Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kinpeygo

Document Subject

Generated Narrative: MedicinalProductDefinition mp6dd92eeff0b9acf2637c14b216fa6b97

identifier: http://ema.europa.eu/identifier/EU/1/22/1657/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kinpeygo 4 mg modified-release hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6dd92eeff0b9acf2637c14b216fa6b97

identifier: http://ema.europa.eu/identifier/EU/1/22/1657/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - kinpeygo

Attesters

What is in this leaflet

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

Kinpeygo contains the active substance budesonide, a corticosteroid medicine which mainly acts locally in the intestine to reduce the inflammation associated with primary immunoglobulin A (IgA) nephropathy.

Kinpeygo is used to treat primary IgA nephropathy in adults 18 years of age or older.

Do not take Kinpeygo:

• If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
• If you have loss of function of your liver that your doctor has told you is severe .

Warnings and precautions
Talk to your doctor or pharmacist before taking Kinpeygo:

• If you are going to have surgery.
• If you have liver problems.
• If you are taking or have recently taken corticosteroids.
• If you have recently had an infection.
• If you have active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex.
• If you have high blood pressure.
• If you have diabetes or someone in your family has had diabetes.
• If you have brittle bones (osteoporosis).
• If you have stomach ulcers.
• If you have glaucoma (increased pressure in the eye) or cataracts or someone in your family has had glaucoma (increased pressure in the eye).

If any of the above apply to you, you may be at increased risk of side effects. Your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine.

Look out for side effects If you get blurred vision or other sight problems, contact your doctor. See section 4 for more information.

Chickenpox or measles Illnesses like chickenpox and measles can be more serious if you are taking this medicine. If you have not yet had these illnesses, keep away from people with chicken pox or measles while taking this medicine. Tell your doctor if you think that you have been infected with chicken pox or measles while taking this medicine.

Adrenal function tests Kinpeygo could affect the results of adrenal function tests (ACTH stimulation test) ordered by your doctor. Tell your doctors that you are taking Kinpeygo before you have any tests.

Children and adolescents Kinpeygo should not be used in children and adolescents below 18 years of age. The use of this medicine in children younger than 18 years of age has not been studied.

Other medicines and Kinpeygo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, and herbal medicines.

This is because Kinpeygo capsules can affect the way some medicines work and some medicines can have an effect on Kinpeygo capsules.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole or itraconazole - to treat infections caused by a fungus.
• Medicines for HIV called protease inhibitors - such as ritonavir, indinavir and saquinavir.
• Erythromycin - an antibiotic used to treat infections.
• Cyclosporin - used to suppress your immune system.
• Carbamazepine - for epilepsy and nerve pain problems.
• Cardiac glycosides - such as digoxin- medicines used to treat heart conditions.
• Diuretics - to remove excess fluid from the body.

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

Kinpeygo with food and drink Do not eat grapefruit or drink grapefruit juice while you are taking Kinpeygo. It can affect the way the medicine works.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine during pregnancy without checking with your doctor first.

Do not take this medicine if you are breast-feeding unless you have checked with your doctor. Budesonide passes in small amounts into the breast milk. Your doctor will help you decide whether you should continue treatment and not breast-feed or if you should stop treatment over the period your baby is being breast-fed.

Driving and using machines Kinpeygo is not expected to affect your ability to drive or use any machines.

Kinpeygo contains sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

How to take The recommended dose of Kinpeygo is 16 mg (4 capsules of Kinpeygo 4 mg) once daily. Take in the morning, at least 1 hour before a meal.

• Swallow whole with a glass of water.
• Do not open, crush or chew as this could affect the release of the medicine. The capsules have a special coating, to ensure that the medicine is released in the correct part of your gut.

When treatment is to be discontinued, your doctor will reduce the dose to 8 mg (2 capsules of Kinpeygo 4 mg) once daily for the last 2 weeks of therapy. If considered necessary by your doctor, the dose may then be reduced to 4 mg once daily (1 capsule of Kinpeygo 4 mg) for another 2 weeks.

If you take more Kinpeygo than you should If you take more Kinpeygo than you should, talk to a doctor or pharmacist straight away. Take the carton with you.

If you have taken more than you should for a long time, the possible side effects listed in section 4 may appear.

