Rizatriptan Mylan Generics

Package Leaflet: Information for the User

Rizatriptan Mylan Generics 5 mg orodispersible tablets, 10 mg orodispersible tablets

rizatriptan
Generic 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 others, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rizatriptan Mylan Generics is and what it is used for

Rizatriptan belongs to a group of medicines known as "selective serotonin receptor agonists" (5 HT ) which are used to treat migraine attacks in adults.
Migraine symptoms may be caused by a temporary dilation of the blood vessels in the head. Rizatriptan is thought to reduce this dilation of blood vessels.
Rizatriptan is used only for the treatment of the headache phase of migraine, with or without aura (warning symptoms).
It should not be used to prevent headache.

2. What you need to know before taking Rizatriptan Mylan Generics

Do not take Rizatriptan Mylan Generics:

• if you are allergic to rizatriptan or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver or severe kidney problems
• if you have had a stroke (cerebrovascular accident, CVA), or a mini-stroke (transient ischaemic attack, TIA)
• if you have moderately severe or severe high blood pressure, or uncontrolled mild hypertension
• if you have or have ever had heart problems, including heart attack or chest pain (angina), or have experienced symptoms related to heart disease
• if you suffer from reduced blood flow in your arms and/or legs due to narrowing or blockage of arteries (peripheral vascular disease)
• if you are currently taking any medicine of the same class, such as sumatriptan, naratriptan or zolmitriptan, for the treatment of your migraine (see section “Other medicines and Rizatriptan Mylan Generics” below)
• if 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 two weeks have passed since you stopped taking MAOIs
• if you are currently taking ergotamine-like medicines, such as ergotamine or dihydroergotamine, to treat your migraine, or methysergide to prevent migraine attacks.

If you are unsure whether any of these conditions apply to you, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rizatriptan Mylan Generics

• if your headache is accompanied by dizziness, difficulty walking, lack of coordination, or weakness in arms and legs
• if you have any of the following risk factors for heart disease: high blood pressure, diabetes, if you smoke or use nicotine replacement therapy, if you are a man over 40 years of age, if you are a post-menopausal woman, or if you have a family history of heart disease
• if you are taking herbal remedies containing St. John’s Wort
• if you have kidney or liver problems
• if you have a specific heart rhythm problem (bundle branch block)
• if you have or have had allergies, particularly to other medicines of the same class, such as sumatriptan, naratriptan or zolmitriptan used to treat your migraine
• if you are taking selective serotonin reuptake inhibitors (SSRIs), such as sertraline, escitalopram oxalate, fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs), such as venlafaxine and duloxetine, for depression

Inform your doctor or pharmacist about your symptoms. Your doctor will determine whether you are suffering from migraine. You should take Rizatriptan Mylan Generics orodispersible tablets only for migraine attacks. Rizatriptan Mylan Generics orodispersible tablets must not be used to treat headaches caused by more serious conditions.
During treatment
While taking this medicine, speak to your doctor immediately and do not take any more rizatriptan if you notice:

• 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 have had short-lived symptoms including chest pain and tightness

If you take Rizatriptan Mylan Generics too often, this may lead to chronic headache. In such cases, you should contact your doctor, as you may need to stop taking Rizatriptan Mylan Generics orodispersible tablets.
Children and adolescents
The use of Rizatriptan Mylan Generics orodispersible tablets in children and adolescents under 18 years of age is not recommended.
Use in patients aged over 65 years
Complete studies on the safety and efficacy of rizatriptan in patients over 65 years of age have not been conducted.
Other medicines and Rizatriptan Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because rizatriptan may affect how some medicines work. Also, other medicines may affect Rizatriptan Mylan Generics orodispersible tablets.
Do not take Rizatriptan Mylan Generics orodispersible tablets:

• if you are already taking 5-HT agonists (sometimes referred to as 'triptans'), such as sumatriptan, naratriptan or zolmitriptan.
• if you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if less than two weeks have passed since you stopped taking an MAOI.
• if you are using ergotamine-like medicines such as ergotamine or dihydroergotamine to treat migraine
• if you are taking methysergide to prevent migraine attacks.

The above-mentioned medicines may increase the risk of side effects when taken with Rizatriptan Mylan Generics orodispersible tablets.
You must wait at least 6 hours after using rizatriptan before taking ergotamine-like medicines (e.g. ergotamine, dihydroergotamine or methysergide).
You must wait at least 24 hours after taking a medicine containing ergotamine before taking rizatriptan.
Ask your doctor for advice and information about the risks of taking Rizatriptan Mylan Generics orodispersible tablets:

• if you are taking propranolol to lower your blood pressure (see section 3)
• if you are taking a selective serotonin reuptake inhibitor (SSRI), e.g. sertraline, escitalopram oxalate, citalopram, fluoxetine, paroxetine, or a serotonin-noradrenaline reuptake inhibitor (SNRI), e.g. venlafaxine, duloxetine, for depression.

Rizatriptan Mylan Generics with food and drink
Rizatriptan Mylan Generics orodispersible tablets work best on an empty stomach. They may also be taken after eating, but may take longer to take effect.
Rizatriptan Mylan Generics orodispersible tablets do not need to be taken with liquids.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Available data on the safety of rizatriptan during the first three months of pregnancy do not suggest an increased risk of birth defects. It is not known whether rizatriptan could be harmful to the fetus when taken during pregnancy after the first three months.
If you are breastfeeding, you may delay breastfeeding for 12 hours after treatment to avoid exposing the infant.
Rizatriptan may be excreted in breast milk.
Driving and using machines
Rizatriptan, or a migraine attack, may cause drowsiness or dizziness. If so, do not drive and do not operate any tools or machinery.
Rizatriptan Mylan Generics contains aspartame
Rizatriptan Mylan Generics 5 mg: This medicine contains 5 mg aspartame in each orodispersible tablet.
Rizatriptan Mylan Generics 10 mg: This medicine contains 10 mg aspartame in each orodispersible tablet.
Aspartame is a source of phenylalanine. It may be harmful to you if you have phenylketonuria, a rare genetic disorder causing phenylalanine to accumulate because the body cannot properly eliminate it.

3. How to take Rizatriptan Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist. The dose is determined by your doctor.
Rizatriptan Mylan Generics orodispersible tablets are used to treat migraine attacks in adults. Take Rizatriptan Mylan Generics orodispersible tablets as soon as possible after the onset of a migraine attack. Do not use it to prevent an attack.
Adults (aged 18 to 65)
The amount of Rizatriptan Mylan Generics orodispersible tablets you take is called the “dose”.
The recommended dose is 10 mg.
If you are taking propranolol for high blood pressure, or if you have mild to moderate kidney or liver problems, your doctor will advise you to take a lower dose (5 mg). If you are taking propranolol, you must not take Rizatriptan Mylan Generics orodispersible tablets within 2 hours of taking propranolol.
If migraine symptoms persist after 2 hours
If the first dose of Rizatriptan Mylan Generics orodispersible tablets does not relieve your migraine, DO NOT take a second dose to treat the same attack.
However, Rizatriptan Mylan Generics orodispersible tablets may be effective the next time you have a migraine attack.
If migraine returns within 24 hours
In some patients, migraine symptoms may return within 24 hours. If you responded to the first dose but migraine symptoms return within 24 hours, you may take an additional dose of Rizatriptan Mylan Generics.
You must always wait at least 2 hours between doses.
DO NOT take more than 2 Rizatriptan Mylan Generics orodispersible tablets within 24 hours (for example, do not take more than two 5 mg or 10 mg orodispersible tablets in a 24-hour period). Always wait at least 2 hours between doses.
If your condition worsens, consult your doctor.
Use in children and adolescents (under 18 years of age) and elderly patients (over 65 years of age)
Children, adolescents, or elderly patients should not take Rizatriptan Mylan Generics orodispersible tablets, as there is insufficient experience with its use in these patient groups.
Method and route of administration
Rizatriptan Mylan Generics orodispersible tablets break easily, so they must be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack by the edges and gently separate one blister from the strip by tearing along the perforations around it.
2. Carefully peel back the backing.
3. Gently push the tablet out.
4. Place the tablet directly on the tongue, where it will dissolve.

Rizatriptan Mylan Generics orodispersible tablets can be used in situations where liquids are not available, or to avoid nausea and vomiting that may occur when swallowing tablets with liquids.
If you take more Rizatriptan Mylan Generics than you should
Contact your doctor or nearest hospital immediately. Take the medicine packaging with you.
Possible signs of overdose may include: dizziness, drowsiness, vomiting, fainting, and slowed heartbeat.
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 everybody gets them. A list of possible side effects is provided below.
In studies of adult patients, the most common side effects reported were dizziness,
drowsiness and fatigue.
If you experience any of the following side effects, contact your doctor immediately or seek
emergency medical help straight away:
Uncommon (may affect up to 1 in 100 patients)

• if you have an allergic reaction. Such reactions may present as anaphylaxis (a severe form of allergic reaction) with symptoms such as:
  • skin rash,
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema),
• anaphylactoid reaction (sudden wheezing, swelling of the lips, tongue and throat or of the body, skin rash, fainting or difficulty swallowing).

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

• stroke. This usually occurs in patients with risk factors for heart disease and blood vessel disorders (hypertension, diabetes, smoking, use of nicotine replacement therapy, family history of stroke, men over 40 years of age, post-menopausal women, specific problems with heart rhythm [bundle branch block]).

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

• epilepsy (seizures/epileptic fits).
• widespread skin rash with blisters and peeling of the skin over large areas of the body, possibly accompanied by fever (toxic epidermal necrolysis)
• 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
• heart attack, spasm of the blood vessels of the heart. These usually occur in patients with risk factors for heart disease and blood vessel disorders (hypertension, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease, men over 40 years of age, post-menopausal women, specific problems with heart rhythm [bundle branch block]).

Other side effects that may occur:
Common (may affect up to 1 in 10 patients)

• tingling or numbness in the hands and feet (paraesthesia), headache, reduced sensation or sensitivity of the skin (hypoesthesia)
• feeling of reduced mental sharpness, sleep disturbances (insomnia)
• dizziness, drowsiness
• rapid or irregular heartbeat (palpitations),
• facial flushing of short duration
• sore throat
• indigestion (dyspepsia), feeling unwell (nausea) or malaise (vomiting), dry mouth, diarrhoea
• feeling of fatigue or heaviness in certain parts of the body, neck pain, stiffness
• stomach or chest pain

Uncommon (may affect up to 1 in 100 patients)

• problems with coordination of muscle movements (ataxia), tremor
• sensation of spinning or that the ground is tilted (vertigo), fainting
• altered taste, bad taste in the mouth
• changes in heart rhythm and rate (arrhythmia)
• abnormalities in the electrocardiogram (a test that records the electrical activity of the heart), increased heart rate (tachycardia)
• high blood pressure (hypertension)
• difficulty breathing (dyspnoea)
• hot flushes, sweating
• feeling of thirst
• itching, development of red, itchy bumps (urticaria), muscle weakness, sensation of tightness in various parts of the body
• confusion, nervousness
• blurred vision
• skin rash
• muscle pain (myalgia)
• facial pain

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

• slowing of the heartbeat (bradycardia)
• laboured breathing

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

• spasm or obstruction of blood vessels in the extremities, including coldness and numbness of the hands or feet
• spasm of blood vessels in the colon (large intestine), which may cause abdominal pain or inflammation of the colon

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 the following website:
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 Mylan Generics

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 pack after "Exp.". The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Rizatriptan Mylan Generics contains
The active substance is rizatriptan.
5 mg: each orodispersible tablet contains 5 mg of rizatriptan (as rizatriptan benzoate).
10 mg: each orodispersible tablet contains 10 mg of rizatriptan (as rizatriptan benzoate).
The other components are: anhydrous colloidal silica, crospovidone (Type B), crospovidone (Type A), mannitol, microcrystalline cellulose, guar galactomannan, magnesium stearate, aspartame (E951) (see section 2 “Rizatriptan Mylan Generics contains aspartame”), mint flavour (contains natural flavour, maltodextrin from maize, modified wheat starch).

Description of the appearance of Rizatriptan Mylan Generics and package contents
5 mg: white to off-white, round, flat tablets with bevelled edges, engraved with “M” on one side and “RN1” on the other.
10 mg: white to off-white, round, flat tablets with bevelled edges, engraved with “M” on one side and “RN2” on the other.
Rizatriptan Mylan Generics orodispersible tablets are packaged in perforated monodose blisters OPA/Al/PVC in packs of 2x1, 3x1, 6x1, 12x1 or 18x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer:
Mylan Hungary Kft.,
H-2900, Komárom, Mylan utca 1,
Hungary

This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark Rizatriptan Viatris 10 mg
Spain Rizatriptan Max Viatris 10 mg buccodispersable tablets EFG
France Rizatriptan Viatris 10 mg orodispersible tablet
Italy Rizatriptan Mylan Generics 5 mg, 10 mg orodispersible tablets
Netherlands Rizatriptan SmeltTab Viatris 5 mg, 10 mg, orodispergeerbare tabletten
Sweden Rizatriptan Viatris 10 mg
Slovenia Rizatriptan Viatris 10 mg

This Patient Information Leaflet was last revised in 09/2025