Apomigra

Package leaflet: Information for the patient

ApoMigra, 50 mg, tablets
ApoMigra, 100 mg, tablets
Sumatriptanum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others.
• The medicine may harm another person, even if their symptoms appear identical.
• If any adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist immediately.

Table of contents:

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 known as triptans (also called 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 work by narrowing these dilated blood vessels. This helps relieve headache pain 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 has had a heart attack;
• if the patient has circulation problems in the legs causing pain during 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 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 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 a group called monoamine oxidase inhibitors (MAOIs), or has taken MAOIs within 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:
Consult 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 gone through the menopause.

In very rare cases, serious heart problems have occurred in some patients after using sumatriptan, even if they previously had no symptoms of heart disease. If any of the above points apply, 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 – e.g. head injury or alcoholism; Inform your doctor so that closer monitoring can be provided.
If the patient has high blood pressure, ApoMigra may not be suitable.
Tell your doctor or pharmacist before starting ApoMigra.
If the patient has liver or kidney disease
If this applies, tell your doctor or pharmacist before starting ApoMigra.
If the patient has intolerance to certain sugars
Inform your doctor so that closer monitoring can be provided.
If the patient is allergic to medicines called sulfonamides
In such cases, 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; 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 and other medicines”;
If the patient uses ApoMigra frequently
Overuse of sumatriptan may lead to worsening of headache. If this applies, inform your doctor. Your 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 resolve quickly. However, if symptoms do not resolve quickly or become severe, seek immediate medical attention. More information on possible side effects can be found in section 4 of this leaflet.
ApoMigra and other medicines
Tell your doctor about all medicines currently taken, recently taken, or planned for use. This includes herbal preparations and over-the-counter medicines.
Some medicines must not be used with ApoMigra, and others may cause adverse effects if taken together. 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 used together with 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 the last dose of ApoMigra.
• Other triptans or medicines known as 5HT receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), and other migraine treatments (see section 2). ApoMigra must not be used together with 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 the last dose of 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, overactive reflexes, muscle stiffness, shivering, rapid heartbeat, and tremor). Inform your doctor immediately if such symptoms occur.
• St. John’s wort ( Hypericum perforatum ). When ApoMigra is used together with herbal medicines containing St. John’s wort, adverse effects may occur more frequently.

Pregnancy, breastfeeding and fertility

• If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should inform her doctor before taking this medicine. Experience with the safety of sumatriptan during pregnancy is limited. To date, available data do not indicate an increased risk of congenital malformations. Discuss with your doctor whether ApoMigra can be used 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. Some breastfeeding women have reported breast and/or nipple pain after using sumatriptan. This pain is usually transient and resolves within 3 to 12 hours.

Driving and operating machinery
Migraine symptoms or the medicine itself 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 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, consult your 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 exceed 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 provides no 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) in 24 hours.

Taking too high a dose of ApoMigra may cause illness. If a patient has taken more than 300 mg within 24 hours:
Contact a doctor for advice.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Some symptoms may be caused by migraine itself.
Allergic reactions: seek immediate medical help.
The following adverse 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 up to 1 in 10 people):

• Pain, heaviness, tightness or pressure 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 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.

Uncommon (may affect up to 1 in 1,000 people):

• Chest pain

Very rare (may affect up to 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 effects 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 visual 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, 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 restless;
• Increased sweating;
• In patients who have recently experienced trauma or who have an inflammatory condition (such as rheumatism or ulcerative colitis), pain or worsening of pain at the site of injury or inflammation may occur;
• Difficulty swallowing.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store ApoMigra
Keep the medicine 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 stated month.
No special storage conditions apply.
Medicines should not be disposed of via the sewage system 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). Each tablet contains 100 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
ApoMigra tablets 50 mg:
White to almost white, oval, biconvex, uncoated tablets, embossed with 'C' on one side and '33' on the other side.
ApoMigra tablets 100 mg:
White to almost white, oval, biconvex, uncoated tablets, embossed with 'C' on one side and '34' on the other side.
ApoMigra is available in blister packs containing 4 or 6 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa

Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmaceutica S.A.
Rua João De Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Italy: Sumatriptan Aurobindo Italia
Malta: Sumatriptan Aurobindo 50 mg/100 mg tablets
Poland: ApoMigra