2.5 mg and 5 mg orodispersible tablets
zolmitriptan
What Zomig Rapimelt is and what it is used for
Zomig Rapimelt contains zolmitriptan and belongs to a group of medicines called triptans.
Zomig Rapimelt is used to treat the headache during a migraine attack in adults aged 18 and over.
- Migraine symptoms can be caused by a dilation of blood vessels in the head. Zomig Rapimelt is thought to reduce the dilation of these blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as nausea, vomiting, and sensitivity to light and sound.
- Zomig Rapimelt only helps when a migraine attack has started. It cannot prevent an attack.
Zomig Rapimelt is not intended for the treatment of other types of headaches, such as tension-type headaches.
2. What you need to know before you use Zomig Rapimelt
Do not use Zomig Rapimelt
Zomig Rapimelt should only be used by you who know that you have a migraine diagnosed by a doctor.
You probably have a migraine if you have recurring headaches such as:
- Has a pulsating character and is one-sided
- Has moderate to the strong intensity and lasts for 4-72 hours
- Worsens with normal physical activity (eg walking or climbing stairs)
- Affects your ability to concentrate and impairs your daily activities
Migraine can be accompanied by other symptoms such as:
- Nausea, sensitivity to light and sound
- Aura symptoms, such as visual field loss, zigzag patterns or flashes in the visual field, and less often numbness or speech difficulties
Consult a doctor or pharmacist if you are unsure or need more information.
Do not use Zomig Rapimelt:
- if you are allergic to zolmitriptan or any of the other ingredients of this medicine (listed in section 6)
- if you have high blood pressure
- if you have or have had heart problems, such as a heart attack, angina (chest pain caused by exercise or exertion), Prinzmetal’s angina (chest pain at rest), or heart-related symptoms such as shortness of breath or chest tightness
- if you have had a stroke or short-term stroke – like symptoms ( TIA , transient ischemic attack, i.e. a transient circulatory disorder in the brain)
- if you have severe kidney problems
- if you simultaneously take certain other anti- migraine medicines (for example medicines with ergotamine or substances similar to ergotamine , such as dihydroergotamine and methysergide) or other triptan anti- migraine medicines . Read the section “Use of other medicines” for further information.
If you are not sure if any of the above applies to you, ask your doctor or pharmacist for advice.
Warnings and precautions
Talk to your doctor before using Zomig Rapimelt:
- if you belong to the risk group for ischemic heart disease (poor blood flow in the coronary arteries of the heart) The risk is higher if you smoke, have high blood pressure , high cholesterol levels, diabetes or if someone in your family has ischemic heart disease
- if you have been told that you have Wolff-Parkinson-White syndrome (a type of heart rhythm disorder)
- if you have or have had liver problems
- if you have a headache that is not similar to a regular migraine headache
- if you are taking any other medicine for depression (see “Using other medicines” later in this section)
If you are admitted to hospital, tell the healthcare staff that you are taking Zomig Rapimelt.
Zomig Rapimelt is not recommended for children and adolescents under 18 years of age or for adults over 65 years of age.
Like other migraine medicines, overconsumption of Zomig Rapimelt can cause daily headaches or worsening migraine headaches. Consult a doctor if you think it has affected you. It may be necessary to stop treatment with Zomig Rapimelt to correct the problem.
Other medicines and Zomig Rapimelt
Tell your doctor or pharmacist if you are using, have recently used or might be using other medicines. This includes herbal medicines and over-the-counter medicines.
Do not use other medicines containing triptans (including other medicines containing sumatriptan, zolmitriptan, rizatriptan, naratriptan, eletriptan, almotriptan) or other medicines containing ergotamine or ergotamine derivatives (including methysergide) together with Zomig Rapimelt.
Consult your doctor before using Zomig Rapimelt, if you are simultaneously treated with any of the following medicines of the MAO inhibitor type:
- Selegelin (for Parkinson’s disease )
Consult your doctor before using Zomig Rapimelt, if you are simultaneously being treated with any of the following medicines for depression:
- Moclobemide or fluvoxamine
- SSRIs (selective serotonin reuptake inhibitors)
- SNRI preparations ( serotonin -norepinephrine reuptake inhibitors), for example venlafaxine , duloxetine
Serotonin syndrome is a rare, life-threatening condition that has been reported in some patients who have taken Zomig at the same time as so-called serotonergic medicines (eg some medicines for the treatment of depression). Symptoms of serotonin syndrome can e.g. be restlessness, tremors, restlessness, fever, heavy sweating, twitching, muscle stiffness, uncoordinated arm, leg or eye movements and uncontrollable muscle twitching. Your doctor can advise you on this.
Consult your doctor before using Zomig Rapimelt, if you are simultaneously being treated with any of the following medicines:
- Cimetidine (for indigestion or stomach ulcers )
- Quinolone – antibiotics (such as ciprofloxacin )
- Propranolol (used for example against high blood pressure )
If you use herbal medicines that contain St. John’s wort ( Hypericum perforatum) , the risk of side effects may increase.
