Rifampicina Tzf

Package Leaflet: Information for the Patient

Rifampicin TZF, 150 mg, hard capsules

Rifampicin TZF, 300 mg, hard capsules

Rifampicin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Rifampicin TZF is a medicine that contains rifampicin as the active substance. Rifampicin is an anti-tuberculosis antibiotic that works 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 newly diagnosed, advanced, and chronic cases;
• leprosy;
• brucellosis, legionellosis, severe infections caused by staphylococci, in combination with other appropriate antibiotics for the specific 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 Taking Rifampicin TZF

When Not to Take Rifampicin TZF

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

Symptoms of hypersensitivity reactions 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").

Warnings and Precautions

Before Starting Rifampicin TZF, Discuss with Your Doctor.

Particular Caution is Advised When Taking 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 experiences numbness and muscle weakness in 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 schedule (the medicine is given 2 to 3 times a week); in this case, severe side effects, especially those related to the immune system, including anaphylactic shock (see section 4), occur more frequently.

Laboratory Tests

• The doctor will order blood tests before starting treatment. Based on the results, the doctor 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 the doctor about the use of rifampicin, as:
• rifampicin may cause false-positive opioid tests;
• rifampicin may mask the results of serum tests performed using microbiological methods to determine folate and vitamin B;
• rifampicin may interfere with 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

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Rifampicin may increase or decrease the effects of other medicines taken at the same time. In some cases, the doctor may change the dosage of medicines that you need to take with anti-tuberculosis medicines. After stopping Rifampicin TZF, the doctor will again modify the dosages of other medicines.

Do not take Rifampicin TZF if you are taking:

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

Tell Your Doctor if You 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, zolpiclone),
• 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 Hormone 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 (growth of 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.

in the treatment of advanced colon and rectal cancer.

Pain Relief, Anti-Inflammatory, and Gout Medicines:

• pain relief medicines (e.g., methadone, narcotic pain relief medicines),
• 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 she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.

Rifampicin TZF may be given to pregnant women only when the benefit to the mother outweighs the risk to the fetus.

There are limited data on the use of rifampicin during pregnancy.

Animal studies have shown that rifampicin 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 give the medicine to a breastfeeding woman, breastfeeding should be discontinued.

Driving and Operating Machines

The effect of Rifampicin TZF on the ability to drive vehicles and operate machines 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 machines.

Rifampicin TZF Contains Sodium

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

3. How to Take Rifampicin TZF

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult your 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 given 450 mg per day.

Patients with a body weight above 50 kg are given 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 given 450 mg per day.

Patients with a body weight above 50 kg are given 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 staphylococcal infections:

Adults

Usually, 600 to 1200 mg per day is administered in 2-4 divided doses, in combination with another appropriate 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.

Treatment 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 is advised if the dose is higher than 600 mg per day.

Elderly Patients

Caution is advised when using rifampicin in this patient group, especially if liver impairment is present.

Duration of Treatment

The doctor will decide when to stop the treatment.

The condition for stopping the treatment is completing the full anti-tuberculosis chemotherapy and having a negative result of bacteriological tests detecting tuberculosis bacteria.

Method of Administration

Rifampicin TZF should be taken 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.

Overdose of Rifampicin TZF

Shortly after overdosing on rifampicin, nausea, vomiting, and even coma may occur.

In case of overdosing on Rifampicin TZF, the unabsorbed medicine should be removed from the body as soon as possible, or its absorption from the gastrointestinal tract should be reduced (inducing vomiting, gastric lavage, administering activated charcoal - if the patient is conscious), and medical help should be sought immediately.

In case of taking a higher dose of the medicine than recommended, seek medical help immediately or go to the nearest emergency department in a hospital. Take the medicine in its original packaging so that the medical staff can accurately check which medicine was taken.

Missing a Dose of Rifampicin TZF

If a dose is missed at the usual time, the medicine should be taken as soon as possible, provided that the time to the next dose is long enough, or the regular administration of the medicine should be continued.

Do not take a double dose to make up for the missed dose.

Stopping Rifampicin TZF Treatment

It is essential to take the medicine according to the recommended treatment cycle. Do not stop the treatment because you feel better. If the treatment cycle is stopped too early, the infection may return.

If you feel worse during treatment or do not feel well after completing the recommended treatment cycle, consult your doctor.

In case of doubts about taking the medicine, consult your 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, stop taking 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 fluid, 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;
• nosebleeds, ear, gum, throat, skin, or stomach bleeding, as well as sensitivity and swelling of the stomach, purple spots on the skin, black tarry stools.

If any of the following symptoms occur, immediatelyconsult your 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, consult your doctor as soon as possible:

• water 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 (getting up, sitting);
• swelling of the fingers and toes and ankles;
• impaired concentration, nervousness, irritability, depression;
• severe fatigue, weakness, difficulty sleeping (insomnia);
• short-term memory loss, anxiety, decreased 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, inform your doctor or pharmacist:

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

Other side effects that you should report to your doctor

• Red or orange discoloration of urine, sweat, tears, and saliva. This is a side effect of taking rifampicin, but it is not a cause for concern. However, keep in mind that soft contact lenses may become permanently discolored. 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 you experience any side effects, including those not listed in this leaflet, tell your 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.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Rifampicin TZF

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

Store in 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Package 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.

• talc, magnesium stearate, sodium lauryl sulfate, red iron oxide (E 172), titanium dioxide (E 171), gelatin.

What Rifampicin TZF Looks Like and Contents of the Package

Hard red gelatin capsule.

Package: 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, contact the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet: