Almotrex

Package leaflet: Information for the user

Almotrex 12.5 mg film-coated tablets

almotriptan
Please read all of this leaflet carefully before 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 only. Never give it to other people, even if their
symptoms are the same as yours, as it may be harmful. If you experience any side effect,
including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet
1. What Almotrex is and what it is used for
2. What you need to know before taking Almotrex
3. How to take Almotrex
4. Possible side effects
5. How to store Almotrex
6. Contents of the pack and other information
1. What Almotrex is and what it is used for
Almotrex is an anti-migraine medicine that belongs to a class of compounds known as selective
serotonin receptor agonists. Almotrex reduces the inflammatory response associated with migraine
by binding to serotonin receptors in the cerebral blood vessels (brain), causing them to constrict.
Almotrex is used to relieve headache associated with migraine attacks, with or without aura.

2. What you should know before taking Almotrex

Do not take Almotrex:

• If you are allergic to almotriptan or to any of the excipients of this medicine (listed in section 6).
• If you have or have had diseases that reduce blood flow to the heart such as:
  • myocardial infarction,
  • chest pain or discomfort that generally occurs during physical activity or stress,
  • heart problems without pain,
  • chest pain at rest,
  • severe hypertension (very high blood pressure),
  • mild or moderate uncontrolled hypertension.
• If you have had a stroke or reduced blood flow to the brain
• If you have had an obstruction of the large arteries in the arms or legs (peripheral vascular disease)
• If you have taken other migraine medicines, including ergotamine, dihydroergotamine, or methysergide, or other serotonin agonists (e.g. sumatriptan)
• If you have severe hepatic disease

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting Almotrex if:

• Your type of migraine has not been diagnosed
• You are allergic (hypersensitive) to antibacterial medicines commonly used to treat urinary tract infections (sulphonamides)
• Your headache symptoms are different from your usual attacks, for example if you hear noises in your ears or have dizziness, if you experience brief paralysis on one side of the body or in the muscles controlling eye movement, or if you notice any new symptom
• You have risk factors for heart disease, such as uncontrolled high blood pressure, high cholesterol, obesity, diabetes, smoking, a strong family history of heart disease, if you are post-menopausal, or if you are a male over 40 years of age
• You have mild or moderate liver disease
• You have severe kidney disease
• You are over 65 years of age (because increases in blood pressure are more likely)
• You are taking antidepressant SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). See also “Other medicines and Almotrex”.

Excessive use of anti-migraine medicines can lead to chronic headache.
Children and adolescents
Children under 18 years of age must not take Almotrex.
Elderly (over 65 years)
If you are over 65 years of age, consult your doctor before taking this medicine.
Other medicines and Almotrex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor:

• If you are taking medicines to treat 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 may cause serotonin syndrome, a potentially dangerous reaction that can be life-threatening. Symptoms of serotonin syndrome include confusion, restlessness, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle spasms, or diarrhea.
• If you are taking preparations containing St. John's wort (Hypericum perforatum), as this may increase the likelihood of adverse effects.

Almotrex must not be taken at the same time as medicines containing ergotamine, which are also used to treat migraine; however, these medicines may be taken one after the other, provided an adequate time interval is respected between each dose.

• 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Only limited data are available on the use of almotriptan during pregnancy; therefore, Almotrex should be used during pregnancy only on medical advice and only after careful consideration of the benefits and risks.
Use caution while breastfeeding; avoid breastfeeding for 24 hours after taking this medicine.
Driving and using machines
Almotrex may cause drowsiness. If you feel drowsy, avoid driving or operating machinery.

3. How to take Almotrex

Almotrex should only be taken to treat a migraine attack once it has started and not to
prevent migraine attacks or headaches.
Take this medicine exactly as your doctor has told you. If you have any doubts, consult your
doctor or pharmacist.

Adults (18–65 years)
The recommended dose is one 12.5 mg tablet taken as soon as possible after the onset of a
migraine attack. If the migraine attack does not subside, do not take a second tablet for the
same attack.

If you have a second migraine attack within 24 hours, a second 12.5 mg tablet may be taken,
but at least two hours must elapse between the first and second tablet.
The maximum daily dose is two 12.5 mg tablets within 24 hours.

The tablets should be taken with a liquid (e.g. water) and may be taken with or without food.
Almotrex should be taken as soon as possible after the onset of migraine, although it remains
effective even when taken at a later stage of the attack.

Severe renal impairment
If you have severe kidney disease, do not take more than one 12.5 mg tablet in 24 hours.

If you take more Almotrex than you should
If you have accidentally taken too many Almotrex tablets, or if someone else or a child takes
this medicine, contact your doctor or pharmacist immediately.

If you forget to take Almotrex
Try to take Almotrex as prescribed. Do not take a double dose to make up for a forgotten tablet.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common side effects (may affect up to 1 in 10 people)

• dizziness,
• drowsiness (somnolence),
• nausea,
• vomiting,
• fatigue.

Uncommon side effects (may affect up to 1 in 100 people)

• sensation of tingling, pricking, or numbness of the skin (paraesthesia)
• headache
• ringing, noise, or buzzing in the ears (tinnitus)
• rapid heartbeat (palpitations)
• tightness in the throat
• diarrhoea
• digestive problems (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• skeletal pain
• chest pain
• weakness (asthenia).

Very rare side effects (may affect up to 1 in 10,000 people)

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

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

• allergic reactions (hypersensitivity reactions), including swelling of the mouth, throat, or hand (angioedema)
• severe allergic reactions (anaphylactic reactions)
• seizures
• visual disturbances, blurred vision (visual disturbances may also occur during a migraine attack)
• intestinal vasospasm, which may cause intestinal damage (intestinal ischaemia). Abdominal pain and bloody diarrhoea may occur.

During treatment with Almotrex, inform your doctor immediately:

• if you experience chest pain, tightness in the chest or throat, or any other symptom that might seem like a heart attack. Inform your doctor immediately and do not take any more Almotrex tablets.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Almotrex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Almotrex contains
The active substance is almotriptan 12.5 mg (as D,L-hydrogenomaleate).
The other components are:
Tablet core: mannitol (E-421), microcrystalline cellulose, povidone, sodium glycolate starch, sodium stearyl fumarate
Coating: hypromellose, titanium dioxide (E-171), Macrogol 400, carnauba wax
Ink: hypromellose, propylene glycol, indigo carmine (E-132)

Description of the appearance of Almotrex and package contents
Almotrex is available as white, round, biconvex, film-coated tablets with a blue "A" printed on one side.
Almotrex is available in blister packs containing 3, 4, 6, or 9 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
ALMIRALL S.A.
General Mitre 151,
08022 BARCELONA – Spain

Manufacturer
Industrias Farmaceuticas Almirall S.L., Ctra Nacional II, Km 593, 08740 Sant Andreu de la Barca (Barcelona) – Spain

This medicinal product is authorized in the European Economic Area Member States
under the following names:
Germany Amignul 12.5 mg Filmtabletten
Italy Almotrex 12.5 mg film-coated tablets
Spain Amignul 12.5 mg film-coated tablets