Rizatriptan Flas PensA 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptán flas pensa 10 mg orodispersible tablets EFG

Read all of 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 prescribed for you only, and you should not give it to others, 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 effects not listed in this leaflet.

Contents of the leaflet:

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

1. What Rizatriptán Flas Pensa is and what it is used for

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

Rizatriptán Flas Pensa is used to treat headache pain during migraine attacks in adults.

Treatment with Rizatriptán Flas Pensa:

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

2. What you need to know before starting to take Rizatriptán Flas Pensa

Do not take Rizatriptán Flas Pensa

• if you are allergic to the active substance (rizatriptan benzoate) or to any of the other components of this medicine (listed in section 6).
• you have moderately severe, severe, or uncontrolled mild high blood pressure.
• you have or have ever had heart problems, including myocardial infarction or chest pain (angina), or have experienced signs related to heart disease.
• you have severe liver or kidney problems.
• you have had a stroke (CVA) or a transient ischemic attack (TIA).
• you have arterial obstruction problems (peripheral vascular disease).
• you are taking monoamine oxidase inhibitors (MAO inhibitors) such as moclobemide, phenelzine, tranylcypromine, or pargyline (medicines for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAO inhibitor.
• you are currently taking an ergotamine-type medicine, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent migraine attacks.
• you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine. (See below: Use of Rizatriptán Flas Pensa with other medicines.)

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before taking Rizatriptán Flas Pensa.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Rizatriptán Flas Pensa.

Before taking Rizatriptán 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 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 ever had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or
• weakness in the arm or leg.
• you take herbal remedies 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 Rizatriptán Flas Pensa too frequently, this may lead to chronic headache. In such cases, contact your doctor, as you may need to stop taking Rizatriptán Flas Pensa.

Inform your doctor or pharmacist about all your symptoms. Your doctor will determine whether you have migraine. You should only take Rizatriptán Flas Pensa for a migraine attack.

Rizatriptán Flas Pensa must not be used to treat other headaches that may be caused by more serious conditions.

Tell your doctor if you are currently using, have recently used, or might need to use any other medicines. This includes herbal remedies and medicines you usually take for migraine. This is because Rizatriptán Flas Pensa may affect how some medicines work. Other medicines may also affect Rizatriptán Flas Pensa.

Use of Rizatriptán Flas Pensa with other medicines

Do not take Rizatriptán 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 less than two weeks have passed since you stopped taking an MAOI.
• if you are taking ergotamine-type medicines, such as ergotamine or dihydroergotamine to treat your migraine.
• if you are taking methysergide to prevent migraine attacks.

The above-mentioned medicines, when taken with Rizatriptán Flas Pensa, may increase the risk of adverse effects.

After taking Rizatriptán Flas Pensa, you must wait at least 6 hours before taking ergotamine-type medicines such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medicines, you must wait at least 24 hours before taking Rizatriptán Flas Pensa.

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

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

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Taking Rizatriptán Flas Pensa with food and drink

Rizatriptán Flas Pensa may take longer to work if taken after meals. Although it is better 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 Rizatriptán 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 delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Use in children

The use of Rizatriptán Flas Pensa is not recommended in children under 18 years of age.

Use in patients over 65 years of age

There are no complete studies evaluating the safety and efficacy of Rizatriptán Flas Pensa in patients over 65 years of age.

Driving and using machines

Rizatriptán Flas Pensa may cause drowsiness or dizziness. If this occurs, do not drive or operate tools or machinery.

Important information about some of the components of Rizatriptán Flas Pensa

This tablet contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Rizatriptan Flas Pensa

Rizatriptan Flas Pensa is used to treat migraine attacks. Take Rizatriptan Flas Pensa as soon as possible after migraine headache symptoms begin. Do not use it to prevent an attack.

Follow exactly the dosing instructions for this medicine provided by your doctor or pharmacist. If in 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 must wait at least 2 hours between taking propranolol and Rizatriptan Flas Pensa, and take no more than 2 doses 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 returns, you may take an additional dose of Rizatriptan Flas Pensa. 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 Rizatriptan Flas Pensa during an attack, you should not take a second dose of Rizatriptan Flas Pensa to treat the same attack. However, you are still likely to respond to Rizatriptan Flas Pensa during the next migraine attack.

Do not take more than 2 tablets of Rizatriptan Flas Pensa within 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

• Peel back the upper aluminum foil and carefully remove the tablet. Do not push the tablet through the aluminum foil.
• Place the tablet on the tongue, where it will dissolve, and swallow it with saliva.
• The orodispersible tablet may be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

If you take more Rizatriptan Flas Pensa than you should

If you take more Rizatriptan Flas Pensa than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 5620420, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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, Rizatriptán Flas Pensa may cause adverse effects, although not everyone experiences them. The following adverse effects may occur with this medicine.

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

Common (may affect up to 1 in 10 people):

• tingling sensation (paresthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, tremor,
• rapid or irregular heartbeat (palpitation), very fast heartbeat (tachycardia),
• flushing (reddening of the face lasting a short time), hot flushes, sweating,
• throat discomfort, difficulty breathing (dyspnea),
• nausea, dry mouth, vomiting, diarrhoea,
• heaviness in parts of the body,
• abdominal or chest pain,
• skin rash.

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

• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision,
• confusion, insomnia, nervousness,
• high blood pressure (hypertension); thirst, indigestion (dyspepsia),
• itching and rash with bumps (urticaria), allergic reaction (hypersensitivity); swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema),
• neck pain, sensation of stiffness in parts of the body, numbness, muscle weakness.

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

• unpleasant taste in the mouth,
• fainting (syncope), 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,
• facial pain, noisy breathing,
• sudden and potentially life-threatening allergic reaction (anaphylaxis); severe peeling of the skin with or without fever (toxic epidermal necrolysis),
• myocardial infarction, spasms of the blood vessels in the heart, stroke.

These events generally occurred in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoking, use of nicotine replacement therapy, 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)).

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

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

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

In addition, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or itching) after taking Rizatriptán Flas Pensa.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of Rizatriptan Flas Pensa

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

Do not use this medicine after the expiry date stated on the carton/pouch/foil pack after "EXP". The expiry date refers to 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 unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan Flas Pensa

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

Appearance of the product and contents of the pack

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

Rizatriptan Flas Pensa 10 mg tablets are available in packs containing 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 most recent revision of this leaflet: January 2013.

Other sources of information:

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