Rizatriptan Sandoz

Package leaflet: Information for the user

Rizatriptan Sandoz 5 mg orodispersible tablets, 10 mg orodispersible tablets

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 other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, please 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 taking 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 Rizatriptan Sandoz orodispersible tablets are and what they are used for

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

2. What you need to know before taking Rizatriptan Sandoz orodispersible tablets

orodispersible tablets
DO NOT take Rizatriptan Sandoz orodispersible tablets if:

• you are allergic to rizatriptan or any of the excipients of this medicine (listed in section 6)
• you are currently taking monoamine oxidase inhibitors (MAO inhibitors), such as moclobemide, phenelzine, tranilcypromine (used to treat depression) or linezolid (a medicine used to treat bacterial infections), or if you have taken MAO inhibitors within the last two weeks ( see section “Other medicines and Rizatriptan Sandoz orodispersible tablets” )
• you have severe impairment of liver or kidney function
• you have previously had a cardiovascular event (cerebrovascular accident, or CVA) or stroke-like symptoms that resolve within a day or two (transient ischaemic attack, or TIA)
• you suffer from moderately severe or severe hypertension, or from mild hypertension that is NOT controlled by medication
• you have ever had heart problems (reduced blood flow in the coronary arteries), a heart attack, or a specific type of chest pain known as "Prinzmetal's angina"
• you have had circulatory problems in the legs (peripheral vascular disease)
• you are already taking any other medicine for migraine, such as ergotamine, ergot-type medicines (dihydroergotamine, methysergide), or another medicine of the same class (i.e. 5-HT receptor agonists), such as sumatriptan, naratriptan or zolmitriptan ( see section “Other medicines and Rizatriptan Sandoz orodispersible 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, you smoke, you are using a nicotine replacement, you have a family history of heart problems, you are a man over 40 years of age, or a post-menopausal woman
• you have kidney or liver problems
• you have a specific condition affecting heart rhythm (bundle branch block)
• you have ever had allergies
• you suffer from a type of headache associated with dizziness, difficulty walking, lack of coordination, or weakness in arms and legs
• you have developed an allergic reaction to these tablets or similar ones, such as swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema)
• you have experienced brief symptoms such as chest pain or 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. Your doctor will determine whether you have migraine. You should take Rizatriptan Sandoz orodispersible tablets only for a migraine attack. Rizatriptan Sandoz orodispersible tablets must not be used to treat headaches that could be due to other, more serious conditions.
If you are over 65 years old, your doctor will advise you whether or not you should take these tablets.
Children and adolescents
The use of Rizatriptan Sandoz orodispersible tablets in children under 18 years of age 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 together with:
monoamine oxidase inhibitors (MAO inhibitors), such as moclobemide, phenelzine, linezolid or tranilcypromine, or if less than two weeks have passed since you stopped taking an MAO inhibitor.
certain other migraine medicines, for example:

• other medicines in the same class as rizatriptan, such as sumatriptan, naratriptan or zolmitriptan
• ergot-type medicines, such as ergotamine, dihydroergotamine or methysergide. After taking Rizatriptan Sandoz orodispersible tablets, you must wait at least 6 hours before taking these medicines, and at least 24 hours must pass between stopping ergot-type 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 receive only the lowest dose of 5 mg of Rizatriptan Sandoz orodispersible tablets
• the herbal remedy St John's wort ( Hypericum perforatum ). Taking this together with 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 may 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, think you may be pregnant, 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 during pregnancy. You should avoid breastfeeding for 24 hours after 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 taking this medicine. If you experience these effects, you must assess your ability to drive or operate machinery safely.
Rizatriptan Sandoz orodispersible tablets contain aspartame
Aspartame is a component of the tablets and is a source of phenylalanine. This 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 exactly as prescribed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Rizatriptan Sandoz orodispersible tablets are not intended for the prevention
of migraine: they are effective only after the onset of an attack.
The usual dose for adults over 18 years of age is 10 mg at the first sign of a migraine
attack. However, for some patients the recommended dose is 5 mg. Your doctor
will determine the most appropriate dosage for your case: it is important that you take the medicine
exactly as directed.
Most migraine attacks are relieved by a single 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 to treat the same migraine attack; instead, seek medical advice.
If an attack is not relieved by Rizatriptan Sandoz orodispersible tablets, it is still likely that a subsequent attack will respond to the medicine.
If you experience a FURTHER migraine attack within 24 hours of the first, you may 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 doses.
Instructions for use
Take the orodispersible tablets as described below:

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

Place the tablet on your tongue, where it will dissolve and can be swallowed with saliva. It is not necessary 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 follow the dose prescribed by your doctor. If you take more tablets
than directed by your doctor, you must seek immediate medical attention, as an overdose can be harmful. Symptoms of overdose include those described in section 4, particularly: dizziness, drowsiness, fainting, and slowed heart rate. You may also
experience an increase in blood pressure and adverse effects on the heart and circulation.
If you have any questions 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 side effects most frequently observed in clinical studies in adults were dizziness, drowsiness and fatigue.
Contact your doctor immediately if you experience symptoms of allergic reactions,
serotonin syndrome, heart attack or stroke:

• allergic reactions, sometimes very severe, including swelling of the face, lips, tongue and throat, which may cause difficulty breathing, speaking or swallowing (angioedema)
• severe allergic reactions with skin rashes, skin redness, blistering on lips, eyes or mouth, skin peeling and fever
• chest pain, feeling of tightness in the chest or throat, or other symptoms suggestive of a heart attack
• weakness or paralysis of limbs or face, difficulty speaking, which may indicate a stroke
• a condition called "serotonin syndrome", characterised 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 (paraesthesia), reduced skin sensitivity (hypoesthesia), reduced mental sharpness
• insomnia
• fast or irregular heartbeat (palpitations)
• sore throat
• nausea (feeling of discomfort), dry mouth, vomiting, diarrhoea, indigestion
• flushing (short-lived redness of the face)
• sensation of heaviness in certain 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, vertigo
• tremor
• fainting
• taste disturbances (bad taste)
• blurred vision
• high blood pressure
• hot flushes
• difficulty breathing
• thirst
• skin rashes, itching and redness with wheals, swelling of the face, lips, tongue and/or throat which may cause breathing and/or swallowing difficulties (angioedema)
• sweating
• sensation of tightness in certain parts of the body, muscle weakness
• irregular heartbeat, electrocardiogram (ECG) abnormalities (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 diseases (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, post-menopausal women, a particular heart rhythm problem [bundle branch block])

• slowed heartbeat

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

• spasms of blood vessels in the extremities including cold sensations and numbness of hands or feet
• seizures
• a syndrome 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
• severe skin peeling with or without fever (toxic epidermal necrolysis)
• ischaemic colitis (inflammation causing abdominal pain or diarrhoea)
• heart attack or spasm of blood vessels in the heart. These generally occur in patients with risk factors for heart and blood vessel diseases. Risk factors include high blood pressure, diabetes, smoking, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, post-menopausal women, a particular heart rhythm problem (bundle branch block).

Reporting of side effects
If you experience any side effects, 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.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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
the word EXP. The expiry date refers to the last day of that month.
Store 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 Sandoz orodispersible tablets contain
The active substance 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 components are:
Calcium silicate
Crospovidone type A
Anhydrous colloidal silica
Silicified microcrystalline cellulose
Mannitol (E421)
Aspartame (E951)
Magnesium stearate
Orange flavour (acacia gum E414, ascorbic acid E300, ethyl butyrate, maltodextrin, orange oil).

Description of the appearance of Rizatriptan Sandoz orodispersible tablets and
pack size
Orodispersible tablets.
Rizatriptan Sandoz 5 mg: flat, round tablets, white to white-grey in colour, engraved with "RZT" on one side and "5" on the other.
Rizatriptan Sandoz 10 mg: flat, round tablets, white to white-grey in colour, engraved with "RZT" on one side and "10" on the other.
Al//Al blister packs: 2, 3, 6, 18 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 EEA Member States 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
Slovakia: 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

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