stada with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 to treat your migraine.
• if you are taking methysergide to prevent a migraine attack.

The above medications, 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 Rizatriptan Stada

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

Taking Rizatriptan Stada with food and drinks

Rizatriptan may take longer to work if taken after meals. Although it is best taken on an empty stomach, you can still take it after eating.

Pregnancy and breastfeeding

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

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 not known 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 may postpone breastfeeding for 12 hours after treatment to avoid exposing the baby.

Use in children

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

Patients with advanced age

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

Driving and using machines

When taking rizatriptan, you may feel drowsy or dizzy. If this occurs, do not drive or use tools or machines.

Rizatriptan Stada contains sodium

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

3. How to take Rizatriptan Stada

Rizatriptan is used to treat migraine attacks. Take rizatriptan as soon as possible after your migraine headache starts. Do not use it to prevent an attack.

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

The recommended doseis 10 mg.

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

If the migraine recurs within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine recurs, you can take an additional dose of rizatriptan. You should 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 rizatriptan during a migraine attack, you should not take a second dose of rizatriptan to treat the same attack. However, you may still respond to rizatriptan during the next attack.

Do not take more than 2 doses of rizatriptan in a 24-hour period (e.g., do not take more than two 10 mg or 5 mg orodispersible tablets in a 24-hour period). You should always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Administration

Rizatriptan orodispersible tablets dissolve in the mouth and can be swallowed with liquid.

Orodispersible 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 orodispersible tablet on your tongue, let it dissolve, and swallow with your saliva.

If you take more Rizatriptan Stada than you should

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

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

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

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone gets them.

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

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

The following side effects may occur with this medication.

In adult studies, the most frequently 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 sharpness, tremor

• rapid or irregular heartbeat (palpitations), very rapid heartbeat (tachycardia)
• flushing (short-term redness of the face), hot flashes, sweating
• throat discomfort, difficulty breathing (dyspnea)
• discomfort (nausea), dry mouth, vomiting, diarrhea
• discomfort or heaviness in parts of the body
• stomach or chest pain

Uncommon(may affect up to 1 in 100 people)

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

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

• fainting (syncope),
• breathing sounds
• allergic reaction (hypersensitivity); sudden and severe allergic reaction (anaphylaxis).
• Stroke (this usually occurs in patients with risk factors for heart and blood vessel disease (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 the heart beats [left bundle branch block])).
• slow heart rate (bradycardia).

Frequency not known(cannot be estimated from available data)

• heart attack, coronary artery spasms, stroke. (These usually occur in patients with risk factors for heart and blood vessel disease (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 the heart beats [left bundle branch block]).
• a syndrome called "serotonin syndrome" that can cause side effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations
• severe skin peeling, even with fever (toxic epidermal necrolysis)
• seizures (convulsions/attacks)
• spasms of the blood vessels of the extremities, including coldness and numbness of the hands or feet.

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. You can also report them 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 medication.

5. Storage of Rizatriptan Stada

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

Do not use this medication after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Rizatriptan Stada

The active ingredient is rizatriptan.

One 10 mg Rizatriptan Stada orodispersible tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.

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

Appearance of the product and pack contents

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Stada, S.L.

Frederic Mompou 5

08960 Sant Just Desvern

(Barcelona) Spain

[email protected]

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 medication is authorized in the EEA member states with the following names:

Names:

Germany: Rizatriptan STADA 10 mg Schmelztabletten

Denmark: Rizasmelt 10 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

Date of the last revision of this package leaflet:June 2024.

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