Dezamigren

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

Package leaflet: information for the patient

Dezamigren, 12.5 mg, coated tablets
Almotriptan malate
Please read this leaflet carefully before taking this 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
the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after taking the medicine, contact your doctor.

Leaflet contents

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

1. What Dezamigren is and what it is used for

Dezamigren is an anti-migraine medicine belonging to a group of medicines called selective
serotonin receptor agonists. The active substance of the medicine (almotriptan) binds to
serotonin receptors in the blood vessels of the brain, causing them to constrict, thereby reducing
the inflammatory response associated with migraine.
Dezamigren is used for the acute treatment of headache associated with acute migraine attacks
with or without aura.
Dezamigren may only be used in patients in whom a doctor has diagnosed migraine.
Dezamigren should not be used for migraine prophylaxis.
Migraine is defined as a pulsating, one-sided, moderate or severe headache, which may worsen
during physical exertion. The headache is accompanied by at least one of the following symptoms:
nausea, vomiting, sensitivity to light, sound, or smells.
The headache may sometimes be preceded by certain symptoms, such as: brief worsening of mood,
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 taking Dezamigren

When not to take Dezamigren

• If the patient is allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6).
• If the patient currently has or has ever had any condition that reduces blood flow to the heart, such as:
  • myocardial infarction (heart attack),
  • angina pectoris,
  • chest pain or discomfort typically occurring during physical exertion 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 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: "Dezamigren with other medicines".
• If the patient has severe hepatic impairment.

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 starting to take Dezamigren, consult a doctor or pharmacist:

• If the type of migraine has not been clearly diagnosed, as Dezamigren should not be used to treat primary migraine (migraine with aura symptoms such as double vision, speech difficulties, clumsy and uncoordinated movements, ringing in the ears, 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 affecting eye movement muscles causing muscle weakness).
• If the patient has an allergy (hypersensitivity) to antibacterial medicines, particularly 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 symptoms differ from usual migraine attacks, for example, if the patient experiences ringing in the ears or dizziness, brief paralysis on one side of the body, or weakness in muscles controlling eye movements, or any other new symptoms.
• 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 or moderate hepatic impairment.
• If the patient has severe renal impairment (see section 3).
• If the patient is over 65 years of age, as they may be at increased risk of elevated blood pressure.
• If the patient is concurrently taking antidepressants such as SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). See section below: "Dezamigren with other medicines".

It is believed that excessive use of migraine medications may lead to chronic headache.
Children and adolescents
Dezamigren must not be used in children and adolescents under 18 years of age.
Elderly patients (over 65 years of age)
If the patient is over 65 years of age, they should not use this medicine without consulting a
doctor.
Dezamigren with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well
as any medicines the patient plans to take.
Inform 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), as these medicines may cause serotonin syndrome, a potentially life-threatening reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated limb or eye movements, involuntary muscle contractions, or diarrhea.
• If the patient is taking St John's wort (Hypericum perforatum), as this may increase the likelihood of adverse effects.

Do not take almotriptan simultaneously with other medicines containing ergotamine, which are also used to treat migraine. These medicines may be used one after another, provided an adequate 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.

Dezamigren and food
Dezamigren may be taken with or without food. The medicine 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.
Available data on use in pregnant women are very limited.
Dezamigren should not be used during pregnancy unless prescribed by a doctor who has carefully
evaluated the benefit-risk balance.
Caution should be exercised when using this medicine during breastfeeding. Breastfeeding should
be avoided for 24 hours after taking this medicine.
Driving and operating machinery
Dezamigren may cause drowsiness.
If the patient experiences drowsiness, they should not drive or operate machinery.
Dezamigren contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Dezamigren

This medicine should always be taken exactly as described in this patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dezamigren may only be used in patients who have been diagnosed with migraine.
Dezamigren should be used exclusively for the treatment of an acute migraine attack, not for the
prevention of migraine attacks or headaches.
Adults (aged 18 to 65 years)
The recommended dose is: one tablet (12.5 mg).
The medicine 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, the patient should 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).
The tablet should be swallowed with fluid (e.g. water). The tablet may be taken with food or
independently of meals.
Severe renal impairment
If the patient has severe renal impairment, they should not take more than one tablet (12.5 mg)
within 24 hours.
Use in children and adolescents
Dezamigren must not be used in children and adolescents under 18 years of age.
Consult your doctor or pharmacist and do not take Dezamigren if you have noticed:

• occurrence of 4 or more migraine attacks within the last 30 days and/or
• a change in symptoms, or an increase in their severity or frequency, and/or
• low effectiveness of treatment.

Taking more Dezamigren than recommended
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 Dezamigren
Dezamigren should be taken as described in section 3 of this patient information leaflet. Do not
take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Immediately contact a doctor or go to the nearest hospital and discontinue
treatment with Dezamigren 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, chest tightness, or tightness in the throat, or any other symptoms that may indicate a heart attack.

Other adverse effects:
Common (occur in 1 to 10 out of 100 people):

• dizziness;
• drowsiness;
• fatigue;
• nausea;
• vomiting.

Uncommon (occur in 1 to 10 out of 1,000 people):

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

Very rare (occur in fewer than 1 out of 10,000 people):

• constriction of blood vessels in the heart (coronary artery spasm);
• heart attack (myocardial infarction);
• rapid heartbeat (tachycardia).

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

• severe allergic reactions (anaphylactic reactions);
• seizure;
• vision disturbances, blurred vision (vision disturbances may also occur during a migraine attack itself);
• constriction of intestinal blood vessels, which may lead to intestinal damage (intestinal ischemia). Abdominal pain and bloody diarrhea may occur.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Dezamigren

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.
There are no special storage instructions 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 will help protect the environment.

6. Contents of the package and other information

What the medicine Dezamigren contains

• The active substance is almotriptan in a dose of 12.5 mg (as almotriptan malate).
• The other ingredients are:
  • Core of the tablet: mannitol, microcrystalline cellulose, povidone K 29/32, sodium carboxymethyl starch (Type A), sodium stearyl fumarate;
  • Film-coating: hypromellose, titanium dioxide (E 171), macrogol 400.

What Dezamigren looks like and contents of the pack
Dezamigren is a white, biconvex, round, film-coated tablet, smooth on both sides.
Dezamigren is packed in PVC/Aluminum blisters. One pack contains 2 or 6 film-coated tablets in a cardboard box.

Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. (42) 22-53-100

Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
SAG Manufacturing S.L.U
Crta. N-I, Km 36, San Agustín de Guadalix,
28750 Madrid
Spain