Apomigra

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

ApoMigra(Sumatriptan Aurobindo)

100 mg, tablets

Sumatriptanum
ApoMigra and Sumatriptan Aurobindo are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others.The medicine may harm another person, even if their symptoms are the same. If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is ApoMigra and what is it 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 is ApoMigra and what is it 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 blood vessel dilation in the head. It is thought that ApoMigra causes the dilation of blood vessels to decrease. This in turn helps to eliminate 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

• monoamine oxidase inhibitors (MAOIs) or if you have taken an MAOI in the last 2 weeks;
• selective serotonin reuptake inhibitors (SSRIs) including citalopram, fluoxetine, fluvoxamine, paroxetine, and 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 you:

You should contact your doctor and not take ApoMigra.

Warnings and precautions

You should talk to your doctor or pharmacist before taking ApoMigra.
Additional risk factors apply to you:

• you are a man over 40 years old, or
• you are a woman who has been through the menopause.

In very rare cases, some patients have developed serious heart problems after taking sumatriptan, even if they had no symptoms of heart disease before. If any of the above points apply to you, this may mean that you are at increased risk of heart disease, so you should inform your doctor, who will check your heart function before prescribing sumatriptan.
If you have had seizures in your medical history
Or if you have other conditions that may increase the likelihood of having a seizure – such as a head injury or alcoholism. You should inform your doctor so that they can monitor you more closely.
If you have high blood pressure, ApoMigra may not be suitable for you.
Before taking ApoMigra, you should tell your doctor or pharmacist.
If you have liver or kidney disease
If this applies to you, before taking ApoMigra, you should tell your doctor or pharmacist.
If you are intolerant to some sugars
You should inform your doctor so that they can monitor you more closely.
If you are allergic to sulfonamide medicines
In this case, you may also be allergic to ApoMigra.
If you are allergic to an antibiotic but do not know if it belongs to the sulfonamide group, you should tell your doctor or pharmacist before taking this medicine; Before taking ApoMigra, you should tell your doctor or pharmacist.
If you are taking antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors).
Before taking ApoMigra, you should tell your doctor or pharmacist.
See also the section below "ApoMigra and other medicines";
If you take ApoMigra frequently
Taking sumatriptan too often may cause your headaches to get worse.
If this applies to you, you should inform your doctor. Your doctor may advise you to stop taking sumatriptan; If you feel pain or pressure in your chest after taking ApoMigra.
Such symptoms may be intense but usually pass quickly. However, if these symptoms do not pass quickly or become severe, you should seek medical help immediately. More information on possible side effects can be found in section 4 of the leaflet.

ApoMigra and other medicines

You should tell your doctor about all medicinesyou are taking now or have taken recently, as well as any medicines you plan to take. This includes all herbal preparations and medicines you have bought without a prescription.
Some medicines must not be taken with ApoMigra, and others may cause side effects if taken at the same time as ApoMigra.
You should inform your doctor if you are taking:

• Ergotamineused to treat migraineor medicines that work in a similar way, such as methysergide (see section 2). You must not take ApoMigra at the same time as these medicines. You should stop taking these medicines at least 24 hours before starting to take ApoMigra. You should not take them again for at least 6 hours after you finish taking 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). You must not take ApoMigra at the same time as these medicines. You should stop taking these medicines at least 24 hours before starting to take ApoMigra. You should not take them again for at least 24 hours after you finish taking ApoMigra.
• Monoamine oxidase inhibitors (MAOIs),used to treat depression. You must not take ApoMigra if you have taken MAOIs in the last 2 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 condition that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle stiffness, shivering, fast heart beat, and trembling). You should immediately inform your doctor if you experience such symptoms.
• St John's Wort (Hypericum perforatum). When taking ApoMigra and herbal medicines containing St John's Wort, side effects may occur more often.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor for advice before taking this medicine. Experience with the safety of sumatriptan during pregnancy is limited. So far, the available data do not indicate an increased risk of congenital anomalies. You should discuss with your doctor whether you can take ApoMigra during pregnancy.
• You should not breastfeed your baby for 12 hours after taking ApoMigra. Breast milk expressed during this time should be discarded and not given to the baby.

