Almogran 12.5mg Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine because it contains important information for you.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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Almogran 12.5mg Tablets but will be referred to as Almogran throughout this leaflet.
What is in this leaflet:
1. What Almogran is and what it is used for
2. What you need to know before you take Almogran
3. How to take Almogran
4. Possible side effects
5. How to store Almogran
6. Contents of the pack and other information
1. What Almogran is and what it is used for
Almogran is an anti-migraine agent which belongs to a class of compounds known as selective serotonin receptor agonists. Almogran 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.
Almogran is used to relieve headaches associated with migraine attacks with or without aura.
2. What you need to know before you take Almogran
Do not take Almogran
- if you are allergic to almotriptan or any of the ingredients of this medicine (listed in section 6).
- if you 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
Package leaflet: Information for the user
Almogran® 12.5mg Tablets
almotriptan (as almotriptan D, L- hydrogen malate)
• heart problems without pain
• chest pain that occurs when you are resting
• severe hypertension (severe high blood pressure)
• uncontrolled mild or moderate high blood pressure.
- if you have had a stroke or experienced a reduction in the blood flow to the brain
- if you have had obstruction of the large arteries in the arms or legs (peripheral vascular disease)
- if you are taking other medicines used to treat migraines
- including ergotamine, dihydroergotamine and methysergide or other serotonin agonists (e.g. sumatriptan)
- if you suffer from severe liver disease
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Almogran:
- if your type of migraine has not been diagnosed
- if you are allergic (hypersensitive) to anti-bacterial 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
- if you are over 65 years of age (as you are more likely to experience blood pressure increases)
- If you are taking anti-depressants SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin nor adrenaline reuptake inhibitors). Also see 'Other medicines and Almogran'.
It has been suggested that excessive use of an anti-migraine medicinal product can lead to daily chronic headache.
Children and Adolescents
Children under the age of 18 should not take Almogran.
Elderly (over 65 years of age)
If you are over 65 years of age you should speak to your doctor before using this medicinal product.
Other medicines and Almogran
T ell 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 nor adrenaline 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
- if you 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
If you 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. Almogran 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
Almogran may cause drowsiness. If you are affected, you should not drive or use any tools or machines.
3. How to take Almogran
Almogran should only be used to treat an actual migraine attack and not to prevent migraine attacks or headaches.
Always take Almogran exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults (18-65 years old)
The usual dose is one 12.5mg tablet which should be taken as early as possible after the onset of the migraine attack. If your 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 12.5mg tablet can be taken but you must leave at least two hours between your first and second tablet.
The maximum daily dose is two (12.5mg) tablets within 24 hours.
Tablet should be swallowed with liquid (e.g. water) and can be taken with or without food.
You should take Almogran as soon as possible after the 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 12.5mg tablet every 24 hours.
If you take more Almogran than you should
If you accidentally take too many tablets, or if someone else or a child takes this medicine, talk to a doctor or pharmacist immediately.
If you forget to take Almogran
T ry to take Almogran 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 product, ask 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 (1 to 10 users in 100):
• dizziness
• sleepiness (somnolence)
• nausea
• vomiting
• tiredness
Uncommon side effects (1 to 10 users in 1,000):
• sensation of tingling, pricking or numbness of the skin (paraesthesia)
• headache
• ringing, roaring or clicking noise in the ears (tinnitus)
• heart pounding (palpitations)
• tightening of the throat
• diarrhoea
• discomfort when digesting food (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling weak (asthenia)
Very rare side effects (less than 1 user in 10,000):
• spasm of the heart blood vessels (coronary vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (tachycardia)
Frequency unknown (frequency cannot be estimated from the available data):
• allergic reactions (hypersensitivity reactions), including mouth, throat or hand oedema (angioedema)
• severe allergic reactions (anaphylactic reactions)
• convulsion (seizure)
• visual impairment, vision blurred (visual disorders may also occur during a migraine attack itself)
During treatment with Almogran, tell your doctor straight
away:
• if you have chest pain, tightness in your chest or throat, or any other symptoms that resembles a heart attack. Please tell your doctor straight away and do not take any more Almogran.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Almogran
Keep out of the sight and reach of children
There are no special storage instructions.
Do not use after the expiry date stated on the box and packaging label after 'Exp'. The expiry date refers to the last day of that month.
Do not dispose of medicines in household rubbish. Any unused tablets should be returned to a pharmacist who will dispose of them properly.
6. Contents of the pack and other information What Almogran contains
Each film-coated tablet contains 12.5mg of the active substance almotriptan (as D, L-hydrogen malate).
Almogran also contains the following ingredients:
Tablet core: mannitol, microcrystalline cellulose, povidone, sodium carboxymethyl starch and sodium stearyl fumarate.
Coating material: hypromellose, titanium dioxide (E171), macrogol 400 and carnauba wax.
Printing ink: hypromellose, propylene glycol, indigo carmine (E132).
What Almogran looks like and contents of the pack
Almogran are available as white, circular, biconvex film-coated tablets with a blue A printed on one side for oral use.
Almogran are available in aluminium blister packs of 6 tablets.
Manufactured by: Almirall Prodesfarma SA, 08022 Barcelona, Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Almogran® 12.5mg Tablets; POM"
PL: 18799/1153 -
Leaflet date: 01.04.2015
Almogran is a registered trademark of Lundbeck Limited
Package leaflet: Information for the user
Almotriptan 12.5mg Tablets
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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Almotriptan 12.5mg Tablets but will be referred to as Almotriptan throughout this leaflet.
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. How to take Almotriptan
4. Possible side effects
5. How to store Almotriptan
6. Contents of the pack and other information
1. What Almotriptan is and what it is used for
Almotriptan is an anti-migraine 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.
2. 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).
- if you 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 hypertension (severe high blood pressure)
• uncontrolled mild or moderate high blood pressure.
- if you have had a stroke or experienced a reduction in the blood flow to the brain
- if you have had obstruction of the large arteries in the arms or legs (peripheral vascular disease)
- if you are taking other medicines used to treat migraines
- including ergotamine, dihydroergotamine and methysergide or other serotonin agonists (e.g. sumatriptan)
- if you suffer from severe liver disease
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Almotriptan:
- if your type of migraine has not been diagnosed
- if you 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
- if you are over 65 years of age (as you are more likely to experience blood pressure increases)
- If you are taking anti-depressants SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin nor adrenaline reuptake inhibitors). Also see 'Other medicines and Almotriptan'.
It has been suggested that excessive use of an anti-migraine
medicinal product can lead to daily chronic headache.
Children and Adolescents
Children under the age of 18 should not take Almotriptan.
Elderly (over 65 years of age)
If you are over 65 years of age you should speak to your doctor before using this medicinal product.
Other medicines and Almotriptan
T ell 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 nor adrenaline 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
- if you 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
If you 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. If you are affected, you should not drive or use any tools or machines.
3. How to take Almotriptan
Almotriptan should only be used to treat an actual migraine attack and not to prevent migraine attacks or headaches.
Always take Almotriptan exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults (18-65 years old)
The usual dose is one 12.5mg tablet which should be taken as early as possible after the onset of the migraine attack. If your 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 12.5mg tablet can be taken but you must leave at least two hours between your first and second tablet.
The maximum daily dose is two (12.5mg) tablets within 24 hours.
Tablet should be swallowed with liquid (e.g. water) and can be taken with or without food.
You should take Almotriptan as soon as possible after the 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 12.5mg tablet every 24 hours.
If you take more Almotriptan than you should
If you accidentally take too many tablets, or if someone else or a 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 product, ask 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 (1 to 10 users in 100):
• dizziness
• sleepiness (somnolence)
• nausea
• vomiting
• tiredness
Uncommon side effects (1 to 10 users in 1,000):
• sensation of tingling, pricking or numbness of the skin (paraesthesia)
• headache
• ringing, roaring or clicking noise in the ears (tinnitus)
• heart pounding (palpitations)
• tightening of the throat
• diarrhoea
• discomfort when digesting food (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling weak (asthenia)
Very rare side effects (less than 1 user in 10,000):
• spasm of the heart blood vessels (coronary vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (tachycardia)
Frequency unknown (frequency cannot be estimated from the available data):
• allergic reactions (hypersensitivity reactions), including mouth, throat or hand oedema (angioedema)
• severe allergic reactions (anaphylactic reactions)
• convulsion (seizure)
• visual impairment, vision blurred (visual disorders may also occur during a migraine attack itself)
During treatment with Almotriptan, tell your doctor straight
away:
• if you have chest pain, tightness in your chest or throat, or any other symptoms that resembles a heart attack. Please tell your doctor straight away and do not take any more Almotriptan.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Almotriptan
Keep out of the sight and reach of children
There are no special storage instructions.
Do not use after the expiry date stated on the box and packaging label after 'Exp'. The expiry date refers to the last day of that month.
Do not dispose of medicines in household rubbish. Any unused tablets should be returned to a pharmacist who will dispose of them properly.
6. Contents of the pack and other information What Almotriptan contains
Each film-coated tablet contains 12.5mg of the active substance almotriptan (as D, L-hydrogen malate).
Almotriptan also contains the following ingredients:
Tablet core: mannitol, microcrystalline cellulose, povidone, sodium carboxymethyl starch and sodium stearyl fumarate.
Coating material: hypromellose, titanium dioxide (E171), macrogol 400 and carnauba wax.
Printing ink: hypromellose, propylene glycol, indigo carmine (E132).
What Almotriptan looks like and contents of the pack
Almotriptan are available as white, circular, biconvex film-coated tablets with a blue A printed on one side for oral use.
Almotriptan are available in aluminium blister packs of 6 tablets.
Manufactured by: Almirall Prodesfarma SA, 08022 Barcelona, Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Almotriptan 12.5mg Tablets;
PL : 18799/1153 -
Leaflet date: 01.04.2015