Apomigra

Package leaflet: Information for the patient

Warning! Keep the package 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 this leaflet carefully before taking 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 pass it on 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.

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 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 blood vessels. This helps relieve headache and reduce other symptoms of a migraine attack, such as nausea or 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 that is adequately treated may use ApoMigra;
• if the patient has severe liver function disorders;
• if the patient is taking other migraine medicines, including those containing ergotamine or medicines with a similar action such as methysergide maleate or other triptans, or medicines known as 5HT1 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 a doctor and do not take ApoMigra.
Warnings and precautions
Talk to a doctor or pharmacist before taking ApoMigra.
Additional risk factors present in the patient:

• if the patient is a chronic tobacco 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 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, so it is important to 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 – for example head injury or alcoholism; Inform your doctor so that they can monitor you more closely.
If the patient has high blood pressure, ApoMigra may not be suitable.
Before starting to use 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 they can monitor you 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, they should inform their doctor or pharmacist before taking this medicine; Before starting to use ApoMigra, inform your doctor or pharmacist.
If the patient is taking antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors).
Before starting to use ApoMigra, inform your doctor or pharmacist.
See also the section below “ApoMigra with other medicines”;
If the patient uses ApoMigra frequently
Excessive use of sumatriptan may worsen headache. If this applies to the patient, inform the doctor. The doctor may recommend stopping the use of sumatriptan;
If the patient experiences chest pain or tightness 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 on 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 medicines with similar action such as methysergide maleate (see section 2). ApoMigra must not be used at the same time as these medicines. These medicines should be discontinued at least 24 hours before starting ApoMigra. They should not be taken again until at least 6 hours after stopping ApoMigra.
• Other triptans or medicines known as 5HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), and other medicines used to treat migraine (see section 2). ApoMigra must not be used at the same time as these medicines. These medicines should be discontinued at least 24 hours before starting ApoMigra. They should not be taken again 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. Using 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 heart rate and tremor). Inform the 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 the doctor whether the patient may use ApoMigra during pregnancy.
• Breastfeeding should be avoided 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, the patient should not drive or operate machinery.
ApoMigra contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which essentially means it is "sodium-free".

3. How to take ApoMigra

ApoMigra should always be taken according to the instructions provided by your doctor or pharmacist. If you have any doubts, contact your doctor or pharmacist.

When to take ApoMigra

• It is best to take ApoMigra as soon as you feel a migraine starting, although you may take it at any point during an attack.
• Do not use ApoMigra to prevent an attack – it should only be used after migraine symptoms have begun.

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.
• Always follow your doctor's instructions.

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 of age)
ApoMigra is not recommended for patients over 65 years of age.

If symptoms return:

• You may take a second ApoMigra tablet if at least 2 hours have passed since the previous dose. 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 triptan for the same attack. ApoMigra may be used again for the next attack.

If ApoMigra does not provide any relief:

• Consult your 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 higher than recommended doses of ApoMigra may cause illness. If you have taken more than 300 mg within 24 hours: contact your doctor for advice.

If you have any further questions about the use of this medicine, consult your 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 medical help immediately.
The following adverse reactions 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 coldness. 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 caused by 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 have 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 (epileptic fits), involuntary movements, neck stiffness;
• Visual disturbances such as blurred vision, narrowed field of vision, double vision, loss of vision, and in some cases even persistent vision loss (these may also be consequences of migraine attack itself);
• Heart disorders, in which the heart may beat faster, slower, or change rhythm, chest pain (angina), or myocardial infarction;
• Pale, bluish 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);
• Diarrhea;
• Joint pain;
• Feeling anxious;
• Increased sweating;
• In patients who have recently had an injury or who have 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 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 at the 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 adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store ApoMigra

Keep this medicine out of the 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 stated month.
No special storage instructions 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 packaging 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, embossed with 'C' on one side and '33' on the other side.
ApoMigra is available in blisters containing 4 or 6 tablets in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Number of the marketing authorization in the Netherlands, country of export: RVG 34979
Parallel import authorization number: 186/25
This medicinal product is authorized in the European Economic Area countries 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