Zolmitriptan STADA – Zolmitriptan uses, dose and side effects


2.5 mg orodispersible tablets

What Zolmitriptan STADA is and what it is used for

Zolmitriptan Stada contains zolmitriptan, which belongs to a group of medicines called triptans.

Zolmitriptan Stada is used to treat headache during a migraine attack.

  • Migraine symptoms are probably caused by a dilation of the blood vessels in the head. Zolmitriptan Stada is thought to reduce the dilation of these blood vessels. This contributes to the disappearance of the headache and other migraine symptoms such as nausea, vomiting, and sensitivity to light and sound.
  • Zolmitriptan Stada only helps when a migraine attack has started. It cannot prevent an attack.

The zolmitriptan contained in Zolmitriptan Stada 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 STADA

Do not use Zolmitriptan STADA

  • you are allergic to zolmitriptan, menthol, or any of the other ingredients of this medicine (listed in section 6)
  • you have high blood pressure
  • you have or have had heart problems, such as heart attack or 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 tightness in the chest
  • you have had a stroke or short-term stroke-like symptoms ( TIA, transient circulatory disorder in the brain)
  • you have severe kidney disease
  • you simultaneously take certain other medicines against migraine (containing, for example, ergotamine or substances similar to ergotamine, such as dihydroergotamine and methysergide) or other migraine medicines belonging to the group of triptans. Read the section “Other medicines and Zolmitriptan Stada” 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 taking Zolmitriptan Stada if:

  • you belong to the risk group for ischemic heart disease (poor blood flow in the coronary arteries). The risk is higher if you smoke, have high blood pressure, high cholesterol levels, or diabetes or if someone in your family has ischemic heart disease
  • you have Wolff-Parkinson-White syndrome (a type of heart rhythm disorder)
  • you have or have had liver problems
  • you have a headache that is not like your usual migraine headache
  • you are taking any other medicine for depression (see “Other medicines and Zolmitriptan Stada” later in this section).

If you are admitted to the hospital, tell the healthcare staff that you are taking Zolmitriptan Stada.

Zolmitriptan Stada is not recommended for people under 18 or over 65.

Like other migraine medicines, overconsumption of Zolmitriptan Stada 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 Zolmitriptan Stada to correct the problem.

Other medicines and Zolmitriptan STADA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

Migraine medication

  • if you take medicines other than Zolmitriptan Stada belonging to the group of triptans, at least 24 hours should pass before you take Zolmitriptan Stada.
  • after you have taken Zolmitriptan Stada, at least 24 hours should pass before you take medicines other than Zolmitriptan Stada belonging to the group of triptans.
  • if you have taken medicines containing ergotamine or substances similar to ergotamine (such as dihydroergotamine or methysergide) you should wait at least 24 hours before taking Zolmitriptan Stada.
  • after you have taken Zolmitriptan Stada, at least 6 hours should pass before you take any medicine containing ergotamine or any substance similar to ergotamine.

Medicines for depression

  • moclobemide or fluvoxamine
  • SSRIs (selective serotonin reuptake inhibitors)
  • SNRI preparations (serotonin-norepinephrine reuptake inhibitors), e.g. venlafaxine, duloxetine.

Other medicines:

  • cimetidine (for indigestion or stomach ulcers )
  • quinolone antibiotics, e.g. Ciprofloxacin.

If you use herbal medicines containing St. John’s wort ( Hypericum perforatum), the risk of side effects with Zolmitriptan Stada may increase.

Zolmitriptan STADA with food, drink, and alcohol

You can take Zolmitriptan Stada with or without food. It does not affect how Zolmitriptan Stada works.

Pregnancy, breastfeeding, and fertility

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 the use of Zolmitriptan Stada during pregnancy is harmful. Therefore, talk to your doctor before using Zolmitriptan Stada if you are pregnant or trying to become pregnant.
  • You should not breastfeed within 24 hours of taking Zolmitriptan Stada.

Driving ability and use of machinery

  • During a migraine attack, the ability to react can be temporarily impaired, which you should bear in mind when driving a car or using machinery.
  • Zolmitriptan Stada is unlikely to affect your ability to drive or use machines. However, you should wait and see how Zolmitriptan Stada affects you before trying any of 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 a doctor or pharmacist if you are unsure.

Zolmitriptan STADA contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.

How to use Zolmitriptan STADA

Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.

You can take Zolmitriptan Stada as soon as you feel a migraine headache coming on, but you can also take Zolmitriptan Stada during an ongoing attack.

  • The recommended starting dose is 1 tablet of 2.5 mg.
  • Place the tablet on the tongue, where it is allowed to disintegrate, and swallow with the saliva. You do not need to take the tablet with liquid.
  • You can take 1 more tablet if the migraine symptoms persist after 2 hours or if the symptoms return within 24 hours.

Talk to your doctor if the tablets do not have a sufficient effect against migraines. The doctor can choose to increase the dose by one to 5 mg or change the treatment.

The prescribed dose should not be exceeded.

  • A maximum of 2 doses may be taken per day. If you have been prescribed the 2.5 mg tablet, the maximum daily dose is 5 mg. If you have been prescribed the 5 mg tablet, the maximum daily dose is 10 mg.

If you have used too much Zolmitriptan STADA 

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 the Zolmitriptan Stada package with you.

If you have any further questions about this medicine, ask 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 described below may be part of the migraine attack itself.

Common (may affect up to 1 in 10 users):

  • abnormal sensory sensations, such as tingling in the fingers and toes or increased sensitivity to touch
  • tiredness, dizziness, or feeling hot
  • headache
  • palpitation
  • 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 (may affect up to 1 in 100 users):

  • increased heart rate
  • slight increase in blood pressure
  • the increased amount of urine and how often you need to urinate.

Rare ( may affect up to 1 in 1,000 users ):

  • allergic reactions/hypersensitivity reactions, including urticaria ( hives ), swelling of the face, lips, mouth, tongue, and throat. If you think you have suffered an allergic reaction, stop the treatment and contact a doctor immediately.

Very rare (may affect up to 1 in 10,000 users):

  • angina (pain in the chest, often brought on by exertion), heart attack, or spasm in the blood vessels of the heart. If you experience chest pain or shortness of breath after taking Zolmitriptan Stada, you should contact your doctor and stop the treatment.
  • spasm of the intestinal blood vessels, which can cause damage to the intestine. You may experience stomach pains or bloody diarrhea. If this happens, contact a doctor and stop the treatment.
  • sudden urge to urinate.

How to store Zolmitriptan STADA

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the blister pack and carton after EXP. The expiration date is the last day of the specified month.

Store in the original packaging. Moisture sensitive.

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.

One Zolmitriptan Stada 2.5 mg orodispersible tablet contains 2.5 mg zolmitriptan.

Other ingredients are:

  • Mannitol
  • Maltodextrin
  • Microcrystalline cellulose
  • Crospovidone type A
  • Sodium bicarbonate
  • Citric acid
  • Colloidal anhydrous silica
  • Saccharin sodium
  • Magnesium stearate
  • Menthol flavor (maltodextrin, natural menthol, modified corn starch)

Appearance and package sizes of the medicine

Zolmitriptan Stada orodispersible tablets are white, round, and flat with beveled edges.

Zolmitriptan Stada orodispersible tablets are packed in aluminum/aluminum blister packs containing 2, 3, 6, 12, or 24 tablets or 2×1, 3×1, 6×1, 12×1, and 24×1 tablets in perforated single-dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel


Other manufacturers

Centrafarm Services BV

Nieuwe Donk 9, 4879 AC Etten Leur


Eurogenerics NV/SA

Heizel Esplanade b22, B-1020 Brussels


PharmaCoDane ApS

Marielundvej 46A, DK-2730 Herlev


Local Representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev


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