Almogran 12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Almogran 12.5 mg Film-coated tablets

Almotriptan

Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Almogran is and what it is used for

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

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

2. What you need to know before taking Almogran

Do not take Almogran:

• 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 any condition that restricts 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 major arteries in the arms or legs (peripheral vascular disease)
  • if you are taking other medicines to treat migraine, 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, pharmacist, or nurse before taking Almogran:

• if your type of migraine has not been diagnosed
• if you are allergic (hypersensitive) 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 ringing in the ears or dizziness, brief paralysis of part of your body, or paralysis of the 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 are 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, as you may be more likely to experience increases in blood pressure
• if you are taking SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors). See also below, Taking Almogran 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 Almogran.

People over 65 years of age

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 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-noradrenaline reuptake inhibitors (e.g., venlafaxine), as these medicines may cause serotonin syndrome, a potentially serious reaction to treatment. Symptoms of serotonin syndrome include: confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle movements, or diarrhea.
• if you are taking St. John's wort (Hypericum perforatum) preparations, as this may increase the likelihood of experiencing 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 passed 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.

Information on the use of almotriptan during pregnancy is very limited. Almogran 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 use of machines

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

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

3. How to take Almogran

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

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Adults (18–65 years of age)

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

If you experience a second attack within the following 24 hours, a second tablet of 12.5 mg may be taken, provided that at least 2 hours have passed between the first and second tablet.

The maximum daily dose is two 12.5 mg tablets within 24 hours.

The tablets may be taken with liquid (for example, water) and may 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 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 Almogran than you should

If you accidentally take too many Almogran tablets, or if someone else or a child takes this medicine, contact 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 about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience 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 crackling in the ears (tinnitus)
• strong or rapid heartbeats (palpitations)
• throat tightness
• diarrhea
• discomfort during digestion (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)

• 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 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 in the intestine, which may cause reduced blood flow and damage to your intestine. You may experience abdominal pain and bloody diarrhea.

During treatment with Almogran, inform your doctor immediately:

• if you have chest pain, tightness in the chest or throat, or any other symptom suggestive of a heart attack. Please report this immediately to your doctor and do not take any further Almogran tablets.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the container, following "EXP". The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Almogran

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

The other components are:

Tablet core: mannitol (E-421), microcrystalline cellulose, povidone, sodium carboxymethylstarch, stearic fumarate and sodium.

Coating material: 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, round, biconvex film-coated tablets for oral use, with the letter A engraved on one side.

Almogran is available in cartons containing 2, 3, 4, 6, 7, 9, 12, 14 or 18 tablets. In Spain, cartons containing 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: January 2021

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