KINPEYGO 4 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Patient Information Leaflet: Information for the Patient

Kinpeygo 4 mg, Modified Release Hard Capsules

budesonide

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 or pharmacist.

• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Kinpeygo and what is it used for

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

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

2. What you need to know before you take Kinpeygo

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 severe liver dysfunction, as indicated by your doctor.

Warnings and precautions

Consult your doctor or pharmacist before taking Kinpeygo:

• If you are going to undergo surgery.
• If you have liver problems.
• If you are taking or have recently taken corticosteroids.
• If you have had a recent infection.
• If you have active or latent tuberculosis, fungal, bacterial, systemic, viral, or parasitic infections that are not being treated, or simple ocular herpes.
• If you have high blood pressure.
• If you have diabetes, or if someone in your family has had diabetes.
• If you have bone fragility (osteoporosis).
• If you have stomach ulcers.
• If you have glaucoma (increased eye pressure) or cataracts, or if someone in your family has had glaucoma (increased eye pressure).

If you are in any of these situations, you may be at greater risk of experiencing side effects. Your doctor will decide what measures are appropriate and whether it is still suitable for you to take this medicine.

Be aware of side effects

If you experience blurred vision or other visual problems, contact your doctor. See section 4 for more information.

Chickenpox or measles

Diseases such as chickenpox and measles can be more serious if you are taking this medicine. If you have not had these diseases, stay away from people with chickenpox or measles while taking this medicine. Inform your doctor if you think you have contracted chickenpox or measles while taking this medicine.

Adrenal function tests

Kinpeygo may affect the results of adrenal function tests (ACTH stimulation test) requested by your doctor. Inform your doctor that you are taking Kinpeygo before undergoing any test.

Children and adolescents

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

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 products.

This is because Kinpeygo may affect the action of some medicines, and some medicines may affect Kinpeygo.

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

Ketoconazole or itraconazole to treat fungal infections.

• HIV medicines called "protease inhibitors", such as ritonavir, indinavir, and saquinavir.
• Erythromycin, an antibiotic used to treat infections.
• Ciclosporin, which is used to suppress the immune system.
• Carbamazepine to treat epilepsy and neurological pain problems.
• Cardiac glycosides, such as digoxin, used to treat heart conditions.
• Diuretics to remove excess fluid from the body.

If you are in any of these cases (or are unsure), consult your doctor or pharmacist before taking Kinpeygo.

Using Kinpeygo with food and drinks

Do not eat grapefruit or drink grapefruit juice while taking Kinpeygo, as it may affect the action of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Do not take this medicine if you are breastfeeding unless you have consulted your doctor. Budesonide passes into breast milk in small amounts. Your doctor will help you decide whether to continue treatment and not breastfeed or to stop treatment while breastfeeding.

Driving and using machines

Kinpeygo is not expected to affect your ability to drive or use machines.

Kinpeygo contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Kinpeygo

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How to take it

The recommended dose of Kinpeygo is 16 mg (4 capsules of 4 mg of Kinpeygo) once a day. It should be taken in the morning, at least 1 hour before eating.

• The capsules should be swallowed whole with a glass of water.
• Do not open, crush, or chew the capsules, as this may affect the release of the medicine. The capsules have a special coating to ensure that the medicine is released in the correct part of the intestine.

When treatment is to be discontinued, your doctor will reduce the dose to 8 mg (2 capsules of 4 mg of Kinpeygo) once a day for the last 2 weeks of treatment. If your doctor considers it necessary, the dose may be reduced to 4 mg once a day (1 capsule of 4 mg of Kinpeygo) for another 2 weeks.

If you take more Kinpeygo than you should

If you take more Kinpeygo than you should, consult your doctor or pharmacist immediately. Bring the pack 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 forget to take a dose of Kinpeygo, wait and take the medicine the next day as usual.

Do not take a double dose to make up for the forgotten dose.

If you stop taking Kinpeygo

Do not stop taking Kinpeygo without consulting your doctor first. If you stop taking the medicine abruptly, you may become ill.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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:

Very common (may affect more than 1 in 10 people)

• Skin rash or itching
• Acne
• Low potassium levels in the blood (hypokalemia)

Common (may affect up to 1 in 10 people)

• High blood pressure
• Swelling of arms or legs, such as in the ankles
• Swelling of the face
• Cushingoid features, such as rounded face, increased body hair, weight gain, and acne
• Indigestion
• Muscle cramps
• Weight gain
• Diabetes mellitus
• Increased white blood cell count (detected by blood tests)

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

• Blurred vision

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. * By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kinpeygo

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 label of the bottle. The expiry date is the last day of the month stated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Kinpeygo

• 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 copolymer, talc, dibutyl sebacate,

Printing ink: shellac, iron oxide black (E172).

Appearance of the product and pack contents

Kinpeygo 4 mg, modified release hard capsules are opaque capsules, 19 mm in length, with a white capsule shell and printed with "CAL10 4MG" in black ink.

The capsules are presented in a white high-density polyethylene (HDPE) bottle with a white polypropylene (PP) child-resistant closure and an induction seal.

This medicine is available in bottles containing 28 or 120 modified release hard capsules and in multipacks of 360 modified release hard capsules, which contain 3 bottles of 120 modified release hard capsules each.

Not all pack sizes may be marketed.

Marketing authorisation holder

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Manufacturer

Tjoapack Netherlands B.V.

Nieuwe Donk 9

4879 AC Etten-Leur

Noord-Brabant

Netherlands

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet: