Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - lupkynis

Document Subject

Generated Narrative: MedicinalProductDefinition mp41b3735a6e59fac8a0512a47fdc116bd

identifier: http://ema.europa.eu/identifier/EU/1/22/1678/001 (180 soft capsules)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Lupkynis 7.9 mg soft capsules

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-41b3735a6e59fac8a0512a47fdc116bd

identifier: http://ema.europa.eu/identifier/EU/1/22/1678/001 (180 soft capsules)

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - lupkynis

Attesters

What is in this leaflet

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

Lupkynis contains the active substance voclosporin. It is used for the treatment of adults from 18 years of age with lupus nephritis (inflammation of the kidney caused by lupus).

The active ingredient in Lupkynis is one of a group of medicines known as calcineurin inhibitors that can be used to control your body s immune response (immunosuppressants). In lupus, the immune system (the body s natural defences) mistakenly attacks parts of your own body, including the kidneys (lupus nephritis). By reducing the response of the immune system, the medicine reduces inflammation of your kidneys and lessens symptoms such as swelling of the legs, ankles or feet, high blood pressure, tiredness, as well as improving your kidney function.

Do not take Lupkynis

• If you are allergic to voclosporin or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines such as ketoconazole tablets (used to treat Cushing s syndrome when the body produces an excess of cortisol), itraconazole or clarithromycin (used to treat certain fungal and bacterial infections).

Warnings and precautions Talk to your doctor or pharmacist before taking Lupkynis if any of the following applies to you:

• if your kidney disease gets worse, your dose of this medicine may need to be changed. Your doctor will regularly check how well your kidneys are working.
• if you have risk factors for pure red cell aplasia (PRCA) a rare disorder in which the bone marrow does not make enough red blood cells. Such risk factors are a former infection with parvovirus B19 or other treatments in the past that may cause PRCA.
• if you suffer from or develop high blood pressure. Your doctor will check your blood pressure every two weeks for the first month and then regularly. He/she may give you a medicine to lower your blood pressure or tell you to stop taking this medicine.
• This medicine can increase the risk of conditions of the nervous system, such as headache, shaking, changes in vision, seizures, confusion or weakness in one or more limbs. If you experience any of these new symptoms or worsening of existing symptoms, your doctor may consider stopping or lowering the dose of this medicine (see section 4).
• if you are planning to have a vaccination or have had a vaccination within the last 30 days. This medicine may affect the response to vaccination, and vaccination during treatment with this medicine may be less effective.
• if you have previously experienced sudden life-threatening allergic reactions (anaphylactic reactions) to soya or peanut, do not take this medicine.

This medicine can increase the potassium levels in your blood, which may be serious and require treatment. Your doctor will check your potassium levels periodically during treatment.

This medicine has not been studied in patients with severe liver problems and is therefore not recommended in these patients.

This medicine may influence the electrical activity of your heart (QT prolongation). This can result in serious heart rhythm disorder. Early symptoms are dizziness and fainting.

Sunlight and UV light This medicine can increase the risk of developing certain types of cancer, particularly of the skin. You should avoid or limit your exposure to sunlight and UV light by wearing appropriate protective clothing and frequently applying sunscreen with a high protection factor.

Infections This medicine can increase your risk of developing infections, some of which may be serious or even fatal. Contact your doctor if you have any signs of infection, such as fever, chills or sore throat. Your doctor will decide whether you need to stop taking this medicine (see section 4).

Children and adolescents Do not take this medicine if you are under the age of 18 years because it has not been studied in this age group.

Elderly This medicine is not recommended if you are over the age of 75 years because it has not been studied in this age group.

Other medicines and Lupkynis Tell your doctor or pharmacist if you are taking or have recently taken or are planning to take any other medicines.

In particular, tell your doctor if you take:

• Medicines used to treat fungal infection such as itraconazole and fluconazole.
• Medicines used to treat Cushing s syndrome (when the body produces an excess of cortisol), such as ketoconazole tablets.
• Medicines used to treat high blood pressure or heart problems such as digoxin, diltiazem and verapamil.
• Medicines to prevent the formation of blood clots such as dabigatran etexilate.
• Medicines used to treat epilepsy such as carbamazepine and phenobarbital.
• Herbal preparations containing St. John s Wort, used to treat mild depression.
• Medicines for the relief of symptoms associated with seasonal allergic rhinitis such as fexofenadine.
• Antibiotic medicines used to treat bacterial infections such as rifampicin, clarithromycin and erythromycin.
• Medicines that lower cholesterol such as simvastatin, atorvastatin, rosuvastatin and pravastatin.
• Medicines used to treat HIV infections, such as the antiretroviral efavirenz.

Lupkynis with food and drink This medicine can be taken with or without food. Avoid eating grapefruit and drinking grapefruit juice during treatment with this medicine, since these can affect how the medicine works.

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 taking this medicine.

This medicine is not recommended during pregnancy and in women of childbearing potential not using contraception.

Tell your doctor if you are breast-feeding. It is not known if the medicine can pass into breast milk and affect your baby. Your doctor will discuss with you whether to stop treatment with this medicine while you are breast-feeding, or to stop breast-feeding.

There are no data on the effect of this medicine on human fertility.

