Posaconazole Biocon

PACKAGE LEAFLET

Package leaflet: information for the patient

Posaconazole Biocon 100 mg gastro-resistant tablets

posaconazole
Generic medicine
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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Posaconazolo Biocon is and what it is used for

Posaconazolo Biocon contains the active substance posaconazole. It belongs to a group of medicines called "antifungals". It is used to prevent and treat many different types of fungal infections.
This medicine works by killing or stopping the growth of certain types of fungi that can cause infections.
Posaconazolo Biocon may be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or if you had to stop taking them:

• infections caused by fungi of the Aspergillus family that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole, or when treatment with these medicines had to be discontinued;
• infections caused by fungi of the Fusarium family that have not improved during treatment with amphotericin B, or when treatment with amphotericin B had to be discontinued;
• infections caused by fungi leading to conditions known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole, or when treatment with itraconazole had to be discontinued;
• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more of the following medicines: amphotericin B, itraconazole or fluconazole, or when treatment with these medicines had to be discontinued.

This medicine may also be used to prevent fungal infections in adults who are at high risk of developing a fungal infection, such as:

• patients with a weakened immune system due to chemotherapy for "acute myeloid leukaemia" (AML) or "myelodysplastic syndromes" (MDS);
• patients receiving "high-dose immunosuppressive therapy" following "haematopoietic stem cell transplantation" (HSCT).

2. What you need to know before taking Posaconazole Biocon

Do not take Posaconazole Biocon

• If you are allergic to posaconazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking terfenadine, astemizole, cisapride, pimozide, halofantrine, quinidine, any medicine containing "ergot alkaloids" such as ergotamine or dihydroergotamine, or a "statin" such as simvastatin, atorvastatin, or lovastatin.

Do not take Posaconazole Biocon if you are in any of the above conditions. If you are unsure, consult your doctor or pharmacist before taking Posaconazole Biocon.
See below "Other medicines and Posaconazole Biocon" for more information, including details on other medicines that may interact with Posaconazole Biocon.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Posaconazole Biocon if you:

• have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole, itraconazole, or voriconazole
• have or have ever had liver problems. You may need blood tests while taking this medicine
• develop severe diarrhoea or vomiting, as these conditions may reduce the effectiveness of this medicine
• have an abnormal heart rhythm trace (ECG) showing a condition called prolonged QTc interval
• have weakened heart muscle or heart failure
• have a very slow heart rate
• have heart rhythm disorders
• have any problem with levels of potassium, magnesium, or calcium in your blood
• are taking vincristine, vinblastine, or other "vinca alkaloids" (medicines used to treat cancer).

If you have any of the conditions listed above (or if you are unsure), consult your doctor, pharmacist, or nurse before taking Posaconazole Biocon.
If you develop severe diarrhoea or vomiting (feeling unwell) while taking Posaconazole Biocon, contact your doctor, pharmacist, or nurse immediately, as this may prevent the medicine from working properly. See section 4 for more information.

Children
Posaconazole Biocon must not be used in children (age 17 years or younger).

Other medicines and Posaconazole Biocon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Posaconazole Biocon if you are taking any of the following medicines:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat symptoms of Tourette's syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm abnormalities). Posaconazole Biocon can increase the levels of these medicines in your blood, which may lead to very serious changes in heart rhythm.
• any medicine containing "ergot alkaloids" such as ergotamine or dihydroergotamine, used to treat migraine. Posaconazole Biocon can increase the levels of these medicines in your blood, which may lead to a severe reduction in blood flow to the fingers or toes and could damage them.
• a "statin" such as simvastatin, atorvastatin, or lovastatin, used to treat high cholesterol levels.

Do not take Posaconazole Biocon if any of the above conditions apply to you. If you have any doubts, consult your doctor or pharmacist before taking this medicine.

Other medicines
Check the list above of medicines that must not be taken while you are taking Posaconazole Biocon. In addition to the medicines listed above, there are other medicines that may increase the risk of heart rhythm problems when taken with Posaconazole Biocon.
Make sure you inform your doctor about all medicines you are taking (with or without a prescription).
Certain medicines may increase the risk of side effects of Posaconazole Biocon by increasing its levels in the blood.
The following medicines may reduce the effectiveness of Posaconazole Biocon by decreasing its levels in the blood:

• rifabutin and rifampicin (used to treat certain infections). If you are already being treated with rifabutin, you will need a blood test and should be cautious about possible side effects of rifabutin.
• certain medicines used to treat or prevent seizures, including phenytoin, carbamazepine, phenobarbital, or primidone.
• efavirenz and fosamprenavir, used to treat HIV infection.

Posaconazole Biocon may likely increase the risk of side effects of certain other medicines by increasing their levels in the blood. These medicines include:

• vincristine, vinblastine, and other "vinca alkaloids" (used to treat tumours)
• cyclosporine (used during or after transplant surgery)
• tacrolimus and sirolimus (used during or after transplantation)
• rifabutin (used to treat certain infections)
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, administered with ritonavir)
• midazolam, triazolam, alprazolam, or other "benzodiazepines" (used as sedatives or muscle relaxants)
• diltiazem, verapamil, nifedipine, nisoldipine, or other "calcium channel blockers" (used to treat high blood pressure)
• digoxin (used to treat heart failure)
• glipizide or other "sulfonylureas" (used to treat high blood sugar levels)
• all-trans retinoic acid (ATRA), also known as tretinoin (used to treat certain blood cancers).

If any of the above conditions apply to you (or if you have any doubts), consult your doctor or pharmacist before taking Posaconazole Biocon.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor before taking Posaconazole Biocon. Do not take Posaconazole Biocon if you are pregnant unless your doctor has specifically instructed you to do so.
Women of childbearing potential must use an effective method of contraception during treatment.
Contact your doctor immediately if you become pregnant while taking Posaconazole Biocon.
Do not breastfeed while taking Posaconazole Biocon. This is because small amounts may pass into breast milk.

Driving and using machines
During treatment with Posaconazole Biocon, you may experience dizziness, drowsiness, or blurred vision, which may affect your ability to drive or operate tools or machinery. If this occurs, do not drive or use tools or machinery and contact your doctor.

Posaconazole Biocon contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".

3. How to take Posaconazole Biocon tablets

Do not switch from taking Posaconazole Biocon tablets to taking posaconazole oral suspension without consulting your doctor or pharmacist, as this may result in reduced effectiveness or an increased risk of adverse reactions.
Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Dosage
The usual dose is 300 mg posaconazole (three 100 mg tablets) twice on the first day, followed by 300 mg (three 100 mg tablets) once daily thereafter.
The duration of treatment may depend on the type of infection you have and may be individually adjusted by your doctor. Do not adjust the dose on your own or modify the treatment regimen without first consulting your doctor.

How to take this medicine

• Swallow the tablet whole with water.
• Do not crush, chew, break, or dissolve the tablet.
• The tablets may be taken with or without food.

If you take more Posaconazole Biocon than you should
If you think you have taken more Posaconazole Biocon than you should, inform a doctor immediately or go to the hospital without delay.

If you forget to take Posaconazole Biocon

• 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 and return to your regular dosing schedule.
• Do not take a double dose to make up for the missed dose.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects
Tell your doctor, pharmacist, or nurse if you notice any of the following serious side effects, as you may need urgent medical treatment:

• nausea or vomiting (feeling unwell), diarrhoea
• signs of liver problems – these include yellowing of the skin or the whites of the eyes, unusually dark urine or pale stools, unexplained feeling of being unwell, stomach problems, loss of appetite, or unusual tiredness or weakness, increased liver enzymes detected in blood tests
• allergic reaction

Other side effects
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

• changes in blood salt levels detected in blood tests – signs include feeling confused or weak
• abnormal skin sensations such as numbness, tingling, itching, goosebumps, prickling, or burning
• headache
• low levels of potassium in the blood – detected in blood tests
• low levels of magnesium – detected in blood tests
• high blood pressure
• loss of appetite, stomach ache, or stomach discomfort, passing wind, dry mouth, taste disturbances
• heartburn (a burning sensation in the chest rising up to the throat)
• low levels of "neutrophils", a type of white blood cells (neutropenia) – this may increase the risk of infections and can be detected in blood tests
• fever
• feeling weak, dizzy, tired, or sleepy
• rash
• itching
• constipation
• rectal discomfort

Uncommon (may affect up to 1 in 100 people)

• Anaemia – signs include headache, feeling tired or dizzy, shortness of breath, pale appearance, and low haemoglobin levels detected in blood tests
• low platelet count (thrombocytopenia) detected in blood tests – this may lead to bleeding
• low levels of "leucocytes", a type of white blood cells (leucopenia) detected in blood tests – this may increase the risk of infections
• high levels of "eosinophils", a type of white blood cells (eosinophilia) – this may occur if you have inflammation
• inflammation of blood vessels
• changes in heart rhythm
• seizures (fits)
• nerve damage (neuropathy)
• abnormal heart rhythm – detected on electrocardiogram (ECG), palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas (pancreatitis) – this may cause severe stomach pain
• interruption of blood supply and oxygen to the spleen (splenic infarction) – this may cause severe stomach pain
• severe kidney problems – signs include increased or decreased urine production with urine of unusual colour
• high levels of creatinine in the blood – detected in blood tests
• cough, hiccups
• nosebleed
• severe sharp chest pain during breathing (pleuritic pain)
• swollen lymph glands (lymphadenopathy)
• reduced sensation, especially in the skin
• tremor
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of being unwell
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual disorders (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• being completely or partially unable to speak
• swelling of the mouth
• abnormal dreams or difficulty sleeping
• problems with coordination or balance
• inflammation of mucous membranes
• stuffy nose
• difficulty breathing
• chest discomfort
• feeling bloated
• mild to severe nausea, vomiting, cramps, and diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling nervous

Rare: may affect up to 1 in 1,000 people

• pneumonia – signs include feeling short of breath and coughing up discoloured sputum
• high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause serious damage to the lungs and heart
• blood problems such as unusual blood clotting or prolonged bleeding
• severe allergic reactions, including widespread blistering skin rash and skin peeling
• mental problems such as hearing voices or seeing things that are not there
• fainting
• problems thinking or speaking, jerky movements, especially in the hands that you cannot control
• stroke – signs include pain, weakness, numbness, or tingling in limbs
• having a blind or dark spot in your field of vision
• heart failure or heart attack, which could lead to cardiac arrest and death, changes in heart rhythm with sudden death
• blood clots in the legs (deep vein thrombosis) – signs include pain
• severe swelling of the legs
• blood clots in the lungs (pulmonary embolism) – signs include feeling short of breath or pain when breathing
• bleeding in the stomach or intestines – signs include vomiting blood or blood in the stools
• blockage in the intestine (intestinal obstruction), especially in the "ileum". The blockage will prevent intestinal contents from passing into the lower part of the intestine – signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
• "haemolytic uraemic syndrome" when red blood cells break down (haemolysis), a condition that may occur with or without kidney failure
• "pancytopenia", a low level of all blood cells (red and white blood cells and platelets) detected in blood tests
• widespread purplish discolouration of the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• adrenal gland dysfunction – this may cause weakness, tiredness, loss of appetite, skin discolouration
• pituitary gland dysfunction – this may cause low blood levels of certain hormones affecting the function of male or female sex organs
• hearing disturbances

Not known: frequency cannot be estimated from the available data

• pseudoaldosteronism, causing hypertension with low potassium levels (detected in blood tests)
• some patients have also reported feeling confused after taking

Tell your doctor, pharmacist, or nurse if you notice any of the side effects listed above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Posaconazole Biocon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack/bottle and outer carton
after "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Posaconazolo Biocon contains
The active substance is posaconazole. Each gastro-resistant tablet contains 100 mg of
Posaconazole.
The other ingredients are:
Tablet core:
Hypromellose acetate succinate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460),
sodium croscarmellose, colloidal silicon dioxide, magnesium stearate.
Film coating:
Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172),
ferrosoferric oxide (E172).

Description of the appearance of Posaconazolo Biocon and package contents
The posaconazole gastro-resistant tablets are film-coated, pale yellow to yellow, oval, biconvex, approximately 17.5 mm in length and 6.7 mm in width, with 'B100' engraved on one side and smooth on the other side, packed in blisters in cartons of 24 (2x12) or 96 (8x12) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biocon Pharma Malta I Limited
The Victoria Centre, Unit 2, Lower Ground Floor,
Valletta Road, Mosta MST 9012, Malta

Manufacturer
Misom Labs Ltd.
Malta Life Sciences Park, LS2.01.06,
Industrial Estate, San Gwann, SGN 3000.

This medicinal product is authorised in the European Economic Area Member States under the
following names:

This leaflet was last approved on {MM/YYYY}