Posaconazole DR. Reddys 40 mg/ml oral suspension – patient leaflet, side effects, dosage

1. What Posaconazole is and what it is used for

Posaconazole Oral Suspension contains a medicine called posaconazole. This belongs to a group of medicines called “antifungals”. It is used to prevent and treat many different fungal infections.

This medicine works by killing or stopping the growth of some types of fungi that can cause infections.

Posaconazole can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have 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 these medicines have had to be stopped;

• infections caused by fungi of the Fusarium family that have not improved

  during treatment with amphotericin B or when amphotericin B has had to be stopped;

• infections caused by fungi that cause the conditions known as

  “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped;

• infections caused by a fungus called Coccidioides that have not improved

  during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medicines have had to be stopped;

• infections in the mouth or throat area (known as “thrush”) caused by fungi

  called Candida, which were not previously treated.

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

• patients who have a weak immune system due to having chemotherapy for

  “acute myelogenous leukaemia” (AML) or “myelodysplastic syndromes” (MDS)

• patients having “high-dose immunosuppressive therapy” after

  “hematopoietic stem cell transplant” (HSCT).

2. What you need to know before you take Posaconazole

Do not take Posaconazole

• 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 medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine, or a “statin” such as simvastatin, atorvastatin or lovastatin.

• if you have just started taking venetoclax or your venetoclax dose is being

  slowly increased for treatment of chronic lymphocytic leukaemia (CLL). Do not take Posaconazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Posaconazole. See “Other medicines and Posaconazole” below for more information including information on other medicines which may interact with posaconazole. Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Posaconazole 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 you are taking this medicine

• develop severe diarrhoea or vomiting, as these conditions may limit the

  effectiveness of this medicine

• have an abnormal heart rhythm tracing (ECG) that shows a problem

  called long QTc interval

• have a weakness of the heart muscle or heart failure
• have a very slow heartbeat
• have heart rhythm disturbance

• have any problem with potassium, magnesium or calcium levels in

  your blood

• are taking vincristine, vinblastine and other “vinca alkaloids”

  (medicines used to treat cancer).

• are taking venetoclax (a medicine used to treat cancer). If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before taking posaconazole.

  Do not take posaconazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Other medicines

  Look at the list of medicines given above that must not be taken while you are taking posaconazole. In addition to the medicines named above there are other medicines that carry a risk of rhythm problems that may be greater when they are taken with posaconazole. Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed). Certain medicines may increase the risk of side effects of Posaconazole by increasing the amount of posaconazole in the blood.

  The following medicines may decrease the effectiveness of Posaconazole by decreasing the amount of posaconazole in the blood:

  • rifabutin and rifampicin (used to treat certain infections). If you are already

    taking rifabutin, you will need a blood test and you will need to look out for some possible side effects of rifabutin.

  • flucloxacillin (antibiotic used against bacterial infections)

  • phenytoin, carbamazepine, phenobarbital or primidone (used to treat or

    prevent fits).

  • efavirenz and fosamprenavir used to treat HIV infection.

  • medicines used to decrease stomach acid such as cimetidine and ranitidine

    or omeprazole and similar medicines that are called proton pump inhibitors. Posaconazole may possibly increase the risk of side effects of some other medicines by increasing the amount of these medicines in the blood. These medicines include:

  • vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
  • venetoclax (used to treat cancer)
  • ciclosporin (used during or after transplant surgery)
  • tacrolimus and sirolimus (used during or after transplant surgery)
  • rifabutin (used to treat certain 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 “sulfonylureas” (used to treat high blood sugar).

  • all-trans retinoic acid (ATRA), also called tretinoin (used to treat certain

    blood cancers).

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking posaconazole.

Posaconazole with food and drink

To improve absorption of posaconazole, whenever possible it should be taken during or immediately after food or a nutritional drink (see section 3 “How to take Posaconazole”). There is no information on the effect of alcohol on posaconazole.

Pregnancy and breast-feeding

Tell your doctor if you are or think you are pregnant before you start to take Posaconazole. Do not take posaconazole if you are pregnant unless you are told to by your doctor.

If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine. If you become pregnant while you are taking posaconazole, contact your doctor straight away.

Do not breast-feed while taking posaconazole. This is because small amounts may pass into breast milk.

Driving and using machines

You may feel dizzy, sleepy, or have blurred vision while taking posaconazole, which may affect your ability to drive or use tools or machines. If this happens, do not drive or use any tools or machines and contact your doctor.

Posaconazole Oral Solution contains glucose

This medicine contains approximately 2.11 g of liquid glucose per 5 mL of suspension.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Posaconazole contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 5 mL of suspension, that is to say essentially ‘sodium-free’.

Posaconazole contains sodium benzoate

This medicine contains 10 mg of sodium benzoate per 5 mL of suspension.

3. How to take Posaconazole

If you develop severe diarrhoea or vomiting (being sick) while taking posaconazole, talk to your doctor, pharmacist or nurse straight away, as this may stop it from working properly. See section 4 for more information. You should avoid sun exposure while being treated. It is important to cover sun exposed areas of skin with protective clothing and use sunscreen with a high sun protection factor (SPF), as an increased sensitivity of skin to the sun’s UV rays can occur.

Children

Posaconazole should not be used in children and adolescents (17 years of age and younger).

Other medicines and Posaconazole

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

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

• terfenadine (used to treat allergies)
• astemizole (used to treat allergies)
• cisapride (used to treat stomach problems)
• pimozide (used to treat symptoms of Tourette's and mental illness)
• halofantrine (used to treat malaria)
• quinidine (used to treat abnormal heart rhythms).

Posaconazole can increase the amount of these medicines in the blood which may lead to very serious changes to your heart rhythm.

• any medicines that contain “ergot alkaloids” such as ergotamine or

  dihydroergotamine used to treat migraines. Posaconazole can increase the amount of these medicines in the blood which may lead to a severe decrease in blood flow to your fingers or toes and could cause damage to them.

• a “statin” such as simvastatin, atorvastatin or lovastatin used to treat

  high cholesterol.

• venetoclax when used at the start of the treatment of a type of cancer,

  chronic lymphocytic leukaemia (CLL).

  Do not switch between posaconazole oral suspension and posaconazole tablets or posaconazole gastro-resistant powder and solvent for oral suspension without talking to your doctor or pharmacist because it may result in a lack of efficacy or an increased risk of adverse reactions.

  Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will monitor your response and condition to determine how long posaconazole needs to be given and whether any change is needed to your daily dose.

  The table below shows the recommended dose and length of treatment which depend on the type of infection that you have and may be individually adapted for you by your doctor. Do not adapt your dose yourself before consulting your doctor or change your treatment regime.

  Whenever possible you should take posaconazole during or immediately after food or a nutritional drink.

  Indication Recommended dose and length of treatment

DR00xxxx If you take more Posaconazole than you should

• blood clots in your lungs (pulmonary embolism) – signs include feeling short of breath or pain while breathing

If you are concerned that you may have taken too much, contact your doctor or healthcare professional immediately.

• bleeding into your stomach or gut – signs include vomiting blood or passing blood in your stool

If you forget to take Posaconazole

• a blockage in your gut (intestinal obstruction) especially in the “ileum”. The

If you have missed a dose, take it as soon as you remember and then carry on as before. However, if it is almost time for your next dose, take your dose when it is due. Do not take a double dose to make up for a forgotten dose.

blockage will prevent the contents of your intestine from passing through to the lower bowel - signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps

• “haemolytic uraemic syndrome” when red blood cells breakup (haemolysis)

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

which may happen with or without kidney failure

• “pancytopenia” low level of all blood cells (red and white blood cells and

4. Possible side effects

platelets) shown in blood tests

• large purple discolourations on the skin (thrombotic thrombocytopenic purpura)

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

• swelling of the face or tongue
• depression

Serious side effects

• double vision

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

• breast pain
• adrenal glands not working properly – this may cause weakness, tiredness, loss of appetite, skin discolouration
• nausea or vomit (feeling or being sick), diarrhoea
• pituitary gland not working properly – this may cause low blood levels of

• signs of liver problems - these include yellowing of your skin or whites of the

  some hormones that affect the function of the male or female sex organs eyes, unusually dark urine or pale faeces, feeling sick for no reason, stomach problems, loss of appetite or unusual tiredness or weakness, an increase in liver enzymes shown up in blood tests

• hearing problems
• pseudoaldosteronism, which results in high blood pressure with a low potassium level (shown in blood test)

• allergic reaction

  Not known: frequency cannot be estimated from the available data

• Some patients have also reported feeling confused after taking

Other side effects

posaconazole.

Tell your doctor, pharmacist or nurse if you notice any of the following side effects:

• redness of the skin.

Common: the following may affect up to 1 in 10 people

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

• a change in the salt level in your blood shown in blood tests - signs include

  feeling confused or weak

• abnormal skin sensations, such as numbness, tingling, itching, creeping,

  Reporting of side effect

  pricking or burning

  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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• headache
• low potassium levels – shown up in blood tests
• low magnesium levels – shown up in blood tests
• high blood pressure

• loss of appetite, stomach pain or upset stomach, passing wind, dry mouth,

  changes in your taste

5. How to store Posaconazole

• heartburn (a burning sensation in the chest rising up to the throat)

  Keep this medicine out of the sight and reach of children.

• low levels of “neutrophils” a type of white blood cell (neutropenia) –this can

  make you more likely to get infections and be shown up in blood tests

  Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

• fever

• feeling weak, dizzy, tired or sleepy

  Do not refrigerate or freeze.

• rash

• itching

  If you have any suspension left in a bottle more than 30 days after it was first opened, you should not use this medicine.

• constipation

• rectal discomfort

  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 to protect the environment.

Uncommon: the following may affect up to 1 in 100 people

• anaemia - signs include headaches, feeling tired or dizzy, being short of

  breath or looking pale and a low level of haemoglobin shown up in blood tests

6. Contents of the pack and other information

• low level of platelets (thrombocytopenia) shown in blood tests – this may

  lead to bleeding

  What Posaconazole Oral Solution contains

• low level of “leukocytes” a type of white blood cell (leukopenia) shown in

  • The active substance in Posaconazol Oral Solution is posaconazole.

blood tests – this can make you more likely to get infections

Each millilitre of oral suspension contains 40 milligrams of posaconazole.

• high level of “eosinophils” a type of white blood cell (eosinophilia) – this can

  • The other ingredients in the suspension are citric acid monohydrate,

happen if you have inflammation

monosodium citrate anhydrous, sodium benzoate (E211), sodium laurilsulfate, simethicone emulsion 30/% (containing: simeticone, methylcellulose, sorbic acid, water), glycerol, xanthan gum, glucose (liquid), titanium dioxide (E171), cherry flavor and purified water.

• inflammation of the blood vessels
• heart rhythm problems
• fits (convulsions)

• nerve damage (neuropathy)

  What Posaconazole Oral Solution looks like and contents of the pack

• abnormal heart rhythm – shown up on a heart trace (ECG), palpitations,

  slow or fast heartbeat, high or low blood pressure

  Posaconazole is a white to yellowish, oral suspension packaged in amber glass (type III) bottles closed with a plastic child resistant screwcap. A measuring spoon suitable to deliver 2.5 ml and 5 ml doses is provided with each bottle.

• low blood pressure

• inflammation of the pancreas (pancreatitis) – this may cause severe

  stomach pain

• oxygen supply to the spleen is interrupted (splenic infarction) - this may

  Marketing Authorisation Holder

  cause severe stomach pain

  Dr. Reddy’s Laboratories (UK) Ltd,

• severe kidney problems – signs include passing more or less urine, that is a

  410 Cambridge Science Park, Milton Road, Cambridge,

  different colour than usual

  CB4 0PE, United Kingdom

• high blood levels of creatinine – shown in blood tests

• cough, hiccups

  Manufacturer

• nose bleeds

  Genepharm S.A., 18 km Marathon Avenue, 15351 Pallini Attikis, Greece

• severe sharp chest pain when breathing in (pleurritic pain)

  Rafarm S.A., Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki, TK 19002, ΤΘ 37 Greece

• swelling of lymph glands (lymphadenopathy)
• reduced feeling of sensitivity especially on the skin

• tremor

  This leaflet was last revised in October 2024

• high or low blood sugar levels
• blurred vision, sensitivity to light
• hair loss (alopecia)
• mouth ulcers
• shivering, feeling generally unwell
• pain, back or neck pain, pain in arms or legs
• water retention (oedema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• being completely or partially unable to talk
• swelling of the mouth
• abnormal dreams, or difficulty sleeping
• problems with co-ordination or balance
• mucosal inflammation
• 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 jittery

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

• pneumonia – signs include feeling short of breath and producing

  discoloured phlegm

• high blood pressure in the blood vessels in the lungs (pulmonary

  hypertension) this can cause serious damage to your lungs and heart

• blood problems such as unusual blood clotting or prolonged bleeding

• severe allergic reactions, including widespread blistering rash and

  skin peeling

• mental problems such as hearing voices or seeing things that are not there
• fainting

• having problems thinking or talking, having jerking movements, especially in

  your hands that you cannot control

• stroke – 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 could lead to the heart stopping beating

  and death, heart rhythm problems, with sudden death

• blood clots in your legs (deep vein thrombosis) – signs include intense pain

  or swelling of the legs

  Submission

  Brand:

  DR Reddy’s

  Country:

  UK

  Product Name:

  Posaconazole -Rafarm

  Strength:

  40 mg/ml

  Form:

  Oral Suspension leaflet

  Pack Size:

  Various

  Date Created:

  04/mar/2019

  Date Modified

  09 October 2024

  Genepharma 210x420mm xx/xxx/xxxx CC1000142983 Project

  Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.