RIZATRIPTAN 5 MG TABLETS

Active substance: RIZATRIPTAN BENZOATE

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J ENSON
Package Leaflet: Information for the user
Rizatriptan 5 mg Tablets
Rizatriptan 10 mg Tablets
(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 get 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 Tablets are and what they are
used for
2. Before you take Rizatriptan Tablets
3. How to take Rizatriptan Tablets
4. Possible side effects
5. How to store Rizatriptan Tablets
6. Further information

1. What Rizatriptan Tablets are and
what they are used for
Rizatriptan belongs to a group of medicines known as
5-HT1 agonists, which reduce the swelling of blood vessels
surrounding the brain. It is this swelling which results in the
headache pain of a migraine attack. Rizatriptan Tablets can
be used to treat migraine attacks which may or may not be
associated with visual disturbances (an aura). They are not
used to prevent migraine attacks.
Please tell your doctor or pharmacist about your symptoms.
Your doctor will decide if you suffer from migraines. You
should take Rizatriptan Tablets only for a migraine attack.
This medicine should not be used to treat headaches that
might be caused by other, more serious conditions.

2. Before you take Rizatriptan Tablets
Do not take Rizatriptan Tablets if you
are allergic (hypersensitive) to rizatriptan or any of the
other ingredients of Rizatriptan tablets (see section 6)
have high blood pressure which is untreated or difficult
to treat
have or have ever had poor blood flow in the arteries of
the heart (ischaemic or coronary heart disease) or
suffer from a particular type of chest pain known as
Prinzmetal's angina
have had a stroke or symptoms similar to a stroke which
disappear after a day or two (a transient ischaemic
attack or TIA)
have a disease of the blood vessels in your arms and legs
(intermittent claudication or peripheral vascular
disease)
have severe liver or kidney disease
are taking monoamine oxidase inhibitors (MAOIs) for
depression (such as moclobemide, phenelzine,
tranylcypromine or pargyline) or if it has been less than
2 weeks since you stopped taking an MAOI
are taking linezolid (an antibiotic)
are taking other medicines for migraine, including
other medicines of this type (5-HT1 agonists
(sumatriptan, naratriptan or zolmitriptan) or ergotaminetype medicines, such as ergotamine, dihydro-ergotamine,
or methysergide). You should wait at least 6 hours after
taking Rizatriptan Tablets before you take ergotaminetype medicines. You should wait at least 24 hours after
taking ergotamine-type medicines before taking
Rizatriptan Tablets.

Take special care with Rizatriptan Tablets if
you have any of the following risk factors for heart
disease:
high blood pressure
diabetes
you smoke or use nicotine replacement therapies
your family has a history of heart disease
you are a man over 40 years of age
you are a post-menopausal woman
you have kidney or liver problems
you have bundle branch block (a particular problem
with the way your heart beats)
you have or have had any allergies
your headache is associated with dizziness, difficulty
walking, lack of co-ordination or weakness in your
leg and/or arm
you use any herbal preparation containing St John's
Wort.

you have previously had an allergic reaction like
swelling of the face, lips, tongue and/or throat which
may cause difficulty breathing and/or swallowing
(angioedema)
you have had short-lived chest pain and tightness
you develop persistent headaches after taking this
medicine. This can happen if you take this medicine
too often. You should contact your doctor if this occurs.

Taking other medicines

Rizatriptan Tablets can affect the way some medicines work
and some medicines can affect the way that Rizatriptan
Tablets work. Please tell your doctor or pharmacist if you
are taking or have recently taken any other medicines
including medicines obtained without a prescription and
herbal medicines.
Ask your doctor about the risks of taking Rizatriptan Tablets
if you:
are taking selective serotonin reuptake inhibitors
(SSRIs) such as sertraline, escitalopram oxalate,
fluoxetine, or serotonin norepinephrine reuptake
inhibitors (SNRIs) such as venlafaxine or duloxetine,
for depression.

Pregnancy and breast-feeding

It is not known whether this medicine is harmful to an
unborn baby when taken in pregnancy. If you are pregnant,
trying to become pregnant or breast-feeding, tell your
doctor before taking this medicine. Breast-feeding should
be avoided for 24 hours after treatment.

Driving and using machines

You may feel sleepy or dizzy while taking Rizatriptan
Tablets. If this happens, do not drive or use any tools or
machines. Talk to your doctor if this causes problems
for you.

Important information about some of the
ingredients of Rizatriptan Tablets

Rizatriptan tablets contain lactose. If your doctor has told
you that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

3. How to take Rizatriptan Tablets
Always take Rizatriptan Tablets exactly as your doctor has
told you to. If you are not sure, check with your doctor
or pharmacist.
The usual dose is 10 mg as soon as you feel your migraine
start.
If you have liver or kidney disease or are taking
propranolol, your doctor may prescribe the 5 mg tablets.
If you are taking propranolol. You should leave at least 2
hours between taking propanolol and Rizatriptan Tablets.
Do not give Rizatriptan Tablets to children and adolescents.
This medicine is not normally prescribed for people under
18 years of age.
Oral use.
Swallow the tablet(s) whole with some water. It is better to
take this medicine on an empty stomach, as it can take
longer to work if it is taken after food. Although you can
still take it if you have eaten.

If you still have a migraine

Only one Rizatriptan tablet should be taken per migraine
attack. If you do not respond to the dose of Rizatriptan
during an attack, do not take a second dose for treatment of
the same attack. It is likely that you will respond to
Rizatriptan Tablets during the next attack.

If your migraine returns

If you get another migraine attack, you can take another
dose as long as two hours have passed since you took your
first dose.
Do not take more than two 5 mg or two 10 mg tablets in a
24-hour period. Wait at least 2 hours between doses.
If your condition worsens, seek medical attention.

If you take more Rizatriptan Tablets than you
should

4. Possible side effects
Like all medicines, Rizatriptan Tablets can cause side
effects, although not everybody gets them.
If you get any of the following rare allergic symptoms
after taking these tablets, contact your doctor at once:
signs of an allergic reaction such as rashes, itching,
sudden wheezing, difficulty breathing, swelling of the
eyelids, face, lips, tongue or throat
peeling and blistering of the skin, mouth, eyes and
genitals
rash affecting your whole body.
Tell your doctor or pharmacist if you notice any of the
following side effects, they get worse or if you notice any
effects not listed.
Common (affects 1 to 10 users in 100)
dizziness, sleepiness, tiredness
headache, dry mouth
stomach pains
chest pains, throat discomfort
heaviness, pain or pressure in the throat, neck, limbs or
chest
palpitations (irregular heart beat), fast racing heart beat
feeling or being sick, diarrhoea
sweating, flushing (redness of the face which lasts a
short time), hot flushes
shaking (tremor) usually of the hands
tingling in the fingers and toes
difficulty thinking
Uncommon (affects 1 to 10 users in 1,000)
neck pain
difficulty sleeping, increased thirst
increased blood pressure
indigestion, blurred vision
unsteadiness when walking
muscle weakness, stiffness and tightness of muscles
itching and lumpy skin rash
confusion, nervousness
Rare (affects 1 to 10 users in 10,000)
fainting, especially on standing
bad taste in your mouth
facial pain
wheezing
serotonin syndrome – which can cause dilated pupils,
fast racing heart, twitching, high blood pressure,
agitation, high temperature and mental confusion
heart attack, spasm of blood vessels of the heart, stroke –
these generally occur in patients with risk factors for
heart and blood vessel disease (see section 2. Before you
take Rizatriptan Tablets)
Frequency not known (frequency cannot be estimated from
the available data)
seizure (convulsions/fits)
spasm of blood vessels of the extremities including
coldness and numbness of the hands or feet
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet please tell your doctor or
pharmacist.

5. How to store Rizatriptan Tablets
Keep out of the reach and sight of children.
Do not use Rizatriptan Tablets after the expiry date which is
stated on the pack as "EXP".
The expiry date refers to the last day of that month.
Do not store above 30ºC.
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.

If you take more tablets than prescribed, contact your doctor
or get other medical advice at once. If possible, take the
tablets, the box and this leaflet with you to show the doctor.

If you forget to take Rizatriptan Tablets

If you forgot or were unable to take Rizatriptan Tablets at
the start of your migraine attack, you can take it at anytime
during the attack.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

(continued overleaf)

J ENSON
6. Further information
What Rizatriptan Tablets contain
The active substance is Rizatriptan.
Each Rizatriptan 5 mg Tablet contains 5 mg of rizatriptan (as
rizatriptan benzoate).
Each Rizatriptan 10 mg Tablet contains 10 mg of rizatriptan
(as rizatriptan benzoate).
The other ingredients are lactose monohydrate,
microcrystalline cellulose, pregelatinised maize starch, iron
oxide red (E172) and magnesium stearate.

What Rizatriptan Tablets look like and contents
of the pack
Rizatriptan 5 mg Tablets are pink round biconvex tablets
with R on one side and 5 on the other.
Rizatriptan 10 mg Tablets are pink round biconvex tablets
with R on one side and 10 on the other.
Rizatriptan Tablets are available in pack sizes of 1, 2, 3, 6,
12 or 18 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Jenson Pharmaceutical Services Ltd
Carradine House
237 Regents Park Road
London N3 3LF
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany
Germany

Rizatriptan Jenson 5 mg Tablets
Rizatriptan Jenson 10 mg Tablets

UK
UK

Rizatriptan 5 mg Tablets
Rizatriptan 10 mg Tablets

This leaflet was last approved in 05/2011.

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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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