Almotriptan Vir 12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Almotriptán VIR 12.5 mg film-coated tablets EFG

almotriptan

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Almotriptán VIR is an antimigraine medication belonging to a class of compounds known as selective serotonin receptor agonists. Almotriptán VIR is believed to reduce the inflammatory response associated with migraines by binding to serotonin receptors on cerebral (cranial) blood vessels, causing vasoconstriction. Almotriptán VIR is used to relieve headache pain associated with migraine attacks, with or without aura.

2. What you need to know before taking Almotriptán VIR

Do not take Almotriptán 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 ever had any condition that reduces blood flow to the heart, such as:
  • myocardial infarction
  • chest pain or discomfort that usually occurs after physical activity or stress
  • heart problems without pain
  • chest pain occurring at rest
  • severe hypertension (very high blood pressure)
  • uncontrolled mild or moderate hypertension
• if you have had a stroke or reduced blood flow to the brain
• if you have had blockage of the major arteries in the arms or legs (peripheral vascular disease)
• if you are taking other migraine medications, including ergotamine, dihydroergotamine, 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 have an allergy (hypersensitivity) to antibacterial medicines used to treat urinary tract infections (sulfonamides)
• if your headache symptoms are different from your usual migraine attacks, for example, if you experience tinnitus or vertigo, brief paralysis of part of your body, or paralysis of the muscles controlling eye movement, or any other new symptom
• if you are at risk of heart disease, including uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, family history of heart disease, postmenopausal women, or men over 40 years of age
• if you have mild or moderate liver disease
• if you have severe kidney disease
• if you are over 65 years of age (since you are more likely to experience increases in blood pressure)
• if you are taking SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors). See also below, Taking Almotriptán VIR with other medicines.

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

Children and adolescents

Children under 18 years of age should not take Almotriptán VIR.

Elderly patients (over 65 years of age)

If you are over 65 years of age, 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 recently taken, or might need to take any other medicines.

Please inform your doctor:

• if you are taking any medicines for depression, such as monoamine oxidase inhibitors (e.g., moclobemide), selective serotonin reuptake inhibitors (e.g., fluoxetine), or serotonin-noradrenaline reuptake inhibitors (e.g., venlafaxine), as these medicines may cause serotonin syndrome, a potentially serious reaction. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle movements, or diarrhea.
• if you are taking preparations containing St. John's Wort (Hypericum perforatum), as this may increase the likelihood of adverse effects.

Almotriptan should not be taken at the same time as other medicines containing ergotamine, which are also used to treat migraine. However, both medicines may be taken one after the other, provided a minimum interval has elapsed 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.

Pregnancy and breastfeeding

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

Information on the use of almotriptan during pregnancy is very limited. Almotriptan should only be used during pregnancy if prescribed by your doctor and only after careful consideration of the benefit-risk balance.

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

Driving and use of machines

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 (1 mmol) 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.

Always follow the instructions for use provided in this leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults (18–65 years of age)

The recommended dose is one 12.5 mg almotriptan 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 following 24 hours, a second 12.5 mg tablet may be taken, provided that at least 2 hours have elapsed between the first and second tablet.

The maximum daily dose is two tablets (of 12.5 mg each) within 24 hours.

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

Almotriptán VIR should be taken as soon as possible after the onset of a migraine attack, although it may still be effective if taken somewhat later.

Severe renal impairment

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 medication 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 a missed dose.

If you have any further 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 experiences them.

Frequent (may affect up to 1 in 10 people)

• dizziness
• somnolence
• nausea
• vomiting
• fatigue

Uncommon (may affect up to 1 in 100 people)

• tingling, itching, or numbness of the skin (paresthesia)
• headache
• ringing, buzzing, or whistling sounds in the ears (tinnitus)
• strong or rapid heartbeat (palpitations)
• throat tightness
• diarrhea
• discomfort during digestion (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)

• Spasm of blood vessels in the heart (coronary vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (tachycardia)

Frequency not known (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 disorders may also occur during a migraine attack itself)
• spasm of blood vessels in the intestine, which may cause reduced blood flow and damage to the intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with Almotriptan, contact your doctor immediately:

• if you experience chest pain, chest tightness, throat tightness, or any other symptom suggesting a heart attack. Please contact your doctor immediately and do not take any further Almotriptan tablets.

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Almotriptan VIR

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

Do not use this medicine after the expiry date stated on the blister and outer packaging following the word "EXP". The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the container and other information / Other information

Composition of Almotriptan VIR

The active substance is almotriptan 12.5 mg (as almotriptan D,L-malic acid salt).

The other components are:

Tablet core: Mannitol, microcrystalline cellulose, povidone, sodium starch glycolate from potato (type A), stearic fumarate and sodium.

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

Appearance of the medicinal product and content of the container

Almotriptan VIR are film-coated tablets, smooth, white, round and biconvex.

Almotriptan VIR is available in packs containing 3, 4, 6, 9 or 12 tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent revision of this leaflet: October 2023