POSACONAZOLO 100 mg Enteric-Coated Tablet

Содержание инструкции

1. Posaconazole Biocon 100 mg gastro-resistant tablets
   1. What is Posaconazole Biocon and what it is used for
   2. What you need to know before you take Posaconazole Biocon
   3. How to take Posaconazolo Biocon
   4. Possible side effects
   5. How to store Posaconazolo Biocon
   6. Package Contents and Other Information

Posaconazole Biocon 100 mg gastro-resistant tablets

posaconazole

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Posaconazole Biocon is and what it’s used for
• 2. What you need to know before you take 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 is Posaconazole Biocon and what it is used for

Posaconazole Biocon contains the active ingredient posaconazole. It belongs to a category 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.
Posaconazole Biocon can be used in adults to treat the following types of fungal infections
when other antifungal medicines have not worked or if you have had to stop taking them:

• infections caused by fungi of the Aspergillusfamily that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole or when you have had to stop treatment with these medicines;
• infections caused by fungi of the Fusariumfamily that have not improved during treatment with amphotericin B or when you have had to stop treatment with amphotericin B;
• infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when you have had to stop treatment with itraconazole;
• infections caused by a fungus called Coccidioidesthat have not improved during treatment with one or more of the following medicines: amphotericin B, itraconazole or fluconazole, or when you have had to stop treatment with these medicines.

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

• patients who have a weakened immune system due to chemotherapy for “acute myeloid leukemia” (AML) or “myelodysplastic syndromes” (MDS);
• patients who are using a “high-dose immunosuppressive therapy” following
• “hematopoietic stem cell transplantation” (HSCT).

2. What you need to know before you take Posaconazole Biocon

Do not take Posaconazole Biocon

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

Do not take Posaconazole Biocon if you have any of the above conditions. If you are not sure, ask your doctor or pharmacist before taking Posaconazole Biocon.
See below “Other medicines and Posaconazole Biocon” for more information, including information about 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 to have blood tests while taking this medicine
• develop severe diarrhoea or vomiting, because these conditions can limit the effectiveness of this medicine
• have an abnormal heart rhythm tracing (ECG) showing a problem called prolonged QTc interval
• have weak heart muscle or heart failure
• have a very slow heart beat
• have heart rhythm disorders
• have any problems with your potassium, magnesium or calcium levels in your blood
• are taking vincristine, vinblastine or other “vinca alkaloids” (medicines used to treat cancer).

If you have any of the conditions above (or if you are not sure) talk to 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 it from working properly. See section 4 for more information.

Children
Posaconazole Biocon should not be used in children (aged 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 medicines that follow:

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat the symptoms of Tourette’s syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat abnormal heart rhythms). Posaconazole Biocon can increase the amount of these medicines in your blood which can lead to very serious changes in your heart rhythm:
• any medicine that contains “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraine. Posaconazole Biocon can increase the amount of these medicines in your blood which can lead to a serious 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 levels of cholesterol.

Do not take Posaconazole Biocon if any of the above conditions apply to you. If you have any doubts, ask your doctor or pharmacist before taking this medicine.
Other medicines
Check the list of medicines above that must not be taken while you are taking Posaconazole Biocon. In addition to the medicines above there are other medicines that carry a risk of heart rhythm problems that may be greater if they are taken with Posaconazole Biocon.
Make sure you tell your doctor about all the medicines you are taking (with or without a prescription).
Certain medicines can increase the risk of side effects of Posaconazole Biocon by increasing the amount in your blood.
The following medicines can decrease the effectiveness of Posaconazole Biocon by decreasing the amount in your blood:

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

Posaconazole Biocon can likely increase the risk of side effects of some other medicines by increasing the amount of these medicines in your blood. These medicines include:

• vincristine, vinblastine and other “vinca alkaloids” (used to treat cancers)
• cyclosporine (used during or after transplant surgery)
• tacrolimus and sirolimus (used during or after a transplant)
• rifabutin (used to treat some infections)
• medicines used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are given 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 “sulphonylureas” (used to treat high blood sugar levels).
• all-trans retinoic acid (ATRA), also called tretinoin (used to treat some blood cancers).

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

Pregnancy and breastfeeding
If you are pregnant, or suspect you might be pregnant, or are planning to become pregnant, talk to your doctor before taking Posaconazole Biocon. Do not take Posaconazole Biocon if you are pregnant unless your doctor tells you to.
If you are a woman of childbearing potential you must use effective 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 can pass into breast milk.

Driving and using machines
While taking Posaconazole Biocon you may feel dizzy, sleepy or have blurred vision, which can affect your ability to drive or operate tools or machines. If this happens, do not drive or operate tools or machines and contact your doctor.

Posaconazole Biocon contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially “sodium-free”.

3. How to take Posaconazolo Biocon

Do not switch from taking Posaconazolo Biocon tablets to taking posaconazole oral suspension without consulting your doctor or pharmacist, as this may lead to a lack of efficacy or an increased risk of adverse reactions.
Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, ask your doctor or pharmacist.

How much to take
The usual dose is 300 mg posaconazole (three 100 mg tablets) twice daily on the first day,
followed by 300 mg (three 100 mg tablets) once daily, subsequently.
The duration of treatment may depend on the type of infection you have and may be adapted personally for you by your doctor. Do not adjust the dose on your own before consulting your doctor or do not modify
the treatment regimen.

How to take this medicine

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

If you take more Posaconazolo Biocon than you should
If you think you have taken more Posaconazolo Biocon than you should, inform a doctor or go
immediately to the hospital.

If you forget to take Posaconazolo Biocon

• If you forget to take a dose, take it as soon as you remember.
• However, if it is almost time for the next dose, skip the forgotten dose and return to your normal dosing schedule.
• Do not take a double dose to make up for a missed dose.

If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

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

Serious side effects
Inform 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 or being sick), diarrhoea
• signs of problems with your liver - these include yellowing of the skin or the white part of your eyes, unusually dark urine or pale stools, feeling unwell without justification, stomach problems, loss of appetite or unusual tiredness or weakness, increased liver enzymes detected in blood tests
• allergic reaction

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

• a change in the levels of salt in your blood detected in blood tests - the signs include feeling confused or weak
• abnormal skin sensations, such as numbness, tingling, itching, goosebumps, prickling or burning
• headache
• low levels of potassium in your blood - detected in blood tests
• low levels of magnesium - detected in blood tests
• high blood pressure
• loss of appetite, stomach pain or stomach upset, passing gas, dry mouth, changes in taste
• heartburn (a burning sensation in your chest that rises into your throat)
• low levels of “neutrophils” a type of white blood cells (neutropenia) - this can increase the risk of getting infections and can be detected in blood tests
• fever
• feeling weak, dizziness, tiredness or drowsiness
• skin rash
• itching
• constipation
• rectal discomfort

Not common (may affect up to 1 in 100)

• Anaemia - the signs include headache, feeling tired or dizzy, shortness of breath or looking pale and a low level of haemoglobin detected in blood tests
• low level of platelets (thrombocytopenia) detected in blood tests - this can lead to bleeding
• low level of “leukocytes”, a type of white blood cells (leukopenia) detected in blood tests - this can increase the risk of getting infections
• high level of “eosinophils”, a type of white blood cells (eosinophilia) - this can happen if you have inflammation
• inflammation of the blood vessels
• changes in heart rate
• fits (convulsions)
• nerve damage (neuropathy)
• abnormal heart rhythm - detected in an ECG, palpitations, slow or fast heartbeat, high or low blood pressure
• low blood pressure
• inflammation of the pancreas (pancreatitis) - this can cause severe stomach pain
• interruption of oxygen supply to the spleen (splenic infarction) - this can cause severe stomach pain
• serious kidney problems - the signs include increased or decreased production of urine that is a different colour than usual
• high levels of creatinine in the blood - detected in blood tests
• cough, hiccups
• nosebleed
• severe sharp chest pain when breathing (pleuritic pain)
• swollen lymph nodes (lymphadenopathy)
• reduced sensation of feeling especially on the skin
• tremor
• high or low blood sugar levels
• blurred vision, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• chills, feeling generally unwell
• pain, back pain or neck pain, arm or leg pain
• 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 the mucous membranes
• blocked nose
• difficulty breathing
• chest discomfort
• feeling of fullness
• nausea from mild to severe, vomiting, cramps and diarrhoea, usually caused by a virus, stomach pain
• burping
• feeling nervous

Rare: may affect up to 1 in 1,000

• high blood pressure in the blood vessels of the lungs (pulmonary hypertension) which can cause serious damage to the lungs and heart
• blood problems such as unusual blood clotting or prolonged bleeding
• serious allergic reactions, including widespread blistering skin rashes and peeling skin
• mental problems such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, jerky movements, especially of the hands that you cannot control
• stroke - the signs include pain, weakness, numbness or tingling in the limbs
• having a blind or dark spot in your field of vision
• heart failure or heart attack which can lead to cardiac arrest and death, changes in heart rhythm with sudden death
• blood clots in the legs (deep vein thrombosis) - the signs include pain
• intense or swelling of the legs
• blood clots in the lungs (pulmonary embolism) - the signs include feeling short of breath or pain when breathing
• bleeding in the stomach or intestine - the signs include vomiting blood or blood in your stools
• blockage in the intestine (bowel obstruction) especially in the “ileum”. The blockage will prevent the contents of the intestine from passing into the lower part of the intestine - the 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 can occur with or without kidney failure
• “pancytopenia” a low level of all blood cells (red blood cells and white blood cells and platelets) detected in blood tests
• widespread purple discolouration of the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• malfunctioning adrenal glands - this can cause weakness, tiredness, loss of appetite, skin discolouration
• malfunctioning pituitary gland - this can cause low blood levels of some hormones that affect the functioning of male or female sex organs
• changes in hearing.

Not known: frequency cannot be estimated from the available data

• pseudoaldosteronism, which causes high blood pressure with a low level of potassium (detected in blood tests)
• some patients have also reported feeling confused after taking

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the
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 Posaconazolo Biocon

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 blister / bottle and on the packaging
after Exp. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in waste water 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 Posaconazolo Biocon Contains
The active ingredient is posaconazole. Each gastro-resistant tablet contains 100 mg of
Posaconazolo
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), ferric oxide (E172)

Description of the Appearance of Posaconazolo Biocon and Package Contents
Posaconazole gastro-resistant tablets are film-coated tablets, pale yellow to
yellow, oval, biconvex, approximately 17.5 mm in length and 6.7 mm in width, with 'B100' imprinted on
one side and smooth on the other side, packaged in blisters in boxes 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 Member States of the European Economic Area with the
following denominations:
This leaflet was last revised {MM/AAAA}