ALMOTRIPTAN 12.5 mg Tabletki powlekane
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Jak stosować ALMOTRIPTAN TSENTIVA
Treść ulotki
Almotriptan Zentiva 12,5 mg film-coated tablets
Generic medicine
Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Almotriptan Zentiva and what it is used for
Almotriptan Zentiva is an anti-migraine medication that belongs to a class of compounds known as
selective serotonin receptor agonists. It is believed that Almotriptan Zentiva reduces 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 attackswith 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 normally occurs with activity or stress,
- heart problems without pain,
- chest pain that occurs when you are at rest,
- severe hypertension (very high blood pressure),
- uncontrolled mild or moderate hypertension.
- if you have had a stroke or a reduction in blood flow to the brain.
- if you have had a blockage of the major arteries in the arms or legs (peripheral vascular disease).
- if you are taking other medicines for the treatment of migraine, including ergotamine, dihydroergotamine and metisergide or other serotonin agonists (e.g. sumatriptan).
- if you suffer from severeliver disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking Almotriptan Zentiva
- if you have not been diagnosed with the type of migraine you have.
- if you are allergic (hypersensitive) to antibacterial medicines generally used for the treatment of urinary tract infections (sulphonamides).
- if the symptoms of your headache are different from your usual attacks, for example if you feel noise in your ears or have dizziness, if you have brief paralysis on one side of the body or of the muscles that control 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 clear family history of heart disease, postmenopausal women or men over the age of 40.
- if you have mild or moderate liver disease.
- if you have severekidney disease.
- if you are over 65 years of age (because you are more likely to have increases in blood pressure).
- if you are taking SSRI (selective serotonin reuptake inhibitors) or SNRI (serotonin and noradrenaline reuptake inhibitors) antidepressants. See also “Other medicines and Almotriptan Zentiva” below.
It has been suggested that excessive use of a migraine medicine can lead to chronic daily headache.
Children and adolescents
Children under the age of 18 should not take Almotriptan Zentiva.
Elderly (over 65 years)
If you are over 65 years old, 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 medicine.
Tell your doctor:
- if you are taking medicines to treat depression such as monoamine oxidase inhibitors (e.g. moclobemide), selective serotonin reuptake inhibitors (e.g. fluoxetine) or serotonin and noradrenaline reuptake inhibitors (e.g. venlafaxine) which can cause serotonin syndrome, a potentially life-threatening drug reaction. Symptoms of serotonin syndrome include confusion, restlessness, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle spasms or diarrhoea;
- if you are taking preparations containing St John's Wort ( Hypericum perforatum) as it may increase the possibility of side effects.
Almotriptan should not be taken at the same time as medicines containing ergotamine, which are also
used for the treatment of migraine. However, these medicines can be taken one after the other:
allowing an adequate period of time to elapse between each dose of medicine.
- Following the use of almotriptan, it is recommended to wait at least 6 hours before taking ergotamine.
- Following the use of ergotamine, it is recommended to wait at least 24 hours before taking almotriptan.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Only very limited data are available for Almotriptan Zentiva in pregnant patients.
Almotriptan should only be used during pregnancy on specific indication of the doctor and only after
carefully evaluating the benefits and risks.
Caution should be exercised when using this medicine during breastfeeding. After taking this
medicine, breastfeeding should be avoided for 24 hours.
Driving and operating machinery
Almotriptan Zentiva can cause drowsiness. If this is the case, you should not drive vehicles or operate
tools or machinery.
3. How to take Almotriptan Zentiva
Almotriptan Zentiva must be taken only to treat an ongoing migraine attack and not to
prevent migraine attacks or headaches.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Adults (18-65 years)
The recommended dose is one 12.5 mg tablet to be taken as soon as possible after
the onset of the migraine attack. If the migraine attack does not subside, you should not take more than one
tablet for the same attack.
If you have a second migraine attack within 24 hours, a second 12.5 mg tablet may be taken,
but at least two hoursmust elapse between the first and second tablet.
The maximum daily dose is two tablets (12.5 mg) within 24 hours.
The tablets should be swallowed with a liquid (e.g. water) and can be taken with or
without food.
