Zolmitriptan Stada

Package Leaflet: Information for the Patient

Zolmitriptan STADA, 2.5 mg, tablets

Zolmitriptan

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Zolmitriptan STADA is and what it is used for
• 2. Important information before taking Zolmitriptan STADA
• 3. How to take Zolmitriptan STADA
• 4. Possible side effects
• 5. How to store Zolmitriptan STADA
• 6. Contents of the pack and other information

1. What is Zolmitriptan STADA and what is it used for

Zolmitriptan STADA contains zolmitriptan and belongs to a group of medicines called triptans.

Zolmitriptan STADA is used to treat migraine headaches

• Migraine symptoms may be caused by the expansion of blood vessels in the head. It is thought that Zolmitriptan STADA narrows these expanded blood vessels. This helps to relieve the headache and other symptoms that occur during a migraine attack, such as nausea or vomiting and sensitivity to light and sound.
• Zolmitriptan STADA only works when a migraine attack has started. The medicine will not prevent a migraine attack from occurring.

2. Important information before taking Zolmitriptan STADA

When not to take Zolmitriptan STADA

• if you are allergic to zolmitriptan, menthol, 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 heart attack, angina pectoris (chest pain caused by physical exertion), or Prinzmetal's angina (chest pain that occurs at rest), or have had other symptoms caused by heart disease, such as shortness of breath or chest tightness;
• if you have ever had a stroke or transient ischaemic attack (TIA, a temporary stroke-like attack);
• if you have severe kidney problems;
• if you are taking other migraine medicines (e.g., ergotamine, ergotamine derivatives, including dihydroergotamine and methysergide) or other triptans for migraine headaches at the same time. See section "Zolmitriptan STADA and other medicines".

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist.

Warnings and precautions

Before taking Zolmitriptan STADA, discuss with your doctor or pharmacist if:

• you are at risk of heart disease (have reduced blood flow to the heart). The risk is greater if you smoke, have high blood pressure, high cholesterol, diabetes, or if anyone in your family has had heart disease;
• your doctor has told you that you have Wolff-Parkinson-White syndrome (a type of heart rhythm disorder);
• you have ever had liver problems;
• you have a headache that is not like a typical migraine;
• you are taking any other medicines for depression (see section "Zolmitriptan STADA and other medicines").

If you are admitted to hospital, tell the medical staff that you are taking Zolmitriptan STADA.
Zolmitriptan STADA is not recommended for use in patients under 18 years of age and in adults over 65 years of age.
Like other migraine medicines, taking too much Zolmitriptan STADA may cause daily headaches or worsen migraine headaches. If you think this applies to you, tell your doctor. It may be necessary to stop treatment with Zolmitriptan STADA to correct these disorders.

Zolmitriptan STADA and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, and about any medicines you plan to take.
In particular, tell your doctor if you are taking any of the following medicines:

• migraine medicines (triptans):
• other triptans than Zolmitriptan STADA: wait 24 hours before taking Zolmitriptan STADA;
• after taking Zolmitriptan STADA, wait 24 hours before taking other triptans;
• if you have taken medicines containing ergotamine or ergotamine-like medicines (such as dihydroergotamine or methysergide), wait 24 hours before taking Zolmitriptan STADA;
• if you have taken Zolmitriptan STADA, wait 6 hours before taking medicines containing ergotamine or ergotamine-like medicines.

Medicines for depression:

• moclobemide and fluvoxamine;
• medicines called SSRIs (selective serotonin reuptake inhibitors);
• medicines called SNRIs (non-selective serotonin reuptake inhibitors), such as venlafaxine and duloxetine.

Other medicines:

• cimetidine (a medicine used for indigestion and stomach ulcers);
• quinolone antibiotics, such as ciprofloxacin.

If you are taking herbal medicines containing St. John's Wort (Hypericum perforatum), side effects after taking Zolmitriptan STADA may occur more frequently.

Zolmitriptan STADA with food and drink

Zolmitriptan STADA can be taken with or without food. This does not affect the action of Zolmitriptan STADA.

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 taking this medicine.

• The use of Zolmitriptan STADA during pregnancy is not known to be harmful. You should tell your doctor if you are pregnant or planning to become pregnant before taking Zolmitriptan STADA.
• Do not breastfeed your baby for 24 hours after taking Zolmitriptan STADA.

Driving and using machines

• During a migraine attack, your reaction time may be slower than usual. You should keep this in mind when driving or operating machinery.
• It is unlikely that Zolmitriptan STADA will affect your ability to drive or use machines. However, it is best to observe how Zolmitriptan STADA affects you before performing these activities.

Zolmitriptan STADA contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 tablet, which means it is essentially "sodium-free".

3. How to take Zolmitriptan STADA

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Zolmitriptan STADA is best taken as soon as possible after the migraine headache starts. The medicine can also be taken at a later stage.

• The recommended dose is 2.5 mg or 5 mg.
• Swallow the tablet with water.
• If your migraine symptoms do not improve within 2 hours or return within 24 hours, you can take another tablet.

Tell your doctor if you do not feel sufficient improvement after taking this medicine. Your doctor may increase the dose to 5 mg or change the treatment.
Do not take more than the dose recommended by your doctor.

• Do not take more than two doses in 24 hours. If your doctor has prescribed a dose of 2.5 mg, the maximum daily dose is 5 mg. If your doctor has prescribed a dose of 5 mg, the maximum daily dose is 10 mg.

Taking more than the recommended dose of Zolmitriptan STADA

If you have taken too many Zolmitriptan STADA tablets, contact your doctor or go to the emergency department of your nearest hospital immediately.
Remember to take the package leaflet with you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of the side effects listed below may be caused by the migraine attack itself.
Common side effects(may affect up to 1 in 10 people):

• abnormal sensations, such as tingling of fingers and toes or skin, and sensitivity to touch,
• feeling sleepy, dizzy, or warm,
• headache,
• irregular heartbeat,
• nausea, vomiting,
• abdominal pain,
• dry mouth,
• muscle weakness or muscle pain,
• weakness (fatigue),
• feeling of pressure, tightness, pain, or heaviness in the throat, neck, limbs, or chest,
• difficulty swallowing.

Uncommon side effects(may affect up to 1 in 100 people):

• rapid heartbeat,
• mild increase in blood pressure,
• passing large amounts of urine or frequent urination.

Rare side effects(may affect up to 1 in 1,000 people):

• allergic reactions/hypersensitivity, including itchy rash (hives) and swelling of the face, lips, tongue, or throat. If you think Zolmitriptan STADA has caused an allergic reaction stop taking the medicine and contact your doctor immediately.

Very rare side effects(may affect up to 1 in 10,000 people):

• angina pectoris (chest pain, often triggered by physical exertion), myocardial infarction, or coronary artery vasospasm. If you experience chest pain or shortness of breath after taking Zolmitriptan STADA, contact your doctor and do not take any more Zolmitriptan STADA,
• intestinal vasospasm, which can cause intestinal damage. This may cause abdominal pain or bloody diarrhea. If you experience these symptoms, contact your doctor and do not take any more Zolmitriptan STADA,
• sudden need to urinate (urinary urgency).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zolmitriptan STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zolmitriptan STADA contains

The active substance is zolmitriptan.
One Zolmitriptan STADA tablet, 2.5 mg, contains 2.5 mg of zolmitriptan.
The other ingredients are:

• Mannitol
• Microcrystalline cellulose
• Maltodextrin
• Colloidal anhydrous silica
• Crospovidone (Type A)
• Sodium bicarbonate
• Citric acid
• Sodium saccharin
• Magnesium stearate
• Menthol flavor PHS-132975 (maltodextrin, natural menthol, cornstarch)

What Zolmitriptan STADA looks like and contents of the pack

Zolmitriptan STADA tablets are round, flat, white tablets with rounded edges.
Zolmitriptan STADA, 2.5 mg, tablets, are packaged in aluminum/aluminum blisters containing 1 or 3 tablets or 1x1, 3x1, 6x1, and 18x1 tablets in single-dose perforated blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

STADA Arzneimittel AG
Stadastrasse 2 – 18
D-61118 Bad Vilbel
Germany

Manufacturer

• 1. Centrafarm Services B.V., Nieuwe Donk 9, NL-4870 AC Etten-Leur, Netherlands
• 2. PharmaCoDane ApS, Marielundvej 46A, DK-2730 Herlev, Denmark
• 3. STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark
Zolmitriptan STADA 2.5 mg tablets
Finland
Zolmitriptan STADA 2.5 mg tablets
Germany
Zolmitriptan STADA 2.5 mg tablets
Poland
Zolmitriptan STADA
Portugal
Zolmitriptano Ciclum 2.5 mg tablets
Sweden
Zolmitriptan STADA 2.5 mg tablets
Date of last revision of the leaflet:11/2021