RIZATRIPTAN FLAS PENSA 10 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Rizatriptan Flas Pensa

Do not take Rizatriptan Flas Pensa

• if you are allergic to the active substance (rizatriptan benzoate) or to 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 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 for migraine, or methysergide for preventing migraine attacks.
• if you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan for migraine. (See also "Using Rizatriptan Flas Pensa with other medications" below).

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Rizatriptan Flas Pensa.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptan Flas Pensa.

Before taking Rizatriptan Flas Pensa, inform your doctor or pharmacist if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or use 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 allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your leg and arm.

if you take herbal remedies containing St. John's Wort.

• if 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.

• if you have had transient symptoms including chest pain and tightness.

If you take Rizatriptan Flas Pensa too frequently, it may cause you to develop chronic headaches. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Flas Pensa.

Tell your doctor or pharmacist about all your symptoms. Your doctor will decide if you have migraines. You should only take Rizatriptan Flas Pensa for a migraine attack.

Rizatriptan Flas Pensa should not be used to treat other types of headaches that may be caused by other, more serious conditions.

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medications. These include herbal remedies and those you normally take for migraines. This is because Rizatriptan Flas Pensa may affect how some medications work, and other medications may also affect Rizatriptan Flas Pensa.

Using Rizatriptan Flas Pensa with other medications

Do not take Rizatriptan Flas Pensa:

• 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 migraines.
• if you are taking methysergide to prevent migraine attacks.

The above medications, when taken with Rizatriptan Flas Pensa, may increase the risk of side effects.

After taking Rizatriptan Flas Pensa, 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 Flas Pensa.

Ask your doctor for instructions on how to take Rizatriptan Flas Pensa and information about the risks

• if you are currently taking propranolol (see section 3 "How to take Rizatriptan Flas Pensa").
• 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.

Tell your doctor or pharmacist that you are using, have recently used, or might use any other medication.

Taking Rizatriptan Flas Pensa with food and drinks

Rizatriptan Flas Pensa 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 Flas Pensa 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 your baby.

Use in children

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

Use in patients over 65 years of age

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

Driving and using machines

When taking Rizatriptan Flas Pensa, you may feel drowsy or dizzy. If this happens, do not drive or use tools or machines.

Important information about some of the ingredients of Rizatriptan Flas Pensa

This tablet contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medication.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Rizatriptan Flas Pensa

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Follow exactly the administration instructions of this medication given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 Rizatriptan Flas Pensa. You should wait at least 2 hours between taking propranolol and Rizatriptan Flas Pensa, up to a maximum of 2 doses in a 24-hour period.

If the migraine comes back within 24 hours

In some patients, migraine symptoms may come back within 24 hours. If your migraine comes back, you can take an additional dose of Rizatriptan Flas Pensa. 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 Flas Pensa during an attack, you should not take a second dose of Rizatriptan Flas Pensa for the treatment of the same attack. However, you may still respond to Rizatriptan Flas Pensa during the next attack.

Do not take more than 2 tablets of Rizatriptan Flas Pensa in a 24-hour period.Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer Rizatriptan Flas Pensa

• Separate the top aluminum foil and carefully remove the tablet. Do not push the tablet through the aluminum foil.
• Place the tablet on your tongue, where it will dissolve, and swallow it with your saliva.
• The orodispersible tablet 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.

If you take more Rizatriptan Flas Pensa than you should

If you take more Rizatriptan Flas Pensa than you should, talk to your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 5620420, indicating the medication and the amount taken. It is recommended to bring the packaging and the package leaflet of the medication to the healthcare professional.

Signs of overdose may include dizziness, drowsiness, 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, Rizatriptan Flas Pensa can cause side effects, although not everybody gets them. 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, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, tremors,
• rapid or irregular heartbeat (palpitations), very rapid heartbeat (tachycardia),
• flushing (brief redness of the face), hot flashes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• nausea, dry mouth, vomiting, diarrhea,
• heaviness in parts of the body,
• abdominal or chest pain,
• skin rash.

Infrequent (may affect up to 1 in 100 people):

• unsteadiness (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension); thirst, indigestion (dyspepsia),
• itching and rash with hives (urticaria), allergic reaction (hypersensitivity); swelling of the face,

lips, tongue, or throat that can cause difficulty breathing or swallowing (angioedema),

• neck pain, stiffness in parts of the body, numbness, muscle weakness.

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

• bad taste in the mouth,
• fainting (syncope), 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,

facial pain, breathing sounds,

• sudden and potentially life-threatening allergic reaction (anaphylaxis); severe skin peeling with or without fever (toxic epidermal necrolysis),

heart attack, spasms of the heart's blood vessels, stroke.

These occurred mainly in patients with risk factors for heart disease or 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)).

Frequency not known (frequency cannot be estimated from the available data):

• seizures (convulsions/fits),
• contraction of the blood vessels in the limbs, including cooling and numbness of hands and feet,
• contraction of the blood vessels in the colon (large intestine), which can cause abdominal pain,
• muscle pain,
• changes in heart rhythm or frequency (arrhythmia), slow heart rate (bradycardia), alterations in the electrocardiogram (a test that records the electrical activity of your heart).

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

Also, tell your doctor if you experience any symptoms that indicate an allergic reaction (such as rash or itching) after taking Rizatriptan Flas Pensa.

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Rizatriptan Flas Pensa

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

Do not use this medication after the expiration date stated on the carton/outer packaging/foil/blister after "EXP". The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medication to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Rizatriptan Flas Pensa

• The active ingredient is rizatriptan. One orodispersible tablet contains 10 mg of rizatriptan, equivalent to 14.53 mg of rizatriptan benzoate.
  • The other components are: lactose monohydrate, microcrystalline cellulose (E460a), calcium silicate, crospovidone, aspartame (E951), peppermint flavor, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

The 10 mg orodispersible tablets are white, flat-faced, and round.

Rizatriptan Flas Pensa 10 mg tablets are available in packs of 2 or 6 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Neuraxpharm Pharmaceutical, S.L.

Avda. de Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Leaflet:January 2013.

Other Sources of Information:

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/