ALMOTRIPTAN VIR 12.5 mg FILM-COATED TABLETS

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

Do not takeAlmotriptán VIR:

• if you are allergic to almotriptán 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
• painless cardiac problems
• 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 to combat migraines, 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 taking Almotriptán VIR:

-if your type of migraine has not been diagnosed

• if you are allergic (hypersensitive) to antibacterial medications 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 a 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, SSRIs (selective serotonin reuptake inhibitors), or SNRIs (serotonin and norepinephrine reuptake inhibitors). 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 old should not take Almotriptán VIR.

Elderly patients (over 65 years old)

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

Taking Almotriptán VIR with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 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 this may increase the likelihood of experiencing side effects.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is only limited information available on the use of almotriptán during pregnancy. Almotriptán should only be used during pregnancy if prescribed by your doctor and only after carefully considering the balance of 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

Almotriptán VIR may cause drowsiness. If you experience this, do 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".

3. How to take Almotriptán VIR

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor. If you are unsure, ask your doctor or pharmacist.

Adults (18-65 years)

The recommended dose is one 12.5 mg almotriptán tablet, which 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 for the same attack.

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

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

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

AlmotriptánVIR 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 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 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. Telephone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Almotriptán VIR

Try to take Almotriptán VIR as prescribed. 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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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, buzzing, or hissing in the ears (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 (coronary 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 disorders may also occur during a migraine attack itself).
• Spasm of the blood vessels of the intestine that can cause lack of blood flow and damage to the intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with Almotriptán, inform your doctor immediately:

• if you experience chest pain, tightness in the chest or throat, or any other symptoms that may suggest a heart attack. Please inform your doctor immediately and do not take any further Almotriptán tablets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Almotriptán VIR

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after "EXP". The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Almotriptán VIR

The active substance is almotriptán 12.5 mg (as almotriptán D,L-malate).

The other ingredients are:

Core of the tablet: Mannitol, microcrystalline cellulose, povidone, potato starch glycolate (type A), fumaric acid stearate, and sodium.

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

Appearance of the product and contents of the pack

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

Almotriptán VIR is available in packs containing 3, 4, 6, 9, or 12 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

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

Date of last revision of this leaflet: October 2023