How to use NOXAFIL 40 mg/mL ORAL SUSPENSION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Noxafil 40mg/ml Oral Suspension
posaconazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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.
Contents of the Package Leaflet
- What is Noxafil and what is it used for
- What you need to know before you take Noxafil
- How to take Noxafil
- Possible side effects
- Storage of Noxafil
- Contents of the pack and further information
1. What is Noxafil and what is it used for
Noxafil contains a medicine called posaconazole, which 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.
Noxafil 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 Aspergillusfamily that have not improved during treatment with the antifungal medicines amphotericin B or itraconazole or when treatment with these medicines has had to be stopped;
- infections caused by fungi of the Fusariumfamily that have not improved during treatment with amphotericin B or when treatment with amphotericin B has had to be stopped;
- infections caused by fungi that cause diseases known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole or when treatment with itraconazole has had to be stopped;
- infections caused by a fungus called Coccidioidesthat have not improved during treatment with one or more medicines, amphotericin B, itraconazole, or fluconazole, or when treatment with these medicines has had to be stopped;
- infections in the mouth or throat area (called "thrush") caused by fungi called Candida, that have not been 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 weakened immune system as a result of having received chemotherapy for "acute myelogenous leukemia" (AML) or "myelodysplastic syndromes" (MDS)
- patients who are receiving "high-dose immunosuppressive treatment" after a "hematopoietic stem cell transplant" (HSCT).
2. What you need to know before you take Noxafil
Do not take Noxafil
- 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 "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 the treatment of chronic lymphocytic leukemia (CLL).
Do not take Noxafil if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking Noxafil.
See the section "Taking Noxafil with other medicines" later for more information, including information about other medicines that may interact with Noxafil.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Noxafil if:
- you have had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole, or voriconazole.
- you have or have had liver problems. You may need to have blood tests while taking this medicine.
- you develop severe diarrhea or vomiting, as these conditions may limit the effectiveness of this medicine.
- you have a heart rhythm problem (ECG) that shows a problem called QTc interval prolongation.
- you have weakness of the heart muscle or heart failure.
- you have a very slow heart rate.
- you have any heart rhythm problems.
- you have any problems with the amounts of potassium, magnesium, or calcium in your blood.
- you are taking vincristine, vinblastine, and other "vinca alkaloids" (medicines used to treat cancer).
- you are taking venetoclax (a medicine used to treat cancer).
You should avoid exposure to the sun while taking this treatment. It is important to cover exposed skin areas with protective clothing and use a sunscreen with a high sun protection factor (SPF), as you may be more sensitive to the UV rays of the sun.
If you are in any of the above situations (or in doubt), consult your doctor, pharmacist, or nurse before taking Noxafil.
If you develop severe diarrhea or vomiting (feel sick) while taking Noxafil, consult your doctor, pharmacist, or nurse immediately, as this condition may prevent the medicine from working properly. For more information, see section 4.
Children
Noxafil oral suspension should not be used in children and adolescents (17 years of age and younger).
Taking Noxafil with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Noxafil 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 problems).
Noxafil may increase the amount of these medicines in your blood, which could cause serious changes in your heart rhythm.
- any medicine that contains "ergot alkaloids", such as ergotamine or dihydroergotamine, used to treat migraines. Noxafil may increase the amount of these medicines in your blood, which could cause a serious decrease in blood flow to your fingers or toes and damage them.
- a "statin", such as simvastatin, atorvastatin, or lovastatin, used to treat high cholesterol.
- venetoclax when used at the start of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).
Do not take Noxafil if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking this medicine.
Other medicines
Consult the list provided earlier with the medicines that you should not use while taking Noxafil. In addition to the medicines mentioned earlier, there are other medicines that may increase the risk of heart rhythm problems, which may be greater when taken with Noxafil. Make sure to inform your doctor of all medicines you are taking (with or without a prescription).
Some medicines may increase the risk of side effects of Noxafil by increasing the amount of Noxafil in your blood.
The following medicines may decrease the effectiveness of Noxafil by reducing its levels in the blood:
- rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need to have a blood test, as well as be aware of some possible side effects of rifabutin.
- phenytoin, carbamazepine, phenobarbital, or primidone (used to treat or prevent seizures).
- efavirenz and fosamprenavir, used to treat HIV infection.
- flucloxacillin (an antibiotic used against bacterial infections).
- medicines used to reduce stomach acid, such as cimetidine and ranitidine or omeprazole and similar medicines called proton pump inhibitors.
Noxafil may increase the risk of side effects of other medicines by increasing the amount of these medicines in your blood. These medicines include:
- vincristine, vinblastine, and other "vinca alkaloids" (used to treat cancer)
- venetoclax (used to treat cancer)
- ciclosporin (used during or after transplants)
- tacrolimus and sirolimus (used during or after transplants)
- 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 levels)
- all-trans retinoic acid (ATRA), also called tretinoin (used to treat some blood cancers).
If you are in any of the above situations (or in doubt), consult your doctor or pharmacist before taking Noxafil.
Taking Noxafil with food and drinks
To improve the absorption of posaconazole, it should be taken during or immediately after a meal or a nutritional drink (see section 3 "How to take Noxafil"). There is no information on the effect of alcohol on posaconazole.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or think you may be pregnant before taking Noxafil.
Do not take Noxafil if you are pregnant, unless your doctor tells you to.
If you are a woman who can become pregnant, you must use effective contraceptive measures while taking this medicine. If you become pregnant while taking Noxafil, contact your doctor immediately.
Do not breastfeed while taking Noxafil, as small amounts may pass into breast milk.
Driving and using machines
You may feel dizzy, sleepy, or have blurred vision while taking Noxafil, 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.
Noxafil contains glucose
Noxafil contains approximately 1.75 g of glucose per 5 ml of suspension. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.
Noxafil contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml of suspension; this is essentially "sodium-free".
Noxafil contains sodium benzoate
This medicine contains 10 mg of sodium benzoate (E-211) per 5 ml of suspension.
Noxafil contains benzyl alcohol
This medicine contains up to 1.25 mg of benzyl alcohol per 5 ml of suspension. Benzyl alcohol may cause allergic reactions.
Noxafil contains propylene glycol
This medicine contains up to 24.75 mg of propylene glycol (E-1520) per 5 ml of suspension.
3. How to take Noxafil
Do not switch between Noxafil oral suspension and Noxafil tablets or Noxafil gastro-resistant powder and solvent for oral suspension without consulting your doctor or pharmacist, as this may lead to a lack of effectiveness or increase the risk of adverse reactions.
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will monitor your response and condition to determine how long you need to take Noxafil and if any change in your daily dose is needed.
The table below shows the recommended dose and duration of treatment, which depend on the type of infection you have and may be adapted individually for you by your doctor. Do not adjust your dose yourself before consulting your doctor, nor change your treatment schedule.
Whenever possible, take posaconazole during or immediately after a meal or a nutritional drink.
Indication | Recommended dose and duration of treatment |
Treatment of Fungal Infections resistant to (invasive aspergillosis, fusariosis, chromoblastomycosis/mycetoma, coccidioidomycosis) | The recommended dose is 200 mg (one 5 ml spoonful) taken four times a day. Alternatively, if your doctor recommends it, you may take 400 mg twice a day (two 5 ml spoonfuls), making sure that you are able to take both doses during or after a meal or a nutritional drink. |
Treatment of Thrush for the first time | On the first day of treatment, take 200 mg (one 5 ml spoonful) once. After the first day, take 100 mg (2.5 ml) once a day. |
Prevention of Serious Fungal Infections | Take 200 mg (one 5 ml spoonful) three times a day. |
If you take more Noxafil than you should
If you are concerned that you may have taken too much of a dose, inform your doctor or healthcare professional immediately.
If you forget to take Noxafil
If you have missed a dose, take it as soon as you remember and then continue 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 missed doses.
If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.
