Download Package leaflet: Information for the user Sumatriptan Actavis 50 mg

Package leaflet: Information for the user
Sumatriptan Actavis 50 mg coated tablets
Sumatriptan Actavis 100 mg coated tablets
Sumatriptan
Read all of this leaflet carefully before you start using 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 or pharmacist.
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 or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Sumatriptan Actavis is and what it is used for
2.
What you need to know before you use Sumatriptan Actavis
3.
How to use Sumatriptan Actavis
4.
Possible side effects
5.
How to store Sumatriptan Actavis
6.
Contents of the pack and other information
1.
What Sumatriptan Actavis is and what it is used for
Sumatriptan Actavis belongs to a group of medicines called triptans.
Migraine headaches are thought to result from the dilatation of blood vessels. Sumatriptan Actavis constricts
these blood vessels, thus relieving the migraine headache.
Sumatriptan Actavis is used to treat migraine attacks with or without aura (a warning sensation that usually
involves distortions, such as light-flashes, zigzag lines, stars, or waves).
2.
What you need to know before you use Sumatriptan Actavis
Do not use Sumatriptan Actavis
- if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
- if you have had a heart attack.
- if you have any heart disease.
- if you have symptoms that might indicate heart disease, such as temporary chest pain or a sensation of
pressure in your chest.
- if you have a history of stroke or transient ischaemic attack (TIA, a minor form of stroke that lasts less
than 24 hrs).
- if you have blood circulation problems in your legs that cause cramps like pains when you walk
(called peripheral vascular disease).
- if you have significantly high blood pressure, or if your blood pressure is high despite medication.
- if you have severely reduced liver function.
- if you use, or have recently used, other migraine medicines, including those which contain ergotamine,
or similar medicines such as methysergide; or any triptans (such as almotriptan, eletriptan, frovatriptan,
naratriptan, rizatriptan or zolmitriptan).
- if you use, or have recently used, MAO inhibitors (for instance moclobemide for depression or
selegiline for Parkinson's disease).
Warnings and precautions
Talk to your doctor or pharmacist before using Sumatriptan Actavis
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if you have symptoms of heart disease, such as transient chest pain or a feeling of pressure in your chest,
which may also radiate towards your throat
if you use medicines to control high blood pressure
if you use medicines which belong to the group of selective serotonin re-uptake inhibitors (for depression
or other mental disorders)
if you have reduced liver or kidney function
if you have epilepsy or any other disease which reduces your seizure threshold
if you are hypersensitive to sulphonamides
if you are considered to be at risk of developing heart disease (e.g. diabetic, heavy smoker or undergoing
nicotine replacement therapy), and particularly if you are a post-menopausal woman or a man over 40
years with these risk factors, your doctor should check your heart function before prescribing
Sumatriptan Actavis. In very rare cases serious heart conditions have occurred after taking Sumatriptan
Actavis, even if no signs of any heart disease were found. Contact your doctor for advice if you have any
concerns.
Sumatriptan Actavis should only be used if your headache is definitely migraine. If the headache is
different from your usual headaches, you should not take Sumatriptan Actavis without first contacting your
doctor.
After taking Sumatriptan Actavis you may feel pain in your chest and a feeling of pressure for a short time,
this can be quite intensive and may radiate up towards your throat. In very rare cases this may be caused by
effects on your heart. Therefore, if the symptoms do not disappear, contact your doctor.
Overuse of Sumatriptan Actavis may cause chronic, daily headache or worsened headache. Ask your doctor
if you think that this is the case for you. It may be necessary to discontinue the treatment with Sumatriptan
Actavis in order to correct the problem.
Children and adolescents
Sumatriptan Actavis is not recommended for children and adolescents under 18 years of age.
Other medicines and Sumatriptan Actavis
Some medicines may influence the effect of Sumatriptan Actavis, and Sumatriptan Actavis may influence
the effects of other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including herbal remedies and natural products.
This is especially important when using medicines that contain
ergotamine (for migraine) or other triptans. These must not be taken at the same time as Sumatriptan
Actavis (see “Do not use Sumatriptan Actavis”). After taking medicines containing ergotamine or
another triptan, you are advised to wait at least 24 hours before taking Sumatriptan Actavis. After
taking Sumatriptan Actavis you are advised to wait at least 6 hours before taking medicines
containing ergotamine and at least 24 hours before taking medicines containing other triptans.
MAO inhibitors (e.g. moclobemide for depression or selegiline for Parkinson's disease),
lithium (for manic/depressive (bipolar) disorders),
selective serotonin re-uptake inhibitors (SSRI's for depression and other mental conditions)
or herbal remedies containing St. Johns wort (Hypericum perforatum).
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.
Experience of use during pregnancy is limited.
Sumatriptan Actavis passes into breast milk. Therefore, breast-feeding should be avoided for 12 hours
after taking sumatriptan. Do not feed your child with milk expressed during this period.
Driving and using machines
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A migraine patient may feel sleepy due to the migraine attack or to the treatment with Sumatriptan Actavis.
This should be taken into consideration when increased attention is required, for instance while driving. See
also Possible side effects.
Sumatriptan Actavis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3.
How to use Sumatriptan Actavis
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. Your doctor will decide on a dose which suits you personally. The
recommended dose should not be exceeded.
- The tablets should be swallowed whole with a ½ glass of water. The 50 mg tablets may be divided into
two equal doses. The tablets can be crushed and mixed with water.
- Sumatriptan Actavis should be taken at the first sign of a migraine attack, but may also be taken during
an ongoing attack.
- Sumatriptan Actavis should not be used as a preventative (prophylactically).
Dosage:
The recommended dose for adults aged 18 to 65 is one 50 mg tablet for a migraine attack. Some patients may
require 100 mg. The maximum dose per day is 300 mg.
Children under 18
Sumatriptan is not recommended for children under 18 years old
Elderly (aged over 65)
Sumatriptan is not recommended for people aged over 65.
If migraine symptoms are relieved after the first dose of the medicine but later return, the dose may be
repeated once during 24 hours provided that there is a minimum interval of 2 hours between the doses.
A daily dose of 300 mg must not be exceeded.
If migraine symptoms are NOT relieved after the first dose and the medicine has no effect, you should
not take further doses during the same migraine attack.
Next time you get migraine, you can try Sumatriptan Actavis again.
If you experience that the effect of Sumatriptan Actavis is too strong or too weak, talk to your doctor or
pharmacist.
If you use more Sumatriptan Actavis than you should:
Overdose symptoms are the same as those listed in section 4 ´Possible side effects´. If you have taken too
many tablets, contact a doctor or hospital.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the
symptoms given below can be caused by a migraine attack itself.
If you get any of the following side effects, you should stop taking Sumatriptan Actavis and contact your
doctor immediately:
•
Sudden wheeziness, fluttering or tightness in the chest, swelling of eyelids, face or lips, skin rash - red
spots or hives (skin lumps), which may be signs of an allergic reaction
•
Fits (usually in people with a history of epilepsy)
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•
Angina (pain in the chest, often brought on by exercise) or heart attack
The above side effects are very rare: may affect up to 1 in 10,000 people.
Common: may affect up to 1 in 10 people
• Flushing (redness of the face lasting a few minutes), dizziness, feelings of weakness, tiredness and
drowsiness
• Short lasting increases in blood pressure soon after taking the medicine
• Feeling sick (nausea) or being sick (vomiting)
• Pain, feeling of heat, or cold, heaviness, pressure or tightness in any part of the body including chest and
throat
• unusual sensations, including numbness and tingling
• Shortness of breath
• Muscle pain
If these effects continue or are particularly severe, especially chest or heart pain which spreads to the arms,
tell your doctor immediately
Very rare: may affect up to 1 in 10,000 people
• Visual disturbances including flickering, double vision and reduced vision. There have been cases where
permanent vision defects have occurred
• Lowering of blood pressure that can lead to a feeling of faintness especially on standing up
• Transient ischaemic ECG changes. Slowing or quickening in the speed of your heart beat, palpitations
(feeling of fast heart beat), changes in heart rhythm
• Shaking, tremors or uncontrolled movements
• Stiffness in the neck
• Liver function changes. If you have a blood test to check your liver function, tell your doctor or nurse
that you are taking Sumatriptan Actavis
• Inflammation of the colon (part of the intestine), which may present as lower left-sided tummy pain
and/or bloody diarrhoea
• Raynaud’s phenomenon, which might appear as paleness or a blue tinge to the skin and/or pain of the
fingers, toes, ears, nose or jaw in response to cold or stress
Not known: frequency cannot be estimated from the available data
•
Diarrhoea
•
Joint pain
•
Anxiety
•
Excessive sweating
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 via the national reporting system listed in Appendix
V. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store Sumatriptan Actavis
Keep this medicine out of the sight and reach of children
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to
the last day of that month.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Sumatriptan Actavis contains
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The active substance is sumatriptan. One tablet contains 50 mg or 100 mg sumatriptan (as sumatriptan
succinate).
The other ingredients are: Core: Lactose monohydrate, anhydrous lactose, croscarmellose sodium,
microcrystalline cellulose, magnesium stearate. Coating: Lactose monohydrate, mannitol, triacetin, talc,
and titanium dioxide (E 171).
What Sumatriptan Actavis looks like and contents of the pack
Coated tablet (tablet).
50 mg: white, oval, biconvex tablets with scoring on both sides and on the edges, imprinted with "SN" on
one side and "50" on the other.
100 mg: white, oval, biconvex tablets, imprinted with "SN" on one side and "100" on the other.
Pack sizes:
Blister packs: 2, 3, 4, 6, 12, 18 and 24 tablets.
Plastic tablet jars: 2, 3, 4, 6, 12, 18 and 24 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Market authorisation holder:
<[To be completed nationally]>
Manufacturer:
Actavis hf., Reykjavikurvegur 76-78, IS-220 Hafnarfjördur, Iceland
Or
Balkanpharma – Dupnitsa AD, 3, Samokovsko Shosse Str., 2600 Dupnitsa, Bulgaria
Or
Specifar SA, 1, 28 Octovriou str., Agia Varvara, 12351, Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
Sweden
Denmark
Italy
Sumatriptan Actavis 50 mg coated tablets
Sumatriptan Actavis 100 mg coated tablets
Sumatriptan Actavis
Sumatriptan Aurobindo
This leaflet was last revised in 16 May 2017.
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