RIZATRIPTAN 5 mg Orodispersible Tablet

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1. RIZATRIPTAN DOC 5 mg orodispersible tablets, 10 mg orodispersible tablets
   1. What is RIZATRIPTAN DOC and what it is used for
   2. What you need to know before taking RIZATRIPTAN DOC
   3. How to take RIZATRIPTAN DOC
   4. Possible side effects
   5. How to store RIZATRIPTAN DOC
   6. Package contents and other information

RIZATRIPTAN DOC 5 mg orodispersible tablets, 10 mg orodispersible tablets

Generic medicine

Important information for you.

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is RIZATRIPTAN DOC and what it is used for

RIZATRIPTAN DOC belongs to a class of drugs called selective serotonin 5-HT receptor agonists.
Your doctor has prescribed RIZATRIPTAN DOC to treat the headache phase of a migraine attack
in adults.
Therapy with RIZATRIPTAN DOC 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 DOC

Do not take RIZATRIPTAN DOC if:

• you are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6)
• you have moderately severe or severe high blood pressure, or mildly high blood pressure that is not controlled with medication;
• you have or have had heart problems, including heart attack or chest pain (angina) or have had symptoms indicative of heart disease
• you have severe kidney or liver problems
• you have had a stroke (cerebrovascular accident CVA) or a mini-stroke (transient ischemic attack TIA)
• you have problems with arterial blockage (peripheral vascular disease);
• you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine or pargyline (drugs for depression), or linezolid (an antibiotic), or have stopped taking MAOI inhibitors less than two weeks ago
• you are taking ergotamine derivatives, such as ergotamine itself or dihydroergotamine, to treat migraine, or methysergide to prevent migraine attacks
• you are taking any other medicine belonging to the same class, such as sumatriptan, naratriptan or zolmitriptan to treat migraine (see “Other medicines and RIZATRIPTAN DOC ”) If you are not sure if any of these situations apply to you, consult your doctor or pharmacist before taking RIZATRIPTAN DOC.

Warnings and precautions
Talk to your doctor or pharmacist before taking RIZATRIPTAN DOC if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you smoke or use nicotine replacement products, there is a history of heart disease in your family, you are a man over 40 years old or a woman in post-menopausal age.
• you have kidney or liver problems.
• you have a particular problem with your heartbeat (bundle branch block)
• you have or have had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination or weakness of arms and legs.
• you are using any herbal preparation containing St. John's Wort (hypericum).
• you have had an allergic reaction such as swelling of the face, lips, tongue and/or throat that may cause difficulty breathing and/or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate and fluoxetine or serotonin and norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have had symptoms of short duration including chest pain and tightness or oppression in the chest.

If you take RIZATRIPTAN DOC too often, this can lead to chronic headache. In
these cases you should contact your doctor because it may be necessary to stop treatment with
RIZATRIPTAN DOC.
Inform your doctor or pharmacist about the symptoms you experience. The doctor will decide if you have migraine. You must
take RIZATRIPTAN DOC only for a migraine attack. RIZATRIPTAN DOC should not be
used to treat headaches that may be due to different and more serious causes.

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

• a 5-HT agonist (sometimes called a “triptan”), such as sumatriptan, naratriptan or zolmitriptan.
• a monoamine oxidase inhibitor (MAOI) such as moclobemide, phenelzine, tranylcypromine, linezolid or pargyline or if you have stopped taking a MAOI inhibitor less than two weeks ago.
• medicines from the ergotamine family such as ergotamine or dihydroergotamine to treat migraine.
• methysergide to prevent migraine attacks.

The medicines listed above, taken with RIZATRIPTAN DOC, can increase the risk of side
effects.
After taking RIZATRIPTAN DOC you must wait at least 6 hours before taking medicines from
the ergotamine family, such as ergotamine or dihydroergotamine or methysergide.
After taking a medicine from the ergotamine family, you must wait at least 24 hours before
taking RIZATRIPTAN DOC.
Ask your doctor for information and what the risks are in using RIZATRIPTAN DOC if you are taking:

• propranolol (see section 3 How to take RIZATRIPTAN DOC)
• SSRIs such as sertraline, escitalopram oxalate and fluoxetine or
• SNRIs such as venlafaxine and duloxetine for depression.

RIZATRIPTAN DOC with food and drink
RIZATRIPTAN DOC may take longer to work if it is taken after a meal. Although it is best
to take it on an empty stomach, you can still take it even after eating.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether RIZATRIPTAN DOC is harmful to the unborn child when taken by a pregnant woman.
Breastfeeding should be avoided for 24 hours after taking the medicine.

Driving and operating machinery
Taking RIZATRIPTAN DOC may cause drowsiness or dizziness. If this happens, do not drive and do not use
tools or machinery.

RIZATRIPTAN DOC contains aspartame.
This medicine contains 1.45 mg of aspartame in one orodispersible tablet.
This medicine contains 2.90 mg of aspartame in one orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare
genetic disorder that causes a build-up of phenylalanine because the body cannot process it properly.

3. How to take RIZATRIPTAN DOC

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
The recommended dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you must use a dose of RIZATRIPTAN DOC
of 5 mg. You must allow at least 2 hours to pass between taking propranolol and RIZATRIPTAN
DOC, up to a maximum of 2 doses within a 24-hour interval.

Take RIZATRIPTAN DOC as soon as possible after the migraine has started. Do not use it to
prevent an attack.
Method of administration

• Open the blister with dry hands
• The incision line is not designed to break the tablet
• The orodispersible tablet must be placed on the tongue, where it dissolves and can be swallowed with saliva
• The orodispersible tablet of RIZATRIPTAN DOC can be used in situations where liquids are not available or to avoid nausea and vomiting that may accompany the ingestion of the tablet together with liquids.

If the migraine returns within 24 hours
In some patients, the symptoms of migraine may return within 24 hours. If your migraine returns, you can take another dose of RIZATRIPTAN DOC. You must always wait an interval of
at least 2 hours between doses.

If the migraine persists after 2 hours
If the first dose of RIZATRIPTAN DOC taken during an attack does not work, you should not take a
second dose of RIZATRIPTAN DOC to treat the same attack. However, RIZATRIPTAN DOC is still likely to
be effective in the next attack.

Do not take more than 2 doses of RIZATRIPTAN DOC in 24 hours. You must always wait at least 2 hours between
doses.
If your condition worsens, consult your doctor.

Use in children and adolescents
The use of RIZATRIPTAN DOC in children under 18 years of age is not recommended.

Use in patients over 65 years
No complete studies have been conducted to verify how safe and effective RIZATRIPTAN DOC is among
patients over 65 years of age.

If you take more RIZATRIPTAN DOC than you should:
If you take more RIZATRIPTAN DOC than you should, speak to your doctor or
pharmacist immediately. Bring the medicine packaging with you.
Signs of overdose include dizziness, drowsiness, vomiting, fainting and slowed heartbeat.
If you have any doubts 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 gets them.
The following side effects may occur with this medicine.
In adult studies, the most commonly observed side effects were dizziness, drowsiness and
fatigue.

Immediately inform your doctor if you have symptoms of an allergic reaction, serotonin
syndrome, heart attack or stroke (see the list below).
Also, inform your doctor of any symptom that suggests an allergic reaction (such as hives or
itching) after taking RIZATRIPTAN DOC.

Common: may affect up to 1 in 10 people

• tingling (paresthesia), headache, decreased skin sensitivity (hypoesthesia), reduced mental acuity, insomnia,
• fast or irregular heartbeat (palpitations),
• hot flushes (temporary facial redness),
• constriction of the throat,
• feeling unwell (nausea), dry mouth, vomiting, diarrhea, indigestion (dyspepsia),
• local heaviness, neck pain, stiffness
• pain in the abdomen or chest.

Uncommon: may affect up to 1 in 100 people

• bad taste in the mouth,
• walking instability (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope),
• confusion, nervousness,
• high blood pressure (hypertension), thirst, hot flashes, sweating,
• skin rash, itching, formation of bumps (wheals), swelling of the face, lips, tongue and/or throat with possible difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnea),
• , feeling of constriction in some parts of the body, muscle weakness,
• changes in the rhythm or rate 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); sudden, life-threatening allergic reaction (anaphylaxis),
• stroke(this usually 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, postmenopausal women, specific heart rhythm problems [bundle branch block]),
• slow heartbeat (bradycardia).

Not known (frequency cannot be estimated from available data):

• heart attack, spasms of the heart blood vessels, (this usually 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, postmenopausal women, specific heart rhythm problems [bundle branch block]),
• a syndrome called “serotonin syndrome” which can cause side effects such as coma, unstable blood pressure, very high body temperature, lack of muscle coordination, agitation and hallucinations,
• severe skin peeling accompanied by fever (toxic epidermal necrolysis),
• seizures,
• spasm of blood vessels in the extremities, with coldness and numbness of hands and feet,
• spasm of blood vessels in the colon (large intestine) which can cause abdominal pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects directly through the national reporting system
at 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 DOC

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 box and blister after SCAD.
The expiry date refers to the last day of that month.
Do not store at a temperature above 30 C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer need. This will help protect the environment.

6. Package contents and other information

What RIZATRIPTAN DOC contains
The active ingredient is rizatriptan.
Each orodispersible tablet contains 7.265 mg of rizatriptan benzoate equivalent to 5 mg of rizatriptan.
Each orodispersible tablet contains 14.53 mg of rizatriptan benzoate equivalent to 10 mg of
rizatriptan.
The other ingredients are: microcrystalline cellulose, corn starch, anhydrous colloidal silica, aspartame
(E951), peppermint powder (consisting of: peppermint oil, mentha piperita oil free of terpenes, eucalyptus oil, menthone,
isomenthone, methyl acetate, menthol), magnesium stearate.

Description of the appearance of RIZATRIPTAN DOC and package contents
The 5 mg orodispersible tablets are white, round, biconvex tablets, 7.1±0.1 mm in
diameter and 2.4±0.2 mm thick.
The 10 mg orodispersible tablets are white, round, biconvex tablets, 10.0±0.1 mm in
diameter and 2.9±0.2 mm thick.
Packs: packs of 2, 3, 6, 12 or 18 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Pharmathen S.A,
6 Dervanakion str., 153 51, Pallini Attiki,
Greece
and
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300
Greece

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Germany Rizatriptan Heumann 5mg & 10mg Schmelztabletten
United Kingdom Rizatriptan 5mg & 10mg Orodispersible tablets
Italy RIZATRIPTAN DOC
Cyprus Mavixan 5mg & 10mg lingual tablets
Greece Flixan 5mg & 10mg ODT tablets
Iceland Rizatriptan Alvogen 10mg ODT tablets