AQUIPTA

Package leaflet: Information for the patient

AQUIPTA 10 mg tablets, 60 mg tablets

atogepant
V
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What AQUIPTA is and what it is used for

AQUIPTA contains the active substance atogepant. AQUIPTA is used to prevent migraine in
adults who have at least 4 migraine days per month.
AQUIPTA is thought to block the activity of the calcitonin receptor/calcitonin gene-related peptide family, which has been associated with migraine.

2. What you need to know before taking AQUIPTA

Do not take AQUIPTA

• if you are allergic to atogepant or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Stop taking AQUIPTA and inform your doctor immediately if you experience any symptoms of
an allergic reaction such as:

• difficulty breathing
• swelling of the face
• skin redness, itching, or hives

Some of these symptoms may occur within 24 hours after the first dose. Sometimes they may occur several days after taking 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 and adolescents under 18 years of age, as 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 side effects (see section 4).
Below is a list of examples of medicines that may require your doctor to reduce the dose of AQUIPTA:

• ketoconazole, itraconazole, clarithromycin, rifampicin (medicines used to treat fungal or bacterial infections)
• ritonavir (a medicine used to treat HIV)
• cyclosporine (a medicine that affects the immune system).

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor before using this medicine.
You must not take AQUIPTA during pregnancy. If you are a woman of childbearing age, you must use adequate contraceptive measures during treatment with AQUIPTA.
If you are breast-feeding or planning to breast-feed, talk to your doctor before using this medicine. You and your doctor must decide together whether to use AQUIPTA while breast-feeding.
Driving and using machines
AQUIPTA may cause drowsiness. Do not drive or operate machinery if you experience this symptom.
AQUIPTA contains sodium
AQUIPTA 10 mg tablets
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
AQUIPTA 60 mg tablets
This medicine contains 31.5 mg of sodium (the main component of table salt) per tablet.
This corresponds to 1.6% of the maximum daily recommended dietary intake for an adult.

3. How to take AQUIPTA

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is 60 mg of atogepant once daily. Your doctor may prescribe you a lower dose if:

• you are taking other medicines (listed in section 2), or
• you have severe kidney problems or are on dialysis.

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

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

If you forget to take AQUIPTA

• If you forget a dose, take it as soon as you remember.
• If you forget a dose for an entire day, skip the missed dose and take a single dose the next day, as usual.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking AQUIPTA
Do not stop treatment with AQUIPTA without first consulting your doctor. Symptoms may return if you stop treatment.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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 experience any symptoms of an allergic reaction such as:

• difficulty breathing
• swelling of the face
• skin redness, 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
• constipation
• fatigue
• somnolence
• reduced appetite
• weight loss

Uncommon (may affect up to 1 in 100 people)

• increased liver enzyme levels

Reporting of side effects

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

5. How to store AQUIPTA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AQUIPTA contains
AQUIPTA 10 mg tablets

• The active substance is atogepant. Each tablet contains 10 mg of atogepant.
• The other components are: polyvinylpyrrolidone/vinyl acetate copolymer, vitamin E polyethylene glycol succinate, mannitol, microcrystalline cellulose, sodium chloride, sodium croscarmellose, colloidal anhydrous silica, and sodium stearate fumarate (see section 2).

AQUIPTA 60 mg tablets

• The active substance is atogepant. Each tablet contains 60 mg of atogepant.
• The other components are: polyvinylpyrrolidone/vinyl acetate copolymer, vitamin E polyethylene glycol succinate, mannitol, microcrystalline cellulose, sodium chloride, sodium croscarmellose, colloidal anhydrous silica, and sodium stearate fumarate (see section 2).

Description of the appearance of AQUIPTA and contents of the pack
AQUIPTA 10 mg tablets
AQUIPTA 10 mg tablet is a white to off-white, round, biconvex tablet, with "A" and "10" engraved on one side. It is available in packs of 28 or 98 tablets.
AQUIPTA 60 mg tablets
AQUIPTA 60 mg tablet is a white to off-white, oval, biconvex tablet, with "A60" engraved on one side. It is available in packs of 28 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

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

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

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

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

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

Ελλάδα Österreich
AbbVie ΦΑΡΜΑΚΕΥΤΙΚΗ Α.Ε. AbbVie GmbH
Τηλ: +30 214 4165 555 Tel: +43 1 20589-0

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

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

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

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

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

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

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

Latvija
AbbVie SIA
Tel: +371 67605000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency:
http://www.ema.europa.eu/

To listen to or request a copy of this package leaflet in an alternative format,
large print> or , please contact the local representative of the Marketing Authorization Holder.