ALMOTRIPTAN STADA 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Almotriptan Stada 12.5 mg Film-Coated Tablets EFG

Read all of this 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

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

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

2. What you need to know before you take Almotriptan Stada

Do not take Almotriptan Stada:

• If you are allergic to almotriptan or any of the other ingredients of this medication (listed in section 6).
• If you have or have ever had any disease that limits blood flow to the heart, such as:

• myocardial infarction
• chest pain or discomfort that occurs normally after physical activity or stress
• painless cardiac problems
• chest pain that occurs at rest
• severe hypertension (very high blood pressure)
• uncontrolled, mild, or moderate hypertension

• If you have had a stroke or a reduction in cerebral blood flow.
• If you have had an obstruction of the large arteries in your arms or legs (peripheral vascular disease).
• If you are taking other medications to treat migraines, including ergotamine, dihydroergotamine, and methysergide or another serotonin agonist (e.g., sumatriptan).
• If you have severeliver 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 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 cholesterol, obesity, diabetes, are a smoker, have a family history of heart disease, are a postmenopausal woman, or are a man over 40 years old.
• If you have mild or moderate liver disease.
• If you have severekidney disease.
• If you are over 65 years old (as you are more likely to experience increases in blood pressure).
• If you are taking antidepressant ISRS (selective serotonin reuptake inhibitors) or IRSN (serotonin and norepinephrine reuptake inhibitors). See also Taking Almotriptan 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.

Elderly (over 65 years old)

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

Taking Almotriptan Stada with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

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 treatment reaction. The symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle spasms, or diarrhea.
• If you are taking St. John's Wort (Hypericum perforatum) preparations, as they 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 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Only very 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 carefully considering the balance between the benefits and risks.

Caution should be exercised when using this medication during breastfeeding. You should avoid breastfeeding during the 24 hours following treatment.

Driving and using machines

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

Almotriptan Stada contains sodium

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

3. How to take Almotriptan Stada

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Almotriptan 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 the 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, a second 12.5 mg tablet can be taken, but always provided that 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 almotriptan 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 Almotriptan Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication 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 on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medication 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, pricking, or numbness of the skin (paresthesia)
• headache
• ringing, noise, or clicking in the ears (tinnitus)
• strong heartbeats (palpitations)
• throat tightness
• diarrhea
• indigestion (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• feeling of weakness (asthenia)

Rare(may affect up to 1 in 10,000 people)

• coronary artery spasm (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 (migraine disorders can also occur during a migraine attack itself)
• spasm of the blood vessels in the intestine that can cause lack of blood flow and damage your intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with almotriptan, inform your doctor immediately:

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Almotriptan Stada

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

Do not use this medication after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month shown.

This medication does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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 ingredients are:

Core of the tablet:mannitol (E-421), microcrystalline cellulose, povidone, sodium starch glycolate Type A potato, and sodium stearyl fumarate.

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

Appearance of the product and contents of the pack

Almotriptan Stada are white, circular, and biconvex film-coated tablets.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory 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 last revision of this leaflet:July 2021

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