RIZATRIPTAN 5 mg Orodispersible Tablet

Зміст інструкції

1. Rizatriptan Sandoz 5 mg orodispersible tablets, 10 mg orodispersible tablets
   1. What is Rizatriptan Sandoz orodispersible tablets and what are they used for?
   2. What you need to know before you take Rizatriptan Sandoz tablets
   3. How to take Rizatriptan Sandoz orodispersible tablets
   4. Possible side effects
   5. How to store Rizatriptan Sandoz orodispersible tablets
   6. Package contents and other information

Rizatriptan Sandoz 5 mg orodispersible tablets, 10 mg orodispersible tablets

Equivalent Medicinal Product

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• 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 Sandoz orodispersible tablets are and what they are used for
• 2. What you need to know before you take Rizatriptan Sandoz orodispersible tablets
• 3. How to take Rizatriptan Sandoz orodispersible tablets
• 4. Possible side effects
• 5. How to store Rizatriptan Sandoz orodispersible tablets
• 6. Contents of the pack and other information

1. What is Rizatriptan Sandoz orodispersible tablets and what are they used for?

The active ingredient of this medicine, rizatriptan, belongs to a group of drugs
called selective serotonin 5-HT receptor agonists.
Rizatriptan Sandoz orodispersible tablets are used in adults to treat the
painful phase of migraine attacks.

2. What you need to know before you take Rizatriptan Sandoz tablets

orodispersible
DO NOT take Rizatriptan Sandoz orodispersible tablets if:

• you are allergic to rizatriptan or to any of the excipients of this medicine (listed in section 6)
• you are already taking monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, tranylcypromine (used to treat depression) or linezolid (a drug used to treat bacterial infections) or if you have taken MAOIs in the last two weeks ( see section “Other medicines and RizatriptanSandoz orodispersible tablets”)
• you suffer from severe impairment of liver or kidney function
• you have previously suffered from a heart condition (stroke, or CVA) or symptoms similar to those of a stroke, which subside after a day or two (transient ischemic attack, or TIA)
• you suffer from moderately severe or severe hypertension, or mild hypertension that is NOT controlled by medication
• you have ever suffered from heart problems (poor blood flow to the arteries of the heart), heart attack, or a particular type of chest pain known as “Prinzmetal’s angina”
• you have suffered from circulatory disorders in the legs (peripheral vascular disease)
• you are already taking any other medicine for migraine, such as ergotamine, ergotamine-like drugs (dihydroergotamine, methysergide) or another medicine from the same class (i.e. 5-HT receptor agonists), such as sumatriptan, naratriptan or zolmitriptan ( see section “Other medicines and Rizatriptan Sandozorodispersible tablets”).

Warnings and precautions
Tell your doctor before taking Rizatriptan Sandoz orodispersible tablets if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, smoking, using a nicotine replacement therapy, a family history of heart disease, are a man over 40 years of age, or a post-menopausal woman
• you suffer from kidney or liver disorders
• you suffer from a particular disorder that affects the heart rate (bundle branch block)
• you have ever suffered from allergies
• you suffer from a type of headache associated with dizziness, difficulty walking, lack of coordination, or weakness of arms and legs
• you have developed an allergic reaction to these tablets or to other similar ones, such as swelling of the face, lips, tongue and/or throat, which can cause difficulty breathing and/or swallowing (angioedema)
• you have experienced short-lived symptoms, including chest pain and chest tightness.

If you take Rizatriptan Sandoz orodispersible tablets too often, you may
develop chronic headache. In this case you should contact your doctor, as it may
be necessary to stop taking these tablets.
Tell your doctor or pharmacist about your symptoms. The doctor will determine if you suffer from
migraine. You should only take Rizatriptan Sandoz orodispersible tablets for a
migraine attack. Rizatriptan Sandoz orodispersible tablets should not be
used to treat headaches that may be due to different and more
serious disorders.
If you are over 65 years of age, your doctor will tell you whether or not it is appropriate for you to take these
tablets.

Children and adolescents
The use of Rizatriptan Sandoz orodispersible tablets in children under the age of 18
is not recommended.

Other medicines and Rizatriptan Sandoz orodispersible tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
DO NOT take Rizatriptan Sandoz orodispersible tablets at the same time as:

monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine, linezolid or
tranylcypromine, or if less than two weeks have passed since you stopped taking an MAOI.

some other medicines for migraine, for example :

• other medicines in the same class as rizatriptan, such as sumatriptan, naratriptan or zolmitriptan
• ergotamine-like drugs, such as ergotamine, dihydroergotamine or methysergide. After taking Rizatriptan Sandoz orodispersible tablets you must wait at least 6 hours before taking these medicines and you must allow at least 24 hours between stopping ergotamine-like medicines and starting treatment with Rizatriptan Sandoz orodispersible tablets.

Consult your doctor for instructions and risks related to taking Rizatriptan
Sandoz orodispersible tablets if you are already taking the following medicines:

• antidepressants, such as sertraline, escitalopram, fluoxetine, venlafaxine and duloxetine
• propranolol (usually used to treat high blood pressure): in this case you should only receive the lowest dose of 5 mg of Rizatriptan Sandoz orodispersible tablets
• the herbal remedy St John's wort ( Hypericum perforatum). Taking it at the same time as Rizatriptan Sandoz orodispersible tablets may increase the risk of side effects. Therefore, you should not take St John's wort together with Rizatriptan Sandoz orodispersible tablets.

Rizatriptan Sandoz orodispersible tablets with food and drink
It is best to take these tablets on an empty stomach, but you can also take them
after a meal. If Rizatriptan Sandoz orodispersible tablets are taken with food,
their effects may take longer to appear.

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 is harmful to the unborn child when taken by a pregnant woman.
You should avoid breastfeeding for the 24 hours following the end of treatment
with Rizatriptan Sandoz orodispersible tablets.

Driving and using machines
In some patients, treatment with Rizatriptan Sandoz orodispersible tablets or
migraine itself may cause drowsiness. Dizziness has also been reported in some patients who received
this medicinal product. If you experience these
effects, you must be able to assess your ability to drive and use
machines safely.

Rizatriptan Sandoz orodispersible tablets contains aspartame
Aspartame is a component of the tablets, which is a source of phenylalanine. This
is harmful may be harmful if you have phenylketonuria (a metabolic disorder that
prevents the normal breakdown of phenylalanine).

3. How to take Rizatriptan Sandoz orodispersible tablets

Take this medicine following the instructions of your doctor exactly. If you have
any doubts, consult your doctor or pharmacist.
Rizatriptan Sandoz orodispersible tablets are not indicated for the prevention
of migraine: they are only effective after the onset of an attack.

The normal dose for adults over 18 yearsis 10 mg at the first sign of a migraine
attack. However, for some patients the recommended dose is 5 mg. The doctor
will establish the dosage most suitable for your case: it is important that you take the medicine
following their instructions exactly.
Most migraine attacks are relieved by one dose (one tablet) of
Rizatriptan Sandoz orodispersible tablets; however, if your migraine does not improve
after taking one tablet, DO NOT take a second tablet for the
treatment of the same migraine attack; rather, seek medical assistance.
If a migraine attack is not relieved by Rizatriptan Sandoz orodispersible
tablets, it is still likely that the next attack will respond to the medicine.
If you experience ANOTHER migraine attack within 24 hours of the first, you can take
an additional dose of Rizatriptan Sandoz orodispersible tablets, but do not take more than
two tablets within a 24-hour period. Always leave at least 2 hours between the two
administrations.

Method of use
Take the orodispersible tablets as described below:

• 1. Tear off a section of the blister by pulling along the perforated line.
• 2. Starting from the side indicated by the arrow, gently peel off the back of the blister.

Place the tablet on your tongue, where it will dissolve and can be swallowed with
saliva. You do not need to take a drink or water to swallow the tablet.

If you take more Rizatriptan Sandoz orodispersible tablets than you should
It is important to adhere to the dose prescribed by your doctor. If you take a number of
tablets higher than that indicated by your doctor, you should seek immediate medical
assistance, as too many tablets can be harmful to you. The effects of an overdose
include symptoms similar to those described in section 4, in particular: dizziness,
drowsiness, fainting and slowing of the heart rate. You may also
experience an increase in blood pressure and undesirable effects on the
cardiac and circulatory systems.
If you have any doubts about the use of this medicine, ask your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects observed most frequently during studies in adults were dizziness, drowsiness and fatigue.

Contact your doctor immediately if you experience symptoms of allergic reactions, serotonin syndrome or heart attack or stroke:

• allergic reactions sometimes very serious, including swelling of the face, lips, tongue and throat, which can cause difficulty breathing, speaking or swallowing (angioedema)
• severe allergic reactions with skin rashes, redness of the skin, blistering on lips, eyes or mouth, skin peeling and fever
• chest pain, a feeling of tightness in the chest or throat or other symptoms compatible with a heart attack
• weakness or paralysis of the limbs or face, difficulty speaking, which may indicate a stroke
• a condition called “serotonin syndrome”, characterized by coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation and hallucinations.

Other side effects

Common(may affect up to 1 in 10 people):

• dizziness, drowsiness and fatigue
• headache, tingling sensation (paresthesia), decreased skin sensitivity (hypoesthesia), reduced mental agility,
• insomnia
• fast or irregular heartbeat (palpitations)
• sore throat
• nausea (feeling unwell), dry mouth, vomiting, diarrhea, indigestion
• flushing (brief redness of the face)
• feeling of heaviness in some parts of the body
• neck pain, stiffness
• stomach or chest pain

Uncommon(may affect up to 1 in 100 people):

• poor muscle coordination, disorientation, nervousness, dizziness
• tremor
• fainting
• taste disturbances (bad taste)
• blurred vision
• high blood pressure
• hot flushes
• difficulty breathing
• thirst
• skin rashes, itching and redness with hives, swelling of the face, lips, tongue and/or throat which can cause difficulty breathing and/or swallowing (angioedema)
• sweating
• feeling of tightness in some parts of the body, muscle weakness
• irregular heartbeat, abnormalities in the electrocardiogram (ECG) (a test that records the electrical activity of the heart)
• facial pain, muscle pain

Rare(may affect up to 1 in 1,000 people):

• wheezing
• allergic reactions (hypersensitivity); a 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 habit, use of nicotine substitutes, family history of heart disease or stroke, men over

40 years old, post-menopausal women, a particular problem with the rhythm of your
heart [bundle branch block])

• slowed heartbeat

Not known(frequency cannot be estimated from available data)

• spasm of blood vessels in the extremities including sensations of cold and numbness in the hands or feet
• convulsions
• a syndrome called "serotonin syndrome" which can cause side effects such as coma, unstable blood pressure, extremely high body temperature, lack of muscle coordination, agitation and hallucinations.
• severe skin peeling with or without fever (toxic epidermal necrolysis)
• ischemic colitis (inflammation that causes abdominal pain or diarrhea)
• heart attack or spasm of blood vessels in the heart. These generally occur in patients with risk factors for heart and blood vessel disease. Risk factors are high blood pressure, diabetes, smoking habit, use of nicotine substitutes, family history of heart disease or stroke, men over 40 years old, post-menopausal women, a particular problem with the rhythm of your heart (bundle branch block).

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
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Rizatriptan Sandoz orodispersible tablets

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the packaging after
the wording EXP. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 Sandoz orodispersible tablets contain
The active ingredient is rizatriptan.
Rizatriptan Sandoz 5 mg orodispersible tablets
Each orodispersible tablet contains 5 mg of rizatriptan (as rizatriptan benzoate).
Rizatriptan Sandoz 10 mg orodispersible tablets
Each orodispersible tablet contains 10 mg of rizatriptan (as rizatriptan
benzoate).
The other ingredients are:
Calcium silicate
Crospovidone type A
Anhydrous colloidal silica
Silicified microcrystalline cellulose
Mannitol (E421)
Aspartame (E951)
Magnesium stearate
Sweet orange flavour (gum arabic E414, ascorbic acid E300, ethyl butyrate,
maltodextrin, orange oil).

Description of the appearance of Rizatriptan Sandoz orodispersible tablets and
package contents
Orodispersible tablets.
Rizatriptan Sandoz 5 mg: flat, round tablets, from white to white-grey in colour,
with the inscription “RZT” on one side and “5” on the other.
Rizatriptan Sandoz 10 mg: flat, round tablets, from white to white-grey in colour,
with the inscription “RZT” on one side and “10” on the other.
Al/Al blisters: 2, 3, 6, 18 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz Spa
Largo U. Boccioni 1
21040 Origgio VA

Manufacturer
Lek Pharmaceuticals d.d. Ljubljana, Slovenia
Lek Pharmaceuticals d.d , Lendava, Slovenia
Lek S.A., Strykow, Poland
Lek S.A., Warsaw, Poland
S.C. Sandoz S.r.l., Targu Mures, Romania
Salutas Pharma Gmbh Gerlingen, Germany

This medicinal product is authorised in the Member States of the EEA under the following
names:
Denmark: Rizatriptan Sandoz
Finland: Rizatriptan Sandoz 5 mg suussa liukeneva tabletti
Rizatriptan Sandoz 10 mg suussa liukeneva tabletti
Germany: Rizatriptan Sandoz 5 mg Schmelztabletten
Rizatriptan Sandoz 10 mg Schmelztabletten
Italy: RIZATRIPTAN SANDOZ 5 mg compresse orodispersibili
RIZATRIPTAN SANDOZ 10 mg compresse orodispersibili
Netherlands: Rizatriptan Sandoz 5 mg, orodispergeerbare tabletten
Rizatriptan Sandoz 10 mg, orodispergeerbare tabletten
Norway: Rizatriptan Sandoz
Slovak Republic: Rizatriptan Sandoz 5 mg dispergovateľné tablety
Rizatriptan Sandoz 10 mg dispergovateľné tablety
Slovenia: Rizatriptan Lek 5 mg orodisperzibilne tablete
Rizatriptan Lek 10 mg orodisperzibilne tablete
Spain: Rizatriptan Sandoz 10 mg comprimidos bucodispersables
Sweden: Rizatriptan Sandoz
United Kingdom: Rizatriptan 5 mg Orodispersible Tablets
Rizatriptan 10 mg Orodispersible Tablets