Joenja 70 mg Film-coated tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• 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. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to leniolisib or any of the other ingredients of this medicine (listed in section 6)

Harm to your unborn baby

Treatment with Joenja during pregnancy can cause harm to your unborn baby. Your doctor may have you take a pregnancy test before starting treatment with Joenja. Women who can become pregnant should use highly effective birth control throughout the duration of treatment with Joenja and for 1 week after the last dose of Joenja. Talk to your doctor about birth control methods that may be right for you.

Liver problems

Talk to your doctor or pharmacist before taking Joenja if you have moderately or severely reduced liver function. Joenja is not recommended in these patients.

Vaccinations

Vaccines that contain live or live but weakened organisms, known as live, attenuated vaccines (like measles, mumps, and rubella vaccines) may be less effective if administered during Joenja treatment.

Do not give Joenja to children under 12 years because it has not been studied in this age group.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Certain medicines taken with Joenja may change how it works or Joenja may stop them from working properly.

Tell your doctor or pharmacist if you are taking any of the following medicines as they may change how Joenja works:

• avasimibe – used to treat build-up of cholesterol plaque in the arteries
• bosentan – used to treat pulmonary arterial hypertension (PAH)
• carbamazepine, phenobarbital, phenytoin – used to treat seizures (epilepsy)
• cobicistat, efavirenz, elvitegravir, etravirine, indinavir, lopinavir, nevirapine, ritonavir, saquinavir, tipranavir – used to treat human immunodeficiency virus (HIV) infection
• danoprevir, dasabuvir, ombitasvir, paritaprevir – used to treat hepatitis C (HCV)
• diltiazem, verapamil – used to treat high blood pressure (hypertension)
• itraconazole, ketoconazole, posaconazole, voriconazole – used to treat fungal infections
• mitotane – cancer therapy
• modafinil – used to treat excessive daytime sleepiness (narcolepsy)
• clarithromycin, erythromycin, nafcillin, rifabutin, rifampin, telithromycin, troleandomycin – used to treat bacterial infections
• St. John’s Wort (Hypericum perforatum) – a herbal medicine for depression and sleep problems

Also, tell your doctor or pharmacist if you are taking any of the following medicines, which may be affected when used with Joenja:

• alosetron – used to treat irritable bowel syndrome (IBS) in women
• duloxetine – used to treat depression
• letermovir – used to prevent cytomegalovirus (CMV) infection
• melatonin, ramelteon, tasimelteon – used to treat insomnia
• rosuvastatin, pitavastatin – used to lower cholesterol
• theophylline – used to treat asthma
• tizanidine – used to relax muscles

Do not eat grapefruit or drink grapefruit juice while taking Joenja. Grapefruit may increase the amount of leniolisib in your body.

• Pregnancy
  • Joenja is not recommended during pregnancy. There is no information about the safety of this medicine in pregnant women. Your doctor will test to see if you are pregnant before beginning treatment with Joenja.
  • For women who could become pregnant, Joenja is not recommended if not using highly effective contraception during treatment. Continue contraception for at least 1 week after the last dose of Joenja. Ask your doctor about suitable methods of contraception.
  • If you think you may be pregnant after starting treatment with Joenja, tell your doctor immediately.
• Breast-feeding
  Do not breast-feed while taking Joenja. Tell your doctor before you take this medicine if you are breast-feeding or are planning to breast-feed. It is not known if Joenja can pass into breast milk or if this would affect the baby.

This medicine has no or negligible influence on your ability to drive or use machines.

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

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

1 tablet twice daily, approximately 12 hours apart in adults and adolescents from 12 years weighing 45 kg or more.

If vomiting occurs within 1 hour after taking the tablet, take another tablet right away. If you vomit more than 1 hour after taking the tablet, take the next dose at your usual time.

This medicine can be taken with or without food. The tablets should be swallowed whole. The tablets should not be split, crushed, or chewed.

Contact your doctor or nearest emergency department immediately for advice if this occurs. Keep the bottle and this leaflet with you so that you can easily describe what you have taken.

If you miss a dose by more than 6 hours, wait and take the next dose at your usual time. Do not take a double dose to make up for a forgotten tablet.

Do not stop taking this medicine unless your doctor tells you to.

Joenja may lower the number of a type of white blood cells called neutrophils.

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is leniolisib. Each film-coated tablet contains leniolisib phosphate equivalent to 70 mg leniolisib.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (Type A), hypromellose, magnesium stearate, colloidal silicon dioxide. The coating ingredients are hypromellose, titanium dioxide, talc, macrogol/polyethylene glycol, iron oxide yellow, and iron oxide red. See section 2 “Joenja contains lactose and sodium”.

Joenja 70 mg film-coated tablets are yellow, oval-shaped, bevelled edge film-coated tablets debossed with “70” on one side and “LNB” on the other side.

Each pack contains 1 bottle with 60 tablets.