You should take Almotriptan Zentiva as soon as possible after the onset of the migraine, although it is
also effective when taken at a more advanced stage of the attack.
Severe kidney disease
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 another person or a child takes this
medicine, consult a doctor or pharmacist immediately.
If you forget to take Almotriptan Zentiva
Try to take Almotriptan Zentiva as it has been prescribed to you. Do not take a double dose to
compensate for the forgotten tablet.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects(may affect up to 1 in 10 people):
- dizziness
- somnolence (drowsiness)
- fatigue
- nausea
- vomiting.
Uncommon side effects(may affect up to 1 in 100 people):
- sensation of tingling, prickling or numbness of the skin (paresthesia)
- headache
- ringing, roaring or clicking in the ears (tinnitus)
- strong heartbeat (palpitations)
- tightness in the throat
- diarrhoea
- discomfort during digestion (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 heart blood vessels (coronary vasospasm)
- heart attack (myocardial infarction)
- increased heart rate (tachycardia). Frequency not known(the frequency cannot be estimated from available data):
- allergic reactions (hypersensitivity reactions), including swelling of the mouth, throat or hand (angioedema)
- severe allergic reactions (anaphylactic reactions)
- convulsions
- impaired vision, blurred vision (visual disturbances may also occur during a migraine attack)
- intestinal vasospasms that can lead to intestinal damage (intestinal ischemia). You may experience abdominal pain and have diarrhoea with blood loss.
During treatment with Almotriptan Zentiva, immediately inform your doctor:
- if you experience chest pain, a feeling of pressure in the chest or throat, or any other symptom that may seem like a heart attack. Immediately inform your doctor and do not take Almotriptan Zentiva tablets anymore.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 particular storage temperature.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Almotriptan Zentiva contains
The active ingredient is almotriptan 12.5 mg (as almotriptan maleate).
The other ingredients are:
Tablet core: mannitol (E 421), microcrystalline cellulose, povidone, sodium glycolate starch
Type A, sodium stearylfumarate.
Film coating: sepifilm 752 white [hypromellose, microcrystalline cellulose, macrogol stearate 2000,
titanium dioxide (E 171)].
Description of the appearance of Almotriptan Zentiva and contents of the pack
Almotriptan Zentiva are film-coated tablets, round, biconvex, white or almost white in colour,
the maximum diameter is 6.2 mm. The packs contain PVC/PVDC/aluminium blisters.
Packs: 2, 3, 6, 9, 12 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia Srl - Viale L. Bodio n. 37/b, 20158 Milano
Manufacturer
Saneca Pharmaceuticals a.s.- Nitrianska 100, 920 27 Hlohovec, Slovak Republic
This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
| Country | Local medicinal product name |
| Czech Republic | Almozen 12.5 mg coated tablets |
| Poland | a Almozen |
| Latvia | n Almotriptan Zentiva 12.5 mg film-coated tablets |
| Lithuania | a Almotriptan Zentiva 12.5 mg film-coated tablets |
| Italy | i Almotriptan Zentiva |
| France | l Almotriptan Zentiva 12.5 mg film-coated tablet |
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- Kraj rejestracji
- Postać farmaceutycznaFilm-coated tablet, 12.5 MG
- Kod ATCN02CC05
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki ALMOTRIPTAN TSENTIVAPostać farmaceutyczna: Film-coated tablet, 12,5 MGSubstancja czynna: almotriptanProducent: ALMIRALL S.A.Wymaga receptyPostać farmaceutyczna: Film-coated tablet, 12.5 MGSubstancja czynna: almotriptanProducent: DOC GENERICI SRLWymaga receptyPostać farmaceutyczna: Film-coated tablet, 12.5 MGSubstancja czynna: almotriptanProducent: MYLAN S.P.A.Wymaga recepty
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ALMOTRIPTAN TSENTIVA wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ALMOTRIPTAN TSENTIVA jest almotriptan. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ALMOTRIPTAN TSENTIVA jest produkowany przez ZENTIVA ITALIA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie ALMOTRIPTAN TSENTIVA jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić ALMOTRIPTAN TSENTIVA w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (almotriptan) to m.in. ALMOTREX, ALMOTRIPTAN DOK JENERIKI, ALMOTRIPTAN MYLAN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
