DELTYBA 50 mg FILM-COATED TABLETS

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 your blood
• if you are taking medicines that strongly induce a certain liver enzyme called "CYP450 3A4" (e.g., carbamazepine).

Warnings and precautions

Tell your doctor, pharmacist, or nurse before taking Deltyba.

Before starting treatment with Deltyba, and during treatment, your doctor may check your heart's electrical activity with an ECG (electrocardiogram) to get a record of your heart's electrical activity. Your doctor may also perform a blood test to check the levels of certain minerals and proteins that are important for heart function.

Tell your doctor if you have any of the following conditions:

• you have reduced levels of albumin, potassium, magnesium, or calcium in your blood.
• you have been told you have heart problems, such as a slow heart rate (bradycardia) or have had a heart attack (myocardial infarction).
• you have a condition called congenital long QT syndrome or severe heart disease or heart rhythm problems.

• you have liver or kidney disease.
• you have HIV.

Children and adolescents

Deltyba is not suitable for children with a body weight of less than 30 kg.

Other medicines and Deltyba

Tell your doctor …

• if you are using, have recently used, or might use any other medicines, including those without a prescription or herbal medicines.
• if you are taking medicines for treating an abnormal heart rhythm (e.g., amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
• if you are taking medicines for treating psychosis (e.g., phenothiazines, sertindole, sultoprida, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression.
• if you are taking certain antibiotics (e.g., erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, or pentamidine).
• if you are taking antifungal medicines based on triazole (e.g., fluconazole, itraconazole, voriconazole).
• if you are taking certain medicines for treating allergic reactions (e.g., terfenadine, astemizole, mizolastine).
• if you are taking certain medicines for treating malaria (e.g., halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
• if you are taking any of the following medicines: cisapride (used for treating stomach disorders), droperidol (used for treating nausea and migraine), domperidone (used for treating nausea and vomiting), bepridil (used for treating certain heart diseases), difemanil (used for treating stomach disorders or excessive sweating), probucol (reduces cholesterol levels in the blood), levomethadyl or methadone (used for treating opioid addiction), vinca alkaloids (anticancer), or arsenic trioxide (used for treating certain types of leukemia).
• if you are taking anti-HIV medicines containing lopinavir/ritonavir or saquinavir.

You may be at greater risk of having dangerous changes in your heart rhythm.

Pregnancy and breastfeeding

Deltyba may be harmful to the development of the fetus. It is not normally recommended during pregnancy.

It is important to tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will weigh the benefits for you against the risks for your baby if you take Deltyba while pregnant.

It is not known if delamanid passes into breast milk in humans. During treatment with Deltyba, breastfeeding is not recommended.

Driving and using machines

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

Deltyba contains lactose monohydrate.

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

3. How to take Deltyba

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist.

The recommended dose as advised by your doctor is:

Adults, adolescents, and children with a body weight of 50 kg or more: two 50 mg tablets twice a day (in the morning and at night).

Children with a body weight of 30 kg or more and less than 50 kg: one 50 mg tablet taken twice a day for 24 weeks.

Tablets should be taken during or after finishing a meal. Swallow the tablets with water.

If you take more Deltyba than you should

In case you take more tablets than prescribed, contact your doctor or the local hospital. Remember to take the package with you so it is clear what medicine you have taken.

If you forget to take Deltyba

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, do not take the missed dose.

Do not take a double dose to make up for missed doses.

If you stop taking Deltyba

DO NOTstop taking the tablets unless your doctor tells you to. Stopping treatment too early could lead to the bacteria recovering and becoming resistant to delamanid.

If you have any other 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 that were reported very frequently (may affect more than 1 in 10 people)in clinical studies with Deltyba were:

• Feeling of irregular and/or strong heartbeat
• Vomiting
• Nausea
• Diarrhea
• Stomach pain
• Headache
• Feeling of tingling, burning, or numbness of the skin (paresthesia)
• Tremor
• Decreased appetite
• Dizziness
• Hearing a persistent sound in the ear that does not exist (tinnitus)
• Feeling of complete lack of energy
• Pain in the joints or muscles
• Difficulty falling or staying asleep
• Increased level of immature red blood cells in the blood
• Low level of potassium in the blood
• Increased level of uric acid in the blood
• Coughing up blood
• Changes found in heart studies (electrocardiogram, ECG)

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

• Anemia
• Increased level of certain white blood cells in the blood (eosinophilia)

• Increased level of triglycerides in the blood
• Psychotic disorder
• Agitation
• Anxiety
• Depression
• Restlessness
• Nerve damage causing numbness or pain (burning) or tingling sensation in hands or feet
• Numbness
• Reduced sensation
• Dry eye
• Decreased tolerance of the eyes to bright light
• Ear pain
• Increased blood pressure (hypertension)
• Decreased blood pressure (hypotension)
• Bruising
• Hot flashes
• Shortness of breath
• Cough
• Pain in the mouth or throat
• Sore throat
• Dry throat
• Nasal discharge (rhinorrhea)
• Chest pain
• Gastritis
• Constipation
• Indigestion
• Dermatitis
• Hives
• Welts
• Papules (small elevations of the skin)
• Rash
• Acne
• Increased sweating
• A bone disease called osteochondrosis
• Muscle weakness
• Bone pain
• Pain in the side
• Pain in the arms or legs
• Blood in urine
• Fever
• Chest pain
• General malaise
• Chest discomfort
• Swelling of the feet, legs, or ankles
• Elevated levels of the hormone cortisol in blood tests

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

• Herpes zoster
• Mouth ulcers
• Fungal skin infection (pityriasis versicolor)
• Low white blood cell count in the blood (leucopenia)
• Low platelet count in the blood (thrombocytopenia)
• Dehydration

• Low level of calcium in the blood
• High level of cholesterol in the blood
• Aggression
• Paranoia
• Panic attacks
• Adjustment disorder with depressed mood
• Neurosis
• Feeling of emotional and mental unease
• Mental aberration
• Sleep disorders
• Increased libido
• Lethargy
• Balance disorder
• Regional pain
• Allergic conjunctivitis
• Heart rhythm problems
• Difficulty swallowing
• Abnormal sensation in the mouth
• Abdominal discomfort
• Hair loss
• Itching or redness of the skin even around the hair roots
• Urinary retention
• Pain while urinating
• Increased need to urinate at night
• Feeling of heat
• Abnormal blood test results related to blood clotting (prolonged APPT)
• Abnormal blood test results related to liver, bile, or pancreas function
• Decreased levels of the hormone cortisol in blood tests
• Increased blood pressure

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects 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 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 the abbreviation "EXP:". The expiry date refers to the last day of the month stated.

Store in the original package to protect from moisture.

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

6. Contents of the pack and other information

Composition of Deltyba

• One film-coated tablet contains 50 mg of the active substance delamanid.
• The other ingredients are hypromellose, povidone, α-tocopherol (racemic mixture), microcrystalline cellulose, sodium carboxymethyl starch, calcium carmellose, colloidal hydrated silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide (E172).

Appearance of Deltyba and contents of the pack

Deltyba 50 mg film-coated tablets are yellow, round.

Deltyba is available in packs of 48 film-coated tablets in aluminum/aluminum blisters.

Marketing authorization holder and manufacturer

Otsuka Novel Products GmbH

Erika-Mann-Straße 21

80636 Munich

Germany

Tel: +49 (0)89 206020 500

Manufacturer

AndersonBrecon (UK) Ltd.

Wye Valley Business Park

Brecon Road

Hay-on-Wye

Hereford, HR3 5PG

United Kingdom

R-Pharm Germany GmbH

Heinrich-Mack-Straße 35

89257 Illertissen

Germany

You can request more information about this medicine from the local representative of the marketing authorization holder:

Date of last revision of this leaflet: <{MM/AAAA}>.

This medicine has been authorized with a "conditional approval". This type of approval means that more information on this medicine is expected.

The European Medicines Agency will review the new information on this medicine at least once a year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.