Posaconazol ahcl 40 mg/ml suspension oral efg
Introduction
Label: Information for the User
Posaconazol AHCL 40 mg/ml Oral Suspension EFG
Posaconazol
Read this label carefully before starting to take this medicine, as it contains important information for you.
- Keep this label, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
1. What is Posaconazol AHCL and what is it used for
Posaconazol AHCL contains a medication called posaconazol, which belongs to a group of medications known as "antifungals". It is used to prevent and treat many different types of fungal infections.
This medication works by killing or preventing the growth of certain types of fungi that can cause infections.
Posaconazol AHCL can be used in adults to treat the following types of fungal infections when other antifungal medications have not worked or you have had to stop taking them:
- Infections caused by fungi from the familyAspergillusthat have not improved during treatment with the antifungal medications amphotericin B or itraconazole or when treatment with these medications had to be interrupted;
- Infections caused by fungi from the familyFusariumthat have not improved during treatment with amphotericin B or when treatment with amphotericin B had to be interrupted;
- Infections caused by fungi that cause the diseases known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when treatment with itraconazole had to be interrupted;
- Infections caused by a fungus calledCoccidioidesthat have not improved during treatment with one or more medications, amphotericin B, itraconazole, or fluconazole, or when treatment with these medications had to be interrupted;
- Infections in the mouth or throat area (called “aphthae”) caused by fungi calledCandidathat have not been previously treated.
This medication can also be used to prevent fungal infections in adults at high risk of contracting a fungal infection, such as:
- Patients with a weakened immune system as a result of having received chemotherapy for “acute myeloid leukemia” (AML) or “myelodysplastic syndromes” (MDS)
- Patients receiving “high doses of immunosuppressive treatment” after a “hematopoietic stem cell transplant” (HSCT).
2. What you need to know before starting Posaconazol AHCL
Do not take Posaconazol AHCL if you:
- are allergic to posaconazol or any of the other components of this medication (including those listed in section 6).
- are taking: terfenadine, astemizol, cisaprida, pimozida, halofantrina, quinidina, any medication that contains "ergot alkaloids", such as ergotamine or dihidroergotamina, or a "statin", such as simvastatina, atorvastatina or lovastatina.
- if you have just started taking venetoclax or your dose of venetoclax is being slowly increased for the treatment of chronic lymphocytic leukemia (CLL).
Do not take Posaconazol AHCL if you are in any of the above circumstances. In case of doubt, consult your doctor or pharmacist before taking Posaconazol AHCL.
See the section “Taking Posaconazol AHCL with other medications” later for more information, including that related to other medications that may interact with Posaconazol AHCL.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Posaconazol AHCL if you:
- have had an allergic reaction to another antifungal medication, such as ketoconazol, fluconazol, itraconazol or voriconazol.
- have or have had liver problems. You may need to have blood tests while taking this medication.
- develop severe diarrhea or vomiting, as these situations may limit the effectiveness of this medication.
- have an abnormal heart rhythm (ECG) that shows a problem called prolongation of the QTc interval.
- have heart muscle weakness or heart failure.
- have a very slow heart rate.
- have any abnormal heart rhythm.
- have any problem with the amounts of potassium, magnesium or calcium in the blood.
- are taking vincristine, vinblastine and other “vinca alkaloids” (medications used to treat cancer).
- are taking venetoclax (a medication used to treat cancer).
If you are in any of the above circumstances (or in case of doubt), consult your doctor, pharmacist or nurse before taking Posaconazol AHCL.
If you develop severe diarrhea or vomiting (feel unwell) while taking Posaconazol AHCL, consult your doctor, pharmacist or nurse immediately, as this situation may prevent the medication from working correctly. For more information, see section 4.
You must avoid exposure to the sun while on treatment. It is essential to cover exposed skin areas with protective clothing and use high-factor sunscreen (SPF) as you may be more sensitive to UV rays from the sun.
Children
Posaconazol AHCL should not be used in children and adolescents (17 years of age and younger).
Taking Posaconazol AHCL with other medications
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.
Do not take Posaconazol AHCL if you are taking any of the following medications:
- terfenadine (used to treat allergies)
- astemizol (used to treat allergies)
- cisaprida (used to treat stomach problems)
- pimozida (used to treat symptoms of Tourette's syndrome and mental disorders)
- halofantrina (used to treat malaria)
- quinidina (used to treat abnormal heart rhythms).
Posaconazol AHCL may increase the amount of these medications in the blood, which could cause severe changes in your heart rhythm.
- any medication that contains "ergot alkaloids", such as ergotamine or dihidroergotamina used to treat migraines. Posaconazol AHCL may increase the amount of these medications in the blood, which could cause severe reduction of blood flow to the fingers of the hands or feet and damage them.
- a "statin", such as simvastatina, atorvastatina or lovastatina used to treat high cholesterol levels.
- venetoclax when used at the start of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).
Do not take Posaconazol AHCL if you are in any of the above circumstances. In case of doubt, consult your doctor or pharmacist before taking this medication.
Other medications
See the list provided earlier with the medications that you should not use while taking Posaconazol AHCL. In addition to the medications mentioned above, there are other medications that present a risk of heart rhythm problems, which may be greater when taken with Posaconazol AHCL. Make sure to inform your doctor of all the medications you are taking (with or without a prescription).
Some medications may increase the risk of adverse effects of Posaconazol AHCL by increasing the amount of Posaconazol AHCL in the blood.
The following medications may reduce the effectiveness of Posaconazol AHCL by reducing its levels in the blood:
- rifabutina and rifampicina (used to treat certain infections). If you are already taking rifabutina, you will need to have blood tests, as well as be aware of some possible adverse effects of rifabutina.
- some medications used to treat or prevent seizures include: phenitoína, carbamazepina, phenobarbital or primidona.
- efavirenz and fosamprenavir, used to treat HIV infection.
- medications used to reduce stomach acidity such as cimetidina and ranitidina or omeprazol and similar medications called proton pump inhibitors.
- Flucloxacilina (antibiotic used to treat bacterial infections).
Posaconazol AHCL may possibly increase the risk of adverse effects of other medications by increasing the amount of these medications in the blood. These medications include:
- vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
- venetoclax (used to treat cancer)ciclosporina (used during or after transplants)
- tacrolimus and sirolimus (used during or after transplants)
- rifabutina (used to treat certain infections)
- medications used to treat HIV called protease inhibitors (including lopinavir and atazanavir, which are administered with ritonavir)
- midazolam, triazolam, alprazolam or other “benzodiazepines” (used as sedatives or muscle relaxants)
- diltiazem, verapamilo, nifedipino, nisoldipino or other “calcium channel blockers” (used to treat high blood pressure)
- digoxina (used to treat heart failure)
- glipizida or other “sulfonilureas” (used to treat high blood sugar levels).
- acid transretinoico (ATRA), also called tretinoína (used to treat some blood cancers).
If you are in any of the above circumstances (or in case of doubt), consult your doctor or pharmacist before taking Posaconazol AHCL.
Taking Posaconazol AHCL with food and drinks
To improve the absorption of posaconazol, it is best to take it during or immediately after a meal or a food drink (see section 3 “How to take Posaconazol AHCL”). There is no information on the effect of alcohol on posaconazol.
Pregnancy and breastfeeding
Inform your doctor if you are or think you may be pregnant before starting to take Posaconazol AHCL.
Do not take Posaconazol AHCL if you are pregnant, unless your doctor tells you to.
If you become pregnant while taking Posaconazol AHCL, contact your doctor immediately.
Do not breastfeed while taking Posaconazol AHCL, as it may pass into breast milk in small amounts.
Driving and using machines
You may feel dizzy, sleepy or have blurred vision while taking Posaconazol AHCL, 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.
Posaconazol AHCL contains glucose
Posaconazol AHCL contains approximately 1.75 g of glucose per 5 ml of suspension. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication
This medication contains less than 1 mmol of sodium (23 mg) per 5 ml of suspension, which means it is essentially “sodium-free”.
3. How to Take Posaconazol AHCL
Do not take Posaconazol tablets and posaconazol oral suspension interchangeably without consulting your doctor or pharmacist, as it may result in reduced efficacy or increased risk of adverse reactions.
Follow exactly the administration instructions for this medication as indicated 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 should take Posaconazol AHCL and if any changes are needed in your daily dose.
The table below shows the recommended dose and treatment duration, 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 regimen.
Whenever possible, take posaconazol during or immediately after a meal or food.
Indication | Recommended dose and treatment duration |
Treatment of resistant fungal infections(invasive aspergillosis, fusariosis, chromoblastomycosis/micetoma, 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), ensuring that you are able to take both doses during or after a meal or food. |
Treatment of first-time oral thrush | 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 severe fungal infections | Take 200 mg (one 5 ml spoonful) three times a day. |
If you take more Posaconazol AHCL than you should
If you are concerned that you may have taken too much, inform your doctor or healthcare professional immediately.
If you forget to take Posaconazol AHCL
If you have forgotten 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 as scheduled. Do not take a double dose to make up for missed doses.
If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Severe side effects
Inform your doctor, pharmacist or nurse immediately if you notice any of the following severe side 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 the white of the eyes, dark or unusual urine, pale stools, feeling sick without apparent reason, stomach problems, loss of appetite or unusual weakness or fatigue, an increase in 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:
Frequent: the following may affect up to 1 in 10 patients
- an abnormal change in blood sodium levels detected in blood tests, whose signs include confusion or weakness
- abnormal sensations in the skin, such as numbness, tingling, itching, crawling, pinching or burning
- headache
- low levels of potassium detected in blood tests
- low levels of magnesium detected in blood tests
- high blood pressure
- loss of appetite, stomach pain or discomfort, flatulence, dry mouth, changes in taste
- heartburn (sensation of burning in the chest that rises to the throat)
- low levels of "neutrophils", a type of white blood cell (neutropenia), which may make you more prone to infections and detected in blood tests
- fever
- sensation of weakness, dizziness, fatigue or drowsiness
- eruption
- itching
- constipation
- rectal discomfort
Rare: the following may affect up to 1 in 100 patients
- anemia, whose signs include headaches, feeling tired or dizzy, difficulty breathing or paleness and low hemoglobin levels detected in blood tests
- low levels of platelets (thrombocytopenia), detected in blood tests. This may cause bleeding
- low levels of "leukocytes", a type of white blood cell (leucopenia), detected in blood tests. This may make you more susceptible to infections
- high levels of "eosinophils", a type of white blood cell (eosinophilia). This may appear if you have an inflammatory process
- inflammation of blood vessels
- problems with heart rhythm
- seizures (convulsions)
- neurological damage (neuropathy)
- abnormal heart rhythm, detected in an electrocardiogram (ECG), palpitations, slow or fast heart rate, high or low blood pressure
- low blood pressure
- inflammation of the pancreas (pancreatitis). This may cause severe stomach pain
- interruption of oxygen supply to the spleen (splenic infarction), which may cause severe stomach pain
- severe kidney problems, whose signs include increased or decreased urination with urine that has a different color than usual
- high levels of creatinine in the blood detected in blood tests
- cough, hiccups
- nasal bleeding
- sharp and intense chest pain when breathing (pleuritic pain)
- inflammation of 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, usual feeling of discomfort
- back or neck pain, arm or leg pain
- fluid retention (edema)
- menstrual problems (abnormal vaginal bleeding)
- insomnia (difficulty sleeping)
- total or partial inability to speak
- swelling of the mouth
- abnormal dreams or difficulty sleeping
- problems with coordination or balance
- inflammation of the mucosa
- nasal congestion
- difficulty breathing
- chest discomfort
- feeling bloated
- nausea, vomiting, cramps and diarrhea of mild to severe, usually caused by a virus, stomach pain
- belching
- sensation of anxiety
Rare: the following may affect up to 1 in 1,000 patients
- pneumonia, whose signs include feeling short of breath and production of discolored mucus
- high blood pressure in the blood vessels of the lungs (pulmonary hypertension), which may cause severe damage to the lungs and heart
- blood clotting 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
- syncope (fainting)
- problems with thinking or speaking, sudden movements, especially in the hands, that you cannot control
- stroke, whose signs include pain, weakness, numbness or tingling in the extremities
- presence of a blind spot or dark spot in the field of vision
- heart failure or heart attack, which may cause cardiac arrest and death, problems with heart rhythm with sudden death
- blood clots in the legs (deep vein thrombosis), whose signs include intense pain and swelling of the legs
- blood clots in the lungs (pulmonary embolism), whose signs include feeling short of breath or chest pain
- bleeding in the stomach or intestines, whose signs include vomiting blood or blood in the stool
- 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 abdominal cramps
- "uricemic hemolytic syndrome" that appears when there is destruction of red blood cells (hemolysis), which may occur with or without kidney failure
- "pancytopenia", low levels of all blood cells (red, white and platelets), detected in blood tests
- purple spots and large patches on the skin (purpura thrombocytopenic thrombosis)
- inflammation of the face or tongue
- depression
- diplopia (double vision)
- mastalgia (breast pain)
- inadequate functioning of the adrenal glands, which may cause weakness, fatigue, loss of appetite, skin discoloration
- inadequate functioning of the pituitary gland, which may cause low levels of certain hormones in the blood that affect the function of male or female sex organs
- hearing problems
- pseudoaldosteronism, which causes high blood pressure with low potassium levels (appears in blood tests)
Frequency not known: cannot be estimated from available data
- some patients have also reported feeling confused after taking Posaconazol AHCL.
- skin flushing
Inform your doctor, pharmacist or nurse if you experience any of the side effects described above.
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Posaconazol AHCL
- Keep this medication out of the sight and reach of children.
- Do not use this medication after the expiration date that appears on the label. The expiration date is the last day of the month indicated.
- This medication does not require any special storage measures.
- If there is any remaining suspension in the bottle after more than four weeks of its first opening, do not use this medication. Return the bottle with the remaining suspension to your pharmacist.
- Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Content of the container and additional information
Composition of Posaconazol AHCL
- The active ingredient is posaconazol. Each milliliter of oral suspension contains 40 milligrams of posaconazol.
- The other components of the suspension are macrogolglycerol hydroxystearate, sodium citrate dihydrate, citric acid monohydrate, simethicone emulsion (which contains polydimethylsiloxane, polyethylene glycol sorbitan triesterate, methylcellulose, silica gel, polyethylene glycol stearate, sorbic acid (E200), benzoic acid (E210), and sulfuric acid (E513)), xanthan gum (E415), sodium benzoate (E211), liquid glucose, glycerol (E422), titanium dioxide (E171), strawberry flavor (contains propylene glycol), and purified water.
Appearance of the product and content of the container
Posaconazol AHCL is a white to off-white, free-flowing oral suspension, packaged in amber glass bottles. Each bottle is provided with a measuring spoon for measuring doses of 2.5 and 5 ml of the oral suspension.
Holder of the marketing authorization
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona s/n,
Edifici Est, 6th floor, Barcelona,
08039 Barcelona, Spain
Manufacturer
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland
Fundacio Dau Laboratories
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Wessling Hungary Kft.
Anomymus u 6
H-1045 Budapest
Hungary
Last review date of this leaflet: {MM/AAAA}
Other sources of information
Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.
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