atogepant: package leaflet

AQUIPTA contains the active substance atogepant. AQUIPTA is used in adult patients to:
- treat an active migraine attack
- prevent migraine in those who have at least 4 migraine days per month

AQUIPTA is thought to block the activity of the calcitonin/calcitonin gene related peptide (CGRP)- receptor family, which have been linked to migraine.

Do not take AQUIPTA
- if you are allergic to atogepant or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Stop taking AQUIPTA and tell your doctor immediately if you experience any symptoms of an allergic reaction such as:
- difficulty breathing
- swelling of the face
- rash, itching, or hives
Some of these symptoms can occur within 24 hours of first use. Sometimes they can happen several days after you take AQUIPTA.

Talk to your doctor, pharmacist, or nurse before taking AQUIPTA if you have severe liver problems.

Children and adolescents
Do not give this medicine to children or adolescents under 18 years old because the use of AQUIPTA has not been studied in this age group.

Other medicines and AQUIPTA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may increase the risk of getting side effects (see section 4).

The following is a list of examples of medicines that may require your doctor to lower the dose of AQUIPTA:
- ketoconazole, itraconazole, clarithromycin, rifampicin (medicines used to treat fungal or bacterial infections)
- ritonavir (medicine used to treat HIV)
- ciclosporin (medicine that affects your immune system)

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

If you are pregnant, you should not take AQUIPTA. If you are a woman who could become pregnant, you should use adequate contraception during treatment with AQUIPTA.

If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
You and your doctor should decide if you will use AQUIPTA while breast-feeding.

Driving and using machines
AQUIPTA may make you feel sleepy. Do not drive or use machines if you are affected.

AQUIPTA contains sodium

AQUIPTA 10 mg tablets
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

AQUIPTA 60 mg tablets
This medicine contains 31.5 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much to take

The maximum dose per day is 60 mg atogepant.

For treatment of a migraine attack as needed, the recommended dose is 60 mg atogepant.

For prevention of migraine, the recommended dose is 60 mg atogepant once a day.

Your doctor may tell you to take a lower dose if:
- you are taking other medicines (listed in section 2)
- you have severe kidney problems or you are undergoing dialysis.

How to take
AQUIPTA is for oral use. Do not split, crush, chew or break the tablet before swallowing. The tablets may be taken with or without food.

If you take more AQUIPTA than you should
If you have taken more tablets than you should, tell your doctor. You may get some of the side effects listed in section 4.

If you forget to take AQUIPTA
If you take AQUIPTA for the prevention of migraine and forget to take it:
- Take it as soon as you remember.
- If you forget your dose for an entire day, just skip the missed dose and take a single dose as usual the following day.
- Do not take a double dose to make up for a forgotten dose.

If you stop taking AQUIPTA
If you take AQUIPTA for the prevention of migraine, do not stop taking it without talking to your doctor first. Your symptoms may return if you stop the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Stop taking AQUIPTA and contact your doctor immediately if you have any of the following symptoms, which may be part of a serious allergic reaction:
- difficulty breathing
- swelling of the face
- rash, itching, or hives

Other side effects
Tell your doctor if you notice any of the following side effects:

Common (may affect up to 1 in 10 people):
- nausea (feeling sick in your stomach)
- constipation
- fatigue (tiredness)
- somnolence (sleepiness)
- decreased appetite
- weight loss

Uncommon (may affect up to 1 in 100 people)
- increased levels of liver enzymes

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listing in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What AQUIPTA contains

AQUIPTA 10 mg tablets
- The active substance is atogepant. Each tablet contains 10 mg of atogepant.
- The other ingredients are: Polyvinylpyrrolidone/Vinyl acetate copolymer, vitamin E polyethylene glycol succinate, mannitol, microcrystalline cellulose, sodium chloride, croscarmellose sodium, colloidal silicon dioxide and sodium stearyl fumarate (see section 2).

AQUIPTA 60 mg tablets
- The active substance is atogepant. Each tablet contains 60 mg of atogepant.
- The other ingredients are: Polyvinylpyrrolidone/Vinyl acetate copolymer, vitamin E polyethylene glycol succinate, mannitol, microcrystalline cellulose, sodium chloride, croscarmellose sodium, colloidal silicon dioxide and sodium stearyl fumarate (see section 2).

What AQUIPTA looks like and contents of the pack

AQUIPTA 10 mg tablets
AQUIPTA 10 mg tablet is a white to off-white, round biconvex tablet debossed with “A” and “10” on one side. It is available in packs containing 7, 28 or 98 tablets.

AQUIPTA 60 mg tablets
AQUIPTA 60 mg tablet is a white to off-white, oval biconvex tablet debossed with “A60” on one side.
It is available in packs containing 2, 7, 28 or 98 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

Manufacturer
AbbVie S.r.l
S.R. 148 Pontina Km 52 Snc
Campoverde di Aprilia, Latina 04011
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
AbbVie SA
Tél/Tel: +32 10 477811
Lietuva
AbbVie UAB
Tel: +370 5 205 3023

България
АбВи ЕООД
Тел.:+359 2 90 30 430
Luxembourg/Luxemburg
AbbVie SA
Belgique/Belgien
Tél/Tel: +32 10 477811

Česká republika
AbbVie s.r.o.
Tel: +420 233 098 111
Magyarország
AbbVie Kft.
Tel.:+36 1 455 8600

Danmark
AbbVie A/S
Tlf: +45 72 30-20-28
Malta
Vivian Corporation Ltd.
Tel: +356 27780331

Deutschland
AbbVie Deutschland GmbH & Co. KG
Tel: 00800 222843 33 (gebührenfrei)
Tel: +49 (0) 611 / 1720-0
Nederland
AbbVie B.V.
Tel: +31 (0)88 322 2843

Eesti
AbbVie OÜ
Tel: +372 623 1011
Norge
AbbVie AS
Tlf: +47 67 81 80 00

Ελλάδα
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε.
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AbbVie GmbH
Tel: +43 1 20589-0

España
AbbVie Spain, S.L.U.
Tel: +34 91 384 09 10
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AbbVie Sp. z o.o.
Tel.: +48 22 372 78 00

France
AbbVie
Tél: +33 (0) 1 45 60 13 00
Portugal
AbbVie, Lda.
Tel: +351 (0)21 1908400

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AbbVie d.o.o.
Tel + 385 (0)1 5625 501
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AbbVie S.R.L.
Tel: +40 21 529 30 35

Ireland
AbbVie Limited
Tel: +353 (0)1 4287900
Slovenija
AbbVie Biofarmacevtska družba d.o.o.
Tel: +386 (1)32 08 060

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Vistor
Sími: +354 535 7000
Slovenská republika
AbbVie s.r.o.
Tel: +421 2 5050 0777

Italia
AbbVie S.r.l.
Tel: +39 06 928921
Suomi/Finland
AbbVie Oy
Puh/Tel: +358 (0)10 2411 200

Κύπρος
Lifepharma (Z.A.M.) Ltd
Τηλ.: +357 22 34 74 40
Sverige
AbbVie AB
Tel: +46 (0)8 684 44 600

Latvija
AbbVie SIA
Tel: +371 67605000

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu/.

To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.