ALMOTREX 12.5 mg Tabletki powlekane
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Treść ulotki
Almotrex 12.5 mg film-coated tablets
almotriptan
Read this leaflet carefully before you start 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 your pharmacist or your nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even
if they have the same symptoms as you, as it may be harmful. If
you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or your nurse. See section 4.
Contents of this leaflet
1. What Almotrex is and what it is used for
2. What you need to know before you take Almotrex
3. How to take Almotrex
4. Possible side effects
5. How to store Almotrex
6. Contents of the pack and other information
1. What Almotrex is and what it is used for
Almotrex is an anti-migraine medicine that belongs to a class of compounds known as
selective serotonin receptor agonists. Almotrex reduces the inflammatory response associated
with migraine by binding to serotonin receptors in the cerebral blood vessels (head),
causing them to constrict.
Almotrex is used to relieve headache associated with migraine attacks with or without aura.
2. What you need to know before taking Almotrex
Do not take Almotrex:
- If you are allergic to almotriptan or any of the excipients of this medicine (listed in section 6).
- If you have or have had diseases that reduce blood flow to the heart such as:
- myocardial infarction,
- chest pain or discomfort that usually occurs with physical activity or stress
- heart problems without pain
- chest pain at rest
- severe hypertension (very high blood pressure)
- mild or moderate uncontrolled hypertension.
- If you have had a stroke or a reduction in blood flow to the brain
- If you have had blockage of the large arteries of the arms or legs (peripheral vascular disease)
- If you have taken other medicines for migraine, including ergotamine, dihydroergotamine, or metisergide, other serotonin agonists (e.g. sumatriptan)
- If you suffer from severeliver disease
Warnings and precautions
Talk to your doctor, pharmacist or nurse before starting to take Almotrex,
- If you have not been diagnosed with the type of your migraine
- If you are allergic (hypersensitive) to antibacterial medicines commonly 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 your body or muscles that control eye movement, or if you experience any new symptoms
- If you have risk factors for heart disease, i.e. high and uncontrolled blood pressure, high cholesterol, obesity, diabetes, smoking, a clear family history of heart disease, or if you are post-menopausal or if you are a male over 40 years of age.
- 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 antidepressant SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors). See also “Other medicines and Almotrex”.
Excessive use of migraine medications can lead to chronic headache.
Children and adolescents
Children under 18 years of age should not take Almotrex.
Elderly (over 65 years)
If you are over 65 years of age, consult your doctor before taking this medicine.
Other medicines and Almotrex
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 may cause serotonin syndrome, a potentially dangerous reaction, which can be life-threatening. The symptoms of serotonin syndrome include confusion, restlessness, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle spasms or diarrhea.
- If you are taking preparations containing St John's Wort (Hypericum perforatum) as it may increase the possibility of side effects.
Almotrex 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 pass between each intake of
medicine.
- 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 you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Limited data are available on the use of almotriptan in pregnancy, therefore Almotrex should be
used in pregnancy only according to the doctor's instructions and only after carefully
considering the benefits and risks.
Use caution during breastfeeding; avoid breastfeeding for 24 hours after taking
this medicine.
Driving and operating machinery
Almotrex can cause drowsiness. If you feel drowsy, do not drive vehicles or operate
machinery.
3. How to take Almotrex
Almotrex must be taken only to treat an ongoing migraine attack and not to
prevent migraine or headache attacks.
Take this medicine following the instructions of your doctor exactly. If you have any doubts
you should consult your doctor or pharmacist.
Adults (18-65 years)
The recommended dose is one 12.5 mg tablet taken as soon as possible after the onset
of the migraine attack. If the migraine attack does not pass, do not take a second
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 pass between the first and second tablet.
The maximum daily dose is two 12.5 mg tablets within 24 hours.
The tablets should be taken with a liquid (e.g. water) and can be taken with or
without food.
Almotrex should be taken 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 within 24 hours.
If you take more Almotrex than you should
If you have accidentally taken too many Almotrex tablets or if someone else or a child
takes this medicine, consult your doctor or pharmacist immediately.
If you forget to take Almotrex
Try to take Almotrex as prescribed. Do not take a double dose to make up for the
forgotten tablet.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist or
the nurse.
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,
- drowsiness,
- nausea,
- vomiting,
- fatigue.
Uncommon side effects(may affect up to 1 in 100 people)
- sensation of tingling, pricking or numbness of the skin (paresthesia)
- headache
- ringing, noise or buzzing in the ears (tinnitus)
- strong heartbeat (palpitations)
- tightness in the throat
- diarrhea
- digestive problems (dyspepsia)
- dry mouth
- muscle pain (myalgia)
- skeletal pain
- chest pain
- weakness (asthenia).
Very rare side effects(may affect up to 1 in 10,000 people)
- spasm of the heart vessels (coronary vasospasm)
- heart attack (myocardial infarction)
- acceleration of the heartbeat (tachycardia)
Frequency not known(the 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)
- convulsions
- impaired vision, blurred vision (visual disturbances may also occur during a migraine attack)
- intestinal vasospasm, which can cause damage to the intestine (intestinal ischemia). Abdominal pain and bloody diarrhea may occur.
During treatment with Almotrex, immediately inform your doctor:
- if you have chest pain, a feeling of pressure in the chest or throat, or any other symptoms that may seem like a heart attack. Immediately inform your doctor and do not take Almotrex 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
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Almotrex
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the blister and the packaging
after “Exp”. The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Almotrex contains
The active ingredient is almotriptan 12.5 mg (as D,L-hydrogen maleate).
The other ingredients are:
Tablet core: mannitol (E-421), microcrystalline cellulose, povidone, sodium glycolate starch,
sodium stearylfumarate
Coating: hypromellose, titanium dioxide (E-171), Macrogol 400, carnauba wax
Ink: hypromellose, propylene glycol, indigo carmine (E-132)
Description of the appearance of Almotrex and contents of the pack
Almotrex is available as white, round, biconvex, film-coated tablets, with a
blue A embossed on one side.
Almotrex is available in blister packs of 3, 4, 6, 9 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
ALMIRALL S.A.
General Mitre 151,
08022 BARCELONA – Spain
Manufacturer
Industrias Farmaceuticas Almirall S.L., Ctra Nacional II, Km 593, 08740 Sant Andreu de la
Barca (Barcelona) – Spain
This medicinal product is authorised in the Member States of the European Economic Area
under the following designations:
Germany Amignul 12.5 mg Filmtablets
Italy Almotrex 12.5 mg film-coated tablets
Spain Amignul 12.5 mg film-coated tablets
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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 ALMOTREXPostać 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 receptyPostać farmaceutyczna: Film-coated tablet, 12.5 MGSubstancja czynna: almotriptanProducent: TEVA ITALIA S.R.L.Wymaga recepty
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ALMOTREX wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w ALMOTREX jest almotriptan. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
ALMOTREX jest produkowany przez ALMIRALL S.A.. 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 ALMOTREX 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 ALMOTREX 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. ALMOTRIPTAN DOK JENERIKI, ALMOTRIPTAN MYLAN, ALMOTRIPTAN TEVA ITALIA. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
