Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Frovatriptan contains the active ingredient frovatriptan which belongs to a group of medicines called triptans. Frovatriptan is used to treat migraine headache in adults.
- you are at a higher risk of heart disease for example if you are a heavy smoker or you use nicotine replacement therapy. Your doctor should make additional checks especially if you are a woman after menopause or a man older than 40 years old. - you have unusual forms of migraine caused by brain or eye problems. - you are taking herbal medicines containing St John's wort (side effects may be more frequent). - you are taking buprenorphine. The use of buprenorphine together with Frovatriptan can lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Frovatriptan"). During treatment If you get a serious allergic reaction when taking Frovatriptan such as flushing of the skin, nettle rash, swelling of the mouth, lips, tongue or throat causing difficulty breathing or swallowing, feeling sick (nausea) or being sick (vomiting), collapse or unconsciousness stop taking this medicine and contact your doctor or go immediately to the nearest hospital emergency department (see section 4 'Possible side effects'). When taking Frovatriptan, you may notice pain or a feeling of tightness in your chest and throat. If these symptoms do not pass quickly, stop taking frovatriptan and tell your doctor immediately. If you have frequent or daily headaches while taking this medicine, stop taking Frovatriptan and contact your doctor. Using painkillers to treat headaches for longer than normal can make the headaches worse. Children and adolescents Frovatriptan should not be given to children and adolescents under the age of 18 as it is not known how this medicine may affect them. Other medicines and Frovatriptan Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, inform your doctor if you are taking: - Triptans other than frovatriptan (such as sumatriptan, almotriptan, eletriptan, naratriptan, rizatriptan or zolmitriptan). Do not take these medicines at the same time as Frovatriptan. After taking Frovatriptan, leave 24 hours before taking other triptans as this may result in high blood pressure, narrowing of the blood vessels of the heart or serotonin syndrome, a potentially life-threatening drug reaction (see section 4 'Possible side effects'). - Buprenorphine. Do not take this medicine at the same time as Frovatriptan as this may result in serotonin syndrome, a potentially life-threatening drug reaction. - Ergotamine or medicines similar to ergotamine (used to treat migraines including methysergide and methylergometrine). Do not take these medicines at the same time as Frovatriptan as this may also result in high blood pressure, narrowing of the veins of the heart or serotonin syndrome. Wait at least 24 hours after taking Frovatriptan before taking these medicines or similarly, wait at least 24 hours after taking these medicines before taking Frovatriptan. - Medicines for depression called selective serotonin re-uptake inhibitors (SSRIs) such as fluoxetine, citalopram, fluvoxamine, paroxetine or sertraline) as this may result in high blood pressure, narrowing of the blood vessels of the heart or serotonin syndrome. - St John's wort (Hypericum perforatum), a herbal remedy used to treat depression, as this may result in serotonin syndrome. - Medicines used to treat depression called monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, isacarboxazid and tranylcypromine as these may cause high blood pressure or serotonin syndrome. - Oral contraceptives as these may increase the amount of frovatriptan in your body. The symptoms of serotonin syndrome may include a combination of the following: involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms. Pregnancy and breast-feeding Pregnancy
Frovatriptan is not recommended in pregnant women and in women of childbearing age who do not use contraception unless clearly necessary as it is not known if it is safe to use. Breast-feeding Frovatriptan may be present in breast milk. Breast-feeding is not recommended unless necessary, in which case avoid breast-feeding for 24 hours after taking Frovatriptan. 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. Driving and using machines This medicine and the migraine itself may make you feel drowsy. Do not drive or operate machinery if you feel drowsy, are affected by a migraine attack or after taking Frovatriptan. Frovatriptan contains lactose and sodium If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately or go to your nearest hospital emergency department if you get the following:
Rare (may affect up to 1 in 1,000 people)
• Burning stomach pain, usually immediately or 1 to 2 hours after eating. This may be a sign of an ulcer in the stomach or upper part of the small intestine Not known (frequency cannot be estimated from the available data)
• Serious allergic reactions such as flushing of the skin, nettle rash, swelling of the mouth, lips, tongue or throat causing difficulty breathing or swallowing, feeling sick (nausea) or being sick (vomiting), collapse or unconsciousness • Sudden chest pain that may spread to the neck or arms with a clammy feeling or a shortness of breath. These may be signs of a heart attack (myocardial infarction) • A pressing, tight or heavy sensation on your chest with chest pain that lasts for a short period of time. These may be signs of a temporary narrowing of the blood vessels of the heart (coronary artery spasm) Other possible side effects include: Common (may affect up to 1 in 10 people)
• Dizziness, headache, abnormal or lack of feeling when touching, tingling, pins and needles in the fingers or toes, sleepiness • Warm sensation (flushing) • Problems with your sight • Increased sweating • Stomach pain, feeling sick (nausea), indigestion, dry mouth • Tiredness, chest discomfort, tightness in the throat Uncommon (may affect up to 1 in 100 people)
• Change in sense of taste, trembling, poor concentration, lethargy, increased sensitivity to touching, twitching muscles • Diarrhoea, difficulty in swallowing, wind, stomach upset, bloated stomach • Fast heartbeat that feels like a thumping in your chest (palpitations), increased heart beat, chest pain • Coldness in feet and hands • Feeling hot, reduced tolerance of heat and cold, pain, weakness, thirst, sluggishness, increased energy, general feeling of being unwell • Foggy head or feeling lightheaded, with a sensation of spinning when sitting or standing (vertigo) • Anxiety, inability to sleep, confusion, nervousness, agitation, depression, loss of sense of personal identity • Runny or stuffy nose, possibly with pain or tenderness in the face, sore throat • Muscle or joint stiffness, muscle or joint pain, pain in the hands and feet, back pain • Pain in the eye, eye irritation, painful oversensitivity to light • Itchiness • Ringing in the ears, earache • Dehydration • Passing abnormally large amounts of urine; urinating more frequently • Increase in blood pressure Rare (may affect up to 1 in 1,000 people)
• An increase or decrease in muscle tone, delay in reflexes, movement problems • Constipation, belching, heartburn, irritable bowel syndrome, lip blisters, lip pain, spasm of the food pipe, blisters in the mouth, pain in the salivary gland, redness, irritation or swelling of the mouth, toothache • Fever • Loss of memory, abnormal dreams, changes to your personality • Nosebleed, hiccups, very quick shallow breathing (hyperventilation), other breathing problems, sore throat • Night blindness
• Skin reddening, sensation of hairs standing on end, purplish spots or patches on skin and mucous surfaces of the body, hives • Slow heart beat • Ear discomfort, earache, ear itchiness, sensitive hearing • Increase in bilirubin (a substance produced in the liver) in the blood or a decrease of calcium in the blood which can be seen in a blood test, abnormal urine test results • Low sugar in the blood • Passing urine frequently at night, pain in the kidneys • Self-inflicted injury (bite) • Swollen lymph nodes • Breast tenderness 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary This leaflet was last revised in May 2024.
Frovatriptan 2.5 mg Film-coated Tablets comes as tablet containing 2.5mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Frovatriptan 2.5 mg Film-coated Tablets is frovatriptan succinate monohydrate.
Medicines with the same active substance, strength and form include: Migard 2.5 mg film-coated tablets, Frovatriptan 2.5 mg film coated tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Frovatriptan 2.5 mg Film-coated Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Acute treatment of the headache phase of migraine attacks with or without aura.
Frovatriptan is indicated in adults.
Posology
Frovatriptan should be taken as early as possible after the onset of a migraine attack but it is also effective when taken at a later stage. Frovatriptan should not be used prophylactically.
If a patient does not respond to the first dose of frovatriptan, a second dose should not be taken for the same attack, since no benefit has been shown. Frovatriptan may be used for subsequent migraine attacks.
Adults (18 to 65 years of age)
The recommended dose of frovatriptan is 2.5 mg.
If the migraine recurs after initial relief, a second dose may be taken, providing there is an interval of at least 2 hours between the two doses.
The total daily dose should not exceed 5 mg per day.
Paediatric population (under 18 years)
The safety and efficacy of frovatriptan in children and adolescents below the age of 18 years have not been established. Therefore, its use in this age group is not recommended. No data are available.
Older people (over 65 years)
Frovatriptan data in patients over 65 years remain limited. Therefore, its use in this category of patients is not recommended.
Renal impairment
No dosage adjustment is required in patients with renal impairment (see section 5.2).
Hepatic impairment
No dosage adjustment is required in patients with mild to moderate hepatic impairment (see section 5.2). Frovatriptan is contraindicated in patients with severe hepatic impairment (see section 4.3).
Method of administration
For oral use.
The tablets should be swallowed whole with water.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
- Patients with a history of myocardial infarction, ischaemic heart disease, coronary vasospasm (e.g. Prinzmetal's angina), peripheral vascular disease, patients presenting with symptoms or signs compatible with ischaemic heart disease.
- Moderately severe or severe hypertension, uncontrolled mild hypertension.
- Previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
- Severe hepatic impairment (Child-Pugh C).
- Concomitant administration of frovatriptan with ergotamine or ergotamine derivatives (including methysergide) or other 5-hydroxytryptamine (5-HT1) receptor agonists.
Frovatriptan should only be used where a clear diagnosis of migraine has been established.
Frovatriptan is not indicated for the management of hemiplegic, basilar or ophthalmoplegic migraine.
As with other treatments of migraine attack, it is necessary to exclude other, potentially serious, neurological conditions before treating the headache of patients without a previous diagnosis of migraine, or migraine patients presenting with atypical symptoms. It should be noted that migraineurs present an increased risk of certain cerebral vascular events (e.g. CVA or TIA).
The safety and efficacy of frovatriptan administered during the aura phase, before the headache phase of migraine, has not been established.
As with other 5-HT1 receptor agonists, frovatriptan must not be administered to patients at risk of coronary artery disease (CAD), including heavy smokers or users of nicotine substitution therapy without a prior cardiovascular evaluation (see section 4.3). Specific attention should be given to post- menopausal women and men over 40 years of age presenting with these risk factors.
However, cardiac evaluations may not identify every patient who has cardiac disease. In very rare cases serious cardiac events have occurred in patients with no underlying cardiovascular disease when taking 5-HT1 receptor agonists.
Frovatriptan administration can be associated with transient symptoms including chest pain or tightness which may be intense and involve the throat (see section 4.8).
Where such symptoms are thought to indicate ischaemic heart disease no further doses of frovatriptan should be taken and additional investigations should be carried out.
Patients should be informed of the early signs and symptoms of hypersensitivity reactions including cutaneous disorders, angioedema and anaphylaxis (see section 4.8). In case of serious allergic / hypersensitivity reactions, frovatriptan treatment should be discontinued immediately and it should not be administered again.
It is advised to wait 24 hours following the use of frovatriptan before administering an ergotamine- type medication. At least 24 hours should be elapse after administration of an ergotamine-containing preparation before frovatriptan is given (see sections 4.3 and 4.5).
In case of too frequent use (repeated administration several days in a row corresponding to a misuse of the product), the active substance can accumulate leading to an increase of the side-effects.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The possibility of Medication Overuse Headache (MOH) should be taken into consideration in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Do not exceed the recommended dose of frovatriptan.
Undesirable effects may be more common during concomitant use of triptans (5HT agonists) and herbal preparations containing St John's wort (Hypericum perforatum).
Concomitant administration of frovatriptan and buprenorphine may result in serotonin syndrome, a potentially life-threatening condition (see section 4.5).
Excipients with known effects
This medicine contains lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Concomitant use contraindicated
Ergotamine and ergotamine derivatives (including methysergide) and other 5 HT1 agonists
Risks of hypertension and coronary artery constriction due to additive vasospastic effects when used concomitantly for the same migraine attack (see section 4.3).
Effects can be additive. It is recommended to wait at least 24 hours after administration of ergotamine-type medication before administering frovatriptan. Conversely it is recommended to wait 24 hours after frovatriptan administration before administering an ergotamine-type medication (see section 4.4).
Concomitant use not recommended
Monoamine oxidase inhibitors
Frovatriptan is not a substrate for MAO-A, however a potential risk of serotonin syndrome or hypertension cannot be excluded (see section 5.2).
Concomitant use requiring caution
Selective serotonin-reuptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)
Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome.
Strict adherence to the recommended dose is an essential factor to prevent this syndrome.
Serotonergic medicinal products (e.g. buprenorphine)
Risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4).
Methylergometrine
Risks of hypertension, coronary artery constriction.
Fluvoxamine
Fluvoxamine is a potent inhibitor of cytochrome CYP1A2 and has been shown to increase the blood levels of frovatriptan by 27-49%.
Oral contraceptives
In female subjects taking oral contraceptives, concentrations of frovatriptan were 30% higher than in females not taking oral contraceptives. No increased incidence in the adverse event profile was reported.
Hypericum perforatum (St. John's wort) (oral route)
As with other triptans the risk of the occurrence of serotonin syndrome may be increased.
Pregnancy
There are no or limited amount of data from the use of frovatriptan in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Frovatriptan is not recommended during pregnancy and in women of childbearing potential not using contraception unless clearly necessary.
Breast-feeding
Frovatriptan and/or its metabolites are excreted in the milk of lactating rats with the maximum concentration in milk being four-fold higher than maximum blood levels. A risk to the breast-feeding newborns/infants cannot be excluded.
Although it is not known whether frovatriptan or its metabolites are excreted in human breast milk, the administration of frovatriptan to women who are breastfeeding is not recommended, unless is clearly needed. In this case, a 24 hours interval must be observed.
No studies on the effects on the ability to drive and use machines have been performed.
Migraine or treatment with frovatriptan may cause somnolence. Patients should be advised to evaluate their ability to perform complex tasks such as driving during migraine attacks and following administration of frovatriptan.
Frovatriptan has been administered to over 2,700 patients at the recommended dose of 2.5 mg and the most common side effects (<10%) include dizziness, fatigue, paraesthesia, headache and vascular flushing. The undesirable effects reported in clinical trials with frovatriptan were transient, generally mild to moderate and resolved spontaneously. Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.
The table below shows all the adverse reactions that are considered to be related to treatment with 2.5 mg frovatriptan and showed a greater incidence than with placebo in the 4 placebo controlled trials. They are listed in decreasing incidence by body-system. Adverse reactions collected in the post-marketing experience are noted with an asterisk *.
System organ class
Common
≥1/100 to <1/10
Uncommon
≥1/1,000 to <1/100
Rare
≥1/10,000 to <1/1,000
Not known
(cannot be estimated from the available data)
Blood and lymphatic system disorders
Lymphadenopathy
Immune system disorders
Hypersensitivity reactions* (including cutaneous disorders, angioedema and anaphylaxis)
Metabolism and nutrition disorders
Dehydration,
Hypoglycaemia
Psychiatric disorders
Anxiety, insomnia, confusional state, nervousness, agitation, depression, depersonalisation
Abnormal dreams, personality disorder
Nervous system disorders
Dizziness, paraesthesia, headache, somnolence, dysaesthesia, hypoaesthesia
Dysgeusia, tremor, disturbance in attention, lethargy, hyperaesthesia, sedation, vertigo, involuntary muscle contractions
Amnesia, Hypertonia, Hypotonia, hyporeflexia, movement disorder
Eye disorders
Visual disturbance
Eye pain, eye irritation, photophobia
Night blindness
Ear and labyrinth disorders
Tinnitus, ear pain
Ear discomfort, ear disorder, ear pruritus, hyperacusis
Cardiac disorders
Palpitations, tachycardia
Bradycardia
Myocardial infarction*, arteriospasm coronary*
Vascular disorders
Flushing
Peripheral coldness, Hypertension
Respiratory, thoracic and mediastinal disorders
Throat tightness
Rhinitis, sinusitis, pharyngolaryngeal pain
Epistaxis, hiccups, hyperventilation, respiratory disorder, throat irritation
Gastrointestinal disorders
Nausea, dry-mouth, dyspepsia, abdominal pain
Diarrhoea, dysphagia, flatulence, stomach discomfort, abdominal distension
Constipation, eructation, gastro-oesophageal reflux disease, irritable bowel syndrome, lip blister, lip pain, oesophageal spasm, oral mucosal blistering, peptic ulcer, salivary gland pain, stomatitis, toothache
Skin and subcutaneous tissue disorders
Hyperhidrosis
Pruritus
Erythema, piloerection, purpura, urticaria
Musculoskeletal, and connective tissue disorders
Musculoskeletal stiffness, musculoskeletal pain, pain in extremity, back pain, arthralgia
Renal and urinary disorders
Pollakiuria, polyuria
Nocturia, renal pain
Reproductive system and breast disorders
Breast tenderness
General disorders and administration site conditions
Fatigue, chest discomfort
Chest pain, feeling hot, temperature intolerance, pain, asthaenia, thirst, sluggishness, energy increased, malaise
Pyrexia
Investigations
Blood bilirubin increased, blood calcium decreased, urine analysis abnormal
Injury, poisoning and procedural complications
Bite
In two open long-term clinical studies the observed effects were not different from those listed above.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
There is limited data on overdose with frovatriptan tablets. The maximum single oral dose of frovatriptan given to male and female patients with migraine was 40 mg (16 times the recommended clinical dose of 2.5 mg) and the maximum single dose given to healthy male subjects was 100 mg (40 times the recommended clinical dose). Both were not associated with side effects other than those mentioned in section 4.8. However, one post-marketing serious case of coronary vasospasm has been reported, following intake of 4 times the recommended dose of frovatriptan on three consecutive days, in a patient taking migraine prophylactic treatment with a tricyclic antidepressant. The patient recovered.
Treatment
There is no specific antidote for frovatriptan. The elimination half-life of frovatriptan is approximately 26 hours (see section 5.2.).
The effects of haemodialysis or peritoneal dialysis on serum concentrations of frovatriptan are unknown.
In case of overdose with frovatriptan, the patient should be monitored closely for at least 48 hours and be given any necessary supportive therapy
Ask anything about Frovatriptan 2.5 mg Film-coated Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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