Posaconazole Almovar 100 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Posaconazole Almovar 100 mg gastro-resistant tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Posaconazol Almovar is and what it is used for

Posaconazol Almovar contains a medicine called posaconazole, which belongs to a group of medicines known as "antifungals". It is used to prevent and treat many different fungal infections.

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

Posaconazole may be used in adults to treat fungal infections caused by fungi of the Aspergillus family.

Posaconazole may be used in adults and children aged 2 years and older who weigh more than 40 kg to treat the following types of fungal infections:

• 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 has 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 has had to be discontinued;
• infections caused by fungi leading to diseases known as "chromoblastomycosis" and "mycetoma" that have not improved during treatment with itraconazole, or when treatment with itraconazole has had to be discontinued;
• infections caused by a fungus called Coccidioides that have not improved during treatment with one or more medicines, such as amphotericin B, itraconazole or fluconazole, or when treatment with these medicines has had to be discontinued.

This medicine may also be used to prevent fungal infections in adults and children aged 2 years and older who weigh more than 40 kg and who are at high risk of developing a fungal infection, such as:

• patients with a weakened immune system due to receiving chemotherapy for "acute myelogenous leukemia" (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 Posaconazol Almovar

Do not take Posaconazol Almovar

• 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.
• if you have just started taking venetoclax or your venetoclax dose is being gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take posaconazole if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking posaconazole.

See section “Other medicines and Posaconazol Almovar” below for further information, including regarding other medicines that may interact with posaconazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

• have previously had an allergic reaction to another antifungal medicine, such as ketoconazole, fluconazole, itraconazole or voriconazole.
• have or have previously 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 (ECG) showing a condition called QTc interval prolongation.
• have weakened heart muscle or heart failure.
• have a very slow heartbeat.
• have any irregular heart rhythm.
• have any imbalance in blood levels of potassium, magnesium or calcium.
• are taking vincristine, vinblastine or other “vinca alkaloids” (medicines used to treat cancer).
• are taking venetoclax (a medicine used to treat cancer).

If you are in any of the above situations (or if in doubt), consult your doctor or pharmacist before taking posaconazole.

If you develop severe diarrhoea or vomiting (feel unwell) while taking posaconazole, contact your doctor or pharmacist immediately, as this may prevent the medicine from working properly. For more information, see section 4.

Children

Posaconazole must not be given to children under 2 years of age.

Other medicines and Posaconazol Almovar

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

Do not take Posaconazol Almovar 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 syndrome and mental illnesses)
• halofantrine (used to treat malaria)
• quinidine (used to treat heart rhythm disorders)

Posaconazole may increase the amount of these medicines in your blood, which could cause serious changes in your heart rhythm.

• any medicine containing “ergot alkaloids”, such as ergotamine or dihydroergotamine, used to treat migraines. Posaconazole may increase the amount of these medicines in your blood, which could cause a serious reduction in blood flow to the fingers of the hands or feet and cause damage.
• a “statin”, such as simvastatin, atorvastatin or lovastatin, used to treat high cholesterol levels.
• venetoclax when used at the beginning of treatment for a type of cancer, chronic lymphocytic leukemia (CLL).

Do not take posaconazole if you are in any of the above situations. If in doubt, consult your doctor or pharmacist before taking this medicine.

Other medicines

Refer to the list above of medicines you must not take while using posaconazole. In addition to the medicines mentioned above, there are other medicines that carry a risk of heart rhythm problems, which may be increased when taken with posaconazole. Make sure you inform your doctor about all medicines you are taking (with or without a prescription).

Some medicines may increase the risk of posaconazole side effects by increasing the amount of posaconazole in the blood.

The following medicines may reduce the effectiveness of posaconazole by decreasing its blood levels:

• rifabutin and rifampicin (used to treat certain infections). If you are already taking rifabutin, you will need to have blood tests and be monitored for possible rifabutin side effects.
• phenytoin, carbamazepine, phenobarbital or primidone (used to treat or prevent seizures).
• efavirenz and fosamprenavir, used to treat HIV infection.

Posaconazole may possibly increase the risk of side effects from other medicines by increasing their blood levels. These medicines include:

• vincristine, vinblastine and other “vinca alkaloids” (used to treat cancer)
• venetoclax (used to treat cancer)
• cyclosporine (used during or after organ transplants)
• tacrolimus and sirolimus (used during or after organ 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 certain blood cancers)

If you are in any of the above situations (or if in doubt), consult your doctor or pharmacist before taking posaconazole.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant, consult your doctor before starting this medicine.

Do not take posaconazole if you are pregnant, unless your doctor specifically tells you to.

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

Do not breastfeed while taking posaconazole, as small amounts may pass into breast milk.

Driving and using machines

You may experience dizziness, drowsiness or blurred vision while taking posaconazole, which may affect your ability to drive or use tools or machines. If this occurs, do not drive or use any tools or machines and contact your doctor.

Posaconazol Almovar contains sodium

Posaconazol Almovar contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Posaconazole Almovar

Do not switch interchangeably between posaconazole tablets and posaconazole oral suspension without consulting your doctor or pharmacist, as this may result in lack of efficacy or increased risk of adverse reactions.

Always follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose to take

The recommended dose is 300 mg (three 100 mg tablets) twice daily 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 for you by your doctor. Do not adjust your dose yourself before consulting your doctor, nor change your treatment schedule.

How this medicine is administered

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

If you take more Posaconazole Almovar than you should

If you think you may have taken too much posaconazole, inform your doctor immediately or go to the hospital straight away.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Posaconazole Almovar

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

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

4. Possible adverse effects

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

Serious adverse effects

Tell your doctor or pharmacist immediately if you notice any of the following serious adverse effects; you may need urgent medical treatment:

• nausea or vomiting (feeling sick or being sick), diarrhoea
• signs of liver problems, including yellowing of the skin or the whites of the eyes, unusually dark urine or pale stools, feeling unwell without apparent reason, stomach problems, loss of appetite, or unusual tiredness or weakness, or increased liver enzymes detected in blood tests
• allergic reaction

Other adverse effects

Tell your doctor or pharmacist if you notice any of the following adverse effects:

Frequent: the following may affect up to 1 in 10 patients

• changes in blood electrolyte levels detected in blood tests, which may include symptoms such as confusion or weakness
• abnormal sensations in the skin, such as numbness, tingling, itching, crawling sensations, pricking, 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 discomfort, flatulence, dry mouth, changes in taste sensation
• heartburn (a burning sensation in the chest rising up to the throat)
• low levels of "neutrophils", a type of white blood cell (neutropenia), which may increase your susceptibility to infections and is detected in blood tests
• fever
• feeling weak, dizzy, tired, or sleepy
• rash
• itching
• constipation
• rectal discomfort

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

• anaemia, with symptoms including headaches, feeling tired or dizzy, shortness of breath, or paleness, and low haemoglobin levels detected in blood tests
• low platelet count (thrombocytopenia), detected in blood tests. This may lead to bleeding
• low levels of "leukocytes", a type of white blood cell (leukopenia), 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 occur if you have an inflammatory condition
• inflammation of blood vessels
• heart rhythm problems
• seizures (fits)
• nerve damage (neuropathy)
• abnormal heart rhythm detected on an 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 to the spleen (splenic infarction), which may cause severe stomach pain
• serious kidney problems, with symptoms including increased or decreased urination with urine of unusual colour
• high blood creatinine levels, detected in blood tests
• cough, hiccups
• nosebleeds
• sharp, severe chest pain when breathing (pleuritic pain)
• swelling of lymph nodes (lymphadenopathy)
• decreased sensitivity, especially in the skin
• tremors
• high or low blood sugar levels
• blurred vision, light sensitivity
• hair loss (alopecia)
• mouth ulcers
• chills, general feeling of discomfort
• pain, back or neck pain, pain in arms or legs
• fluid retention (oedema)
• menstrual problems (abnormal vaginal bleeding)
• inability to sleep (insomnia)
• complete or partial inability to speak
• swelling of the mouth
• abnormal dreams or sleep disturbances
• problems with coordination or balance
• inflammation of the mucosa
• nasal congestion
• difficulty breathing
• chest discomfort
• feeling bloated
• nausea, vomiting, cramps, and mild to severe diarrhoea, usually caused by a virus, stomach pain
• belching
• feeling restless

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

• pneumonia, with symptoms including shortness of breath and production of 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 skin rash with blisters and skin peeling
• mental problems, such as hearing voices or seeing things that are not there
• fainting
• problems with thinking or speaking, sudden jerky movements, especially in the hands, that you cannot control
• stroke, with symptoms including 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 may lead to cardiac arrest and death, heart rhythm problems with sudden death
• blood clots in the legs (deep vein thrombosis), with symptoms including severe pain or swelling in the legs
• blood clots in the lungs (pulmonary embolism), with symptoms including shortness of breath or pain when breathing
• bleeding in the stomach or intestines, with symptoms including vomiting blood or blood in the stools
• intestinal blockage (intestinal obstruction), especially of the "ileum". This blockage prevents intestinal contents from passing through the colon, with symptoms including bloating, vomiting, severe constipation, loss of appetite, and cramps
• "haemolytic uraemic syndrome" that occurs when red blood cells are destroyed (haemolysis), which may occur with or without kidney failure
• "pancytopenia", low levels of all blood cells (red blood cells, white blood cells, and platelets), detected in blood tests
• large purple spots on the skin (thrombotic thrombocytopenic purpura)
• swelling of the face or tongue
• depression
• double vision
• breast pain
• inadequate adrenal gland function, which may cause weakness, fatigue, loss of appetite, skin discolouration
• inadequate pituitary gland function, which may lead to low blood levels of certain hormones affecting male or female sexual organ function
• hearing problems
• pseudoaldosteronism, causing high blood pressure with low potassium levels (detected in blood tests)

Frequency not known: cannot be estimated from available data

• some patients have also reported confusion after taking posaconazole.

Tell your doctor or pharmacist if you experience any of the adverse effects listed above.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Posaconazole Almovar

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

Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Posaconazol Almovar

• The active substance is posaconazole. Each tablet contains 100 mg of posaconazole.
• The other components are:
  Tablet core: Hypromellose acetate succinate, microcrystalline cellulose, hydroxypropylcellulose, colloidal anhydrous silica, sodium croscarmellose, magnesium stearate
  Coating material: Poly(vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172)

Appearance of the product and contents of the pack

Posaconazol Almovar gastro-resistant tablets are yellow, film-coated, oblong, biconvex tablets (17.7 mm in length and 7.0 mm in width).

Posaconazol Almovar film-coated tablets are available in packs containing 24, 48, and 96 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lote 15

3450-232 Mortágua,

Portugal

Manufacturer

Laboratórios Basi - Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15, 16

3450-232 Mortágua

Portugal

Further information on this medicinal product can be obtained from the local representative of the Marketing Authorization Holder:

LAPHYSAN, S.A.U.

Anabel Segura 11, Edificio A, 4th Floor, Door D,

28108 Alcobendas - Madrid

Spain

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

Portugal: Posaconazol Almovar
Spain: Posaconazol Almovar 100 mg gastro-resistant tablets EFG

Date of the most recent review of this leaflet: September 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/