APOMIGRA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
ApoMigra ( Sumatryptan Aurobindo )
100 mg, tablets
Sumatriptanum
ApoMigra and Sumatryptan Aurobindo are different brand names of the same medicine.
Please read this 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 only. Do not give it to others. The medicine may harm another person, 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 or pharmacist.

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 called triptans (also known as 5HT1 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 helps relieve headache pain and reduce other symptoms of a migraine attack, such as nausea, vomiting, and sensitivity to light and sound.

2. Important information before using ApoMigra

When not to use 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. Patients with mild high blood pressure who are receiving appropriate treatment may use ApoMigra;
• if the patient has severe liver function disorders;
• if the patient is taking other migraine medicines, including those containing ergotamine or ergot-like medicines such as methysergide maleate, or other triptans, or medicines known as 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 present in the patient:

• if the patient is a regular smoker or uses nicotine replacement therapy, and especially 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 had no previous symptoms of heart disease. If any of the above points apply to the patient, this may mean the patient is at increased risk of heart disease. Therefore, inform your 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 – such as head injury or alcoholism. Inform your doctor so that closer monitoring can be arranged.
If the patient has high blood pressure, ApoMigra may not be suitable.
Inform your doctor or pharmacist before starting ApoMigra.
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 closer monitoring can be arranged.
If the patient is allergic to medicines called sulfonamides
In this case, the patient may also be allergic to ApoMigra.
If the patient is allergic to an antibiotic but is unsure whether it belongs to the sulfonamide group, the patient should 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
Overuse of sumatriptan may lead to worsening of headaches.
If this applies to the patient, inform your doctor. The doctor may advise stopping the use of sumatriptan.
If the patient experiences pain or tightness in the chest after taking ApoMigra.
These symptoms may be intense but usually resolve quickly. However, if these symptoms do not resolve quickly or become severe, seek immediate medical help. 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, recently taken, or planned to be taken. This includes herbal preparations and medicines purchased without a prescription.
Some medicines must not be used with ApoMigra, and others may cause side effects if taken at the same time.
Inform your doctor if the patient is taking:

• Ergotamine, also used to treat migraine, or ergot-like medicines such as methysergide maleate (see section 2). ApoMigra must not be taken at the same time as these medicines. These medicines should be discontinued at least 24 hours before starting ApoMigra. They should not be restarted until at least 6 hours after stopping ApoMigra.
• Other triptans or medicines known as 5HT receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), as well as other medicines used to treat migraine (see section 2). ApoMigra must not be taken at the same time as these medicines. These medicines should be discontinued at least 24 hours before starting ApoMigra. They should not be restarted until at least 24 hours after stopping ApoMigra.
• Monoamine oxidase inhibitors (MAOIs), used to treat depression. ApoMigra must not be taken 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. Taking ApoMigra with these medicines may cause serotonin syndrome (a group of symptoms which may include restlessness, confusion, sweating, hallucinations, overactive reflexes, muscle spasms, 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, side effects may occur more frequently.

Pregnancy, breastfeeding and fertility

• If the patient is pregnant or breastfeeding, suspects she is pregnant 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 for feeding the baby.

Driving and operating machinery
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, meaning it is essentially "sodium-free".

3. How to use ApoMigra

Apomigra should always be taken as directed by a doctor or pharmacist. If in doubt, contact a doctor or pharmacist.

When to take ApoMigra

• It is best to take ApoMigra as soon as the patient feels a migraine coming on, 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 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 more than 300 mg has been taken within 24 hours:
Contact a doctor for advice.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some symptoms may be caused by migraine itself.
Allergic reactions: seek immediate medical help.
The following adverse reactions have occurred with an 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 immediate medical attention. In a small number of people, these symptoms may be due to a heart attack.

Other adverse reactions 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 to undergo a blood test to check liver function, inform the doctor or nurse that the patient is taking ApoMigra.

The following adverse reactions 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 loss (these may also be caused by the migraine attack itself);
• Heart disorders, in which the heart may beat faster, slower or change rhythm, chest pain (angina) or heart attack;
• Pale, bluish skin and/or pain in fingers, toes, ears, nose or jaw triggered by cold or stress (Raynaud's phenomenon);
• Feeling faint (low blood pressure);
• Diarrhea;
• Joint pain;
• Feeling restless;
• Increased sweating;
• In patients who have recently had an injury or who have an inflammatory condition (such as rheumatism or inflammatory bowel disease), pain or worsening of pain at the site of injury or inflammation may occur;
• Difficulty swallowing.

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

5. How to store ApoMigra

Keep the medicine out of the 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.
This will help protect the environment.

6. Contents of the pack and other information

What ApoMigra contains

• The active substance is sumatriptan (Sumatriptanum). Each tablet contains 100 mg of sumatriptan (as sumatriptan succinate).
• The other ingredients are: sodium croscarmellose, polysorbate 80, calcium hydrogen phosphate, microcrystalline cellulose, sodium bicarbonate, magnesium stearate.

What ApoMigra looks like and contents of the pack
White or almost white, capsule-shaped, biconvex, uncoated tablets, with the letter 'C' embossed on one side and the number '34' on the other.
ApoMigra is available in PA/PVC/Aluminium blister packs contained in a cardboard box.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

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

Manufacturer:
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road, Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Birzebbugia, BBG 3000
Malta

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation number in the Netherlands, the country of export: RVG 34980
Parallel Import Licence number: 427/22

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