Rizatriptan Doc

Package leaflet: Information for the user

RIZATRIPTAN DOC 5 mg orodispersible tablets, 10 mg orodispersible tablets

Equivalent medicine
Please read this leaflet carefully before you start 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 RIZATRIPTAN DOC is and what it is used for

RIZATRIPTAN DOC belongs to a class of medicines called selective 5-HT\ receptor agonists of serotonin.
Your doctor has prescribed RIZATRIPTAN DOC to treat the headache phase of a migraine attack in adults.
Treatment 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 to any of the other ingredients of this medicine (listed in section 6);
• you have moderately severe or severe high blood pressure, or uncontrolled mild high blood pressure;
• you have or have had heart problems, including heart attack or chest pain (angina), or have experienced symptoms suggestive of heart disease;
• you have severe kidney or liver 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 you have stopped taking MAOIs less than two weeks ago;
• you are taking ergotamine-derived medicines, 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 unsure whether any of these situations applies 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, smoking or use of nicotine replacement products, a family history of heart disease, if you are a man over 40 years of age or a postmenopausal woman;
• you have kidney or liver problems;
• you have a specific heart rhythm problem (bundle branch block);
• you have or have had any allergies;
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in arms and legs;
• you use herbal preparations containing St. John’s wort (Hypericum perforatum);
• 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 and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression;
• you have experienced brief symptoms including chest pain, tightness or pressure in the chest.

If you take RIZATRIPTAN DOC too frequently, this may lead to chronic headache. In such cases, you should contact your doctor, as it may become necessary to discontinue treatment with RIZATRIPTAN DOC.
Inform your doctor or pharmacist about any symptoms you experience. Your doctor will determine whether you have migraine. You should take RIZATRIPTAN DOC only for a migraine attack. RIZATRIPTAN DOC must not be used to treat headaches that may arise from other, more serious causes.

Other medicines and RIZATRIPTAN DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription. This includes herbal medicines and those you usually take for migraine. This is because RIZATRIPTAN DOC may affect how some medicines work, and other medicines may 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 an MAOI less than two weeks ago;
• ergotamine-family medicines such as ergotamine or dihydroergotamine to treat migraine;
• methysergide to prevent migraine attacks.

Taking the medicines listed above together with RIZATRIPTAN DOC may increase the risk of adverse effects.
After taking RIZATRIPTAN DOC, you must wait at least 6 hours before taking ergotamine-family medicines such as ergotamine, dihydroergotamine or methysergide.
After taking an ergotamine-family medicine, you must wait at least 24 hours before taking RIZATRIPTAN DOC.
Ask your doctor for advice about the risks of 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 taken after a meal. Although it is preferable to take it on an empty stomach, you may still take it after eating.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 using machines
RIZATRIPTAN DOC may cause drowsiness or dizziness. If this occurs, do not drive and do not operate 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 causing accumulation of phenylalanine because the body cannot eliminate it properly.

3. How to take RIZATRIPTAN DOC

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 10 mg.
If you are taking propranolol or have kidney or liver problems, you should use a dose of RIZATRIPTAN DOC
of 5 mg. You must wait at least 2 hours between taking propranolol and taking RIZATRIPTAN
DOC, up to a maximum of 2 doses within a 24-hour period.
Take RIZATRIPTAN DOC as soon as possible after migraine onset. Do not use it to
prevent an attack.

Administration method

• Open the blister pack with dry hands
• 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
• The RIZATRIPTAN DOC orodispersible tablet may be used in situations where liquids are not available or to avoid nausea and vomiting that may accompany ingestion of the tablet with liquids.

If migraine recurs within 24 hours
In some patients, migraine symptoms may recur within 24 hours. If your migraine returns, you
may take another dose of RIZATRIPTAN DOC. Always wait at least 2 hours between doses.

If migraine persists after 2 hours
If the first dose of RIZATRIPTAN DOC taken during an attack is not effective, do not take a
second dose of RIZATRIPTAN DOC to treat the same attack. However, RIZATRIPTAN DOC may still be effective for subsequent attacks.

Do not take more than 2 doses of RIZATRIPTAN DOC within 24 hours. 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 of age
Complete studies to determine the safety and efficacy of RIZATRIPTAN DOC in patients over 65 years of age have not been conducted.

If you take more RIZATRIPTAN DOC than you should:
If you take more RIZATRIPTAN DOC than prescribed, contact your doctor or pharmacist immediately. Bring the medicine packaging with you.
Signs of overdose 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 medicinal product can cause side effects, although not everyone experiences them. The following side effects may occur with this medicine.
In studies in adults, the most commonly observed side effects were dizziness, drowsiness and fatigue.
Contact your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, heart attack or stroke (see list below).
Also, inform your doctor of any symptoms suggesting an allergic reaction (such as hives or itching) after taking RIZATRIPTAN DOC.

Common: may affect up to 1 in 10 people

• tingling (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), reduced mental sharpness, insomnia,
• fast or irregular heartbeat (palpitations),
• hot flushes (short-lived reddening of the face),
• tightness in the throat,
• feeling unwell (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia),
• sensation of local heaviness, 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, restlessness,
• high blood pressure (hypertension), thirst, hot flushes, sweating,
• skin rash, itching, formation of lumps (wheals), swelling of the face, lips, tongue and/or throat with possible difficulty in breathing and/or swallowing (angioedema), difficulty in breathing (dyspnoea),
• sensation of tightness in certain parts of the body, muscle weakness,
• changes in heart rhythm or rate (arrhythmia), abnormalities in 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 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 therapy, 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 available data) :

• heart attack, spasms of blood vessels in the heart (this usually occurs in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years, post-menopausal women, specific heart rhythm problems [bundle branch block]),
• a condition called "serotonin syndrome" which may cause side effects such as coma, unstable blood pressure, very high body temperature, lack of muscle coordination, agitation and hallucinations,
• severe peeling of the skin accompanied by fever (toxic epidermal necrolysis),
• seizures,
• spasm of blood vessels in the extremities, causing coldness and numbness in hands and feet,
• 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 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 stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
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 need. This will help protect the environment.

6. Package contents and other information

What RIZATRIPTAN DOC contains
The active substance 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 components are: microcrystalline cellulose, maize starch, anhydrous colloidal silica, aspartame (E951), mint flavour (composed of: peppermint oil, terpene-free peppermint oil, eucalyptol, 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.
Pack sizes: cartons containing 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 Milano
Italy

Manufacturer
Pharmathen S.A,
6 Dervenakion 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 European Economic Area countries under the following names:
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