RILAMIG

Package leaflet: Information for the user

RILAMIG 2.5 mg film-coated tablets

Frovatriptan
Please 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 they have the same symptoms as you, 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 RILAMIG is and what it is used for;
2. What you need to know before taking RILAMIG;
3. How to take RILAMIG;
4. Possible side effects;
5. How to store RILAMIG;
6. Contents of the pack and other information.

1. What RILAMIG is and what it is used for

RILAMIG 2.5 mg tablets contain frovatriptan, a medication for the treatment of migraine belonging to the class of triptans (selective agonists of the 5-hydroxytryptamine (5HT₁) receptors).
RILAMIG 2.5 mg tablets are a medication used to treat 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).
RILAMIG 2.5 mg tablets must not be taken to prevent a migraine attack.
RILAMIG is used to treat migraine attacks in adults.

2. What you need to know before taking RILAMIG

Your doctor must have clearly diagnosed migraine.
Do not take RILAMIG:

• 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 pressing chest pain, which may extend to the left arm) or circulatory disorders in the legs or arms (especially in the fingers of the 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 RILAMIG:

• 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 postmenopausal woman or a man over 40 years of age.

Stop taking RILAMIG 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 with triptan use, even in patients who have never had cardiovascular disease (see also section 4);
• you develop skin rashes (cutaneous rash) or generalized itching, sudden swelling (especially around the lips, eyes, and tongue), possibly with sudden difficulty 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) because the safety and efficacy of RILAMIG have not been established in these age groups.
Other medicines and RILAMIG
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 elapse between stopping treatment with these medicines and taking RILAMIG 2.5 mg tablets. Similarly, you must not take these medicines within 24 hours after taking a dose of RILAMIG 2.5 mg tablets;
• particularly other triptans (5-HT agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan, or zolmitriptan). Unless otherwise directed by your doctor, you must not take this medicine together with monoamine oxidase inhibitor (MAOI) medicines used to treat depression (phenelzine, isocarboxazide, tranylcypromine, moclobemide).
• Inform your doctor or pharmacist if you are taking an oral contraceptive or selective serotonin reuptake inhibitor (SSRI) medicines (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).

Concomitant use of RILAMIG 2.5 mg tablets with St. John’s wort (Hypericum perforatum) is not recommended.
The concomitant use of RILAMIG 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, sudden muscle contractions, nausea, fever, confusion).
If you have any doubts about taking other medicines together with RILAMIG 2.5 mg tablets, consult your doctor or pharmacist.
RILAMIG with food and drink
RILAMIG 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.
RILAMIG 2.5 mg tablets must not be taken during pregnancy or while breastfeeding unless advised by your doctor. In any case, you must not breastfeed for 24 hours after taking RILAMIG, and you must discard any milk expressed during this period.
Driving and using machines
RILAMIG 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.
RILAMIG contains lactose
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take RILAMIG

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
Take RILAMIG 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 is not effective, do not take a second dose during the same attack. However, RILAMIG 2.5 mg tablets may be taken for subsequent attacks.
If you get 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 RILAMIG 2.5 mg tablets constitutes improper 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
RILAMIG 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 RILAMIG is not recommended in this age group.

If you take more RILAMIG 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 taking RILAMIG
No special precautions are required when stopping treatment with this 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 everyone experiences them.
Stop taking RILAMIG and contact your doctor immediately if you experience any of the following symptoms:

• a feeling 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 with triptan use, even in patients who have never had cardiovascular disease;
• skin rashes or generalized itching, sudden swelling (especially around the lips, eyes, tongue, or mucous membranes), possibly accompanied by 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 RILAMIG 2.5 mg tablets were temporary, generally mild to moderate, 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 arms and legs, reduced or altered tactile sensation, 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 sensation, 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);
• feeling 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, agitation, 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, eructation, heartburn, irritable bowel syndrome, blistering on the lips, lip pain, oesophageal spasm, blistering in the mouth, gastric or duodenal ulcer, pain in 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 mucous membranes, urticaria;
• slow heartbeat;
• ear discomfort and disturbances, ear itching, increased hearing sensitivity;
• increased bilirubin (a substance produced by the liver) in blood, decreased blood calcium, abnormal urine test results;
• 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 rashes or generalized itching, sudden swelling (especially around the lips, eyes, or tongue), possibly accompanied by sudden difficulty breathing and rapid heartbeat with palpitations (anaphylaxis);
• heart attack (myocardial infarction);
• chest discomfort or pain caused by 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 RILAMIG

Do not use this medicine after the expiry date stated on the pack. 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 the sight and reach of children.
Do not dispose of any medicine 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 RILAMIG 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), colloidal anhydrous silica.
Tablet coating: OPADRY White: titanium dioxide (E171), anhydrous lactose,
hypromellose (E464), macrogol 3000, triacetin.
Description of the appearance of RILAMIG and pack sizes
RILAMIG 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" on the other.
RILAMIG is packaged in:
HDPE child-resistant bottles: 30 tablets per bottle
PVC/PE/ACLAR/aluminum blisters: 1, 2, 3, 4, 6 or 12 tablets per blister
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Menarini International Operations Luxembourg SA
1, Avenue de la Gare – L-1611, Luxembourg
Marketing Authorisation Holder (Sales Licensee):
Laboratori Guidotti S.p.A. - Pisa
Manufacturer:
Almac Pharma Services Limited
Almac House, 20 Seagoe Industrial Estate
Craigavon – County Armagh
Northern Ireland (Northern Ireland)
BT63 5UA - United Kingdom (UK)
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 authorised in the European Economic Area countries under the
following names:
France (RMS) Isimig
Austria Eumitan Hungary Migard Poland Migard
Belgium Migard Iceland Migard Portugal Migard
Republic of Ireland Miguar Slovakia Migard
Czech
Republic
Estonia Migard Italy Rilamig Slovenia Migard
Denmark Migard Latvia Migard Spain Forvey
Finland Migard Lithuania Migard Sweden Migard
Luxembourg Migard Netherlands Migard
Germany Migard
or
Greece Pitunal Norway Migard United Kingdom Migard
(England)
This leaflet was last revised on:
Frovatriptan was developed by Vernalis Ltd.