AQUIPTA 60 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: patient information

AQUIPTA 10 mg tablets

AQUIPTA 60 mg tablets

atogepant

This medicinal product is subject to additional monitoring, which will allow rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to 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 others, even if they have the same symptoms as you, since it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the 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 believed to block the activity of the calcitonin/calcitonin gene-related peptide (CGRP) receptor family, which has been associated with migraine.

2. What you need to know before starting to take 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 contact 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 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 starting to take AQUIPTA if you have severe liver problems.

Children and adolescents

Do not give this medicine to children or 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 need to take any other medicines. Some medicines may increase the risk of adverse effects (see section 4).

The following list includes examples of medicines that may require your doctor to reduce your 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 your immune system).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

If you are pregnant, you must not take AQUIPTA. If you are a woman who could become pregnant, you should use appropriate contraceptive methods during treatment with AQUIPTA.

If you are breastfeeding or planning to breastfeed, consult your doctor before using this medicine. You and your doctor should decide whether you will take AQUIPTA while breastfeeding.

Driving and using machines

AQUIPTA may make you feel sleepy. Do not drive or operate machinery if affected.

AQUIPTA contains sodium

AQUIPTA 10 mg tablets

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

AQUIPTA 60 mg tablets

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

3. How to take AQUIPTA

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

The recommended dose is 60 mg of atogepant once daily. Your doctor may advise you to take a lower dose if:

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

How to take

AQUIPTA is administered orally. Do not split, crush, chew, or break the tablet before swallowing. Tablets may be taken with or without food.

If you take more AQUIPTA than you should

If you take more tablets than you should, consult your doctor. You may experience some of the adverse effects mentioned in section 4.

If you forget to take AQUIPTA

• If you miss a dose, take it as soon as you remember.
• If you forget for an entire day, skip the missed dose and take your next dose at the usual time the following day.
• Do not take a double dose to make up for missed doses.

If you stop taking AQUIPTA

Do not stop taking AQUIPTA without first consulting your doctor. Symptoms may return if you stop treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious side effects

Stop taking AQUIPTA and contact your doctor immediately if you experience any of the following symptoms, which may be part of a severe allergic reaction:

• difficulty breathing
• swelling of the face
• rash, itching, or hives

Other side effects

Inform your doctor if you notice any of the following adverse effects:

Common (may affect up to 1 in 10 people):

• nausea (feeling sick);
• 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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of AQUIPTA

AQUIPTA 10 mg tablets

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

Appearance of the product and contents of the pack

AQUIPTA 10 mg tablets

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

AQUIPTA 60 mg tablets

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

Only some 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.

To listen to or request a copy of this leaflet in, or as an