RIZATRIPTAN 5 mg Orodispersible Tablet

Зміст інструкції

1. Rizatriptan Teva 5 mg Orodispersible Tablets, 10 mg Orodispersible Tablets
   1. What is Rizatriptan Teva 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. Package contents and other information

Rizatriptan Teva 5 mg Orodispersible Tablets, 10 mg Orodispersible Tablets

Generic medicine

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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Rizatriptan Teva 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 for the treatment of migraine attacks with or without aura.
Rizatriptan Teva is used to treat the headache that develops during a migraine attack in
adults.
Treatment with Rizatriptan Teva:
Reduces the dilation of blood vessels surrounding the brain. This dilation, in fact,
causes the 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 any of the other ingredients of this medicine (listed in section 6).
• if your blood pressure is moderately or severely high, or if you have mildly 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 experienced symptoms 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 ischemic attack - TIA).
• if you have problems with blocked 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 less than two weeks have passed since you stopped taking MAOIs.
• if you are currently taking ergotamine medications, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent migraine attacks.
• if you are taking any other medicine of the same class, such as sumatriptan, naratriptan or zolmitriptan, for the treatment of migraine (see Other medicines andRizatriptan Tevabelow).

If you are not sure if any of the above applies to you, talk to 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 are 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 particular problem related to your heartbeat (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 legs and arms.
• 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 that can 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 often, your headache may become chronic. In these cases you should
contact your doctor, as it may be necessary to stop taking Rizatriptan
Teva.
Tell your doctor or pharmacist about your symptoms. The doctor will assess whether you suffer from migraine. You must
only take Rizatriptan Teva for a migraine attack. Rizatriptan Teva should not be
used for the treatment of headaches that may be caused by other, more serious medical conditions.

Use in patients over 65 years of age
Appropriate studies have not been conducted to evaluate the safety and efficacy of Rizatriptan Teva
in patients over 65 years of age.

Use in children and adolescents
The use of Rizatriptan Teva in children and adolescents under the age of 18 is not
recommended.

Other medicines and Rizatriptan Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines you buy without a prescription, herbal medicines
and those you usually take for migraine. This is because Rizatriptan Teva can affect how some medicines work. Also, other medicines can affect how
Rizatriptan Teva works.
Do not take Rizatriptan Teva:

• if you are already taking a 5HT receptor 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 using ergotamine medications, such as ergotamine or dihydroergotamine, to treat migraine.
• if you are using methysergide to prevent migraine attacks.

The medicines listed above, when taken together with Rizatriptan Teva, can
increase the risk of side effects.
You must wait at least 6 hours after taking Rizatriptan Teva before taking ergotamine medications such as ergotamine or dihydroergotamine or methysergide.
You must wait at least 24 hours after taking ergotamine medications before taking
Rizatriptan Teva.
Ask 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 it is taken after meals. Therefore, it is
preferable to take the medicine on an empty stomach, although it can also be taken after
eating.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice.
It is not known whether Rizatriptan Teva is harmful to the baby when taken by a pregnant
woman.
Breastfeeding should be avoided for 24 hours after taking the medicine.

Driving and operating machinery
While taking Rizatriptan Teva you may feel drowsy or dizzy. If this happens, do not
drive and do not use tools or machinery.

Rizatriptan Teva contains aspartame (E951) and lactose
Contains aspartame, a source of phenylalanine. May be harmful to people with
phenylketonuria.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Rizatriptan Teva

Rizatriptan Tevais used to treat migraine attacks. Take Rizatriptan Tevaimmediately
after the start of a migraine headache. Do not use the medicine to prevent an attack.
Always take this medicine exactly as your doctor or pharmacist has told you.
Consult your doctor or pharmacist.
The recommended dose is 10 mg.
If you are currently taking propranolol or suffer from kidney or liver problems, you should use the
5 mg dose of Rizatriptan Teva. You must allow at least 2 hours to pass between taking
propranolol and Rizatriptan Teva, for a maximum of 2 doses 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 in cases where you do not have liquids available,
or to avoid nausea or vomiting that may be associated with taking tablets with
liquids.
Do not touch the orodispersible tablets with wet hands, as they may break.

• 1. Hold the blister strip by the edges and separate a section where the tablet is housed from the rest of the strip, tearing lightly along the perforated lines.
• 2. Carefully lift off the covering film.
• 3. Gently push the tablet out.
• 4. Place the tablet on your tongue, where it will dissolve rapidly, thus facilitating swallowing.

If the migraine returns after 24 hours
In some patients, migraine symptoms may reappear within 24 hours. If the migraine returns,
you can take a further dose of Rizatriptan Teva. You must always wait at least
2 hours between doses.

If you still have a migraine after 2 hours
If you do not respond to the first dose of Rizatriptan Teva during the attack, you should not take a
second dose of Rizatriptan Teva to treat the same attack.
However, it is still likely that you will respond to Rizatriptan Teva during the next 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 2 10 mg orodispersible tablets within 24
hours). You must always wait at least 2 hours between the two doses.
If your symptoms worsen, seek medical assistance.

If you take more Rizatriptan Teva than you should
If you have taken more Rizatriptan Teva than you should, seek immediate medical or
pharmacist advice. Bring the medicine packaging with you.
Signs of an overdose include dizziness, drowsiness, vomiting, fainting and
slowing of the heartbeat.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common:may affect up to 1 in 10 people

• tingling (paresthesia), headache, decreased skin sensitivity (hypoesthesia), decreased mental acuity, insomnia
• fast or irregular heartbeat (palpitations) - flushing (short-lived facial redness)
• discomfort to the throat
• feeling unwell (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia)
• feeling of heaviness in parts of the body, neck pain, stiffness
• pain in the abdomen or chest

Uncommon:may affect up to 1 in 100 people

• bad taste in the mouth
• instability when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope)
• confusion, nervousness
• high blood pressure (hypertension), thirst, hot flashes, sweating
• skin rash, itching and rash with the formation of bumps (urticaria), swelling of the face, lips, tongue and/or throat which can cause difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea)
• feeling of oppression in parts of the body, muscle weakness
• changes in the rhythm or frequency of the heartbeat (arrhythmia), abnormalities in the electrocardiogram (a test that records the electrical activity of the heart), very fast heartbeat (tachycardia)
• facial pain, muscle pain.

Rare:may affect up to 1 in 1000 people

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

Not known: frequency cannot be estimated based on available data

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

Immediately inform your doctor if you experience symptoms of allergic reactions, serotonin
syndrome, heart attack or stroke.
Also inform your doctor if symptoms appear that may suggest an allergic reaction
after taking Rizatriptan Teva.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 package to protect the tablets from moisture.
Do not dispose of any medicine in 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 ingredient is rizatriptan.
A 5 mg orodispersible tablet contains 5 mg of rizatriptan corresponding to 7.265 mg of
rizatriptan benzoate.
A 10 mg orodispersible tablet contains 10 mg of rizatriptan corresponding to 14.53 mg
of rizatriptan benzoate.
The other ingredients are: Lactose monohydrate, corn starch, Mannitol (E421), Starch (corn)
pregelatinized, Aspartame (E951), Peppermint flavour, Colloidal anhydrous silica, Sodium stearyl
fumarate.

Description of the appearance of Rizatriptan Teva and package contents
Rizatriptan Teva 5 mg orodispersible tablets: orodispersible tablets of white to off-white
ivory colour, round in shape, flat, with bevelled corners, inscribed with the writing ‘IZ’ on one side and ‘5’
on the other side.
Rizatriptan Teva 10 mg orodispersible tablets: orodispersible tablets of white to
off-white ivory colour, round in shape, flat, with bevelled corners, inscribed with the writing ‘IZ’ on one side and
‘10’ on the other side.
Packs: 2, 3, 6, 12, 18, 28 or 30 orodispersible tablets per pack.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan

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 authorised in the Member States of the European Economic Area under the
following denominations:

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