Almotriptan 12.5 Mg Film-Coated Tablets
Out of date information, search anotherteva UK Ref 231-30-50215-B LEA ALMOTRIPTAN 12.5mg FC TAB TUK <CHA Version: 1 15 July 2014
teva UK Ref 231-30-50215-B LEA ALMOTRIPTAN 12.5mg FC TAB TUK <CHA Version: 1 15 July 2014
ALMOTRIPTAN 12.5 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE PATIENT
Read all of 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 further questions, askyour doctor or pharmacist.
• This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• Ifyou getany side effects, talkto your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Almotriptan is and what it is used for
2. What you need to know before you take Almotriptan
3. Howto take Almotriptan
4. Possible side effects
5. Howto store Almotriptan
6. Contents of the pack and other information
O What Almotriptan is and what it is used for
Almotriptan is an antimigraine agent which belongs to a class of compounds known as selective serotonin receptor agonists.
Almotriptan is believed to reduce the inflammatory response associated with migraines by binding to the serotonin receptors in the brain (cranial) blood vessels and causing them to narrow.
Almotriptan is used to relieve headaches associated with migraine attacks with or without aura.
What you need to know before you take Almotriptan Do not take Almotriptan if you:
• are allergic to almotriptan or any of the ingredients of this medicine (listed in section 6) • have or have ever suffered from diseases that restrict the blood supply 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 resting • severe high blood pressure (severe hypertension)
• uncontrolled mild or moderate high blood pressure
• have had a stroke or experienced a reduction in the blood flowto the brain • have had obstruction of the large arteries in the arms or legs (peripheral vascular disease)
• are taking other medicines used to treat migraines including ergotamine, dihydroergotamine and methysergide or other serotonin agonists (e.g. sumatriptan)
• suffer from severe liver disease.
Warnings and precautions:
Talkto your doctor or pharmacist before taking Almotriptan:
• if your type of migraine has not been diagnosed • ifyou are allergic (hypersensitive) to antibacterial medicines mainly used for treatment of urinary tract infections (sulphonamides)
• if your headache symptoms are different from your usual attacks i.e. you have a noise in your ears or vertigo, you have short lived paralysis of one side of the body or paralysis of the
muscles that control eye movement or if you have any new symptoms
• if you are at risk of heart disease, this includes uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, clear family history of heart disease, postmenopausal females or males over the age of 40
• if you have mild to moderate liver disease
• if you suffer from severe kidney disease
• ifyou are over 65 years of age (as you are more likely to experience blood pressure increases)
• you are taking anti-depressants SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin noradrenaline reuptake inhibitors). Also see 'Other medicines and Almotriptan’ below.
It has been suggested that excessive use of an anti-migraine medicinal product can lead to daily chronic headache.
Children and adolescents
Children underthe age of 18 should nottake Almotriptan.
Elderly (over 65 years of age)
Ifyou are over 65 years of age you should speak to your doctor before using this medicinal product.
Other medicines and Almotriptan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Please tell your doctor if you:
• are taking medicines used to treat 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. The symptoms of serotonin syndrome include; confusion, restlessness, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrollable muscle twitches or diarrhoea
• are taking herbal St John’s Wort (Hypericum perforatum) as this may increase the likelihood of side effects.
Almotriptan should not be taken at the same time as ergotamine-containing medicines, which are also used to treat migraine. However, the medicines may be taken after one another, provided a suitable amount of time is left between taking each medicine:
• following use of almotriptan, it is advised to wait at least 6 hours before taking ergotamine
• following use of ergotamine, it is advised to wait at least 24 hours before taking almotriptan.
Pregnancy and breast-feeding Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Only very limited data is available for almotriptan in pregnant patients. Almotriptan should only be used during pregnancy if instructed by your doctor and only after they have carefully considered the benefits and risks.
Caution should be taken when using this medicine whilst breast-feeding. You should avoid breast-feeding for 24 hours after taking this medicine.
Driving and using machines
Almotriptan may cause drowsiness. Ifyou are affected, you should not drive or use any tools or machines.
o How to take Almotriptan
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Almotriptan should only be used to treat an actual migraine attackand not to prevent migraine attacks or headaches.
Adults (18-65 years old)
The usual dose is one 12.5 mg tablet which should betaken as early as possible afterthe onset of the migraine attack. If your migraine attack does not subside, do not take more than one tablet forthe same attack.
Ifyou experience a second migraine attack within 24 hours, a second 12.5 mg tablet can be taken but you must leave at least two hours between your first and second tablet.
The maximum daily dose is two (12.5 mg) tablets within 24 hours.
Tablet(s) should be swallowed with liquid (e.g. water) and can betaken with or without food.
You should take Almotriptan as soon as possible afterthe onset of the migraine, although it is still effective if taken at a later stage.
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 than you should
Ifyou accidentally take too many tablets, or if someone else ora child takes this medicine, talk to a doctor or pharmacist immediately.
If you forget to take Almotriptan
Try to take Almotriptan as you have been prescribed. Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
Possible side effects
Like all medicines, Almotriptan can cause side effects, although not everybody gets them.
If you experience the following side effects during treatment with Almotriptan, you should stop taking the medicine and contact your doctor or go to the hospital straight away:
Uncommon: may affect up to 1 in 100 people
• ifyou have chest pain, tightness in your chest or throat, or any other symptoms that resembles a heart attack.
Very rare: may affect up to 1 in 10,000 people
• severe chest, arm, neck or jaw pain (coronary vasospasm)
• heart attack (myocardial infarction).
Not known: frequency cannot be estimated from the available data
• allergic reactions (hypersensitivity reactions), including mouth, throat and hand water retention (oedema), serious allergic reaction causing swelling of the face and throat (angioedema)
• severe allergic reactions causing difficulty in breathing or dizziness (anaphylactic reactions).
In addition to the above, the following side effects have been reported:
Common: may affect up to 1 in 10 people
• dizziness
• sleepiness (somnolence)
• feeling sick (nausea)
• being sick (vomiting)
• tiredness.
Uncommon: may affect up to 1 in 100 people
• sensation of tingling, pricking or numbness of the skin (paraesthesia)
• headache
• ringing, roaring or clicking noise in the ears (tinnitus)
• awareness of your heartbeat (palpitations)
• diarrhoea
• discomfort after eating (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• feeling weak (asthenia).
Very rare: may affect up to 1 in 10,000 people
• increased heart rate (tachycardia).
Not known: frequency cannot be estimated from the available data
• convulsion (seizure)
• visual impairment, vision blurred (visual disorders may occur also during the migraine attack itself).
Ifyou getany side effects,talktoyourdoctoror pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Howto store Almotriptan
Keep this medicine out of the sight and reach of children.
Do not use Almotriptan after the expiry date which is stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Askyour pharmacist howto throw away medicines you no longer use. These measures will help protect the environment.
©Contents of the pack and other information
What Almotriptan Film-coated Tablets contain
The active substance is almotriptan.
Each film-coated tablet contains 12.5 mg almotriptan as almotriptan malate.
The other ingredients are:
Tablet core: mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate Type A, sodium stearyl fumarate.
Coating material: hypromellose (E464), titanium dioxide (E171), Macrogol 400, carnauba wax. What Almotriptan Film-coated Tablets look like and contents of the pack Almotriptan 12.5 mg Film-coated Tablets are available as a white to off white coloured, round, biconvex film-coated tablet.
Almotriptan 12.5 mg Film-coated Tablets are available in blister packs containing 2,3,4, 6,9,
12 and 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, United
Kingdom
Manufacturer
JSC Grindeks, 53 Krustpils street, Riga, LV-1057, Latvija
This leaflet was last revised in 07/2014
PL 00289/1898
TrJW71 50215-B
TEVA UK LIMITED 297 X 148
KR/Drugs/KTK/25/460/2001
PET002199-UK
LA9136