Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - aquipta

Document Subject

Generated Narrative: MedicinalProductDefinition mpaac724bbfae048108e8444486a06d7e6

identifier: http://ema.europa.eu/identifier/EU/1/23/1750/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: AQUIPTA 10 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-aac724bbfae048108e8444486a06d7e6

identifier: http://ema.europa.eu/identifier/EU/1/23/1750/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - aquipta

Attesters

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

AQUIPTA contains the active substance atogepant. AQUIPTA is used to prevent migraine in adult patients who have at least 4 migraine days per month. AQUIPTA is thought to block the activity of the calcitonin/calcitonin gene related peptide (CGRP)- receptor family, which have been linked to migraine.

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 if you have severe liver 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 (see section 4). The following is a list of examples of medicines that may require your doctor to lower the dose of AQUIPTA:

ketoconazole, itraconazole, clarithromycin, rifampicin (medicines used to treat fungal or bacterial infections)

ritonavir (medicine used to treat HIV)

ciclosporin (medicine that affects your immune system) Pregnancy, breast-feeding and fertility 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. If you are pregnant, you should not take AQUIPTA. If you are a woman who could become pregnant, you should use adequate contraception during treatment with AQUIPTA. If you are breast-feeding or are planning to breast-feed, you should not take AQUIPTA. You and your doctor should decide if you will breast-feed or take AQUIPTA. Driving and using machines AQUIPTA may make you feel sleepy. Do not drive or use machines if you are affected. AQUIPTA contains sodium AQUIPTA 10 mg tablets This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium- free . AQUIPTA 60 mg tablets This medicine contains 31.5 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to take The recommended dose is 60 mg atogepant once a day. Your doctor may tell you to take a lower dose if:

you are taking other medicines (listed in section 2)

you have severe kidney problems or you are undergoing dialysis. How to take AQUIPTA is for oral use. Do not split, crush, chew or break the tablet before swallowing. The tablets may be taken with or without food. If you take more AQUIPTA than you should If you have taken more tablets than you should, tell your doctor. You may get some of the side effects listed in section 4. If you forget to take AQUIPTA

If you miss a dose, take it as soon as you remember.

If you forget your dose for an entire day, just skip the missed dose and take a single dose as usual the following day.

Do not take a double dose to make up for a forgotten dose. If you stop taking AQUIPTA Do not stop taking 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 or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice any of the following side effects: Common (may affect up to 1 in 10 people):

nausea (feeling sick in your stomach)

constipation

fatigue (tiredness)

somnolence (sleepiness)

decreased appetite

weight loss Uncommon (may affect up to 1 in 100 people)

increased levels of liver enzymes Not known (cannot be estimated from the available data)

allergic reactions (such as rash, itching, hives, swelling of the face) Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listing in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. 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. This medicine does not require any special storage conditions. 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.

What AQUIPTA contains AQUIPTA 10 mg tablets

The active substance is atogepant. Each tablet contains 10 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 (see section 2). AQUIPTA 60 mg tablets

The active substance is atogepant. Each tablet contains 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 (see section 2). 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. It is available in packs containing 28 or 98 tablets. AQUIPTA 60 mg tablets AQUIPTA 60 mg tablet is a white to off-white, oval biconvex tablet debossed with A60 on one side. It is available in packs containing 28 or 98 tablets. Not all pack sizes may be marketed. Marketing Authorisation 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 04Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AbbVie SA T l/Tel: +32 10 477Lietuva AbbVie UAB Tel: +370 5 205 3

.:+359 2 90 30 Luxembourg/Luxemburg AbbVie SA Belgique/Belgien T l/Tel: +32 10 477 esk republika AbbVie s.r.o. Tel: +420 233 098 Magyarorsz g AbbVie Kft. Tel.:+36 1 455 8Danmark AbbVie A/S Tlf: +45 72 30-20-Malta Vivian Corporation Ltd. Tel: +356 27780Deutschland AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (geb hrenfrei) Tel: +49 (0) 611 / 1720-0 Nederland AbbVie B.V. Tel: +31 (0)88 322 2Eesti AbbVie O Tel: +372 623 1Norge AbbVie AS Tlf: +47 67 81 80
AbbVie . . : +30 214 4165 sterreich AbbVie GmbH Tel: +43 1 20589-0 Espa a AbbVie Spain, S.L.U. Tel: +34 91 384 09 Polska AbbVie Sp. z o.o. Tel.: +48 22 372 78 France AbbVie T l: +33 (0) 1 45 60 13 Portugal AbbVie, Lda. Tel: +351 (0)21 1908Hrvatska AbbVie d.o.o. Tel + 385 (0)1 5625 Rom nia AbbVie S.R.L. Tel: +40 21 529 30 Ireland AbbVie Limited Tel: +353 (0)1 4287Slovenija AbbVie Biofarmacevtska dru ba d.o.o. Tel: +386 (1)32 08 sland Vistor hf. S mi: +354 535 7Slovensk republika AbbVie s.r.o. Tel: +421 2 5050 0Italia AbbVie S.r.l. Tel: +39 06 928Suomi/Finland AbbVie Oy Puh/Tel: +358 (0)10 2411
Lifepharma (Z.A.M.) Ltd .: +357 22 34 74 Sverige AbbVie AB Tel: +46 (0)8 684 44 Latvija AbbVie SIA Tel: +371 67605United Kingdom (Northern Ireland) AbbVie Deutschland GmbH & Co. KG Tel: +44 (0)1628 561This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. 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.