Rizatriptan Teva

Patient Information Leaflet

Rizatriptan Teva 5 mg Orodispersible Tablets, 10 mg Orodispersible Tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rizatriptan Teva is and what it is used for

Rizatriptan Teva belongs to a class of medicines called selective serotonin 5-HT receptor agonists.
Rizatriptan Teva is used to treat migraine attacks with or without aura.
Rizatriptan Teva is used to treat the headache phase of a migraine attack in adults.
Treatment with Rizatriptan Teva:
Reduces the dilation of blood vessels surrounding the brain. This dilation is responsible for headache during a migraine attack.

2. What you need to know before taking Rizatriptan Teva

Do not take Rizatriptan Teva

• if you are allergic to rizatriptan or to any of the excipients of this medicine (listed in section 6).
• if you have moderately or severely high blood pressure, or if you have mild high blood pressure that is not controlled with medication.
• if you have or have ever had heart problems, including heart attacks or chest pain (angina), or if you have shown signs related to heart disease.
• if you suffer from severe liver or kidney problems.
• if you have had a stroke (cerebrovascular accident - CVA) or a mini-stroke (transient ischaemic attack - TIA).
• if you have arterial occlusion problems (peripheral vascular disease).
• if you are currently 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 MAOIs.
• if you are currently taking ergotamine-containing medicines, such as ergotamine or dihydroergotamine, to treat your migraine, or methysergide to prevent a migraine attack.
• if you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan or zolmitriptan, for the treatment of migraine (see Other medicines and Rizatriptan Teva below).

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before
taking Rizatriptan Teva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rizatriptan Teva

• if you have any of the following risk factors for heart disease: high blood pressure, diabetes, if you are a smoker or using nicotine replacement therapy, if there is a family history of heart disease, if you are a man over 40 years of age, or if you are a post-menopausal woman.
• if you have kidney or liver problems.
• if you have a specific heart rhythm problem (bundle branch block).
• if you have or have had allergies.
• if your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arms and legs.
• if you are using herbal preparations containing St. John’s wort.
• if you have ever experienced allergic reactions such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema).
• if you are taking selective serotonin reuptake inhibitors (SSRIs), such as sertraline, escitalopram oxalate and fluoxetine, or serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine, for depression.
• if you have experienced transient symptoms including chest pain and tightness.

If you take Rizatriptan Teva too frequently, your headache may become chronic. In such cases, you
should contact your doctor, as it may be necessary to discontinue treatment with Rizatriptan
Teva.
Inform your doctor or pharmacist about your symptoms. Your doctor will assess whether you suffer
from migraine. You should take Rizatriptan Teva only for a migraine attack. Rizatriptan Teva must not
be used to treat headaches that could be caused by more serious underlying medical conditions.
Use in patients over 65 years of age
Appropriate studies to evaluate the safety and efficacy of Rizatriptan Teva in patients over 65 years
of age have not been conducted.
Use in children and adolescents
The use of Rizatriptan Teva in children and adolescents under 18 years of age is not recommended.
Other medicines and Rizatriptan Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This includes over-the-counter medicines, herbal remedies, and medicines you usually
take for migraine. This is because Rizatriptan Teva may affect how some medicines work. In addition,
other medicines may affect how Rizatriptan Teva works.
Do not take Rizatriptan Teva:

• if you are already taking a 5HT receptor agonist (sometimes referred to as '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 using ergotamine-containing medicines, such as ergotamine or dihydroergotamine, to treat migraine.
• if you are using methysergide to prevent migraine attacks.

The above-mentioned medicines, when taken concomitantly with Rizatriptan Teva, may
increase the risk of adverse effects.
You must wait at least 6 hours after taking Rizatriptan Teva before taking ergotamine-containing
medicines such as ergotamine or dihydroergotamine or methysergide.
You must wait at least 24 hours after taking ergotamine-containing medicines before taking
Rizatriptan Teva.
Consult your doctor for instructions on how to use the medicine and for possible risks associated
with taking Rizatriptan Teva

• if you are taking propranolol (see section 3 How to take Rizatriptan Teva)
• if you are taking SSRIs such as sertraline, escitalopram oxalate and fluoxetine or SNRIs such as venlafaxine and duloxetine for depression.

Rizatriptan Teva with food and drink
The effect of Rizatriptan Teva may be delayed if taken after meals. Therefore, it is preferable to take
the medicine on an empty stomach, although it may also be taken after eating.
Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding,
consult your doctor or pharmacist.
It is not known whether Rizatriptan Teva is harmful to the baby when taken during pregnancy.
Breast-feeding should be avoided for 24 hours after taking the medicine.
Driving and using machines
While taking Rizatriptan Teva, you may feel drowsy or dizzy. If this occurs, do not drive or operate tools or machinery.
Rizatriptan Teva contains aspartame (E951) and lactose
Contains aspartame, a source of phenylalanine. It may be harmful for people with phenylketonuria.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor
before taking this medicine.

3. How to take Rizatriptan Teva

Rizatriptan Teva is used to treat migraine attacks. Take Rizatriptan Teva as soon as possible after the onset of a migraine headache. Do not use this medicine to prevent an attack.
Always take this medicine exactly as instructed by your doctor or pharmacist.
Consult your doctor or pharmacist if you are unsure.

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 Teva. You must wait at least 2 hours between taking propranolol and Rizatriptan Teva, and no more than 2 doses should be taken within 24 hours.

How to administer Rizatriptan Teva
Rizatriptan Teva is an orodispersible tablet that dissolves in the mouth.
The orodispersible tablet can be used when liquids are not available, or to avoid nausea or vomiting that may occur when swallowing tablets with liquid.
Do not touch the orodispersible tablets with wet hands, as they may break.

