Leaflet: information for the user

Rizatriptan Tillomed 10 mg tablets EFG

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Rizatriptan tablets are and what they are used for

2. What you need to know before you start taking Rizatriptan tablets

3. How to take Rizatriptan tablets

4. Possible side effects

5. Storage of Rizatriptan tablets

6. Contents of the pack and additional information

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

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

Rizatriptán treatment: Reduces the swelling of blood vessels surrounding the brain. This swelling causes the headache of a migraine attack. Do not use it to prevent an attack.

Do not take Rizatriptan tablets:

• 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 mild high blood pressure that is not controlled with medication,
• if you have or have had any 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 or a transient ischemic attack (TIA),
• if you have peripheral vascular disease (obstruction in your arteries),
• if 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 an MAOI,
• if you are currently taking an ergotamine-type medication, such as ergotamine or dihydroergotamine for your migraine, or methysergide to prevent a migraine attack,
• if you are taking any other medication of the same class, such as sumatriptan, naratriptan, or zolmitriptan for your migraine. (See below Use of Rizatriptan tablets with other medicines).

If you are unsure whether 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 tablets.

Before taking Rizatriptan tablets, inform your doctor or pharmacist if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, or using 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 (left 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 medicines that contain 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, escitalopram oxalate, or fluoxetine, or serotonin and noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression,
• you have had transient symptoms including chest pain and pressure.

If you take this medicine frequently, it may cause chronic headache. In such cases, you should contact your doctor, as you may need to stop taking this medicine.

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

Inform your doctor that you are using, have used recently, or may need to use any other medicine. This includes herbal medicines and those you normally take for migraine. This is because Rizatriptan tablets may affect the way some medicines work. Other medicines may also affect this medicine.

Use of Rizatriptan tablets with other medicines

Do not take Rizatriptan tablets:

• 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 your migraine,
• if you are taking methysergide to prevent migraine attacks.

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

After taking this medicine, 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 this medicine.

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

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

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medicine.

Children and adolescents

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

Taking Rizatriptan tablets 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, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The safety of Rizatriptan tablets for use during pregnancy is unknown.

It is recommended to avoid breastfeeding for 24 hours after treatment.

Use in patients over 65 years

There are no completed studies to evaluate the safety and efficacy of Rizatriptan tablets in patients over 65 years of age.

Driving and operating machinery

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

Rizatriptan tablets contain 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 a certain sugar intolerance, consult with them before taking this medicine.

Rizatriptan tablets are used to treat migraine attacks. Take Rizatriptan tablets as soon as possible once your migraine headache has started. Do not use it to prevent an attack.

Follow exactly the administration instructions for this medication indicated 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 must use the 5 mg dose of Rizatriptan tablets. You must wait at least 2 hours between taking propranolol and Rizatriptan tablets 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 the migraine reappears in 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine reappears, you can take an additional dose of Rizatriptan tablets. 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 tablets during an attack, do not take a second dose of this medication for the same attack. However, you are still likely to respond to Rizatriptan tablets during the next attack.

Do not take more than 2 doses of this medication 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 must 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 tablets than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Service, phone: (91) 5620420, 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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia,
• rapid or irregular heart rate (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.

Less frequent (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 flashes, sweating,
• skin rash, itching, and hives (urticaria); swelling of the face, lips, tongue, 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 heart rate (tachycardia),
• facial pain; muscle pain.

Rare (may affect up to 1 in 1,000 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, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40 years old, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)),
• slow heart rate (bradycardia).

Unknown frequency (frequency 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, smoking, nicotine substitute use, family history of heart disease or stroke, male over 40 years old, postmenopausal woman, and a specific problem with the way the heart beats (left branch block)),
• a syndrome called "serotonin syndrome" that may cause side effects such as coma, unstable blood pressure, extremely high fever, muscle coordination problems, agitation, and hallucinations.
• severe skin peeling with or without fever (toxic epidermal necrolysis),
• seizures (convulsions/spasms),
• contraction of blood vessels in the extremities, including cooling and numbness of hands and feet,
• contraction of blood vessels in 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 symptoms that indicate an allergic reaction (such as rash or itching) after taking this medicine.

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 of Pharmacovigilance of human medicines:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box or in the blisterafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacisthow to dispose ofpackaging and medications that you no longerneed. In this way, you will help protect the environment.

Composition of Rizatriptan tablets

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

Appearance of the product and content of the container

The 10 mg tablets are pale pink, capsule-shaped, engraved with ‘HP’ on one face and “245” on the other.

Rizatriptan Tillomed tablets are available in pre-cut blister packs of aluminum (OPA/Alu/PVC) and aluminum-coated (PAP/PET/AL) containers of 3, 6, 12, and 18 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorios Tillomed Spain, S.L.U.

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

28016 Madrid

Spain

Responsible for manufacturing:

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 with the following names:

Last review date of thisleaflet:02/2017

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