Almotriptan Doc Generici

Package leaflet: Information for the patient

ALMOTRIPTAN DOC Generici 12.5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What ALMOTRIPTAN DOC Generici is and what it is used for

ALMOTRIPTAN DOC Generici is a migraine treatment medicine belonging to a class of compounds known as selective serotonin receptor agonists. ALMOTRIPTAN DOC Generici reduces the inflammatory response associated with migraine by binding to serotonin receptors in the cerebral blood vessels (head), causing them to constrict.
ALMOTRIPTAN DOC Generici is used to relieve headache associated with migraine attacks, with or without aura.

2. What you need to know before taking ALMOTRIPTAN DOC Generici

Do not take ALMOTRIPTAN DOC Generici

• 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 had diseases that reduce 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 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 medicines, including ergotamine, dihydroergotamine and methysergide, or other serotonin agonists (e.g. sumatriptan)
• if you have severe liver disease

Warnings and precautions
Talk to your doctor or pharmacist before taking ALMOTRIPTAN DOC Generici:

• if the type of your migraine has not been diagnosed
• if you are allergic (hypersensitive) to antibacterial medicines commonly used to treat urinary tract infections (sulfonamides)
• if 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 of the muscles controlling eye movement, or if you notice any new symptom
• if 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, or if you are post-menopausal, or if you are a male over 40 years of age
• if you have mild or moderate liver disease
• if you have severe kidney disease
• if you are over 65 years of age (because increases in blood pressure are more likely)
• if you are taking SSRI (selective serotonin reuptake inhibitors) or SNRI (serotonin-norepinephrine reuptake inhibitors) antidepressants. See also “Other medicines and ALMOTRIPTAN DOC Generici” below.

Excessive use of anti-migraine medicines may lead to chronic daily headache.
Children and adolescents
Children under 18 years of age must not take ALMOTRIPTAN DOC Generici.
Elderly (over 65 years of age)
If you are over 65 years of age, consult your doctor before taking this medicine.
Other medicines and ALMOTRIPTAN DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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 life-threatening reaction. 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 side effects.

Almotriptan 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 observed 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
There is limited data on the use of almotriptan during pregnancy. ALMOTRIPTAN DOC Generici should be used during pregnancy only on medical advice and only after careful consideration of the benefits and risks.
Use caution when taking this medicine during breastfeeding. Breastfeeding should be avoided for 24 hours after taking this medicine.

Driving and using machines
ALMOTRIPTAN DOC Generici may cause drowsiness. If you experience drowsiness, avoid driving or operating machinery.

3. How to take ALMOTRIPTAN DOC Generici

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
ALMOTRIPTAN DOC Generici should be taken only to treat an acute migraine attack and not to prevent migraine attacks or headaches.
Adults (18-65 years of age)
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 tablets (12.5 mg each) within 24 hours.
The tablets should be swallowed with liquid (e.g. water) and may be taken with or without food.
ALMOTRIPTAN DOC Generici 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 ALMOTRIPTAN DOC Generici than you should
If you have accidentally taken too many tablets, or if someone else or a child takes this medicine, contact your doctor or pharmacist immediately.
If you forget to take ALMOTRIPTAN DOC Generici
Try to take ALMOTRIPTAN DOC Generici 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 sensation of the skin (paraesthesia)
• headache
• ringing, noise, or buzzing in the ears (tinnitus)
• fast heartbeat (palpitations)
• tightness in the throat
• diarrhoea
• digestive discomfort (dyspepsia)
• dry mouth
• muscle pain (myalgia)
• bone pain
• chest pain
• weakness (asthenia)

Very rare: (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)

Not known: (frequency cannot be estimated from the available data)

• seizures
• allergic reactions (hypersensitivity reactions), including swelling of the mouth, throat, and hand (angioedema)
• severe allergic reactions (anaphylactic reactions)
• changes in vision, blurred vision (visual disturbances may also occur during a migraine attack itself)
• intestinal vasospasm, which may lead to intestinal damage (intestinal ischaemia). This may present as abdominal pain and bloody diarrhoea

During treatment with ALMOTRIPTAN DOC Generici, inform your doctor immediately:

• if you experience chest pain, pressure in the chest or throat, or any other symptom that might suggest a heart attack. Inform your doctor immediately and do not take any more ALMOTRIPTAN DOC Generici.

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 "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 ALMOTRIPTAN DOC Generici

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 on the carton after "Exp." The expiry date refers to the last day of that 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 ALMOTRIPTAN DOC Generici contains
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 carboxymethylstarch Type A, sodium stearyl fumarate
Coating: Hypromellose (E464), titanium dioxide (E171), macrogol 400, carnauba wax.
Description of the appearance of ALMOTRIPTAN DOC Generici and pack contents
ALMOTRIPTAN DOC Generici is available as film-coated tablets, white to almost white, round, biconvex.
ALMOTRIPTAN DOC Generici is available in blister packs containing 3 and 6 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano
Manufacturer
Chanelle Medical, Loughrea Co. Galway, Ireland
JSC Grindeks, 53 Krustpilu Street, Riga, LV-1057, Latvia