Package leaflet: Information for the patient

Sumatriptan US Pharmacia, tablets, 50 mg
Sumatriptanum
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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist.

Table of contents

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

1. What Sumatriptan US Pharmacia is and what it is used for

Sumatriptan US Pharmacia contains 50 mg of sumatriptan in the form of sumatriptan succinate – an antimigraine substance. Migraine symptoms may be related to transient dilation of blood vessels in the carotid circulation. Sumatriptan belongs to a group of medicines known as 5HT1 receptor antagonists, which constrict these blood vessels.

2. Important information before using Sumatriptan US Pharmacia

When not to use Sumatriptan US Pharmacia:

if the patient is allergic to the active substance or to any of the other components of this medicine (listed in section 6) or to sulfonamides;
in children under 18 years of age, due to the fact that the safety of the medicine has not been established in this age group;
in patients:
who have had a myocardial infarction, or who have ischemic heart disease, coronary vasospasm (Prinzmetal's angina), or peripheral vascular disease;
who have previously experienced stroke or transient ischemic attack (TIA) with severe hepatic impairment;
with moderate or severe hypertension or moderate uncontrolled hypertension;
who are concurrently using preparations containing ergotamine or its derivatives (including methysergide), monoamine oxidase (MAO) inhibitors, or within two weeks after discontinuation of such medications.

Warnings and precautions
Sumatriptan should be used only in patients with a clearly diagnosed migraine. Due to lack of data, it is not recommended in patients with hemiplegic, basilar, or ophthalmoplegic migraine. In patients with migraine-type headache who have not previously been diagnosed with migraine, alternative causes of the symptoms should be considered. The same applies to patients with previously diagnosed migraine but who experience an atypical headache attack. It should be remembered that patients with migraine may belong to a group at risk of developing cerebrovascular damage, such as transient ischemic attack or stroke.
After administration of sumatriptan, transient chest pain and pressure sensations in the chest and throat may occur, sometimes of significant intensity. If the nature of these symptoms suggests ischemic heart disease, appropriate diagnostic tests are recommended.
Sumatriptan should not be used in individuals at risk of cardiovascular disorders, including chronic tobacco smokers or patients using nicotine replacement therapy, without prior appropriate diagnostic evaluation to exclude such conditions. This group includes, among others, postmenopausal women and men over 40 years of age. However, it should be noted that diagnostic tests do not always correctly identify existing heart disease, and in very rare cases, severe cardiac symptoms may occur even in the absence of underlying cardiovascular disease.
Sumatriptan may cause transient increases in blood pressure and peripheral vascular resistance. Therefore, the medicine should be used with great caution in patients with controlled hypertension.
The medicine should also be administered cautiously in patients in whom altered absorption, metabolism, or excretion may be expected, e.g., in cases of impaired liver or kidney function. Sumatriptan should be used cautiously in patients with a history of seizures.
In patients allergic to sulfonamides, administration of sumatriptan may lead to allergic reactions of varying severity, ranging from mild skin changes to anaphylactic shock.
Available data on this issue are limited; therefore, sumatriptan should be used cautiously in patients with known hypersensitivity to sulfonamides.
Concomitant use of sumatriptan and preparations containing St. John's wort (Hypericum perforatum) may increase the frequency of adverse reactions associated with sumatriptan.
Do not use a higher dose than recommended.
Prolonged use of any analgesic medications may lead to worsening of headache.
If a patient experiences such headache or it is suspected, the medicine should be discontinued and medical advice sought. In patients who experience frequent or daily headaches despite (or because of) regular use of headache medications, medication-overuse headache should be considered.
Children
The efficacy and safety of sumatriptan in children have not been established.
Use of Sumatriptan US Pharmacia in elderly patients
Data on the use of sumatriptan in patients over 65 years of age are limited. No significant differences in pharmacokinetics have been demonstrated between this age group and younger individuals. Until more comprehensive clinical data are available, the use of sumatriptan in this patient group is not recommended.
Sumatriptan US Pharmacia and other medicines
Inform your doctor about all medicines you are currently using or have recently used, as well as any medicines you plan to use.
Studies have not shown interactions between sumatriptan and ethanol, or with medications such as propranolol (used in the treatment of hypertension), flunarizine (used in the treatment of cerebral circulation disorders), or pizotifen (used in the treatment of migraine).
When ergotamine (used in the treatment of migraine) is used concomitantly, prolonged vasoconstriction has been reported. Since these effects may be additive, sumatriptan should not be administered earlier than 24 hours after taking any ergotamine-containing preparation. Conversely, ergotamine-containing preparations may be administered 6 hours after sumatriptan administration.
Rare interactions between sumatriptan and selective serotonin reuptake inhibitors (used in depression) may occur.
Pregnancy and breastfeeding
During pregnancy, breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor before using this medicine.
Pregnancy
Adequate studies in humans have not been conducted. The use of this medicine in pregnant women should be limited to cases where the expected benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Sumatriptan passes into breast milk. Breastfeeding should be avoided for 12 hours after taking sumatriptan.
Driving and operating machinery
Somnolence may occur during treatment with sumatriptan, which may adversely affect activities requiring increased attention, precise motor coordination, and rapid decision-making (e.g., driving a car, operating machinery, working at heights, etc.). Patients should not drive or operate machinery for 24 hours after administration.
Sumatriptan US Pharmacia contains aspartame and lactose
The medicine contains aspartame, a substance that increases phenylalanine levels. It may therefore be harmful to patients with phenylketonuria.
The medicine contains lactose. If the patient has been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine.

