ALMOZEN 12.5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
   1. 5 mg, coated tablets
   2. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   3. Table of contents of the leaflet:
3. What is Almozen and what is it used for
4. Important information before taking Almozen
   1. When not to take Almozen
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients (over 65 years)
   5. Other medicines and Almozen
   6. The patient should tell their doctor:
   7. Pregnancy and breastfeeding
   8. Driving and using machines
5. How to take Almozen
   1. Almozen should only be used to treat a current migraine attack, and not to prevent migraine attacks or headaches.
   2. Adults (18 to 65 years)
   3. Taking more than the recommended dose of Almozen
   4. Missing a dose of Almozen
6. Possible side effects
   1. Reporting side effects
   2. How to store Almozen
7. Contents of the packaging and other information
   1. What Almozen contains
   2. What Almozen looks like and contents of the pack
   3. Marketing authorization holder in France, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 20/23 Date of leaflet approval: 14.02.2023

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Almozen(Almotriptan Zentiva)

12.5 mg, coated tablets

Almotriptanum
Almozen and Almotriptan Zentiva are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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.

Table of contents of the leaflet:

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

1. What is Almozen and what is it used for

Almozen is an anti-migraine medicine that belongs to a group of medicines called selective serotonin receptor agonists. Almozen 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.
Almozen is used for the relief of migraine headachewith or without aura.

2. Important information before taking Almozen

When not to take Almozen

• 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,
• chest pain or discomfort that usually occurs during activity or stress,
• heart problems without accompanying chest pain,
• chest pain that occurs at rest,
• severe high blood pressure (severe hypertension),
• 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 for migraine that contain ergotamine, dihydroergotamine, or methysergide, or other serotonin agonist medicines (e.g., sumatriptan).
• If the patient has severeliver disease.

Warnings and precautions

Before starting to take Almozen, the patient should discuss it with their doctor or pharmacist:

• if the type of migraine has not been diagnosed.
• if the patient is allergic (hypersensitive) to antibacterial medicines, especially those used to treat urinary tract infections (sulfonamides).
• if the symptoms associated with 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: 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 severekidney disease.
• if the patient is over 65 years old (as they are at greater risk of increased blood pressure).
• if the patient is taking antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and norepinephrine reuptake inhibitors). See below "Other medicines and Almozen".

It is thought that overuse of anti-migraine medicines may lead to chronic headache.

Children and adolescents

Almozen 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 consult their doctor before taking this medicine.

Other medicines and Almozen

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

The patient should tell their doctor:

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

The patient should not take almotriptan at the same time as medicines that contain ergotamine, which may also be used to treat migraine. However, these medicines can be used one after the other, provided that an appropriate time interval is observed 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.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Only limited data are available on the use of Almozen in pregnant women.
Almotriptan should only be used during pregnancy if the doctor recommends it and after careful consideration of the benefits and risks.
Cautious use of this medicine is recommended during breastfeeding. The patient should avoid breastfeeding for 24 hours after taking this medicine.

Driving and using machines

Almozen may cause drowsiness.
If this affects the patient, they should not drive or operate any tools or machines.

3. How to take Almozen

Almozen should only be used to treat a current migraine attack, and not to prevent migraine attacks or headaches.

This medicine should always be taken exactly as prescribed by the doctor.
In case of doubt, the patient should consult their doctor or pharmacist.

Adults (18 to 65 years)

The recommended dose is one 12.5 mg tablet, which should be taken as soon as possible after the onset of a migraine attack. If the migraine attack does not subside, the patient should not take more than one tablet during the same attack.
If the patient experiences another migraine attack within 24 hours, they can take a second 12.5 mg tablet, provided that they wait at least 2 hours between the first and second tablets.
The maximum daily dose is two 12.5 mg tablets in 24 hours.
The tablet(s) should be swallowed with a drink of water. The tablet(s) can be taken with or without food.
Almozen 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, they should not take more than one 12.5 mg tablet in 24 hours.

Taking more than the recommended dose of Almozen

If the patient accidentally takes too many tablets or if someone else takes this medicine, they should immediately consult their doctor or pharmacist.

Missing a dose of Almozen

The patient should take Almozen as prescribed by their doctor. They should not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Almozen can cause side effects, although not everybody gets them.
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)

Very 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
• vision disturbances, blurred vision (vision 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

The patient should immediately consult their doctor:

• if they experience chest pain, tightness in the chest or throat, or any other symptoms that may indicate a heart attack. The patient should immediately consult their doctor and not take any more Almozen tablets

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

• 5.

How to store Almozen

The medicine should be stored 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 storage precautions for the medicinal product.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Almozen contains

The active substance is almotriptan in a dose of 12.5 mg, in the form of almotriptan succinate.
The other ingredients are:

• tablet core: mannitol (E 421), microcrystalline cellulose, povidone, sodium carboxymethyl cellulose (type A), sodium stearyl fumarate.
• coating: Sepifilm 752 White: hypromellose, microcrystalline cellulose, macrogol stearate 2000, titanium dioxide (E 171).

What Almozen looks like and contents of the pack

Almozen is a white to off-white, round, biconvex, film-coated tablet with a diameter of not more than 6.2 mm. The cardboard boxes contain PVC/PVDC/Aluminum blisters.
Pack size: 3 or 6 tablets.
For more detailed information, the patient should consult the marketing authorization holder or the parallel importer.

Marketing authorization holder in France, the country of export:

Zentiva France
35 Rue du Val de Marne
75013 Paris, France

Manufacturer:

Saneca Pharmaceuticals a.s.
Nitrianska 100, 920 27 Hlohovec
Slovak Republic

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in France, the country of export:34009 300 286 6 7

Parallel import authorization number: 20/23 Date of leaflet approval: 14.02.2023

[Information about the trademark]