RIZATRIPTAN 5 mg Tablet

Зміст інструкції

1. RIZATRIPTAN DOC Generici 5 mg tablets, 10 mg tablets
   1. What is RIZATRIPTAN DOC Generici and what is it 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

RIZATRIPTAN DOC Generici 5 mg tablets, 10 mg 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, because it could be dangerous.
• If any undesirable effects occur, including any not listed in this leaflet, tell 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 you take 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 is RIZATRIPTAN DOC Generici and what is it used for

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

Do not take RIZATRIPTAN DOC Generici 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 the blockage of arteries (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-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

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Generici”).
If you are not sure if 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, smoke or use nicotine replacement therapy, there is a family history of heart disease, you are a man over 40 years old or you are a post-menopausal woman
• 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 can 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 experienced short-lived symptoms including chest pain and tightness or oppression of the chest.

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

Other medicines and RIZATRIPTAN DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including those you can buy without a prescription. This includes
herbal medicines and those you usually take for migraine. This is because RIZATRIPTAN
DOC Generici can affect how some medicines work. Also, other medicines can
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 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 Generici, may increase the risk of side
effects.
After taking RIZATRIPTAN DOC Generici 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 Generici.
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Ask your doctor for information and what the risks are in 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 it is taken after a meal. Although it is
best to take it on an empty stomach, you can still take it after eating.

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

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

3. How to take RIZATRIPTAN DOC Generici

Take this medicine following exactly the instructions of 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 allow at least 2 hours between taking propranolol and RIZATRIPTAN DOC Generici,
up to a maximum of 2 doses within a 24-hour interval.

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 must be taken orally and swallowed whole with some
liquid. The score line is not designed to break the tablet.

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

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

Do not take more than 2 doses of RIZATRIPTAN DOC Generici in 24 hours. You must 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
No complete studies have been conducted to verify how safe and effective RIZATRIPTAN DOC Generici is
in patients over 65 years of age.

If you take more RIZATRIPTAN DOC Generici than you should:
If you take more RIZATRIPTAN DOC Generici 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 studies in adults, 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 Generici.

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),
• feeling of 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,
• instability when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope),
• confusion, nervousness,
• high blood pressure (hypertension), thirst, indigestion (dyspepsia), 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 1,000 people

• wheezing,
• allergic reaction(hypersensitivity); sudden life-threatening allergic reaction

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(anaphylaxis),

• stroke (this effect 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 based on 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, 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: 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 which is stated on the package and on the 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 dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What RIZATRIPTAN DOC Generici contains

• The active ingredient 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 ingredients are: microcrystalline cellulose, corn starch, pregelatinized corn starch, red iron oxide (E172), magnesium stearate.

Description of the appearance of RIZATRIPTAN DOC Generici and contents of the pack
The 5 mg tablets are pale pink, round, biconvex tablets with dimensions of 6.0±0.1mm and
thickness 3.0±0.2mm.
The 10 mg tablets are pale pink, round, biconvex tablets, with a score line on one
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side and dimensions 8.0±0.1mm and thickness 3.5±0.2mm.
Packs: blister packs of 2, 3, 6, 12 or 18 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 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 under the
following denominations:
Germany Rizatriptan Heumann 5mg & 10mg Tablets
United Kingdom Rizatriptan 5mg & 10mg Tablets
Italy RIZATRIPTAN DOC Generici
Cyprus Mavixan 5mg & 10mg tablets
Greece Flixan 5mg & 10mg tablets
Spain RIZATRIPTAN PHARMATHEN 10 MG COMPRIMIDOS
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