Apomigra

Leaflet accompanying the packaging: patient information

ApoMigra, 50 mg, tablets

ApoMigra, 100 mg, tablets

Sumatriptan

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 worsen or if any side effects not mentioned in the leaflet occur, 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 packaging 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 believed 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 have taken an MAOI in the last 2 weeks,
• selective serotonin reuptake inhibitors (SSRIs), such as citalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline,
• serotonin and noradrenaline reuptake inhibitors (SNRIs), such as 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 already gone through menopause.

In very rare cases, some patients have developed severe heart disorders after taking sumatriptan, even if they had no previous symptoms of heart disease. If any of the above points apply to you, it may mean that you are at increased risk of heart disease, so you should inform your doctor, who should check your heart function before prescribing sumatriptan; If you have a history of seizures or if you have other conditions that may increase the likelihood of seizures – e.g., 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. You should tell your doctor or pharmacist before starting to take ApoMigra. If you have liver or kidney disease If this applies to you, you should tell your doctor or pharmacist before starting to take ApoMigra. 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; You should tell your doctor or pharmacist before starting to take ApoMigra. If you are taking antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors). You should tell your doctor or pharmacist before starting to take ApoMigra. See also the section below "ApoMigra and other medicines"; If you frequently use ApoMigra Too frequent use of sumatriptan can cause worsening of headache. 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 the 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 currently taking or have recently taken, 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 this medicine. 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 contractions, shivering, rapid heartbeat, 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 frequently.

Pregnancy, breastfeeding, and fertility

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

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 according to the doctor's or pharmacist's recommendations. 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:

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

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 start to return:

• You can take a second ApoMigra tablet if at least 2 hours have passed since the previous tablet. 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 can 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 can 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 doubts about taking this medicine, you should consult 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 available data):

• Allergic symptoms, including skin rash, hives (itchy rash); wheezing; swollen eyelids, face, or lips; anaphylaxis. 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 small number of people, 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 flushing.
• 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 inform your doctor or nurse that you are taking ApoMigra.

In some patients, the following side effects may occur with an unknown frequency:

• seizures (fits), involuntary movements, neck stiffness;
• visual disturbances, such as blurred vision, limited vision, double vision, loss of vision, and in some cases, even permanent vision loss (these may also be symptoms of the migraine itself);
• heart disorders, in which the heart may beat faster, slower, or irregularly, chest pain (angina), or heart attack;
• pale, blue-tinged skin and/or pain in the fingers of the hands, toes, ears, nose, or cheek 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 at the site of injury or inflammation may occur;
• difficulty swallowing.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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 Side effects can also be reported to the marketing authorization holder. 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 carton after EXP. The expiry date refers to the last day of the month. There are no special storage requirements. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What ApoMigra contains

• The active substance of ApoMigra is sumatriptan (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, calcium hydrogen phosphate, microcrystalline cellulose, sodium bicarbonate, magnesium stearate.

What ApoMigra looks like and contents of the pack

ApoMigra 50 mg tablets:
White to almost white, oval, biconvex tablets without coating, with 'C' embossed on one side and '33' on the other side.
ApoMigra 100 mg tablets:
White to almost white, oval, biconvex tablets without coating, with 'C' embossed on one side and '34' on the other side.
ApoMigra is available in blisters containing 4 or 6 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

Manufacturer/Importer:

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial EstateHal Far
Birzebbugia, BBG 3000
Malta

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

Date of last revision of the leaflet: 04/2021