Leaflet: information for the user

Imigran Neo 50 mg film-coated tablets

Sumatriptan (as sumatriptan succinate)

Read this 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 must not give it to otherseven if they have the same symptoms as you, as it may harm them.

-Ifyouexperienceside effects, consult your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Imigran Neo contains the active ingredient sumatriptan and belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).

This medicine is indicated to relieve headache pain and other symptoms of a migraine attack.

The dilation of blood vessels in the head is considered to be the cause of the headache that appears in a migraine. This medicine constricts the blood vessels in the head and relieves the symptoms of a migraine.

Do not take Imigran Neo

• if you are allergicto sumatriptan or any of the other ingredients of this medicine (listed in section 6)
• if you have heart problemssuch as narrowing of the arteries(coronary heart disease)or chest pain(angina), or have had a heart attack
• if you have circulation problems in your legsthat cause pain, such as cramps when walking(peripheral vascular disease)
• if you have had a strokeor a mini-stroke(also known as transient ischaemic attack or TIA)
• if you have high blood pressure. You can take Imigran Neoif your blood pressure is slightly elevated and you are being treated
• if you have liver disease,consult your doctor. If your 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 triptan/5-HT1 receptor agonist(medicines also used to treat migraine)
• with antidepressants called MAOIs(monoamine oxidase inhibitors),or if you have taken these medicines in the last two weeks

If any of these cases apply to you

?Inform your doctor, and do not use Imigran Neo.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Imigran Neo.

Before taking Imigran Neo, your doctor needs to knowif you have any extra risk factors for heart disease:

• if you are a man over 40 years old
• if you are a woman who has started the menopause
• if you smoke or are overweight
• if you have diabetes or high cholesterol
• if you have a family history of heart disease.

In very rare cases, people have developed severe heart problems after usingImigran Neo, even if they did not have any signs of heart disease beforehand. If any of the above points happen to you, it may mean that you have a higher risk of developing heart disease, so

?Inform your doctor to check your heart functionbefore Imigran Neo is prescribed for you.

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(convulsions)

Or if you have other conditions that may make you more likely to have seizures – for example, a head injury or alcoholism.

?Inform your doctor to be closely monitored.

If you are allergic to sulphonamide antibiotics

If you are, you may also be allergic toImigran Neo. If you know you are allergic to antibiotics, but are not sure if it is a sulphonamide

?Inform your doctor or pharmacist before usingImigran Neo.

If you are taking antidepressants called SSRIs(Selective Serotonin Reuptake Inhibitors)orSNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)

?Inform your doctor or pharmacist before usingImigran Neo.See also below,Other medicines and Imigran Neo.

If you useImigran Neofrequently

A frequent use ofImigran Neomay make your headaches worse.

?Inform your doctor if this happens to you.Your doctor may recommend that you stop usingImigran Neo.

If you feel pain or pressure in your chest 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

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. This includes any herbal remedies or medicines that have been bought without a prescription.

Some medicines should not be taken with Imigran Neo and others may cause side effects if taken with Imigran Neo.Inform your doctor if you are taking other medicines, such as:

• ergotamineis also used to treat migraine,or similar medicines like methysergide (see section 2 Do not takeImigran Neo). Do not useImigran Neoat the same time as these medicines. Stop taking these medicines at least 24 hours before usingImigran Neo. Do not take any other medicine that contains ergotamine or similar compounds to ergotamine for at least 6 hours after usingImigran Neo
• other triptans/5-HT1 receptor agonists(such as naratriptan, rizatriptan, zolmitriptan),also used to treatmigraine,(see section 2 Do not takeImigran Neo). Do not useImigran Neoat the same time as these medicines. Stop taking these medicines at least 24 hours before usingImigran Neo. Do not take another triptan/5-HT1 receptor agonist for at least 24 hours after usingImigran Neo
• SSRIs(Selective Serotonin Reuptake Inhibitors)orSNRIs(Serotonin and Noradrenaline Reuptake Inhibitors)used to treatdepression. The use ofImigran Neowith 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). Inform your doctor immediately if you are affected in this way
• MAOIs(monoamine oxidase inhibitors)used to treatdepression. Do not use Imigran Neo if you have taken these medicines in the last two weeks
• St John's Wort(Hypericum perforatum). You are more likely to experience side effects if you take herbal remedies that contain St John's Wort while usingImigran Neo.

Fertility, pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning 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 you should or should not use Imigran Neo while pregnant.

You should not breastfeed your baby for at least12 hours after taking Imigran Neo. If you express milk during this time, discard the milk and do not give it to your baby.

Driving and using machines

This medicine, like migraine, can cause drowsiness. If you experience these effects, avoid driving or using machines as it may be dangerous.

Imigran Neo contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Only use Imigran Neo after your migraine headache has started.

Do not use Imigran Neo to prevent a migraine attack.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Imigran Neo. Do not discontinue treatment before.

The tablets should be taken as soon as the symptoms of migraine appear; however, they can be taken at any time during an attack.

Administration is not recommended for children, adolescents under 18 years old, or elderly patients.

The recommended dose of Imigran Neo is one 50 mg tablet, although some patients may need a dose of 100 mg (two 50 mg tablets).

If you obtain an improvement of symptoms after the first dose, but symptoms reappear, you can take a second Imigran Neo tablet, at least two hours after the first dose.

If you do not obtain improvement after administration of a dose, do not take a second dose for the same migraine attack. Imigran Neo can be taken for subsequent attacks.

If you do not observe relief of symptoms with Imigran Neo, you can take your usual medication for headache, as long as 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, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you forgot to take Imigran Neo

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Imigran Neocan cause side effects, although not everyone will experience them.

Some of these symptoms may be caused by the migraine itself.

Allergic reactions: seek medical help immediately

• The following side 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 (chest wheezing); swollen eyelids, face, or lips, complete collapse.

If you notice any of these symptoms shortly after usingImigran Neo:

?Do not use it again.Contact your doctor immediately.

Frequent side effects

(affects up to1 in 10people)

• Pain, heaviness, pressure, oppression, or pain in the chest, throat, or other parts of the body, or unusual sensations, including numbness, tingling, and heat or cold. These effects can be intense, but generally disappear quickly.

If these effects persist or worsen(especially chest pain):

?Seek urgent medical help.In a reduced number of people, these symptoms may be caused by heart attacks.

Other frequent side effects include:

• Nausea or vomiting, although this may be due to the migraine itself.
• Tiredness or drowsiness.
• Dizziness, feeling weak, or hot flushes.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.

Rare side effects

(affects up to1 in 10,000people)

• Abnormalities in liver function. Inform your doctor or nurse that you are takingImigran Neo, if you are to have a blood test to check liver function.

Some patients may experience any of the following side effects, but the frequency with which they occur is unknown

• Seizures/attacks, tremors, muscle spasms, neck stiffness.
• Visual disturbances such as blinking, reduced vision, double vision, loss of vision, and in some cases, even permanent defects (although these may be due to the migraine attack itself).
• Cardiac problems, in which the heart may beat faster, slower, or with changes in rhythm, chest pain (angina) or heart attack.
• Pallor, blue skin, and/or pain in the fingers of the hands, toes, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon).
• Pain in the lower left abdomen and bloody diarrhea (ischemic colitis).
• Diarrhea.
• If you have had a recent injury or have inflammation (such as arthritis or colon inflammation), you may experience pain or worsening of pain at the site of the injury or inflammation.
• Joint pain.
• Anxiety.
• Difficulty swallowing.
• Excessive sweating.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Imigran Neo:

The active ingredient 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 triacetin glycerol.

Appearance of the product and contents of the packaging

Imigran Neo is presented in the form of coated tablets. The tablets are triangular in shape, pink in color. Each package contains 4 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Phone: +34 900 202 700

[email protected]

Responsible manufacturer:

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Last review date of this leaflet: September 2020.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/