Package leaflet: Information for the user

Sumanor, 50 mg, film-coated tablets
Sumatriptan
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Sumanor is and what it is used for
Important information before taking Sumanor
How to take Sumanor
Possible side effects
How to store Sumanor
Contents of the pack and other information

1. What Sumanor is and what it is used for
Sumanor contains sumatriptan, which belongs to a group of medicines called triptans [also known as selective serotonin receptor agonists (5HT)].
Sumanor is used in adults for the acute treatment of migraine attacks with or without aura.
Migraine symptoms may be caused by temporary dilation of blood vessels in the head. Sumatriptan is believed to reduce this dilation. This in turn helps relieve headache pain and alleviate other symptoms of migraine, such as nausea, vomiting, and sensitivity to light and sound.

2. Important information before taking Sumanor

When not to take Sumanor:

if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6)
if you have heart disease, such as coronary artery narrowing (ischaemic heart disease) or chest pain (angina), or if you have had a heart attack
if you have circulation problems in the legs causing pain when walking, similar to cramps (peripheral vascular disease)
if you have had a stroke or mini-stroke [also known as transient ischaemic attack (TIA)]
if you have high blood pressure. Patients with adequately treated, mild hypertension may take sumatriptan.
if you have severe liver disease
if you are taking other anti-migraine medicines, including those containing ergotamine or medicines with similar action, such as methysergide or other triptans, or medicines known as 5HT receptor agonists (such as naratriptan or zolmitriptan)
if you are taking MAOIs (monoamine oxidase inhibitors) used to treat depression, or have taken MAOIs within the past 2 weeks.

Warnings and precautions
Before prescribing Sumanor, your doctor should confirm that your headache is due to migraine and not another condition.
Before starting Sumanor, consult your doctor or pharmacist if any of the following apply to you:

you are a regular smoker or use nicotine replacement therapy, especially if you are:
- a man over 40 years of age, or
- a woman who has gone through the 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 apply to you, this may mean you are at increased risk of heart disease. Inform your doctor, who may need to check your heart function before prescribing sumatriptan;
you have a history of seizures (fits) or other conditions that may increase the risk of seizures – for example, head injury or alcoholism
you have liver or kidney disease
you are allergic to medicines called sulphonamides. In such cases, you may also be allergic to sumatriptan. If you are allergic to an antibiotic but are unsure whether it belongs to the sulphonamide group, inform your doctor or pharmacist before taking this medicine
you take sumatriptan frequently. Overuse of sumatriptan may lead to worsening of headaches. Your doctor may advise you to stop taking sumatriptan.
you experience pain or tightness in the chest after taking sumatriptan. These symptoms may be intense but usually resolve quickly. However, if they do not resolve quickly or become severe, seek immediate medical attention. See also section 4.

Children and adolescents
The safety and efficacy of Sumanor in children and adolescents (under 18 years of age) have not been established, and therefore it should not be used in this age group.

Sumanor and other medicines
Some medicines must not be taken with Sumanor, while others may cause adverse effects when taken at the same time.
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including herbal products and over-the-counter medicines.
Please inform your doctor if you are taking:

Ergotamine, also used to treat migraine, or medicines with similar action, such as methysergide. Do not take Sumanor at the same time as these medicines. You should stop taking these medicines at least 24 hours before starting Sumanor. You should also avoid taking them again for at least 6 hours after stopping Sumanor.
Other triptans or medicines known as 5HT receptor agonists (such as naratriptan or zolmitriptan). Do not take Sumanor at the same time as these medicines. You should stop taking these medicines at least 24 hours before starting Sumanor. You should also avoid taking them again for at least 24 hours after stopping Sumanor.
Monoamine oxidase inhibitors (MAOIs), used to treat depression. Do not take Sumanor if you have taken such medicines within the past 2 weeks.
Selective serotonin reuptake inhibitors (SSRIs), including citalopram, fluoxetine, fluvoxamine, paroxetine and sertraline, and serotonin-noradrenaline reuptake inhibitors (SNRIs), including venlafaxine and duloxetine, used to treat depression. Taking Sumanor with these medicines may cause serotonin syndrome (a group of symptoms which may include restlessness, confusion, excessive sweating, hallucinations, increased reflexes, muscle stiffness, shivering, rapid heartbeat and tremor). Inform your doctor immediately if such symptoms occur.
St John’s wort (Hypericum perforatum). Taking Sumanor together with herbal medicines containing St John’s wort may increase the risk of side effects.
Lithium, a medicine used to treat bipolar disorder (manic depression). Taking sumatriptan together with lithium may cause serotonin syndrome.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
There is limited information on the safety of sumatriptan in pregnant women. To date, there is no evidence of an increased risk of congenital malformations. Your doctor will discuss with you whether you can use Sumanor during pregnancy.

Breastfeeding
Do not breastfeed for 12 hours after taking Sumanor. Breast milk expressed during this time should be discarded and not used to feed the baby.
Some breastfeeding women have reported breast pain and/or nipple pain after taking sumatriptan. The pain is usually transient and resolves within 3 to 12 hours.

Driving and using machines
Migraine symptoms or the medicine itself may cause drowsiness. If you feel drowsy, do not drive or operate machinery.

Sumanor contains lactose.
This medicine contains 44 mg of lactose (as monohydrate). If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Other excipients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to take Sumanor

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
When to take Sumanor
Sumanor should be taken as soon as the patient feels that a migraine attack is about to occur, although
it may also be taken at any time during a migraine attack.
Do not take Sumanor to prevent a migraine attack. This medicine should be taken only after
migraine symptoms have started.
What dose should be used
The recommended dose for adults is one tablet. Some patients may require two tablets. Always
follow your doctor's instructions.
In case of recurrence of symptoms
A second tablet of Sumanor may be taken only if at least 2 hours have passed since the first tablet
was taken. Do not take more than 300 mg (six tablets) in total within any 24-hour period.
If there is no improvement after taking one tablet
Do not take a second tablet of Sumanor or any other medicine containing sumatriptan during the
same migraine attack. Sumanor may be used again during the next attack. If Sumanor does not
provide relief, consult your doctor for advice.
Elderly patients (over 65 years of age)
Sumanor is not recommended for use in patients over 65 years of age.
Method of administration
The tablets do not have a score line, so they should be swallowed whole with water.
Taking more Sumanor than recommended
Taking too much Sumanor may cause illness. Symptoms of overdose are the same as those listed in
section 4.
If too many tablets have been taken, consult 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.

Severe allergic reactions
Frequency unknown (frequency cannot be determined from available data):

Skin allergic reactions: Skin rashes, for example in the form of red spots or hives (skin wheals).
Anaphylaxis (severe allergic reactions), such as swelling of the eyelids, face or lips, and sudden onset of wheezing, irregular heartbeat, chest tightness or collapse.

If any of these symptoms occur shortly after taking Sumanor, stop taking
Sumanor immediately and seek medical advice without delay.

Common (may affect up to 1 in 10 people):

Pain, sensation of heaviness, pressure or tightness in the chest, throat or other parts of the body, or unusual sensations including numbness, tingling, and feelings of heat or cold. These adverse effects may be intense but usually resolve quickly. 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 possible adverse reactions
Common (may affect up to 1 in 10 people):

Dizziness, drowsiness
Transient increase in blood pressure (occurring shortly after administration), sudden flushing of the face
Breathing difficulties
Nausea or vomiting
Muscle pain
Feeling weak, fatigue.

Rare (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 due to have a blood test to check liver function, inform the doctor about taking Sumanor.

Frequency unknown (frequency cannot be determined from available data):

Anxiety
Seizures (epileptic fits), involuntary movements (dystonia), tremors, nystagmus
Visual disturbances such as blurred vision, restricted vision, or loss of vision (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 myocardial infarction
Low blood pressure, Raynaud's phenomenon (a condition characterized by paleness and numbness in fingers and toes)
Inflammation of the large intestine (symptoms include pain in the lower left part of the abdomen and bloody diarrhoea), diarrhoea, difficulty swallowing
Increased sweating
Neck stiffness, joint pain
In patients who have recently had an injury or who have an inflammatory condition (such as rheumatism or inflammation of the large intestine), pain or worsening of pain may occur at the site of injury or inflammation.

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 of 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sumanor

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the cardboard box or blister pack. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
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 Sumanor contains

The active substance is sumatriptan. One tablet contains 50 mg of sumatriptan (as sumatriptan succinate).
The other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, titanium dioxide (E 171), polydextrose, hypromellose, triacetin, polyethylene glycol 8000.

What Sumanor looks like and contents of the pack
Coated tablet (tablet)
White, triangular, biconvex tablet, embossed with "SUM" on one side and "50" on the other. The length and width of the tablet is 8 mm.
Pack sizes
Sumanor, 50 mg is available in blisters containing 2 tablets in a cardboard box.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
This medicinal product is authorised in the European Economic Area member states under the following names:
Finland: Sumatriptan Orion Pharma
Norway: Oriptan
Poland: Sumanor
Sweden: Sumatriptan Orion