SUMATRIPTAN 50 mg Tabletka

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1. Sumatriptan Aurobindo Italia 50 mg tablets, 100 mg tablets
   1. What is Sumatriptan Aurobindo Italia and what it is used for
   2. What you need to know before taking Sumatriptan Aurobindo Italia
   3. How to take Sumatriptan Aurobindo Italia
   4. Possible side effects
   5. How to store Sumatriptan Aurobindo Italia
   6. Package contents and other information

Sumatriptan Aurobindo Italia 50 mg tablets, 100 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as 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 you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Sumatriptan Aurobindo Italia is and what it is used for
• 2. What you need to know before you take Sumatriptan Aurobindo Italia
• 3. How to take Sumatriptan Aurobindo Italia
• 4. Possible side effects
• 5. How to store Sumatriptan Aurobindo Italia
• 6. Contents of the pack and other information

1. What is Sumatriptan Aurobindo Italia and what it is used for

Sumatriptan Aurobindo Italia belongs to a group of medicines called triptans ( also known as

5HT receptor agonists).
Sumatriptan Aurobindo Italia is used to treat migraine attacks.
The symptoms of a migraine can be caused by a temporary dilation of the blood vessels in the
head.
It is believed that Sumatriptan Aurobindo Italia works by reducing the dilation of these blood vessels.
This, in turn, helps to make the headache go away and to relieve the symptoms of a migraine attack, such as feeling sick or unwell (nausea or vomiting) and sensitivity to light or
noise.

2. What you need to know before taking Sumatriptan Aurobindo Italia

Do not take Sumatriptan Aurobindo Italia

• If you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems, such as narrowing of the arteries (ischaemic heart disease) or chest pain (angina), or have had a heart attack.
• If you have problems with the circulation in your legs that cause pain similar to cramps when walking (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 Aurobindo Italia if your high blood pressure is mild and under treatment.
• If you have severe liver problems.
• With other medicines for migraine, including those containing ergotamine, or similar medicines such as methysergide maleate or any triptan/5HT receptor agonist (such as naratriptan or zolmitriptan).
• With any of the following antidepressants:
• 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-norepinephrine reuptake inhibitors) including venlafaxine and duloxetine
• For children under the age of 18 years. If any of the following applies to you:
• Tell your doctor and do not take Sumatriptan Aurobindo Italia.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sumatriptan Aurobindo Italia if you have any other
risk factors:

• if you smoke heavily or are using nicotine replacement therapy, and especially
• if you are a man over 40 years of age, or
• if you are a woman in menopause.

In very rare cases, some people have developed serious heart conditions after using sumatriptan,
even without previous signs of heart disease. If any of the above applies to you it could
mean you have a higher risk of developing heart disease – therefore:

• Tell your doctor so they can check your heart function before prescribing Sumatriptan Aurobindo Italia.

If you have a history of seizures (convulsions)
Or if you suffer from other conditions that may make you more likely to have seizures – for example
a head injury or alcoholism.

• Tell your doctor so they can monitor you more closely.

If you have had high blood pressure Sumatriptan Aurobindo Italia may not be suitable for you.

• Tell your doctor or pharmacist before taking Sumatriptan Aurobindo Italia.

If you suffer from a kidney or liver disease
If any of these two conditions applies to you

• Tell your doctor so they can monitor you more closely.

If you are intolerant to certain sugars

• Tell your doctor so they can monitor you more closely.

If you are allergic to antibiotics called sulfonamides
In this case you may also be allergic to Sumatriptan Aurobindo Italia. If you know you are allergic to
an antibiotic but are not sure if it is a sulfonamide:

• Tell your doctor or pharmacist before using Sumatriptan Aurobindo Italia.

If you are taking antidepressants called SSRIs (selective serotonin reuptake inhibitors) or
SNRIs (serotonin-norepinephrine reuptake inhibitors)

• Tell your doctor or pharmacist before using Sumatriptan Aurobindo Italia. See also “Other medicines and Sumatriptan Aurobindo Italia” below.

If you use Sumatriptan Aurobindo Italia frequently.
Using Sumatriptan Aurobindo Italia too often can worsen your headaches.

• Tell your doctor if this applies to you. They may recommend that you stop using Sumatriptan Aurobindo Italia.

If you experience pain or a feeling of tightness in your chest and throat after using Sumatriptan
Aurobindo Italia.
These effects can be intense but usually pass quickly. If they do not pass quickly, or
if they become severe:
more information on these possible side effects.

Other medicines and Sumatriptan Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes herbal medicines and medicines you bought without
a prescription.
Some medicines must not be taken with Sumatriptan Aurobindo Italia and others may cause
side effects if taken with Sumatriptan Aurobindo Italia. You must tell your doctor if you are
taking:

• Ergotamine, also used for migraine, or similar medicines such as methysergide (see section 2). Do not use Sumatriptan Aurobindo Italia together with these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan Aurobindo Italia. Do not take medicines containing ergotamine or ergotamine-like compounds again for at least 6 hours after using Sumatriptan Aurobindo Italia.
• Other triptans/5HT receptor agonists(such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine (see section 2). Do not use Sumatriptan Aurobindo Italia together with these medicines. Do not take other triptans/5HT receptor agonists for at least 24 hours after using Sumatriptan Aurobindo Italia.
• MAOIs used to treat depression. Do not use Sumatriptan Aurobindo Italia if you have taken them in the last 2 weeks.
• SSRIs or SNRIsused to treat depression. Using Sumatriptan Aurobindo Italia with these medicines can cause serotonin syndrome (a collection of symptoms that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, rapid heartbeat and tremor). Tell your doctor immediately if you experience these symptoms.
• St John’s Wort(Hypericum perforatum). Taking herbal remedies that contain St John’s Wort together with Sumatriptan Aurobindo Italia may make side effects more likely.

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine. Information on safety in pregnant women is limited, although so far there is no evidence of an increased risk of birth defects. Your doctor will discuss with you whether or not to use Sumatriptan Aurobindo Italia during pregnancy.
• Do not breastfeed your baby for 12 hours after using Sumatriptan Aurobindo Italia. The breast milk obtained during this time interval should be discarded and not given to the baby.

Driving and operating machinery
Both migraine symptoms and the medicine can cause drowsiness. If this happens, do not drive
vehicles and do not use machines.

3. How to take Sumatriptan Aurobindo Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
When to take Sumatriptan Aurobindo Italia

• It is best to take Sumatriptan Aurobindo Italia as soon as you feel a migraine coming on, although you can take it at any time during the attack
• Do not use Sumatriptan Aurobindo Italia to prevent an attack - use it only after the start of migraine symptoms.

How much medicine to take
Adults aged 18 to 65 years:

• The usual dose for adults aged 18 to 65 years is one Sumatriptan Aurobindo Italia 50 mg tablet, to be swallowed whole with water. Some patients may need a 100 mg dose - you should follow your doctor's advice.

Children under 18 years of age
Sumatriptan Aurobindo Italia is not recommended in children under 18 years of age.
Elderly (over 65 years of age)
Sumatriptan Aurobindo Italia is not recommended for people over 65 years of age.
If symptoms start to return:

• You can take a second Sumatriptan Aurobindo Italia tablet if at least 2 hours have passed since the first tablet. Do not take more than 300 mg in total within 24 hours.

If the first tablet has no effect

• Do not take a second tablet or any other preparation containing sumatriptan for the same attack. Sumatriptan Aurobindo Italia can still be used for the next attack.

If Sumatriptan Aurobindo Italia does not give you any relief:

• Ask your doctor or pharmacist for advice.

If you take more Sumatriptan Aurobindo Italiathan you should

• Do not take more than 6 tablets of 50 mg or 3 tablets of 100 mg (300 mg in total) within 24 hours.

Taking an excessive dose of Sumatriptan Aurobindo Italia can make you feel unwell. If you have taken more than
300 mg in 24 hours:
Ask your doctor for advice.
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 everybody gets them.
Some symptoms may be caused by the migraine itself.
Allergic reaction: seek immediate medical attention.
The following side effects have been reported but their exact frequency is unknown:

• Signs of allergy include skin rash, hives (itchy rash); shortness of breath; swelling of the eyelids, face or lips; complete collapse. If you experience any of these symptoms immediately after using Sumatriptan Aurobindo Italia:
• Do not use it again. Contact your doctor immediately.

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

• Pain, heaviness, pressure or a feeling of tightness in the chest, throat or other parts of the body, or unusual sensations including numbness, tingling or a feeling of warmth or cold. These effects may be intense but generally resolve quickly. If these effects continue or become severe(particularly chest pain):
• Seek urgent medical attention.In a small number of people these symptoms may be caused by a heart attack.

Other common side effects include:

• Feeling sick (nausea) and being sick (vomiting), which may be due to the migraine itself
• Tiredness or drowsiness
• Dizziness, feeling of weakness or hot flushes
• Temporary increase in blood pressure
• Shortness of breath
• Muscle pain.

Very rare(may affect up to 1 in 10,000 people):

• Changes in liver function. If you have had a blood test to check your liver function, tell your doctor or nurse if you are taking Sumatriptan Aurobindo Italia.

Some patients may develop the following effects but their frequency is unknown

• Seizures/convulsions, muscle spasm, stiff neck.
• Vision problems such as eye twitching, reduced vision, double vision, loss of vision and in some cases also permanent defects (although these may also be due to the migraine attack itself)
• Heart problems, where the heartbeat may be faster, slower or change rhythm, chest pain (angina) or heart attack.
• Pale, bluish skin and/or pain in the fingers of the hands, feet, ears, nose and jaw in response to cold or stress (Raynaud’s phenomenon)
• Feeling of fainting (low blood pressure)
• Pain in the left side of the abdomen and diarrhoea with blood (ischaemic colitis)
• Diarrhoea
• Joint pain
• Feeling anxious
• Excessive sweating.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sumatriptan Aurobindo Italia

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 package and on the blister after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Sumatriptan Aurobindo Italia contains

• The active ingredient is sumatriptan. Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate). Each tablet contains 100 mg of sumatriptan (as sumatriptan succinate).
• The other ingredients are: croscarmellose sodium, polysorbate 80, anhydrous calcium hydrogen phosphate, microcrystalline cellulose (PH-200), sodium hydrogen carbonate and magnesium stearate.

Description of the appearance of Sumatriptan Aurobindo Italiaand package contents
Tablet.

Sumatriptan Aurobindo Italia50 mg tablets
Tablets from white to almost white, capsule-shaped, biconvex, with ‘C’ imprinted on one side and
‘33’ on the other side.

Sumatriptan Aurobindo Italia100 mg tablets
Tablets from white to almost white, capsule-shaped, biconvex, with ‘C’ imprinted on one side and
‘34’ on the other side.
Sumatriptan Aurobindo Italia tablets are available in blister packs containing 4 and 6
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA) Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Republic: Sumatriptan Aurovitas
Italy: Sumatriptan Aurobindo Italia
Malta: Sumatriptan Aurobindo 50 mg/100 mg tablets
Poland: Sumatriptan Aurovitas
Portugal: Sumatriptano Aurovitas