2.5 mg and 5 mg film-coated tablets
zolmitriptan
What Zolmitriptan is and what it is used for
Zolmitriptan belongs to a group of drugs called “selective serotonin ( 5HT 1 ) agonists” and is used to treat the symptoms of migraine.
Zolmitriptan Teva is used for the treatment of migraine. You should not take Zolmitriptan Teva to prevent a migraine attack.
The zolmitriptan contained in Zolmitriptan Teva 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 take Zolmitriptan Teva
Do not take Zolmitriptan Teva:
- If you are allergic to zolmitriptan, para orange (E110), Allura red AC (E129), or any of the other ingredients of this medicine (listed in section 6).
- If you have high blood pressure that is difficult to treat or poorly controlled blood pressure. Consult your doctor if you are unsure.
- If you have had a heart attack, have heart disease, angina (chest pain), or other circulatory problems.
- If you are simultaneously taking certain other medicines against migraine, eg ergotamine, dihydroergotamine, methysergide, sumatriptan, or naratriptan.
- If you have severe kidney disease.
- If you have had a stroke or a transient cerebrovascular accident (smaller strokes that go away completely within a day or two).
Do not take Zolmitriptan Teva if any of the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Zolmitriptan Teva.
Warnings and precautions
Talk to your doctor or pharmacist before using Zolmitriptan Teva if you:
- have an irregular heartbeat.
- has a disease called Wolff-Parkinson-White syndrome, which is characterized by an abnormal heart rhythm.
- smoke, have high cholesterol levels, diabetes, and high blood pressure if someone in your family has heart disease or you belong to a risk group for developing heart disease. Your doctor may do further tests to make sure it is safe for you to take Zolmitriptan Teva. This applies especially to men over 40 and women in menopause.
- takes a herbal remedy called St. John’s wort.
- takes medication for depression such as fluoxetine, sertraline, or venlafaxine. Taking Zolmitriptan Teva at the same time as any of these medicines can cause serotonin syndrome, a life-threatening condition that causes restlessness, hallucinations, faster heartbeats, coordination difficulties, vomiting, nausea, and diarrhea.
If you experience chest pain or chest pressure, stop taking the medicine and contact your doctor immediately.
Zolmitriptan Teva can cause increased blood pressure. If your blood pressure becomes too high, you may experience symptoms such as headaches, dizziness, and ringing in the ears. Contact your doctor if this happens to you.
Overconsumption of common pain relievers can worsen headaches. If you take common pain relievers (e.g. paracetamol ) regularly and have recurring or daily headaches, you should consult your doctor.
You should not take Zolmitriptan Teva during the aura phase (the period before the headache phase) to prevent migraine headaches. You should take your medication during the headache phase of the migraine attack.
Other medicines and Zolmitriptan Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of Zolmitriptan Teva may change and side effects may occur if you take other medicines. In particular, tell your doctor if you are taking any of the following:
- Ergotamine (treatment of migraine ) or ergotamine-like medicines, such as dihydroergotamine or methysergide. If you have taken ergotamine, at least 24 hours should pass before taking Zolmitriptan Teva. If you have taken Zolmitriptan Teva, at least 6 hours should pass before taking ergotamine.
- Other triptans such as sumatriptan or naratriptan. After taking other triptans, at least 24 hours should pass before taking Zolmitriptan Teva, and if you have taken Zolmitriptan Teva, at least 24 hours should pass before taking other triptans.
- Moclobemide, fluvoxamine, selegiline or fluoxetine, paroxetine, or sertraline (treatment of depression).
- SNRIs (serotonin-norepinephrine reuptake inhibitors) such as venlafaxine and duloxetine (for the treatment of depression).
- Cimetidine (treatment of indigestion or stomach ulcers ).
- Certain antibiotics to treat infection (eg ciprofloxacin, levofloxacin, norfloxacin, and ofloxacin).
- St. John’s wort (natural medicine).
Zolmitriptan Teva with food and drink
You can take Zolmitriptan Teva with or without food. It does not affect the way Zolmitriptan Teva works.
Pregnancy, breastfeeding, and fertility
Pregnancy:
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.
Breastfeeding:
The active substance in your medicine can pass into breast milk. To minimize the risk of exposing the baby to the medicine, do not breastfeed within 24 hours of taking Zolmitriptan Teva.
Driving ability and use of machinery
During a migraine attack, you may feel drowsy. If you feel drowsy, do not drive, operate machinery or perform hazardous tasks that require full attention.
You 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 leaflet. Therefore, read all the information in this leaflet. Discuss with a doctor or pharmacist if you are unsure.
Auxiliary substances
Zolmitriptan Teva 2.5 mg and 5 mg film-coated tablets
Zolmitriptan Teva contains lactose
If you have received information from your doctor that you are hypersensitive to certain sugars, contact your doctor before taking this medicine.
Zolmitriptan Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it is almost “sodium-free”.
Zolmitriptan Teva 5 mg film-coated tablets
Zolmitriptan Teva contains Allura red AC (E129)
May cause allergic reactions.
Zolmitriptan Teva contains orange (E110)
How to take Zolmitriptan Teva
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 2.5 mg as soon as you feel the migraine headache coming on. It works even if you take it later.
If dose one of 2.5 mg does not provide sufficient effect, your doctor may choose to increase dose one to 5 mg. You are more likely to have side effects at a higher dose (5 mg).
You can take another dose if the migraine symptoms return within 24 hours. However, you must wait at least 2 hours before taking another dose.
Swallow the tablets whole with water. A maximum of 2 doses may be taken per day. The maximum daily dose is 10 mg.
If you have liver problems or take certain other medicines, your doctor may prescribe a lower dose.
Zolmitriptan Teva is not recommended for children and adolescents under 18 years of age or for patients over 65 years of age.
If you have taken too much Zolmitriptan Teva
If you have ingested too much Zolmitriptan Teva 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.
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.
If you notice any of the following side effects, stop taking Zolmitriptan Teva and contact your doctor immediately:
Rare: affects up to 1 in 1,000 users
- Allergic reactions including hives, swelling of the face, lips, mouth, tongue, or throat, or difficulty breathing
Very rare: affects up to 1 in 10,000 users
- Heart attack or chest pains
- Intestinal and splenic infarction, can cause stomach pain or bloody diarrhea.
Other possible side effects are:
Common: may affect up to 1 in 10 users
- Abnormal sensory sensations, such as tingling in the skin, feeling of heat, increased sensitivity to touch or sound
- Dizziness or headache
- Somnolence
- Palpitation
- Stomach pain, nausea, vomiting or dry mouth, dysphagia (difficulty swallowing)
- Muscle weakness or muscle pain
- Impotence
- Heaviness, tightness, pain, or pressure in the throat, neck, arms and legs, or chest.
Uncommon: may affect up to 1 in 100 users
- Increased heart rate
- Blood pressure increase
- More frequent urges to urinate or increased amount of urine.
Very rare: may affect up to 1 in 10,000 users
- Urinary incontinence
Some of the symptoms described above may be part of the migraine attack itself.
How to store Zolmitriptan Teva
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated after EXP on the carton and blister card. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice visible signs of deterioration.
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 Teva 2.5 mg tablet:
- Each 2.5 mg tablet contains 2.5 mg zolmitriptan
- Other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate
- Other ingredients in the tablet coating are polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172)
Zolmitriptan Teva 5 mg tablet:
- Each 5 mg tablet contains 5 mg zolmitriptan
- Other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), magnesium stearate
- Other ingredients in the tablet coating are titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80, Allura red AC (E129), para orange (E110)
Appearance and package sizes of the medicine
- Zolmitriptan 2.5 mg film-coated tablets are yellow, round, biconvex tablets debossed with “Z2.5” on one side.
- Zolmitriptan Teva 5 mg film-coated tablets are pink, round, biconvex tablets debossed with “93” on one side and “8146” on the other.
The tablets are packed in blisters containing 2, 3, 6, 12, or 18 tablets.