Prospecto: information for the user

Zolmitriptán Normon 2.5 mg film-coated tablets

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Zolmitriptán Normon and for what it is used

2. What you need to know before starting to take Zolmitriptán Normon

3. How to take Zolmitriptán Normon

4. Possible adverse effects

5. Storage of Zolmitriptán Normon

6. Contents of the package and additional information

Zolmitriptán Normon contains zolmitriptan and belongs to a group of medicines called triptans.

Zolmitriptán Normon is used to treat migraine headache in adults aged 18 years and older..

• The symptoms of migraine may be caused by a dilation of blood vessels in the head. It is believed that Zolmitriptán Normon reduces the dilation of these blood vessels. This helps the disappearance of headache pain and other symptoms of a migraine attack, such as a feeling of discomfort (nausea or vomiting) and sensitivity to light and noise.

• Zolmitriptán Normon acts only when a migraine attack has begun. It will not prevent you from experiencing an attack.

Do not take Zolmitriptán Normon:

-if you are allergic to zolmitriptán or any of the other ingredients of this medication (listed in section 6).

-if you have high blood pressure.

-if you have had any heart problems, including a heart attack, angina (chest pain caused by exercise or effort), Prinzmetal's angina (chest pain that occurs at rest) or if you have experienced heart-related symptoms, such as shortness of breath or pressure on the chest.

-if you have had a stroke (cerebrovascular accident) or symptoms of a short duration similar to a stroke (transient ischemic attack or TIA).

-if you have severe kidney problems.

-if you are taking other medications for migraine (such as ergotamine or ergot-type medications like dihydroergotamine and methysergide) at the same time. For additional information, see the section “Use of Zolmitriptán Normon with other medications.”

If you are unsure whether any of these apply to you, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolmitriptán Normon:

-if you are at risk of developing ischemic heart disease (insufficient blood flow to the heart). The risk is higher if you smoke, have high blood pressure, high cholesterol levels, diabetes, or if a family member has ischemic heart disease.

-if you have been told that you have Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).

-if you have had any liver problems.

-if you have different types of headaches other than your usual migraine headache.

-if you are taking any other medication for depression (see “Use of Zolmitriptán Normon with other medications”).

If you are admitted to a hospital, inform the medical staff that you are taking Zolmitriptán Normon.

Zolmitriptán Normon is not recommended for people under 18 years or over 65 years of age.

Like other migraine treatments, excessive use of Zolmitriptán Normon may cause daily headaches or worsening of your migraine headaches. Consult your doctor if you think this is the case. You may need to stop using Zolmitriptán Normon to correct the problem.

Other medications and Zolmitriptán Normon

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes herbal remedies and medications you purchase without a prescription.

Especially, inform your doctor if you are using any of the following medications:

Migraine medications

• If you take other triptans different from Zolmitriptán Normon, leave 24 hours before taking Zolmitriptán Normon.
• After taking Zolmitriptán Normon, leave 24 hours before taking other triptans different from Zolmitriptán Normon.
• If you take medications containing ergotamine or ergot-type medications (such as dihydroergotamine or methysergide), leave 24 hours before taking Zolmitriptán Normon.
• After taking Zolmitriptán Normon, leave 6 hours before taking ergotamine or ergot-type medications.

Depression medications

• MAO inhibitors, also known as IMAO (such as moclobemide).
• Medications known as SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine, or sertraline.
• Medications known as SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine and duloxetine.

Serotonin syndrome is a rare and potentially life-threatening condition that has been reported in some patients taking zolmitriptán in combination with certain serotoninergic medications (such as some medications for depression). Symptoms of serotonin syndrome may include agitation, restlessness, fever, excessive sweating, tremors, uncoordinated movements of the limbs or eyes, uncontrollable muscle spasms, and muscle rigidity. Your doctor may advise you on this.

Other medications

• Cimetidine (for indigestion or stomach ulcers).
• A quinolone antibiotic (such as ciprofloxacin).

If you are using herbal preparations containing St. John's Wort (Hypericum perforatum), it may be more likely that adverse effects will occur with the use of Zolmitriptán Normon.

Taking Zolmitriptán Normon with food and drinks

You can take this medication with or without food. This does not affect how zolmitriptán works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

• The safety of taking Zolmitriptán Normon during pregnancy is unknown. If you are pregnant or intend to become pregnant, consult your doctor before using this medication.
• Avoid breastfeeding within 24 hours after taking zolmitriptán.

Driving and operating machinery

During a migraine crisis, your reactions may be slower than usual. Be aware of this when driving or operating tools or machinery.

It is unlikely that zolmitriptán will affect driving or operating tools or machinery. However, it is best to wait and see how Zolmitriptán Normon affects you before attempting these activities.

Excipients

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free.”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You can take this medication as soon as a migraine headache begins. You can take it once a headache has started.

• The recommended dose is one tablet (2.5 mg).
• Swallow the tablet with water.
• You can take another tablet after two hours if the migraine still persists or if it reappears within 24 hours.

If these tablets did not provide enough help for your migraine, inform your doctor. Your doctor may increase the dose to 5 mg or change your treatment.

Do not take more than the dose prescribed.

• Do not take more than two doses in a day. If you have been prescribed 2.5 mg, the maximum daily dose is 5 mg.

Administration Form

Oral route.

The tablet must be swallowed whole (do not chew) and with water.

What to Do If You Take More Zolmitriptán Normon Than You Should

If you have taken more Zolmitriptán Normon than your doctor prescribed, inform your doctor immediately, go to the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20.Bring the Zolmitriptán Normon medication with you.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Some of the symptoms listed below may be part of the migraine itself.

Stop taking Zolmitriptán Normon 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 people):

• Allergic reactions/hypersensitivity, including hives and swelling of the face, lips, mouth, tongue, and throat; difficulty swallowing or breathing difficulties.

Very rare side effects (may affect fewer than 1 in 10,000 people):

Other side effects that may occur:

Frequent side effects (may affect up to 1 in 10 people):

• Abnormal sensations such as tingling in the fingers of the hands and feet or sensitive skin.
• Sensation of drowsiness, dizziness, or heat.
• Headache.
• Irregular heartbeat.
• Feeling unwell (nausea) or vomiting.
• Abdominal pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Sensation of weakness.
• Weight, tension, pain, or pressure in the throat, neck, arms, and legs or chest.
• Difficulty swallowing.

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

• Very rapid heartbeat.
• Slightly higher blood pressure.
• Increased urine production or the need to urinate more frequently.

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

• Urgent and sudden need to urinate.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Zolmitriptán Normon

• The active ingredient is zolmitriptán. Zolmitriptán Normon 2.5 mg film-coated tablets contain 2.5 mg ofzolmitriptán.
• The other components are:

Core:Lactose, microcrystalline cellulose, sodium starch glycolate type A(from potato), macrogol 8000, magnesium stearate, anhydrous colloidal silica.Covering:Yellow Opadry 03B92520 (contains hypromellose, titanium dioxide [E171], talc, macrogol 400, and yellow iron oxide [E172])

Appearance of the product and contents of the packaging

Zolmitriptán Normon 2.5mg film-coated tablets are yellow, round, biconvex tablets, engraved with “2.5” on one face and nothing on the other.

They are presented in blisters containing 2, 3, 6, 12, and 18 film-coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet: August 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es