Sumatriptan Medical Vallei

Package Leaflet: Information for the Patient

Sumatriptan Medical Valley, Tablets, 50 mg

Sumatriptan

Read the package leaflet carefully before taking the medicine, 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 medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine 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, tell 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. Contents of the pack and other information

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

Sumatriptan Medical Valley contains 50 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 medicine (listed in section 6) or sulfonamides;
• in children under 18 years of age, as the safety of the medicine in this age group has not been established;
• in patients:
• who have had a heart attack, or who have coronary heart disease, Prinzmetal's angina, or peripheral vascular disease
• who have had a stroke or transient ischemic attack in the past with severe liver dysfunction;
• with moderate or severe hypertension and uncontrolled moderate hypertension;
• taking ergotamine or its derivatives (including methysergide) concurrently, taking MAO inhibitors, and within two weeks of stopping treatment with these drugs.

Warnings and precautions

Sumatriptan can only be used in patients with a well-established diagnosis of 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, in whom migraine has not been previously diagnosed, another cause of the complaint 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 administration of sumatriptan, transient chest 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 coronary 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 appropriate 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 can 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 medicine should be used with caution.
The medicine should also be administered with caution to patients who may have changes in absorption, metabolism, or excretion, e.g., in patients with impaired liver or kidney function.
Sumatriptan should be used with caution in patients who have had seizure attacks.
In patients allergic to sulfonamides, after administration of sumatriptan, 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 take more than the recommended dose of sumatriptan.
Long-term use of any painkillers can lead to an intensification of headache. If the patient experiences or suspects such a cause of headache, they should stop taking the medicine 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.

Use of Sumatriptan Medical Valley in the elderly

Data on the use of sumatriptan in people over 65 years of age are limited. No significant differences in pharmacokinetics have been 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 medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Studies have not shown interactions between sumatriptan and ethanol, as well as drugs 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 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. On the other hand, ergotamine-containing preparations can be administered 6 hours after sumatriptan administration.
Rarely, interactions may occur between sumatriptan and selective serotonin reuptake inhibitors (used in depression).

Pregnancy and breastfeeding

In pregnancy, during breastfeeding, or if you think you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Pregnancy
There are no adequate human data. The use of the 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. For 12 hours after taking sumatriptan, you should not breastfeed.

Driving and using machines

During the use of sumatriptan, 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 taking the medicine.

Sumatriptan Medical Valley contains aspartame and lactose

The medicine contains aspartame, a source of phenylalanine. It may therefore be harmful to patients with phenylketonuria.
The medicine contains lactose. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

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 justified. In case of recurrence of symptoms, you can take one more dose of Sumatriptan Medical Valley, and in rare cases, a maximum of two doses of the medicine 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 medicine taken at any stage of the headache is equally effective. The 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. Tablets should not be pushed through the foil.

Taking a higher dose of Sumatriptan Medical Valley than recommended

Consult a doctor or pharmacist immediately.

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 medicines, this medicine can cause side effects, although not everybody gets them.
Common(in more than 1 in 100, less than 1 in 10 patients): pain, sensation of tingling, heat, or cold, sensation of heaviness, expansion, or compression (usually transient, may be intense, and may affect any part of the body, including the chest and throat), sensation of weakness and fatigue (in most cases, they are mild to moderate), drowsiness, dizziness, flushing, transient blood pressure elevation immediately after administration of the medicine, and hot flashes, nausea, vomiting, dyspnea, muscle pain.
Very rare(in less than 1 in 10,000 patients): liver function disorders. If you have blood tests to check liver function, you should 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 (the symptoms of which are facial, tongue, or throat edema, difficulty swallowing, urticaria, and breathing difficulties), seizure attacks, which have 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 (a disorder of the natural state of muscle and/or vascular tone), oculogyric crisis, sensation of light flickering, double vision, visual impairment, loss of vision with cases of permanent visual impairment, (bradycardia, tachycardia, palpitations, arrhythmias, transient ischemic changes in the ECG, coronary artery spasm, angina pectoris, myocardial infarction, hypotension, Raynaud's phenomenon), 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 the leaflet, tell 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 provide more information on the safety of this medicine. Side effects can also be reported to the marketing authorization holder.

5. How to store Sumatriptan Medical Valley

Keep the medicine out of the sight and reach of children.
Store in a temperature 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 Medical Valley contains

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

What Sumatriptan Medical Valley looks like and contents of the pack

Available packs:
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