Imigran Neo 50 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Imigran Neo 50 mg film-coated tablets
Sumatriptan (as sumatriptan succinate)
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Imigran Neo is and what it is used for
- What you need to know before taking Imigran Neo
- How to take Imigran Neo
- Possible side effects
- How to store Imigran Neo
- Contents of the pack and other information
1. What Imigran Neo is and what it is used for
Imigran Neo contains the active substance sumatriptan and belongs to a group of medicines known as triptans (also known as 5-HT1 receptor agonists).
This medicine is indicated for the relief of headache and other symptoms of a migraine attack.
The dilation of blood vessels in the brain is thought to be the cause of the headache occurring in migraine. This medicine constricts the blood vessels in the brain and relieves migraine symptoms.
2. What you need to know before taking Imigran Neo
Do not take Imigran Neo
- if you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6)
- if you have heart problems such as narrowing of the arteries (coronary ischaemic disease) or chest pain (angina), or have had a heart attack
- if you have circulation problems in your legs causing pain, such as cramps when walking (peripheral vascular disease)
- if you have had a stroke or a mini-stroke (also called transient ischaemic attack or TIA)
- if you have high blood pressure. You may use Imigran Neo if your blood pressure is slightly elevated and is being treated
- if you have liver disease, consult your doctor. If liver disease is severe, Imigran Neo is not suitable for you
- with other migraine medicines, including those containing ergotamine, or similar medicines such as methysergide, or any triptans/5-HT1 receptor agonists (medicines also used to treat migraine)
- with antidepressants called MAOIs (monoamine oxidase inhibitors), or if you have taken these medicines within the last two weeks.
If any of these apply to you
?Tell your doctor, and do not use Imigran Neo.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Imigran Neo.
Before taking Imigran Neo, your doctor needs to know if you have any additional risk factors for heart disease:
- if you are a man over 40 years of age
- if you are a woman who has reached menopause
- if you smoke or are overweight
- if you have diabetes or high cholesterol
- if you have a family history of heart disease.
Very rarely, people have developed serious heart problems after using Imigran Neo, even though they had no prior signs of heart disease. If any of the above apply to you, it may mean you have a higher risk of developing heart disease, so
?Tell your doctor to check your heart function before Imigran Neo is prescribed.
If you have high blood pressure
Imigran may not be suitable for you:
?Consult your doctor or pharmacist before using Imigran Neo.
If you have kidney or liver disease
?Consult your doctor or pharmacist before using Imigran Neo.
If you have a history of seizures (fits)
Or if you have other conditions that may make seizures more likely – for example, head injury or alcoholism.
?Tell your doctor so you can be monitored more closely.
If you are allergic to antibiotics called sulphonamides
If so, you may also be allergic to Imigran Neo. If you know you are allergic to antibiotics, but are unsure whether they are sulphonamides.
?Tell your doctor or pharmacist before using Imigran Neo.
If you are taking antidepressants called SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Noradrenaline Reuptake Inhibitors)
?Tell your doctor or pharmacist before using Imigran Neo. See also below, Other medicines and Imigran Neo.
If you use Imigran Neo frequently
Taking Imigran Neo too often may worsen your headaches.
?Tell your doctor if this happens to you. Your doctor may advise you to stop using Imigran Neo.
If you feel chest pain or tightness after using Imigran Neo
These effects may intensify but usually pass quickly. If they do not pass quickly or become more severe:
?Get medical help immediately. See section 4 of this leaflet for more information about these possible side effects.
Other medicines and Imigran Neo
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This includes any herbal medicines or medicines bought without a prescription.
Some medicines should not be taken with Imigran Neo and others may cause side effects when taken with Imigran Neo. Tell your doctor if you are taking other medicines, such as:
- ergotamine, also used to treat migraine, or similar medicines such as methysergide (see section 2 Do not take Imigran Neo). Do not use Imigran Neo at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran Neo. Do not take any other medicine containing ergotamine or ergotamine-like compounds until at least 6 hours after using Imigran Neo
- other triptans/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan), also used to treat migraine (see section 2 Do not take Imigran Neo). Do not use Imigran Neo at the same time as these medicines. Stop taking these medicines at least 24 hours before using Imigran Neo. Do not take another triptan/5-HT1 receptor agonist within at least 24 hours after using Imigran Neo
- SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Noradrenaline Reuptake Inhibitors) used to treat depression. Using Imigran Neo with these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, chills, increased heart rate, and agitation). Tell your doctor immediately if you experience these symptoms
- MAOIs (monoamine oxidase inhibitors) used to treat depression. Do not use Imigran Neo if you have taken these medicines within the last two weeks
- St John’s wort (Hypericum perforatum). You are more likely to experience adverse effects if you take herbal remedies containing St John’s wort while using Imigran Neo.
Fertility, pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine. There is limited information on the safety of Imigran Neo in pregnant women, although so far there is no evidence that it increases the risk of birth defects. Your doctor will assess with you whether or not you should use Imigran Neo during pregnancy.
You must not breast-feed your baby for 12 hours after taking Imigran Neo. If you express breast milk during this time, discard the milk and do not give it to your baby.
Some women have reported breast and/or nipple pain after using sumatriptan. The pain is usually temporary and resolves within 3 to 12 hours.
Driving and using machines
This medicine, like migraine itself, may cause drowsiness. If you experience these effects, avoid driving or using machines as it could be dangerous.
Imigran Neo contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.
3. How to take Imigran Neo
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Use Imigran Neo only after your migraine headache has started.
Do not use Imigran Neo to prevent a migraine attack.
Remember to take your medicine.
Your doctor will indicate how long you should take Imigran Neo. Do not stop treatment earlier.
The tablets should be taken as soon as migraine symptoms appear; however, they may be taken at any time during an attack.
Administration to children, adolescents under 18 years of age, and elderly patients is not recommended.
The recommended dose of Imigran Neo is one 50 mg tablet, although some patients may require a dose of 100 mg (two 50 mg tablets).
If symptoms improve after the first dose but then return, a second tablet of Imigran Neo may be taken, provided at least two hours have passed since the first dose.
If no improvement is observed after taking a dose, a second dose should not be taken for the same migraine attack. Imigran Neo may be used for subsequent attacks.
If no symptom relief is observed with Imigran Neo, you may take your usual headache medication, provided it does not contain ergotamine or dihydroergotamine.
Swallow the tablets whole, with a little water.
If you take more Imigran Neo than you should:
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 5620420, indicating the medicine and the amount ingested.
If you forget to take Imigran Neo
Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Imigran Neo can cause adverse effects, although not everyone experiences them.
Some of these symptoms may be caused by migraine itself.
Allergic reactions: seek immediate medical help
- The following adverse effects have occurred in a very small number of people, and their exact frequency is unknown. Signs of allergy include rash, hives (itching and rash); wheezing (whistling in the chest); swollen eyelids, face or lips; complete collapse.
If you notice any of these symptoms shortly after using Imigran Neo:
? Do not use it again. Contact your doctor immediately.
Frequent adverse effects
(affects up to 1 in 10 people)
- Pain, heaviness, pressure, tightness, or pain in the chest, throat, or other parts of the body, or unusual sensations, including numbness, tingling, and sensations of heat or cold. These effects may be intense but usually disappear quickly.
If these effects persist or worsen (especially chest pain):
? Seek urgent medical help. In a small number of people, these symptoms may be caused by heart attacks.
Other frequent adverse effects include:
- Nausea or vomiting, although this may be due to migraine itself.
- Tiredness or drowsiness.
- Dizziness, feeling weak, or flushing.
- Temporary increase in blood pressure.
- Difficulty breathing.
- Muscle pain.
Rare adverse effects
(affect up to 1 in 1,000 people)
- Breast pain.
Very rare adverse effects
(affect up to 1 in 10,000 people)
- Changes in liver function. Inform your doctor or nurse that you are taking Imigran Neo if you are due to have a blood test to check liver function.
Some patients may experience any of the following adverse effects, but the frequency with which they occur is unknown
- Seizures/attacks, tremors, muscle spasms, neck stiffness.
- Visual disturbances such as flashing lights, reduced vision, double vision, vision loss, and in some cases even permanent defects (although these may be due to the migraine attack itself).
- Heart problems, in which the heart may beat faster, slower, or with changes in rhythm, chest pain (angina), or heart attack.
- Paleness, bluish skin, and/or pain in the fingers, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon).
- Pain in the lower left side of the abdomen and bloody diarrhoea (ischaemic colitis).
- Diarrhoea.
- If you have recently suffered an injury or have inflammation (such as rheumatism or inflammation of the colon), you may experience pain or worsening of pain at the site of injury or inflammation.
- Joint pain.
- Anxiety.
- Difficulty swallowing.
- Excessive sweating.
Reporting of adverse effects:
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Imigran Neo
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Imigran Neo:
The active substance is sumatriptan (as sumatriptan succinate). Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate).
The other components are calcium hydrogen phosphate, microcrystalline cellulose, sodium hydrogen carbonate, sodium croscarmellose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), iron oxide red (E172) and glyceryl triacetate.
Appearance of the product and contents of the pack
Imigran Neo is presented as film-coated tablets. The tablets are triangular-shaped and pink in colour. Each pack contains 4 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline, S.A.
P.T.M. C/ Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Tel: +34 900 202 700
Manufacturer:
Delpharm Poznan Spólka Akcyjna
ul. Grunwaldzka 189
60-322 Poznan
Poland
Date of the most recent review of this leaflet: August 2025.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/