Almotriptan Stada 12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Almotriptan Stada 12.5 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

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

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

Almotriptán Stada is an antimigraine medicinal product belonging to a class of compounds known as selective serotonin receptor agonists. Almotriptán is believed to reduce the inflammatory response associated with migraines by binding to serotonin receptors on cerebral (cranial) blood vessels, causing vasoconstriction.

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

2. What you need to know before taking Almotriptán Stada

Do not take Almotriptán Stada:

• 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 restricts blood flow to the heart, such as:

  • myocardial infarction
  • chest pain or discomfort usually occurring during physical activity or stress
  • heart problems without chest 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 large arteries in the arms or legs (peripheral vascular disease).

• If you are taking other migraine medications, including ergotamine, dihydroergotamine, methysergide, or another serotonin agonist (e.g., sumatriptan).

• If you have severe liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking almotriptan:

• 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 ringing in the ears or vertigo, brief paralysis of part of your body, paralysis of 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, if you are a postmenopausal woman, or if you are a man 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 may be more likely to experience increases in blood pressure).
• If you are taking SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). See also Taking Almotriptán Stada with other medicines.

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

Children and adolescents

Children under 18 years of age should not take almotriptan.

Elderly people (over 65 years of age)

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

Taking Almotriptán Stada 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-norepinephrine 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 spasms, 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 passed between doses:

• After taking almotriptan, wait at least 6 hours before taking ergotamine.
• After taking ergotamine, 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.

There is very limited information available on the use of almotriptan during pregnancy. Almotriptán STADA 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 using machines

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

Almotriptán Stada contains sodium

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

3. How to take Almotriptan Stada

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Almotriptan 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 12.5 mg 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 (12.5 mg) within 24 hours.

The tablet should be swallowed with liquid (e.g. water) and may be taken with or without food.

You should take almotriptan as soon as possible after the onset of a migraine attack, although it is also effective if taken somewhat later.

Severe renal impairment

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

If you take more Almotriptan Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount taken.

If you forget to take Almotriptan Stada

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

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

Frequent (may affect up to 1 in 10 people)

• dizziness
• drowsiness
• nausea
• vomiting
• fatigue

Uncommon (may affect up to 1 in 100 people)

• tingling, prickling, or numbness of the skin (paraesthesia)
• headache
• ringing, noises, or clicking sounds in the ears (tinnitus)
• pounding or racing heartbeat (palpitations)
• throat tightness
• diarrhoea
• 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)

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

Frequency unknown (cannot be estimated from available data)

• seizures
• allergic reactions (hypersensitivity reactions), including swelling of the mouth, throat, or hands (angioedema)
• severe allergic reactions (anaphylactic reactions)
• visual disturbance, blurred vision (visual disorders may also occur during a migraine attack itself)
• spasm of the blood vessels in the intestine, which may cause reduced blood flow and damage to the intestine. You may experience abdominal pain and bloody diarrhoea.

During treatment with almotriptan, inform your doctor immediately:

• if you have chest pain, tightness in the chest or throat, or any other symptom suggesting a heart attack. Please inform your doctor immediately and do not take any more almotriptan.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Almotriptan Stada

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

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

6. Package contents and other information

Composition of Almotriptan Stada

• The active substance is almotriptan. Each film-coated tablet contains 12.5 mg of almotriptan as almotriptan malate.
• The other components are:

Tablet core: mannitol (E-421), microcrystalline cellulose, povidone, sodium starch glycolate Type A from potato, and sodium stearyl fumarate.

Coating material: hypromellose (E-464), titanium dioxide (E-171), macrogol 400, and carnauba wax.

Appearance of the medicinal product and contents of the pack

Almotriptan Stada are white, film-coated, round, biconvex tablets.

Almotriptan Stada is available in packs containing 2, 3, 4, 6, 9, 12 or 14 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, H62 FH90

Ireland

Date of the most recent revision of this leaflet: July 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/