Almozen

Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Almozen (Almotriptan Zentiva), 12.5 mg, film-coated tablets
Almotriptanum
Almozen and Almotriptan Zentiva are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Almozen is and what it is 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 Almozen is and what it is used for

Almozen is a medicine for migraine, belonging to a group of medicines called selective serotonin receptor agonists. Almozen binds to serotonin receptors in the blood vessels in the brain (cranial vessels), causing them to constrict, thereby reducing the inflammatory response associated with migraine.
Almozen is used for the treatment of headache associated with migraine attacks, with or without aura.

2. Important information before using Almozen

When not to take Almozen

• If the patient is allergic to almotriptan or to any of the other ingredients of this medicine (listed in section 6).
• If the patient currently has or has ever had a disease that reduces blood flow to the heart, such as:
  • heart attack,
  • chest pain or discomfort usually occurring during physical activity or stress,
  • heart problems without accompanying chest pain,
  • chest pain occurring at rest,
  • severe hypertension (severe 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 the 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).
• If the patient has severe liver disease.

Warnings and precautions
Before taking Almozen, discuss with your doctor or pharmacist:

• if the type of headache has not been diagnosed as migraine.
• if the patient is allergic (hypersensitive) to antibacterial medicines, especially those used to treat urinary tract infections (sulfonamides).
• if headache symptoms are different from those usually experienced during migraine attacks, e.g. if the patient experiences noises in the ears or dizziness, temporary paralysis on one side of the body, or muscle weakness affecting eye movements, or other new symptoms.
• if the patient has risk factors for heart disease, such as: 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 to moderate liver disease.
• if the patient has severe kidney disease.
• if the patient is over 65 years of age (because they are at higher risk of increased blood pressure).
• if the patient is concurrently taking antidepressant SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). See section below "Other medicines and Almozen".

It is believed that excessive use of 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 of age)
If the patient is over 65 years of age, they should consult their doctor before using this medicine.

Other medicines and Almozen
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Tell your doctor:

• if the patient is taking 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), because these may cause serotonin syndrome, a potentially life-threatening drug reaction. Symptoms of serotonin syndrome include confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, involuntary muscle contractions, and diarrhoea.
• if the patient is taking St John's wort (Hypericum perforatum), as this may increase the likelihood of adverse effects.

Do not take almotriptan at the same time as medicines containing ergotamine, which may also be used to treat migraine. However, these medicines may be used one after another, provided an appropriate time interval is observed between doses.

• After taking almotriptan, a minimum interval of 6 hours is recommended before taking ergotamine.
• After taking ergotamine, a minimum interval of 24 hours is recommended before taking almotriptan.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Only limited data are available on the use of Almozen in pregnant women.
Almotriptan should be used during pregnancy only if prescribed by a doctor and only after careful consideration of benefits and risks.
Caution should be exercised when using this medicine during breastfeeding. The patient should avoid breastfeeding for 24 hours after taking this medicine.

Driving and operating machinery
Almozen may cause drowsiness.
If this affects the patient, they should not drive or operate any tools or machinery.

3. How to use Almozen

Almozen should only be used to treat an acute migraine attack and not for the prevention of migraine attacks or headaches.
This medicine should always be used exactly as recommended by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Adults (aged 18 to 65 years)
The recommended dose is one 12.5 mg tablet, taken as early 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 another migraine attack occurs within 24 hours, a second 12.5 mg tablet 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 (12.5 mg) within 24 hours.
The tablet(s) should be swallowed with liquid (e.g. water). The tablet(s) may be taken with or without food.
Almozen should be taken as early as possible after the onset of a migraine attack; however, the medicine 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 per 24 hours.
Taking more Almozen than recommended
If the patient accidentally takes too many tablets, or if someone else (especially a child) takes the medicine, seek immediate advice from a doctor or pharmacist.
If you miss a dose of Almozen
Take Almozen exactly as prescribed by your doctor. Do not take a double dose to make up for a missed dose.
If you have any further questions about 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.

Common adverse effects (may affect up to 1 in 10 people):

• dizziness
• drowsiness
• fatigue
• nausea
• vomiting

Uncommon adverse effects (may affect up to 1 in 100 people):

• tingling, pricking, or numbness sensations (paraesthesia)
• headache
• ringing, buzzing, or crackling sounds in the ears (tinnitus)
• irregular heartbeat (palpitations)
• sensation of tightness in the throat
• diarrhoea
• indigestion, dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling of weakness (asthenia)

Very rare adverse effects (may affect up to 1 in 10,000 people):

• constriction of blood vessels in the heart (coronary vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (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
• visual disturbances, blurred vision (visual disturbances may also occur during a migraine attack itself)
• constriction of blood vessels in the intestines, which may lead to intestinal damage (intestinal ischaemia). This may cause abdominal pain and bloody diarrhoea.

During treatment with Almozen, seek immediate medical advice:

• if the patient experiences chest pain, chest tightness, or throat tightness, or any other symptoms which may indicate a heart attack. Immediate medical attention must be sought and further doses of Almozen tablets must not be taken.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Almozen

Keep this 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 stated month.
No special temperature storage conditions are required.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Almozen contains
The active substance is almotriptan, 12.5 mg (as almotriptan hemifumarate).
The other ingredients are:

• tablet core: mannitol, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), sodium stearyl fumarate.
• tablet coating: Sepifilm 752 White [hypromellose, microcrystalline cellulose, polyglycolized glycerides 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.
Carton boxes containing blisters made of PVC/PVDC/Aluminium foil.
Pack sizes: 3, 6, 9, and 12 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the parallel importer.
Marketing Authorisation Holder in France, country of export:
Zentiva France
35, rue du Val de Marne, 75013 Paris, France
Manufacturer:
Saneca Pharmaceuticals A.S.
Nitrianska 100, 920 27 Hlohovec, Slovakia
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
French Marketing Authorisation numbers, country of export: 34009 300 286 3 6
34009 300 286 4 3
34009 300 286 5 0
34009 300 286 6 7
Parallel import authorisation number: 225/24