Zolmitriptan Normon 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolmitriptan Normon 2.5 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

• The symptoms of migraine may be caused by the dilation of blood vessels in the head. Zolmitriptán Normon is believed to reduce this dilation of blood vessels, helping to relieve headache pain and other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.

• Zolmitriptán Normon works only once a migraine attack has started. It will not prevent migraine attacks from occurring.

2. What you need to know before taking 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 exertion or physical effort), Prinzmetal's angina (chest pain occurring at rest), or if you have experienced heart-related symptoms such as shortness of breath or chest tightness.
• if you have had a stroke (cerebrovascular accident) or transient stroke-like symptoms (transient ischemic attack or TIA).
• if you have severe kidney problems.
• if you are currently taking other migraine medications (e.g., ergotamine or ergot-type medications such as dihydroergotamine and methysergide) or other migraine medicines from the triptan group. For further information, see section “Use of Zolmitriptan Normon with other medicines”.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Zolmitriptan Normon:

• if you are at risk of ischemic heart disease (reduced blood flow in the heart arteries). 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 diagnosed with Wolff-Parkinson-White syndrome (a type of abnormal heart rhythm).
• if you have ever had liver problems.
• if you experience headaches different from your usual migraine headaches.
• if you are taking any other medication for depression (see “Use of Zolmitriptan Normon with other medicines”).

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

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

Like other migraine treatments, excessive use of Zolmitriptan Normon may lead to daily headaches or worsening of your migraine headaches. Consult your doctor if you think this may apply to you. It may be necessary to stop using Zolmitriptan Normon to resolve the problem.

Other medicines and Zolmitriptan Normon

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

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

Migraine medications

• If you are taking 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 are taking medications containing ergotamine or ergot-type medications (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 medications.

Medications for depression

• Monoamine oxidase inhibitors (MAOIs), such as moclobemide.
• Medications known as SSRIs (selective serotonin reuptake inhibitors), such as fluoxetine, paroxetine, fluvoxamine, or sertraline.
• Medications known as SNRIs (serotonin-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 who took zolmitriptan in combination with so-called serotonergic medicines (e.g., certain antidepressants). Signs of serotonin syndrome may include agitation, restlessness, fever, excessive sweating, tremors, uncoordinated movements of limbs or eyes, uncontrollable muscle jerks, spasms, and muscle rigidity. Your doctor can advise you further.

Other medicines

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

If you are using herbal remedies containing St. John’s wort (Hypericum perforatum), you may be more likely to experience adverse effects when taking Zolmitriptan Normon.

Taking Zolmitriptan Normon with food and drink

You may 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 become pregnant, consult your doctor or pharmacist before using this medicine.

• It is unknown whether taking Zolmitriptan Normon during pregnancy is harmful. If you are pregnant or planning to become pregnant, consult your doctor before using this medicine.
• Avoid breastfeeding within 24 hours after taking zolmitriptan.

Driving and using machines

During a migraine attack, your reactions may be slower than usual. Take this into account when driving or operating tools or machinery.

It is unlikely that zolmitriptan will affect your ability to drive or operate tools or machinery. However, it is advisable to wait and observe how Zolmitriptan Normon affects you before attempting these activities.

Excipients

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Zolmitriptán Normon

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

You may take this medicine as soon as a migraine headache begins. You may take it once an attack has started.

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

If these tablets have not provided sufficient relief 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 prescribed dose.

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

Method of administration

Oral use.

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

If you take more Zolmitriptán Normon than you should

If you have taken more Zolmitriptán Normon than prescribed by your doctor, inform your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at telephone number 91 562 04 20. Take the Zolmitriptán Normon medicine with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. Some of the symptoms listed 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 adverse effects:

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

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

Very rare adverse effects (may affect less than 1 in 10,000 people):

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

Other adverse effects that may occur:

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

• Abnormal sensations such as tingling in the fingers or toes or skin sensitivity to touch.
• Feeling drowsy, dizzy, or warm.
• Headache.
• Irregular heartbeat.
• Feeling unwell (nausea) or being sick (vomiting).
• Stomach pain.
• Dry mouth.
• Muscle weakness or muscle pain.
• Feeling weak.
• Heaviness, tightness, pain, or pressure in the throat, neck, arms, legs, or chest.
• Difficulty swallowing.

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

• Very fast heartbeat.
• Slightly increased blood pressure.
• Increased amount of urine produced or increased frequency of urination.

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

• Sudden and urgent need to urinate.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of any containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other 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 components are:

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

Appearance of the product and contents of the pack

Zolmitriptan Normon 2.5 mg film-coated tablets are yellow, round, biconvex tablets, engraved with "2.5" on one side and blank on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: August 2021

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