Riptanax 12.5 mg film-coated tablet EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Riptanax 12.5 mg film-coated tablets EFG

almotriptan

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

• Keep this leaflet, as 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Riptanax is and what it is used for

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

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

2. What you need to know before taking Riptanax

Do not take Riptanax

• 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 a condition that reduces blood flow to the heart, such as:

• myocardial infarction

• chest pain or discomfort that usually occurs during 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 large 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 hepatic disease

Warnings and precautions:

Talk to your doctor or pharmacist before taking Riptanax:

• 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, 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, if you smoke, have a family history of heart disease, are a postmenopausal woman, or a man over 40 years of age
• if you have mild or moderate liver disease
• if you have severe renal 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 below, Taking Riptanax 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 Riptanax.

Elderly patients (over 65 years of age)

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

Taking Riptanax 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, involuntary muscle contractions, 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, 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 only 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 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

Riptanax may 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 almotriptan film-coated tablet; this is essentially "sodium-free".

3. How to take Riptanax

Follow exactly the administration instructions for this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Riptanax should only be used to treat an already developed migraine attack 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 (of 12.5 mg) within 24 hours.

The tablets can be taken with liquid (e.g., water) and may 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 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 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. Telephone: 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Riptanax

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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, noises, or clicking sounds in the ears (tinnitus)
• strong heartbeats (palpitations)
• throat tightness
• diarrhea
• discomfort during digestion (dyspepsia)
• 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 blood vessels in the heart (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 intestinal blood vessels which may cause intestinal damage (intestinal ischemia). You may experience abdominal pain and bloody diarrhea.

During treatment with Riptanax, 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 further Riptanax tablets.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Riptanax Storage

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 outer packaging following 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. Instead, return any unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Riptanax

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 (E421), microcrystalline cellulose, povidone, sodium starch glycolate Type A from potato, sodium stearyl fumarate.

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

Appearance of the product and contents of the pack

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

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

Only certain 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

Further information about this medicinal product can be requested from the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.,
P.O. Box 36007
2832094 Madrid, Branch Office 36

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

Date of the last revision of this leaflet: January 2021

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