50 mg and 100 mg tablet
sumatriptan
1. What Imigran Novum is and what it is used for
Imigran Novum containing sumatriptan belonging to a group of drugs called triptans ( also known as 5-HT 1 – receptor agonists).
Imigran Novum is used for treating migraines.
The migraine symptoms are probably caused by a temporary dilation of the blood vessels in the head. Imigran Novum is considered to reduce the dilation of these blood vessels. This contributes to the disappearance of the headache as well as other migraine symptoms such as nausea, vomiting, and sensitivity to light and sound.
2. What you need to know before using Imigran Novum
Do not use Imigran Novum
- 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 narrowed blood vessels (ischemic heart disease), chest pain (angina) or have previously had a heart attack.
- If you have problems with blood circulation in the legs that cause cramp-like pain when you walk (so-called peripheral vascular disease).
- If you have had a stroke (stroke) or TIA (transient circulatory disorder in the brain).
- If you have high blood pressure . You can use Imigran Novum if you have been treated for mild hypertension.
- If you have any serious liver disease.
- If you are taking other medicines to treat migraine which contain ergotamine or compounds similar to ergotamine such as methysergide or any triptan / 5-HT 1 – receptor agonist (medicines which are also used to treat migraine ).
- If you are being treated with antidepressant medicines such as monoamine oxidase inhibitors ( MAOIs ) or if you have been treated with any such medicine within the last two weeks.
If any of the above applies to you:
→ Contact a doctor and do not use Imigran Novum.
Warnings and cautions
Talk to your doctor or pharmacist before using Imigran Novum.
If you have any additional risk factors
- 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 the menstrual age.
In very rare cases, severe heart conditions have occurred after taking Imigran Novum despite the fact that no signs of heart disease have been detected. If any of the above risk factors apply to you, it may mean that you have a greater risk of developing heart disease:
→ Tell your doctor so that your heart function can be checked before treatment with Imigran Novum.
If you have previously had seizures or if there are other factors that may increase the risk of seizures, such as brain damage or alcoholism:
→ Tell your doctor so that you can be checked more often.
If you have any liver or kidney disease:
→ Tell your doctor so that you can be checked more often.
If you are allergic to antibiotics of the type sulfonamides
If so, you may also be allergic to Imigran Novum. If you know you are allergic to antibiotics, but if you are not sure if they are sulphonamides:
→ Talk to your doctor or pharmacist before using Imigran Novum.
If you are taking antidepressants called SSRIs (selective serotonin reuptake inhibitors ) or SNRIs ( serotonin noradrenaline reuptake inhibitors):
→ Tell your doctor or pharmacist before using Imigran Novum. See also section “Other medicines and Imigran Novum”.
If you use Imigran Novum frequently
Using Imigran Novum too often can make your headache worse:
→ Tell your doctor if this applies to you. Your doctor may recommend that you stop using Imigran Novum.
If you feel any pain or tightness in your chest after using Imigran Novum
These symptoms can be intense but they usually go away quickly. If they do not disappear quickly or if they get worse:
→ Seek medical attention immediately. See section 4 of this leaflet for more information on these possible side effects.
Other medicines and Imigran Novum
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It also includes herbal remedies or over-the-counter remedies.
Some medicines should not be taken with Imigran Novum and others may cause side effects when used concomitantly. You must tell your doctor if you use:
- ergotamine , which is used to treat migraines , or similar medicines such as methysergide (see section 2 “Do not use Imigran Novum”). Do not use Imigran Novum at the same time as these medicines. You must stop taking them for at least 24 hours before using Imigran Novum. Do not take any medicines that contain ergotamine or compounds similar to ergotamine again for at least 6 hours after taking Imigran Novum.
- triptan / 5-HT 1 – receptor agonist (such as naratriptan, rizatriptan, zolmitriptan) also used for the treatment of migraine (see Section 2 “do not use Imigran Novum”). Do not use Imigran Novum at the same time as these medicines. You must stop taking them for at least 24 hours before using Imigran Novum. Do not take any other medicine containing triptan / 5-HT 1 – receptor agonist again for at least 24 hours after taking Imigran Novum.
- SSRIs (selective serotonin reuptake inhibitors) or SNRIs ( serotonin – noradrenaline reuptake inhibitors) used in the treatment of depression . Using Imigran Novum with these medicines can cause serotonergic syndrome (a collection of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle twitching, tremors, palpitations and tremors). If you get these symptoms, tell your doctor straight away.
- MAO ( monoamine oxidase inhibitor ) used in the treatment of depression . Do not use Imigran Novum if you have been taking such medicines in the last two weeks.
- St. John’s wort (Hypericum perforatum) . With concomitant use of Imigran Novum and herbal medicines containing St. John’s wort , side effects mayoccur to an increased extent.
Pregnancy and breastfeeding
- 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. There is only limited information on the safety of Imigran Novum when used in pregnant women, although there is no evidence of an increased risk of birth defects to date. Your doctor will discuss with you whether to use Imigran Novum during pregnancy.
- You should not breast-feed your baby for the next 12 hours after using Imigran Novum. Breast milk pumped out during these 12 hours should not be given to your baby, but should be discarded.
Driving and using machines
Both the migraine symptoms and your medication can make you drowsy. If you are affected, do not drive or operate machinery. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
Imigran Novum contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
3. How to use Imigran Novum
Imigran Novum should only be used when the migraine attack has started.
Do not use Imigran Novum to try to prevent an attack.
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
How much to use
Adults (18 to 65 years)
- The usual dose for adults (18 to 65 years) is a 50 mg tablet. Some people may need 100 mg. However, a single dose higher than 100 mg does not produce a better effect.
Imigran Novum is not recommended for people under 18 years of age or older than 65 years.
When to use Imigran Novum
- It is best to take Imigran Novum as soon as you feel that the migraine attack has started , but you can also take Imigran Novum later in the attack.
If the symptoms start to come back
- You can take a second dose if the symptoms return. However, at least two hours must have elapsed between doses . Do not take more than 300 mg for 24 hours.
→ Contact a doctor or pharmacist for advice
If the first dose one has no effect
- Do not use a second dose or any other Imigran product during the same migraine attack. If you do not get any effect of Imigran Novum:
→ Contact a doctor or pharmacist for advice.
If you use more Imigran Novum than you should
- Do not take more than 300 mg of Imigran Novum for 24 hours.
- Taking too much Imigran Novum can make you sick. If you have taken more than 300 mg in 24 hours:
→ Contact a doctor for advice.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, always contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
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. Some symptoms can be caused by the migraine disease itself.
Allergic reactions: seek medical attention immediately
The following side effects have occurred in a very small number of people but the exact frequency is not known.
- Signs of allergy include skin rash, hives (itchy rash), wheezing, swollen eyelids, face or lips, unconsciousness . If you get any of these symptoms immediately after taking Imigran Novum:
→ Do not take more of this medicine. Contact a doctor immediately.
Usual
(may affect up to 1 in 10 users):
- Pain, heaviness, feeling of pressure or tightness or pain in the chest, pharynx or other parts of the body. Unusual sensations such as numbness, tingling, feeling of heat or cold. These symptoms can be intense but are usually transient.
If these symptoms persist or worsen (especially chest pain):
→ Seek medical attention immediately. In a small number of people, these symptoms can be caused by a heart attack.
- Nausea or vomiting. These symptoms may be part of the migraine attack itself.
- Fatigue or drowsiness.
- Dizziness, feeling of weakness, feeling hot and redness ( flush )
- Transient increase in blood pressure
- Respiratory distress
- Muscle aches
Very rare
(may affect up to 1 in 10,000 users):
- Changes in liver function. If you are taking a blood test to check your liver function, tell your doctor or nurse that you are using Imigran Novum.
Some patients may experience any of the following side effects, but it is not known how often they occur
- Seizures, tremors, muscle cramps, neck stiffness
- Visual disturbances such as visual flicker, visual impairment, double vision, loss of vision which in some cases may become permanent. These visual disturbances can also be caused by the migraine attack itself.
- Heart problems, slowing or rapid heartbeat (palpitations), changes in heart rhythm, chest pain (angina) or heart attack
- Pale, blue skin and / or pain in fingers, toes, ears, nose or jaw in cold or stress (Raynaud’s phenomenon)
- Fainting sensation (depending on a drop in blood pressure)
- Pain in the lower left part of the abdomen and bloody diarrhea (ischemic colitis )
- Diarrhea
- 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 .
- Joint pain
- Feeling anxious
- Difficulty swallowing
- Abundant sweating.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
5. How to store Imigran Novum
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is sumatriptan succinate equivalent to 50 mg and 100 mg sumatriptan, respectively, per tablet.
The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium bicarbonate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171), and glycerol triacetate. The 50 mg tablet also contains red iron oxide (E172).
What the medicine looks like and contents of the pack
Imigran Novum is packed in cartons with child-resistant blister packs. Available in packs of 2, 6, or 18 tablets.
Not all pack sizes may be provided.
Marketing Authorization Holder / Information provided by:
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel: 08-638 93 00
Email: info.produkt@gsk.com