DEZAMIGREN 12.5 mg Tablets

Contents of the leaflet

1. What is Dezamigren and what is it used for
2. Important information before taking Dezamigren
   1. When not to take Dezamigren
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients (over 65 years old)
   5. Dezamigren and other medicines
   6. You should tell your doctor:
   7. Dezamigren with food
   8. Pregnancy and breastfeeding
   9. Dezamigren should not be used during pregnancy, unless it is recommended by a doctor who has carefully weighed the benefits and risks.
   10. Driving and operating machinery
   11. Dezamigren contains sodium
3. How to take Dezamigren
   1. Dezamigren should only be used to treat an ongoing migraine attack, and not to prevent migraine attacks or headaches.
   2. Adults (from 18 to 65 years old)
   3. Use in children and adolescents
   4. You should consult your doctor or pharmacist and not take Dezamigren if you notice:
   5. Taking more than the recommended dose of Dezamigren
   6. Missing a dose of Dezamigren
4. Possible side effects
   1. You should immediately inform your doctor or go to the nearest hospital and stop taking Dezamigren if you experience the following symptoms after taking the medicine:
   2. Other side effects:
   3. Reporting side effects
5. How to store Dezamigren
6. Contents of the packaging and other information
   1. What Dezamigren contains
   2. What Dezamigren looks like and what the packaging contains
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

1. What is Dezamigren and what is it used for

Dezamigren is a migraine medicine that belongs to a group of medicines called selective serotonin receptor agonists. The active substance of the medicine (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.
Dezamigren is used for the acute treatment of headache associated with migraine attacks with or without aura.
Dezamigren should only be used in patients who have been diagnosed with migraine by a doctor.
Dezamigren should not be used for migraine prevention.
Migraine is characterized by a pulsating, one-sided, moderate or severe headache that may worsen during physical exertion. 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: short-term mood deterioration, irritability, anxiety, or loss of appetite. In some people, a so-called aura (transient visual disturbances with a sensation of light flashes, flickering spots, or lines of light) may appear shortly before the headache.

2. Important information before taking Dezamigren

When not to take Dezamigren

• If you are allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have or have ever had a disease that limits blood flow to the heart, such as:
• heart attack,
• angina pectoris,
• chest pain or discomfort that usually occurs after physical exertion or stress,
• heart problems without accompanying chest pain,
• chest pain that occurs during rest,
• severe high blood pressure (very high blood pressure),
• uncontrolled mild or moderate high blood pressure.
• If you have had a stroke or reduced blood flow to the brain.
• If you have had a blockage in the large blood vessels of the arms or legs (peripheral vascular disease).
• If you are taking other medicines used to treat migraine that contain ergotamine, dihydroergotamine, or methysergide, or other medicines from the group of serotonin agonists (e.g., sumatriptan). See section: "Dezamigren and other medicines".
• If you have severe liver failure.

Warnings and precautions

Before starting treatment with the medicine, you should complete a diagnostic test to assess whether your health condition allows for self-administration of the medicine. If you have any doubts, you should discuss them with your doctor or pharmacist.
Before starting to take Dezamigren, you should discuss it with your doctor or pharmacist:

• If the type of migraine has not been clearly diagnosed, because Dezamigren should not be used to treat basal migraine (migraine with aura symptoms such as double vision, speech difficulties, clumsy and 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 nerves of the eye socket, causing muscle weakness controlling eye movements).
• If you are allergic (hypersensitive) to antibacterial medicines, especially those used to treat urinary tract infections (sulfonamides). People allergic to sulfonamides and/or antibiotics may also react with hypersensitivity to triptan medicines. If you know you are allergic to antibiotics but are not sure if you are allergic to sulfonamides, you should consult your doctor or pharmacist.
• If your headache symptoms are different from your usual migraine attacks, for example, you experience ringing in the ears or dizziness, have short-term paralysis of one side of the body or muscles controlling eye movements, or any other new symptoms.
• If you have 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 you have mild or moderate liver failure.
• If you have severe kidney failure (see section 3).
• If you are over 65 years old, as you are then at risk of increased blood pressure.
• If you are taking antidepressant medicines from the group of SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and norepinephrine reuptake inhibitors). See section below "Dezamigren and other medicines".

It is believed that excessive use of migraine medicines may lead to chronic headache.

Children and adolescents

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

Elderly patients (over 65 years old)

If you are over 65 years old, you should not use this medicine without consulting your doctor.

Dezamigren and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

You should tell your doctor:

• If you are taking any medicines used to treat 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 these medicines may cause serotonin syndrome, a potentially life-threatening reaction associated with treatment. Symptoms of serotonin syndrome include: disorientation, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrolled muscle movements, or diarrhea.
• If you are taking St. John's Wort (Hypericum perforatum), as it may increase the likelihood of side effects.

You should not take almotriptan at the same time as other medicines containing ergotamine, which are also used to treat migraine. You can take these medicines one after the other, provided you maintain an appropriate time interval 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.

Dezamigren with food

Dezamigren can be taken with or without food. The medicine should be taken with a liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
There is only limited information available on the use of the medicine in pregnant women.

Dezamigren should not be used during pregnancy, unless it is recommended by a doctor who has carefully weighed the benefits and risks.

Cautious use of this medicine is recommended during breastfeeding. You should avoid breastfeeding for 24 hours after taking this medicine.

Driving and operating machinery

Dezamigren may cause drowsiness.
If you experience drowsiness, you should not drive or operate machinery.

Dezamigren contains sodium

The 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 leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult your doctor or pharmacist.
Dezamigrenshould only be used in patients with diagnosed migraine.

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

Adults (from 18 to 65 years old)

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 when taken at a later stage.
If the migraine attack does not subside, you should not take more than one tablet during the same attack.
If you experience another migraine attack within 24 hours, you can take a second tablet at a dose of 12.5 mg, provided you maintain a minimum 2-hour interval between the administration of the first and second tablets.
The maximum daily dose is two tablets (25 mg).
The tablet should be swallowed with a liquid (e.g., water). The tablet can be taken with or without food.
Severe kidney failure
If you have severe kidney failure, you should not take more than one tablet (12.5 mg) within 24 hours.

Use in children and adolescents

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

You should consult your doctor or pharmacist and not take Dezamigren if you notice:

• four or more migraine attacks in the last 30 days and/or
• changes in symptoms or increased severity or frequency, and/or low efficacy of treatment.

Taking more than the recommended dose of Dezamigren

If you accidentally take too many tablets or if someone else takes the medicine, you should immediately consult your doctor or pharmacist.

Missing a dose of Dezamigren

You should take Dezamigren as described in section 3 of the patient leaflet. You should not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You should immediately inform your doctor or go to the nearest hospital and stop taking Dezamigren if you experience the following symptoms after taking the 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 that may indicate a heart attack.

Other side effects:

Frequent(occurring in 1 to 10 people out of 100):

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

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

• 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(occurring in less than 1 person out of 10,000):

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

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

• 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 can lead to intestinal damage (intestinal ischemia). Abdominal pain and bloody diarrhea may occur.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 the medicine.

5. How to store Dezamigren

The medicine should be stored 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 month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dezamigren contains

• The active substance of the medicine is almotriptan in a dose of 12.5 mg (in the form of almotriptan succinate).
• Other ingredients are:
• tablet core: mannitol, microcrystalline cellulose, povidone K 29/32, sodium carboxymethylcellulose (Type A), sodium stearyl fumarate;
• tablet coating: hypromellose, titanium dioxide (E 171), macrogol 400.

What Dezamigren looks like and what the packaging contains

Dezamigren is a white, biconvex, round, coated tablet, smooth on both sides.
Dezamigren is packaged in PVC/Aluminum blisters. One package contains 2 or 6 coated tablets in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Phone: (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

Date of last revision of the leaflet: