Ficha técnica de Posaconazol tarbis 100 mg comprimidos gastrorresistentes efg – Espanha

Como usar Posaconazol tarbis 100 mg comprimidos gastrorresistentes efg

Introduction

Package Insert: Information for the User

Posaconazol Tarbis 100 mg gastro-resistant tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

Keep this package insert, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only, and you must 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, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

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

Posaconazol Tarbis 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.

This medication can be used in adults to treat fungal infections caused by fungi of the familyAspergillus.

Posaconazol can be used in adults and children aged 2 years or older and weighing more than 40 kg to treat the following types of fungal infections:

Infections caused by fungi of the familyAspergillusthat have not improved during treatment with the antifungal medications amphotericin B or itraconazole or when treatment with these medications has had to be interrupted;
Infections caused by fungi of the familyFusariumthat have not improved during treatment with amphotericin B or when treatment with amphotericin B has 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 has 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 has had to be interrupted.

This medication can also be used to prevent fungal infections in adults and children aged 2 years or older and weighing more than 40 kg with a high risk of contracting a fungal infection, such as:

Patients who present a weakened immune system as a result of having received chemotherapy for "acute myeloid leukemia" (AML) or "myelodysplastic syndromes" (MDS)
Patients who are receiving "high doses of immunosuppressive treatment" after a "hematopoietic stem cell transplant" (HSCT).

2. What you need to know before starting to take Posaconazol Tarbis

Do not take Posaconazol Tarbis

if you are allergic to posaconazol or any of the other components of this medication (listed in section 6).
if you 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 gradually increased for the treatment of chronic lymphocytic leukemia (CLL).

Do not take posaconazol if you are in any of the above circumstances. In case of doubt, consult your doctor or pharmacist before taking posaconazol.

See the section “Taking Posaconazol Tarbis with other medications” later for more information, including that related to other medications that may interact with posaconazol.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take posaconazol if:

you have had an allergic reaction to another antifungal medication, such as ketoconazol, fluconazol, itraconazol or voriconazol.
you have or have had liver problems. You may need to have blood tests while taking this medication.
you develop severe diarrhea or vomiting, as these situations may limit the effectiveness of this medication.
you have a heart rhythm alteration (ECG) that shows a problem called prolongation of the QTc interval.
you have heart muscle weakness or heart failure.
you have a very slow heart rate.
you have any heart rhythm alteration.
you have any problem with the amounts of potassium, magnesium or calcium in your blood.
you are taking vincristine, vinblastine and other “vinca alkaloids” (medications used to treat cancer).
you 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.

If you develop severe diarrhea or vomiting (you feel sick) while taking posaconazol, consult your doctor, pharmacist or nurse immediately, as this situation may prevent the medication from working correctly. For more information, see section 4.

You should 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 experience increased skin sensitivity to UV sun rays.

Children

Posaconazol should not be given to children under 2 years of age.

Taking Posaconazol Tarbis 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 Tarbis 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 syndrome and mental disorders)
halofantrina (used to treat malaria)
quinidina (used to treat heart rhythm alterations).

Posaconazol may increase the amount of these medications in your 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 Tarbis may increase the amount of these medications in your blood, which could cause severe reduction of blood flow to your fingers or toes 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 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. In addition to the medications mentioned earlier, there are other medications that present a risk of heart rhythm problems, which may be greater when taken with posaconazol. 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 posaconazol side effects by increasing the amount of posaconazol in your blood.

The following medications may decrease the effectiveness of posaconazol by reducing its levels in your 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 side effects of rifabutina.
phenytoin, carbamazepine, phenobarbital or primidona (used to treat or prevent seizures).
efavirenz and fosamprenavir, used to treat HIV infection.
flucloxacilina (antibiotic used to treat bacterial infections).

Posaconazol may possibly increase the risk of side effects of other medications by increasing the amount of these medications in your 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)
all-trans retinoic acid (ATRA), also known as tretinoína (used to treat certain blood cancers).

If you are in any of the above circumstances (or in case of doubt), consult your doctor or pharmacist before taking posaconazol.

Pregnancy and breastfeeding

Inform your doctor if you are or think you may be pregnant before starting to take posaconazol.

Do not take posaconazol if you are pregnant, unless your doctor tells you to. If you are a woman who may become pregnant, you should use effective contraceptive measures while taking this medication. If you become pregnant while taking Posaconazol Tarbis, contact your doctor immediately.

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

Driving and using machines

You may feel dizziness, drowsiness or experience blurred vision while taking posaconazol, 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 Tarbis contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

3. How to Take Posaconazol Tarbis

Do not interchange Posaconazol Tarbis tablets and oral suspension without consulting your doctor or pharmacist, as it may lead to reduced efficacy or increased risk of adverse reactions.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

What dose is administered

The recommended dose is 300 mg (three 100 mg tablets) twice a day on the first day and subsequently 300 mg (three 100 mg tablets) once a day.

The duration of treatment may depend on the type of infection you have and may be individually adapted for you by your doctor. Do not adjust your dose yourself before consulting your doctor, nor change your treatment schedule.

How to administer this medication

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

If you take more Posaconazol Tarbis than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Posaconazol Tarbis

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

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 may cause bleeding
low white blood cell levels (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
heart rhythm problems
seizures
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 is a different color from usual
high creatinine levels 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, light sensitivity
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
total or partial inability to speak
swelling of the mouth
abnormal dreams or sleep problems
coordination or balance problems
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 exfoliation
mental problems, such as hearing voices or seeing things that are not there
syncope
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 or 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
large purple spots and patches on the skin (thrombotic thrombocytopenic purpura)
inflammation of the face or tongue
depression
double vision
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 posaconazole.
- skin redness.

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 Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Posaconazol Tarbis

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

Do not use this medication after the expiration date that appears on the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

6. Content of the container and additional information

Composition of Posaconazol Tarbis

The active ingredient is posaconazol.

Each gastro-resistant tablet contains 100 mg of posaconazol.

Tablet core:Acetate succinate of hypromellose, microcrystalline cellulose, hydroxypropyl cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Tablet coating:Polialcohol vinílico (E1203), titanium dioxide (E171), macrogol 3350, (E1521), talc (E553b), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and content of the container

Posaconazol Tarbis gastro-resistant tablets are orange-colored, oblong, coated tablets with a "H" on one face and "P11" on the other.

Blister packs of 24 and 96 tablets and perforated single-dose blister packs of 24 x 1 and 96 x 1 tablets.

Only some container sizes may be commercially available.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Posaconazol Amarox 100 mg gastro-resistant tablets

Spain:Posaconazol Tarbis 100 mg gastro-resistant tablets EFG

Netherlands:Posaconazol Amarox 100 mg, gastric-resistant tablets

Last review date of this leaflet:

September 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/