SUMATRIPTAN MYLAN

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Sumatriptan Mylan 50 mg film-coated tablets, 100 mg film-coated tablets

Generic Medicine
sumatriptan succinate
Please read all of this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Sumatriptan Mylan is and what it is used for
2. What you need to know before taking Sumatriptan Mylan
3. How to take Sumatriptan Mylan
4. Possible side effects
5. How to store Sumatriptan Mylan
6. Contents of the pack and other information

1. WHAT SUMATRIPTAN MYLAN IS AND WHAT IT IS USED FOR

This medicinal product contains the active substance sumatriptan succinate. Sumatriptan succinate
belongs to a group of medicines known as 5HT1 receptor agonists, which are used to treat migraine attacks.
Migraine causes episodes of headache, sometimes accompanied by nausea or other symptoms; for
example, some people become sensitive to light or sound. The symptoms of migraine may be caused by a temporary dilation of the blood vessels in the head. Sumatriptan Mylan is thought to work by reducing this dilation of the blood vessels. Sumatriptan Mylan must not be used when migraine has not been diagnosed and cannot prevent a migraine attack.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SUMATRIPTAN MYLAN

Do not take Sumatriptan Mylan:

• If you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart problems, such as reduced blood flow to the heart muscle with symptoms of chest pain, including heart attack (ischaemic heart disease), or chest pain due to contraction of the vessel walls (Prinzmetal's angina), or if you suffer from hardening of the arteries, or circulation problems in the legs causing pain such as cramps felt when walking (peripheral vascular disease).
• If you have ever had a heart attack (myocardial infarction).
• If you have ever had a stroke (cerebrovascular accident) in the past or have experienced symptoms of a stroke that lasted only a short time and from which you fully recovered (transient ischaemic attack).
• If you have severe liver problems, if your blood pressure is uncontrolled, or if you are being treated for moderately or severely high blood pressure (hypertension).
• If you are taking or have taken within the last 24 hours medicines for migraine containing ergotamine or methysergide, or any triptan or 5-HT1 receptor agonist such as naratriptan or zolmitriptan (see “Other medicines and Sumatriptan Mylan” for further information).
• If you are taking, or have recently taken, certain medicines used to treat depression or Parkinson’s disease called Monoamine Oxidase Inhibitors (MAOIs) within the last two weeks.
• If you are taking lithium (commonly used to treat mental health conditions such as severe depression, mania, or severe types of headache known as cluster headaches).

Warnings and precautions
Sumatriptan Mylan must not be used for unusual forms of migraine caused by brain or eye problems (e.g. hemiplegic, basilar, or ophthalmic migraine).
Talk to your doctor or pharmacist before taking Sumatriptan Mylan:

• If you have risk factors for heart disease such as:
  • a family history of heart problems,
  • diabetes,
  • high cholesterol levels in the blood,
  • you are overweight,
  • you are a regular smoker or use any form of nicotine replacement therapy (NRT),
  • you are a man over 40 years of age or a post-menopausal woman.
• If you have been treated for moderately high blood pressure (hypertension) that has been controlled.
• If you have previously had seizures or epileptic fits.
• If you have kidney problems.
• If you have liver problems.
• If you are allergic to antibiotics called sulfonamides (such as co-trimoxazole).
• If you use sumatriptan together with medicines used to treat depression (see “Other medicines and Sumatriptan Mylan” for further information), as this may cause increased heart rate, chills, sweating, fever, high blood pressure, agitation, confusion, hallucinations, restlessness—symptoms of serotonin syndrome.

If you use Sumatriptan Mylan regularly
Taking Sumatriptan Mylan too often may cause or worsen headaches. This may also occur if you find you need to regularly use other medicines such as painkillers for migraine. Inform your doctor if this applies to you.
Sumatriptan Mylan may cause a sensation of tightness in the chest and throat
You may feel pain or a sensation of tightness in the chest and throat after taking sumatriptan. If these symptoms do not go away quickly, inform your doctor immediately.
Other medicines and Sumatriptan Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. In particular, inform your doctor if you are taking:

• antidepressants called SSRIs (e.g. citalopram, fluoxetine, fluvoxamine, paroxetine or sertraline), SNRIs (such as venlafaxine or duloxetine (which may also be used for urinary disorders)). If you are taking SSRIs and SNRIs together with sumatriptan, this may increase the risk of developing a potentially serious side effect called serotonin syndrome (see “Warnings and precautions”). Your doctor will monitor you closely.
• lithium (see “Do not take Sumatriptan Mylan” for further information).
• medicines used to treat depression or Parkinson’s disease called Monoamine Oxidase Inhibitors (MAOIs). Do not take sumatriptan if you have taken an MAOI within the last 2 weeks.
• herbal preparations containing St. John’s wort.

If you are taking or have taken other migraine medicines
If you have taken another medicine for migraine such as ergotamine or ergotamine derivatives (e.g. methysergide) or a triptan/5-HT1 receptor agonist (e.g. naratriptan or zolmitriptan), you must wait at least 24 hours before taking sumatriptan.
If you have taken sumatriptan, you must wait at least 6 hours before taking ergotamine or ergotamine derivatives (e.g. methysergide), and wait at least 24 hours before taking a triptan/5-HT1 receptor agonist.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is only limited information on the safety of Sumatriptan in pregnant women, although so far there is no evidence of any increased risk of birth defects. Your doctor will discuss with you whether to use Sumatriptan during pregnancy.
If taken during breastfeeding, it is important to know that sumatriptan passes into breast milk.
Do not breastfeed for 12 hours after using Sumatriptan Mylan. Breast milk produced during this period should be discarded.
Some breastfeeding women report breast and/or nipple pain after using sumatriptan. The pain is usually temporary and disappears within 3–12 hours.
Driving and using machines
You may experience drowsiness, dizziness, or malaise due to migraine itself or due to taking these tablets. If this occurs, your ability to drive or use machinery may be impaired.
Caution is advised if you engage in such activities.
Sumatriptan Mylan contains lactose and sodium.
If you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. HOW TO TAKE SUMATRIPTAN MYLAN

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Take this medicine as soon as possible after the onset of a migraine attack. This does not exclude the possibility of taking it at any time during an attack.
• This medicine must not be taken to prevent a migraine attack.