If you forget to take Kinpeygo If you miss a dose of Kinpeygo, wait and take the medicine the next day as usual.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Kinpeygo Do not stop taking Kinpeygo without discussing it with your doctor first. If you suddenly stop taking the medicine, you may become ill.

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 with this medicine:

Common (may affect up to 1 in 10 people)

• Increased blood pressure

• Swelling of arms or legs   such as ankle swelling 

• Cushingoid features such as a rounded face, increased body hair, weight gain and acne  

• Indigestion
• Muscle cramps
• Rash or itchy skin
• Weight gain
• Diabetes mellitus

Rare (may affect up to 1 in 1 000 people)

• Blurred vision

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 listed 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 on the bottle label. 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 protect the environment.

What Kinpeygo contains

• The active substance is budesonide. Each modified-release hard capsule contains 4 mg of budesonide.

• The other ingredients are: Capsule content: Sugar spheres (sucrose and corn starch), hypromellose, macrogol, citric acid monohydrate, ethylcellulose, medium chain triglycerides, oleic acid (see also section 2 Kinpeygo contains sucrose ). Capsule shell: Hypromellose, macrogol, titanium dioxide (E171), methacrylic acid-methyl methacrylate co-polymers, talc, dibutyl sebacate,
  Printing ink: Shellac, black iron oxide (E172).

What Kinpeygo looks like and contents of the pack Kinpeygo 4 mg modified-release hard capsules are 19 mm white coated opaque capsules printed with CAL10 4MG in black ink.

The capsules are supplied in a white high-density polyethylene (HDPE) bottle with a white polypropylene (PP) child-resistant closure with an induction seal. This medicine is available in bottles containing 120 modified-release hard capsules and in multipacks of 360 modified-release hard capsules comprising 3 bottles, each containing 120 modified-release hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
STADA Arzneimittel AG Stadastrasse 2-61118 Bad Vilbel Germany

Manufacturer

Tjoapack Netherlands B.V. Nieuwe Donk 9 4879 AC Etten-Leur Noord-Brabant Netherlands

STADA Arzneimittel AG
Stadastrasse 2 61118 Bad Vilbel
Germany

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

Belgi /Belgique/Belgien
EG (Eurogenerics) NV
T l/Tel: +32 24797Lietuva
UAB STADA Baltics
Tel: +370 52603
STADA Bulgaria EOOD
Te .: +359 29624Luxembourg/Luxemburg
EG (Eurogenerics) NV
T l/Tel: +32 24797 esk republika
STADA PHARMA CZ s.r.o. Tel: +420 257888Magyarorsz g
STADA Hungary Kft
Tel.: +36 18009Danmark STADA Nordic ApS Tlf: +45 44859Malta Pharma.MT Ltd. Tel: + 356 21337Deutschland
STADAPHARM GmbH
Tel: +49 61016Nederland
Centrafarm B.V.
Tel.: +31 765081Eesti UAB STADA Baltics
Tel: +370 52603Norge
STADA Nordic ApS Tlf: +45 44859
F RAN S.A. : +30 2106254 sterreich STADA Arzneimittel GmbH
Tel: +43 136785Espa a Laboratorio STADA, S.L.
Tel: +34 934738Polska STADA Poland Sp. z o.o. Tel: +48 227377France EG Labo - Laboratoires EuroGenerics
T l: +33 146948Portugal Stada, Lda. Tel: +351 211209Hrvatska STADA d.o.o. Tel: +385 13764Rom nia STADA M&D SRL
Tel: +40 213160Ireland Clonmel Healthcare Ltd.
Tel: +353 526177Slovenija Stada d.o.o. Tel: +386 15896 sland STADA Nordic ApS Tlf: +45 44859Slovensk republika STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621Italia EG SpA Tel: +39 028310Suomi/Finland STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416
STADA Arzneimittel AG
: +30 2106664Sverige STADA Nordic ApS
Tel: +45 44859Latvija UAB STADA Baltics
Tel: +370 52603United Kingdom (Northern Ireland) STADA Arzneimittel AG
Tel: +49 61016This leaflet was last revised in 07/2023 .

This medicine has been given conditional approval . This means that there is more evidence to come about this medicine.

The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.