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AQUIPTA 60 mg tablets {equilateral_black_triangle}

Active Ingredient:
atogepant
Company:  
AbbVie Ltd See contact details
ATC code: 
N02CD07
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 04 Sep 2023

{equilateral_black_triangle} This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 41042/0089.

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AQUIPTA 10 mg and 60 mg tablets

Package leaflet: Information for the patient

AQUIPTA 10 mg tablets

AQUIPTA 60 mg tablets

atogepant

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • 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.

What is in this leaflet

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

1. What AQUIPTA is and what it is used for

AQUIPTA contains the active substance atogepant.

How AQUIPTA works

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.

What AQUIPTA is used for

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

2. What you need to know before you take AQUIPTA
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

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

  • have liver problems
  • have kidney 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.

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.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

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

AQUIPTA contains sodium

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’.

3. How to take AQUIPTA

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

How much to take

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.

How to take

AQUIPTA may be taken with or without food.

If you take more AQUIPTA than you should

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

If you forget to take AQUIPTA

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.

If you stop taking AQUIPTA

Do not stop using AQUIPTA 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, pharmacist or nurse.

4. Possible side effects

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

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

Reporting of side effects

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.

5. How to store AQUIPTA

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

This medicinal product does not require any special storage conditions.

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.

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.

6. Contents of the pack and other information
What AQUIPTA contains

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.

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.

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.

Marketing Authorisation Holder
AbbVie Ltd.
Maidenhead
SL6 4UB
UK

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:

United Kingdom

AbbVie Ltd
Tel: +44 (0)1628 561090

This leaflet was last revised in June 2023.

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.

AbbVie Ltd
Company image
Address
AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4UB, UK
WWW
www.abbviemedinfo.com
WWW
www.abbvie.co.uk
Telephone
+44 (0)1628 561 092
Medical Information e-mail
[email protected]
Out of Hours Telephone
+44 (0)1628 561 092