ANSATIPIN 150 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Ansatipin 150mg Hard Capsules

rifabutin

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Ansatipin 150 mg and what is it used for
2. What you need to know before taking Ansatipin 150 mg
3. How to take Ansatipin 150 mg
4. Possible side effects
5. Storage of Ansatipin 150 mg
6. Contents of the pack and other information

1. What is Ansatipin 150 mg and what is it used for

Ansatipin 150 mg is an antibiotic belonging to the group of rifamycins.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

It is used in adults for the prevention of Mycobacterium avium-intracellulare (MAC)infections in patients with HIV (Human Immunodeficiency Virus) infection, when clinically necessary.

Ansatipin is also used in adults for the treatment of the following infections when other treatments are not suitable:

• Treatment of symptomatic localized or disseminated infection caused by atypical mycobacteria (such as Mycobacterium aviumand other species) in patients with HIV infection.

• Treatment of pulmonary tuberculosis (Mycobacterium tuberculosis) when treatment with rifampicin is not suitable due to the risk of pharmacological interactions or in cases of resistance to rifampicin and confirmed sensitivity to rifabutin.

For the treatment of atypical mycobacteria and pulmonary tuberculosis, Ansatipin will always be given in combination with other active anti-mycobacterial drugs.

Consult your doctor if you have any questions about how Ansatipin works or why it has been prescribed for you.

2. What you need to know before taking Ansatipin 150 mg

Do not take Ansatipin 150mg

• if you are allergic to rifabutin or other medicines of the same family (rifamycins) such as rifampicin, or to any of the other components of this medicine (listed in section 6).
• if you are receiving treatment with medicines containing rilpivirine administered as a prolonged-release injectable suspension.

Warnings and Precautions

Consult your doctor or pharmacist before starting treatment if:

• You have a severe kidney or liver disease, as your doctor may need to adjust the dose of Ansatipin.
• You are taking medicines for HIV, as they may interact with Ansatipin (see section Other medicines and Ansatipin 150 mg).
• You are taking oral contraceptives, as Ansatipin may reduce their contraceptive effectiveness.

Consult your doctor or pharmacist if during treatment:

• You experience severe skin reactions such as inflammation of the skin and mucous membranes that can be very severe (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis), or drug rash with eosinophilia and systemic symptoms (DRESS, which includes skin rash, lymph node inflammation, and elevated eosinophils and inflammation of internal organs [liver, lungs, heart, kidneys, and large intestine]). In these cases, you should immediately consult your doctor, who will decide whether to discontinue rifabutin administration.
• You are diagnosed with active tuberculosis, as you will need to be given anti-tuberculosis drugs.
• You develop eye inflammation (uveitis). You should consult with your ophthalmologist and your doctor to determine if the dose should be reduced or treatment with Ansatipin discontinued.
• You experience diarrhea, abdominal pain, or fever during or after treatment, as these may be symptoms of a severe intestinal disease. Inform your doctor, who will decide whether to discontinue treatment with Ansatipin or apply another suitable therapeutic measure.

Ansatipin may cause a reddish-orange discoloration of urine, as well as skin or other body secretions. Contact lenses may be permanently stained.

Children and Adolescents

The safety and efficacy of Ansatipin in children have not been established.

Other medicines and Ansatipin 150mg

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

It is possible that treatment with Ansatipin may require modification of the doses of other medicines that are associated with treatment or that you are taking habitually due to interactions between them (increase or decrease of the effect of the medicines).

Therefore, if you start treatment with Ansatipin, it may be necessary for your doctor to closely monitor you and/or adjust the doses of certain medicines you are taking, such as:

• medicines to prevent blood clotting (warfarin)
• medicines to treat pain (opioid analgesics such as codeine and morphine)
• anti-inflammatory medicines (corticosteroids)
• immunosuppressants used to prevent transplant rejection (cyclosporine, tacrolimus)
• medicines to treat heart diseases (digoxin, quinidine, verapamil, beta-blockers disopyramide or mexiletine)
• medicines to treat diabetes (oral hypoglycemics)
• antiepileptics (phenytoin and other anticonvulsants)
• anxiolytics or sedatives (diazepam and barbiturates)
• medicines to reduce triglycerides in the blood (clofibrate)
• antibiotics to treat bacterial infections (dapsone, sulfamethoxazole-trimethoprim, clarithromycin, and chloramphenicol)
• antifungals to treat fungal infections (ketoconazole, fluconazole, voriconazole, posaconazole, and itraconazole)
• antiretrovirals to treat HIV (delavirdine, didanosine, dolutegravir, doravirine, elvitegravir/cobicistat, etravirine, indinavir, saquinavir, rilpivirine [for oral use, e.g., tablets], ritonavir, zidovudine, nelfinavir, amprenavir, bictegravir, combinations of atazanavir, darunavir, fosamprenavir, tipranavir, and lopinavir with ritonavir)
• medicines to treat hepatitis C (sofosbuvir)
• antitubercular medicines to treat tuberculosis (bedaquiline, ethambutol, isoniazid, rifampicin, and p-aminosalicylic acid). If rifabutin and p-aminosalicylic acid are administered, they should be taken 12 hours apart, as the latter may alter the absorption of Ansatipin.
• antacids. If you take them, you should do so 3 hours after taking Ansatipin
• oral contraceptives, as rifabutin may reduce their contraceptive effectiveness (ethinylestradiol/norethisterone)

