PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Rizatriptan Zentiva Italia 10 mg orodispersible tablets

Generic medicine
Read this entire leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Rizatriptan Zentiva Italia is and what it is used for
What you need to know before taking Rizatriptan Zentiva Italia
How to take Rizatriptan Zentiva Italia
Possible side effects
How to store Rizatriptan Zentiva Italia
Contents of the pack and other information

1. What Rizatriptan Zentiva Italia is and what it is used for

Rizatriptan Zentiva Italia belongs to a class of medicines called selective serotonin 5-HT receptor agonists.
Your doctor has prescribed Rizatriptan Zentiva Italia to treat the headache phase of a migraine attack in adults. Do not use it to prevent an attack.
Treatment with Rizatriptan Zentiva Italia reduces the vasodilation of blood vessels surrounding the brain. This vasodilation causes the headache phase of a migraine attack.

2. What you need to know before taking Rizatriptan Zentiva Italia

Do not take Rizatriptan Zentiva Italia if:

you are allergic to rizatriptan benzoate or to any of the other ingredients of Rizatriptan Zentiva Italia (listed in section 6);
you have moderate to severe high blood pressure, or uncontrolled mild high blood pressure;
you currently have or have previously had heart problems, including heart attack or chest pain (angina), or have experienced signs related to heart disease;
you have severe liver or kidney problems;
you have had a stroke (cerebrovascular accident, CVA) or a mini-stroke (transient ischaemic attack, TIA);
you have arterial occlusion 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 2 weeks have passed since you stopped taking MAO inhibitors;
you are taking ergotamine-like medicines, such as ergotamine or dihydroergotamine for migraine, or methysergide to prevent migraine attacks;
you are taking any other medicine belonging to the same class, such as sumatriptan, naratriptan, or zolmitriptan, for treating migraine (see "Other medicines and Rizatriptan Zentiva Italia" below). Page 1 of 6

If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking Rizatriptan Zentiva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rizatriptan Zentiva Italia if:

you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking or use of nicotine replacement products, family history of heart disease, if you are a man over 40 years of age, or a post-menopausal woman;
you have kidney or liver problems;
you have a specific heart rhythm problem (bundle branch block);
you have or have had allergies;
your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in the arms or legs;
you are using herbal preparations containing St. John’s wort;
you have had an allergic reaction such as swelling of the face, lips, tongue, and/or throat, which could cause difficulty breathing and/or swallowing (angioedema);
you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, or fluoxetine, or serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine or duloxetine for depression, or you are taking buprenorphine (a strong painkiller) with or without naloxone. Using these medicines with Rizatriptan Zentiva Italia may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Rizatriptan Zentiva Italia").
you have experienced brief episodes of symptoms including chest pain or tightness.

If you take Rizatriptan Zentiva Italia too frequently, it may cause chronic headache. In this case, inform your doctor, as you may need to stop treatment with Rizatriptan Zentiva Italia.
Inform your doctor or pharmacist about any symptoms you experience. Your doctor will determine whether you have migraine.
Use Rizatriptan Zentiva Italia only for the treatment of migraine attacks. Rizatriptan Zentiva Italia must not be used to treat headaches that could be caused by more serious conditions.
Other medicines and Rizatriptan Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This includes herbal preparations and what you usually take for migraine. This is because Rizatriptan Zentiva Italia may affect how other medicines work. Other medicines may also affect how Rizatriptan Zentiva Italia works.
Do not take Rizatriptan Zentiva Italia if you are taking:

a 5-HT agonist (sometimes known as "triptans"), such as sumatriptan, naratriptan, or zolmitriptan;
a monoamine oxidase inhibitor (MAOI) such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if less than 2 weeks have passed since stopping an MAO inhibitor;
ergotamine-like medicines, such as ergotamine or dihydroergotamine, for treating migraine;
methysergide to prevent migraine attacks.

Taking the above medicines together with Rizatriptan Zentiva Italia may increase the risk of adverse effects.
You must wait at least 6 hours after taking Rizatriptan Zentiva Italia before taking ergotamine-like medicines such as ergotamine or dihydroergotamine, or methysergide.
You must wait at least 24 hours after taking ergotamine-like medicines before taking Rizatriptan Zentiva Italia.
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Ask your doctor for advice and information about the risks associated with taking Rizatriptan Zentiva Italia if you are taking:

propranolol (see section 3).

Some medicines may increase the adverse effects of Rizatriptan Zentiva Italia and sometimes may cause a very serious reaction called serotonin syndrome.
Do not take other medicines while taking Rizatriptan Zentiva Italia without first talking to your doctor, especially:

SSRIs such as sertraline, escitalopram oxalate, or fluoxetine, or
SNRIs such as venlafaxine or duloxetine for depression.
Buprenorphine (a strong painkiller) with or without naloxone.

These medicines may interact with Rizatriptan Zentiva Italia and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, hyperreflexia, increased muscle rigidity, and body temperature above 38°C.
Contact your doctor if you experience any of these symptoms.
Rizatriptan Zentiva Italia with food and drink
The effect of Rizatriptan Zentiva Italia may be delayed by food intake. Although it is preferable to take the medicine on an empty stomach, you may take it even if you have already eaten.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is not known whether Rizatriptan Zentiva Italia is harmful to the unborn child when taken during pregnancy.
Breastfeeding should be avoided for 24 hours after taking the medicine.
Driving and using machines
You may feel drowsy or dizzy while taking Rizatriptan Zentiva Italia. If this occurs, do not drive or operate machinery.
Rizatriptan Zentiva Italia contains aspartame
This medicine contains 2.90 mg of aspartame per orodispersible tablet. Aspartame is a source of phenylalanine. This may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Rizatriptan Zentiva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The usual dose is 10 mg.
If you are taking propranolol or if you have kidney or liver problems, you should take a 5 mg dose of
rizatriptan. You must wait at least 2 hours between taking propranolol and Rizatriptan Zentiva Italia, and
no more than 2 doses should be taken within a 24-hour period.
Administration method

For oral use.
Open the blister pack with dry hands. Page 3 of 6
Orodispersible tablets cannot be considered divisible into two equal doses.
The score line is not intended for breaking the tablet.
The orodispersible tablet should be placed on the tongue, where it dissolves and can be swallowed with saliva.
Rizatriptan Zentiva Italia orodispersible tablets can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquids.

If migraine recurs within 24 hours
In some patients, migraine symptoms may return within a 24-hour period. If migraine recurs, you may take an additional dose of Rizatriptan Zentiva Italia. Always respect an interval of at least 2 hours between doses.
If migraine persists after 2 hours
If you do not respond to the first dose of Rizatriptan Zentiva Italia during an attack, do not take a second dose of Rizatriptan Zentiva Italia for the treatment of the same attack. However, you may still respond to Rizatriptan Zentiva Italia during a subsequent attack.
Do not take more than 2 doses of Rizatriptan Zentiva Italia within 24 hours. Always wait at least 2 hours between doses.
If your condition worsens, contact your doctor.
Use in children and adolescents
There is no experience with the use of rizatriptan in children and adolescents under 18 years of age; therefore, Rizatriptan Zentiva Italia must not be administered to children and adolescents.
Use in patients over 65 years of age
Complete studies to determine the safety and efficacy of rizatriptan in patients over 65 years of age have not been conducted.
If you take more Rizatriptan Zentiva Italia than you should
If you take more Rizatriptan Zentiva Italia than prescribed, contact your doctor or pharmacist immediately.
Take the medicine package with you.
Signs of overdose may include dizziness, drowsiness, vomiting, fainting, or slowed heartbeat.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with this medicine.
In clinical studies, the most common side effects reported were dizziness, drowsiness, and fatigue.
Contact your doctor immediately if you experience symptoms of allergic reactions, serotonin syndrome,
heart attack, or stroke (see list below).
Also, tell your doctor if you experience any symptoms suggestive of an allergic reaction (such as rash or itching) after taking Rizatriptan Zentiva Italia.

Common (may affect up to 1 in 10 people)

tingling sensations (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), reduced mental sharpness
rapid or irregular heartbeat (palpitations)
tightness in the throat
feeling unwell (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia)
sensation of heaviness in parts of the body Page 4 of 6
insomnia
neck pain, stiffness
stomach 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
confusion, nervousness
high blood pressure (hypertension); thirst
skin rash, itching and lumpy skin rash (hives); swelling of the face, lips, tongue and/or throat which may cause difficulty breathing and/or swallowing (angioedema)
sensation of tightness in parts of the body, muscle weakness
changes in heart rhythm or rate (arrhythmia), abnormalities in electrocardiogram (an examination that records the heart's electrical activity), very fast heartbeat (tachycardia)
tremor, fainting (syncope)
hot flushes (facial redness of short duration), hot flashes
difficulty breathing (dyspnoea)
sweating
facial pain, muscle pain.

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

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

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

seizures
spasm of blood vessels in the extremities, including coldness and numbness in hands or feet
a condition 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 – Lyell’s syndrome)
heart attack, spasm of blood vessels in the heart; these usually occur in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement products, family history of heart disease or stroke, men over 40 years, post-menopausal women, specific heart rhythm problems [bundle branch block])
spasm of blood vessels in the colon (large intestine) which may cause abdominal pain.

Reporting of side effects
If you experience any side effect, 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rizatriptan Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
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Do not store above 30°C.
Do not dispose of any medicine 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 Zentiva Italia contains
The active substance is rizatriptan.
Each orodispersible tablet contains 10 mg of rizatriptan as 14.53 mg of rizatriptan benzoate.
The other components are: microcrystalline cellulose, maize starch, anhydrous colloidal silica, aspartame (E
951), peppermint powder (composed of: peppermint oil, terpene-free peppermint oil, eucalyptol, menthone,
isomenthone, methyl acetate, menthol) and magnesium stearate.

Description of the appearance of Rizatriptan Zentiva Italia and the contents of the pack
The 10 mg orodispersible tablets are white, round, biconvex, with a break line on one side, measuring 10.0±0.1 mm in diameter and 2.9±0.2 mm in thickness.
Packs containing 2, 3, 6, 12, or 18 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milano, Italy

Manufacturers:
Pharmathen S.A.
6, Dervenakion str., 153 51, Pallini, Attiki
Greece
Pharmathen International S.A
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Rizatriptan Zentiva Italia

This leaflet was last updated on:
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