Zomig Rapimelt with food and drink
You can take Zomig Rapimelt with or without food. It does not affect how Zomig Rapimelt works.
Pregnancy and breastfeeding
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 using this medicine.
- It is not known whether using Zomig Rapimelt during pregnancy is harmful. Before taking Zomig Rapimelt, tell your doctor if you are pregnant or trying to become pregnant.
- You should not breast-feed within 24 hours of taking Zomig Rapimelt.
Driving ability and use of machinery
- During a migraine attack, you may have a longer reaction time than usual. Keep this in mind when driving or using tools or machinery.
- Zomig Rapimelt is unlikely to affect your ability to drive or use tools or machines. However, you should wait and see how Zomig Rapimelt affects you before trying any of these activities.
You yourself are responsible for assessing whether you can drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect this ability is the use of drugs due to their effects and/or side effects . A description of these effects and side effects can be found under other headings in the package insert. Therefore, read all the information in this leaflet. Discuss with a doctor or pharmacist if you are unsure.
Zomig Rapimelt contains aspartame
Zomig Rapimelt 2.5 mg contains 5 mg of aspartame per orodispersible tablet.
Zomig Rapimelt 5 mg contains 10 mg of aspartame per orodispersible tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.
Zomig Rapimelt contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to use Zomig Rapimelt
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
You can use Zomig Rapimelt as soon as you feel a migraine headache coming on, but you can also use Zomig Rapimelt during an ongoing attack.
Usual dose for adults (18-65 years) is 1 tablet (either 2.5 mg or 5 mg).
- Pull up the blister pack as shown on the foil. The tablet should not be pushed through the foil.
- Place the tablet on the tongue where it dissolves and is swallowed with saliva. You do not need to drink water to swallow the tablet.
- You can take 1 more dose if the migraine symptoms persist after 2 hours or if the symptoms return within 24 hours.
- You may take a maximum of 2 doses per day. If you take the 2.5 mg tablet, the maximum daily dose is 5 mg. If you take the 5 mg tablet, the maximum daily dose is 10 mg.
You must contact a doctor if symptoms worsen or do not improve within 3 days.
If you have used too much Zomig Rapimelt
If you have ingested too much Zomig Rapimelt or if, for example, a child has ingested the medicine by mistake, contact a doctor, or hospital for an assessment of the risk and advice. Take the Zomig Rapimelt pack with you.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them. Some of the symptoms described below may be part of the migraine attack itself.
Stop using Zomig Rapimelt and contact your doctor immediately if you experience any of the following side effects:
Rare side effects (may affect up to 1 in 1,000 users):
- Allergic/hypersensitivity reactions, including urticaria ( hives ) and swelling of the face, lips, mouth, tongue or throat, difficulty swallowing or difficulty breathing.
Very rare side effects (may affect up to 1 in 10,000 users):
- Vascular spasm (pain in the chest, often brought on by exertion), heart attack or spasm in the blood vessels of the heart. You may have chest pains or become short of breath.
- Spasm in the intestinal blood vessels, which can cause damage to the intestine. You may experience stomach pains or have bloody diarrhea.
Other side effects that may occur:
Common side effects (may affect up to 1 in 10 users):
- Abnormal sensory sensations, such as tingling in fingers and toes or increased skin sensitivity to touch
- Fatigue, dizziness or feeling hot
- Headache
- Irregular heartbeat
- Nausea, vomiting
- Stomach pain
- Dry mouth
- Muscle weakness or muscle pain
- Impotence
- Heaviness, tightness, pain or pressure in the throat, neck, arms and legs or chest
- Difficulty swallowing
Uncommon side effects (may affect up to 1 in 100 users):
- Very high heart rate
- Slight increase in blood pressure
- Increased amount of urine or more frequent urges to urinate
How to store Zomig Rapimelt
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
- Store at a maximum of 30 °C.
- Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is zolmitriptan. Zomig Rapimelt orodispersible tablets contain either 2.5 mg or 5 mg zolmitriptan.
Other ingredients are: aspartame (E951), anhydrous citric acid, colloidal silicon dioxide, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor and sodium bicarbonate.
Appearance and package sizes of the medicine
- Zomig Rapimelt orodispersible tablet 2.5 mg is white, flat, round and embossed with “Z” on one side.
- Zomig Rapimelt orodispersible tablet 5 mg is white, flat, round and debossed with “Z 5” on one side.
- Zomig Rapimelt orodispersible tablet 2.5 mg and 5 mg are supplied in aluminum laminate blister packs with peelable foil containing 2, 6 or 12 (2 x 6) tablets with or without a storage case.
The storage case is a hard plastic case in which you can conveniently store your tablets. If you use the storage case, you should still keep the outer carton and this leaflet, as you may need to read the information again.
Not all pack sizes may be marketed.
Zomig is also available as a nasal spray 2.5 mg/dose and 5 mg/dose, and as a film-coated tablet 2.5 mg and 5 mg.
Marketing Authorisation Holder
Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany.
Manufacturer
Farmaceutici Formenti SPA, Via Di Vittorio 2, 21040 Origgio (VA), Italy or
Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany