Auradol

Package leaflet: Information for the user

AURADOL 2.5 mg film-coated tablets

Frovatriptan
Read this entire 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AURADOL is and what it is used for

AURADOL 2.5 mg tablets contain frovatriptan, a medication for the treatment of migraine belonging to the class of triptans (selective 5-hydroxytryptamine (5HT₁) receptor agonists).
AURADOL 2.5 mg tablets are a medicinal product for the treatment of the headache phase of a migraine attack, with or without aura (a transient, unusual sensation experienced before a migraine, which varies from person to person but may, for example, affect vision, smell, or hearing).
AURADOL 2.5 mg tablets must not be taken to prevent a migraine attack.
AURADOL is used to treat migraine attacks in adults.

2. What you should know before taking AURADOL

Your doctor must have clearly diagnosed you with migraine.
Do not take AURADOL:

• if you are allergic to frovatriptan or to any of the other ingredients of this medicine (listed in section 6);
• if you have had a heart attack or if you have or have previously had a confirmed cardiovascular disease, such as angina pectoris (characterized by a squeezing-type chest pain, which may extend to the left arm) or circulation problems in the legs or arms (especially in the fingers of hands and feet);
• if you have had a stroke or a transient ischemic attack (TIA);
• if you have severely or moderately high blood pressure or if your blood pressure is not adequately controlled;
• if you have severe liver disease;
• in combination with certain other medicines also used to treat migraine (ergotamine and ergotamine derivatives (including methysergide) or other triptans (5-hydroxytryptamine (5HT) agonists).

Warnings and precautions
Talk to your doctor before taking AURADOL:

• if you are a patient at risk of coronary heart disease, including:
• if you are a heavy smoker or are undergoing nicotine replacement therapy;
• if you are a post-menopausal woman or a man over 40 years of age.

Stop taking AURADOL and consult your doctor immediately if:

• you experience a sensation of pressure or pain in the chest, difficulty breathing and/or pain or discomfort in one or both arms, back, shoulders, neck, jaw, or upper stomach; these could be symptoms of a heart attack, which may occur when taking triptans, even in patients who have never had cardiovascular diseases (see also section 4);
• you develop skin rashes or generalized itching, sudden swelling (especially around the lips, eyes, and tongue), possibly with sudden difficulty in breathing and a rapid heartbeat with palpitations. These are all symptoms and signs of allergy and systemic hypersensitivity reactions (see also section 4).

Children and adolescents
Do not give this medicine to children and adolescents (under 18 years of age) as the safety and efficacy of AURADOL have not been established in these age groups.
Other medicines and AURADOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

You must not take this medicine together with certain other medicines used to treat migraine:

• particularly ergotamine, ergotamine derivatives (including methysergide); at least 24 hours must pass between stopping treatment with these medicines and taking AURADOL 2.5 mg tablets. Likewise, you must not take these medicines within 24 hours after taking a dose of AURADOL 2.5 mg tablets;
• particularly other triptans (5-HT agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan, or zolmitriptan).
  Except as directed by your doctor, you must not take this medicine together with monoamine oxidase inhibitors (MAOIs) used to treat depression (phenelzine, isocarboxazide, tranylcypromine, moclobemide).
  Inform your doctor or pharmacist if you are taking an oral contraceptive or selective serotonin reuptake inhibitors (SSRIs) (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

It is recommended not to take AURADOL 2.5 mg tablets together with St. John’s wort (Hypericum perforatum).
Concomitant use of AURADOL with the above-mentioned medicines (especially monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, and St. John’s wort) may also increase the risk of serotonin syndrome (symptoms of which include: chills, sweating, agitation, tremor and sudden muscle contractions, nausea, fever, confusion).
If you have any doubts about taking other medicines together with AURADOL 2.5 mg tablets, consult your doctor or pharmacist.
AURADOL with food and drink
AURADOL 2.5 mg tablets can be taken with food or on an empty stomach, always with an adequate amount of water.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
AURADOL 2.5 mg tablets must not be taken during pregnancy or breastfeeding unless advised by your doctor. In any case, you must not breastfeed for 24 hours after taking AURADOL and must discard any milk expressed during this period.
Driving and using machines
AURADOL 2.5 mg tablets and migraine itself may cause drowsiness. In such cases, driving a vehicle or operating machinery may be dangerous and should be avoided.
AURADOL contains lactose
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take AURADOL

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Take AURADOL 2.5 mg tablets as soon as possible after the onset of a migraine attack with headache. Swallow the tablet whole with water.
If the first dose has no effect, do not take a second dose during the same attack. However, for subsequent attacks, you may take AURADOL 2.5 mg tablets.
If you obtain relief after the first dose but the migraine returns within 24 hours, you may take a second dose provided that at least 2 hours have passed between the two doses.
Do not exceed the maximum dose of 5 mg (two tablets) within 24 hours.
Excessive use (repeated for several consecutive days) of AURADOL 2.5 mg tablets constitutes inappropriate use of the medicine and may lead to an increase in adverse effects and may result in chronic daily headache, in which case treatment should be temporarily discontinued. Consult your doctor if you begin to experience headaches that are too frequent or occur daily, as this may indicate medication-overuse headache.
Use in children and adolescents
AURADOL must not be used in patients under 18 years of age.
Elderly
Due to limited experience in patients over 65 years of age, the use of AURADOL is not recommended in this age group.
If you take more AURADOL than you should
In case of accidental overdose, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department, remembering to bring the medicine package or this leaflet with you.
If you stop treatment with AURADOL
No special precautions are required when stopping the medicine.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Stop taking AURADOL and contact your doctor immediately if you experience any of the following symptoms:

• a feeling of tightness or pain in the chest, difficulty breathing and/or pain or discomfort in one or both arms, back, shoulders, neck, jaw, or upper part of the stomach; these could be symptoms of a heart attack, which may occur with triptan use, even in patients who have never had cardiovascular disease;
• skin rash or widespread itching, sudden swelling (especially around the lips, eyes, tongue or mucous membranes), possibly with sudden difficulty breathing, rapid heartbeat and palpitations. These are all symptoms and signs of allergy and systemic hypersensitivity reactions (hypersensitivity reactions, angioedema, anaphylaxis).

The side effects reported with AURADOL 2.5 mg tablets were temporary, generally mild to moderate in intensity, and resolved spontaneously. Some of the symptoms reported may be caused by migraine itself.
The following side effects were observed commonly (estimated frequency: more than 1 in 100 and less than 1 in 10):

• nausea (feeling unwell), dry mouth, indigestion, stomach ache;
• fatigue, chest discomfort (feeling of mild heaviness, pressure or tightness in the chest);
• headache, dizziness, tingling and prickling sensations, especially in the arms and legs, reduced or altered tactile sensations, marked drowsiness;
• hot flushes;
• tightness in the throat;
• visual disturbances;
• increased sweating;

The following side effects were observed uncommonly (estimated frequency: more than 1 in 1,000 and less than 1 in 100):

• altered taste, tremor, poor concentration, lethargy, increased tactile sensations, drowsiness, involuntary muscle contractions;
• diarrhoea, difficulty swallowing, gas in the stomach or intestines, stomach discomfort, bloated abdomen;
• increased awareness of heartbeat (palpitations), rapid heartbeat, elevated blood pressure, chest pain (intense pressure or tightness in the chest);
• sensation of warmth, reduced tolerance to heat and cold, pain, weakness, thirst, fatigue, increased energy, general feeling of malaise, sensation of dizziness;
• anxiety, insomnia, confusion, nervousness, restlessness, depression, loss of sense of personal identity;
• cold sensation in hands and feet;
• nasal irritation, sinus inflammation (sinusitis), sore throat and/or vocal cords;
• muscle stiffness, muscle and bone pain, pain in hands and feet, back pain, joint pain;
• eye pain, eye irritation, pain due to light sensitivity;
• itching sensations;
• ringing in the ears, earache;
• dehydration;
• frequent need to urinate, increased volume of urine produced.

The following side effects were observed rarely (estimated frequency: more than 1 in 10,000 and less than 1 in 1,000):

• muscle cramps, muscle flaccidity, decreased reflexes (hyporeflexia), movement disorders;
• constipation, belching, heartburn, irritable bowel syndrome, blistering on the lips, lip pain, oesophageal spasm, blistering in the mouth, stomach or duodenal ulcer, pain in the salivary glands, mouth inflammation, toothache;
• fever;
• memory loss, abnormal dreams, personality disorders;
• nosebleeds, hiccups, laboured breathing, respiratory disorders, throat irritation;
• night blindness;
• skin redness, piloerection (goosebumps), purpuric spots or patches on the skin and mucosal surfaces of the body, urticaria;
• slowed heartbeat;
• ear discomfort and disturbances, ear itching, sensitive hearing;
• increased bilirubin (a substance produced by the liver) in the blood, decreased blood calcium, altered urine tests;
• low blood sugar;
• frequent need to urinate at night, kidney pain;
• self-inflicted injuries (e.g. biting or bruising);
• swollen lymph nodes;
• breast pain or discomfort.

Although the frequency cannot be estimated from the available data, the following events have also been reported:

• allergic (hypersensitivity) reactions including skin rash or widespread itching, sudden swelling (especially around the lips, eyes or tongue), possibly with sudden difficulty breathing and rapid heartbeat and palpitations (anaphylaxis);
• heart attack (myocardial infarction);
• chest discomfort or pain caused by a temporary spasm (constriction) of the coronary arteries (the blood vessels supplying oxygen or nutrients to the heart, e.g. coronary artery spasm).

Reporting of side effects
If you get any side effects, including ones 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.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store AURADOL

Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month.
Do not store above 30°C.
Blister: keep in the original packaging to protect the product from moisture.
Bottle: keep the bottle tightly closed to protect the product from moisture.
Keep this medicine out of sight and reach of children.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What AURADOL contains
The active substance is frovatriptan succinate monohydrate.
Each tablet contains 2.5 mg of frovatriptan.
The other components are:
Tablet core: anhydrous lactose, microcrystalline cellulose, magnesium stearate, sodium starch
glycolate (type A), anhydrous colloidal silica.
Tablet coating: OPADRY White: titanium dioxide (E171), anhydrous lactose,
hypromellose (E464), macrogol 3000, triacetin.
Description of the appearance of AURADOL and pack sizes
AURADOL 2.5 mg film-coated tablets are available as round, film-coated tablets, with the letter "m" engraved on one side and the number "2.5" engraved on the other.
AURADOL is packaged in:
HDPE child-resistant bottles: 30 tablets per bottle
PVC/PE/ACLAR/Aluminium blisters: 1, 2, 3, 4, 6 or 12 tablets per blister.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori – Strada 6 – Edificio L – 20089 Rozzano, Milan, Italy
Manufacturers:
Almac Pharma Services Limited
Almac House, 20 Seagoe Industrial Estate
Craigavon – County Armagh
Northern Ireland (Northern Ireland)
BT63 5UA - United Kingdom (United Kingdom)
or
Berlin-Chemie AG
Glienicker Weg 125 – D-12489 Berlin, Germany
or
A. Menarini Manufacturing Logistics and Services S.r.l.
Via Campo di Pile – L’Aquila (AQ), Italy
or
Laboratorios Menarini S.A.
Alfonso XII, 587, E-08918 Badalona (Barcelona), Spain
This medicinal product is authorized in the European Economic Area member states under the
following names:
France (RMS) Tigreat
Austria Frovamig Hungary Frovalon Poland Migren
Belgium Frovatex Iceland Tigreat Portugal Dorlise
Republic of Ireland Frovex Slovakia Frovamen
Fromen
Czech Republic
Estonia Frovamig Italy Auradol Slovenia Frotan
Denmark Tigreat Latvia Frovamig Spain Perlic
Finland Tigreat Lithuania Frovamig Sweden
Germany Allegro Luxembourg Frovatex Netherlands Fromirex
Greece Migralin Norway Tigreat United Kingdom
This leaflet was last reviewed on:
Frovatriptan was developed by Vernalis Ltd