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

You should not use Ansatipin during pregnancy unless your doctor considers it necessary.

Consult your doctor if you use oral contraceptives, as Ansatipin may reduce their contraceptive effectiveness.

It is not known whether rifabutin is excreted in breast milk. If you are breastfeeding, consult your doctor to determine whether to interrupt breastfeeding or discontinue treatment with Ansatipin.

Driving and Using Machines

The influence of this medicine on the ability to drive or use machines is negligible or nonexistent.

Ansatipin 150mg Hard Capsules contain Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule; it is essentially "sodium-free".

3. How to take Ansatipin 150 mg

Follow exactly the administration instructions of this medicine as indicated by your doctor. If in doubt, consult your doctor again.

The recommended dose of Ansatipin is taken once a day at any time of the day, regardless of meals. In patients with nausea, vomiting, or other gastrointestinal problems, administration with food is recommended.

Adults

• If you take Ansatipin as the only treatment:

• If you take Ansatipin with other treatments:

Your doctor will decide the duration of treatment based on the response obtained.

In patients with liver or kidney disease, your doctor will assess whether to adjust the dose of Ansatipin.

If you take more Ansatipin 150mg than you should

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

If you forget to take Ansatipin

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Ansatipin

Do not stop treatment with Ansatipin before your doctor has indicated, as symptoms may worsen or reappear.

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

4. Possible side effects

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

Consult your doctor immediatelyif you experience any of the following side effects:

• Severe allergic reactions (anaphylactic shock) (frequency not known)
• Severe skin reactions (see Warnings and Precautions)(frequency not known)

The following are other side effects that may occur:

The side effects very common (at least 1 in 10 patients)are:

• Decrease in white blood cells (leukopenia).

The side effects common (at least 1 in 100 patients)are:

• Decrease in the number of red blood cells in the blood (anemia).
• Rash.
• Nausea.
• Muscle pain (myalgia).
• Fever.

The side effects uncommon (at least 1 in 1,000 patients)are:

• Decrease in all blood cells (pancytopenia).
• Decrease in granulocytes, a type of blood cell (granulocytopenia or agranulocytosis).
• Decrease in neutrophils, a type of blood cell (neutropenia).
• Decrease in lymphocytes, a type of blood cell (lymphopenia).
• Decrease in platelets (thrombocytopenia).
• Increase in eosinophils, a type of blood cell (eosinophilia).
• Allergic reactions (hypersensitivity).
• Narrowing of the airways that makes it difficult for air to pass to the lungs (bronchospasm).
• Eye inflammation (uveitis).
• Eye disorders (corneal deposits).
• Vomiting.
• Yellowing of the skin and mucous membranes (jaundice).
• Increased liver enzymes.
• Change in skin color.
• Joint pain (arthralgia).

The side effects with frequency not knownare:

• Skin reactions: drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), erythema multiforme, exfoliative dermatitis, bullous dermatitis.
• Clostridiodes difficilecolitis, a severe intestinal disease.
• Change in urine color.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ansatipin

Store below 25°C.

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

Do not use this medicine after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

Do not use this medicine if you notice that the carton is damaged or has been opened.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicinal products in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ansatipin

• The active substance is rifabutin.
• The other components (excipients) are: microcrystalline cellulose (E460i), sodium lauryl sulfate (E487), magnesium stearate (E470b), and colloidal silica. The components of the capsule are: gelatin, red iron oxide (E172), and titanium dioxide (E171).

Appearance of the product and contents of the pack

Ansatipin is presented as hard gelatin capsules, opaque, and reddish-brown in color, packaged in transparent PVC/Aluminum blisters. Each pack contains 30 hard capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Binesa 2002, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid), Spain

Local Representative

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid), Spain

Manufacturer

Pfizer Italia S.r.L.

Via del Commercio

63046, Marino del Tronto, Ascoli-Piceno, Italy.

Date of the last revision of this package leaflet:June 2024

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