Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - deltyba

Document Subject

Generated Narrative: MedicinalProductDefinition mp247338c6ac4af4d25ce31dba51e05ac4

identifier: http://ema.europa.eu/identifier/EU/1/13/875/004

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Deltyba 50 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-247338c6ac4af4d25ce31dba51e05ac4

identifier: http://ema.europa.eu/identifier/EU/1/13/875/004

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - deltyba

Attesters

What is in this leaflet

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

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.

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 concentration 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.

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), probucol (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.

Deltyba 50 mg film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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: Adults, adolescents and children with a body weight of 50 kg or more: two 50 mg film-coated tablets taken twice a day (morning and evening) for 24 weeks. Children with a body weight of 30 kg or more and less than 50 kg: one 50 mg film-coated tablet taken twice daily for 24 weeks.

For children with a body weight of less than 30 kg please 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 just after a meal. Swallow the tablets with water.

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.

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)
• 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.

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.

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.

What Deltyba 50 mg film-coated tablets contain

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

What Deltyba 50 mg film-coated tablets look like and contents of the pack Deltyba 50 mg film-coated tablets are round, and yellow.

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-Stra e 80636 M nchen Germany Tel: +49 (0)89 206020 Manufacturer: R-Pharm Germany GmbH Heinrich-Mack-Stra e 89257 Illertissen Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BE Otsuka Novel Products GmbH T l/Tel: +49 (0)89 206020 LT Otsuka Novel Products GmbH Tel: +49 (0)89 206020 BG Otsuka Novel Products GmbH Te .: +49 (0)89 206020 LU Otsuka Novel Products GmbH T l/Tel: +49 (0)89 206020 CZ Otsuka Novel Products GmbH Tel: +49 (0)89 206020 HU Otsuka Novel Products GmbH Tel.: +49 (0)89 206020 DK Otsuka Novel Products GmbH Tlf: +49 (0)89 206020 MT Otsuka Novel Products GmbH Tel: +49 (0)89 206020 DE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 NL Otsuka Novel Products GmbH Tel: +49 (0)89 206020 EE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 NO Otsuka Novel Products GmbH Tlf: +49 (0)89 206020 EL Otsuka Novel Products GmbH : +49 (0)89 206020 AT Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 ES Otsuka Pharmaceutical S.A. Tel: +34 93 208 10 PL Otsuka Novel Products GmbH Tel.: +49 (0)89 206020 FR Otsuka Pharmaceutical France SAS T l. : +33 (0)1 47 08 00 PT Otsuka Novel Products GmbH Tel: +49 (0)89 206020 HR Otsuka Novel Products GmbH Tel: +49 (0)89 206020 RO Ewopharma Rom nia SRL Tel.: +40 (0)21 260 13 44; +40 (0)21 260 14 IE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 SI Otsuka Novel Products GmbH Tel: +49 (0)89 206020 IS Otsuka Novel Products GmbH S mi: +49 (0)89 206020 SK Otsuka Novel Products GmbH Tel: +49 (0)89 206020 IT Otsuka Pharmaceutical Italy S.r.l. Tel: +39 (0)2 00632FI Otsuka Novel Products GmbH Puh/Tel: +49 (0)89 206020 CY Otsuka Novel Products GmbH : +49 (0)89 206020 SE Otsuka Novel Products GmbH Tel: +49 (0)89 206020 LV Otsuka Novel Products GmbH Tel: +49 (0)89 206020 UK (XI) Otsuka Novel Products GmbH Tel: +49 (0)89 206020 This leaflet was last revised in <{MM/YYYY}>.

This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency web site: