Package Insert: Information for the Patient

Rizatriptan ratiopharm 10 mg Bucodispersible Tablets EFG

Rizatriptan

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Rizatriptan ratiopharm and how is it used

2. What you need to know before taking Rizatriptan ratiopharm

3. How to take Rizatriptan ratiopharm

4. Possible adverse effects

5. Storage of Rizatriptan ratiopharm

6. Contents of the package and additional information

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

Rizatriptán ratiopharm is used to treat the headaches of migraine attacks in adults.

Treatment with Rizatriptán ratiopharm:

Reduces the swelling of blood vessels surrounding the brain. This swelling causes the headache of a migraine attack.

Do not take Rizatriptán ratiopharm if

• You are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6)
• You have moderately severe or severe high blood pressure, or mild hypertension that is not controlled by medication
• You have or have had any heart problems, including myocardial infarction or chest pain (angina), or have experienced symptoms related to heart disease
• You have severe liver or kidney problems
• You have had a stroke or a transient ischemic attack (mini-stroke)
• You have peripheral vascular disease (blockage in your arteries)
• 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 MAOIs
• You are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for migraine, or methysergide to prevent a migraine
• You are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan for migraine (SeeUse of Rizatriptán ratiopharm with other medicinesbelow)

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptán ratiopharm.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptán ratiopharm 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 (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 are taking 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 and/or swallowing (angioedema)
• You are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
• You have had transient symptoms including chest pain and tightness

If you take Rizatriptán ratiopharm frequently, this may lead to chronic headache. In such cases, contact your doctor and stop taking Rizatriptán ratiopharm.

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

Children and adolescents

The use of Rizatriptán ratiopharm in children and adolescents under 18 years of age is not recommended.

Use in patients over 65 years

There are no completed studies that evaluate the safety and efficacy of Rizatriptán ratiopharm in patients over 65 years.

Use of Rizatriptán ratiopharm with other medicines

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine, including over-the-counter medications. This includes herbal preparations and those you take regularly for migraines. This is because Rizatriptán ratiopharm may affect the mechanism of action of some medications. Other medications may also affect Rizatriptán ratiopharm.

Do not take Rizatriptán ratiopharm if:

• You are already taking a 5-HT1B/1D agonist (sometimes called "triptans"), such as sumatriptan, naratriptan, or zolmitriptan
• 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
• You are taking ergotamine-type medications, such as ergotamine or dihydroergotamine for migraine
• You are taking methysergide to prevent a migraine

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

After taking Rizatriptán ratiopharm, wait at least 6 hours before taking ergotamine-type medications, such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medications, wait at least 24 hours before taking Rizatriptán ratiopharm.

Ask your doctor about the instructions and risks of taking Rizatriptán ratiopharm

• If you are taking propranolol (see section 3How to take Rizatriptán ratiopharm)
• If you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression

Use of Rizatriptán ratiopharm with food, drink, and alcohol

Rizatriptán ratiopharm may take longer to take effect 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, consult your doctor or pharmacist before using this medicine.

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 whether Rizatriptán ratiopharm 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.

Driving and operating machinery

After taking Rizatriptán ratiopharm, you may feel drowsiness or dizziness. If this occurs, do not drive or use tools or machinery.

Rizatriptán ratiopharm contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Rizatriptán ratiopharm contains aspartame (E951)

This medicine contains 2.0 mg of aspartame per buccodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Rizatriptán ratiopharm contains benzoate

This medicine contains 4.5 mg of benzoate (as rizatriptan benzoate) per buccodispersible tablet.

Rizatriptán ratiopharm contains sodium

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

Rizatriptan ratiopharm is used to treat migraine attacks. Take Rizatriptan ratiopharm as soon as possible once your migraine headache has started. Do not use it to prevent a migraine attack.

Always follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is 10 mg.

If you are taking propranolol or have kidney or liver problems, you must take the 5 mg dose of rizatriptan. This dose may be available for other medications that contain rizatriptan on the market. You must wait at least 2 hours between the intake of propranolol and rizatriptan up to a maximum of 2 doses in a 24-hour period.

How to administer Rizatriptan ratiopharm

Rizatriptan ratiopharm is a buccal disintegrating tablet that dissolves in the mouth.

The buccal disintegrating tablet can be used in situations where there are no liquids available, or to avoid nausea and vomiting that may accompany the ingestion of tablets with liquids.

Do not handle the tablets with wet hands as the buccal disintegrating tablets can break.

1. Hold the blister pack by the edges and separate one blister from the rest of the strip along the perforations.
2. Separate the back carefully.
3. Gently push the tablet out.
4. Deposit the tablet on your tongue. It will dissolve directly in your mouth, and you can swallow it easily.

If the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear in a 24-hour period. If your migraine reappears, you can take an additional dose of Rizatriptan ratiopharm. 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 Rizatriptan ratiopharm during an attack, do not take a second dose of Rizatriptan ratiopharm for the treatment of the same attack.

However, it is still likely that you will respond to Rizatriptan ratiopharm during the next attack.

Do not take more than 2 doses of Rizatriptan ratiopharm in a 24-hour period (for example, do not take more than 2 buccal disintegrating tablets of 10 mg in a 24-hour period). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

If you take more Rizatriptan ratiopharm than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Rizatriptán ratiopharm can cause side effects, although not everyone will experience them. The following side effects may occur with this medicine.

In studies in adults, the side effects reported most frequently 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, insomnia,
• rapid or irregular heartbeat (palpitations),
• flushing (temporary redness of the face),
• throat discomfort,
• unpleasantness (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia)
• heaviness in parts of the body, neck pain, numbness,
• abdominal or chest pain

Infrequent:may affect up to 1 in 100 people

• unsteadiness (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope),
• confusion, nervousness,
• high blood pressure (hypertension); thirst, hot flushes, sweating,
• skin rash, itching, and hives (urticaria); swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea),
• sensation of stiffness in parts of the body, muscle weakness,
• changes in heart rhythm or frequency (arrhythmia); electrocardiogram (ECG) abnormalities, rapid heartbeat (tachycardia)
• facial pain, muscle pain.

Rare:may affect up to 1 in 1000 people

• breathing sounds,
• allergic reaction,(hypersensitivity); sudden and potentially life-threatening allergic reaction (anaphylaxis)

• stroke (this usually occurs in patients with risk factors for

heart disease or blood vessel disease (hypertension, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years old, postmenopausal woman, and a specific problem with the way your heart beats (left branch block)),

• slow heartbeat (bradycardia).

Unknown:cannot be estimated from available data

• heart attack, spasms of the heart's blood vessels (these usually occur in patients with risk factors for heart disease or blood vessel disease (hypertension, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years old, postmenopausal woman, and a specific problem with the way your heart beats (left branch block)),
• a 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 peeling of the skin with or without fever (toxic epidermal necrolysis),
• seizure (convulsion)
• spasm of the blood vessels of the extremities including coldness and numbness of the hands or feet
• contraction of the blood vessels of the colon (large intestine), which may cause abdominal pain.

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

Also, inform your doctor if you experience any symptom that suggests an allergic reaction (such as rash or itching) after taking Rizatriptán ratiopharm.

Reporting of side effects:

If you experience any 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 directly through the Spanish System for the 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 after the abbreviation 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. Dispose of packaging and medications you no longer need at your local SIGRE drop-off point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rizatriptan ratiopharm

The active ingredient is rizatriptan. The other components are: Lactose monohydrate, Cornstarch, Mannitol (E421), Pregelatinized cornstarch, Aspartame (E951), Peppermint flavor, Anhydrous colloidal silica, Sodium stearate fumarate

Appearance of the product and content of the container

Rizatriptan ratiopharm 10 mg buccal dispersible tablets: are white to off-white, round, smooth, beveled-edge tablets, engraved with ‘IZ’ on one side and ‘10’ on the other side.

Container sizes: 2x1, 3x1, 6x1, 12x1, 18x1, 28x1 or 30x1 buccal dispersible tablets in OPA/Aluminum/PVC-Aluminum pre-cut single-dose blisters.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid

Spain

Responsible for manufacturing

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Operations Poland Sp.z.o.o.

ul. Mogilska 80. 31-546, Krakow

Poland

or

Merckle GmbH

Ludwig-Merckle-Straße 3, 89143 Blaubeuren

Germany

or

S.C. LABORMED-PHARMA S.A.,

44B Theodor Pallady Blvd., 3rd district,

Bucharest, code 032266,

Romania

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

Germany: Rizatriptan AbZ 10mg Melting tablets

Spain: Rizatriptan ratiopharm 10mg buccal dispersible tablets EFG

Revision date of this leaflet:July 2024

The updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/