Sumatriptan Medical Vallei

Package Leaflet: Information for the Patient

Sumatriptan Medical Valley, Tablets, 100 mg

Sumatriptan

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.

Table of Contents of the Leaflet

• 1. What is Sumatriptan Medical Valley and what is it used for
• 2. Important information before taking Sumatriptan Medical Valley
• 3. How to take Sumatriptan Medical Valley
• 4. Possible side effects
• 5. How to store Sumatriptan Medical Valley
• 6. Package contents and other information

1. What is Sumatriptan Medical Valley and what is it used for

Sumatriptan Medical Valley contains 100 mg of sumatriptan in the form of sumatriptan succinate - an anti-migraine substance. Migraine symptoms may depend on the temporary expansion of blood vessels in the cervical artery circulation. Sumatriptan belongs to a group of drugs that are 5HT receptor antagonists, which narrow these blood vessels.

2. Important information before taking Sumatriptan Medical Valley

When not to take Sumatriptan Medical Valley:

• if you are allergic to the active substance or any of the other ingredients of this medication (listed in section 6) or sulfonamides;
• in children under 18 years of age, as the safety of the medication in this age group has not been established;
• in patients who have had a heart attack, or who have ischemic heart disease, coronary artery spasm (Prinzmetal's angina), or peripheral vascular disease;
• in patients who have had a stroke or transient ischemic attack in the past, especially with severe liver impairment;
• with moderate or severe hypertension and uncontrolled moderate hypertension;
• when taking ergotamine or its derivatives (including methysergide) concurrently, or MAO inhibitors, or within two weeks of stopping treatment with these medications.

Warnings and precautions

Sumatriptan can only be used in patients with a properly diagnosed migraine. Due to the lack of data, it is not recommended for patients with hemiplegic, basilar, or ophthalmoplegic migraine. In patients with a headache of a migrainous type, but without a previous diagnosis of migraine, another cause of the symptoms should be considered. A similar note applies to patients with previously diagnosed migraine but with an atypical picture of the current headache attack. It should be remembered that patients with migraine may belong to a group at risk of cerebrovascular damage, such as transient ischemic attack or stroke. After sumatriptan administration, transient pain and a feeling of pressure in the chest and throat may occur, sometimes of significant intensity. If the nature of these symptoms may indicate ischemic heart disease, it is recommended to perform appropriate tests. Sumatriptan should not be used in people at risk of cardiovascular disease, as well as in people who smoke or use nicotine replacement therapy, before performing tests to rule out these diseases. This group will include, among others, women after menopause, men over 40 years of age. However, it should be taken into account that not all tests performed allow for a proper diagnosis of existing heart disease, and that in very rare cases, severe cardiac symptoms may occur without underlying cardiovascular disease. Sumatriptan may cause a temporary increase in blood pressure and an increase in peripheral vascular resistance. For this reason, in patients with controlled hypertension, the medication should be used with caution. The medication should also be administered with caution to patients who may have changes in absorption, metabolism, or excretion, such as impaired liver or kidney function. Sumatriptan should be used with caution in patients who have had seizure attacks. In patients allergic to sulfonamides, after sumatriptan administration, symptoms of allergy of varying severity may occur, from minor skin changes to anaphylactic shock. Information on this is limited, so sumatriptan in patients with known hypersensitivity to sulfonamides should be used with caution. The use of sumatriptan and preparations containing St. John's Wort (Hypericum perforatum) may increase the frequency of adverse reactions to sumatriptan. Do not exceed the recommended dose of sumatriptan. Long-term use of any painkillers may cause an intensification of headache. If the patient experiences or suspects such a cause of headache, they should stop taking the medication and consult a doctor. In patients who experience frequent or daily headaches despite (or due to) regular use of headache medications, consideration should be given to the diagnosis of medication-overuse headache.

Children

The efficacy and safety of sumatriptan in children have not been established.

Using Sumatriptan Medical Valley in the elderly

Data on the use of sumatriptan in patients over 65 years of age are limited. No significant differences in pharmacokinetics were found between this group of patients and younger individuals. Until more detailed clinical data are collected, the use of sumatriptan in this group of patients is not recommended.

Sumatriptan Medical Valley and other medications

Inform your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take. Studies have not shown interactions between sumatriptan and ethanol, or medications such as propranolol (used to treat hypertension), flunarizine (used to treat cerebral circulation disorders), and pizotifen (used to treat migraine). During the use of ergotamine (used to treat migraine), prolonged vasospasm has been reported. Since these effects may be additive, sumatriptan should not be administered earlier than 24 hours after taking any ergotamine-containing preparation. However, preparations containing ergotamine can be administered 6 hours after sumatriptan use. Rarely, interactions may occur between sumatriptan and selective serotonin reuptake inhibitors (used in depression).

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if you suspect you are pregnant, or plan to become pregnant, consult your doctor before taking this medication. Pregnancy There are no adequate human studies. The use of the medication 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. For 12 hours after sumatriptan administration, you should not breastfeed.

Driving and operating machinery

During sumatriptan use, drowsiness may occur, which may have a negative impact on activities that require increased attention, precise coordination, and quick decision-making (e.g., driving, operating machinery, working at heights, etc.). Do not drive or operate machinery for 24 hours after administration.

Sumatriptan Medical Valley contains aspartame and lactose

The medication contains aspartame, a substance that increases the amount of phenylalanine. It may therefore be harmful to patients with phenylketonuria. The medication contains lactose. If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medication.

3. How to take Sumatriptan Medical Valley

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 recommended. In case of recurrence of symptoms, you can take one dose of Sumatriptan Medical Valley again, and in rare cases, a maximum of two doses of the medication within 24 hours, taking into account the fact that the minimum interval between doses is 2 hours. The maximum daily dose should not exceed 300 mg. Sumatriptan should be taken as soon as possible after the onset of a migraine attack, but the medication is equally effective when taken at any stage of the headache. Tablets should be swallowed whole, with water. To open, bend a single square of the blister with the tablet and then tear it off along the perforation line. To remove the tablet, carefully remove the protective aluminum foil. The foil should be torn off from the corner with a smooth surface. Do not push the tablets through the foil.

Taking a higher dose of Sumatriptan Medical Valley than recommended

Immediately contact your doctor or pharmacist.

Missing a dose of Sumatriptan Medical Valley

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medications, Sumatriptan Medical Valley can cause side effects, although not everybody gets them. Frequently(in more than 1 in 100, less than 1 in 10 patients): pain, sensation of tingling, warmth, or cold, feeling of heaviness, swelling, or pressure (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, flushing, transient blood pressure elevation after administration, and hot flashes, nausea, vomiting, dyspnea, muscle pain. Very rarely(in less than 1 in 10,000 patients): liver function disorders. If you have blood tests to check liver function, inform your doctor or nurse that you are taking Sumatriptan Medical Valley. Frequency not known(cannot be estimated from the available data): hypersensitivity reactions - from skin hypersensitivity reactions to rare cases of anaphylactic shock (whose symptoms are facial swelling, tongue or throat swelling, difficulty swallowing, urticaria, and breathing difficulties), seizure attacks, which occurred in people with a history of seizure attacks or with co-existing risk factors for their occurrence, as well as in people without risk factors, tremors, dystonia (disorder of the natural state of muscle tension and/or blood vessels), oculogyric crisis, glitter, sensation of light flickering, double vision, visual impairment, loss of vision with cases of permanent visual impairment, bradycardia (slow heart rate), tachycardia (rapid heart rate), palpitations, arrhythmias, transient ischemic changes in the ECG, coronary artery spasm, angina pectoris, myocardial infarction, hypotension, Raynaud's phenomenon (pain, pallor, and then cyanosis of the fingers of the hands and feet, usually caused by exposure to cold or stress), ischemic colitis, diarrhea, neck stiffness, joint pain, restlessness, excessive sweating. In a patient who has recently had an injury or has an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain at the site of injury or inflammation may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. By reporting side effects, you can help gather more information on the safety of this medication. Side effects can also be reported to the marketing authorization holder.

5. How to store Sumatriptan Medical Valley

Store the medication out of sight and reach of children. Store at a temperature below 25°C. Do not use this medication after the expiry date stated on the package.

6. Package contents and other information

What Sumatriptan Medical Valley contains

• The active substance of the medication is sumatriptan in the form of sumatriptan succinate.
• Other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, mint flavor and aroma, talc, aspartame, povidone, magnesium stearate.

What Sumatriptan Medical Valley looks like and what the package contains

Available packages: 2, 4, 6 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical Valley Invest AB Brädgårdsvägen 28 Höllviken, 236 32 Sweden

Manufacturer

Laboratorios Liconsa, S.A. Av. Miralcampo, No 7, poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara) Spain Date of last revision of the leaflet:29.09.2020