Rifampicina Tzf

Leaflet attached to the packaging: patient information

Rifampicin TZF, 150 mg, hard capsules

Rifampicin TZF, 300 mg, hard capsules

Rifampicin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Rifampicin TZF and what is it used for
• 2. Important information before using Rifampicin TZF
• 3. How to use Rifampicin TZF
• 4. Possible side effects
• 5. How to store Rifampicin TZF
• 6. Contents of the packaging and other information

1. What is Rifampicin TZF and what is it used for

Rifampicin TZF is a medicine that contains rifampicin as an active substance. Rifampicin is an anti-tuberculosis antibiotic that acts bactericidally.

Indications for use

Rifampicin is used to treat the following infections:

• tuberculosis; in combination with other anti-tuberculosis medicines, it is used to treat all forms of tuberculosis, including those diagnosed for the first time, advanced chronic and drug-resistant;
• leprosy;
• brucellosis, legionellosis, severe infections caused by staphylococci, in combination with other antibiotics suitable for the infection.

Rifampicin may also be used in:

• preventing meningococcal meningitis in asymptomatic carriers of Neisseria meningitidis;
• treating asymptomatic carriers of Haemophilus influenzaeand preventing the development of infection in children under 4 years of age who are in contact with this bacterium.

2. Important information before using Rifampicin TZF

When not to use Rifampicin TZF

• If the patient is hypersensitive (allergic) to rifampicin or any of the other ingredients of this medicine (listed in section 6).

Symptoms of an allergic reaction include: rash, swallowing or breathing problems, swelling of the lips, face, throat, or tongue.

• If the patient has jaundice (yellowing of the skin and whites of the eyes).
• If the patient is being treated with saquinavir or ritonavir (medicines used to treat HIV infection; see "Rifampicin TZF and other medicines"). If any of the above conditions apply to the patient, they should not take Rifampicin TZF. In case of doubt, before starting treatment with Rifampicin TZF, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting treatment with Rifampicin TZF, the patient should discuss it with their doctor.

Special caution should be exercised when using Rifampicin TZF if:

• the patient has impaired liver function; the doctor will determine the dosage of Rifampicin TZF based on the degree of liver impairment and will order liver function tests before starting treatment;
• the patient has symptoms indicating kidney function disorders, and the dose used is higher than 600 mg per day;
• the patient has diabetes; maintaining proper blood sugar levels may be more difficult during rifampicin treatment;
• the patient has numbness and weakness of the muscles of the arms and legs (peripheral neuropathy);
• the patient is underweight or malnourished;
• the patient has porphyria (a rare metabolic disorder related to blood); the symptoms of the disease may worsen under the influence of the medicine;
• the patient wears soft contact lenses; they may become discolored, as saliva, sputum, tears, and urine may have a red or orange color while taking Rifampicin TZF;
• the patient is a child;
• the patient is 65 years old or older;
• the patient is being treated in an intermittent regimen (the medicine is administered 2 to 3 times a week); in this case, severe side effects occur more frequently, especially those related to the immune system, including anaphylactic shock (see section 4).

Laboratory tests

• The doctor will order blood tests before starting treatment. Based on the results, they will determine if the medicine causes any changes in the patient's blood and, if necessary, order regular liver function tests.
• Before performing laboratory tests, the patient should inform their doctor about the use of rifampicin, as:
• rifampicin may cause false-positive opioid tests;
• rifampicin may mask the results of serum tests performed using the microbiological method to determine folic acid and vitamin B;
• rifampicin may disrupt the excretion of contrast agents used in gallbladder imaging; therefore, bilirubin levels, alkaline phosphatase activity, or aminotransferase, as well as gallbladder imaging, should be performed in the morning, before taking the medicine.

Rifampicin TZF and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Rifampicin may enhance or reduce the effect of medicines taken at the same time. In some cases, the doctor may change the dosage of medicines that the patient must take at the same time as anti-tuberculosis medicines. After discontinuing Rifampicin TZF, the doctor will again modify the dosages of medicines.
The patient should not take Rifampicin TZF if they are taking:

• saquinavir or ritonavir (medicines used to treat HIV infection).

The patient should inform their doctor if they are taking any of the following medicines.

Medicines used to treat heart and blood vessel diseases:

• medicines used to treat high blood pressure (e.g., losartan, bisoprolol, propranolol, isradipine, diltiazem, nizoldipine, nicardipine, isradipine, enalapril),
• medicines used to treat heart diseases and arrhythmias (e.g., mexiletine, quinidine, tocainide, propafenone, disopyramide, digitalis glycosides, nifedipine, verapamil),
• medicines that reduce blood clotting (e.g., warfarin),
• medicines that lower cholesterol levels (e.g., clofibrate, simvastatin),
• medicines with a diuretic effect (e.g., eplerenone),
• nimodipine.

Medicines used to treat mental illnesses, epilepsy, and nervous system disorders:

• medicines used to treat thought, emotional, and behavioral disorders, antipsychotic medicines (e.g., haloperidol, aripiprazole),
• medicines used to treat anxiety and tension (e.g., diazepam, other benzodiazepine derivatives, zolpidem, zolpiklon),
• sleeping pills (barbiturates),
• antiepileptic medicines (e.g., phenytoin),
• certain medicines used to treat depression (e.g., amitriptyline, nortriptyline),
• riluzole - used to treat neurological disorders leading to muscle weakness, atrophy, and paralysis.

Medicines used to treat infections and immune system disorders:

• certain medicines used to treat viral infections (e.g., zidovudine, saquinavir, indinavir, nelfinavir, atazanavir, lopinavir, nevirapine, efavirenz, amprenavir),
• medicines used to treat fungal infections (e.g., fluconazole, itraconazole, ketoconazole, voriconazole),
• medicines used to treat bacterial infections - antibiotics (e.g., chloramphenicol, doxycycline, clarithromycin, dapsone, fluoroquinolones, telithromycin),
• medicines used to weaken the immune system, i.e., immunosuppressive medicines (e.g., cyclosporine, tacrolimus, sirolimus), usually used in patients after organ transplantation,
• praziquantel (an antiparasitic medicine used to treat tapeworm infection),
• atovaquone (an antimalarial medicine used to treat pneumonia),
• medicines used to treat tuberculosis (para-aminosalicylic acid - PAS, isoniazid).

Medicines used in hormonal therapy and cancer treatment:

• certain hormonal medicines (e.g., estrogen, progestogen hormonal contraceptives); Rifampicin TZF may reduce the effectiveness of oral contraceptives,
• certain hormonal medicines (anti-estrogens) used to treat endometriosis (proliferation of the uterine lining) or breast cancer (e.g., tamoxifen, toremifene, gestrinone),
• certain medicines used to treat cancer - cytotoxic medicines (e.g., imatinib),
• medicines used to treat thyroid function disorders (e.g., levothyroxine - thyroid hormone),
• irinotecan used to treat advanced colon and rectal cancer.

irinotecan used to treat advanced colon and rectal cancer.

Painkillers, anti-inflammatory medicines, and medicines used to treat gout:

• painkillers (e.g., methadone, narcotic painkillers),
• corticosteroids used to treat inflammatory conditions (e.g., hydrocortisone, betamethasone, prednisolone).

Other medicines

• medicines used to treat diabetes (e.g., chlorpropamide, tolbutamide, glibenclamide, gliclazide, glipizide, glimepiride, rosiglitazone),
• medicines used to relax muscles before surgery, anesthetics (e.g., halothane),
• certain medicines used to prevent and treat nausea and vomiting (e.g., aprepitant, ondansetron),
• quinine used to treat malaria,
• theophylline used to treat asthma and other lung diseases,
• antacids (e.g., sodium bicarbonate, aluminum hydroxide, magnesium trisilicate) reduce the absorption of rifampicin; it is recommended to take these medicines at least 1 hour after taking rifampicin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Rifampicin TZF may only be administered to pregnant women when the benefit to the mother outweighs the risk to the fetus.
There are no data or only limited data on the use of rifampicin during pregnancy.
Animal studies, after the use of high doses of rifampicin, have shown that it has a harmful effect on reproduction.
Rifampicin used in the last months of pregnancy may cause postpartum bleeding in both the mother and the newborn. In such cases, vitamin K is recommended.
Rifampicin passes into breast milk. If it is necessary to administer the medicine to a breastfeeding woman, breastfeeding should be discontinued.

Driving and operating machinery

The effect of Rifampicin TZF on the ability to drive vehicles and operate machinery has not been studied. However, if side effects occur that reduce concentration (e.g., pain, dizziness) or impair vision (see section 4. Possible side effects), the patient should not drive vehicles or operate machinery.

Rifampicin TZF contains sodium

Rifampicin TZF 150 mg or 300 mg contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to use Rifampicin TZF

This medicine should always be used as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

Recommended dosage

Tuberculosis
Adults
Usually, 10 mg/kg body weight per day is administered.
Patients with a body weight below 50 kg are administered 450 mg per day.
Patients with a body weight above 50 kg are administered 600 mg per day.
Children
Usually, 10 to 20 mg/kg body weight per day is administered. The dose should not exceed 600 mg per day.
Leprosy
Usually, 600 mg is administered once a month or 10 mg/kg body weight per day.
Patients with a body weight below 50 kg are administered 450 mg per day.
Patients with a body weight above 50 kg are administered 600 mg per day.
In the treatment of leprosy, rifampicin should always be used in combination with at least one other anti-leprosy medicine.
Brucellosis, legionellosis, severe infections caused by staphylococci:
Adults
Usually, 600 to 1200 mg per day is administered in 2 to 4 divided doses, in combination with another suitable antibiotic, to prevent the development of resistant bacterial strains.
Prevention of meningococcal meningitis
Adults
600 mg twice a day for 2 days.
Children
Children aged 1 to 12 years: 10 mg/kg body weight twice a day for 2 days.
Children aged 3 to 12 months: 5 mg/kg body weight twice a day for 2 days.
Prevention of Haemophilus influenzaeinfections
Adults and children
If Haemophilus influenzaeinfection occurs in a family with a child under 4 years of age, it is recommended to administer rifampicin to all family members (including the child) at a dose of 20 mg/kg body weight per day (maximum 600 mg per day) for 4 days.
The administration of the medicine should be started before the infected person is discharged from the hospital.
Newborns (1st month)
10 mg/kg body weight per day for 4 days.
Patients with impaired liver function
The dose should not exceed 8 mg/kg body weight per day.
Patients with impaired kidney function
Caution should be exercised if the dose is higher than 600 mg per day.
Elderly patients
Caution should be exercised when using rifampicin in this patient group, especially if liver impairment is present.

Duration of treatment

The doctor will decide when to end the treatment.
The condition for ending the treatment is the completion of full anti-tuberculosis chemotherapy and a negative result of bacteriological tests detecting mycobacteria.

Method of administration

Rifampicin TZF should be used in combination with other anti-tuberculosis medicines.
The medicine should be taken on an empty stomach, with a glass of water, at least 30 minutes before eating or 2 hours after eating.

Using a higher dose of Rifampicin TZF than recommended

Shortly after overdosing on rifampicin, nausea, vomiting, and even coma may occur.
In case of an overdose of Rifampicin TZF, the patient should immediately remove the unabsorbed medicine from the body or reduce its absorption from the gastrointestinal tract (induce vomiting, rinse the stomach, administer activated charcoal - if the patient is conscious) and contact their doctor as soon as possible.
In case of using a higher dose of the medicine than recommended, the patient should immediately contact their doctor or go to the nearest emergency department in a hospital. The patient should bring the medicine in its original packaging so that the medical staff can accurately check which medicine was used.

Missing a dose of Rifampicin TZF

If a dose of the medicine is missed at a fixed, specified time, the patient should take it as soon as possible, if the time to the next dose is long enough, or continue taking the medicine regularly.
The patient should not take a double dose to make up for the missed dose.

Discontinuing Rifampicin TZF

It is essential to use the medicine according to the recommended treatment cycle. The patient should not stop the treatment because they feel better. If the treatment cycle is interrupted too early, the infection may return.
If the patient feels worse during treatment or does not feel well after completing the recommended treatment cycle, they should consult their doctor.
In case of doubts related to the use of the medicine, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Rifampicin TZF can cause side effects, although not everybody gets them.
The following side effects may occur during daily or intermittent administration of the medicine.
If any of the following symptoms occur, the patient should stop using the medicine and immediatelygo to the nearest emergency department in a hospital:

• allergic reaction: rash, swelling of the lips, face, tongue, or throat, and difficulty breathing and swallowing;
• fever, yellowing of the skin or whites of the eyes, loss of appetite, nausea, vomiting, fatigue; these may be the first symptoms of liver function disorders (including jaundice);
• small bruises, skin peeling, bleeding, blisters, also filled with serum, occurring on the skin of the face, mouth, eyes, nose, hands, feet, and genitals; this may indicate severe skin reactions;
• tendency to bruise, painful skin rashes, spots, partially disappearing under pressure (petechiae); these may be symptoms of thrombocytopenia, a serious blood disorder;
• chills, dizziness, fatigue, extremely pale skin, rapid heartbeat, dark urine; these may be symptoms of anemia;
• blood in the urine, increased or decreased urine output, swelling, especially of the legs, ankles, or feet; this may indicate a serious kidney function disorder;
• sudden, severe headache; this may be a symptom of brain bleeding;
• shortness of breath, wheezing;
• confusion, drowsiness, impaired concentration, cold sweaty skin, shallow breathing, rapid heartbeat, paleness; these may be symptoms of shock;
• increased susceptibility to infections, sore throat, mouth ulcers; these may indicate a decreased white blood cell count;
• bleeding from the nose, ear, gums, throat, skin, or stomach, as well as sensitivity and swelling of the stomach, purple spots on the skin, black tarry stools.

If any of the following symptoms occur, the patient should immediatelyconsult their doctor:

• psychiatric disorders, unusual thoughts, hallucinations (seeing, hearing, or feeling things that do not exist);
• severe diarrhea, watery, persistent, accompanied by fever; this may be a symptom of severe colitis (pseudomembranous colitis);
• flu-like symptoms, including chills, headaches, dizziness, bone pain.

If any of the following symptoms occur, the patient should consult their doctor as soon as possible:

• fluid retention in the body (edema), which may cause swelling of the face, abdomen, arms, or legs;
• muscle weakness, pain, loss of muscle reflexes;
• dizziness, weakness, fainting, especially when changing position quickly (getting up, sitting down);
• swelling of the fingers and toes and ankles;
• impaired concentration, nervousness, irritability, depression;
• severe fatigue, weakness, difficulty sleeping (insomnia);
• short-term memory loss, anxiety, reduced reaction speed, decreased alertness;
• wasting of muscles and other body tissues;
• weight loss, night sweats; these may be symptoms of eosinophilia (increased eosinophil count in a blood smear);
• nausea or vomiting.

If any of the following symptoms worsen or persist for more than a few days, the patient should inform their doctor or pharmacist:

• redness or itching of the skin;
• disorders of the menstrual cycle;
• diarrhea or stomach problems;
• loss of appetite (anorexia);
• headache.

Other side effects that the patient should report to their doctor

• Red or orange discoloration of urine, sweat, tears, and saliva. This is a symptom caused by taking rifampicin, but the patient should not be concerned, however, they should be aware that soft contact lenses may become permanently discolored. The discoloration of tears may persist for some time after stopping Rifampicin TZF.

Blood tests

• Blood test results may show changes in liver function parameters.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Rifampicin TZF

The medicine should be stored out of sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from light and moisture.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Rifampicin TZF contains

The active substance of the medicine is rifampicin.
Rifampicin TZF, 150 mg –one hard capsule contains 150 mg of rifampicin.
Rifampicin TZF, 300 mg –one hard capsule contains 300 mg of rifampicin.
Other ingredients of the medicine are: talc, magnesium stearate, sodium lauryl sulfate, red iron oxide (E 172), titanium dioxide (E 171), gelatin.

• gelatin.

What Rifampicin TZF looks like and contents of the packaging

Hard red gelatin capsule.
Packaging: 100 capsules in a container, in a cardboard box.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone: 22-811-18-14
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet: