TRYMIGAN 12.5 mg Tablets

Contents of the leaflet

1. Trymigan Medication Can Only Be Taken by Patients Who Have Been Diagnosed by a Doctor
   1. Before Taking the Medication, Read the Leaflet and Complete the Diagnostic Test. Subsequent Migraine Attacks Should Be Noted in the Migraine Diary.
   2. Leaflet Included in the Packaging: Patient Information
   3. Trymigan, 12.5 mg, Coated Tablets
   4. Carefully Read the Contents of the Leaflet Before Taking the Medication, as It Contains Important Information for the Patient.
   5. Table of Contents of the Leaflet
2. What is Trymigan and what is it used for
3. Important information before taking Trymigan
   1. When not to take Trymigan
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients (over 65 years old)
   5. Trymigan and other medications
   6. Taking Trymigan with food
   7. Pregnancy and breastfeeding
   8. Driving and operating machinery
   9. Trymigan contains sodium
4. How to take Trymigan
   1. Trymigan should only be used to treat an ongoing migraine attack, not to prevent migraine attacks or headaches.
   2. Adults (18 to 65 years old)
   3. Use in patients with renal impairment
   4. Method of administration
   5. Use in children and adolescents
   6. Consult a doctor or pharmacist and do not take Trymigan if the patient has:
   7. Overdose of Trymigan
   8. Missing a dose of Trymigan
5. Possible side effects
   1. Immediately inform a doctor or go to the nearest hospital and stop taking Trymigan if the patient experiences any of the following symptoms after taking the medication:
   2. Reporting side effects
6. How to store Trymigan
7. Contents of the packaging and other information
   1. What Trymigan contains
   2. What Trymigan looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. SAG Manufacturing S.L.U.
   7. Date of last revision of the leaflet:

Trymigan Medication Can Only Be Taken by Patients Who Have Been Diagnosed by a Doctor

Migraine.

Before Taking the Medication, Read the Leaflet and Complete the Diagnostic Test. Subsequent Migraine Attacks Should Be Noted in the Migraine Diary.

Leaflet Included in the Packaging: Patient Information

Trymigan, 12.5 mg, Coated Tablets

Almotriptan

Carefully Read the Contents of the Leaflet Before Taking the Medication, as It Contains Important Information for the Patient.

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet to be able to read it again if necessary.
• If advice or additional information is needed, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If the patient does not improve or feels worse after taking the medication, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Trymigan and what is it used for
• 2. Important information before taking Trymigan
• 3. How to take Trymigan
• 4. Possible side effects
• 5. How to store Trymigan
• 6. Contents of the packaging and other information

1. What is Trymigan and what is it used for

Trymigan is an anti-migraine medication that belongs to a group of medications called selective serotonin receptor agonists. The active substance (almotriptan) binds to serotonin receptors in blood vessels in the brain, causing them to constrict, which leads to a reduction in the inflammatory response associated with migraine.

Trymigan is used for the acute treatment of headache associated with migraine attacks with or without aura.

Trymigan should only be used in patients who have been diagnosed with migraine by a doctor.

Trymigan should not be used for migraine prevention.

In case of doubt, consult a doctor or pharmacist.

Migraine is characterized by moderate or severe headache. The pain is usually on one side of the head, is pulsating, and may worsen with physical activity. The headache is accompanied by at least one of the following symptoms: nausea, vomiting, sensitivity to light, sounds, or smells. The headache may sometimes be preceded by certain symptoms, such as mood changes, irritability, restlessness, or loss of appetite. In some people, a so-called aura (transient visual disturbances with flashing lights, shimmering spots, or lines of light) may appear shortly before the headache.

2. Important information before taking Trymigan

When not to take Trymigan

.

• If the patient is allergic to almotriptan or any of the other ingredients of this medication (listed in section 6).
• If the patient has a history of a disease that limits blood flow to the heart, such as:
• heart attack,
• angina pectoris,
• chest pain or discomfort that occurs during activity or stress,
• heart problems without accompanying chest pain,
• chest pain that occurs at rest,
• severe high blood pressure (very high blood pressure),
• uncontrolled mild or moderate high blood pressure.
• If the patient has had a stroke or has experienced a reduction in blood flow to the brain.
• If the patient has a blockage in the large blood vessels of the arms or legs (peripheral vascular disease).
• If the patient is taking other medications for migraine that contain ergotamine, dihydroergotamine, or methysergide, or other serotonin agonist medications (e.g., sumatriptan). See section: "Trymigan and other medications".
• If the patient has severe liver failure,
• In migraine prevention.

