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RIZATRIPTAN 5MG ORODISPERSIBLE TABLETS

Active substance(s): RIZATRIPTAN BENZOATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rizatriptan 5 mg Orodispersible Tablets
Rizatriptan 10 mg Orodispersible Tablets

SZ00000LT000

Rizatriptan

Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Rizatriptan is and what it is used
for
2. Before you take Rizatriptan
3. How to take Rizatriptan
4. Possible side effects
5. How to store Rizatriptan
6. Further information

1

What Rizatriptan is and what
it is used for

The active ingredient in this medicine,
rizatriptan belongs to a group of medicines
called 5-HT1B/1D receptor agonists. Your
doctor has prescribed this medicine to
treat the headache phase of your migraine
attacks.

2

Before you take Rizatriptan

Do NOT take Rizatriptan if you:
• are allergic (hypersensitive) to rizatriptan
or any of the other ingredients of
Rizatriptan (see Section 6 and end of
Section 2).
• are currently taking monoamine oxidase
(MAO) inhibitors such as moclobemide,
phenelzine, tranylcypromine (used to
treat depression) or linezolid (drug used
to treat bacterial infections), or have
taken MAO inhibitors within the last two
weeks (see section ʻTaking other
medicinesʼ).
• have severely impaired liver or kidney
function.
• have had a previous stroke
(cerebrovascular accident or CVA) or
symptoms similar to a stroke which wear
off after a day or two (transient
ischaemic attack or TIA).
• have moderately severe or severe high
blood pressure, or mild high blood
pressure that is NOT controlled by
medication.
• have ever suffered from heart disease
(poor blood flow in the arteries of the
heart), heart attack or a particular type of
chest pain known as Prinzmetalʼs
angina.
• have had problems with the blood supply
to your legs (peripheral vascular
disease).
• are taking any other medicine for your
migraine such as ergotamine,
ergotamine-type medicines
(dihidroergotamine, methysergide), or
another medicine in the same class (i.e.
5-HT1B/1D receptor agonists, such as
sumatriptan, naratriptan or
zolmitriptan)(see section ʻTaking other
medicinesʼ).
Take special care with Rizatriptan
Before taking Rizatriptan, tell your doctor,
if you have:
• any of the following risk factors for heart
disease:
- high blood pressure or diabetes
- you smoke or are using a nicotine
substitute
- a family history of heart disease
- you are a man over 40 years, or a
post-menopausal woman.
• kidney or liver problems .
• a particular problem with the way your
heart beats (bundle branch block).
• ever had any allergies.
• a headache associated with dizziness,
difficulty in walking, lack of coordination
or weakness in the leg and arm.
• had an allergic reaction to these or
similar tablets such as swelling of the
face, lips, tongue and/or throat which
may cause difficulty breathing and/or
swallowing.
• had short-lived symptoms including
chest pain and tightness.

If you take Rizatriptan too often you may
get a chronic headache. If this happens,
you should contact your doctor as you may
have to stop taking these tablets.
Please tell your doctor or pharmacist about
your symptoms. Your doctor will decide
if you have a migraine. You should only
take Rizatriptan for a migraine attack.
Rizatriptan should not be used to treat
headaches that might be caused by other,
more serious conditions.

Rizatriptan should only be used for
patients over the age of 18 years.

If you are older than 65 years, your doctor
will advise whether you can take these
tablets.

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
DO NOT take Rizatriptan with:

Monoamine oxidase (MAO) inhibitors
such as moclobemide, phenelzine,
linezolid or tranylcypromine, or if it is less
than two weeks since you stopped taking
an MAO inhibitor.

Certain other migraine medicines i.e.
• other medicines in the same class as
rizatriptan, for example sumatriptan,
naratriptan or zolmitriptan.
• ergotamine-type medicines such as
ergotamine, dihydroergotamine or
methysergide. You should wait at least 6
hours before taking these medicines
after taking Rizatriptan, and you should
allow at least 24 hours between stopping
ergotamine-type medicines and starting
Rizatriptan.

Ask your doctor for instructions and the
risks about taking Rizatriptan if you are
also taking:
• antidepressants such as sertraline,
escitalopram, fluoxetine, venlafaxine,
and duloxetine.
• propranolol (usually used to treat high
blood pressure)
- you should receive only the lower 5 mg
dose of Rizatriptan.
• the herbal remedy St. Johnʼs Wort
(Hypericum perforatum). Taking this
together with Rizatriptan may increase
the likelihood of side effects. It is
recommended that you do not take
Rizatriptan at the same time.

Taking Rizatriptan with food
It is better to take these tablets on an
empty stomach, but you can also take it
after you have had a meal. If Rizatriptan is
taken with food, it may take longer to work.
Pregnancy and breast-feeding
You must tell your doctor if you are
pregnant or intend to become pregnant. If
you are pregnant you may take Rizatriptan
only if your doctor decides it is clearly
needed.
If you are breast-feeding, or planning to
breast-feed, consult your doctor before
taking the medicine. You should avoid
breast-feeding for 24 hours following
treatment with Rizatriptan.

Ask your doctor or pharmacist for advice
before taking any medicine.

Driving and using machines
Migraine itself or treatment with Rizatriptan
may cause sleepiness in some patients.
Dizziness has also been reported in some
patients receiving this medicine. If you
experience these effects you should check
your ability to drive or to operate
machinery safely.

Important information about some of
the ingredients of Rizatriptan
Aspartame is an ingredient in these
tablets, which is a source of phenylalanine.
It may be harmful for people with
phenylketonuria (a metabolic disorder
which prevents the normal breakdown of
phenylalanine).

Continued on the next page >>

3

How to take Rizatriptan

Always take Rizatriptan exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure.

Rizatriptan is not intended for prevention
of migraine. It will only work once an attack
has started.
The usual dose for adults over 18 years
is 10 mg at the first signs of a migraine
attack. However in certain patients the
recommended dose is 5 mg. Your doctor
will have decided which dose is
appropriate for you and it is important you
take your medicine as your doctor has
instructed.
Most migraine attacks are relieved with
one dose (one tablet) of Rizatriptan, but if
your migraine is not relieved after a single
tablet, DO NOT take a second tablet to
treat the same migraine attack, but seek
medical advice.
Even if one migraine is not relieved by
Rizatriptan, it is still likely that your next
migraine attack will respond to the
medicine.

If you have ANOTHER migraine attack
within 24 hours of the first attack, you can
take one further tablet of Rizatriptan, but
do not take more than two tablets in a 24
hour period. Always leave at least 2 hours
between doses.
Method of administration
Take the orodispersible tablet as follows
1. Tear off one blister cell along the
perforations.
2. Carefully peel off the backing, starting
on the side indicated by the arrow.

Place the tablet on your tongue, where it
will dissolve and be swallowed with the
saliva.
You do not have to take a drink of water in
order to swallow your tablet.

If you take more Rizatriptan than you
should
It is important to keep to the dose the
doctor has prescribed. If you do take more
tablets than the doctor has advised, you
should seek medical attention immediately
as too many tablets can make you ill. The
effects of taking too many tablets will
include similar effects to those detailed in
Section 4, especially: dizziness,
sleepiness, fainting and slowed heart rate.
You may also experience raised blood
pressure and side effects affecting your
heart and circulation.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4

Possible side effects

Like all medicines, Rizatriptan can cause
side effects, although not everybody gets
them.
In clinical studies, the most frequently
reported side effects were dizziness,
sleepiness and tiredness.

If any of the following happen, contact
your doctor immediately. These are rare
serious side effects (affecting fewer
than 1 in 1,000 people).
• allergic reactions sometimes very
severe, including swelling of the face,
lips, tongue and throat which may cause
difficulty in breathing, speaking or
swallowing
• severe allergic reaction with rash, red
skin, blistering of the lips, eyes or mouth,
skin peeling, and fever
• chest pain, tightness in the chest or
throat or other symptoms consistent with
heart attack
• weakness or paralysis of limbs or face,
difficulty speaking which may indicate a
stroke (see the end of this section)
• a syndrome called "serotonin syndrome"
characterised by coma, unstable blood
pressure, extremely high body
temperature, lack of muscle
coordination, agitation, and
hallucinations.
Other possible side effects
Common (affects 1 to 10 users in 100):
• headache, sensation of pins and
needles, decreased sensitivity to touch
and pain, decreased mental agility,
trembling
• sensations of irregular and rapid
heartbeat
• hot flushes/flashes
• throat discomfort, difficulty breathing
• nausea (feeling sick), dry mouth,
vomiting, diarrhoea
• flushing of the skin, sweating
• feelings of heaviness in parts of the body
• stomach or chest pain.

Uncommon (affects 1 to 10 users in
1,000):
• poor muscle coordination, disorientation,
sleeplessness, nervousness, spinning
sensation
• blurred vision
• high blood pressure
• thirst, indigestion
• itching, itchy rash
• neck pain, feelings of tightness in parts
of the body, stiffness, muscle weakness.

Rare (affects 1 to 10 users in 10,000):
• fainting, disturbed sense of taste (bad
taste)
• wheezing
• facial pain.

Not known (frequency cannot be
estimated from the available data):
• reduced blood supply to the hands and
feet
• fits
• slower or irregular heart beat
• abnormal ECG heart tracing
• ischaemic colitis (inflammation which
causes abdominal pain or diarrhoea)
• muscle pain.

As with other medicines in this class, there
have been very rare reports of heart attack
and stroke and most of these events have
occurred in patients with risk factors for
heart and blood vessel disease (high blood
pressure, diabetes, smoking, family history
of heart disease or stroke).
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

5

How to store Rizatriptan

Keep out of the reach and sight of
children.

Do not use Rizatriptan after the expiry date
which is stated on the carton after EXP.
The expiry date refers to the last day of
that month.
Store in the original package.

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

6

Further information

What Rizatriptan contains
- The active substance is rizatriptan.

Rizatriptan 5 mg
Each orodispersible tablet contains 5 mg
of rizatriptan (as rizatriptan benzoate).

Rizatriptan 10 mg
Each orodispersible tablet contains 10 mg
of rizatriptan (as rizatriptan benzoate).
- The other ingredients are:
Calcium silicate; Crospovidone type A;
Silica, Colloidal Anhydrous; Silicified
Microcrystalline Cellulose; Mannitol
(E421); Aspartame (E951); Magnesium
Stearate; Sweet Orange Flavour (Arabic
gum E414, Ascorbic acid E300, Ethyl
butyrate, Maltodextrin, Orange oil).

What Rizatriptan looks like and
contents of the pack
Orodispersible tablet
Rizatriptan 5 mg: white to grey-white,
round, flat tablet, debossed with “RZT” on
one side, and “5” on the other side.
Rizatriptan 10 mg: white to grey-white,
round, flat tablet, debossed with “RZT” on
one side, and “10” on the other side.
Rizatriptan 5 mg Orodispersible Tablets:
Al//Al blisters: 2, 3, 6, 18 orodispersible
tablets.

Rizatriptan 10 mg Orodispersible Tablets:
Al//Al blisters: 2, 3, 6, 12, 18 orodispersible
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Lek Pharmaceuticals d.d., Verovškova 57,
1526 Ljubljana, Slovenia or Lek
Pharmaceuticals d.d., Trimlini 2D, 9220
Lendava, Slovenia or LEK S.A., ul.
Podlipie 16, 95-010 Stryków, Poland or
LEK S.A., ul. Domaniewska 50 C, 02-672
Warszawa, Poland or Salutas Pharma
GmbH, Otto-von-Guericke-Allee 1, 39179
Barleben, Germany or Salutas Pharma
GmbH, Dieselstrasse 5, 70839 Gerlingen,
Germany or S.C. Sandoz S.R.L, Str.
Livezeni nr. 7A, RO - 540472,
Targu-Mures, Romania.
This leaflet was last revised in 04/2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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