RIFAMAZID 300 mg/150 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Rifamazid, 150 mg + 100 mg, Hard Capsules
3. Rifamazid, 300 mg + 150 mg, Hard Capsules
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Rifamazid and what is it used for
   1. Indications for Use
5. Important Information Before Taking Rifamazid
   1. When Not to Take Rifamazid:
   2. Warnings and Precautions
   3. Rifamazid and Other Medicines
   4. Effect on Laboratory Test Results
   5. Pregnancy and Breastfeeding
   6. Driving and Operating Machines
   7. Rifamazid Contains Azorubine (E 122) and Sodium
6. How to Take Rifamazid
   1. Adults
   2. Use in Patients with Renal and/or Hepatic Impairment
   3. Elderly Patients
   4. Treatment Duration
   5. Taking a Higher Than Recommended Dose of Rifamazid
   6. Missing a Dose of Rifamazid
   7. Do Not Take a Double Dose to Make Up for a Missed Dose.
   8. Discontinuing Rifamazid
   9. In Case of Any Further Doubts About Taking This Medicine, Consult a Doctor.
7. Possible Side Effects
   1. If Any of the Following Serious Side Effects Occur, Discontinue the Medicine and Immediately Inform Your Doctor or Go to the Nearest Emergency Department in the Hospital.
   2. If Any of the Following Side Effects Occur, Contact a Doctor Immediately:
   3. Other Side Effects That May Occur During Treatment
   4. Reporting Side Effects
8. How to Store Rifamazid
9. Contents of the Pack and Other Information
   1. What Rifamazid Contains
   2. What Rifamazid Looks Like and What the Pack Contains
   3. Marketing Authorization Holder and Manufacturer
   4. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Rifamazid, 150 mg + 100 mg, Hard Capsules

Rifamazid, 300 mg + 150 mg, Hard Capsules

Rifampicin (Rifampicinum) + Isoniazid (Isoniazidum)

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Rifamazid and what is it used for

Rifamazid is a medicine that contains two active substances: rifampicin and isoniazid. It is used to treat tuberculosis. The combination of these two substances in one medicine prevents the reduction of sensitivity of the tubercle bacilli (bacteria that cause tuberculosis) to the medicine.

Indications for Use

All forms of pulmonary and extrapulmonary tuberculosis, both newly diagnosed and recurrent, with preserved sensitivity of the tubercle bacilli to rifampicin and isoniazid.

2. Important Information Before Taking Rifamazid

Before starting treatment with Rifamazid and several times during treatment, the doctor may order a test to determine the sensitivity of the tubercle bacilli to rifampicin and isoniazid.
If it turns out that the tubercle bacilli are resistant to rifampicin and/or isoniazid, and the patient does not respond to treatment, the doctor will change the treatment method.

When Not to Take Rifamazid:

• if the patient is allergic to rifampicin, isoniazid, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has severe liver failure or jaundice (yellowing of the skin and whites of the eyes).
• if the patient is being treated with saquinavir or ritonavir (medicines used in patients with HIV infection; see "Rifamazid and other medicines").

➢ If the above circumstances apply to the patient, they should not take Rifamazid.
In case of doubts before starting treatment with Rifamazid, consult a doctor or pharmacist.

Warnings and Precautions

Before starting treatment with Rifamazid, discuss it with your doctor or pharmacist.

• During treatment, the patient should remain under the control of a pulmonologist or another doctor of the relevant specialty.
• For each patient before starting treatment with Rifamazid, the doctor will order liver function tests and blood tests.
• For patients with normal liver function, liver function tests are repeated if the patient experiences: fever, vomiting, jaundice, or other symptoms that worsen the patient's condition. If the patient experiences any of these symptoms while taking Rifamazid, they should inform their doctor.
• For patients with liver failure, the doctor will determine the dosage of Rifamazid based on the degree of liver failure and order liver function tests before starting treatment, then once a week for the first 2 weeks of treatment, and then every 2 weeks throughout the treatment period.
• If serious symptoms of liver failure occur during treatment, Rifamazid should be discontinued. The doctor will consider another method of treating tuberculosis. When the liver test results return to normal, the doctor may consider re-administering Rifamazid, ordering daily laboratory tests (monitoring liver function parameters).
• For patients with normal liver function, an increase in bilirubin levels, liver enzyme activity (alkaline phosphatase or aminotransferases) at the beginning of treatment is not a reason to discontinue the medicine. These symptoms are usually transient. The doctor will order a repeat test during treatment.
• For patients treated in an intermittent regimen (the medicine is administered less frequently than 2 to 3 times a week), severe side effects are more common, especially those related to the immune system (see section 4 "Possible side effects"). Patients treated in this way should be under close medical supervision. The doctor will also recommend frequent tests to avoid complications related to this dosing regimen.
• Special caution should be exercised when treating elderly patients, those who are debilitated, or those with a predisposition to neuropathy (a disease of the peripheral nerves, the symptoms of which are most often numbness and pain in the hands and feet).
• During treatment with Rifamazid, saliva, sputum, tears, urine may have a reddish-brown or orange color. Soft contact lenses may also be discolored.
• During treatment with Rifamazid, do not drink alcohol, as it increases the risk of liver damage.
• During treatment with Rifamazid, periodic eye exams are recommended, especially for patients with eye diseases.
• If the patient has porphyria (a rare metabolic disorder related to blood), they should inform their doctor before starting treatment with Rifamazid, as the symptoms of the disease may worsen under the influence of the medicine.

Consult a doctor, even if the above warnings apply to a situation that occurred in the past.
In case of doubts whether the above circumstances apply to the patient, consult a doctor or pharmacist before starting treatment with Rifamazid.

Rifamazid and Other Medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Rifampicin and isoniazid may enhance or weaken the effect of medicines taken at the same time.
In most cases, the doctor must change the dosage of medicines that must be taken at the same time as anti-tuberculosis medicines. After discontinuing Rifamazid, the doctor will again modify the dosages of the medicines.
Below are examples of medicines that interact with rifampicin and/or isoniazid:
Medicines used for heart diseases [e.g., mexiletine, quinidine, disopyramide, lorcaide, tocainide, verapamil, bisoprolol, cardiac glycosides (digitoxin, digoxin)].
Antiepileptic medicines (phenytoin, carbamazepine, ethosuximide).
Medicines used for mental illnesses (e.g., haloperidol).
Medicines that reduce blood clotting (e.g., acenocoumarol, warfarin).
Medicines used for fungal infections (fluconazole, itraconazole, ketoconazole).
Medicines used for anxiety and tension (diazepam, other benzodiazepine derivatives, hexobarbital).
Medicines used for bacterial infections (chloramphenicol, doxycycline).
Dapsone (a medicine with anti-inflammatory and antibacterial effects).
Medicines from the sulfonamide group with anti-inflammatory and anti-rheumatic effects (sulfasalazine).
Medicines used in patients with HIV infection (zidovudine).
Medicines that lower blood pressure (nifedipine, losartan).
Corticosteroids used for inflammatory conditions (e.g., hydrocortisone, betamethasone, prednisolone).
Medicines that lower cholesterol levels (clofibrate).
Oral anti-diabetic medicines (chlorpropamide, tolbutamide, oral sulfonylurea derivatives).
Medicines that suppress the immune system, usually used in patients after organ transplantation (cyclosporine, azathioprine).
Painkillers (methadone, narcotic painkillers).
Quinine used for malaria treatment.
Theophylline used for asthma and other lung diseases.
Triazolam (a medicine used for insomnia).
Oral contraceptives: Rifamazid may reduce their effectiveness. To avoid unplanned pregnancy, use a non-hormonal contraceptive method.
Cimetidine (a medicine used for stomach and duodenal ulcers, reflux esophagitis).
Medicines that neutralize stomach acid (sodium bicarbonate, aluminum hydroxide, magnesium trisilicate) may reduce the absorption of rifampicin and isoniazid. If it is necessary to use these medicines during tuberculosis treatment, Rifamazid should be taken at least 1 hour before the acid-neutralizing medicine.

Effect on Laboratory Test Results

Rifamazid may change laboratory test results. If it is necessary to perform any laboratory tests during treatment with Rifamazid, inform your doctor.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.
A pregnant woman may take Rifamazid only if the tuberculosis process is active and, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
Rifampicin used in the last months of pregnancy may cause postpartum bleeding in both the mother and the newborn. In such cases, the doctor may recommend vitamin K.
Rifampicin and isoniazid pass into breast milk. If it is necessary to administer the medicine to a breastfeeding woman, breastfeeding should be discontinued.

Driving and Operating Machines

It has not been found that Rifamazid affects the ability to drive vehicles and operate machines.
However, if side effects occur that impair concentration (e.g., pain, dizziness), vision disturbances (see section 4 "Possible side effects"), it is not recommended to drive vehicles or operate machines.

Rifamazid Contains Azorubine (E 122) and Sodium

Rifamazid 150 mg + 100 mg contains azorubine (E 122), which may cause allergic reactions.
Rifamazid 300 mg + 150 mg contains azorubine (E 122), which may cause allergic reactions.
Rifamazid 150 mg + 100 mg contains less than 1 mmol (23 mg) of sodium per capsule, i.e., the medicine is considered "sodium-free".
Rifamazid 300 mg + 150 mg contains less than 1 mmol (23 mg) of sodium per capsule, i.e., the medicine is considered "sodium-free".

3. How to Take Rifamazid

This medicine should always be taken according to the doctor's recommendations.
In case of doubts, consult a doctor.
Recommended dose

Adults

Patients with a body weight below 50 kg: 3 capsules of 150 mg + 100 mg per day, in a single dose.
Patients with a body weight above 50 kg: 2 capsules of 300 mg + 150 mg per day, in a single dose.

