Trymigan

Trymigan should only be taken by patients in whom a doctor has diagnosed
migraine.
Before taking the medicine, read the package leaflet and complete the diagnostic test. Subsequent migraine attacks should be recorded in the Migraine Diary.

Package leaflet: Information for the patient

Trymigan, 12.5 mg, coated tablets
Almotriptanum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after taking the medicine, consult your doctor.

Contents of the leaflet

1. What Trymigan is and what it is 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 pack and other information

1. What Trymigan is and what it is used for

Trymigan is an anti-migraine medicine belonging to a group of medicines called selective serotonin receptor agonists. The active substance (almotriptan) binds to serotonin receptors in the blood vessels of the brain, causing them to narrow, thereby reducing 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 in whom a doctor has diagnosed migraine.
Trymigan should not be used for migraine prophylaxis.
If in doubt, consult your doctor or pharmacist.
Migraine is characterized by moderate or severe headache. The pain usually affects one side of the head, is pulsating, and may worsen during physical activity. The headache is accompanied by at least one of the following symptoms: nausea, vomiting, sensitivity to light, sound, or smells. Headache may sometimes be preceded by certain symptoms such as temporary mood changes, irritability, anxiety, or loss of appetite. In some individuals, shortly before the onset of headache, a so-called aura may occur (transient visual disturbances such as flashes of light, flickering spots, or light lines).

2. Important information before using Trymigan

When not to use Trymigan

• If the patient is allergic to almotriptan or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has or has ever had a disease that reduces blood flow to the heart, such as:
  • heart attack,
  • angina pectoris,
  • chest pain or discomfort usually occurring during physical activity or stress,
  • heart problems without accompanying pain,
  • chest pain occurring at rest,
  • severe hypertension (very high blood pressure),
  • uncontrolled mild or moderate high blood pressure.
• If the patient has had a stroke or experienced reduced blood flow to the brain.
• If the patient has obstruction in large blood vessels of the arms or legs (peripheral vascular disease).
• If the patient is concurrently taking other migraine medications containing ergotamine, dihydroergotamine or methysergide, or other medicines from the group of serotonin agonists (e.g. sumatriptan). See section: "Trymigan and other medicines".
• If the patient has severe hepatic impairment,
• For migraine prophylaxis.

Warnings and precautions

Before starting treatment, a diagnostic test should be completed to assess whether the patient's health status allows for self-administration of the medicine. If there are any doubts, consult a doctor or pharmacist.

Before taking Trymigan, discuss with your doctor or pharmacist:

• if the type of migraine has not been clearly diagnosed, because Trymigan should not be used to treat primary migraine (migraine with aura symptoms such as double vision, speech difficulties, clumsy and uncoordinated movements, tinnitus, reduced level of consciousness), hemiplegic migraine (migraine with aura including one-sided muscle weakness), or ophthalmoplegic migraine (migraine headache involving one or more cranial nerves causing weakness of muscles controlling eye movements).
• if the patient has an allergy (hypersensitivity) to antibacterial medicines, especially those used to treat urinary tract infections (sulfonamides); patients allergic to sulfonamides and/or antibiotics may also react with hypersensitivity to triptans. If the patient knows they are allergic to antibiotics but is unsure whether they are allergic to sulfonamides, they should consult a doctor or pharmacist.
• if headache-related symptoms are different than usual during migraine attacks, e.g. the patient experiences sounds in the ears or dizziness, brief paralysis on one side of the body or muscles controlling eye movements, or other new symptoms not previously experienced;
• if the patient has risk factors for heart disease, such as: uncontrolled high blood pressure, high cholesterol levels, obesity, diabetes, smoking, family history of heart disease, post-menopausal status in women, or age over 40 years in men;
• if the patient has mild to moderate hepatic impairment;
• if the patient has severe renal impairment (see section 3);
• if the patient experiences four or more migraine attacks per month;
• if the patient does not experience complete resolution of symptoms between migraine attacks;
• if the patient is over 65 years of age (as they are at greater risk of increased blood pressure);
• if the patient is concurrently taking antidepressant medicines SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). See section below: "Trymigan and other medicines".

It is considered that excessive use of anti-migraine medicines may lead to chronic headache.

Children and adolescents

Trymigan must not be used in children and adolescents under 18 years of age.

Elderly patients (over 65 years)

If the patient is over 65 years of age, they should consult a doctor before using this medicine.

Trymigan and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Tell your doctor:

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

Do not take almotriptan at the same time as medicines containing ergotamine, which may also be used to treat migraine. However, these medicines may be used one after another, provided an appropriate time interval is maintained between doses.

• After taking almotriptan, a minimum interval of 6 hours should be observed before taking ergotamine.
• After taking ergotamine, a minimum interval of 24 hours should be observed before taking almotriptan.

Taking Trymigan with food

Trymigan may be taken with or without food. The tablet should be taken with liquid.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

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

Trymigan must not be used during pregnancy, unless prescribed by a doctor who has carefully considered the benefit-risk balance.

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

Driving and operating machinery

Trymigan may cause drowsiness.

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

Trymigan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Trymigan

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Trymigan should only be used in patients diagnosed with migraine.
Trymigan should be used solely for the treatment of an acute migraine attack, and not
for the prevention of migraine attacks or headaches.
Adults (aged 18 to 65 years)
The recommended dose is one tablet (12.5 mg of almotriptan). The tablet should be taken as soon
as possible after the onset of a migraine attack. The medicine is also effective if taken at a later stage.
If the migraine attack does not subside, do not take more than one tablet during the same attack.
If another migraine attack occurs within 24 hours, a second tablet of 12.5 mg may be taken, provided
that at least a 2-hour interval is maintained between the first and second tablet.
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 renal impairment, no more than one tablet (12.5 mg) should be taken within
24 hours.
Method of administration
The tablet should be swallowed with liquid (e.g. water).
The tablet may be taken with or without food.
Use in children and adolescents
Trymigan should not be used in children and adolescents under 18 years of age.
Consult your doctor or pharmacist and do not take Trymigan if the patient has noticed:

• occurrence of 4 or more migraine attacks within the last 30 days, and/or
• changes in symptoms, or increased severity or frequency of attacks, and/or
• reduced effectiveness of treatment.

Taking more than the recommended dose of Trymigan
If the patient accidentally takes too many tablets, or if someone else or a child takes the medicine,
seek immediate advice from a doctor or pharmacist.
Missed dose of Trymigan
Take Trymigan exactly as described in section 3 of this patient leaflet. Do not take a double dose to
make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately inform your doctor or go to the nearest hospital and stop taking
the medicine Trymigan if the patient experiences any of the following symptoms after taking this medicine:

• 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 which may indicate a heart attack.

Common adverse reactions (may affect up to 1 in 10 people):

• dizziness
• drowsiness
• fatigue
• nausea
• vomiting

Uncommon adverse reactions (may affect up to 1 in 100 people):

• sensation of tingling, pricking or numbness (paraesthesia)
• headache
• sensation of ringing, buzzing or noise in the ears (tinnitus)
• irregular heartbeat (palpitations)
• sensation of tightness in the throat
• diarrhoea
• indigestion, dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling of weakness (asthenia)

Very rare adverse reactions (may affect up to 1 in 10,000 people):

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

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Trymigan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Trymigan contains
The active substance is almotriptan. One tablet contains 12.5 mg of almotriptan (as almotriptan succinate).
The other ingredients (excipients) are:

• tablet core: mannitol, microcrystalline cellulose, sodium carboxymethyl starch, 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 coated tablet.
The cardboard box contains a PVC/aluminum blister.
Pack sizes: 2, 3, 4, 6 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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