Package Insert: Information for the Patient

Almotriptán Stada 12.5 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Almotriptán Stada is an anti-migraine medication that belongs to a class of compounds known as selective serotonin receptor agonists. It is believed that almotriptán reduces the inflammatory response associated with migraines by binding to the serotonin receptors of the cerebral blood vessels (cranial),causing their vasoconstriction.

Almotriptán is used to relieve the headaches associated with migraine attacks with or without aura.

Do not take Almotriptán Stada:

• If you are allergic to almotriptan or any of the other components of this medication (listed in section 6).
• If you have or have had any condition 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, mild, or moderate hypertension

• If you have had a stroke or reduced 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 medications for migraine, including ergotamine, dihydroergotamine, and methysergide or other serotonin agonists (e.g. sumatriptan).
• If you have severe liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take almotriptan:

• If your type of migraine has not been diagnosed.
• If you have an allergy (hypersensitivity) to antibiotics used to treat urinary tract infections (sulfonamides).
• If your headache symptoms are different from your usual migraine attacks, for example, you hear ringing in your ears or feel vertigo, have 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 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 Taking Almotriptán Stada with other medications.

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 almotriptan.

Older adults (over 65 years of age)

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

Taking Almotriptán Stada with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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, uncontrollable muscle spasms, 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 there is a minimum time 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, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Only limited information is available on the use of almotriptan during pregnancy. Almotriptan STADA should only be used during pregnancy if prescribed by your doctor and only after careful consideration of the balance between 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

Almotriptan Stada may cause drowsiness. If you experience this, you should not drive or use tools or machines.

Almotriptán Stada contains sodium

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

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

Almotriptán should only be used to treat a migraine attack that has already appeared and not to prevent migraine or headache attacks.

Adults (18-65 years)

The recommended dose is one 12.5 mg tablet that should be taken as soon as possible after the onset of the 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 tablet should be swallowed with liquid (e.g. water) and can be taken with or without food.

You should take almotriptán as soon as possible after the onset of a migraine crisis, although it is also effective if taken a bit 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 Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount taken.

If you forgot to take Almotriptán Stada

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

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

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)

• tingling, pins and needles, or numbness of the skin (paresthesia)
• headache
• ringing, buzzing, or clicking in the ears (tinnitus)
• 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)

• seizures
• allergic reactions (hypersensitivity reactions) including swelling of the mouth, throat, or hands (angioedema)
• severe allergic reactions (anaphylactic reactions)
• visual disturbances, blurred vision (migraine disorders may also occur during a migraine attack itself)
• intestinal blood vessel spasm that may cause inadequate blood flow and damage to your intestine. You may experience abdominal pain and diarrhea with blood.

Inform your doctor immediately during treatment with almotriptan:

• 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 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse 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 packaging, after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. This will help protect the environment.

Composition of Almotriptán Stada

• The active ingredient 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 glycolate Type A potato starch and sodium stearate fumarate.

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

Appearance of the product and content of the container

Almotriptán Stada are white, circular, biconvex film-coated tablets.

Almotriptán Stada is available in containers of 2, 3, 4, 6, 9, 12 or 14 tablets.

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

Chanelle Medical Unlimited Company

Dublin Road, Loughrea, H62 FH90

Ireland

Last review date of this leaflet:July 2021

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/