ALMOTRIPTAN ZENTIVA

Package leaflet: Information for the user

Almotriptan Zentiva 12.5 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Almotriptan Zentiva is and what it is used for
2. What you need to know before taking Almotriptan Zentiva
3. How to take Almotriptan Zentiva
4. Possible side effects
5. How to store Almotriptan Zentiva
6. Contents of the pack and other information

1. What Almotriptan Zentiva is and what it is used for

Almotriptan Zentiva is a migraine medicine that belongs to a class of compounds known as
selective serotonin receptor agonists. Almotriptan Zentiva is believed to reduce the inflammatory response
associated with migraine by binding to serotonin receptors in the cerebral blood vessels (head), causing them to constrict.
Almotriptan Zentiva is used to relieve headache associated with migraine attacks with or without aura.

2. What you need to know before taking Almotriptan Zentiva

Do not take Almotriptan Zentiva

• if you are allergic to almotriptan or to any of the other ingredients of this medicine (listed in section 6).
• if you have or have had diseases that reduce blood flow to the heart such as:
• heart attack,
• chest pain or discomfort that usually occurs during physical activity or stress,
• heart problems without pain,
• chest pain occurring at rest,
• severe hypertension (very high blood pressure),
• uncontrolled mild or moderate hypertension.
• if you have had a stroke or reduced blood flow to the brain.
• if you have had blockage of the large arteries in the arms or legs (peripheral vascular disease).
• if you are taking other medicines for migraine treatment, including ergotamine, dihydroergotamine, methysergide, or other serotonin agonists (e.g. sumatriptan).
• if you have severe liver disease.

Warnings and precautions
Talk to your doctor or pharmacist before taking Almotriptan Zentiva

• if you have not been diagnosed with migraine headache.
• if you are allergic (hypersensitive) to antibacterial medicines commonly used to treat urinary tract infections (sulfonamides).
• if your headache symptoms are different from your usual attacks, for example if you hear noises in your ears or have dizziness, brief paralysis on one side of the body, or muscle problems affecting eye movement, or if you experience any new symptoms.
• if you are at risk of heart disease, including uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, a strong family history of heart disease, post-menopausal women, or men over 40 years of age.
• if you have mild or moderate liver disease.
• if you have severe kidney disease.
• if you are over 65 years of age (because high blood pressure is more likely).
• if you are taking SSRI (selective serotonin reuptake inhibitors) or SNRI (serotonin-noradrenaline reuptake inhibitors) antidepressants. See also “Other medicines and Almotriptan Zentiva” below.

It has been suggested that excessive use of migraine medication may lead to chronic daily headache.
Children and adolescents
Children under 18 years of age must not take Almotriptan Zentiva.
Elderly (over 65 years)
If you are over 65 years of age, consult your doctor before taking this medicine.
Other medicines and Almotriptan Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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-noradrenaline reuptake inhibitors (e.g. venlafaxine), as these may cause serotonin syndrome, a potentially life-threatening drug reaction. Symptoms of serotonin syndrome include confusion, restlessness, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle spasms, or diarrhea;
• if you are taking herbal preparations containing St. John’s Wort (Hypericum perforatum), as this may increase the likelihood of side effects.

Almotriptan must not be taken at the same time as medicines containing ergotamine, which are also used to treat migraine. However, these medicines may be taken one after the other, provided an adequate time interval is allowed between each dose.

• After using almotriptan, wait at least 6 hours before taking ergotamine.
• After using ergotamine, wait at least 24 hours before taking almotriptan.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Only very limited data are available on Almotriptan Zentiva in pregnant patients.
Almotriptan should be used during pregnancy only on specific medical advice and only after careful evaluation of benefits and risks.
Caution should be exercised when using this medicine during breastfeeding. Breastfeeding should be avoided for 24 hours after taking this medicine.

Driving and using machines
Almotriptan Zentiva may cause drowsiness. If this applies to you, do not drive or operate tools or machinery.

3. How to take Almotriptan Zentiva

Almotriptan Zentiva should only be taken to treat an acute migraine attack and not to
prevent migraine attacks or headaches.
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults (18–65 years of age)
The recommended dose is one 12.5 mg tablet, 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 for the same attack.
If you experience a second migraine attack within 24 hours, a second 12.5 mg tablet may be taken, but at least two hours must elapse between the first and second tablet.
The maximum daily dose is two tablets (12.5 mg each) within 24 hours.
The tablets should be swallowed with a liquid (e.g. water) and may be taken with or without food.
You should take Almotriptan Zentiva as soon as possible after the onset of migraine, although it remains effective even when taken at a later stage of the attack.
Severe renal impairment
If you have severe kidney disease, do not take more than one 12.5 mg tablet every 24 hours.
If you take more Almotriptan Zentiva than you should
If you have accidentally taken too many tablets, or if someone else or a child has taken this medicine, contact a doctor or pharmacist immediately.
If you forget to take Almotriptan Zentiva
Try to take Almotriptan Zentiva as prescribed. Do not take a double dose to make up for a missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• dizziness
• drowsiness (somnolence)
• fatigue
• nausea
• vomiting

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

• tingling, prickling or numbness of the skin (paraesthesia)
• headache
• ringing, buzzing or clicking noise in the ears (tinnitus)
• rapid heartbeat (palpitations)
• throat tightness
• diarrhoea
• digestive discomfort (dyspepsia), 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):

• spasm of the 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 mouth, throat or hand (angioedema)
• severe allergic reactions (anaphylactic reactions)
• seizures
• visual disturbances, blurred vision (visual disturbances may also occur during a migraine attack)
• intestinal vasospasm which may lead to intestinal damage (intestinal ischaemia). You may experience abdominal pain and have diarrhoea with blood loss.

During treatment with Almotriptan Zentiva, inform your doctor immediately:

• if you have chest pain, a feeling of pressure in the chest or throat, or any other symptom that might seem like a heart attack. Inform your doctor immediately and do not take any more Almotriptan Zentiva tablets.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Almotriptan Zentiva

Keep this medicine out of the sight and reach of children.
Do not use Almotriptan Zentiva after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Almotriptan Zentiva contains
The active substance is almotriptan 12.5 mg (as almotriptan maleate).
The other components are:
Tablet core: mannitol (E 421), microcrystalline cellulose, povidone, sodium glycolate starch
Type A, sodium stearyl fumarate.
Coating film: sepifilm 752 white [hypromellose, microcrystalline cellulose, polyglycol stearate 2000,
titanium dioxide (E 171)].
Description of the appearance of Almotriptan Zentiva and package contents
Almotriptan Zentiva are white or almost white, round, biconvex, film-coated tablets,
with a maximum diameter of 6.2 mm. The packages contain PVC/PVDC/aluminium blisters.
Pack sizes: 2, 3, 6, 9, 12 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia Srl - Viale L. Bodio No. 37/b, 20158 Milan, Italy
Manufacturer
Saneca Pharmaceuticals a.s. - Nitrianska 100, 920 27 Hlohovec, Slovak Republic
This medicinal product is authorized in the European Economic Area countries
under the following names: