Sumatriptan medical valley

Patient Information Leaflet

Sumatriptan Medical Valley, tablets, 100 mg
Sumatriptanum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, 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

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

Sumatriptan Medical Valley contains 100 mg of sumatriptan as sumatriptan succinate – a medicine used to treat migraine. Migraine symptoms may be related to the temporary dilation of blood vessels in the carotid circulation. Sumatriptan belongs to a group of medicines called 5HT receptor antagonists, which act by constricting these blood vessels.

2. Important information before using Sumatriptan Medical Valley

When not to use Sumatriptan Medical Valley:

• 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 lack of established safety data in this age group;
• in patients:
• who have had myocardial infarction, or who have ischemic heart disease, coronary artery spasm (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 with moderate uncontrolled hypertension;
• who are currently taking medications containing ergotamine or its derivatives (including methysergide), MAO inhibitors, or within two weeks after discontinuation of such drugs.

Warnings and precautions

Sumatriptan should be used only in patients with a confirmed diagnosis of migraine. Due to lack of data, it is not recommended in patients with hemiplegic, basilar, or ophthalmoplegic migraine.

In patients experiencing migraine-type headache who have not previously been diagnosed with migraine, alternative causes of headache should be considered. The same applies to patients with previously diagnosed migraine but who present with an atypical headache attack. It should be noted that patients with migraine may belong to a high-risk group for cerebrovascular events 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 marked intensity. If the nature of these symptoms suggests ischemic heart disease, appropriate diagnostic evaluation is recommended.

Sumatriptan should not be used in patients at risk of cardiovascular disorders, including chronic tobacco smokers or those using nicotine replacement therapy, until appropriate investigations have excluded such conditions. This group includes, among others, women after menopause and men over 40 years of age. However, it should be noted that diagnostic tests do not always reliably detect existing heart disease, and in very rare cases, serious 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 drug should be used with great caution in patients with controlled hypertension.

The drug should also be administered cautiously in patients in whom altered absorption, metabolism, or excretion may be expected, such as 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 cause allergic reactions of varying severity, ranging from mild skin changes to anaphylactic shock. Data on this 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.

A dose higher than the recommended dose of sumatriptan should not be used.

Long-term use of any analgesic medications may lead to worsening of headache. If such headache occurs or is suspected, the patient should discontinue the medication and consult a physician. 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 Medical Valley 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 detailed clinical data are available, use of sumatriptan in this patient group is not recommended.

Sumatriptan Medical Valley and other medicines

Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to use.

Studies have not shown interactions between sumatriptan and ethanol, or with propranolol (used in the treatment of hypertension), flunarizine (used in the treatment of cerebral circulation disorders), or pizotifen (used in migraine prophylaxis).

Cases of prolonged vasoconstriction have been reported during concomitant use of ergotamine (used in migraine treatment). Because 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 no sooner than 6 hours after administration of sumatriptan.

Rare interactions between sumatriptan and selective serotonin reuptake inhibitors (used in depression) may occur.

Pregnancy and breastfeeding

During pregnancy, while breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor before using this medicine.

Pregnancy

Adequate human studies are lacking. Use of this medicine during pregnancy 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 following administration of sumatriptan.

Driving and operating machinery

Somnolence may occur during treatment with sumatriptan, which may adversely affect activities requiring heightened attention, precise motor coordination, and rapid decision-making (e.g., driving a car, operating machinery, working at heights, etc.). Patients should refrain from driving or operating mechanical equipment for 24 hours after administration.

Sumatriptan Medical Valley contains aspartame and lactose

This medicine contains aspartame, a substance that increases phenylalanine levels. It may therefore be harmful to patients with phenylketonuria.

This medicine contains lactose. If the patient has been diagnosed with intolerance to certain sugars, the patient should consult a physician before taking this medicine.

3. How to use 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 beneficial. If symptoms recur, a second dose of Sumatriptan Medical Valley may be taken; in rare cases, up to two doses of the medicine may be taken within 24 hours, keeping 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, although 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 blister square containing the tablet and then tear it along the perforated line. To remove the tablet, gently peel back the aluminium protective foil. The foil should be peeled from the corner with the smooth surface. Do not push the tablets through the foil.
Use of a higher than recommended dose of Sumatriptan Medical Valley
Seek immediate medical advice from a doctor or pharmacist.
Missed dose of Sumatriptan Medical Valley
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 they do not occur in everyone.
Common (in more than 1 in 100 and less than 1 in 10 patients): pain, tingling sensation, warmth or
cold sensation, feeling 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, hot flushes, nausea, vomiting, shortness of breath, muscle pain.
Very rare (in less than 1 in 10,000 patients): liver function disorders. If the patient undergoes blood
tests to check liver function, they should inform the doctor or nurse that they are taking Sumatriptan Medical Valley.
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 patients with a history of seizures or with coexisting predisposing factors, as well as in patients without risk factors, tremor, dystonia (disorder of the natural state of muscle and/or blood vessel tension), nystagmus, scotoma, perception of flickering light, double vision, worsening of vision, loss of vision with cases of permanent visual defects, bradycardia (slowing of heart function), tachycardia (acceleration of heart function), 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 had trauma or who have an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain at the site of injury or inflammation may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 allows gathering more information on the safety of the medicine. Adverse reactions can also be reported to the responsible entity.

5. How to store Sumatriptan Medical Valley

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 Medical Valley contains

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

What Sumatriptan Medical Valley looks like and contents of the pack
Available pack sizes:
2, 4, 6 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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