Sumatriptan Aurobindo Italia

Package leaflet: Information for the user

Sumatriptan Aurobindo Italia 50 mg tablets, 100 mg tablets

Equivalent 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to 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 taking 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 Sumatriptan Aurobindo Italia is 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 migraine may be caused by a temporary dilation of the blood vessels in the head.
Sumatriptan Aurobindo Italia is thought to work by reducing this dilation of blood vessels, thereby helping to relieve headache and providing relief from symptoms of a migraine attack, such as feeling unwell or discomfort (nausea or vomiting) and sensitivity to light or sound.

2. What you should know before taking Sumatriptan Aurobindo Italia

Do not take Sumatriptan Aurobindo Italia

• If you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6).
• You have heart problems, such as narrowing of the arteries (ischaemic heart disease) or chest pain (angina), or have already had a heart attack.
• You have circulation problems in the legs causing cramp-like pain when walking (peripheral vascular disease).
• You have had a stroke or a mini-stroke (also called transient ischaemic attack or TIA).
• You have high blood pressure. You may be able to use Sumatriptan Aurobindo Italia if your high blood pressure is mild and under treatment.
• You have severe liver problems.
• Together with other migraine medicines, including those containing ergotamine, or similar medicines such as methysergide maleate, or any triptans/5HT receptor agonists (such as naratriptan or zolmitriptan).
• With any of the following antidepressants:
• MAOIs (monoamine oxidase inhibitors) or if you have taken an MAOI within 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.
• In children under 18 years of age. If any of the following apply to you: → Inform 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 postmenopausal woman.

In very rare cases, some people have developed serious heart conditions after using sumatriptan,
even without prior signs of heart disease. If any of the above points apply to you, this may mean you
have a higher risk of developing heart disease – therefore:
→ Inform your doctor so they can check your heart function before prescribing
Sumatriptan Aurobindo Italia.
If you have a history of epileptic seizures (convulsions)
Or if you suffer from other conditions that may make seizures more likely – for example a
head injury or alcoholism.

• Inform 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.

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

If you suffer from kidney or liver disease
If either of these conditions applies to you

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

If you are intolerant to certain sugars

• Inform 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 unsure whether it is a sulfonamide:
→ Inform 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)
→ Inform 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 may worsen your headaches.
→ Inform your doctor if this applies to you. They may recommend that you stop using Sumatriptan
Aurobindo Italia.
If you experience chest or throat pain or tightness 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:
→ Seek immediate medical attention. Section 4 of this leaflet contains more information about these possible side effects.
Other medicines and Sumatriptan Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. This includes herbal products and medicines purchased 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 inform 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 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 MAOIs within the last 2 weeks.
• SSRIs or SNRIs used to treat depression. Using Sumatriptan Aurobindo Italia with these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, rapid heartbeat and tremor). Inform your doctor immediately if you experience any of these symptoms.
• St. John’s Wort (Hypericum perforatum). Taking herbal remedies containing St. John’s Wort together with Sumatriptan Aurobindo Italia may make side effects more likely.

Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, 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 you should use Sumatriptan Aurobindo Italia during pregnancy.
• Do not breastfeed for 12 hours after using Sumatriptan Aurobindo Italia. Breast milk expressed during this time should be discarded and not given to the baby. Some breastfeeding women report breast and/or nipple pain after using sumatriptan. This pain is usually temporary and resolves within 3–12 hours.

Driving and using machines
Both migraine symptoms and this medicine may cause drowsiness. If this occurs, do not drive
and do not operate machinery.
Sumatriptan Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Sumatriptan Aurobindo Italia

Take this medicine exactly as directed by 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 attack starting, although you may take it at any time during the attack.
• Do not use Sumatriptan Aurobindo Italia to prevent an attack – use it only after migraine symptoms have started.

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

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

Children under 18 years of age
Sumatriptan Aurobindo Italia is not recommended for 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 may take a second tablet of Sumatriptan Aurobindo Italia if at least 2 hours have passed since the first tablet. Do not take more than a total of 300 mg within 24 hours.

If the first tablet has no effect:

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

If Sumatriptan Aurobindo Italia does not provide any relief:

• Consult your doctor or pharmacist.

If you take more Sumatriptan Aurobindo Italia than 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 excessive doses of Sumatriptan Aurobindo Italia may make you feel unwell. If you have taken more than 300
mg within 24 hours:
Consult your doctor.
If you have any doubts 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 everybody will experience them.
Some symptoms may be caused by migraine itself.
Allergic reaction: seek medical help immediately.
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 eyelids, face or lips; complete collapse. If you experience any of these symptoms immediately after using Sumatriptan Aurobindo Italia: → Stop using it immediately. Contact your doctor at once.

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

• Pain, tightness, pressure or squeezing sensation in the chest, throat or other parts of the body, or unusual sensations including numbness, tingling, or feeling hot or cold. These effects may be intense but usually resolve quickly. If these effects persist or become severe (especially chest pain):

→ Seek urgent medical attention. In a small number of people, these symptoms may be due to a heart attack.
Other common side effects include:

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

Rare (may affect up to 1 in 1,000 people):

• Breast 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, inform your doctor or nurse that you are taking Sumatriptan Aurobindo Italia.

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

• Seizures, muscle spasms, neck stiffness.
• Vision disturbances such as eye tremors, reduced vision, double vision, vision loss, and in some cases even permanent defects (although these may also be due to the migraine attack itself).
• Heart problems, including faster, slower or irregular heartbeat, chest pain (angina), or heart attack.
• Pale, bluish skin and/or pain in fingers, toes, ears, nose and jaw in response to cold or stress (Raynaud's phenomenon).
• Feeling faint (drop in blood pressure).
• Pain in the left side of the abdomen and diarrhoea with blood (ischaemic colitis).
• Diarrhoea.
• Joint pain.
• Feeling anxious.
• Excessive sweating.
• If you have recently had an injury or have an inflammation (such as rheumatism or colon inflammation), you may experience pain or worsening of pain at the site of injury or inflammation.
• Difficulty swallowing.

Reporting of side effects
If you experience any side effect, 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.aifa.gov.it/content/segnalazioni-reazioni-avverse. 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 carton and on the blister after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater 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 substance is sumatriptan. Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate). Each tablet contains 100 mg of sumatriptan (as sumatriptan succinate).
• The other components are: croscarmellose sodium, polysorbate 80, calcium hydrogen phosphate, microcrystalline cellulose (PH-200), sodium hydrogen carbonate and magnesium stearate.

Description of the appearance of Sumatriptan Aurobindo Italia and contents of the pack
Tablet.
Sumatriptan Aurobindo Italia 50 mg tablets
White to almost white, capsule-shaped, biconvex tablets, marked with ‘C’ on one side and ‘33’ on the other side.
Sumatriptan Aurobindo Italia 100 mg tablets
White to almost white, capsule-shaped, biconvex tablets, marked with ‘C’ 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 European Economic Area Member States under the following names:
Italy: Sumatriptan Aurobindo Italia
Malta: Sumatriptan Aurobindo 50 mg/100 mg tablets
Poland: ApoMigra