Apomigra

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
ApoMigra (Sumatriptan Aurobindo), 50 mg, tablets
Sumatriptanum
ApoMigra and Sumatriptan Aurobindo are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not give it to others.
• It may harm other people, even if their symptoms are the same.
• If any of the adverse effects worsen or if any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse.

Table of contents of the leaflet:
1 What ApoMigra is and what it is used for

2. Important information before taking ApoMigra
3. How to take ApoMigra
4. Possible side effects
5. How to store ApoMigra
6. Contents of the pack and other information

1. What ApoMigra is and what it is used for
ApoMigra belongs to a group of medicines known as triptans (also called 5HT receptor agonists).
ApoMigra is used to treat migraine attacks.
Migraine symptoms may be caused by temporary dilation of blood vessels in the head. ApoMigra is believed to cause constriction of these dilated vessels. This in turn helps relieve headache and alleviate other symptoms of a migraine attack, such as nausea or vomiting, and sensitivity to light and sound.

2. Important information before taking ApoMigra

When not to take ApoMigra

• if the patient is allergic to sumatriptan or any of the other ingredients of this medicine listed in section 6.
• if the patient has heart diseases such as coronary artery narrowing (ischaemic heart disease) or chest pain (angina), or if the patient has had a heart attack;
• if the patient has circulation problems in the legs causing pain when walking, similar to cramps (peripheral vascular disease);
• if the patient has had a stroke or mini-stroke [also known as transient ischaemic attack (TIA)];
• if the patient has high blood pressure. A patient with mild high blood pressure adequately treated may take ApoMigra;
• if the patient has severe liver function disorders;
• if the patient is taking other migraine medicines, including those containing ergotamine or medicines with similar action such as methysergide maleate, or other triptans, or medicines called 5HT receptor agonists (such as naratriptan or zolmitriptan);
• if the patient is taking any antidepressant medicines:
• medicines belonging to the group called monoamine oxidase inhibitors (MAOIs), or has taken MAOIs within the last 2 weeks,
• selective serotonin reuptake inhibitors (SSRIs), including: citalopram, fluoxetine, fluvoxamine, paroxetine or sertraline,
• serotonin and noradrenaline reuptake inhibitors (SNRIs), including: venlafaxine and duloxetine,
• in children under 18 years of age.

If any of the above situations apply to the patient:
Contact your doctor and do not take ApoMigra.
Warnings and precautions
Talk to your doctor or pharmacist before taking ApoMigra.
Additional risk factors exist for the patient:

• if the patient is a smoker or uses nicotine replacement therapy, particularly if:
• the patient is a man over 40 years of age, or
• the patient is a woman who has already gone through menopause.

In very rare cases, serious heart problems have developed in some patients after using sumatriptan, even if they previously had no symptoms of heart disease. If any of the above points apply to the patient, this may mean that the patient is in a higher risk group for heart disease, so the patient should inform the doctor, who should check heart function before prescribing sumatriptan.
If the patient has a history of seizures
Or if the patient has other conditions that may increase the likelihood of a seizure – e.g. head injury or alcoholism. Inform your doctor so that he or she can monitor the patient more closely.
If the patient has high blood pressure, ApoMigra may not be suitable.
Before starting to take ApoMigra, inform your doctor or pharmacist.
If the patient has liver or kidney disease
If this applies to the patient, inform your doctor or pharmacist before starting ApoMigra.
If the patient has intolerance to certain sugars
Inform your doctor so that he or she can monitor the patient more closely.
If the patient is allergic to medicines called sulfonamides
In such a case, the patient may also be allergic to ApoMigra. If the patient is allergic to an antibiotic but does not know whether it belongs to the sulfonamide group, inform the doctor or pharmacist before taking this medicine. Inform your doctor or pharmacist before starting ApoMigra.
If the patient is taking antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors).
Inform your doctor or pharmacist before starting ApoMigra. See also the section below “ApoMigra with other medicines”.
If the patient frequently uses ApoMigra
Excessive use of sumatriptan may lead to worsening of headache. If this applies to the patient, inform the doctor. The doctor may advise stopping the use of sumatriptan.
If the patient experiences chest pain or tightness after taking ApoMigra.
These symptoms may be intense but usually pass quickly. However, if these symptoms do not resolve quickly or become severe, seek medical help immediately. More information about possible side effects can be found in section 4 of this leaflet.
ApoMigra with other medicines
Tell your doctor about all medicines currently taken or recently used, as well as any medicines the patient plans to use. This includes herbal preparations and medicines purchased without a prescription.
Some medicines must not be used with ApoMigra, and others may cause adverse effects if used at the same time as this medicine. Inform your doctor if the patient is taking:

• Ergotamine, also used to treat migraine, or medicines with similar action such as methysergide maleate (see section 2). ApoMigra must not be used at the same time as these medicines. The patient must stop taking these medicines at least 24 hours before starting ApoMigra. The patient should also not take them again for at least 6 hours after stopping ApoMigra.
• Other triptans or medicines called 5HT receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), as well as other medicines used to treat migraine (see section 2). ApoMigra must not be used at the same time as these medicines. The patient must stop taking these medicines at least 24 hours before starting ApoMigra. The patient should also not take them again for at least 24 hours after stopping ApoMigra.
• Monoamine oxidase inhibitors (MAOIs), used to treat depression. Do not take ApoMigra if the patient has taken such medicines within the last two weeks.
• Selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs), used to treat depression. Using ApoMigra with these medicines may cause serotonin syndrome (a group of symptoms which may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, rapid heartbeat and tremor). Inform your doctor immediately if such symptoms occur.
• St John's wort (Hypericum perforatum). When taking ApoMigra and herbal medicines containing St John's wort, adverse effects may occur more frequently.

Pregnancy, breastfeeding and effects on fertility

• If the patient is pregnant or breastfeeding, suspects pregnancy or plans to become pregnant, she should inform her doctor before taking this medicine. Experience with the safety of sumatriptan use during pregnancy is limited. Available data so far do not indicate an increased risk of congenital malformations. Discuss with your doctor whether the patient may use ApoMigra during pregnancy.
• Do not breastfeed for 12 hours after taking ApoMigra. Breast milk expressed during this time should be discarded and not used to feed the baby.

Driving and using machines
Migraine symptoms or the medicine used may cause drowsiness. If this occurs, do not drive or operate machinery.
ApoMigra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to use ApoMigra

ApoMigra should always be used as directed by a doctor or pharmacist. If in doubt, contact a doctor or pharmacist.
ApoMigra is available in the following strengths: 50 mg and 100 mg.
When to take ApoMigra

• It is best to take ApoMigra as soon as the patient feels a migraine is beginning, although it may be taken at any time during an attack.
• ApoMigra should not be used to prevent an attack – it should only be used after migraine symptoms have started.

Dosage:
Adults aged 18 to 65 years

• The usual dose for adults aged 18 to 65 is one 50 mg ApoMigra tablet, swallowed whole with water. Some patients may require a 100 mg dose – follow the doctor's instructions.

Children and adolescents under 18 years
ApoMigra is not recommended for children and adolescents under 18 years of age.
Elderly patients (over 65 years)
ApoMigra is not recommended for patients over 65 years of age.
If symptoms return:

• A second ApoMigra tablet may be taken if at least 2 hours have passed since the previous tablet was taken. Do not take more than 300 mg within 24 hours.

If the first tablet does not provide relief:

• Do not take a second tablet or any other medicine containing a sumatriptan for the same attack. ApoMigra may be used again for the next attack.

If ApoMigra does not provide any relief:

• Consult a doctor or pharmacist for advice.

Taking more than the recommended dose of ApoMigra

• Do not take more than six 50 mg tablets or three 100 mg tablets (total 300 mg) within 24 hours.

Taking excessive doses of ApoMigra may cause illness. If a patient has taken more than 300 mg within 24 hours:
Contact a doctor for advice.
If there are any further doubts about the use of this medicine, consult a 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 migraine itself.
Allergic reactions: seek medical help immediately.
The following side effects have occurred with unknown frequency (frequency cannot be estimated
from the available data):

• Allergic symptoms including skin rash, urticaria (itchy rash); wheezing; swollen eyelids, face or lips; collapse. If any allergic reactions occur shortly after taking ApoMigra, stop taking the medicine immediately and consult a doctor without delay.

Common (may affect fewer than 1 in 10 people):

• Pain, heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations such as numbness, tingling, warmth or cold. These sensations may be intense but short-lived. If these symptoms persist or become severe (especially chest pain), seek medical help immediately. In a small number of people, these symptoms may be due to a heart attack.

Other side effects include:

• Nausea or vomiting, although this may be due to migraine itself.
• Fatigue or drowsiness.
• Dizziness, feeling weak or hot flushes.
• Temporary increase in blood pressure.
• Shortness of breath.
• Muscle pain.

Very rare (may affect fewer than 1 in 10,000 people):

• Liver function disorders. If the patient is due to have a blood test to check liver function, inform the doctor or nurse that the patient is taking ApoMigra.

The following side effects may occur in some patients, with unknown frequency:

• Seizures, involuntary movements, neck stiffness;
• Visual disturbances such as blurred vision, restricted vision, double vision, loss of vision, and in some cases even persistent visual disturbances (these may also be due to the migraine attack itself);
• Heart disorders, in which the heart may beat faster, slower or irregularly, chest pain (angina) or myocardial infarction;
• Pale, blue-coloured skin and/or pain in fingers, toes, ears, nose or jaw in response to cold or stress (Raynaud's phenomenon);
• Feeling faint (low blood pressure);
• Diarrhoea;
• Joint pain;
• Feeling anxious;
• Increased sweating;
• Pain or worsening of pain at the site of recent injury or in areas affected by inflammatory conditions (such as rheumatism or ulcerative colitis);
• Difficulty swallowing.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store ApoMigra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What ApoMigra contains

• The active substance is sumatriptan (Sumatriptanum). Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate).
• The other ingredients are: sodium croscarmellose, polysorbate 80, calcium hydrogen phosphate, microcrystalline cellulose, sodium hydrogen carbonate, magnesium stearate.

What ApoMigra looks like and contents of the pack
White to almost white, oval, biconvex, uncoated tablets with the imprint 'C' on one side and '33' on the other side.
ApoMigra is available in blisters containing 6 tablets per cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Netherlands, country of export:
Aurobindo Pharma B.V.
Baarnsche Dijk 1
3741 LN Baarn
The Netherlands

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Birzebbugia, BBG 3000
Malta

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Registration number in the Netherlands, country of export: RVG 34979
Parallel import licence number: 221/25

This medicinal product is authorised in the European Economic Area member states under the following names:
Czech Republic: Sumatriptan Aurovitas
Italy: Sumatriptan Aurobindo Italia
Malta: Sumatriptan Aurobindo 50 mg/100 mg tablets
Poland: ApoMigra
Portugal: Sumatriptano Aurovitas