Warnings and precautions

Before starting to take the medication, complete a diagnostic test to assess whether the patient's health allows for self-administration of the medication. In case of any doubts, consult a doctor or pharmacist.

Before taking Trymigan, discuss with a doctor or pharmacist:

• if the migraine diagnosis is not clear, because Trymigan should not be used to treat primary migraine (migraine with aura symptoms such as double vision, speech difficulties, uncoordinated movements, ringing in the ears, decreased level of consciousness), hemiplegic (migraine with aura, including one-sided muscle weakness) or ophthalmoplegic (migraine headache with involvement of one or more eye nerves causing muscle weakness controlling eye movements).
• if the patient is allergic (hypersensitive) to antibacterial medications, especially those used to treat urinary tract infections (sulfonamides); individuals allergic to sulfonamides and/or antibiotics may also react with hypersensitivity to triptan medications. If the patient knows they are allergic to antibiotics but is not sure if they are allergic to sulfonamides, they should consult a doctor or pharmacist.
• if the symptoms associated with the headache are different from those usually experienced during migraine attacks, e.g., the patient hears sounds in their ears or experiences dizziness, has transient paralysis of one side of the body or muscles controlling eye movements, or has other symptoms that have not occurred before;
• if the patient has factors that increase the risk of heart disease, such as uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, a history of heart disease in the family, postmenopausal status in women, or age over 40 in men;
• if the patient has mild to moderate liver failure;
• if the patient has severe kidney failure (see section 3);
• if the patient experiences four or more migraine attacks per month;
• if the patient does not experience complete relief from symptoms between migraine attacks;
• if the patient is over 65 years old (as they are more likely to experience increased blood pressure);
• if the patient is taking antidepressant medications SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and norepinephrine reuptake inhibitors). See section below "Trymigan and other medications".

It is believed that excessive use of anti-migraine medications may lead to chronic headache.

Children and adolescents

Trymigan should not be used in children and adolescents under the age of 18.

Elderly patients (over 65 years old)

If the patient is over 65 years old, they should consult a doctor before taking this medication.

Trymigan and other medications

Tell the doctor or pharmacist about all medications the patient is currently taking or has recently taken, as well as any medications they plan to take.

Tell the doctor:

• if the patient is taking any medications for depression, such as monoamine oxidase inhibitors (e.g., moclobemide), selective serotonin reuptake inhibitors (e.g., fluoxetine), or serotonin and norepinephrine reuptake inhibitors (e.g., venlafaxine), as they may cause serotonin syndrome, a potentially life-threatening reaction to medications. Symptoms of serotonin syndrome include disorientation, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrolled muscle contractions, and diarrhea.
• if the patient is taking medications containing St. John's Wort (Hypericum perforatum), as this may increase the risk of side effects.

Do not take almotriptan at the same time as medications containing ergotamine, which may also be used to treat migraine. However, these medications can be taken one after the other, provided that an appropriate time interval is maintained between their administration.

After taking almotriptan, it is recommended to wait at least 6 hours before taking ergotamine,

After taking ergotamine, it is recommended to wait at least 24 hours before taking almotriptan.

Taking Trymigan with food

Trymigan can be taken with or without food. The medication should be taken with a liquid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medication.

There is only limited data available on the use of almotriptan in pregnant women.

Trymigan should not be used during pregnancy, unless advised by a doctor who has carefully weighed the benefits and risks.

Caution should be exercised when taking this medication during breastfeeding. The patient should avoid breastfeeding for 24 hours after taking this medication.

Driving and operating machinery

Trymigan may cause drowsiness.

If the patient experiences drowsiness, they should not drive or operate any tools or machinery.

Trymigan contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Trymigan

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Trymigan should only be used in patients with diagnosed migraine.

