ALMOTRIPTAN COMBIX 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for theuser

AlmotriptanCombix12.5 mg film-coated tabletsEFG

Read the entirepackage leaflet carefullybefore starting to take this medicine,asit containsimportantinformationforyou.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of thepackage leaflet:

1. What Almotriptan Combix is and what it is used for
2. What you need to know before taking Almotriptan Combix
3. How to take Almotriptan Combix
4. Possible side effects
5. Storage of Almotriptan Combix
6. Package contents and additional information

1. What Almotriptan Combix is and what it is used for

Almotriptan Combix is an antimigraine drug that belongs to a class of compounds known as selective serotonin receptor agonists. It is believed that Almotriptan Combix reduces the inflammatory response associated with migraines by binding to serotonin receptors in cerebral blood vessels, causing vasoconstriction.

Almotriptan Combix is used to relieve headache pain associated with migraine attacks with or without aura.

2. What you need to know before taking Almotriptan Combix

Do not take AlmotriptanCombix

• If you are allergic to almotriptan or any of the other ingredients of this medicine (listed in section 6).
• If you have or have ever had any disease that limits blood flow to the heart, such as:

• Myocardial infarction,
• Chest pain or discomfort that occurs normally after physical activity or stress,
• Silent cardiac disease,
• Chest pain that occurs at rest,
• Severe hypertension (very high blood pressure),
• Uncontrolled, mild, or moderate hypertension

• If you have had a stroke or a reduction in cerebral blood flow,
• If you have had an obstruction of the large arteries of the arms or legs (peripheral vascular disease),
• If you are taking other medicines for migraine, including ergotamine, dihydroergotamine, and methysergide or another selective serotonin receptor agonist (e.g., sumatriptan),
• If you have severe liver disease.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Almotriptan Combix:

• If your type of migraine has not been diagnosed,
• If you are allergic (hypersensitive) to antibacterial medicines used to treat urinary tract infections (sulfonamides),
• If the symptoms of your headache are different from those of your usual migraine attacks, for example, you hear noise in your ears or feel dizzy, you have brief paralysis of a part of your body or paralysis of the muscles that control your eye movements, or any other new symptoms,
• If you are at risk of having heart disease, including high blood pressure and uncontrolled high blood pressure, high cholesterol, obesity, diabetes, are a smoker, have a family history of heart disease, are a postmenopausal woman, or are a man over 40 years old
• If you have mild or moderate liver disease,
• If you have severe kidney disease,
• If you are over 65 years old, as you are more likely to experience increases in blood pressure,
• If you are taking antidepressants, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs). See also "Taking Almotriptan Combix with other medicines" below.

It has been suggested that excessive use of antimigraine medicines may lead to chronic headache.

Children and adolescents

Children under 18 years old should not take Almotriptan Combix.

Over 65 years old

If you are over 65 years old, you should consult your doctor before taking this medicine.

Taking Almotriptan Combix with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

Please inform your doctor:

• If you are taking any medicine for depression, such as monoamine oxidase inhibitors (e.g., moclobemide), selective serotonin reuptake inhibitors (e.g., fluoxetine), or serotonin and norepinephrine reuptake inhibitors (e.g., venlafaxine), as these medicines may cause serotonin syndrome, a potentially very serious reaction to treatment. The symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrolled muscle movements, or diarrhea,
• If you are taking St. John's Wort (Hypericum perforatum) preparations, as they may increase the risk of side effects.

Almotriptan should not be taken at the same time as other medicines that contain ergotamine, which are also used to treat migraine. However, both medicines can be taken one after the other, provided that a minimum amount of time has passed between doses:

• After taking almotriptan, it is recommended to wait at least 6 hours before taking ergotamine,
• After taking ergotamine, it is recommended to wait at least 24 hours before taking almotriptan.

Taking Almotriptan Combix with food and drinks

Almotriptan Combix can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is only limited information available on the use of almotriptan during pregnancy. Almotriptan Combix should only be used during pregnancy if prescribed by your doctor and only after careful consideration of the benefits and risks.

Caution should be exercised when using this medicine during breastfeeding. You should avoid breastfeeding during the 24 hours following treatment.

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.

3. How to take Almotriptan Combix

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

Almotriptan Combix should only be used to treat a migraine attack that has already started and not to prevent migraine attacks or headaches.

Adults (18-65 years)

The recommended dose is one Almotriptan Combix tablet (12.5 mg of almotriptan) to be taken as soon as possible after the onset of a migraine attack. If the attack does not subside, do not take more than one tablet.

If you experience a second attack within the next 24 hours, you can take a second tablet of 12.5 mg, but only if at least 2 hours have passed between the first and second tablets.

The maximum daily dose is two tablets of 12.5 mg in 24 hours.

The tablets can be taken with liquid (e.g., water) and can be taken with or without food.

Almotriptan Combix should be taken as soon as possible after the onset of a migraine attack, although it is also effective if taken later.

Severe kidney disease

If you have severe kidney disease, do not take more than one tablet of 12.5 mg in 24 hours.

If you take more Almotriptan Combix than you should

If you accidentally take too many Almotriptan Combix tablets, or if someone else or a child takes this medicine, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Almotriptan Combix

Try to take Almotriptan Combix as prescribed. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common(may affect up to 1 in 10 people)

• dizziness,
• drowsiness,
• nausea,
• vomiting,
• fatigue

Uncommon(may affect up to 1 in 100 people)

• tingling, itching, or numbness of the skin (paresthesia),

• headache,
• ringing, noises, or clicking (tinnitus),
• strong heartbeat (palpitations),
• throat tightness,
• diarrhea,
• indigestion (dyspepsia),
• dry mouth,
• muscle pain (myalgia),
• bone pain,
• chest pain,
• feeling of weakness (asthenia).

Rare(may affect up to 1 in 10,000 people)

• coronary artery spasm (vasospasm),
• heart attack (myocardial infarction),
• increased heart rate (tachycardia).

Frequency not known(cannot be estimated from the available data)

• allergic reactions (hypersensitivity reactions), including swelling of the mouth, neck, or hands (angioedema)
• severe allergic reactions (anaphylactic reactions)
• seizures
• visual disturbances, blurred vision (visual disturbances can also occur during a migraine attack itself).

During treatment with Almotriptan Combix, inform your doctor immediately:

• If you have chest pain, tightness in the chest or throat, or any other symptoms that may indicate a heart attack. Please inform your doctor immediately and do not take any more Almotriptan Combix tablets.

Reporting of side effects:

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Almotriptan Combix

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Almotriptan Combix

• The active ingredient is almotriptan.

Each film-coated tablet contains 12.5 mg of almotriptan (as almotriptan malate).

• The other ingredients are: Tablet core: mannitol (E421), microcrystalline cellulose (E460i), potato starch, povidone K30, sodium stearyl fumarate (E470a), and magnesium stearate (E470b). Tablet coating: Opadry white 03F580010 (hypromellose (E464), titanium dioxide (E171), macrogol 4000 (E1521), and talc (E553b)).

Appearance of the product and package contents

White or almost white, round, biconvex, smooth film-coated tablets.

PVC/PVDC-Aluminum and OPA/Al/PVC-Aluminum blisters, standard or single-dose.

Almotriptan Combix is available in packs of 4 and 6 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the last revision of this package leaflet: October 2014.

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/.