Package Insert: Information for the Patient

Riptanax 12.5 mg Film-Coated Tablets

almotriptán

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 for you only, 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.

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

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

Do not take Riptanax

• 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 vascular 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 selective serotonin receptor agonists (e.g. sumatriptan).
• if you have severe liver disease

Warnings and precautions:

Consult your doctor or pharmacist before starting to takeRiptanax:

• 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 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 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 noradrenaline reuptake inhibitors (SNRIs). See also below, TakingRiptanaxwith 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 takeRiptanax.

Older adults (over 65 years)

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

Taking Riptanax with other medications

Inform your doctor or pharmacist that you are taking or 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. 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 taking almotriptan.

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 medication.

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

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

Riptanax contains sodium

This medication contains less than 23 mg of sodium (1mmol) per 12.5mg of almotriptan film-coated tablets; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Adults (18-65 years)

The recommended dose is a 12.5 mg 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.

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

Riptanax should 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 Riptanax 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. Phone 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Riptanax

Try to take Almotriptan as prescribed. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience 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 clicking in the ears (tinnitus)
• palpitations
• throat constriction
• diarrhea
• indigestion when food is digested (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)

Of 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 (visual disturbances may also occur during a migraine attack itself)
• intestinal ischemia, which can cause intestinal damage. You may experience abdominal pain and bloody diarrhea.

During treatment with Riptanax, immediately inform your doctor:

• if you have chest pain, throat constriction, or any other symptoms that suggest a heart attack. Please inform your doctor immediately and do not take any other Riptanax tablets.

Reporting 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 Pharmacovigilance of Medicines 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 and packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines 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. By doing so, you will help protect the environment.

Composition ofRiptanax

The active principleis Almotriptán.

Each coated tablet contains 12.5 mg of almotriptán in the form of almotriptán malate

The other components:

Core tablet: Mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate Type A potato, sodium stearate fumarate.

Coating: Hypromellose (E464), titanium dioxide (E171), macrogol 400, carnauba wax

Appearance of the product and contents of the package

Riptanaxis presented as coated tablets with a white or almost white film-coated, round and biconvex.

Riptanax 12.5 mg coated tablets with EFG film coating are available in blister packs containing 2, 3, 4, 6, 9, 12 and 14 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Bluefish Pharmaceuticals AB,

P.O. Box 49013,

100 28 Stockholm,

Sweden

Responsible for manufacturing

Chanelle MedicalUnlimited Company, Loughrea, Co.Galway, Ireland

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medication is authorized in the member states of the European Economic Area with the following names:

Last reviewed date of this leaflet January 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/