Rizatriptan TilloMed 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptan Tillomed 10 mg tablets EFG

Read the entire 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 should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Rizatriptan tablets are and what they are used for
2. What you need to know before taking Rizatriptan tablets
3. How to take Rizatriptan tablets
4. Possible side effects
5. How to store Rizatriptan tablets
6. Contents of the pack and other information

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

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

Rizatriptan is used to treat headache pain during migraine attacks in adults.

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

2. What you need to know before taking Rizatriptan tablets

Do not take Rizatriptan tablets:

• if you are allergic to rizatriptan (benzoate) or to any of the other ingredients 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 symptoms related to heart disease,
• you have severe liver or kidney problems,
• you have had a stroke or transient ischaemic attack (TIA),
• you have arterial obstruction problems (peripheral vascular disease),
• you are taking monoamine oxidase inhibitors (MAOIs) 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 MAOI,
• 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 Rizatriptan tablets with other medicines).

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

Warnings and precautions

Talk to 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, 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 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 are taking 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 or tightness.

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

Inform your doctor or pharmacist about all your symptoms. Your doctor will determine whether you have migraine. You should only take this medicine for a migraine attack. This medicine should not be used to treat other types of headache that may be caused by more serious conditions.

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies and any medicines you usually take for migraine. This is because Rizatriptan tablets may affect how 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 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 Rizatriptan tablets, may increase the risk of adverse effects.

After taking this medicine, 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 this medicine.

Ask your doctor for instructions on how to take Rizatriptan tablets and information about 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, and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 drink

This medicine may take longer to work if taken after meals. Although it is best taken 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.

It is unknown whether Rizatriptan tablets are harmful to the fetus when taken by pregnant women.

Breastfeeding should be avoided for 24 hours after treatment.

Use in patients over 65 years of age

There are no complete studies evaluating the safety and efficacy of Rizatriptan tablets in patients over 65 years of age.

Driving and using machines

When taking Rizatriptan tablets, you may feel drowsy or dizzy. If this occurs, do not drive or operate 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 informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Rizatriptan tablets

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

Follow exactly the instructions for use 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 tablets. You must wait at least 2 hours between taking propranolol and taking Rizatriptan tablets, and no more than 2 doses should be taken within a 24-hour period.

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

If migraine recurs within 24 hours

In some patients, migraine symptoms may reappear within a 24-hour period. If your migraine recurs, you may take an additional dose of Rizatriptan tablets. 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 tablets during an attack, you should not take a second dose of this medicine to treat 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 medicine within a 24-hour period (for example, do not take more than two 10 mg or 5 mg tablets within 24 hours). 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, contact your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Poison Information Service, telephone: (91) 5620420, stating the medicine and the amount ingested.

Take the medicine packaging with you.

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, this medicine can cause adverse effects, although not everyone will experience them.

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

Common (may affect up to 1 in 10 people)

• tingling sensation (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental sharpness, insomnia,
• fast or irregular heartbeat (palpitations),
• flushing (reddening of the face lasting a short time),
• throat discomfort,
• malaise (nausea), dry mouth, vomiting, diarrhoea, 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, tremor, fainting (syncope),
• confusion, nervousness,
• high blood pressure (hypertension); thirst, hot flushes, sweating,
• skin rash, itching and rash with lumps (urticaria); swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnoea),
• sensation of stiffness in parts of the body, muscle weakness,
• changes in heartbeat rhythm or frequency (arrhythmia); electrocardiogram abnormalities (a test that records the electrical activity of your heart), very fast heartbeat (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 (hypertension, diabetes, smoker, 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 your heart beats (left bundle branch block))),
• slow heartbeat (bradycardia).

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

• myocardial infarction, spasms of the blood vessels in the heart (these usually occur in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, 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 your heart beats (left bundle branch block))),
• 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.
• severe peeling of the skin with or without fever (toxic epidermal necrolysis),
• 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.

Contact 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 this medicine.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Rizatriptan Tablets

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

Do not use this medicine after the expiry date stated on the carton or blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Rizatriptan tablets

• The active substance is rizatriptan. One 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 contents of the pack

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

Rizatriptán Tillomed tablets are available in single-dose pre-cut aluminum blisters (forming film: OPA/Alu/PVC) with aluminum lidding foil (PAP/PET/AL) containing 3, 6, 12, and 18 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Tillomed Spain, S.L.U.

C/ Cardenal Marcelo Spínola 8, planta 1ª, puerta F

28016 Madrid

Spain

Manufacturer:

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road

Portmarnock, Co. Dublin

Ireland

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: 02/2017

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