50 mg film-coated tablets
sumatriptan
What Oriptan is and what it is used for
Each tablet contains a single dose of sumatriptan and belongs to a group of medicines called triptans (also called 5-HT1 receptor agonists ).
Oriptan is used to treat migraine attacks with or without aura.
The migraine symptoms are probably due to a temporary dilation of blood vessels in the head. Sumatriptan is believed to reduce the dilation of these blood vessels. This in turn results in relief of headaches and reduction of other migraine symptoms such as nausea or vomiting and sensitivity to light and sound.
Oriptan is not intended for the treatment of other types of headaches, e.g. tension headaches.
Sumatriptan contained in Oriptan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Oriptan
Do not use Oriptan
- if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
- -if you have heart problems such as arterial stenosis or chest pain (angina), or have already had a heart attack.
- if you have poor blood circulation in your legs that causes cramp-like pain when you walk ( peephole ).
- if you have had a stroke or mini- stroke (also called transient ischemic attack or TIA ).
- if you have high blood pressure . You may be able to take sumatriptan if your high blood pressure is mild and being treated.
- if you have severe liver disease .
- if you are taking other migraine medications including those containing ergotamine or similar medicines such as methysergide maleate or any triptan or 5-HT1 receptor agonist (such as naratriptan or zolmitriptan)
- you are taking any of the following antidepressant drugs :
- MAO inhibitors ( monoamine oxidase inhibitors ) or if you have taken MAO inhibitors in the last two weeks.
- SSRIs (selective serotonin reuptake inhibitors) including citalopram , fluoxetine , fluvoxamine, paroxetine or sertraline .
- SNRIs ( serotonin -noradrenaline reuptake inhibitors) including venlaflaxine and duloxetine.
- you are a child under 18 years of age .
Warnings and cautions
Before you start taking Oriptan, a doctor should have confirmed that your headache is due to a migraine and not to any other problem.
Talk to your doctor before using Oriptan if any of the following apply to you:
- if you are a heavy smoker or use nicotine replacement therapy, and especially
- if you are a man over 40 years, or
- if you are a woman and have passed menopause.
In very rare cases, severe heart problems have occurred after taking sumatriptan even though no signs of heart disease have been seen before. If any of the risk factors are right for you, it may mean that you are at greater risk of developing heart disease. Consult your doctor so that your heart function can be checked before sumatriptan is prescribed to you.
- if you have previously had seizures (epileptic seizures) or if you have other conditions that may make you more likely to have a seizure – such as a head injury or alcoholism.
- if you have liver or kidney problems.
- if you are intolerant to any type of sugar.
- if you are allergic to antibiotics called sulfonamides . In that case, you may also be allergic to sumatriptan. If you know that you are allergic to antibiotics but you are not sure if it is a sulfonamide, talk to your doctor or pharmacist before taking this medicine.
- if you are taking antidepressants called SSRIs ( selective serotonin reuptake inhibitors) or SNRIs ( serotonin noradrenaline reuptake inhibitors). See also Other medicines and Oriptan below.
- if you take sumatriptan often . Using sumatriptan too often can make your headache worse. Your doctor may recommend that you stop taking sumatriptan.
- if you feel pain or tightness in the chest after taking sumatriptan. These symptoms can be intense but they usually go away quickly. If they do not go away quickly or if they get worse, seek medical help immediately.
Other medicines and Oriptan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes any herbal products, supplements such as vitamins, iron or calcium, or medicines that you have purchased without a prescription.
Some medicines should not be taken with Oriptan and others may cause side effects if taken with Oriptan. You must tell your doctor if you are taking:
- ergotamine which is also used to treat migraines , or similar medicines like methysergide maleate. Do not take Oriptan while taking these medicines. Stop taking these medicines for at least 24 hours before taking Oriptan. Do not take them again until at least 6 hours after taking Oriptan.
- or any triptan or 5 – HT 1 agonist (eg naratriptan, sumatriptan, rizatriptan, eletriptan, almotriptan or zolmitriptan). Do not take Oriptan while taking these medicines. Stop taking these medicines for at least 24 hours before taking Oriptan. Do not take them again until at least 24 hours after taking Oriptan.
- MAO inhibitors used to treat depression . Do not take Oriptan if you have been taking MAOIs for the past 2 weeks.
- SSRIs and SNRIs used to treat depression . Concomitant use of Oriptan and these medicines can cause serotonergic syndrome (a collection of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, increased heart rate and tremors). Tell your doctor immediately if you are affected in this way.
- St. John’s wort (Hypericum perforatum). Using herbal remedies containing St. John’s wort with Oriptan may increase the risk of side effects .
- lithium, a drug used to treat manic / depressive (bipolar) disorder.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
If you are pregnant or think you may be pregnant, talk to your doctor before taking Oriptan. There is only limited information on the safety of Oriptan in pregnant women, but to date, there is no evidence of an increased risk of birth defects. Your doctor will discuss with you whether or not to use Oriptan during your pregnancy.
Breast-feeding:
Do not breastfeed your baby within 12 hours of taking Oriptan. Breast milk pumped out during these 12 hours should be discarded and not given to your baby.
Driving and using machines
Migraine or treatment with Oriptan may make you drowsy. Do not drive or use any tools or machines if you are affected.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Oriptan contains lactose
This medicine contains 176.3 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Other ingredients
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to use Oriptan
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- It is best to take Oriptan as early as possible during a migraine attack, but can also be taken during an ongoing attack.
- Do not take Oriptan to prevent a migraine attack, take it only after you start to feel migraine symptoms.
Adults
The recommended dose is a 50 mg tablet for migraine attacks, which should be swallowed whole with water. do not take more than 100 mg during the same migraine attack.
You must contact a doctor if the symptoms worsen or do not improve within 3 days.
Children and young people under 18 years of age
Oriptan is not recommended for children under 18 years of age.
Older people (over 65 years)
Oriptan is not recommended for people over 65 years of age.
If your symptoms start to come back
If migraine symptoms are relieved after the first dose (50 mg) but recur later, an additional 50 mg may be taken. You must wait at least 2 hours after taking the first dose before you can take the second dose. Maximum 100 mg over 24 hours.
If the first tablet has no effect
Do not take a second tablet of Oriptan or any other sumatriptan preparation for the same attack. If the first tablet has no effect, you can take other painkillers such as paracetamol, acetylsalicylic acid, or non-steroidal anti-inflammatory drugs. Oriptan can still be taken in the next attack.
If Oriptan does not give you relief, it may mean that you do not have a migraine. Ask your doctor for advice.
If you take more Oriptan than you should
Do not take more than two 50 mg tablets (100 mg in total) for 24 hours. Excessive intake of Oriptan can make you sick. The overdose symptoms are the same as those listed in section 4 “Possible side effects”.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions
No known frequency (can not be calculated from the available data):
Allergic skin reactions: Skin rash with red spots or hives (skin lumps). Anaphylactic reaction (Severe allergic reaction with swelling of eg eyelids, face or lips, sudden breathing problems, palpitations, pressure over the chest, or total collapse).
If allergic reactions occur, stop taking Oriptan. If the reaction is severe, seek medical attention immediately.
Other possible side effects
Common (affects 1 in 100 to 1 of 10 users):
- Ant crawling, dizziness, drowsiness, unusual sensation
- Transient increase in blood pressure (occurs shortly after taking the drug), feeling hot
- Breathing difficulties
- Nausea, vomiting
- Feeling of heaviness, muscle pain
- Pain, heat or feeling of cold, pressure or tightness. These symptoms are generally transient and can occur in any part of the body, including the chest and neck. Feeling weak, tired.
Very rare (affects less than 1 user in 10,000):
- Minor disturbances in liver function tests have sometimes been observed.
No known frequency (can not be calculated from the available data):
- Anxiety
- Seizures (epileptic seizures), involuntary movements, tremors, involuntary eye movements ( nystagmus )
- Vision problems such as flicker, impaired vision, vision loss (these can also be due to the migraine attack itself)
- Heart problems in the form of changes in heart rhythm (may beat faster, slower or change rhythm), chest pain (angina) or heart attack
- Low blood pressure , Raynaud’s syndrome (a condition in which fingers and toes become whitish and numb)
- Colon inflammation (which is felt in the form of pain in the far left of the abdomen or bloody diarrhea), diarrhea
- Abundant sweating
- Neck stiffness, joint pain
- If you have recently been injured or if you have an inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening pain at the site of the injury or inflammation .
- Difficulty swallowing.
How to store Oriptan
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is sumatriptan 50 mg as sumatriptan succinate.
- Other ingredients are:Tablet core : lactose monohydrate and lactose , croscarmellose sodium, microcrystalline cellulose, magnesium stearateFilm coating : lactose monohydrate , mannitol, titanium dioxide (E 171), triacetin, talc.
What the medicine looks like and contents of the pack
50 mg film-coated tablet:
Round, white, film-coated tablets, marked with “RDY” on one side and “292” on the other.
Pack size: 2 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd, medinfo@orionpharma.com
This medicinal product is authorized under the European Economic Area under the names
| Finland, Sweden | Oriptan |
| Poland, Czech Republic | Framing |
| Hungary | Sumatriptan Orion |