AQUIPTA 60 mg tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

AQUIPTA works by blocking the activity of the calcitonin gene-related peptide (CGRP) molecule which has been linked to migraine. This reduction in CGRP’s activity reduces migraine attacks.

AQUIPTA is used to prevent migraine in adult patients who have at least 4 migraine days per month.

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

Talk to your doctor, pharmacist or nurse before taking AQUIPTA, especially if you:

• have liver problems
• have kidney problems

Allergic reactions

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 several days after you take AQUIPTA.

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.

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.

The following is a list of examples of medicines that may require your doctor to lower the dose of AQUIPTA:

• ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, rifampicin (medicines used to treat fungal or bacterial infections)
• atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir (medicines used to treat HIV)
• ciclosporin (medicine that affects your immune system)
• telmisartan (medicine used to treat high blood pressure)

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking AQUIPTA.

AQUIPTA is not recommended during pregnancy.

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.

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

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

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

The recommended dose is 60 mg once a day. Your doctor may tell you to take a lower dose if you are taking other medicines (listed in section 2) or if you have severe kidney problems. Speak to your doctor if you are undergoing dialysis.

AQUIPTA may be taken with or without food.

If you have used more AQUIPTA than you should, tell your doctor.

A missed dose should be taken straight away. If it is close to your scheduled next dose, do not take a double dose to make up for a forgotten tablet.

Do not stop using AQUIPTA without talking to your doctor first. Your symptoms may return if you stop the treatment.

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

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

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

• feeling sick (nausea)
• constipation
• tiredness (fatigue) or sleepiness (somnolence)
• decreased appetite
• weight loss

Uncommon (may affect up to 1 in 100 people)

• increased levels of liver enzymes

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is atogepant.

• Each tablet contains either 10 mg or 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.

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.

AQUIPTA 60 mg tablets

AQUIPTA 60 mg tablet is a white to off-white, oval biconvex tablet debossed with “A60” on one side.

Each blister contains 7 tablets, each pack contains 28 or 98 tablets.

Not all pack sizes may be marketed.

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

United Kingdom