IMIGRAN NEO 50 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Imigran Neo 50 mg Film-Coated Tablets

Sumatriptan (as sumatriptan succinate)

Read all of this leaflet carefully before you start taking 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Imigran Neo and what is it used for
2. What you need to know before you take Imigran Neo
3. How to take Imigran Neo
4. Possible side effects
5. Storing Imigran Neo
6. Contents of the pack and other information

1. What is Imigran Neo and what is it used for

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

This medicine is indicated for the relief of headache and other symptoms of a migraine attack.

It is thought that the dilation of blood vessels in the brain is the cause of the headache that occurs during a migraine. This medicine constricts the blood vessels in the brain and relieves the symptoms of migraine.

2. What you need to know before you take Imigran Neo

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 (ischemic heart disease)or chest pain (angina), or have had a heart attack
• if you have circulation problems in your legsthat cause pain when walking (peripheral vascular disease)
• if you have had a strokeor a mini-stroke (also called a transient ischemic attack or TIA)
• if you have high blood pressure. You can use Imigran Neo if your blood pressure is slightly elevated and is being treated
• if you have liver disease,consult your doctor. If the liver disease is severe, Imigran Neo is not suitable for you
• with other anti-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

?Tell 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 know if 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 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 serious heart problems after using Imigran Neo, even though they had no previous signs of heart disease. If any of the above points apply to you, it may mean that you have a higher risk of developing heart disease, so

?Tell 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.

?Tell your doctor to be monitored more closely.

If you are allergic to antibiotics called sulfonamides

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

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

If you useImigran Neofrequently

Too frequent use of Imigran Neo may worsen your headaches.

?Tell your doctor if this happens to you.Your doctor may recommend that you stop using Imigran Neo.

If you feel pain or pressure in your chest after using Imigran Neo

These effects can be intense but usually pass quickly. If they do not pass quickly or become more severe:

?Get medical help immediately.See section 4 of this leaflet, which contains more information on these possible side effects.

Other medicines and Imigran Neo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes any herbal products or medicines that you have bought without a prescription.

Some medicines must 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:

• ergotamineused to treat migraine,or similar medicines like 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 that contains ergotamine or ergotamine-like compounds until at least 6 hours after using Imigran Neo
• other triptans/5-HT1 receptor agonists1(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 for 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 can cause serotonin syndrome (a set of symptoms that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate, and agitation). Tell your doctor immediately if you are affected in this way
• MAOIs(monoamine oxidase inhibitors)used to treat depression. 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 you are using Imigran Neo.

Fertility, pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, 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 you are pregnant.

Do not breastfeed your baby before12 hours have passed since you took Imigran Neo. If you express breast 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 notice these effects, avoid driving or using machines, as it can 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 of administration of this medicine 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 medicine.

Your doctor will tell you how long to take Imigran Neo. Do not stop 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.

It is not recommended to administer to children, adolescents under 18 years of age, 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 there is an improvement in symptoms after the first dose, but the symptoms recur, a second Imigran Neo tablet can be taken at least two hours after the first dose.

If there is no improvement after taking a dose, a second dose should not be taken for the same migraine attack. Imigran Neo can be taken for subsequent attacks.

In case of not observing 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 medicine and the amount taken.

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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Imigran Neo can cause side effects, although not everybody gets them.

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

Allergic reactions: get 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 (whistling in the chest); swelling of the eyelids, face or lips, collapse.

If you notice any of these symptoms soon after using Imigran Neo:

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

Common side effects

(affects up to 1 in 10people)

• Pain, heaviness, pressure, tightness, or pain in the chest, throat, or other parts of the body, or unusual sensations, including numbness, tingling, and warmth or cold. These effects can be intense but usually pass quickly.

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

?Get urgent medical help. In a small number of people, these symptoms can be caused by heart attacks.

Other common side effects include:

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

Very rare side effects

(affects up to 1 in 10,000people)

• Liver function changes. Tell your doctor or nurse that you are taking Imigran Neo if you are going to have a blood test to check your 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, stiffness of the neck.
• 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).
• Heart problems, in which the heart may beat faster, slower, or with changes in rhythm, chest pain (angina) or heart attack.
• Pallor, bluish skin and/or pain in the fingers of the hands, fingers of the feet, 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 if you have inflammation (such as rheumatism or colon inflammation), you may experience pain or worsening of pain at the site of the injury or inflammation.
• Pain in the joints.
• Anxiety.
• Difficulty swallowing.
• Excessive sweating.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium hydrogen carbonate, sodium croscarmellose, magnesium stearate, hypromellose (E464), titanium dioxide (E171), red iron oxide (E172), and glycerol triacetate.

Appearance of the product and contents of the pack

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

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

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Delpharm Poznan Spólka Akcyjna

ul. Grunwaldzka 189

60-322 Poznan

Poland

Date of last revision of this leaflet:September 2020.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/