Patient Information Leaflet: Summary of Product Characteristics

Deltyba 50 mg Film-Coated Tablets

delamanid

This medicine is subject to additional monitoring. This will help speed up the detection of any new safety information. You can contribute by reporting any side effects you may get. The final part of section 4 includes information on how to report these side effects.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

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

Inform your doctor, pharmacist or nurse before taking Deltyba.

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

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

• have low levels of albumin, potassium, magnesium or calcium in your blood.
• have been told you have heart problems, for example, a slow heart rate (bradycardia) or have a history of heart attack (myocardial infarction).
• have a condition called long QT syndrome or a serious heart disease or heart rhythm problems.

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

Children and adolescents

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

Other medicines and Deltyba

Inform your doctor …

• if you are using, have used recently or may have to use any other medicine, including over-the-counter or herbal medicines.
• if you are taking medicines for the treatment of an abnormal heart rhythm (e.g., amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
• if you are taking medicines for the treatment of psychosis (e.g., phenothiazines, sertindole, sulpiride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression.
• if you are taking certain antibiotics (e.g., erythromycin, clarithromycin, moxifloxacin, gatifloxacin, bedaquiline or pentamidine).
• if you are taking antifungals (medicines for treating fungal infections) 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 a state of vomiting and migraine), domperidone (used against a state of nausea and vomiting), bepridil (used for treating certain heart diseases), difemanil (used for treating stomach disorders or excessive sweating), probucol (reduces the level of cholesterol in the bloodstream), levometadrol or methadone (used for treating opioid addiction), vinca alkaloids (anticancer medicines), or arsenic trioxide (used for treating certain types of leukemia).
• if you are taking HIV medicines that contain lopinavir/ritonavir or saquinavir.

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

Pregnancy and breastfeeding

Deltyba may be harmful to the fetus. Normally, it is not recommended to use it during pregnancy.

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

It is not known whether delamanid passes into human breast milk. During treatment with Deltyba, breastfeeding is not recommended.

Driving and operating machinery

Deltyba is not expected to have any influence on your ability to drive and use machines. If you experience side effects that may 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 him before taking this medicine.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects that were reported frequently (may affect more than 1 in 10 people)in clinical studies withDeltybawere:

• Irregular or strong heartbeats
• Vomiting
• Nausea
• Diarrhea
• Stomach pain
• Headache
• Sensation of tingling, burning, or itching, or numbness of the skin (paresthesia)
• Tremor
• Loss of appetite
• Dizziness
• Perception of a persistent sound in the ear when it does not exist (tinnitus)
• Sensation of absolute lack of energy
• Pain in the joints or muscles
• Difficulty falling or staying asleep
• Increase in immature red blood cells in the blood
• Low potassium levels in the blood
• Increased levels 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 withDeltybawere:

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

• Increased triglyceride levels in the blood
• Psychotic disorder
• Agitation
• Anxiety
• Depression
• Restlessness
• Nerve damage causing numbness or pain, or sensation of tingling in the hands or feet
• Numbness
• Reduced sensation
• Dry eyes
• Decreased tolerance of the eyes to bright light
• Ear pain
• Increased blood pressure (hypertension)
• Decreased blood pressure (hypotension)
• Cardinal
• Hot flashes
• Shortness of breath
• Coughing
• Pain in the mouth or throat
• Irritation of the throat
• Dry throat
• Nasal secretion (rhinorrhea)
• Chest pain
• Gastritis
• Constipation
• Indigestion
• Dermatitis
• Urticaria
• Hives
• Papules (small skin elevations)
• Erupción
• Acne
• Increased sweating
• A bone disease called osteocondrosis
• Muscle weakness
• Bone pain
• Pain in the side
• Pain in the arms or legs
• Blood in the urine
• Fever
• Chest pain
• General discomfort
• Discomfort in the chest
• Swelling of the feet, legs, or ankles
• Abnormal values of the cortisol hormone in blood tests

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

• Herpes zoster
• Oral aphthae
• Skin fungal infection (pityriasis versicolor)
• Low white blood cell count in the blood (leucopenia)
• Low platelet count in the blood (thrombocytopenia)
• Dehydration

• Low calcium levels in the blood
• High cholesterol levels in the blood
• Aggression
• Paranoia
• Panic attacks
• Adjustment disorder with depressed mood
• Neurosis
• Sensation of emotional and mental unease
• Mental aberration
• Sleep problems
• Increased libido
• Letargy
• Balance disorder
• Regional pain
• Allergic conjunctivitis
• Cardiac rhythm problems
• Swallowing problems
• Abnormal sensation in the mouth
• Abdominal discomfort
• Hair loss
• Itching or redness of the skin, even around the hair roots
• Urinary retention
• Painful urination
• Increased need to urinate at night
• Sensation of heat
• Abnormal values in blood tests related to coagulation (prolonged APTT)
• Abnormal blood values related to liver, biliary, or pancreatic function
• Decreased cortisol hormone levels in blood tests
• Increased blood pressure

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister pack after the abbreviation «CAD». The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or trash. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment..

Composition of Deltyba

• Each film-coated tablet contains 50 mg of the active ingredient delamanid.
• The other components are hypromellose phthalate, povidone, racemic α-tocopherol, microcrystalline cellulose, sodium carboxymethylcellulose, calcium carbonate, hydrated colloidal silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, and iron oxide (E172).

Appearance of the product 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 aluminium/aluminium blisters.

Marketing Authorisation Holder and Responsible Person for Manufacturing

Otsuka Novel Products GmbH

Erika-Mann-Straße 21

80636 Munich

Germany

Phone: +49 (0)89 206020 500

Responsible Person for Manufacturing

AndersonBrecon (UK) Ltd.

Wye Valley Business Park

Brecon Road

Hay-on-Wye

Hereford, HR3 5PG

UK

R-Pharm Germany GmbH

Heinrich-Mack-Straße 35

89257 Illertissen

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics: <{MM/AAAA}>.

This medicinal product has been granted a conditional approval. This type of approval means that more information is expected to be obtained about this medicinal product.

The European Medicines Agency will review the new information about this medicinal product at least once a year and this summary of product characteristics will be updated as necessary.

Further information about this medicinal product can be found on the website of the European Medicines Agency:http://www.ema.europa.eu.There are also links to other websites about rare diseases and orphan medicinal products.