Nomigren

The medicine can only be taken by patients who have been diagnosed by a doctor

migraine.

Before taking the medicine, read the leaflet and fill out the questionnaire.

Subsequent migraine attacks should be recorded in the Migraine Diary.

Leaflet attached to the packaging: information for the patient

NOMIGREN

12.5 mg, coated tablets

Almotriptan

Carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is the medicine and what is it used for

is a migraine medicine that belongs to a group of medicines called selective serotonin receptor agonists. The active substance - almotriptan binds to serotonin receptors in blood vessels in the brain (skull) causing them to constrict, which leads to a reduction in the inflammatory response associated with migraine.
The medicine is used for the acute treatment of headache in acute migraine attacks with or without aura.
The medicine can only be used in patients who have been diagnosed with migraine by a doctor.
The medicine 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 affects one side of the head, is pulsating, and worsens with physical activity. The pain is accompanied by at least one of the following symptoms: nausea, vomiting, sensitivity to light, sounds, or smells.
Headache can sometimes be preceded by certain symptoms, such as short-term mood deterioration, irritation, anxiety, or loss of appetite. In some people, shortly before the onset of headache, a so-called aura may appear (transient visual disturbances with a sensation of light flashes, flickering spots, or lines of light).

2. Important information before taking the medicine

When not to take the medicine

• For migraine prevention.
• If the patient is allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6).
• If the patient has a disease that limits blood flow to the heart, such as:
• heart attack,
• angina pectoris,
• pain or discomfort in the chest that usually occurs during activity or stress,
• heart problems without accompanying pain,
• chest pain that occurs during 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 had 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 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: "Medicine and other medicines".
• If the patient has severe liver failure.

Warnings and precautions

Before starting to use the medicine, discuss it with a doctor or pharmacist:

• if the type of migraine has not been diagnosed. The medicine should not be used to treat basic migraine (double vision, speech and movement disorders, decreased level of consciousness), hemiplegic (one-sided muscle weakness), or ophthalmoplegic (weakness of the muscles controlling eye movements);
• if the patient is 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 the patient is 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 headache are different from those that usually occur during migraine attacks, e.g., the patient hears sounds in their ears or feels dizzy, has short-term 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: 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 disease;
• if the patient has severe kidney disease (see section 3);
• if the patient has 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 then at risk of increased blood pressure.
• if the patient is taking antidepressant medicines SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and norepinephrine reuptake inhibitors). See section below "Medicine and other medicines".

It is believed that excessive use of migraine medicines may lead to chronic headache.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

Children and adolescents

The medicine should not be used in children and adolescents under 18 years of age.

Elderly patients (over 65 years)

If the patient is over 65 years old, they should not use this medicine without consulting a doctor.

Medicine and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Tell your doctor:

• if you are taking 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 they may cause serotonin syndrome, a potentially life-threatening reaction to medicines. Symptoms of serotonin syndrome include disorientation, restlessness, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrolled muscle contractions, and diarrhea,
• if you are taking products containing St. John's Wort (Hypericum perforatum), as it may increase the risk of side effects.

Do not take almotriptan at the same time as medicines containing ergotamine, which may also be used to treat migraine. However, you can take these medicines one after the other, provided you leave a suitable 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.

Taking the medicine with food

The medicine can be taken with or without food. The medicine should be taken with a liquid (e.g., water).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
There are only limited data on the use of almotriptan in pregnant women.
The medicine should not be used during pregnancy, unless advised by a doctor who has carefully weighed the benefits and risks.
Caution should be exercised when using this medicine during breastfeeding. You should avoid breastfeeding for 24 hours after taking this medicine.

Driving and using machines

may cause drowsiness. While taking this medicine, do not drive or operate any tools or machines.

3. How to take the medicine

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
should only be used for the treatment of an ongoing migraine attack and not for the prevention of migraine attacks or headaches.
The medicine can only be used in patients with diagnosed migraine.
The medicine should not be used for migraine prevention.

Adults (18 to 65 years)

The recommended dose is one tablet (12.5 mg). The tablet should be taken as soon as possible after the onset of a migraine attack. 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 at 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) within 24 hours.
The tablet should be swallowed with a liquid (e.g., water). The tablet can be taken with or without food.
The medicine should be taken as soon as possible after the onset of a migraine attack, but it is also effective when taken at a later stage.
Severe kidney disease
If the patient has severe kidney disease, do not take more than one 12.5 mg tablet in 24 hours.

Consult a doctor or pharmacist and do not take the medicine if you have noticed:

• 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 a higher dose of the medicine than recommended

If you have taken too many tablets or if someone else or a child has taken the medicine, consult a doctor or pharmacist immediately.

Missing a dose of the medicine

Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with the medicine, immediately consult a doctor and do not take any more tablets of the medicine if you experience the following symptoms:

• allergic reactions (hypersensitivity reactions) or anaphylactic reactions (severe allergic reactions), including swelling of the lips, throat, or hands (angioedema), shortness of breath, wheezing, rash;
• if you experience chest pain, tightness in the chest or throat, or any other symptoms that may indicate a heart attack.

Other side effects:
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
• 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):

• seizure
• vision disturbances, blurred vision (vision 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 any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +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 the medicine

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance of the medicine is almotriptan. One tablet contains 12.5 mg of almotriptan (in the form of almotriptan succinate).
• Other ingredients (excipients) are:
• tablet core: microcrystalline cellulose, mannitol, sodium carboxymethylcellulose (type A), povidone K29-32, sodium stearyl fumarate,
• coating: hypromellose, titanium dioxide (E 171), macrogol 400, carnauba wax.

What the medicine looks like and contents of the pack

The medicine is a white, round, biconvex, film-coated tablet.
One pack of the medicine contains 2 or 6 film-coated tablets in OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box.

Marketing authorization holder

PHARMACEUTICAL COMPANY HASCO-LEK S.A.
51-131 Wroclaw, ul. Żmigrodzka 242 E
tel.: +48 71 352 95 22
fax: +48 71 352 76 36

Manufacturer/Importer

Chanelle Medical Unlimited Company
Dublin Road, H62 FH90 Loughrea
Ireland

Medicine information

tel.: (22) 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: