Package Insert:Information for the User

AlmotriptánCombix12.5 mg Film-Coated Tablets

Read the entire package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist or nurse.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Package Insert Content

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

2.What you need to know before starting to take Almotriptán Combix

3.How to take Almotriptán Combix

4.Possible adverse effects

5.Storage of Almotriptán Combix

6.Contents of the package and additional information

AlmotriptánCombixis an antimigraine medication that belongs to a class of compounds known as selective serotonin receptor agonists.

AlmotriptánCombixis believed to reduce the inflammatory response associated with migraines by binding to the serotonin receptors of the cerebral blood vessels (cranium), causing vasoconstriction.

AlmotriptánCombixis used to relieve headaches associated with migraine attacks with or without aura.

Do not take AlmotriptánCombix

• If you are allergic to almotriptán or any of the other components of this medication (listed in section 6).
• If you have or have 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,
• Cardiac problems without pain,
• Chest pain that occurs at rest,
• Severe hypertension (very high blood pressure),
• Uncontrolled hypertension, mild or moderate

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

Warnings and precautions

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

• If your type of migraine has not been diagnosed,
• If you have an allergy (hypersensitivity) to antibiotics used for the treatment of urinary tract infections (sulfonamides),
• If your headache symptoms are different from your usual migraine symptoms, for example, you hear ringing in your ears or feel vertigo, have a brief paralysis of a part of your body or paralysis of the muscles that control your eye movement, or any other new symptom,
• If you have a risk of developing heart disease, including high blood pressure and uncontrolled, high cholesterol, obesity, diabetes, are a smoker, have a family history of heart disease, are a postmenopausal womanor are a male 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 increased blood pressure,
• If you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs). See also below “Taking AlmotriptánCombixwith other medications”.

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

Children and adolescents

Children under 18 years should not take AlmotriptánCombix.

Over 65 years of age

Ifyouareover65years,youshouldconsultwithyourdoctorbeforetakingthismedication.

Taking AlmotriptánCombixwith other medications

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

Please inform your doctor:

• If you are taking any medication 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 medications may causeserotonin syndrome, a potentially very serious treatment reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle movements or diarrhea,
• If you are taking preparations based on St. John's Wort (Hypericum perforatum), as it may increase the likelihood of adverse effects.

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

• After taking almotriptán, 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 almotriptán.

Taking AlmotriptánCombixwith food and drinks

AlmotriptánCombixcan be taken regardless of meals.

Pregnancy and lactation

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

There is very limited information available on the use of almotriptán during pregnancy. AlmotriptánCombixshould only be used during pregnancy if prescribed by your doctor and only after careful consideration of the balance of benefits and risks.

Care should be taken when using this medication during breastfeeding. You should avoid breastfeeding for 24 hours after treatment.

Driving and operating machinery

This medication, like migraine, may cause drowsiness If you experience these effects, avoid driving or operating machinery as it may be hazardous.

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

AlmotriptánCombixshould only be used to treat a migraine attack that has already appeared and not to prevent migraine attacks or headaches.

Adults (18-65 years)

The recommended dose is one AlmotriptánCombixtablet (12.5 mg of almotriptan) that should 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 after at least2 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 a liquid (e.g., water) and can be taken with or without food.

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

Severe renal disease

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

If you take more AlmotriptánCombixthan you should

If you accidentally take too many AlmotriptánCombixtablets, or if another person or child takes this medication, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take AlmotriptánCombix

Try to take AlmotriptánCombixas prescribed. Do not take a double dose to make up for the missed dose.

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

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

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

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

• headache,
• ringing, buzzing, or clicking sounds (tinnitus),
• strong heartbeats (palpitations),
• throat constriction,
• diarrhea,
• discomfort when digesting food (dyspepsia),
• dry mouth,
• muscle pain (myalgia),
• bone pain,
• chest pain,
• sensation of weakness (asthenia).

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

• spasm of the coronary blood vessels (coronary vasospasm),
• heart attack (myocardial infarction),
• increased heart rate (tachycardia).

Unknown frequency(cannot be estimated from 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 may also occur during a migraine attack itself).

During treatment with AlmotriptánCombix, inform your doctor immediately:

• If you experience chest pain, throat constriction or any other symptom that may suggest a heart attack. Please inform your doctor immediately and do not take any other AlmotriptánCombixtablets.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist or nurse, 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:https://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.

No special storage conditions are required.

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.

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

Composition of AlmotriptánCombix

• The active ingredient is almotriptán.

Each coated tablet contains 12.5 mg of almotriptán (in the form of almotriptán malate).

• The other components are: Tablet core: mannitol (E421), microcrystalline cellulose (E460i), potato starch, povidone K30, sodium fumarate estearate (E470a) and magnesium stearate (E470b). Tablet coating: Opadry white 03F580010 (hypromellose (E464),dióxidode titanio(E171),macrogol 4000 (E1521) andtalco (E553b)).

Appearance of the product and contents of the packaging

Coated tablets with white or off-white film, round, biconvex, smooth on both faces.

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

AlmotriptánCombixis available in packaging of4and6 tablets. Some packaging sizes may only be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz, 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: October 2014.

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