Trymigan should only be used to treat an ongoing migraine attack, not to prevent migraine attacks or headaches.

Adults (18 to 65 years old)

The recommended dose is one tablet (12.5 mg of almotriptan). The tablet should be taken as soon as possible after the migraine attack occurs. The medication is also effective when taken at a later stage.

If the migraine attack does not subside, do not take more than one tablet during the same attack.

If the patient experiences another migraine attack within 24 hours, a second tablet can be taken in a dose of 12.5 mg, provided that at least a 2-hour interval is maintained between the administration of the first and second tablets.

The maximum daily dose is two tablets (25 mg of almotriptan) within 24 hours.

Use in patients with renal impairment

If the patient has severe kidney failure, they should not take more than one tablet (12.5 mg) within 24 hours.

Method of administration

The tablet should be swallowed with a liquid (e.g., water).

The tablet can be taken with or without food.

Use in children and adolescents

Trymigan should not be used in children and adolescents under the age of 18.

Consult a doctor or pharmacist and do not take Trymigan if the patient has:

• experienced four or more migraine attacks in the last 30 days and/or
• experienced a change in symptoms or an increase in their severity or frequency, and/or low efficacy of treatment.

Overdose of Trymigan

If the patient has taken too many tablets or if someone else has taken the medication, they should immediately consult a doctor or pharmacist.

Missing a dose of Trymigan

Take Trymigan as described in section 3 of the patient leaflet. Do not take a double dose to make up for a missed dose.

In case of any further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Trymigan can cause side effects, although not everybody gets them.

Immediately inform a doctor or go to the nearest hospital and stop taking Trymigan if the patient experiences any of the following symptoms after taking the medication:

• allergic reactions (hypersensitivity reactions), including swelling of the lips, throat, or hands (angioedema);
• chest pain, tightness in the chest or throat, or any other symptoms that may indicate a heart attack.

Common side effects(may affect up to 1 in 10 people):

• dizziness
• drowsiness
• fatigue
• nausea
• vomiting

Uncommon side effects(may affect up to 1 in 100 people):

• tingling, prickling, or numbness (paresthesia)
• headache
• ringing, buzzing, or hissing in the ears (tinnitus)
• irregular heartbeat (palpitations)
• feeling of tightness in the throat
• diarrhea
• indigestion, dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling of weakness (asthenia)

Rare side effects(may affect up to 1 in 10,000 people):

• constriction of blood vessels in the heart (coronary vasospasm)
• heart attack (myocardial infarction)
• rapid heartbeat (tachycardia)

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

• allergic reactions (hypersensitivity reactions), including swelling of the lips, throat, or hands (angioedema)
• severe allergic reactions (anaphylactic reactions)
• seizure
• visual disturbances, blurred vision (visual disturbances may also occur during the migraine attack itself)
• constriction of blood vessels in the intestines, which may lead to intestinal damage (intestinal ischemia). Abdominal pain and bloody diarrhea may occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.

• Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medication.

5. How to store Trymigan

Keep the medication out of sight and reach of children.

Do not use this medication after the expiration date (EXP) stated on the packaging.

The expiration date refers to the last day of the month stated.

There are no special precautions for storing the medication.

Medications should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Trymigan contains

The active substance of Trymigan is almotriptan. One tablet contains 12.5 mg of almotriptan (as almotriptan malate).

The other ingredients (excipients) are:

• tablet core: mannitol, microcrystalline cellulose, sodium carboxymethylcellulose, povidone, sodium stearyl fumarate.
• tablet coating: hypromellose (E 464), titanium dioxide (E 171), macrogol.

What Trymigan looks like and contents of the pack

Trymigan is a white, smooth, round, biconvex, film-coated tablet.

Cardboard box containing a blister pack of PVC/Aluminum.

Package sizes: 2, 3, 4, 6 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Biofarm Sp. z o.o.

ul. Wałbrzyska 13

60-198 Poznań

Tel. +48 61 66 51 500

e-mail: [email protected]

Manufacturer

SAG Manufacturing S.L.U.

Crta. N-I, Km 36

San Agustín de Guadalix

28750 Madrid

Spain

Galenicum Health, S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Date of last revision of the leaflet: