ALMOGRAN 12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Almogran 12.5 mg Film-Coated Tablets

Almotriptan

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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not mentioned in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Almogran and what is it used for

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

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

2. What you need to know before you take Almogran

Do not take Almogran:

• 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:
  • 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 of the arms or legs (peripheral vascular disease)
  • if you are taking other medications 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

Consult your doctor, pharmacist, or nurse before starting to take Almogran:

• 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, have a brief paralysis of a part of your body or paralysis of the muscles that control your eye movements, or any other new symptom

• if you are at risk of having 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 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) or (SNRIs). See also below, Taking Almogran 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 Almogran.

Over 65 years old

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

Taking Almogran with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 may cause serotonin syndrome, a potentially very serious treatment reaction. The symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrolled muscle movements, or diarrhea.

• if you are taking St. John's Wort (Hypericum perforatum) preparations, as this 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.

There is only limited information available on the use of almotriptan during pregnancy. Almogran should only be used during pregnancy if prescribed by your doctor and only after carefully considering the benefits and risks.

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

Driving and using machines

Almogran may cause drowsiness. If you experience this, do not drive or operate machinery.

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

3. How to take Almogran

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

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

Adults (18-65 years)

The recommended dose is one Almogran tablet (12.5 mg of almotriptan) to 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.

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.

Almogran 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 Almogran than you should

If you accidentally take too many Almogran 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.

If you forget to take Almogran

Try to take Almogran 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 medicine, ask your doctor, pharmacist, or nurse.

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, noises, or clicking (tinnitus)
• strong heartbeat (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 (coronary vasospasm)
• heart attack (myocardial infarction)
• increased heart rate (tachycardia)

Frequency not known(cannot be estimated from the available data)

• allergic reactions (hypersensitivity reactions), including swelling of the mouth, neck, or hands (angioedema)
• severe allergic reactions (anaphylactic reactions)
• seizures
• visual disturbances, blurred vision (visual disorders may also occur during a migraine attack itself)
• spasm of the blood vessels of the intestine that can cause lack of blood flow and damage to the intestine. 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 Almogran tablets.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not mentioned in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Almogran

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

Do not use this medicine after the expiry date which is stated on the carton, after “EXP”. The expiry date refers to the last day of the month shown.

This medicine 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 further information

Composition of Almogran

The active substance is almotriptan 12.5 mg (as almotriptan D,L-malate salt).

The other ingredients are:

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

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

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Appearance of the product and contents of the pack

Almogran is available as white, circular, and biconvex film-coated tablets for oral use, with a letter A engraved on one side.

Almogran is available in packs containing 2, 3, 4, 6, 7, 9, 12, 14, or 18 tablets. In Spain, packs of 4, 6, and 9 tablets are marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A. General Mitre, 151 08022 - Barcelona (Spain).

Manufacturer

Industrias Farmacéuticas Almirall, S.A. Ctra. de Martorell, 41-61 08740 Sant Andreu de la Barca - Barcelona (Spain).

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

Date of last revision of this leaflet: January 2021

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