Prospect: information for the patient

Ansatipin 150mg hard capsules

rifabutin

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Ansatipin 150mg

3.How to take Ansatipin 150mg

4.Possible adverse effects

5.Storage of Ansatipin 150mg

6.Contents of the package and additional information

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

It is used in adults to prevent infections byMycobacterium avium-intracellulare (MAC)in patients with HIV (Human Immunodeficiency Virus) infection, when clinically necessary.

Ansatipin is also used in adults to treat the following infections when other treatments are not suitable:

• Treatment of localized or disseminated infection caused by atypical mycobacteria (such asMycobacterium aviumand other species),inpatients with HIV infection

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

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

Consult your doctor if you have any questions about how Ansatipin works or why you have been prescribed this medication.

Do not take Ansatipin 150mg

• If you are allergic to rifabutin or to 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 that contain rilpivirina and are administered as a prolonged-release injectable suspension.

Warnings and precautions

Consult your doctor or pharmacistbefore starting treatmentif:

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

Consult your doctor or pharmacist ifduring treatment:

• You experience severe skin reactions such as skin inflammation and mucous membrane inflammation that can be very serious (Stevens-Johnson syndrome), skin inflammation with blisters (toxic epidermal necrolysis) or drug-induced rash with eosinophilia and systemic symptoms (DRESS, which includes skin rash, lymph node inflammation, and elevated eosinophils [a type of white blood cell] and internal organ inflammation [liver, lungs, heart, kidneys, and large intestine]). In these cases, you should immediately consult your doctor, who will decide whether to discontinue the administration of rifabutin.
• You are diagnosed with active tuberculosis, as you will need to administer antituberculosis medicines.
• You develop eye inflammation (uveitis). You should consult with your ophthalmologist and your doctor if necessary to reduce the dose or discontinue treatment with Ansatipin.
• You experience diarrhea, abdominal pain, or fever during treatment or after treatment, as it may be a symptom of a serious intestinal disease. Inform your doctor, who will decide whether to discontinue treatment with Ansatipin or apply another appropriate therapeutic measure.

Ansatipin may cause a reddish-orange discoloration of the urine, as well as the skin or other bodily secretions. Contact lenses may become 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 used recently, or may need to use any other medicine.

The treatment with Ansatipin may require modification of the doses of other medicines that are associated with treatment or that the patient takes habitually due to interactions between them (increase or decrease of the effect of the medicines).

Therefore, if you start treatment with Ansatipin, you may need close follow-up by your doctor, and/or adjustment of the doses of certain medicines that you were taking, such as:

• Medicines to prevent blood coagulation (warfarin)
• Medicines to treat pain (opioid analgesics such as codeine and morphine)
• Anti-inflammatory medicines (corticosteroids)
• Immunosuppressants, used to prevent transplant rejection (ciclosporin, tacrolimus)
• Medicines to treat heart disease (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, rilpivirina [for oral use, e.g., tablets], ritonavir, zidovudine, nelfinavir, amprenavir, bictegravir, combinations of atazanavir, darunavir, fosamprenavir, tipranavir, and lopinavir with ritonavir)
• Medicines to treat hepatitisC (sofosbuvir)
• Antituberculosos, to treat tuberculosis (bedaquilina, etambutol, isoniazida, rifampicin, and p-aminosalicylic acid). If rifabutin and p-aminosalicylic acid are administered, you should space the administration of both medicines 12 hours apart, as the latter may alter the absorption of Ansatipin.
• Antacids. If you take them, you should do so three hours after taking Ansatipin.
• Oral contraceptives, as rifabutin may reduce their effectiveness (ethinylestradiol / noretisterone)

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 intend 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 effectiveness.

The safety of rifabutin during breastfeeding is unknown. If you are breastfeeding, consult your doctor if you need to discontinue breastfeeding or discontinue treatment with Ansatipin.

Driving and operating machinery

The influence of this medicine on the ability to drive or operate machinery is negligible or insignificant.

Ansatipin 150mg hard capsules contain sodium

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

Follow exactly the administration instructions for this medication 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, it is recommended to take with food.

Adults

• If taking Ansatipin as the only treatment:

• If taking 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 Ansatipin dosage.

If taking more Ansatipin 150mg than prescribed

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 medication and the amount ingested.

If you forget to take Ansatipin

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ansatipin

Do not interrupt 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 medication, ask your doctor or pharmacist.

Like all medicines, this medicine mayproduceside effects, although not everyone will experience them.

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

• Severe allergic reactions (anaphylactic shock) (unknown frequency)
• Severe skin adverse reactions(see Warnings and Precautions)(unknown frequency)

The following are other side effects that may occur:

Common side effects (occurring in at least 1 in 10 patients)are:

• Decrease in white blood cells (leucopenia).

Side effects that areoccurring in at least 1 in 100 patientsare:

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

Side effects that areoccurring in at least 1 in 1,000 patientsare:

• 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).
• Increased eosinophils, a type of blood cell (eosinophilia).
• Allergic reactions (hypersensitivity).
• Narrowing of the airways that makes it difficult topass air to the lungs (bronchopasm).
• Inflammation of the eye (uveitis).
• Eye changes (deposits in the cornea).
• Vomiting.
• Yellowing of the skin and mucous membranes (jaundice).
• Increased liver enzymes.
• Change in skin color.
• Pain in the joints (arthralgia).

Side effects withunknown frequencyare:

• Skin adverse reactions: drug reaction with eosinophilia and systemic symptoms (DRESS), toxic epidermal necrolysis (NET), Stevens-Johnson syndrome (SSJ), acute generalized pustular psoriasis (PEGA), erythema multiforme, exfoliative dermatitis, bullous dermatitis.
• Clostridioides difficile colitis, a severe intestinal disease.
• Change in urine color.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Store below 25°C.

Keep this medication out of sight and reach of children.

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

Do not use this medication if you observe that the box is damaged or has been opened.

Medications should not be thrown down the drains or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Ansatipin

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

Appearance of the product and contents of the packaging

Ansatipin is presented as hard, opaque, brown-red gelatin capsules, packaged in transparent PVC/Aluminum blisters. Each package contains 30 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

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

Responsible for manufacturing

Pfizer Italia S.r.L.

Via del Commercio

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

Last review date of this leaflet: June 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )