2.5 mg and 5 mg film-coated tablets
zolmitriptan
What Zolmitriptan Rivopharm is and what it is used for
Zolmitriptan Rivopharm contains zolmitriptan and belongs to a group of medicines called triptans.
Zolmitriptan Rivopharm is used to treat migraine.
Migraine symptoms may be due to dilation of the blood vessels in the head. Zolmitriptan Rivopharm is thought to reduce the dilation of these blood vessels. This contributes to the disappearance of the headache and other symptoms of a migraine attack, e.g. feeling sick or sick (retching or vomiting) and sensitivity to light and sound.
Zolmitriptan Rivopharm only works when a migraine attack has started. The medicine does not prevent you from having a seizure.
The zolmitriptan contained in Zolmitriptan Rivopharm may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions
What you need to know before you use Zolmitriptan Rivopharm
Do not use Zolmitriptan Rivopharm
- 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 ever had heart problems, including a heart attack, angina (chest pain caused by exercise or exertion), Prinzmetal’s angina (chest pain that comes on at rest), or have had heart-related symptoms such as shortness of breath or chest tightness.
- if you have circulation problems (restricted blood flow in the legs or arms).
- if you have had a stroke or short-term symptoms similar to a stroke ( transient ischemic attack or TIA ).
- if you have severe kidney problems.
- if you are simultaneously taking certain other medicines for migraine (eg ergotamine or ergotamine-like medicines such as dihydroergotamine and methysergide) or other medicines with triptans for migraine. See the section below: “Other medicines and Zolmitriptan Rivopharm” for further information.
If you are not sure if this applies to you, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Zolmitriptan Rivopharm
- if you are at risk of developing ischemic heart disease (poor blood flow in the arteries of the heart ). The risk is greater 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 abnormal heartbeat).
- if you have ever had liver problems.
- if you have a headache that is not like your usual migraine headache.
- if you are taking any medicines to treat depression (see “Other medicines and Zolmitriptan Rivopharm” below in this section).
When you take Zolmitriptan Rivopharm at the same time as SSRI or SNRI preparations, which are used to treat depression, there is a risk of developing a so-called serotonin syndrome. Symptoms can be severe and include chills, overreactive reflexes, nausea, fever, sweating, delirium, mental confusion, and coma. If you take this combination, your doctor should monitor you closely, especially at the beginning of treatment, when doses are increased or if another serotonergic drug is added. If you experience any of these symptoms, contact your doctor immediately.
Like other migraine treatments, using too much zolmitriptan can cause daily headaches or make migraines worse. Ask your doctor if you think this applies to you. You may need to stop taking zolmitriptan to get rid of the problem.
If you go to the hospital, tell the healthcare staff that you are taking Zolmitriptan Rivopharm.
Children and young people
Zolmitriptan Rivopharm is not recommended for people under 18.
Older
Zolmitriptan Rivopharm is not recommended for people over 65 years of age.
Other medicines and Zolmitriptan Rivopharm
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies above all if you are taking any of the following medicines:
Migraine medication
- if you take medicines other than Zolmitriptan Rivopharm belonging to the group of triptans, at least 24 hours should pass before taking Zolmitriptan Rivopharm.
- if you are taking medicines containing ergotamine or ergotamine-like medicines (eg dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptan Rivopharm and
- wait 6 hours after taking Zolmitriptan Rivopharm before taking ergotamine or ergotamine-like medicines.
Medicines for depression (see also “Warnings and precautions” above)
- moclobemide or fluvoxamine.
- medicines called SSRIs (selective serotonin reuptake inhibitors).
- medicines called SNRI preparations (serotonin-norepinephrine reuptake inhibitors), e.g. venlafaxine and duloxetine.
Other medicines
- cimetidine (for indigestion or stomach ulcers ).
- quinolone antibiotics (eg ciprofloxacin ).
If you use herbal medicines that contain St. John’s wort ( Hypericum perforatum ), it is more likely that you will have side effects from Zolmitriptan Rivopharm.
Taking Zolmitriptan Rivopharm with food and drink
You can take Zolmitriptan Rivopharm with or without food. It does not affect the effect of Zolmitriptan Rivopharm.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 it is harmful to take Zolmitriptan Rivopharm during pregnancy. Tell your doctor if you are pregnant or trying to become pregnant before taking Zolmitriptan Rivopharm.
Do not breastfeed for 24 hours after taking Zolmitriptan Rivopharm.
Driving ability and use of machinery
During a migraine attack, your reactions may be slower than usual. Remember this when driving or using tools or machinery.
Zolmitriptan Rivopharm is unlikely to affect driving or using tools or machines.
However, it is best to wait and see how Zolmitriptan Rivopharm affects you before doing these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zolmitriptan Rivopharm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine
How to use Zolmitriptan Rivopharm
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
You can take Zolmitriptan Rivopharm as soon as the migraine attack starts. You can also take it when a seizure is in progress.
The recommended dose is one tablet (either 2.5 mg or 5 mg).
You can take another tablet if the migraine persists after two hours or if it returns within 24 hours.
Tell the doctor if the tablets do not provide sufficient relief from the migraine. The doctor may increase the dose to 5 mg of zolmitriptan or change the treatment.
Do not take more than the dose prescribed.
Do not take more than two doses in one day. If you have been prescribed a 2.5 mg tablet, the maximum dose is 5 mg. If you have been prescribed a 5 mg tablet, the maximum dose is 10 mg.
Swallow the tablet with a glass of water.
If you have used too much Zolmitriptan Rivopharm
If you have ingested too much medicine 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 Zolmitriptan Rivopharm with you.
If you have taken too many tablets, the symptoms may include drowsiness.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the symptoms mentioned below may be part of the migraine attack itself.
If you experience any of the following serious side effects, stop using Zolmitriptan Rivopharm and contact your doctor immediately:
Rare (may affect up to 1 in 1,000 users):
- Allergic reactions include itchy rash (hives) and swelling of the face, lips, mouth, tongue, and throat.
Very rare (may affect up to 1 in 10,000 users)
- Angina (chest pain, often associated with exercise), heart attack, or spasm in the blood vessels of the heart. You may notice chest pain and shortness of breath.
- Spasms in the blood vessels of the intestinal tract, can lead to damage to the intestinal tract. You may notice stomach pain or bloody diarrhea.
Other possible side effects may occur:
Common (may affect up to 1 in 10 users):
- Abnormal sensory sensations such as tingling in the fingers and toes or skin that is sensitive to the touch
- Feeling sleepy, dizzy, or warm
- Headache
- Irregular heartbeats
- The feeling of nausea, vomiting
- Stomach pain
- Dry mouth
- Difficulty swallowing
- Muscle weakness or muscle pain
- Feeling of weakness
- Heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest
Uncommon (may affect up to 1 in 100 users):
- Very fast heartbeat
- Slightly elevated blood pressure
- Increased amount of urine or increased need to urinate
Very rare (may affect up to 1 in 10,000 users):
- Sudden urgent need to urinate
Reporting of side effects are
If you get side effects, talk to a doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the Swedish Medicines Agency, Box 26, SE-751 03 Uppsala. Website: www.lakemedelsverket.se. By reporting side effects, you can contribute to increasing information about drug safety.
How to store Zolmitriptan Rivopharm
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the 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. Zolmitriptan Rivopharm film-coated tablets contain either 2.5 mg or 5 mg zolmitriptan.
- Other ingredients are tablet core: lactose (anhydrous), microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate; tablet coating: hypromellose (E464), titanium dioxide (E171), polydextrose, talc, maltodextrin, triglycerides, medium chain, yellow iron oxide (E172) and black iron oxide (E172), (only 2.5 mg) or red iron oxide (E172) (only 5 mg).
Appearance and package sizes of the medicine
Zolmitriptan Rivopharm 2.5 mg film-coated tablets are light yellow, round, biconvex tablets with “ZL 2.5” embossed on one side.
Zolmitriptan Rivopharm 5 mg film-coated tablets are pale pink, round, biconvex tablets with “ZL 5” debossed on one side.
Zolmitriptan Rivopharm 2.5 mg and 5 mg are supplied in blister packs of 3, 6, 12, or 18 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Manufacturer:
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZIN3000
Malta
Agent:
SanoSwiss UAB
Lviv 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.co