Deltyba: detailed information

Brand name Deltyba

Form tablets, film-coated

Active substance / Dosage

DELAMANID

Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription

ATC code

J04AK06

Registration number 043367

Manufacturer OTSUKA NOVEL PRODUCTS GMBH

Table of Contents

Package leaflet: Information for the patient
Deltyba 50 mg film-coated tablets
Package leaflet: Information for the patient
Deltyba 25 mg dispersible tablets
Deltyba 50 mg film-coated tablets.

Package leaflet: Information for the patient

Deltyba 50 mg film-coated tablets

delamanid
Please 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 questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Deltyba is and what it is used for
What you need to know before taking Deltyba
How to take Deltyba
Possible side effects
How to store Deltyba
Contents of the pack and other information

1. What Deltyba is and what it is used for

Deltyba contains the active substance delamanid, an antibiotic for the treatment of pulmonary tuberculosis caused by bacteria not eliminated by the antibiotics commonly used to treat tuberculosis.
It must always be taken together with other medicines for the treatment of tuberculosis.
Deltyba is used in adults, adolescents, children, and young children weighing at least 10 kg.

2. What you need to know before taking Deltyba

Do not take Deltyba

if you are allergic to delamanid or to 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 increase the activity of a specific 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 starting Deltyba and during treatment, your doctor may monitor the electrical activity of your
heart using an electrocardiogram (ECG) machine. Your doctor may also take a blood sample to check
the levels of certain electrolytes (salts) and proteins important for heart function.
Inform your doctor if you have any of the following conditions:

low levels of albumin, potassium, magnesium, or calcium in your blood.
if you have been diagnosed with heart problems, such as slow heart rate (bradycardia), or if you have previously had a heart attack (myocardial infarction).
if you have a condition called congenital long QT syndrome, severe heart disease, or problems with your heart rhythm.
if you have liver disease or severe kidney disease.

Inform your doctor immediately while taking this medicine:

if tuberculosis symptoms reappear or worsen (see section 4. Possible side effects).

Children and adolescents
Deltyba is not suitable for children weighing less than 10 kg, as sufficient data are not available to determine correct dosing in these patients.
Other medicines and Deltyba
Inform your doctor if

you are taking, have recently taken, or might take any other medicines.
you are taking medicines to treat heart rhythm disorders (e.g. amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
you are taking medicines to treat psychosis (e.g. phenothiazines, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or depression.
you are taking certain antibacterial medicines (e.g. erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, or pentamidine).
you are taking certain triazole antifungal medicines (e.g. fluconazole, itraconazole, voriconazole).
you are taking certain medicines to treat allergic reactions (e.g. terfenadine, astemizole, mizolastine).
you are taking certain medicines to treat malaria (e.g. halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
you are taking any of the following medicines: cisapride (used to treat stomach disorders), droperidol (used for nausea and migraine), domperidone (used for nausea and vomiting), difemanyl (used to treat stomach disorders or excessive sweating), probucol (lowers cholesterol levels in the blood), levometadil or methadone (used to treat opioid dependence), vinca alkaloids (cancer medicines), or arsenic trioxide (used to treat certain types of leukemia).
if you are taking antiretroviral medicines for human immunodeficiency virus (HIV) containing lopinavir/ritonavir or saquinavir. You may be at higher risk of dangerous changes in heart rhythm.

Pregnancy and breastfeeding
Deltyba may harm the unborn child. Its use is not normally recommended during pregnancy.
It is important to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy. Your doctor will assess the benefits to you against the risks to the unborn child from taking
Deltyba during pregnancy.
It is not known whether delamanid passes into human breast milk. Breastfeeding is not
recommended during treatment with Deltyba.
Driving and using machines
Deltyba is expected to have a moderate effect on the ability to drive and use machines. If you experience side effects that may impair your concentration or reaction time, do not drive or operate machinery.
Deltyba 50 mg film-coated tablets contain lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking
this medicine.

3. How to take Deltyba

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
As advised by your doctor, the recommended dose is:
Adults, adolescents and children with body weight equal to or greater than 50 kg: two 50 mg film-coated tablets taken twice daily (morning and evening) for 24 weeks.
Children with body weight equal to or greater than 30 kg but less than 50 kg: one 50 mg film-coated tablet twice daily for 24 weeks.
For children with body weight below 30 kg, see the Package Leaflet for Deltyba 25 mg dispersible tablets.
Your doctor may decide to prescribe the 50 mg film-coated tablets for longer than 24 weeks.
The film-coated tablets must be taken during or immediately after a meal. Swallow the tablets with water.

If you take more Deltyba than you should
If you have taken more tablets than prescribed, contact your doctor or the nearest hospital immediately. Remember to bring the medicine pack with you so that it is clear which 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 your next dose, 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 treatment too early may allow the bacteria to recover and become resistant to delamanid.

If you have any doubts about how to use 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.

Very common side effects (may occur in more than 1 in 10 people) observed in clinical studies with Deltyba were:

Reduced appetite
Disturbed sleep, including nightmares*
Dizziness
Feeling unwell (nausea)
Headache
Stomach irritation (gastritis)
Vomiting

*Cases were reported predominantly in children.

Common side effects (may occur in up to 1 in 10 people) observed in clinical studies with Deltyba were:

Chest pain
Reduced thyroid activity (hypothyroidism)
Heart rhythm disorder that may lead to fainting, dizziness and palpitations (QT prolongation on electrocardiogram)
Depression
Feeling anxious (anxiety)
Hallucination (seeing, hearing or sensing something that does not exist)*
Heart rhythm disorder (first-degree atrioventricular block)
Indigestion (dyspepsia)
Irregular heartbeats (ventricular extrasystoles)
Muscle weakness
Muscle spasms
Numbness, reduced sensation in hands and/or feet (hypoesthesia)
Awareness of heartbeat (palpitations)
Increased blood cortisol levels
Tremors (often in the hands)
Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that do not exist
Throat irritation

*Cases were reported predominantly in children.

Uncommon side effects (may occur in up to 1 in 100 people) observed in clinical studies with Deltyba were:

Lack of energy (lethargy)

Other side effects reported with the use of Deltyba: frequency cannot be estimated from the available data

Paradoxical drug reactions (tuberculosis symptoms may reappear or new symptoms may occur after initial improvement during treatment)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system referred to in Annex 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 sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister, following 'Scad.' or 'EXP'. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Deltyba 50 mg film-coated tablets contains

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

Description of the appearance of Deltyba 50 mg film-coated tablets and pack sizes
Deltyba 50 mg film-coated tablets are round and yellow in colour.
Deltyba is supplied in packs of 48 film-coated tablets in aluminium/aluminium blisters.

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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BE LT
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Tél/Tel: +49 (0)89 206020 500 Tel: +49 (0)89 206020 500

BG LU
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Teл.: +49 (0)89 206020 500 Tél/Tel: +49 (0)89 206020 500

CZ HU
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500 Tel.: +49 (0)89 206020 500

DK MT
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Tlf.: +49 (0)89 206020 500 Tel: +49 (0)89 206020 500

DE NL
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500 Tel: +49 (0)89 206020 500

EE NO
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500 Tlf: +49 (0)89 206020 500

EL AT
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Τηλ: +49 (0)89 206020 500 Tel: +49 (0)89 206020 500

ES PL
Otsuka Pharmaceutical S.A. Otsuka Novel Products GmbH
Tel: +34 (0)93 208 10 20 Tel.: +49 (0)89 206020 500

FR PT
Otsuka Pharmaceutical France SAS Otsuka Novel Products GmbH
Tél : +33 (0)1 47 08 00 00 Tel: +49 (0)89 206020 500

HR RO
Otsuka Novel Products GmbH Swixx Biopharma S.R.L.
Tel: +49 (0)89 206020 500 Tel: +40 (0)37 1530 850

IE SI
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500 Tel: +49 (0)89 206020 500

IS SK
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Sími: +49 (0)89 206020 500 Tel: +49 (0)89 206020 500

IT FI
Otsuka Pharmaceutical Italy S.r.l. Otsuka Novel Products GmbH
Tel: +39 (0)2 00632710 Puh/Tel: +49 (0)89 206020 500

CY SE
Otsuka Novel Products GmbH Otsuka Novel Products GmbH
Τηλ: +49 (0)89 206020 500 Tel: +49 (0)89 206020 500

LV
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500

More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/. In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

Package leaflet: Information for the patient

Deltyba 25 mg dispersible tablets

delamanid
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, because it may be dangerous.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What Deltyba is and what it is used for
What you need to know before taking Deltyba
How to take Deltyba
Possible side effects
How to store Deltyba
Package contents and other information

1. What Deltyba is and what it is used for

Deltyba contains the active substance delamanid, an antibiotic for the treatment of pulmonary tuberculosis
caused by bacteria not eradicated by the antibiotics commonly used to treat
tuberculosis.
It must always be taken together with other tuberculosis medicines.
Deltyba is used in adults, adolescents, children and young children weighing at least
10 kg.

2. What you need to know before taking Deltyba

Do not take Deltyba

if you are allergic to delamanid or to 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 increase the activity of a specific liver enzyme called 'CYP450 3A4' (for example, carbamazepine [a medicine used to treat epilepsy and prevent seizures]).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Deltyba.
Before starting Deltyba and during treatment, your doctor may check the electrical activity of your heart using an electrocardiogram (ECG) machine. Your doctor may also take a blood sample to check the levels of certain electrolytes (salts) and proteins important for heart function.
Inform your doctor if you have any of the following conditions:

low levels of albumin, potassium, magnesium, or calcium in your blood.
if you have been diagnosed with heart problems, such as slow heart rate (bradycardia), or have previously had a heart attack (myocardial infarction).
if you have a condition called congenital long QT syndrome, severe heart disease, or problems with heart rhythm.
if you have liver disease or severe kidney disease.

Inform your doctor immediately while taking this medicine:

if tuberculosis symptoms reappear or worsen (see section 4. Possible side effects).

Children and adolescents
Deltyba is not suitable for children weighing less than 10 kg, as there are insufficient data available in these patients to determine correct dosing.

Other medicines and Deltyba
Inform your doctor if

you are taking, have recently taken, or might take any other medicines.
you are taking medicines for heart rhythm disorders (for example, amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol).
you are taking medicines for psychosis (for example, phenothiazines, sertindole, sulpiride, chlorpromazine, haloperidol, mesoridazine, pimozide, or thioridazine) or for depression.
you are taking certain antibacterial medicines (for example, erythromycin, clarithromycin, moxifloxacin, sparfloxacin, bedaquiline, or pentamidine).
you are taking certain triazole antifungal medicines (for example, fluconazole, itraconazole, voriconazole).
you are taking certain medicines for allergic reactions (for example, terfenadine, astemizole, mizolastine).
you are taking certain medicines for malaria (for example, halofantrine, quinine, chloroquine, artesunate/amodiaquine, dihydroartemisinin/piperaquine).
you are taking any of the following medicines: cisapride (used to treat stomach disorders), droperidol (used for nausea and migraine), domperidone (used for nausea and vomiting), difenamidil (used for stomach disorders or excessive sweating), probucol (reduces cholesterol levels in the blood), levometadyl or methadone (used to treat opioid dependence), vinca alkaloids (cancer medicines), or arsenic trioxide (used to treat certain types of leukemia).
you are taking human immunodeficiency virus (HIV) medicines containing lopinavir/ritonavir or saquinavir. You may be at higher risk of dangerous changes in heart rhythm.

Pregnancy and breastfeeding
Deltyba may harm the unborn child. Its use is generally not recommended during pregnancy.
It is important to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Your doctor will assess the benefits to you against the risks to the baby of taking Deltyba during pregnancy.
It is not known whether delamanid passes into human breast milk. Breastfeeding is not recommended during treatment with Deltyba.

Driving and using machines
Deltyba is expected to have a moderate effect on the ability to drive and use machines. If you experience side effects that may impair your concentration or reaction ability, do not drive or operate machinery.

3. How to take Deltyba

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose, as advised by your doctor, is:
Children with body weight equal to or greater than 20 kg but 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 body weight equal to or greater than 10 kg but less than 20 kg: one 25 mg dispersible tablet in the morning and one 25 mg dispersible tablet in the evening for 24 weeks.
For children with body weight equal to or greater than 30 kg, see the Package Leaflet for

Deltyba 50 mg film-coated tablets.

The dispersible tablets should be taken during or just after a meal.
Place the 25 mg dispersible tablet(s) into a glass or cup.
Add 10 to 15 mL of water (approximately 1 tablespoon) per 25 mg dispersible tablet into the glass or cup.
Wait for the dispersible tablet(s) to dissolve completely (approximately 30 seconds), and gently swirl the glass or cup to obtain a uniform suspension. The resulting white suspension should be taken immediately. Then, add another 10 to 15 mL of water (approximately 1 tablespoon) per 25 mg dispersible tablet to the glass or cup, swirling it gently to ensure dispersion of any remaining suspension, and immediately consume this second portion as well.

If you take more Deltyba than you should
If you have taken more tablets than your prescribed dose, contact your doctor or the nearest hospital immediately. Remember to bring the medicine pack with you so that it is clear which 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 your next dose, 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 treatment too early may allow the bacteria to recover and become resistant to delamanid.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common side effects (may occur in more than 1 in 10 people) observed in clinical studies with Deltyba were:

Reduced appetite
Disturbed sleep, including nightmares*
Dizziness
Feeling unwell (nausea)
Headache
Stomach irritation (gastritis)
Vomiting

*Cases were reported predominantly in children.

Common side effects (may occur in up to 1 in 10 people) observed in clinical studies with Deltyba were:

Chest pain
Reduced thyroid activity (hypothyroidism)
Heart rhythm disorder that may lead to fainting, dizziness, and palpitations (QT prolongation on electrocardiogram)
Depression
Feeling anxious (anxiety)
Hallucination (seeing, hearing, or sensing something that does not exist)*
Heart rhythm disorder (first-degree atrioventricular block)
Indigestion (dyspepsia)
Irregular heartbeats (ventricular extrasystoles)
Muscle weakness
Muscle spasms
Numbness, reduced sensation in hands and/or feet (hypoesthesia)
Awareness of heartbeat (palpitations)
Increased blood cortisol levels
Tremors (often in the hands)
Signs of psychosis: loss of contact with reality, such as hearing voices or seeing things that do not exist
Throat irritation

*Cases were reported predominantly in children.

Uncommon side effects (may occur in up to 1 in 100 people) observed in clinical studies with Deltyba were:

Lack of energy (lethargy)

Other side effects reported with the use of Deltyba: frequency cannot be estimated from the available data

Paradoxical drug reactions (tuberculosis symptoms may reappear or new symptoms may arise after initial improvement during treatment)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex 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 stated on the carton or blister,
respectively after 'Scad.' or 'EXP'. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture and light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Deltyba 25 mg dispersible tablets contain

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

Description of the appearance of Deltyba 25 mg dispersible tablets and pack sizes
Deltyba 25 mg dispersible tablets are round and white to off-white in colour.
Deltyba is supplied in packs of 48 dispersible tablets in aluminium/aluminium blisters.

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