Driving and using machines Lupkynis is not expected to have any effect on your ability to drive and use machines.

Lupkynis contains alcohol This medicine contains 21.6 mg of alcohol (ethanol) in each capsule. Therefore, a dose of 3 capsules of Lupkynis contains 64.8 mg ethanol, which is equivalent to less than 2 mL beer or 1 mL wine. This small amount of alcohol in this medicine will not have any noticeable effects.

Lupkynis contains sorbitol This medicine contains 28.7 mg of sorbitol in each capsule.

Lupkynis may contain soya lecithin
This medicine may contain trace amounts of soya lecithin. If you experience anaphylactic reactions to soya or peanut, you must not use this medicine.

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

The recommended dose of Lupkynis is three capsules twice daily, taken by mouth.

The capsules must be swallowed whole and can be taken with or without food.

Take the daily doses at around the same time each day, at least 8 hours apart and ideally as close to hours apart as possible (for example, at 8:00 am in the morning and 8:00 pm in the evening).

This medicine should be used in combination with another immunosuppressant medicine, mycophenolate mofetil.

If you take more Lupkynis than you should If you have accidentally taken too many capsules, contact your doctor or nearest hospital emergency department immediately. Symptoms of overdose may include a fast heartbeat and tremors (uncontrolled shaking or trembling in one or more parts of the body).

If you forget to take Lupkynis If a dose is missed, take it as soon as possible and within 4 hours of missing the dose. If more than 4 hours have passed since the time you normally take the medicine, just skip that dose and take the next regular dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lupkynis Do not stop your treatment unless your doctor tells you to do so.

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. The following side effects may happen with this medicine:

Serious side effects

If any of these occur, seek immediate medical advice as your doctor may advise you to stop taking this medicine or reduce the dose.

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

• Symptoms of infection (such as fever, body aches, feeling tired, coughing or sneezing, nausea, vomiting or diarrhoea)

Common (may affect up to 1 in 10 people)

• Newly developing symptoms of nerve or brain problems, such as seizures

Other side effects

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

• Upper chest infection
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)
• Headache
• Increased blood pressure
• Cough
• Diarrhoea
• Pain in the abdomen (belly)
• Changes in your kidney function which could reduce the amount of urine you produce and may cause new or worsening swelling in your legs or feet

Common (may affect up to 1 in 10 people)

• Infections, that can either be bacterial such as urinary tract infections or viral such as shingles
• Inflammation of the stomach and intestines
• Flu
• Increased levels of potassium seen in blood test
• Decreased appetite
• Tremors
• Feeling sick
• Abnormal swelling, bleeding and/or inflammation of the gums
• Indigestion
• Hair loss
• Excessive and/or abnormal hair growth on any part of the body

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 blister after EXP . The expiry date refers to the last day of that month. Store in the original blister in order to protect from moisture. 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 Lupkynis contains

• The active substance is voclosporin. Each soft capsule of Lupkynis contains 7.9 mg of voclosporin.
• The other ingredients are: Capsule content: ethanol, vitamin E (E307) polyethylene glycol succinate (tocofersolan), polysorbate 40 and medium-chain triglycerides Capsule shell: gelatin, sorbitol, glycerin, purified water, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172) Processing aid: soya lecithin

What Lupkynis looks like and contents of the pack Lupkynis 7.9 mg pink/orange, soft capsules measuring approximately 13 mm 6 mm packed in blisters. Each blister contains 18 soft capsules. One carton contains 180 or 576 soft capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 1101 CT Amsterdam Netherlands

Manufacturer Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YD60, Ireland

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

Belgi /Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. T l/Tel: +31 (0) 20 85 46 Lietuva Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46
Otsuka Pharmaceutical Netherlands B.V. Te : +31 (0) 20 85 46 Luxembourg/Luxemburg Otsuka Pharmaceutical Netherlands B.V. T l/Tel: +31 (0) 20 85 46 esk republika Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Magyarorsz g Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Danmark Otsuka Pharma Scandinavia AB Tlf: +46 (0) 8 545 286 Malta Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Deutschland Otsuka Pharma GmbH Tel: +49 (0) 69 1700 Nederland Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Eesti Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Norge Otsuka Pharma Scandinavia AB Tlf: +46 (0) 8 545 286
Otsuka Pharmaceutical Netherlands B.V. Th : +31 (0) 20 85 46 sterreich Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Espa a Otsuka Pharmaceutical S.A Tel: +34 (0) 93 208 1Polska Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 France Otsuka Pharmaceutical France SAS T l: +33 (0) 1 47 08 00 Portugal Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Hrvatska Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Rom nia Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Ireland Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Slovenija Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 sland Otsuka Pharma Scandinavia AB S mi: +46 (0) 8 545 286 Slovensk republika Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Italia Otsuka Pharmaceutical Italy S.r.l. Tel: +39 (0) 2 0063 2Suomi/Finland Otsuka Pharma Scandinavia AB Puh/Tel: +46 (0) 8 545 286
Otsuka Pharmaceutical Netherlands B.V. Th : +31 (0) 20 85 46 Sverige Otsuka Pharma Scandinavia AB Tel: +46 (0) 8 545 286 Latvija Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 United Kingdom (Northern Ireland) Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: