RIZATRIPTAN TILLOMED 10 mg TABLETS

2. What you need to know before you take Rizatriptan

Do not take Rizatriptan:

• if you are allergic to rizatriptan (benzoate) or any of the other ingredients of this medicine (listed in section 6),
• if you have moderately severe, severe, or uncontrolled high blood pressure,
• if you have or have 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 ergotamine-like medicines, such as ergotamine or dihydroergotamine for your migraine, or methysergide for preventing migraine attacks,
• if you are taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine. (See below Use of Rizatriptan with other medicines).

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Rizatriptan.

Before taking Rizatriptan, tell 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 certain 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 take herbal remedies 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),
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, oxalate of escitalopram, 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 this medicine too frequently, it may produce chronic headache. In such cases, you should contact your doctor, as you may need to stop taking this medicine.

Tell your doctor or pharmacist about all your symptoms. Your doctor will decide if you have migraine. You should only take this medicine for a migraine attack. This medicine should not be used to treat other types of headaches that may be caused by other more serious diseases.

Tell your doctor or pharmacist that you are taking or have recently taken or might take any other medicines. These include herbal remedies and those medicines that you take normally for migraine. This is because Rizatriptan may affect the way some medicines work. Other medicines may also affect the way Rizatriptan works.

Use of Rizatriptan with other medicines

Do not take Rizatriptan:

• 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 take ergotamine-like medicines, such as ergotamine or dihydroergotamine for your migraine.
• if you take methysergide to prevent migraine attacks.

The medicines mentioned above, when taken with Rizatriptan, may increase the risk of side effects.

After taking this medicine, you should wait at least 6 hours before taking ergotamine-like medicines such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-like medicines, you should wait at least 24 hours before taking Rizatriptan.

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

• if you are currently taking propranolol (see section 3 How to take Rizatriptan),
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, oxalate of escitalopram, and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Tell your doctor or pharmacist that you are taking or have recently taken or might take any other medicines.

Children and adolescents

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

Taking Rizatriptan with food and drinks

This medicine may take longer to work if you take it 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if Rizatriptan is harmful to the fetus when taken by a pregnant woman.

Breastfeeding should be avoided for 24 hours after treatment.

Use in patients over 65 years of 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 happens, do not drive or use tools or machines.

Rizatriptan contains lactose monohydrate

This medicine contains lactose. The 10 mg tablet contains 94.87 mg of lactose monohydrate. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Rizatriptan

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 exactly the administration instructions of this medicine 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. You should wait at least 2 hours between taking propranolol and Rizatriptan, up to a maximum of 2 doses in a 24-hour period.

Rizatriptan tablets should be taken orally and swallowed whole with a liquid.

If your 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 another dose of Rizatriptan. You should always wait at least 2 hours between doses.

If after 2 hours you still have migraine

If you do not respond to the first dose of Rizatriptan during a migraine attack, you should not take a second dose of this medicine for the treatment of the same attack. However, you may still respond to Rizatriptan during the next attack.

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

If your condition worsens, seek medical attention.

If you take more Rizatriptan than you should

If you take more Rizatriptan than you should, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Service, phone: (91) 5620420, indicating the medicine and the amount taken.

Bring the medicine package with you.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In adult studies, the most commonly reported side effects were dizziness, drowsiness, and fatigue.

Common (may affect up to 1 in 10 people)

• tingling sensation (paresthesia), headache, reduced sensitivity in the skin (hypoesthesia), decreased mental sharpness, insomnia,
• rapid or irregular heart rate (palpitations),
• flushing (redness of the face that lasts a short time),
• throat discomfort,
• nausea, dry mouth, vomiting, diarrhea, indigestion (dyspepsia),
• heaviness in parts of the body, neck pain, numbness,
• abdominal or chest pain.

Uncommon (may affect up to 1 in 100 people)

• bad taste in the mouth,
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremors, fainting (syncope),
• confusion, nervousness,
• high blood pressure (hypertension); thirst, hot flushes, sweating,
• skin rash, itching, and rash with hives (urticaria); swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnea),
• feeling of stiffness in parts of the body, muscle weakness,
• changes in heart rate or rhythm (arrhythmia); alterations in the electrocardiogram (a test that records the electrical activity of your heart), very rapid heart rate (tachycardia),
• facial pain; muscle pain.

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

• noisy breathing,
• allergic reaction (hypersensitivity); sudden and potentially life-threatening allergic reaction (anaphylaxis),
• stroke (this usually occurs in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years old, postmenopausal woman, and a certain problem with the way the heart beats (left bundle branch block)),
• slow heart rate (bradycardia).

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

• heart attack, spasms of the blood vessels of the heart (these usually occur in patients with risk factors for heart or blood vessel disease (high blood pressure, diabetes, smoker, use of nicotine substitutes, family history of heart disease or stroke, man over 40 years old, postmenopausal woman, and a certain 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 with or without fever (toxic epidermal necrolysis),
• seizures (convulsions/fits),
• contraction of the blood vessels of the limbs including cooling and numbness of hands and feet,
• contraction of the blood vessels of the colon (large intestine), which can cause abdominal pain.

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 symptom that indicates an allergic reaction (such as rash or itching) after taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for human use medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan

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

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan

• The active substance is rizatriptan. One tablet contains 10 mg of rizatriptan, equivalent to 14.53 mg of rizatriptan benzoate.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (E-460), pregelatinized starch (E1401), red iron oxide (E-172), and magnesium stearate (E-572).

Appearance of the product and pack contents

The 10 mg tablets are pale pink, capsule-shaped, and engraved with 'HP' on one side and '245' on the other.

Rizatriptan Tillomed is available in packs with unidose aluminum blister packs (OPA/Alu/PVC) and aluminum cover (PAP/PET/AL) of 3, 6, 12, and 18 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Tillomed Spain, S.L.U.

C/ Cardenal Marcelo Spínola 8, 1st floor, door F

28016 Madrid

Spain

Manufacturer:

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road

Portmarnock, Co. Dublin

Ireland

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:02/2017

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