InfoCons Consumer Protection informs you – Deltyba – Package Leaflet

Before anything else

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

ℹ️ 1. What Deltyba is and what it is used for

Deltyba contains the active substance delamanid, an antibiotic for the treatment of tuberculosis in the lung caused by bacteria that are not killed by the most commonly used antibiotics to treat tuberculosis.

It must always be taken together with other medicines for treating tuberculosis.

Deltyba is used in adults, adolescents, children and infants who are weighing at least 10 kg.

⚠️ 2. What you need to know before you take Deltyba

Do not take Deltyba

• if you are allergic to delamanid or any of the other ingredients of this medicine (listed in section 6).
• if you have very low levels of albumin, in the blood.
• if you are taking medicines that strongly increase the activity of a certain liver enzyme called ‘CYP450 3A4’ (e.g. carbamazepine [a medicine used to treat epilepsy and prevent seizures]).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Deltyba.

Before you start taking Deltyba, and during the treatment, your doctor may check your heart’s electrical activity using an ECG (electrocardiogram) machine (electrical recording of the heart). Your doctor may also perform a blood test to check the concentra tion of some minerals and proteins which are important for the function of your heart. Tell your doctor if you have one of the following conditions:

• you have reduced levels of albumin, potassium, magnesium or calcium in the blood.
• you have been told that you have heart problems, for example a slow heart rhythm (bradycardia) or have a history of heart attack (myocardial infarction).
• if you have a condition called congenital long QT syndrome or have a serious heart disease or problems with heart rhythm.
• you have liver disease or severe kidney disease.

46 Inform your doctor immediately while taking this medicine:

• if you experience reappearance or worsening of symptoms of tuberculosis (see 4. Possible side effects).

Children and adolescents

Deltyba is not suitable for children with a body weight of less than 10 kg because there are not enough data available in those patients to determinate the correct doses.

Other medicines and Deltyba

Tell your doctor:

• if you are taking, have recently taken or might take any other medicines.
• if you are taking medicines to treat an abnormal heart rhythm (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
• if you are taking medicines to treat psychoses (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression.
• if you are taking certain antimicrobial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, or pentamidine).
• if you are taking triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
• if you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine).
• if you are taking certain medicines to treat malaria (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
• if you are taking any of the following: cisapride (used to treat stomach disorders), droperidol (used against vomiting and migraine), domperidone (used against nausea and vomiting), diphemanil (used to treat stomach disorders or excessive sweating), probu col (lowers the level of cholesterol in the bloodstream), levomethadyl or methadone (used for the treatment of opiate addiction), vinca alkaloids (anti -cancer medicines), or arsenic trioxide (used to treat certain types of leukaemia).
• if you are taking HIV -medicines containing lopinavir/ritonavir, or saquinavir.

You may be more at risk for dangerous changes of the heart rhythm.

Pregnancy and breast -feeding Deltyba may cause harm to an unborn baby. It is not usually recommended for use during pregnancy.

It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to get pregnant. Your doctor will weigh up the benefits to you against the risks to your baby of taking Deltyba whilst you are pregnant.

It is not known if delamanid passes into breast milk in humans. Breast -feeding is not recommended during treatment with Deltyba.

Driving and using machines

Deltyba is expected to have a moderate influence on your ability to drive and use machines. If you experience side effects that might affect your ability to concentrate and react, do not drive or use machines.

💊 3. How to take Deltyba

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 as advised by your doctor is:

Children with a body weight of 20 kg or more and less than 30 kg: two 25 mg dispersible tablets in the morning and one 25 mg dispersible tablet in the evening for 24 weeks.

Children with a body weight of 10 kg or more and less than 20 kg: one 25 mg dispersible tablet in the morning and one 25 mg dispersible tablet in the evening for 24 weeks.

47 For children with a body weight of 30 kg or more please see the package leaflet for Deltyba 50 mg film-coated tablets.

The dispersible tablets must be taken during or just after a meal.

Place the 25 mg dispersible tablet(s) in a glass or a cup. Pour 10 to 15 mL of water (approximately 1 tablespoon) per 25 mg dispersible tablet in the cup or the glass. Wait until the dispersible tablet(s) dissolve(s) completely (approximately 30 seconds) and gently swirl to make a uniform suspension.

The resulting whitish suspension must be ingested immediately. Thereafter, a further 10 to 15 mL of water (approximately 1 tablespoon) per 25 mg dispersible tablet must be added to the glass or cup, swirl gentl y ensuring that potentially remaining suspension is dispersed and the resulting suspension must also be ingested immediately.

If you take more Deltyba than you should

If you have taken more tablets than your prescribed dose, contact your doctor or your local hospital.

Remember to take the pack with you so that it is clear what medicine you have taken.

If you forget to take Deltyba

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, just skip the missed dose.

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

If you stop taking Deltyba

DO NOT stop taking the tablets unless your doctor tells you to. Stopping too early could allow the bacteria to recover and to become resistant to delamanid.

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.

Side effects very commonly (may affect more than 1 in 10 people) reported in clinical studies with Deltyba were:

• Decreased appetite
• Disturbed sleep, including nightmares*
• Feeling dizzy
• Feeling sick (nausea)
• Headache
• Stomach irritation (gastritis)
• Vomiting *Cases were mostly reported in children.

Side effects commonly (may affect up to 1 in 10 people) reported in clinical studies with Deltyba were:

• Chest pain
• Decrease in the thyroid gland activity (hypothyroidism)
• Defect in cardiac rhythm that predisposes to fainting, dizziness and palpitations (electrocardiogram QT prolonged)
• Depression
• Feeling anxious (anxiety)
• Hallucination (seeing, hearing or feeling things that are not there)*
• Heart rhythm disturbance (atrioventricular block first degree) 48 • Indigestion (dyspepsia)
• Irregular heartbeats (ventricular extrasystoles)
• Muscular weakness
• Muscle spasms
• Numbness, decreased sensation in hands and/or feet (hypoaesthesia)
• Pounding heartbeat (palpitations)
• Rise in the level of cortisol in your blood
• Shakiness (often in the hands) (tremor)
• Signs of psychosis: a loss of contact with reality, such as hearing voices or seeing things that are not there
• Throat irritation *Cases were mostly reported in children.

Side effects uncommonly (may affect up to 1 in 100 people) reported in clinical studies with Deltyba were:

• Lack of energy (lethargy) Other side effects that have been reported with Deltyba use: frequency cannot be estimated from the available data
• Paradoxical drug reactions (symptoms of tuberculosis may recur or new symptoms may appear after initial improvement during treatment)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

🌡️ 5. How to store Deltyba

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 or blister after ‘EXP:’. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture and light.

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.

📦 6. Contents of the pack and other information

What Deltyba 25 mg dispersible tablets contain

• One dispersible tablet contains 25 mg of the active substance delamanid.
• The other ingredients are hypromellose phthalate, povidone (K-25), all- rac-α-tocopherol, mannitol, crospovidone, sucralose, colloidal hydrated silica, cherry micron OT-22685, calcium stearate.

What Deltyba 25 mg dispersible tablets look like and contents of the pack Deltyba 25 mg dispersible tablets are round, and white to off -white.

Deltyba is supplied in packs of 48 dispersible tablets in aluminium/aluminium blisters.

49 Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Otsuka Novel Products GmbH Erika -Mann -Straße 21 80636 München Germany Tel: +49 (0)89 206020 500

Manufacturer

R-Pharm Germany GmbH Heinrich -Mack -Straße 35 89257 Illertissen Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BE Otsuka Novel Products GmbH Tél/Tel: +49 (0)89 206020 500 LT Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 BG Otsuka Novel Products GmbH Teл.: +49 (0)89 206020 500 LU Otsuka Novel Products GmbH Tél/Tel: +49 (0)89 206020 500 CZ Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 HU Otsuka Novel Products GmbH Tel.: +49 (0)89 206020 500 DK Otsuka Novel Products GmbH Tlf.: +49 (0)89 206020 500 MT Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 DE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 NL Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 EE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 NO Otsuka Novel Products GmbH Tlf: +49 (0)89 206020 500 EL Otsuka Novel Products GmbH Τηλ: +49 (0)89 206020 500 AT Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 ES Otsuka Pharmaceutical S.A.

Tel: +34 (0)93 208 10 20 PL Otsuka Novel Products GmbH Tel.: +49 (0)89 206020 500 FR Otsuka Pharmaceutical France SAS Tél: +33 (0)1 47 08 00 00 PT Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 HR Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 RO Swixx Biopharma S.R.L.

Tel: +40 (0)37 1530 850 50 IE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 SI Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 IS Otsuka Novel Products GmbH Sími: +49 (0)89 206020 500 SK Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 IT Otsuka Pharmaceutical Italy S.r.l.

Tel: +39 (0)2 00632710 FI Otsuka Novel Products GmbH Puh/Tel: +49 (0)89 206020 500 CY Otsuka Novel Products GmbH Τηλ: +49 (0)89 206020 500 SE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500 LV Otsuka Novel Products GmbH Tel: +49 (0)89 206020 500

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu/ . There are also links to other websites about rare diseases and treatments.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Deltyba (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/13/875).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.