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SUMATRIPTAN 100MG FILM-COATED TABLETS

Active substance: SUMATRIPTAN SUCCINATE

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Package leaflet: Information for the user
Sumatriptan 50mg film-coated Tablets
Sumatriptan 100mg film-coated Tablets
(sumatriptan)
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- 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 only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet

1.
2.
3.
4.
5.
6.

What Sumatriptan is and what it is used for
What you need to know before you take Sumatriptan
How to take Sumatriptan
Possible side effects
How to store Sumatriptan
Contents of the pack and other information

1. What Sumatriptan is and what it is used for
Each Sumatriptan film-coated tablet contains a single dose of sumatriptan, which belongs to a group of
medicines called triptans (also known as 5-HT1 receptor agonists).
Sumatriptan is used to treat migraine headache.
Migraine symptoms may be caused by the temporary widening of blood vessels in the head. Sumatriptan is
believed to reduce the widening of these blood vessels. This in turn helps to take away the headache and
relieve other symptoms of a migraine attack, such as feeling or being sick (nausea or vomiting) and
sensitivity to light and sound.

2. What you need to know before you take Sumatriptan
Do not take Sumatriptan:











If you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
If you have a heart problem such as narrowing of the arteries (Ischaemic heart disease) or chest pains
(angina), or have already had a heart attack
If you have circulation problems in your legs that cause cramp-like pains when you walk (peripheral
vascular disease)
If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)
If you have high blood pressure. You may be able to use Sumatriptan if your high blood pressure is
mild and is being treated
If you have serious liver disease
With other migraine medicines, including those which contain ergotamine, or similar medicines such
as methysergide maleate; or any triptan or 5HT1 agonist (such as naratriptan or zolmitriptan)
With any of the following anti-depressants:
MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI in the last 2 weeks
SSRIs (selective serotonin reuptake inhibitors) including citalopram, fluoxetine, fluvoxamine, paroxetine
and sertraline
SNRIs (serotonin noradrenaline reuptake inhibitors) including venlafaxine and duloxetine
For children under 18 years of age.

If any of these apply to you:
Tell your doctor, and do not take Sumatriptan film-coated tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sumatriptan.
If you have any extra risk factors
• If you are a heavy smoker, or using nicotine replacement therapy, and especially
• If you are a man aged over 40, or
• If you are a woman who has been through the menopause.
In very rare cases, people have developed serious heart conditions after using Sumatriptan, even though
they had no signs of heart disease before. If any of the points above applies to you it could mean you have a
greater risk of developing heart disease - so:
Tell your doctor so that your heart function can be checked before Sumatriptan is prescribed for you.
If you have a history of fits (seizures)
Or if you have other conditions which might make it more likely that you’ll have a fit - for example, a head
injury or alcoholism:
Tell your doctor so that you can be supervised more closely.
If you have liver or kidney disease
If you have an intolerance to some sugars
If any of these apply to you:
Tell your doctor so that you can be supervised more closely

If you are allergic to antibiotics called sulphonamides

If so, you may also be allergic to Sumatriptan. If you know you are allergic to an antibiotic but you are not
sure whether it is a sulphonamide:
Tell your doctor or pharmacist before using Sumatriptan.

If you are taking anti-depressants called SSRIs
(Selective Serotonin Reuptake Inhibitors) or SNRIs (Seratonin Noradrenaline Reuptake Inhibitors)
Tell your doctor or pharmacist before using Sumatriptan. Also see Other medicines and Sumatriptan,
below.
If you use Sumatriptan frequently.
Using Sumatriptan too often may make your headaches worse.
Tell your doctor if this applies to you. He or she may recommend you stop using Sumatriptan.
If you feel pain or tightness in your chest after you use Sumatriptan
These effects may be intense but they usually pass quickly. If they do not pass quickly, or they become
severe:
Get medical help immediately. Section 4 has more information about these possible side effects.

Other medicines and Sumatriptan

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other
medicines.
Some medicines must not be taken with Sumatriptan and others may cause adverse effects if they are taken
with Sumatriptan.

You must tell your doctor if you are taking:

• ergotamine also used to treat migraine, or similar medicines such as methysergide (see section 2 Do








not take Sumatriptan). Do not use Sumatriptan at the same time as these medicines. Stop taking these
medicines at least 24 hours before using Sumatriptan. Do not take any medicines which contain
ergotamine or compounds similar to ergotamine again for at least 6 hours after using Sumatriptan.
other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to
treat migraine, (see section 2 Do not take Sumatriptan). Do not use Sumatriptan at the same time as
these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan. Do not take
another triptan/5-HT1 receptor agonist again for at least 24 hours after using Sumatriptan.
MAOIs used to treat depression. Do not use Sumatriptan if you have taken these in the last 2 weeks
SSRIs and SNRIs used to treat depression. Using Sumatriptan with these medicines can cause
serotonin syndrome (a collection of symptoms which can include restlessness, confusion, sweating,
hallucinations, increased reflexes, muscle spasms, shivering, increased heartbeat and shaking). Tell
your doctor immediately if you are affected in this way.
St John’s Wort (Hypericum perforatum). Taking herbal remedies that contain St John’s Wort together
with Sumatriptan may make side effects more likely.

Pregnancy and breast-feeding




If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine. There is only limited information
about the safety of Sumatriptan for pregnant women, though up until now there is no evidence of any
increased risk of birth defects. Your doctor will discuss with you whether or not you should use
Sumatriptan while you are pregnant
Do not breast-feed your baby for 12 hours after using Sumatriptan. If you express any breast milk
during this time, discard the milk and do not give it to your baby.

Driving and using machines

Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, do not drive
or operate machinery.

Sumatriptan contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to take Sumatriptan
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

When to take Sumatriptan

• It’s best to take Sumatriptan as soon as you feel a migraine coming on, although - you can take it at


any time during an attack
Do not use Sumatriptan to try to prevent an attack - only use it after your migraine symptoms start.

How much to take

Adults aged 18 to 65
• The usual dose for adults aged 18 to 65 is one Sumatriptan 50 mg film-coated tablet, swallowed
whole with water. Some patients may need a 100 mg dose - you should follow your doctor’s advice.
Children under 18
• Sumatriptan is not recommended for children under 18 years old.
Older people (aged over 65)

Sumatriptan is not recommended for people aged over 65.

If your symptoms start to come back


You can take a second Sumatriptan film-coated tablet if at least 2 hours have passed since the first
tablet.
Do not take more than 300 mg in total in 24 hours.

If the first tablet has no effect


Do not take a second tablet or any other Sumatriptan preparation for the same attack. Sumatriptan
can still be used for your next attack.

If Sumatriptan does not give you any relief:
Ask your doctor or pharmacist for advice.

If you take more Sumatriptan than you should


Do not take more than six 50 mg tablets or three 100 mg tablets (that’s 300 mg in total) in 24 hours.

Taking too much Sumatriptan could make you ill. If you have taken more than 300 mg in 24 hours:
Contact your doctor for advice.
If you have any further questions on 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 everybody gets them. Some
symptoms may be caused by the migraine itself.
Allergic reaction: get doctor’s help straight away
The following side effects have occurred but their exact frequency is not known.
• The signs of allergy include rash, hives (itchy rash); wheezing; swollen eyelids, face or lips;
complete collapse.
If you get any of these symptoms soon after using Sumatriptan:
Don’t use any more. Contact a doctor straight away.

Common side effects (affect up to 1 in 10 people)


Pain, heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual
sensations, including numbness, tingling and warmth or cold. These effects may be intense but
generally pass quickly.

If these effects continue or become severe (especially the chest pain):

Get medical help urgently. In a very small number of people these symptoms can be caused by a heart
attack.

Other common side effects include:







Feeling sick (nausea) or being sick (vomiting), although this may be due to the migraine itself
Tiredness or drowsiness
Dizziness, feeling weak, or getting hot flushes
Temporary increase in blood pressure
Shortness of breath
Aching muscles.

Very rare side effects (affect up to 1 in 10,000 people)

• Liver function changes. If you have a blood test to check your liver function, tell your doctor that you are
taking Sumatriptan.

Some patients may get the following side effects but it is not known how often they occur

• Seizures/fits, tremors, muscle spasm, neck stiffness
• Visual disturbances such as flickering, reduced vision, double vision, loss of vision, and in some cases
even permanent defects (although these may be due to the migraine attack itself)

• Heart problems, where your heartbeat may go faster, slower or change rhythm, chest pains (angina) or
heart attack

• Pale, blue-tinged skin and/or pain in your fingers, toes, ears, nose or jaw in response to cold or stress







(Raynaud’s phenomenon)
Feeling faint (blood pressure may go down)
Pain in the lower left side of the stomach and bloody diarrhoea (ischaemic colitis)
Diarrhoea
Pain in the joints
Feeling anxious
Excessive sweating

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Sumatriptan
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 blister/carton after ‘Exp (MM/YY)’.
The expiry date refers to the last day of that month.
Do not store above 25˚C.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Sumatriptan contains
-

The active substance is sumatriptan.
Sumatriptan 50 mg: Each film coated tablet contains 50mg sumatriptan (as the succinate).
Sumatriptan 100 mg: Each film coated tablet contains 100mg sumatriptan (as the succinate).

-

The other ingredients are: Core: lactose monohydrate, lactose anhydrous, crosscarmellose sodium,
microcrystalline cellulose, magnesium stearate. Coating: Lactose monohydrate, mannitol (E421),
titanium dioxide (E171), triacetin and talc.

What Sumatriptan looks like and contents of the pack
50mg: Round white film coated tablets embossed ‘RDY’ on one face and ‘292’ on the other.
100mg: Capsule shaped white film coated tablets embossed ‘RDY’ on one face and ‘293’ on the other.

Pack sizes:

2, 3, 4, 6, 12 and 18 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Rd, Beverley, HU17 0LD, UK

This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany
Italy
United Kingdom

Sumatriptan beta 50 mg, 100 mg Filmtabletten
Sumatriptan TecniGen 50 mg, 100 mg compresse rivestite con film
Sumatriptan 50mg, 100mg film-coated Tablets

This leaflet was last revised in February 2015

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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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