Zolmiles

1. What is Zolmiles and what is it used for

Zolmiles contains zolmitriptan and belongs to a group of medicines called triptans.
Zolmiles is used to treat migraine headaches.
Migraine symptoms may be caused by the expansion of blood vessels in the head. It is thought that Zolmiles narrows the expanded blood vessels. This in turn helps to reduce headache and other symptoms of a migraine attack, such as nausea or vomiting and sensitivity to light and sound.
Zolmiles only works at the start of a migraine attack. It will not prevent an attack from happening.

2. Important information before taking Zolmiles

When not to take Zolmiles:

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

Warnings and precautions

Before taking Zolmiles, discuss with your doctor or pharmacist if:

• you are at risk of ischaemic heart disease (reduced blood flow through the heart's blood vessels). The risk is greater if you smoke, have high blood pressure, high cholesterol, diabetes, or if there have been cases of ischaemic heart disease in your family
• you have been told you have Wolff-Parkinson-White syndrome (a type of heart rhythm disorder)
• you have ever had liver problems
• you have headaches that are not typical migraines
• you are taking other medicines for depression (see the section "Zolmiles and other medicines" below).

If Zolmiles is taken with certain antidepressant medicines (SSRIs or SNRIs), there is a risk of serotonin syndrome. Symptoms can be severe and include shivering, overactivity, nausea, fever, increased sweating, confusion, and coma. If you are taking combined treatment, your doctor should carefully monitor your condition, especially at the start of treatment, when the dose is increased, or when other serotoninergic medicines are added to the treatment. If you experience any of these symptoms, contact your doctor as soon as possible.
As with other migraine treatments, taking too much zolmitriptan may cause daily headaches or worsen migraine headaches. If you suspect this applies to you, consult your doctor. To resolve the problem, it may be necessary to stop taking zolmitriptan.
In case of hospitalization, inform the hospital staff that you are taking Zolmiles.

Children and adolescents

Zolmiles is not recommended for patients under 18 years of age.

Elderly

Zolmiles is not recommended for patients over 65 years of age.

Zolmiles and other medicines

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

Medicines for depression (see also the section above "Warnings and precautions")

• moclobemide or fluvoxamine
• medicines called selective serotonin reuptake inhibitors (SSRIs)
• medicines called selective noradrenaline reuptake inhibitors (SNRIs), such as venlafaxine, duloxetine.

Other medicines

• cimetidine (used for indigestion or stomach ulcers)
• quinolone antibiotics (such as ciprofloxacin).

If you are taking herbal preparations containing St. John's Wort (Hypericum perforatum), the risk of adverse reactions to Zolmiles is more likely.

Zolmiles with food and drink

Zolmiles can be taken with or without food. Meals do not affect the action of Zolmiles.

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.
It is not known whether taking Zolmiles during pregnancy harms the baby.
Do not breastfeed for 24 hours after taking Zolmiles.

Driving and using machines

During a migraine attack, your reactions may be slower than usual. This should be taken into account when driving, using tools, or operating machinery.
It is unlikely that Zolmiles will affect your ability to drive, use tools, or operate machinery. However, it is best to wait and see how Zolmiles affects you before performing these activities.

Zolmiles contains glucose (maltodextrin component)

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking Zolmiles.

Zolmiles contains aspartame (E951)

Each 2.5 mg oral disintegrating tablet of Zolmiles contains 4 mg of aspartame.
Each 5 mg oral disintegrating tablet of Zolmiles contains 8 mg of aspartame.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU).
This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

Zolmiles contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per oral disintegrating tablet, which means it is essentially 'sodium-free'.

3. How to take Zolmiles

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are not sure, ask your doctor or pharmacist.
Zolmiles should be taken after the first symptoms of a migraine attack appear. It can also be taken during an attack.
The recommended dose is one tablet (2.5 mg or 5 mg).
A second tablet can be taken if the migraine does not improve after 2 hours orwhen it returns within 24 hours.
If the tablets do not bring significant improvement in migraine symptoms, consult your doctor. Your doctor may recommend increasing the dose to 5 mg or changing the treatment.
Do not take more than the recommended dose.
Do not take more than two doses in 24 hours. If 2.5 mg tablets are prescribed, the maximum daily dose is 5 mg. If 5 mg tablets are prescribed, the maximum daily dose is 10 mg.
Instructions for use

• 1. Do not push the tablet through the foil (Figure 1).

Figure 1

• 2. Tear off one pocket from the blister pack (Figure 2).

Figure 2

• 3. Carefully peel off the covering foil, starting from the place indicated by the arrow (Figures 3 and 4).

Figure 3

Figure 4

• 4. Remove the tablet from the packaging with dry hands and place it on the tongue (Figure 5). The tablet will dissolve quickly and can be swallowed without water.

Figure 5

Overdose of Zolmiles

If you have taken more Zolmiles than your doctor prescribed, contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you.
If you have swallowed too many oral disintegrating tablets, you may experience side effects, including drowsiness.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zolmiles can cause side effects, although not everybody gets them.
Some of the side effects listed below may be part of the migraine attack itself.

If you experience any of the following serious side effects, stop taking Zolmiles and tell your doctor immediately:

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

• Allergic reactions including itchy rash (hives) and swelling of the face, lips, tongue, and throat.

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

• Angina pectoris (chest pain, often caused by exertion), heart attack, or coronary artery spasm. Symptoms include chest pain and shortness of breath.
• Spasm of blood vessels in the intestine, which can cause damage to the intestine. Symptoms include abdominal pain or bloody diarrhea.

Other possible side effects include:
Common (may affect up to 1 in 10 people)

• abnormal sensations, such as tingling in the fingers and toes or skin sensitivity to touch
• feeling sleepy, dizzy, or warm
• headache
• irregular heartbeat
• nausea, vomiting
• abdominal pain
• dry mouth
• swallowing difficulties
• muscle weakness or muscle pain
• feeling weak
• heaviness, tension, pain, or pressure in the throat, neck, arms, and legs, or chest.

Uncommon (may affect up to 1 in 100 people)

• very fast heartbeat
• mild increase in blood pressure
• increased amount of urine passed or frequency of urination.

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

• sudden, urgent need to urinate.

Reporting side effects

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

5. How to store Zolmiles

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.
The expiry date refers to the last day of the month.
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. This will help protect the environment.

6. Contents of the pack and other information

What Zolmiles contains

• The active substance is zolmitriptan. Zolmiles 2.5 mg oral disintegrating tablets contain 2.5 mg of zolmitriptan. Zolmiles 5 mg oral disintegrating tablets contain 5 mg of zolmitriptan.
• The other ingredients are: mannitol, calcium silicate, microcrystalline cellulose, aspartame, sodium carboxymethylcellulose (type A), crospovidone (type B), colloidal anhydrous silica, magnesium stearate, and orange flavor containing: flavoring substances identical to natural ones, flavoring agents, natural flavoring substances, maltodextrin (contains glucose), gum arabic, ascorbic acid (E 300), butylhydroxyanisole (E 320).

What Zolmiles looks like and contents of the pack

Zolmiles 2.5 mg oral disintegrating tablets are white, round, and flat, with a diameter of 7.5 mm.
Zolmiles 5 mg oral disintegrating tablets are white, round, and flat, with a diameter of 9.5 mm.
Zolmiles is packaged in blisters covered with a removable foil containing 2, 3, 6, or 12 oral disintegrating tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer

Actavis Ltd.
BLB 016, Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

For more information on this medicine and its authorized names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

Date of last revision of the leaflet: May 2023