1. Hold the blister strip by the edges and separate one tablet section from the rest of the strip by gently tearing along the perforated lines.
2. Carefully lift the foil covering.
3. Gently push the tablet out.
4. Place the tablet on your tongue, where it will dissolve rapidly, facilitating swallowing.

If migraine recurs after 24 hours
In some patients, migraine symptoms may reappear within 24 hours. If the migraine returns, you may take an additional dose of Rizatriptan Teva. Always wait at least 2 hours between doses.

If migraine persists after 2 hours
If there is no response to the first dose of Rizatriptan Teva during an attack, do not take a second dose of Rizatriptan Teva to treat the same attack.
However, you may still respond to Rizatriptan Teva during a subsequent attack.

Do not take more than two doses of Rizatriptan Teva within 24 hours (for example, do not take more than two 5 mg orodispersible tablets or two 10 mg orodispersible tablets in 24 hours). Always wait at least 2 hours between doses.
If symptoms worsen, seek medical advice from your doctor.

If you take more Rizatriptan Teva than you should
If you have taken more Rizatriptan Teva than you should, contact your doctor or pharmacist immediately. Take the medicine pack with you.
Signs of overdose may include dizziness, drowsiness, vomiting, fainting, and slowed heart rate.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.
In studies conducted in adults, the most commonly reported side effects were dizziness, drowsiness, and fatigue.

Common: may affect up to 1 in 10 people

• tingling sensations (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), reduced mental sharpness, insomnia
• rapid or irregular heartbeat (palpitations) – flushing (short-lived redness of the face)
• throat irritation
• feeling unwell (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
• sensation of heaviness in parts of the body, neck pain, stiffness
• 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 skin rash with raised lumps (urticaria), swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea)
• sensation of tightness in parts of the body, muscle weakness
• changes in heart rhythm or rate (arrhythmia), abnormalities in the electrocardiogram (an examination that records the electrical activity of the heart), very fast heartbeat (tachycardia)
• facial pain, muscle pain

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

• shortness of breath
• allergic reaction (hypersensitivity); sudden potentially life-threatening allergic reaction (anaphylaxis)
• stroke (this generally occurs in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapies, family history of heart disease or stroke, men over 40 years, post-menopausal women, specific heart rhythm problems (bundle branch block))).
• slow heartbeat (bradycardia)

Not known: frequency cannot be estimated from the available data

• heart attack, spasm of blood vessels in the heart (this generally occurs in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapies, family history of heart disease or stroke, men over 40 years, post-menopausal women, specific heart rhythm problems (bundle branch block))).
• a syndrome called "serotonin syndrome" which may cause side effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation, and hallucinations.
• severe peeling of the skin, with or without fever (toxic epidermal necrolysis).
• seizures (convulsions/attacks).
• spasm of blood vessels in the limbs, including coldness and numbness of the hands and feet.
• spasm of blood vessels in the colon (large intestine), which may cause abdominal pain.

Contact your doctor immediately if you experience symptoms of allergic reactions,
serotonin syndrome, heart attack or stroke.
Also inform your doctor if you develop symptoms suggesting an allergic reaction (such as skin rash or itching) after taking Rizatriptan Teva.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rizatriptan Teva

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 cardboard box and on the
blister after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the tablets from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Rizatriptan Teva contains
The active substance is rizatriptan.
One 5 mg orodispersible tablet contains 5 mg of rizatriptan, equivalent to 7.265 mg of
rizatriptan benzoate.
One 10 mg orodispersible tablet contains 10 mg of rizatriptan, equivalent to 14.53 mg of
rizatriptan benzoate.
The other components are: Monohydrate lactose, maize starch, Mannitol (E421), Pregelatinized starch (maize), Aspartame (E951), Peppermint flavor, Anhydrous colloidal silica, Sodium stearyl fumarate.

Description of the appearance of Rizatriptan Teva and contents of the pack
Rizatriptan Teva 5 mg orodispersible tablets: White to off-white, round, flat orodispersible tablets with bevelled edges, marked with the code 'IZ' on one side and '5' on the other side.
Rizatriptan Teva 10 mg orodispersible tablets: White to off-white, round, flat orodispersible tablets with bevelled edges, marked with the code 'IZ' on one side and '10' on the other side.
Pack sizes: 2, 3, 6, 12, 18, 28 or 30 orodispersible tablets per pack.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano, Italy

Manufacturers
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
TEVA Pharmaceutical Works Private Limited Company, H-2100 Gödöllő, Táncsics Mihály út 82, Hungary
TEVA UK Ltd, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
Teva Operations Poland Sp. z.o.o., ul. Mogilska 80, 31-546 Krakow, Poland
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

This medicinal product is authorized in the European Economic Area countries under the
following names:
Rizatriptan Teva 5 mg orodispersible tablets
Denmark: Rizatriptan Teva
Germany: Rizatriptan ratiopharm 5 mg Schmelztabletten
Italy: Rizatriptan Teva
Netherlands: Rizatriptan disp 5 mg Teva, orodispergeerbare tabletten
Sweden: Rizatriptan Teva 5 mg munsönderfallande tabletter

Rizatriptan Teva 10 mg orodispersible tablets
Denmark: Rizatriptan Teva
France: Rizatriptan Teva 10 mg, comprimé orodispersible
Germany: Rizatriptan ratiopharm 10 mg Schmelztabletten
Italy: Rizatriptan Teva
Netherlands: Rizatriptan disp 10 mg Teva, orodispergeerbare tabletten
Spain: Rizatriptan Teva 10mg comprimidos bucodispersables EFG
Sweden: Rizatriptan Teva 10 mg munsönderfallande tabletter
United Kingdom: Rizatriptan 10 mg Orodispersible Tablets