3. How to use Sumatriptan US Pharmacia

Adults:
The recommended oral dose of sumatriptan is 1 tablet of 50 mg. However, sometimes a dose of 100 mg is recommended.
If there is no response to the first dose, taking a second dose during the same migraine attack is not beneficial. If symptoms recur, Sumatriptan US Pharmacia may be taken again once; in rare cases, up to two doses may be taken within 24 hours, bearing in mind that the minimum interval between doses must be 2 hours. The maximum daily dose must not exceed 300 mg.
Sumatriptan should be taken as soon as possible after the onset of a migraine attack; however, the medicine is equally effective when administered at any stage of the headache. Tablets should be swallowed whole with water.
To open, bend the individual square of the blister containing the tablet and then peel it open along the perforated line. To remove the tablet, gently peel back the aluminium protective foil starting from the corner with the smooth surface. Do not push the tablet through the foil.
Use of a higher than recommended dose of Sumatriptan US Pharmacia
Seek immediate medical advice from a doctor or pharmacist.
Missed dose of Sumatriptan US Pharmacia
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common (affects more than 1 in 100 and less than 1 in 10 patients): pain, tingling sensation, feeling of heat or
cold, sensation of heaviness, pressure or tightness (usually transient, may be intense and may affect any part of the body, including the chest and throat), feeling of weakness and
fatigue (in most cases mild to moderate), drowsiness, dizziness,
facial flushing, transient increase in blood pressure shortly after administration of the medicine and hot flushes, nausea, vomiting, shortness of breath, muscle pain.
Very rare (affects less than 1 in 10,000 patients): liver function disorders. If the patient has blood tests to check liver function, they should inform the doctor or nurse that they are taking Sumatriptan US Pharmacia.
Frequency not known (cannot be estimated from available data): hypersensitivity reactions – from skin hypersensitivity reactions to rare cases of anaphylactic shock (symptoms include swelling of the face, tongue or throat, difficulty swallowing, urticaria and breathing difficulties), seizures which occurred in individuals with a history of seizures or with coexisting predisposing factors, as well as in individuals without risk factors, tremor, dystonia (disorder of the natural state of tension in muscles and/or blood vessels), nystagmus, scotoma, sensation of flickering light, double vision, worsening of vision, loss of vision with cases of permanent visual field defects, (bradycardia (slowing of heart rate), tachycardia (acceleration of heart rate), palpitations, cardiac arrhythmias, transient ischaemic changes in ECG recording, coronary artery spasm, angina pectoris, myocardial infarction, hypotension, Raynaud's phenomenon (pain, pallor, followed by cyanosis of fingers and toes, usually triggered by exposure to cold or stress), ischaemic colitis, diarrhoea, neck stiffness, joint pain, restlessness, excessive sweating. In patients who have recently experienced trauma or who have an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain may occur at the site of trauma or inflammation.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine. Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Sumatriptan US Pharmacia

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Sumatriptan US Pharmacia contains

The active substance is sumatriptan in the form of sumatriptan succinate.
The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, peppermint flavouring, talc, aspartame, povidone, magnesium stearate.

What Sumatriptan US Pharmacia looks like and contents of the pack
Available pack sizes: 2, 4, 6 tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
Manufacturer
Laboratorios Liconsa, S.A.
Av. Miralcampo, No 7, poligono Industrial Miralcampo 19200
Azuqueca de Henares (Guadalajara)
Spain