Frovatriptan 2.5 Mg Film-Coated Tablets
Package leaflet: Information for the user
Frovatriptan 2.5 mg Film-coated Tablets
[Frovatriptan (as frovatriptan succinate monohydrate)]
Read all of this 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 further questions, ask your doctor or pharmacist (chemist).
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Frovatriptan is and what it is used for
2. What you need to know before you take Frovatriptan
3. How to take Frovatriptan
4. Possible side effects
5. How to store Frovatriptan
6. Contents of the pack and other information
1. What Frovatriptan is and what it is used for
Frovatriptan contain frovatriptan (as frovatriptan succinate monohydrate), which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).
Frovatriptan are used to treat migraine with or without aura (a temporary subjective feeling before a migraine attack, which varies greatly from person to person and which can affect vision, sense of smell, or hearing).
Frovatriptan should not be used to prevent migraines.
2. What you need to know before you take Frovatriptan
The diagnosis of a migraine episode must have been clearly established by your doctor.
Do not take Frovatriptan:
• If you are allergic to frovatriptan, or any of the other ingredients of this medicine (listed in section 6)
• If you have a heart problem such as heart failure or chest pains (angina), or have already had a heart attack
• If you have circulation problems in your legs that cause cramp-like pains when you walk (peripheral vascular disease)
• If you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)
• If you have moderate to severe high blood pressure. You may be able to take Frovatriptan if your high blood pressure is mild and is being treated
• If you have severe liver disease
• With other migraine medicines, including those which contain ergotamine, or with similar medicines such as methysergide, or with other 5-HT1 receptor agonists, such as sumatriptan.
If any of these apply to you, tell your doctor, and do not take Frovatriptan.
Warnings and precautions
Talk to your doctor or pharmacist before takingFrovatriptan
Take special care with Frovatriptan if you are a patient with cardiovascular risk factors, including if:
• You are a heavy smoker or taking smoking-cessation medicines
• If you are a woman in post-menopause or a man over 40 years of age.
In these cases, ask your doctor for advice before taking Frovatriptan.
In some rare cases, symptoms such as chest pain and feeling of heaviness may appear in patients on triptans, even in cases with no history of cardiovascular diseases.
If you notice any of these symptoms, contact your doctor and do not take any further doses of this medicine.
Other medicines and Frovatriptan
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take this medicine at the same time as certain other medicines used to treat migraines:
• Especially ergotamine and ergotamine derivatives (including methysergide), sumatriptan or other 5-HT1 receptor agonists; a period of at least 24 hours must be observed between stopping these medicines and administering Frovatriptan. Similarly, these medicines must not be administered within 24 hours of administering frovatriptan.
• Particularly other triptans (5-HT1 agonists, such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan).
Do not take this medicine, unless otherwise advised by your doctor, at the same time as monoamine oxidase inhibitors (MAOI) type medicines used to treat depression (iproniazid, isocarboxazid, tranylcypromine, moclobemide).
Inform your doctor or pharmacist if you are taking oral contraceptives (the pill) or selective serotonin re-uptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline).
Taking Frovatriptan together with St John’s Wort (Hypericum perforatum) is not recommended.
The combination of Frovatriptan with the above medicines (particularly monoamine oxidase inhibitors, selective serotonin reuptake inhibitors and St John’s Wort) may increase the risk of serotonin syndrome (the symptoms of this syndrome include: chills, sweating, agitation, muscle tremor and spasm, nausea, fever and confusion).
If you have any doubts about the use of other medicines and Frovatriptan, ask your doctor or pharmacist.
Frovatriptan with food and drink
Frovatriptan may be taken with food or fasting, and always with plenty of water.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Unless otherwise advised by your doctor, the use of Frovatriptan is not recommended while pregnant or breast-feeding. In any case, you should not breast-feed for 24 hours after taking the medicine. The milk expressed during this period should be discarded.
Driving and using machines
• Either the symptoms of migraine or your medicine may make you drowsy. If you are affected, do not drive or use any tools or machines.
Frovatriptan contains lactose
Frovatriptan contain a small amount of a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Frovatriptan.
3. How to take Frovatriptan
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take Frovatriptan as soon as possible after the onset of the migraine.
Do not use this medicine to prevent migraines.
The tablet must be swallowed whole with a large glass of water.
If you feel no relief after the first dose, a second dose must not be taken during the same episode. Frovatriptan may be used for the next attack.
If you obtain relief after the first dose but pain re-appears within 24 hours, a second tablet may be taken, provided that you observe an interval of at least 2 hours between the two doses.
Do not exceed the maximum dose of 5 mg in 24 hours (i.e. two tablets).
Prolonged use (repeated use over several days) of Frovatriptan is not recommended, and may cause an increase in side effects and lead to daily headaches requiring discontinuation of treatment. Consult your doctor if you experience frequent or daily headaches, as a diagnosis of headache due to medication misuse should be considered.
Frovatriptan should not be used in children under 18 years.
There are limited data on the safety and efficacy in patients over 65 years, so Frovatriptan is not recommended in these patients.
If you take more Frovatriptan than you should
If you accidentally take more Frovatriptan than you should, consult your doctor or pharmacist immediately, or go to your nearest hospital emergency department. Take any remaining tablets or this leaflet with you.
The symptoms of overdose are: dizziness, drowsiness, vomiting, feeling unwell and decreased heart rate.
If you stop taking Frovatriptan
No special precautions are necessary when stopping this treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Description of the side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A feeling of pressure or pain in the chest, at times intense and which could extend to the throat, may appear some minutes after taking the medicine. If you notice these symptoms, contact your doctor and do not take any further doses of this medicine.
The side effects reported during the clinical studies with Frovatriptan were temporary, mild to moderate and spontaneously disappeared. Certain symptoms reported as side effects could be attributed to the migraine episode.
The following effects were common (affecting more than 1 in 100 people and fewer than 1 in 10 people):
• nausea, dry mouth, indigestion, stomach pain,
• fatigue, chest discomfort (feeling of heaviness, pressure or tightness in the chest),
• headache, dizziness, pins and needles in arms and legs, reduced or increased sensations of touch, extreme desire to sleep,
• hot flushes,
• tightness in throat,
• visual disorders,
• increased sweating.
The following effects were uncommon (affecting more than 1 in 1,000 people and fewer than 1 in 100 people):
• taste alteration, tremor, poor concentration, lethargy, skin hypersensitivity, drowsiness, involuntary muscle contractions,
• diarrhoea, difficulty swallowing, bloatedness, stomach discomfort, flatulence,
80637 LA11263 Frovatirptan 2.5 UK leaflet.indd 1 21/07/2016 14:09
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—J?PW Design & Prht |
KPW Design & Print Ballinasloe, Co. Galway, Ireland |
Version No. 5 | |
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Customer |
Chanelle |
KPW Job No. |
80637 |
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Description |
Frovatriptan 2.5 UK Minimum Font Size 8.5pt | ||
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Item Code |
LA11263 |
Pharmacode | |
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Size |
148x700mm |
Date |
21 July 2016 2:06 PM |
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Colour |
Black ■ Keyline | ||
• i ncreased heart rate, palpitations, high blood pressure, chest pain (intense feeling of tightness or pressure in the chest),
• feeling hot, decreased tolerance to hot and cold, pain, weakness, fever, thirst, lack of energy, hyperactivity, feeling unwell, a feeling of intoxication, dizziness,
• anxiety, insomnia, confusion, agitation, nervousness, depression, personality disorders, cold extremities,
• rhinitis, sinusitis, sore throat,
• muscle stiffness, bone and muscle pain, pain in hands and feet, joint pain, back pain, eye pain, eye irritation, discomfort looking at light,
• pruritus,
• ringing in the ears, earache,
• dehydration,
• urinary urgency, increased urination,
• high blood pressure.
The following effects are rare (affecting more than 1 in 10,000 people and less than 1 in 1,000 people):
• muscle spasms, decreased muscle tone, reduced muscle reflexes (hyporeflexia), movement disorders,
• constipation, belching, heartburn, intestinal irritation, mouth ulcers, lip pain, oesophageal spasm, gastroduodenal ulcer, pain in salivary gland, inflammation of the mouth, toothache,
• fever,
• memory loss, nightmares, personality disorders,
• nosebleeds, increased respiratory rate, hiccups, throat irritation,
• night blindness,
• purple marks on skin or mucous membranes, skin redness, hives, goose bumps,
• bradycardia
• hearing disorders, ear discomfort, itchy ears, sensitive hearing,
• increased blood bilirubin, decreased blood calcium, abnormal urinalysis,
• hypoglycaemia,
• night-time urinary urgency, kidney pain,
• self-mutilation (such as biting, bruising),
• enlarged lymph nodes,
• breast pain.
Some cases of allergic reactions to Frovatriptan have been reported, manifesting as a rash, as well as a generalised severe allergic reaction (anaphylaxis) which can cause breathing difficulties, increased heart rate and palpitations. In this case, contact your doctor immediately.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the UK Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Frovatriptan
Keep this medicine out of the sight and reach of children.
Do not store above 30°C
Do not use this medicine after the expiry date which is stated on the blister and on the outer carton after EXP The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Content of the pack and other information
What Frovatriptan 2.5 mg Film-coated Tablets contain
The active substance is frovatriptan.
Each film-coated tablet contains 2.5 mg of frovatriptan (as frovatriptan succinate monohydrate).
The other ingredients are:
Tablet core: silicified microcrystalline cellulose, lactose anhydrous*, silicon dioxide, sodium starch glycolate (Type A) and magnesium stearate.
Film-coating: hypromellose (E464), lactose monohydrate*, macrogol 3350 (E1521), triacetin and titanium dioxide (E171). *Contains approximately 107 mg of lactose per tablet.
What Frovatriptan 2.5 mg Film-coated Tablets look like and contents of the pack
Frovatriptan 2.5 mg Film-coated Tablets are white to off white round film-coated tablets, plain on both sides. They are available in blister packs of 1, 2, 3, 4, 6 or 12 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder and manufacturer is Chanelle Medical, Loughrea, Co. Galway, Ireland.
This medicinal product is authorised in the Member States of the EEA under the following names:
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The Netherlands |
Frovatriptan Chanelle 2,5 mg filmomhulde tabletten |
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Austria |
Frovatriptan Chanelle 2,5 mg Filmtabletten |
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Finland |
Frovaptan 2,5 mg tabletti, kalvopaallysteinen |
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Italy |
FROVATRIPTAN EG. |
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Ireland |
Frovatriptan 2.5 mg Film-coated Tablets |
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United Kingdom |
Frovatriptan 2.5 mg Film-coated Tablets |
This leaflet was last revised in: 06/2016 LA11263
21/07/2016 14:09
80637 LA11263 Frovatirptan 2.5 UK leaflet.indd 2