Adults
The recommended dose is one 50 mg tablet. In some cases, a dose of 25 or 100 mg may be required. Since the tablet cannot be divided into two equal doses, if necessary, your doctor should prescribe other medicines containing the same active substance, dosage, and pharmaceutical form available as divisible tablets.
If the first dose relieves your headache but the migraine returns nevertheless, you may take a second dose within 24 hours, provided there is at least a 2-hour interval between the two doses.
The maximum dose is 300 mg of sumatriptan within 24 hours. Swallow the tablet whole with a glass of water.

Do not take a second dose if the first dose was not effective. If Sumatriptan Mylan has not provided relief after the first dose, another painkiller such as paracetamol, acetylsalicylic acid, or a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen may be taken instead.

Use in children and adolescents (under 18 years of age)
Sumatriptan Mylan is not recommended for use in children and adolescents.

Use in elderly patients (over 65 years of age)
Sumatriptan Mylan is not recommended.

Patients with liver problems
If you have mild to moderate liver problems, your doctor may prescribe a lower starting dose.

If you take more Sumatriptan Mylan than you should
Contact your doctor or the nearest hospital emergency department immediately.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some of the reported adverse reactions may be related to the symptoms of migraine itself.
If you experience any of the following adverse reactions, stop taking the medicine immediately and seek urgent medical assistance:
Not known (frequency cannot be estimated from the available data).

• sudden, life-threatening allergic reaction with signs such as skin rash, itching or hives, swelling of the face, lips, tongue or other body parts, shortness of breath, wheezing or difficulty breathing (anaphylactic reactions)
• seizures or generalized epileptic seizures (these are more likely in patients at risk of epilepsy)
• heart attack (myocardial infarction), presenting as chest pain, shortness of breath, indigestion, nausea, vomiting, lack of energy or discomfort in the upper body
• chest pain (angina pectoris) or reduced blood flow to the heart muscle causing chest pain (ischemic heart disease)
• inflammation of the colon (which may present as pain on the left side of the abdomen with bloody diarrhea)

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

• tingling sensation, itching and numbness of the hands or feet (paresthesia), reduced sensation or particularly reduced skin sensitivity (hypoesthesia), or
  sensations of heat and cold, pain, heaviness, pressure or tightness that may affect any part of the body, including the chest and throat
• sensation of flushing (sudden redness of the face (often the cheeks), neck or upper chest), dizziness or drowsiness
• fatigue, weakness, although these symptoms are transient
• increase in blood pressure
• feeling of discomfort (nausea) or malaise (vomiting)
• shortness of breath (dyspnea)
• muscle pain, tenderness or muscle weakness not caused by physical exercise (myalgia)

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

• breast pain

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

• changes in liver function test results (detectable by blood tests)

Not known (frequency cannot be estimated from the available data):

• eye or vision problems, such as flickering, double vision, reduced vision, blind spots resembling a dark spot (visual field defect), or vision loss, which may be permanent. Repetitive, involuntary, alternating eye oscillations (nystagmus) may also occur
• twisting movements, repetitive movements or abnormal postures (dystonia)
• tremors
• anxiety
• irregular, fast or slow heartbeat, changes in heart rhythm or pulse (detected on ECG, a test to assess the heart's electrical activity), palpitations
• spasms of blood vessels supplying the heart, with symptoms of chest pain
• decrease in blood pressure
• diarrhea
• Raynaud's phenomenon, which may present as paleness, numbness or pain in the fingers and toes in response to cold
• neck stiffness
• joint pain, swelling (arthralgia)
• excessive sweating (hyperhidrosis)
• difficulty swallowing
• if you have recently sustained an injury or have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of injury or inflammation.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SUMATRIPTAN MYLAN

• Keep this medicine out of sight and reach of children.
• This medicine does not require any special storage conditions.
• Do not use this medicine after the expiry date stated on the carton or blister pack after "Exp". The expiry date refers to the last day of that month.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENT AND OTHER INFORMATION

What Sumatriptan Mylan contains
There are two available strengths of this medicine. Each tablet contains 50 mg or 100 mg of the active substance sumatriptan (as succinate). The tablets also contain lactose monohydrate, microcrystalline cellulose, sodium croscarmellose and magnesium stearate. The coating contains titanium dioxide (E171), polydextrose, hypromellose, glycerol triacetate and macrogol. In addition, the coating of the 50 mg tablet contains red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Sumatriptan Mylan and pack contents
The 50 mg tablets are round, pink, marked with "SU 50" on one side; the 100 mg tablets are round, white, marked with "SU 100" on one side. Tablets of both strengths have the letter "G" marked on the other side.
Sumatriptan Mylan tablets are available in blister packs containing 2, 3, 4, 4x1, 5, 6, 10, 12, 18, 20 and 24 tablets.
Not all pack sizes may be marketed.
The blister may contain empty triangular-shaped support tabs which do not contain tablets. Only the round pockets of the blister contain tablets.

Marketing Authorisation Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturers
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13 – Ireland
Mylan Hungary Kft
Mylan útca 1
Komárom
Hungary

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Italy Sumatriptan Mylan
Spain Sumatriptan Viatris film-coated tablets EFG
United Kingdom (Northern Ireland) Sumatriptan 50 mg and 100 mg film-coated tablets

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