Frovex (frovatriptan)

Warning!

• This medicine should not be used to prevent migraines.
• This medicine should only be used by people with a clear diagnosis of migraine from their doctor.
• If the first dose of this medicine doesn't relieve your migraine headache then you should NOT take another dose for the same attack, as trials have shown that this is not effective. (You can still take Migard for your next attack.) If the first dose does initially relieve your migraine, but the headache then comes back, you can take a second dose. However, if you need a second dose because your migraine has returned, you should NOT take it within two hours of your first dose. Do not exceed the recommended dose.
• Using any painkillers for headaches too often or for too long can actually make the headaches worse. If you find you need to use this medicine frequently you should consult your doctor for advice.
• This medicine can cause feelings of warmth, heaviness, pressure, tightness, tingling or pain in certain parts of the body, including the chest or throat. Although sometimes very strong, these feelings usually only last a few minutes. If they continue or are particularly severe (especially chest pain), you should not take any more tablets and consult your doctor immediately.
• This medicine may cause drowsiness. If affected do not drive or operate machinery.

Use with caution in

• People with risk factors for coronary heart disease, such as smoking, high cholesterol levels, diabetes, obesity, or a family history of heart disease.
• Men over 40 years of age.
• Post-menopausal women.
• Depression.

Not to be used in

• Severely decreased liver function.
• People who have had a heart attack.
• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina.
• A severe form of angina pectoris, not caused by exertion (Prinzmetal's angina).
• Narrowing of blood vessels in the extremities (peripheral vascular disease), eg problems with blood circulation in the legs or arms.
• Uncontrolled or moderate to severe high blood pressure (hypertension).
• People who have had a stroke.
• History of small temporary strokes (transient ischaemic attacks).
• A form of migraine associated with paralysis of the eye muscles (ophthalmoplegic migraine).
• A form of migraine associated with temporary paralysis of one side of the body (hemiplegic migraine).
• A type of migraine where there is a disturbance in brain function which initially presents with total blindness followed by dizziness, speach disturbances, ringing in the ears and double vision (basilar migraine).
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Migard tablets contain lactose).
• This medicine is not recommended for children and adolescents aged under 18 years, or people aged over 65 years, as there is no information available regarding its safety in these age groups.
• This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. It is not recommended for use during breastfeeding unless considered essential by your doctor. If you are breastfeeding and your doctor recommends you to take this medicine, you should avoid breastfeeding for 24 hours after taking the medicine, and any milk expressed during this time should be discarded. Seek further medical advice from your doctor.

Label warnings

• This medication may cause drowsiness. If affected do not drive or operate machinery.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Dizziness.
• Fatigue.
• Headache.
• Flushing.
• Changes in sensation, for example pins and needles, tingling or numb sensations.
• Sleepiness (somnolence).
• Dry mouth.
• Chest pain.
• Awareness of your heartbeat (palpitations).
• Feeling of tightness in the throat.
• Increased sweating.
• Visual disturbances.
• Disturbances of the gut such as nausea, indigestion, diarrhoea, constipation, flatulence or abdominal pain.
• Anxiety or agitation.
• Confusion or concentration difficulties.
• Mood changes.
• Abnormal thinking.
• Difficulty sleeping (insomnia).
• Feeling weak.
• Increase in blood pressure.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Do not take this medicine if you have taken ergotamine or its derivatives, eg dihydroergotamine or methysergide, in the previous 24 hours. These medicines should not be taken within 24 hours of taking frovatriptan.

If your first dose of frovatriptan does not work to relieve your migraine, it is fine to take a painkiller containing aspirin, paracetamol, or a non-steroidal anti-inflammatory drug (NSAID), such as ibuprofen. However, as noted above, you should not take ergotamine, dihydroergotamine or methysergide for at least 24 hours after taking frovatriptan.

This medicine must not be taken in combination with other 5HT agonists (triptans), eg sumatriptan, zolmitriptan, rizatriptan, naratriptan, eletriptan, almotriptan.

The manufacturer states that this medicine is not recommended for people taking an MAOI antidepressant, eg phenelzine, tranylcypromine, isocarboxazid, because the combination may have an increased risk of side effects.

There may be an increased risk of a rare side effect called the serotonin syndrome if frovatriptan is taken in combination with other medicines that enhance the activity of serotonin in the central nervous system, such as the following:

• selective serotonin reuptake inhibitor antidepressants (SSRIs), such as citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine or sertraline (fluvoxamine may also prevent the breakdown of frovatriptan in the body and could increase the risk of all its side effects)
• serotonin noradrenaline reuptake inhibitors (SNRIs), such as venlafaxine or duloxetine
• sibutramine
• the herbal remedy St John's wort (Hypericum perforatum). This medicine is not recommended for use in combination with St John's wort.

References:

https://www.drugs.com/cdi/frovatriptan.html

http://www.netdoctor.co.uk/medicines/aches-and-pains/a8458/migard-frovatriptan/

https://en.wikipedia.org/wiki/Frovatriptan

https://patient.info/medicine/frovatriptan-for-migraine-migard

http://www.medicinenet.com/frovatriptan-oral/article.htm

https://www.drugs.com/mtm/frovatriptan.html