RIPTANAX 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Riptanax 12.5 mg Film-Coated Tablets EFG

almotriptan

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Riptanax and what is it used for
2. What you need to know before you take Riptanax
3. How to take Riptanax
4. Possible side effects
5. Storage of Riptanax
6. Package Contents and Further Information

1. What is Riptanax and what is it used for

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

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

2. What you need to know before you take Riptanax

Do not take Riptanax

• if you are allergic to almotriptan 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:

• heart attack
• chest pain or discomfort that occurs normally after physical activity or stress
• pain-free heart problems
• chest pain that occurs at rest
• severe high blood pressure (very high blood pressure)
• uncontrolled, mild, or moderate high blood pressure

• 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:

Talk to your doctor or pharmacist before taking Riptanax:

• 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 levels, obesity, diabetes, if you are a smoker, if you have a family history of heart disease, if you 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 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 Riptanax 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 Riptanax.

Elderly Patients (over 65 years old)

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

Taking Riptanax with other medicines

Tell your doctor or pharmacist that you are taking or have recently taken or may need to 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 can cause serotonin syndrome, a potentially very serious reaction. 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 preparations (Hypericum perforatum), as it may increase the likelihood of experiencing side effects.

Almotriptan should not be taken at the same time as other medications containing ergotamine, which are also used to treat migraines. However, both medications can be taken one after the other, provided that a minimum amount of time has passed 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is only 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 carefully considering the balance of benefits and risks.

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

Driving and Using Machines

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

Riptanax contains sodium

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

3. How to take Riptanax

Follow the instructions for administration of this medicine contained in this package leaflet or as 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 occurred and not to prevent migraine attacks or headaches.

Adults (18-65 years old)

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 next 24 hours, you can take a second 12.5 mg tablet, but always provided that 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.

Riptanax 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 Riptanax 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. Phone 915 620 420, indicating the medicine and the amount taken.

If you forget to take Riptanax

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, ask your doctor or pharmacist.

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, noise, or clicking in the ears (tinnitus)
• strong heartbeat (palpitations)
• throat tightness
• diarrhea
• indigestion
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling of weakness (asthenia)

Rare:may affect up to 1 in 10,000 people

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

Frequency not known:cannot be estimated from the 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 disorders may also occur during a migraine attack itself)
• spasm of the intestine's blood vessels that can cause intestinal damage (intestinal ischemia). You may experience abdominal pain and bloody diarrhea.

Tell your doctor immediately:

• if you have 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 more Riptanax tablets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet.

You can also report side effects directly to the Spanish Medicines Surveillance System for human use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Riptanax

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Further Information

Composition of Riptanax

The active substance is Almotriptan.

Each film-coated tablet contains 12.5 mg of almotriptan in the form of almotriptan malate.

The other ingredients are:

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

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

Appearance of the product and package contents

Riptanax is presented as white or almost white, round, and biconvex film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder

Bluefish Pharmaceuticals AB,

P.O. Box 49013,

100 28 Stockholm,

Sweden

Manufacturer

Chanelle Medical Unlimited Company, Loughrea, Co. Galway, Ireland

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

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Branch 36

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this package leaflet January 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/