Severe Adverse Effects
Tell your doctor, pharmacist, or nurse immediately if you notice any of the following severe adverse effects; you may need urgent medical treatment:
- nausea or vomiting (feeling or being sick), diarrhea
- signs of liver problems, including yellowing of the skin or whites of the eyes, unusually dark urine or pale stools, feeling sick without apparent reason, stomach problems, loss of appetite or unusual tiredness or weakness, increased liver enzymes detected in blood tests
- allergic reaction
Other Adverse Effects
Tell your doctor, pharmacist, or nurse if you notice any of the following adverse effects:
Frequent: the following may affect up to 1 in 10 patients
- a change in blood salt levels detected in blood tests, whose signs include a feeling of confusion or weakness
- abnormal sensations in the skin, such as numbness, tingling, itching, crawling, pinching, or burning
- headache
- low potassium levels, detected in blood tests
- low magnesium levels, detected in blood tests
- high blood pressure
- loss of appetite, stomach pain or stomach discomfort, flatulence, dry mouth, changes in taste
- heartburn (a burning sensation in the chest that rises to the throat)
- low levels of "neutrophils", a type of white blood cell (neutropenia), which can make you more prone to infections and are detected in blood tests
- fever
- feeling of weakness, dizziness, tiredness, or drowsiness
- rash
- itching
- constipation
- rectal discomfort
Uncommon: the following may affect up to 1 in 100 patients
- anemia, whose signs include headaches, feeling tired or dizzy, difficult breathing, or paleness and low hemoglobin levels detected in blood tests
- low platelet levels (thrombocytopenia), detected in blood tests. This can cause bleeding
- low levels of "leukocytes", a type of white blood cell (leukopenia), detected in blood tests. This can make you more susceptible to infections
- high levels of "eosinophils", a type of white blood cell (eosinophilia). This can appear if you have an inflammatory process
- inflammation of blood vessels
- heart rhythm problems
- seizures (convulsions)
- nerve damage (neuropathy)
- abnormal heart rhythm, detected in an electrocardiogram (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), which can cause severe stomach pain
- severe kidney problems, whose signs include increased or decreased urination with urine of a different color than usual
- high blood creatinine levels, detected in blood tests
- cough, hiccups
- nosebleeds
- sharp and intense chest pain when breathing (pleuritic pain)
- inflammation of the lymph nodes (lymphadenopathy)
- decreased sensitivity, especially in the skin
- tremors
- high or low blood sugar levels
- blurred vision, sensitivity to light
- hair loss (alopecia)
- mouth ulcers
- chills, feeling of discomfort
- pain, back or neck pain, pain in arms or legs
- fluid retention (edema)
- menstrual problems (abnormal vaginal bleeding)
- inability to sleep (insomnia)
- complete or partial inability to speak
- mouth swelling
- abnormal dreams or sleep problems
- coordination or balance problems
- mucosal inflammation
- nasal congestion
- breathing difficulties
- chest discomfort
- feeling bloated
- nausea, vomiting, cramps, and diarrhea from mild to severe, usually caused by a virus, stomach pain
- belching
- feeling of restlessness
Rare: the following may affect up to 1 in 1,000 patients
- pneumonia, whose signs include shortness of breath and production of discolored phlegm
- 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
- severe allergic reactions, including widespread skin rash with blisters and skin peeling
- mental problems, such as hearing voices or seeing things that are not there
- fainting
- problems thinking or speaking, sudden movements, especially in your hands, that you cannot control
- stroke, whose signs include pain, weakness, numbness, or tingling in the limbs
- presence of a blind spot or dark spot in the field of vision
- heart failure or heart attack, which can cause cardiac arrest and death, heart rhythm problems with sudden death
- blood clots in the legs (deep vein thrombosis), whose signs include intense pain or swelling of the legs
- blood clots in the lungs (pulmonary embolism), whose signs include shortness of breath or pain when breathing
- bleeding in the stomach or intestine, whose signs include vomiting blood or blood in the stool
- blockage of the intestine (intestinal obstruction), especially of the "ileum". This blockage prevents the contents of the intestine from passing through the colon and whose signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
- "hemolytic uremic syndrome" that appears when there is destruction of red blood cells (hemolysis), which can occur with or without kidney failure
- "pancytopenia", low levels of all blood cells (red, white, and platelets), detected in blood tests
- large purple spots on the skin (thrombocytopenic purpura)
- inflammation of the face or tongue
- depression
- double vision
- breast pain
- inadequate functioning of the adrenal glands, which can cause weakness, tiredness, loss of appetite, skin discoloration
- inadequate functioning of the pituitary gland, which can cause low blood levels of some hormones that affect the function of male or female sexual organs
- hearing problems
- pseudoaldosteronism, which causes high blood pressure with low potassium levels (appears in blood tests)
Frequency not known: cannot be estimated from the available data
- some patients have also reported feeling confused after taking Noxafil
- redness of the skin
Tell your doctor, pharmacist, or nurse if you experience any of the adverse effects described above.
