ZOLMITRIPTAN NORMON 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Zolmitriptan Normon 2.5 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Zolmitriptan Normon and what is it used for
2. What you need to know before you take Zolmitriptan Normon
3. How to take Zolmitriptan Normon
4. Possible side effects
5. Storage of Zolmitriptan Normon
6. Contents of the pack and further information

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

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

Zolmitriptan Normon is used to treat migraine headaches in adults aged 18 and over.

• The symptoms of migraine can be caused by the dilation of blood vessels in the head. It is thought that Zolmitriptan Normon reduces the dilation of these blood vessels. This helps to relieve the headache and other symptoms of a migraine attack, such as feeling sick (nausea or vomiting) and sensitivity to light and sound.

• Zolmitriptan Normon only works when a migraine attack has already started. It will not prevent you from getting a migraine attack.

2. What you need to know before you take Zolmitriptan Normon

Do not take Zolmitriptan Normon:

• 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 effort), Prinzmetal's angina (chest pain that occurs at rest), or if you have experienced symptoms related to the heart, such as shortness of breath or pressure on the chest.
• if you have had a stroke (cerebrovascular accident) or symptoms of short duration similar to a stroke (transient ischaemic attack or TIA).
• if you have severe kidney problems.
• if you are taking other medicines for migraine (such as ergotamine or ergot-type medicines like dihydroergotamine and methysergide) or other migraine medicines from the triptan group at the same time. For more information, see the section "Using Zolmitriptan Normon with other medicines".

If you are not sure if any of these apply to you, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolmitriptan Normon:

• if you are at risk of having a heart condition called ischaemic 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 a family member has had heart disease.
• If you have been told you have Wolff-Parkinson-White Syndrome (a type of abnormal heartbeat).
• if you have ever had liver problems.
• if you have headaches other than your usual migraine headache.
• if you are taking any other medicine for depression treatment (see "Using Zolmitriptan Normon with other medicines").

If you go to hospital, tell the medical staff that you are taking Zolmitriptan Normon.

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

As with other migraine treatments, overuse of Zolmitriptan Normon can lead to daily headaches or worsening of your migraine headaches. Talk to your doctor if you think this is the case. You may need to stop using Zolmitriptan Normon to correct the problem.

Other medicines and Zolmitriptan Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes herbal medicines and medicines you have bought without a prescription.

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

Migraine medicines

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

Medicines for depression

• Monoamine oxidase inhibitors, also known as MAOIs (such as moclobemide).
• Medicines called SSRIs (selective serotonin reuptake inhibitors) such as fluoxetine, paroxetine, fluvoxamine, or sertraline.
• Medicines called SNRIs (serotonin and norepinephrine reuptake inhibitors) such as venlafaxine and duloxetine.

Serotonin syndrome is a rare but potentially life-threatening condition that has been reported in some patients taking zolmitriptan in combination with so-called serotonergic medicines (for example, certain medicines for depression treatment). The signs of serotonin syndrome can be, for example, agitation, restlessness, fever, excessive sweating, tremors, uncoordinated muscle movements or eye movements, involuntary muscle contractions, and muscle stiffness. Your doctor may advise you on this.

Other medicines

• Cimetidine (for indigestion or stomach ulcers).
• An antibiotic from the quinolone group (such as ciprofloxacin).

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

Taking Zolmitriptan Normon with food and drinks

You can take this medicine with or without food. This does not affect how zolmitriptan works.

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 Normon during pregnancy is not known to be harmful. If you are pregnant or planning to become pregnant, talk to your doctor before taking this medicine.
• Avoid breastfeeding for 24 hours after taking zolmitriptan.

Driving and using machines

During a migraine attack, your reactions may be slower than usual. Bear this in mind when driving or using tools or machines.

It is unlikely that zolmitriptan will affect your ability to drive or use machines. However, it is best to wait and see how Zolmitriptan Normon affects you before attempting to do these activities.

Excipients

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially "sodium-free".

3. How to take Zolmitriptan Normon

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

You can take this medicine as soon as a migraine headache starts. You can take it once a migraine attack has started.

• The recommended dose is one tablet (2.5 mg).
• Swallow the tablet with water.
• You can take another tablet after 2 hours if the migraine is still present or if it comes back within 24 hours.

If these tablets do not give you enough help with your migraine, tell your doctor. Your doctor may increase the dose to 5 mg or change your treatment.

Do not take more than the dose that has been prescribed for you.

• Do not take more than two doses in a 24-hour period. If you have been prescribed 2.5 mg, the maximum daily dose is 5 mg.

Method of administration

Oral use.

The tablet should be swallowed whole (not chewed) with water.

If you take more Zolmitriptan Normon than you should

If you have taken more Zolmitriptan Normon than your doctor has prescribed, talk to your doctor or go to the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20. Take the medicine Zolmitriptan Normon with you.

4. 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.

Stop taking Zolmitriptan 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 rash, swelling of the face, lips, mouth, tongue, and throat; difficulty swallowing or breathing difficulties.

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

• Angina (chest pain, often caused by exercise), heart attack, or spasm of the heart's blood vessels. You may notice chest pain or shortness of breath.
• Spasm of the intestine's blood vessels that can damage your intestine. You may notice stomach pain or bloody diarrhea.
• Bleeding in the brain (cerebral haemorrhage) or stroke.

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 and toes or sensitive skin.
• Feeling sleepy, dizzy, or warm.
• Headache.
• Irregular heartbeat.
• Feeling sick (nausea) or being sick (vomiting).
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tension, pain, or pressure in the throat, neck, arms, and legs, or chest.
• Difficulty swallowing.

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

• Very fast heartbeat.
• Slightly higher blood pressure.
• Increased amount of urine produced or number of times you need to urinate.

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

• Sudden and urgent need to urinate.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zolmitriptan Normon

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Zolmitriptan Normon

• The active substance is zolmitriptan. Zolmitriptan Normon 2.5 mg film-coated tablets contain 2.5 mg of zolmitriptan.
• The other ingredients are:

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

Appearance of the product and pack contents

Zolmitriptan Normon 2.5 mg film-coated tablets are yellow, round, and biconvex, engraved with "2.5" on one side and nothing on the other.

They are available in blister packs containing 2, 3, 6, 12, and 18 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:August 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es