Deltyba
delamanid
delamanid
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
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.
What Deltyba is and what it is used for
What you need to know before you take Deltyba
3. How to take Deltyba
Possible side effects
How to store Deltyba
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.
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 ofa certain liver enzyme called
“CYP450 3A4” (e.g. carbamazepine [a medicine used to treat epilepsy and prevent seizures]).
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.
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.
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.
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.
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.
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.
The film-coated tablets must be taken during or just after a meal. Swallow the tablets with water.
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 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 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.
Sensations of irregular and/or forceful beating of the heart
Vomiting
Nausea
Diarrhoea
Stomach pain
Headache
A tingling, burning or pricking sensation or numbness of the skin (paresthesia)
Shaking (tremor)
Decreased appetite
Dizziness
Hearing a persistent sound in your ear when no sound exists (tinnitus)
Intense lack of energy
Joint or muscle pain
Difficulties with falling or staying asleep
Increase in immature red blood cells
Low blood potassium level
Increased blood uric acid level
Coughing up blood
Changes found in investigations (electrocardiogram, ECG) of the heart
Anaemia
Increase of certain white blood cells (eosinophilia)
Increased blood tryglycerides
Psychotic disorder
Agitation
Anxiety
Depression
Restlessness
Hallucination (seeing, hearing or feeling things that are not there)*
Nerve damage causing numbness or pain (burning) or tingling feeling in hands or feet
Drowsiness
Reduced sensation
Dry eye
Decreased tolerability of the eyes for bright light
Ear pain
Increase of blood pressure (hypertension)
Decrease of blood pressure (hypotension)
Bruising
Hot flushes
Shortness of breath
Cough
Pain in the mouth or throat
Throat irritation
Dry throat
Runny nose
Chest pain
Gastritis
Constipation
Indigestion
Dermatitis
Hives
Itching
Papules (small skin elevations)
Rash
Acne
Increased sweating
A bone disease called osteochondrosis
Muscular weakness
Pain in bones
Flank pain
Pain in arms or legs
Blood in urine
Fever
Chest pain
Feeling unwell
Chest discomfort
Foot, leg or ankle swelling
Increased values for blood investigations for the hormone cortisol
*Cases were mostly reported in children.
Shingles
Oral thrush
Yeast infection of the skin (tinea versicolor)
Low white blood cell count (leukopenia)
Low blood platelets count (thrombocytopaenia)
Dehydration
Low blood calcium level
High blood cholesterol level
Aggression
Paranoia
Panic attacks
Adjustment disorder with depressed mood
Neurosis
Feeling of emotional and mental discomfort
Mental aberration
Problems with sleeping
Increase of libido
Lethargy
Balance disorder
Regional pain
Allergic conjunctivitis
Heart rhythm problems
Swallowing problems
Abnormal feeling in the mouth
Tenderness in the abdomen
Hair loss
Itchy or red skin including around the hair roots.
Urine retention
Painful urination
Increased need to urinate at night
Feeling hot
Abnormal values for blood investigations related to coagulation (prolonged APPT)
Abnormal blood values related to the function of the liver, biliary system or pancreas
Decreased values for blood investigations for the hormone cortisol
Increased blood pressure
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.
One 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, carmellose calcium, colloidal hydrated
silica, magnesium stearate, lactose monohydrate, hypromellose, macrogol 8000, titanium dioxide, talc, iron oxide (E172).
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: Otsuka Novel Products GmbH Erika-Mann-Straße 21
80636 München
Germany
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:
Otsuka Novel Products GmbH
Tél/Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Teл.: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Tél/Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
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Tel.: +49 (0)89 206020 500
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Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
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Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
Otsuka Novel Products GmbH
Tel: +49 (0)89 206020 500
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.
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