KINPEYGO 4 мг Капсулы с модифицированным высвобождением

Содержание инструкции

1. Kinpeygo 4 mg extended-release hard capsules
   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. How to store Kinpeygo
   6. Package contents and other information

Kinpeygo 4 mg extended-release hard capsules

budesonide

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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

1. What is Kinpeygo and what is it used for

Kinpeygo contains the active ingredient budesonide, a corticosteroid medicine that works
mainly at a local level in the intestine to reduce inflammation associated with primary
immunoglobulin A (IgA) nephropathy.
Kinpeygo is used for the treatment of primary IgA nephropathy in adults starting 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 impaired liver function and your doctor has told you that it 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 had a recent infection;
• if you have active or latent tuberculosis, 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 fragile bones (osteoporosis);
• if you have stomach ulcers;
• if you have glaucoma (increased pressure in the eye) or cataracts, or if someone in your family has had glaucoma.

If you fall into any of the above categories, you may be at a higher risk of developing
undesirable effects. Your doctor will decide what measures are appropriate and whether it is appropriate for you to take
this medicine anyway.
Pay attention to side effects
If you experience blurred vision or other vision problems, see your doctor. See section 4 for
further information.
Chickenpox or measles
Illnesses such as chickenpox and measles may be more severe if you are taking this medicine.
If you have not had these diseases before, do not come into contact with people with chickenpox or measles
during the period of taking this medicine. See your doctor if you think you have contracted
chickenpox or measles during treatment with this medicine.
Adrenal function tests
Kinpeygo may affect the results of adrenal function tests (ACTH stimulation test) prescribed by your doctor. Tell your doctor that you are taking Kinpeygo before undergoing
any tests.

Children and adolescents
Kinpeygo should not be used in children and adolescents under 18 years of age. The use of
this medicine in children under 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.
Kinpeygo capsules may affect the mechanism of action of some medicines and some
medicines may 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 fungal infections;
• medicines for HIV so-called “protease inhibitors”, such as ritonavir, indinavir and saquinavir;
• erythromycin, an antibiotic used to treat infections;
• cyclosporine, used to suppress the immune system;
• carbamazepine, for epilepsy and problems related to neuralgia;
• cardiac glycosides, such as digoxin, medicines used for the treatment of heart disorders;
• diuretics, to eliminate excess fluids from the body.

If you fall into any of the above categories (or are unsure), see your doctor or pharmacist
before taking Kinpeygo.

Kinpeygo with food and drink
Do not eat grapefruit or drink grapefruit juice during the period of taking Kinpeygo. It can
affect the way this medicine works.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy without first consulting your doctor.
Do not take this medicine if you are breastfeeding without first consulting your doctor. Budesonide
passes in small amounts into breast milk. Your doctor will help you decide whether to continue treatment and
not breastfeed or to stop treatment for the period in which the baby is breastfed.

Driving and using machines
Kinpeygo is not expected to impair the ability to drive vehicles or operate machinery.

Kinpeygo contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking
this medicine.

3. How to take Kinpeygo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

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

• Swallow the capsules whole with a glass of water.
• Do not open, crush or chew the capsules, 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 the intestine.

When the treatment needs to be stopped, your doctor will reduce the dose to 8 mg (2 capsules of Kinpeygo
4 mg) once a day for the last 2 weeks of therapy. If your doctor considers it necessary, the
dose may be reduced to 4 mg once a day (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, contact your doctor or pharmacist immediately. Bring
the package with you.
If you take more medicine than you should for a prolonged period of time, possible undesirable 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 a missed dose.

If you stop taking Kinpeygo
Do not stop taking Kinpeygo without first consulting your doctor. If you suddenly stop taking this
medicine, you may feel unwell.
If you have any questions about 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.
Inform your doctor if you notice any of the following side effects associated with this medicine:

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

• Skin rash or itching
• Acne
• Reduced levels of potassium in the blood (hypokalaemia)

Common (may affect up to 1 in 10 people)

• Increased blood pressure
• Swelling of arms or legs, for example swelling of the ankle
• Facial swelling
• Cushingoid features, such as moon face, increased body hair and weight gain
• Indigestion
• Muscle cramps
• Weight gain
• Diabetes mellitus
• Increased number of white blood cells (detected by blood tests)

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

• Blurred vision

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system
listed in Annex V.* By reporting side effects you can help to provide more information on the safety
of this medicine.

5. How to store Kinpeygo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the box and on the label of the bottle.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kinpeygo contains

• The active ingredient is budesonide. Each modified-release hard capsule contains 4 mg of budesonide.
• Other ingredients are: Capsule contents: 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), acrylic acid and methyl methacrylate copolymers, talc, dibutyl sebacate.
Ink on the inscription: shellac, black iron oxide (E172).

Description of the appearance of Kinpeygo and package contents
Kinpeygo 4 mg modified-release hard capsules are opaque 19 mm capsules, coated in
white, with the inscription “CAL10 4MG” printed in black.
The capsules are supplied in a white high-density polyethylene (HDPE) bottle with a
child-resistant polypropylene (PP) closure with an induction seal.
This medicinal product is available in bottles containing 28, 100, 120 modified-release hard
capsules and in multi-packs 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 2-18
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
For further information on this medicinal product, contact the local representative of the
marketing authorisation holder:

België/Belgique/Belgien
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Lietuva
UAB „STADA Baltics“
Tel: +370 52603926

България
STADA Bulgaria EOOD
Teл.: +359 29624626

Luxembourg/Luxemburg
EG (Eurogenerics) NV
Tél/Tel: +32 24797878

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111

Magyarország
STADA Hungary Kft
Tel.: +36 18009747

Danmark
STADA Nordic ApS
Tlf: +45 44859999

Malta
Pharma.MT Ltd.
Tel: + 356 21337008

Deutschland
STADAPHARM GmbH
Tel: +49 61016030

Nederland
Centrafarm B.V.
Tel.: +31 765081000

Eesti
UAB „STADA Baltics“
Tel: +370 52603926

Norge
STADA Nordic ApS
Tlf: +45 44859999

Ελλάδα
FΑRAN S.A.
Τηλ: +30 2106254175

Österreich
STADA Arzneimittel GmbH
Tel: +43 136785850

España
Laboratorio STADA, S.L.
Tel: +34 934738889

Polska
STADA Poland Sp. z o.o.
Tel: +48 227377920

France
EG Labo - Laboratoires EuroGenerics
Tél: +33 146948686

Portugal
Stada, Lda.
Tel: +351 211209870

Hrvatska
STADA d.o.o.
Tel: +385 13764111

România
STADA M&D SRL
Tel: +40 213160640

Ireland
Clonmel Healthcare Ltd.
Tel: +353 526177777

Slovenija
Stada d.o.o.
Tel: +386 15896710

Ísland
STADA Nordic ApS
Tlf: +45 44859999

Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
EG SpA
Tel: +39 028310371

Suomi/Finland
STADA Nordic ApS, Suomen sivuliike
Puh/Tel: +358 207416888

Κύπρος
STADA Arzneimittel AG
Τηλ: +30 2106664667

Sverige
STADA Nordic ApS
Tel: +45 44859999

Latvija
UAB „STADA Baltics“
Tel: +370 52603926

United Kingdom (Northern Ireland)
STADA Arzneimittel AG
Tel: +49 61016030

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATIONS FOR VARIATIONS TO THE
MARKETING AUTHORISATIONS
Scientific conclusions
In light of the assessment by the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Reports (PSURs) for budesonide (only for centrally
authorised products and those indicated for primary immunoglobulin A nephropathy), the
PRAC’s scientific conclusions are as follows:
In light of the available data from clinical studies on hypokalaemia, a spontaneous report, and
considering a plausible mechanism of action, the PRAC considers that a causal relationship
between budesonide (for centrally authorised products and those indicated for primary IgA) and
hypokalaemia is at least a reasonable possibility. The PRAC concluded that the product information
for products containing budesonide (for centrally authorised products and those indicated for
primary IgA) should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Medicinal Products for Human
Use (CHMP) agrees with the PRAC’s overall conclusions and with the justifications for the
recommendation.

Justifications for variations to the marketing authorisations
Based on the scientific conclusions on budesonide (only for centrally authorised products and
indicated for primary immunoglobulin A nephropathy), the CHMP considers that the benefit/risk
balance of the medicinal products containing budesonide (only for centrally authorised products and
indicated for primary immunoglobulin A nephropathy) remains unchanged subject to the proposed
amendments to the product information.
The CHMP recommends the variation to the marketing authorisations.