Almozen

Package Leaflet: Information for the Patient

Almozen, 12.5 mg, Coated Tablets

Almotriptan Malate

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your 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 pack and other information

1. What is Almozen and what is it used for

Almozen is a migraine treatment that belongs to a group of medicines called selective serotonin receptor agonists. Almozen 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. Almozen is used for relief of migraine headachewith or without aura.

2. Important information before taking Almozen

When Not to Take Almozen

• If you are allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have had a heart attack or have a history of heart disease that reduces blood flow to the heart, such as:
• heart attack,
• chest pain or discomfort that occurs during activity or stress,
• heart problems without chest pain,
• chest pain that occurs at rest,
• severe high blood pressure,
• uncontrolled mild or moderate high blood pressure.
• If you have had a stroke or have had a reduction in blood flow to the brain.
• If you have a blockage in the large blood vessels of the arms or legs (peripheral vascular disease).
• If you are taking other migraine treatments that contain ergotamine, dihydroergotamine, or methysergide, or other serotonin agonists (e.g., sumatriptan).
• If you have severeliver disease.

Warnings and Precautions

Before taking Almozen, discuss with your doctor or pharmacist:

• if your migraine has not been diagnosed.
• if you are allergic (hypersensitive) to antibacterial medicines, especially sulfonamides.
• if your headache symptoms are different from those usually experienced during migraine attacks, e.g., you hear sounds in your ears or experience dizziness, have transient paralysis of one side of the body or muscles controlling eye movements, or have other unusual symptoms.
• if you have risk factors for heart disease, such as high blood pressure, high cholesterol, obesity, diabetes, smoking, family history of heart disease, or are post-menopausal or over 40 years old.
• if you have mild to moderate liver disease.
• if you have severekidney disease.
• if you are over 65 years old (as you may be more prone to increased blood pressure).
• if you are 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 migraine treatments may lead to chronic headache.

Children and Adolescents

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

Elderly (Over 65 Years Old)

If you are over 65 years old, you should consult your doctor before taking this medicine.

Other Medicines and Almozen

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

Tell Your Doctor:

• if you 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. Symptoms of serotonin syndrome include confusion, agitation, fever, sweating, uncoordinated movements, or muscle twitching.
• if you are taking 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 between taking them. After taking almotriptan, wait at least 6 hours before taking ergotamine. After taking ergotamine, wait at least 24 hours before taking almotriptan.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is limited experience with the use of Almozen in pregnant women. Almotriptan should only be used during pregnancy if your doctor advises it and only after careful consideration of the benefits and risks. Caution should be exercised when taking this medicine during breastfeeding. You should avoid breastfeeding for 24 hours after taking this medicine.

Driving and Using Machines

Almozen may cause drowsiness. If this happens to you, do not drive or operate machinery.

3. How to Take Almozen

Almozen Should Only be Used to Treat a Migraine Attack, Not to Prevent Migraine Attacks or Headaches.

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Adults (18 to 65 Years Old)

The recommended dose is one 12.5 mg tablet, which should be taken as soon as possible after the migraine attack has started. If the migraine attack has not gone away, do not take more than one tablet for that attack. If you have another migraine attack within 24 hours, you can take a second tablet, provided you leave at least a 2-hour gap between the first and second tablets. The maximum dose in 24 hours is two 12.5 mg tablets. 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 migraine attack has started, but it is also effective if taken later. Severe kidney disease: If you have severe kidney disease, do not take more than one 12.5 mg tablet in 24 hours.

Taking More Than the Recommended Dose of Almozen

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

Missing a Dose of Almozen

Take Almozen as advised by your doctor. Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your 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)

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 (anaphylaxis)
• 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.

If you experience any of the following, contact your doctor immediately:

• chest pain, tightness in the chest or throat, or any other symptoms that may indicate a heart attack. Stop taking Almozen and contact your doctor immediately.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicines Monitoring, 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, e-mail: ndl@urpl.gov.pl. You can also report side effects to the marketing authorization holder or its representative in Poland. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Almozen

Keep this medicine out of the 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 stated. There are no special storage instructions for this medicine. Store in the original packaging to protect from moisture. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Other Information

What Almozen Contains

The active substance is almotriptan in a dose of 12.5 mg (as almotriptan malate). The other ingredients are:

• tablet core: mannitol, microcrystalline cellulose, povidone K 40, sodium carboxymethylcellulose (type A), sodium stearyl fumarate.
• tablet 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 not exceeding 6.2 mm. The tablets are packaged in cardboard boxes containing blisters of PVC/PVDC/Aluminum. Pack sizes: 2, 3, 6, 9, 12 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

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

For More Information on This Medicine, Including Its Name in Member States of the European Economic Area, Please Contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel: (22) 375 92 00

Date of Last Revision of the Leaflet: