Prospecto: information for the user

Almotriptán VIR 12.5 mg film-coated tabletsEFG

almotriptán

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

- Keep this prospectus, as you may need to read it again.

- If you have any doubts, consult your doctor, pharmacist, or nurse.

- This medicine has been prescribed only for you, and you must 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 prospectus. See section 4.

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

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

3.How to take Almotriptán VIR

4.Possible adverse effects

5Storage of Almotriptán VIR

6. Contents of the pack and additional information

Almotriptán VIR is a migraine-preventing medication that belongs to a class of compounds known as selective serotonin receptor agonists. It is believed that Almotriptán VIR reduces the inflammatory response associated with migraines by binding to the serotonin receptors of the cerebral (cranial) blood vessels, causing vasoconstriction. Almotriptán VIR is used to alleviate the headaches associated with migraine attacks with or without aura.

Do not takeAlmotriptán VIR:

- if you are allergic to almotriptan or to any of the other ingredients of this medicine (listed in section 6).

- if you have or have had any disease that limits the blood supply 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 peripheral artery disease (obstruction of the large arteries of the arms or legs)

- if you are taking other migraine medications, 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 Almotriptán VIR:

- if your type of migraine has not been diagnosed

- if you are allergic (hypersensitive) to antibiotics used to treat 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 dizzy, 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 are at 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 woman or a man over 40 years old

- if you have mild or moderate liver disease

- if you have kidney diseasesevere

- 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 noradrenaline reuptake inhibitors (SNRIs). See also below, Taking Almotriptán VIR with other medicines.

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 Almotriptán VIR.

Older adults (over 65 years of age)

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

Taking Almotriptán VIR with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Please inform your doctor:

- if you are taking any medication for depression such as monoamine oxidase inhibitors (e.g. meclobemide), selective serotonin reuptake inhibitors (e.g. fluoxetine) or serotonin and noradrenaline 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.

Almotriptan 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 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 takingalmotriptan.

Pregnancy and breastfeeding

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

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

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

Driving and operating machinery

Almotriptán VIR may cause drowsiness. If you experience this, you should not drive or operate machinery.

Almotriptán VIR contains sodium

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

Almotriptán VIR should be used to treat a migraine attack that has already started and not to prevent migraine attacks or headaches.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Adults (18-65 years)

The recommended dose is a 12.5 mg almotriptán tablet that should be taken as soon as possible after the onset of a migraine crisis. If the crisis does not subside, do not take more than one tablet for the same crisis.

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

The maximum daily dose is two tablets (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.

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

Severe kidney disease

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

If you take more Almotriptán VIR than you should

If you accidentally take too many tablets, 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. Telephone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Almotriptán VIR

Try to take Almotriptán VIR as prescribed. Do not take a double dose to make up for the missed doses.

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.

Frequent(may affect up to 1 in 10 people)

• dizziness

• drowsiness

• nausea

• vomiting

• fatigue

Infrequent(may affect up to 1 in 100 people)

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

• headache

• ringing, buzzing, or hissing in the ears (tinnitus)

•strong heartbeats (palpitations)

• throat constriction

• diarrhea

• discomfort when digesting food (dyspepsia)

• dry mouth

• muscle pain (myalgia)

• bone pain

• chest pain

• feeling of weakness (asthenia)

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

• coronary artery spasm

• 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 crisis itself)
• intestinal blood vessel spasm that can cause poor blood flow and damage to your intestine. You may experience abdominal pain and bloody diarrhea.

During treatment withAlmotriptán, immediately inform your doctor:

• if you have chest pain, throat constriction, or any other symptom that suggests a heart attack. Please inform your doctor immediately and do not take any otherAlmotriptántablets.

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 the Pharmacovigilance of Medicinal Products 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 use this medication after the expiration date that appears on the blister pack and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

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 point at 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 Almotriptán VIR

The active principle is almotriptan 12.5 mg (in the form of almotriptan D,L-malate acid).

The other components are:

Tablet core: Mannitol, microcrystalline cellulose, povidone, glicolatoalmond of sodium of potato (type A), stearate of fumarate and sodium.

Coating: Hypromellose, titanium dioxide (E-171), Macrogol 400.

Appearance of the product and contents of the packaging

Almotriptán VIR are film-coated, smooth, white, circular, and biconvex tablets.

Almotriptán VIR is available in boxes containing 3, 4, 6, 9, or 12 tablets. Some packaging sizes may only be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Responsible manufacturer

GALENICUM HEALTH, S.L.U.

San Gabriel, 50

08950 Esplugues de Llobregat (Barcelona), Spain

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

SAG MANUFACTURING S.L.U.

Carretera Nacional I, Km. 36

28750 San Agustin de Guadalix, Spain

Last review date of this leaflet October 2023