Driving and using machines

Migraine symptoms or the medicine may cause drowsiness. If this symptom occurs, you should 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 take ApoMigra

ApoMigra should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
When to take ApoMigra

• It is best to take ApoMigra as soon as you feel a migraine coming on, although you can take it at any time during an attack.
• You should not take ApoMigra to prevent an attack - it should only be taken after migraine symptoms have started.

Dosage:
Adults aged 18 to 65 years:

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

Children and adolescents under 18 years of age
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 come back:

• You may take a second ApoMigra tablet if at least 2 hours have passed since the first tablet was taken. You should not take more than 300 mg in 24 hours.

If the first tablet does not provide relief

• You should not take a second tablet or any other sumatriptan-containing medicine for the same attack. ApoMigra may be used again for a subsequent attack.

If ApoMigra does not provide relief:

• You should ask your doctor or pharmacist for advice.

Taking more than the recommended dose of ApoMigra

• You should not take more than six 50 mg tablets or three 100 mg tablets (a total of 300 mg) in 24 hours.

Taking too much ApoMigra may cause illness.
If you have taken more than 300 mg in 24 hours:
You should contact your doctor for advice.
If you have any further questions on the use of this product, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, ApoMigra can cause side effects, although not everybody gets them.
Some symptoms may be caused by the migraine itself.
Allergic reactions: you should 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 rashes, hives (itchy rash); wheezing; swollen eyelids, face or lips; collapse. If you experience any allergic reactions soon after taking ApoMigra, you should stop taking the medicine and seek medical help immediately.

Common(may 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, warmth, or cold. These sensations may be intense but are usually short-lived. If these symptoms persist or become severe (especially chest pain), you should seek medical help immediately. In a few cases, these symptoms may be caused by a heart attack.

Other side effects include:

• Nausea (feeling sick) or vomiting, although this may be caused by the migraine itself.
• Fatigue or drowsiness.
• Dizziness, feeling weak or flushed.
• Temporary increase in blood pressure.
• Shortness of breath.
• Muscle pain.

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

• Liver function disorders. If you are going to have a blood test to check your liver function, you should tell your doctor or nurse that you are taking ApoMigra.

In some patients, the following side effects have occurred with an unknown frequency:

• seizures (fits), involuntary movements, neck stiffness;
• vision disturbances such as blurred vision, visual field loss, double vision, loss of vision, and in some cases even permanent loss of vision (these may also be symptoms of the migraine itself);
• heart problems, in which the heart beats faster, slower, or with an irregular rhythm, chest pain (angina), or heart attack;
• pale, blue-tinged skin and/or pain in the fingers of the hands, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon);
• feeling faint (low blood pressure);
• diarrhea;
• joint pain;
• feeling restless;
• increased sweating;
• in a patient who has recently had an injury or has an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain may occur at the site of the injury or condition;
• difficulty swallowing.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ApoMigra

The medicine should be stored 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 month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste.
You should 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 of ApoMigra is sumatriptan (Sumatriptanum). Each tablet contains 100 mg of sumatriptan (as sumatriptan succinate).
• The other ingredients are: croscarmellose sodium, polysorbate 80, calcium hydrogen phosphate, microcrystalline cellulose, sodium bicarbonate, magnesium stearate.

What ApoMigra looks like and contents of the pack

White or almost white, biconvex, uncoated tablets in capsule shape, with 'C' embossed on one side and '34' on the other side.
ApoMigra is available in PA/PVC/Aluminium blisters in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Aurobindo Pharma B.V.
Baarnsche Dijk 1
3741 LN Baarn, 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 by:

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 authorization number in the Netherlands, the country of export: RVG 34980

Parallel import authorization number: 427/22 Date of approval of the leaflet: 12.12.2022

This medicinal product is authorized in the Member States of the European Economic Area 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
[Information on the trademark]