Aquipta 10 mg comprimidos

Product Information for the Patient

AQUIPTA 10 mg Tablets

AQUIPTA 60 mg Tablets

atogepant

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

AQUIPTA contains the active ingredient atogepant. AQUIPTA is used to prevent migraine in adults who experience at least 4 days of migraine per month.

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

Do not take AQUIPTA

• if you are allergic to atogepant or any of the other ingredients in this medication (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

• facial swelling

• rash, itching, or urticaria

Some of these symptoms may occur within 24 hours after the first use. In some cases, they may occur several days after taking AQUIPTA.

Consult your doctor, pharmacist, or nurse before starting AQUIPTA if you have severe liver problems.

Children and adolescents

Do not administer this medication to children or adolescents under 18 years of age, as AQUIPTA has not been studied in this age group.

Other medications and AQUIPTA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Some medications may increase the risk of adverse effects (see section 4).

The following list contains examples of medications that may require your doctor to reduce your AQUIPTA dose:

• ketoconazole, itraconazole, clarithromycin, rifampicin (medications used to treat fungal or bacterial infections);
• ritonavir (medication used to treat HIV);
• ciclosporin (medication that affects your immune system).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication.

Do not take AQUIPTA if you are pregnant. If you are a woman and may become pregnant, use suitable contraceptive methods during AQUIPTA treatment.

Do not take AQUIPTA if you are breastfeeding or plan to breastfeed. You and your doctor must decide whether to breastfeed or take AQUIPTA.

Driving and operating machinery

AQUIPTA may cause drowsiness. Do not drive or operate machinery if it affects you.

AQUIPTA contains sodium

AQUIPTA 10 mg tablets

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

AQUIPTA 60 mg tablets

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

Follow exactly the administration instructions for this medication as indicated 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 a day. Your doctor may instruct you to take a lower dose if:

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

How to take

AQUIPTA is administered orally. Do not break, crush, chew, or split the tablet before swallowing it. Tablets can 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 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 regular dose the next day.
• Do not take a double dose to make up for the missed doses.

If you interrupt treatment with AQUIPTA

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

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe 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

• facial swelling

• rash, itching, or urticaria

Other Side Effects

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

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

• nausea (urge to vomit);
• constipation;
• fatigue (tiredness);
• drowsiness (tendency to sleep);
• decreased appetite;
• weight loss.

Rare(may affect up to 1 in 100 people):

• increase in liver enzyme levels.

Reporting 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 prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of AQUIPTA

AQUIPTA 10 mg tablets

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

AQUIPTA 60 mg tablets

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

Appearance of the product and contents of the package

AQUIPTA 10 mg tablets

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

AQUIPTA 60 mg tablets

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

Only some package sizes may be marketed.

Marketing Authorization Holder

AbbVie Deutschland GmbH & Co. KG

Knollstrasse

67061 Ludwigshafen

Germany

Responsible for manufacturing

AbbVie S.r.l

S.R. 148 Pontina Km 52 Snc

Campoverde di Aprilia, Latina 04011

Italy

For more information about this medication, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medication is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

To listen to or request a copy of this leaflet in, or listen to it in , please contact the local representative of the marketing authorization holder.