Rizatriptan Stada 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Rizatriptán Stada 10 mg orodispersible tablets EFG

Read the entire 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 prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Rizatriptán Stada is and what it is used for
2. What you need to know before taking Rizatriptán Stada
3. How to take Rizatriptán Stada
4. Possible adverse effects
5. How to store Rizatriptán Stada
6. Contents of the pack and other information

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

Rizatriptán STADA belongs to a group of medicines called selective 5-HT1B/1D receptor agonists.

Your doctor has prescribed rizatriptán to treat the headache phase 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 associated with a migraine attack.

2. What you need to know before starting to take Rizatriptan Stada

Do not take Rizatriptan Stada

• If you are allergic to rizatriptan benzoate, menthol, or any of the other components of this medicine (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 myocardial infarction 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 transient ischemic attack (TIA).
• If you have arterial obstruction problems (peripheral vascular disease).
• If you are taking monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranylcypromine, or pargyline (medications for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAOI.
• If you are currently taking an ergot-type medication, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent a migraine attack.
• If you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan, to treat your migraine (see "Taking Rizatriptan Stada with other medicines").

If you are unsure whether any of the above apply to you, speak with 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 using nicotine replacement therapy, your family has a history of heart disease, you are a man over 40 years of age, or you are a postmenopausal woman.
• You have kidney or liver problems.
• You have a specific problem with your heart rhythm (left bundle 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 or arm.
• You are using herbal preparations containing St. John’s wort.
• You have had allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (angioedema).
• You are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• You have experienced transient symptoms including chest pain and tightness.

If you take rizatriptan too frequently, this may lead to chronic headache. In such cases, you should contact your doctor and stop taking Rizatriptan Stada.

Please inform your doctor or pharmacist about all your symptoms. Your doctor will determine whether 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 conditions.

Taking Rizatriptan Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because rizatriptan may affect how some medicines work. Other medicines 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 less than two weeks have passed since you stopped taking an MAOI.
• If you are taking ergot-type medications, such as ergotamine or dihydroergotamine to treat your migraine.
• If you are taking methysergide to prevent a migraine attack.

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

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

After taking ergot-type medications, you must wait at least 24 hours before taking rizatriptan.

Ask your doctor for advice and information about the risks of taking 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-noradrenaline 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 preferable to take it on an empty stomach, you may still take it even if you have eaten.

Pregnancy and breastfeeding

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

Available data on the safety of rizatriptan during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown whether 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Use in children

The use of rizatriptan is not recommended in children under 18 years of age.

Elderly patients

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

Driving and use of machines

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

Rizatriptan Stada contains sodium

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

3. How to take Rizatriptán Stada

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

Always follow your doctor's instructions on how to take this medicine. If in doubt, consult your doctor or pharmacist again.

Recommended dose

The recommended dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems, you should use the 5 mg dose of rizatriptán. You must wait at least 2 hours between taking propranolol and rizatriptán. No more than 2 doses should be taken within a 24-hour period.

If migraine recurs within 24 hours

In some patients, migraine symptoms may recur within a 24-hour period. If your migraine recurs, you may take an additional dose of rizatriptán. Always wait at least 2 hours between doses.

If you still have migraine after 2 hours

If you do not respond to the first dose of rizatriptán during an attack, you should not take a second dose of rizatriptán for 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 rizatriptán within a 24-hour period (for example, do not take more than two 10 mg or 5 mg orodispersible tablets within 24 hours). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

Administration

Rizatriptán orodispersible tablets dissolve in the mouth and may be swallowed with liquid.

Orodispersible tablets may be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid. Place the orodispersible tablet on the tongue, allow it to dissolve, and swallow it with saliva.

If you take more Rizatriptán Stada than you should

If you take more rizatriptán than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, stating the medication and the amount ingested. Take the medicine packaging 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

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

In addition, inform your doctor if you experience any symptom suggesting an allergic reaction (such as rash or itching) after taking rizatriptan.

The following adverse effects may occur with this medicine.

In studies in adults, the most frequently reported adverse effects were dizziness, drowsiness, and fatigue.

Frequent (may affect up to 1 in 10 people)

tingling sensation (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, tremor

• fast or irregular heartbeat (palpitation), very rapid heartbeat (tachycardia)
• flushing (temporary reddening of the face), hot flushes, sweating
• throat discomfort, difficulty breathing (dyspnea)
• discomfort (nausea), dry mouth, vomiting, diarrhoea
• heaviness or discomfort 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 (sensation 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 may cause difficulty breathing and/or swallowing (angioedema)
• neck pain, sensation of stiffness in parts of the body, numbness, muscle weakness
• changes in heart rhythm or rate (arrhythmia); abnormalities in the electrocardiogram (ECG, 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)
• noisy breathing
• 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 of age, 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)

• myocardial infarction, spasms of the blood vessels of the heart, stroke (these generally occurred in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, and a specific problem with the way the heart beats [left bundle branch block]))

• a syndrome called "serotonin syndrome" which may cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation, and hallucinations

• severe peeling of the skin, even accompanied by fever (toxic epidermal necrolysis)

• seizures (fits/seizures)

• spasms of blood vessels in the limbs, including coldness and numbness of the hands or feet

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan Stada

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptán Stada

The active substance is rizatriptan.

One 10 mg orodispersible tablet of Rizatriptán Stada 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, colloidal anhydrous silica, magnesium stearate, menthol flavour (maltodextrin, natural menthol, modified corn starch).

Appearance of the medicinal product and contents of the pack

The orodispersible tablets of Rizatriptán Stada 10 mg are round, flat, white or almost white, 10 mm in diameter, with bevelled edges.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in EEA Member States under the following names:

Germany: Rizatriptan STADA 10 mg Schmelztabletten

Denmark: Rizasmelt 10 mg Smeltetabletter

Spain: Rizatriptán Stada 10 mg orodispersible tablets EFG

Finland: Rizastad 10 mg tabletti, suussa hajoava

France: Rizatriptan 10 mg, comprimé orodispersible

Sweden: Rizasmelt 10 mg munsönderfallande tabletter

Date of the most recent revision of this leaflet: June 2024.

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