Rizatriptan Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

RIZATRIPTAN DOC Generici 5 mg tablets, 10 mg tablets

Equivalent medicine
Please read this 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, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

RIZATRIPTAN DOC Generici belongs to a class of medicines called selective serotonin 5-HT receptor agonists.
Your doctor has prescribed RIZATRIPTAN DOC Generici for the treatment of the headache phase of migraine attacks in adults.
Treatment with RIZATRIPTAN DOC Generici reduces the vasodilation of blood vessels surrounding the brain. This vasodilation is responsible for the headache phase of a migraine attack.

2. What you need to know before taking RIZATRIPTAN DOC Generici

Do not take RIZATRIPTAN DOC Generici 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 mild high blood pressure not controlled by medication
• 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 disorders (peripheral vascular disease)
• you are currently 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 medicines derived from ergotamine, 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 Generici”).

If you are unsure whether any of these situations apply to you, consult your doctor or pharmacist before taking RIZATRIPTAN DOC Generici.

Warnings and precautions

Talk to your doctor or pharmacist before taking RIZATRIPTAN DOC Generici 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 any allergies
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in arms and legs
• you are using any herbal remedy 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 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-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression
• you have experienced brief symptoms including chest pain and tightness or pressure in the chest.

If you take RIZATRIPTAN DOC Generici too often, 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 Generici.
Inform your doctor or pharmacist about any symptoms you experience. Your doctor will determine whether you have migraine. You should take RIZATRIPTAN DOC Generici only for a migraine attack. RIZATRIPTAN DOC Generici must not be used to treat headaches that may arise from other, potentially more serious, causes.

Other medicines and RIZATRIPTAN DOC Generici

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 Generici may affect how some medicines work. Also, other medicines may affect how RIZATRIPTAN DOC Generici works.

Do not take RIZATRIPTAN DOC Generici if you are taking:

• a 5HT 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
• medicines from the ergotamine family, such as ergotamine or dihydroergotamine, to treat migraine
• methysergide to prevent migraine attacks.

Taking the above medicines together with RIZATRIPTAN DOC Generici may increase the risk of adverse effects.

After taking RIZATRIPTAN DOC Generici, wait at least 6 hours before taking ergotamine-family medicines such as ergotamine or dihydroergotamine, or methysergide.

After taking an ergotamine-family medicine, wait at least 24 hours before taking RIZATRIPTAN DOC Generici.

Ask your doctor for information about the risks associated with using RIZATRIPTAN DOC Generici if you are taking:

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

RIZATRIPTAN DOC Generici with food and drink

RIZATRIPTAN DOC Generici 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, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

It is not known whether RIZATRIPTAN DOC Generici is harmful to the unborn child when taken during pregnancy. Breastfeeding should be avoided for 24 hours after treatment.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

RIZATRIPTAN DOC Generici may cause drowsiness or dizziness. If this occurs, do not drive and do not operate tools or machinery.

3. How to take RIZATRIPTAN DOC Generici

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 must use a dose of RIZATRIPTAN
DOC Generici of 5 mg. You must leave at least 2 hours between taking propranolol and taking
RIZATRIPTAN DOC Generici, up to a maximum of 2 doses within a 24-hour period.
Take RIZATRIPTAN DOC Generici as soon as possible after the onset of migraine. Do not use it
to prevent an attack.
The RIZATRIPTAN DOC Generici tablet should be taken by mouth and swallowed whole with liquid. The
score line is not intended for dividing the tablet.
If migraine recurs within 24 hours
In some patients, migraine symptoms may recur within 24 hours. If your migraine recurs, you may
take another dose of RIZATRIPTAN DOC Generici. Always wait at least 2 hours between doses.
If migraine persists after 2 hours
If the first dose of RIZATRIPTAN DOC Generici taken during an attack is ineffective, do not take a
second dose of RIZATRIPTAN DOC Generici to treat the same attack. However, RIZATRIPTAN DOC
Generici is still likely to be effective in subsequent attacks.
Do not take more than 2 doses of RIZATRIPTAN DOC Generici within 24 hours. Always wait
at least 2 hours between doses.
If your condition worsens, consult your doctor.
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Use in children and adolescents
The use of RIZATRIPTAN DOC Generici in children under 18 years of age is not recommended.
Use in patients over 65 years of age
Complete studies to assess the safety and efficacy of RIZATRIPTAN DOC Generici in patients over 65
years of age have not been conducted.
If you take more RIZATRIPTAN DOC Generici than you should:
If you take more RIZATRIPTAN DOC Generici than you should, speak immediately with your doctor or
pharmacist. Bring the medicine package 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 medicine can cause side effects, although not everyone gets 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 Generici.

Common: may affect up to 1 in 10 people

• tingling (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), reduced mental alertness, insomnia,
• fast or irregular heartbeat (palpitations),
• hot flushes (short-lived facial redness),
• tightness in the throat,
• feeling unwell (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia),
• localised sensation of 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, nervousness,
• high blood pressure (hypertension), thirst, indigestion (dyspepsia), hot flushes, sweating,
• skin rash, itching, formation of lumps (wheals), swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing and/or swallowing (angioedema), difficulty breathing (dyspnoea),
• sensation of tightness in certain parts of the body, muscle weakness,
• changes in heart rhythm or rate (arrhythmia), abnormalities on 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 effect usually occurs in patients with risk factors for heart and blood vessel diseases (high blood pressure, diabetes, smoking, use of nicotine substitutes, 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 the 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 substitutes, 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: 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 DOC Generici

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 use. This will help protect the environment.

6. Package contents and other information

What RIZATRIPTAN DOC Generici contains

• The active substance is rizatriptan. Each tablet contains 7.625 mg of rizatriptan benzoate, equivalent to 5 mg of rizatriptan. Each tablet contains 14.53 mg of rizatriptan benzoate, equivalent to 10 mg of rizatriptan.
• The other components are: microcrystalline cellulose, maize starch, pregelatinized maize starch, red iron oxide (E172), magnesium stearate.

Description of the appearance of RIZATRIPTAN DOC Generici and pack sizes
The 5 mg tablets are pale pink, round, biconvex, with dimensions of 6.0±0.1 mm and thickness of 3.0±0.2 mm.
The 10 mg tablets are pale pink, round, biconvex, with a score line on one side, and dimensions of 8.0±0.1 mm and thickness of 3.5±0.2 mm.
Pack sizes: boxes containing 2, 3, 6, 12 or 18 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names:
Germany \tRizatriptan Heumann 5mg & 10mg Tabletten
United Kingdom \tRizatriptan 5mg & 10mg Tablets
Italy \tRIZATRIPTAN DOC Generici
Cyprus \tMavixan 5mg & 10mg tablets
Greece \tFlixan 5mg & 10mg tablets
Spain \tRIZATRIPTAN PHARMATHEN 10 MG COMPRIMIDOS
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