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the national notification system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
5. Storage of Noxafil
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated.
Do not freeze.
If there is suspension left in the bottle after more than four weeks of its first opening, you should not use this medicine. Return the bottle with the remaining suspension to your pharmacist.
Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.
6. Package Contents and Additional Information
Noxafil Composition
- The active ingredient of Noxafil is posaconazole. Each milliliter of oral suspension contains 40 milligrams of posaconazole.
- The other components of the suspension are polysorbate 80, simethicone, sodium benzoate (E-211), sodium citrate dihydrate, citric acid monohydrate, glycerol, xanthan gum, liquid glucose, titanium dioxide (E-171), artificial cherry flavor that containsbenzyl alcohol and propylene glycol (E-1520) and purified water.
Product Appearance and Package Contents
Noxafil is 105 ml of white oral suspension with a cherry flavor, packaged in amber glass bottles. Each bottle comes with a measuring spoon to measure doses of 2.5 and 5 ml of the oral suspension.
Marketing Authorization Holder Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem Netherlands | Manufacturer Organon Heist bv Industriepark 30 2220 Heist-op-den-Berg Belgium Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem Netherlands |
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
België/Belgique/Belgien MSD Belgium Tel: +32(0)27766211 | Lietuva UAB Merck Sharp & Dohme Tel: +370 5 2780 247 |
| Luxembourg/Luxemburg MSD Belgium Tel: +32(0)27766211 |
Ceská republika Merck Sharp & Dohme s.r.o. Tel: +420 233 010 111 | Magyarország MSD Pharma Hungary Kft. Tel: +36 1 888 5300 |
Danmark MSD Danmark ApS Tel: +45 4482 4000 | Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) |
Deutschland MSD Sharp & Dohme GmbH Tel: +49 (0) 89 20 300 4500 | Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) |
Eesti Merck Sharp & Dohme OÜ Tel: +372 614 4200 | Norge MSD (Norge) AS Tel: +47 32 20 73 00 |
Ελλ?δα MSD Α.Φ.Ε.Ε. Tel: +30 210 98 97 300 | Österreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 |
España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 | Polska MSD Polska Sp. z o.o. Tel: +48 22 549 51 00 |
France MSD France Tel: +33 (0) 1 80 46 40 40 | Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700 |
Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 6611 333 | România Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00 |
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 | Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386 1 520 4201 |
Ísland Vistor ehf. Tel: +354 535 7000 | Slovenská republika Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010 |
Italia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) | Suomi/Finland MSD Finland Oy Tel: +358 (0)9 804 650 |
Κ?προς Merck Sharp & Dohme Cyprus Limited Tel: 800 00 673 (+357 22866700) | Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 |
Latvija SIA Merck Sharp & Dohme Latvija Tel: +371 67025300 |
Date of the Last Revision of this Prospectus:<{MM/AAAA}><{month AAAA}>.
Other Sources of Information
Detailed information about this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.
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- Country of registration
- Dosage formORAL SOLUTION/SUSPENSION, {"pl":null}
- ATC codeJ02AC04
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to NOXAFIL 40 mg/mL ORAL SUSPENSIONDosage form: TABLET, 100 mg/tabletActive substance: posaconazoleManufacturer: Merck Sharp & Dohme B.V.Prescription requiredDosage form: INJECTABLE PERFUSION, 300 mg/vial (18 mg/ml)Active substance: posaconazoleManufacturer: Merck Sharp & Dohme B.V.Prescription requiredDosage form: TABLET, 100 mgActive substance: posaconazoleManufacturer: Abdi Farma Unipessoal Lda.Prescription required
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Frequently Asked Questions
NOXAFIL 40 mg/mL ORAL SUSPENSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in NOXAFIL 40 mg/mL ORAL SUSPENSION is posaconazole. This information helps identify medicines with the same composition but different brand names.
NOXAFIL 40 mg/mL ORAL SUSPENSION is manufactured by Merck Sharp & Dohme B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether NOXAFIL 40 mg/mL ORAL SUSPENSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy NOXAFIL 40 mg/mL ORAL SUSPENSION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (posaconazole) include NOXAFIL 100 mg GASTRO-RESISTANT TABLETS, NOXAFIL 300 MG CONCENTRATE FOR INFUSION SOLUTION, POSACONAZOL ABDI 100 mg GASTRO-RESISTANT TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