Use in Patients with Renal and/or Hepatic Impairment

If the patient has renal and/or hepatic impairment, they should inform their doctor before starting treatment with Rifamazid. For these patients, the doctor will individually determine the dosage based on the degree of renal and/or hepatic impairment.

Elderly Patients

Elderly patients, especially those with liver failure, during treatment with Rifamazid, should be under close medical supervision.

Treatment Duration

The doctor will decide when to end treatment.
The condition for ending treatment is completing the full anti-tuberculosis chemotherapy and a negative result of bacteriological tests detecting tubercle bacilli.
Method of administration
Rifamazid should be taken once a day, with a glass of water, 1 hour before a meal or 2 hours after a meal.

Taking a Higher Than Recommended Dose of Rifamazid

Shortly after overdosing on Rifamazid, the following may occur: nausea, vomiting, dizziness, slurred speech, blurred and blurred vision, visual hallucinations, liver damage, jaundice, coma. After a significant overdose, the following may occur: inhibition of respiratory and nervous system function, seizures. In laboratory tests, metabolic acidosis, acetonuria, and high blood sugar levels are found. Depending on the dose, orange or reddish-brown discoloration of the skin, saliva, sputum, urine, tears, sweat may appear.
In case of an overdose of Rifamazid, the unabsorbed medicine should be removed from the body as soon as possible or its absorption from the gastrointestinal tract should be reduced (induced vomiting, stomach lavage, administration of activated charcoal - if the patient is conscious) and contact a doctor as soon as possible.
In case of taking too much medicine (overdose), consult a doctor or go directly to the hospital. Show the medicine packaging.

Missing a Dose of Rifamazid

In case of missing a dose of the medicine at a fixed, specified time, the medicine should be taken as soon as possible, if the time to administer the next dose is long enough, or continue regular administration of the medicine.

Do Not Take a Double Dose to Make Up for a Missed Dose.

Discontinuing Rifamazid

It is essential to take the medicine according to the recommended treatment cycle. Do not discontinue treatment, even if the patient feels better. If the treatment cycle is discontinued 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 attending doctor.

In Case of Any Further Doubts About Taking This Medicine, Consult a Doctor.

4. Possible Side Effects

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

If Any of the Following Serious Side Effects Occur, Discontinue the Medicine and Immediately Inform Your Doctor or Go to the Nearest Emergency Department in the Hospital.

• Sudden shortness of breath and chest tightness, swelling of the eyelids, face, or lips.
• Severe skin rashes, which may be accompanied by the formation of blisters on the limbs, eyes, mouth, throat, and genitals.
• Loss of consciousness (fainting).
• Flu-like symptoms (fever, chills, headaches, and muscle pain, dizziness), shortness of breath, wheezing, decreased blood pressure, increased granulocyte count.
• Minor bruising on the skin of the lower limbs and torso, less often on the face and on the mucous membrane in the mouth (bleeding from the gums). These may be symptoms of thrombocytopenia. They mainly affect patients treated in an intermittent regimen. These symptoms disappear after discontinuing the medicine.

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• Lack of appetite, nausea, vomiting, fatigue, weakness - may be symptoms of severe liver function disorders.
• Diarrhea of significant severity, usually watery with blood and mucus, persistent, accompanied by abdominal pain and/or fever. This may be a symptom of severe colitis (pseudomembranous colitis), which can occur after taking antibiotics.

If Any of the Following Side Effects Occur, Contact a Doctor Immediately:

• Pancreatitis causing severe abdominal and back pain (frequency not known).
• Severe, extensive skin damage (exfoliation and separation of the skin and mucous membranes) (toxic epidermal necrolysis [TEN], may occur in less than 1 in 1000 people).
• Drug reaction causing rash, fever, inflammation of internal organs, hematological abnormalities, and systemic disease (DRESS syndrome, may occur in less than 1 in 1000 people).
• Jaundice or yellowing of the skin and whites of the eyes, or darker urine and lighter stools, fatigue, weakness, malaise, loss of appetite, nausea, or vomiting caused by liver disease (hepatitis, may occur in less than 1 in 100 people).

Other Side Effects That May Occur During Treatment

changes in blood cell count (decrease in red or white blood cell count and platelets),
abnormal breakdown of red blood cells (hemolytic anemia); these disorders may be the cause of such symptoms as fever, nosebleeds, pale skin;
menstrual disorders (in women treated with rifampicin for a long time);
headache and dizziness, drowsiness and fatigue, coordination disorders, confusion, concentration disorders, pain and numbness of limbs;
vision disorders;
heartburn, abdominal pain, decreased appetite, nausea, vomiting, bloating, diarrhea;
yellowing of the skin or whites of the eyes or dark urine and light stools: these may be symptoms of liver function disorders;
mild, self-limiting skin reactions, such as redness, itching, sometimes rash;
muscle weakness;
blood in urine, increased or decreased urine output - may indicate kidney function disorders;
orange or reddish-brown discoloration of saliva, urine, tears, sweat, feces;
inflammation of blood vessels, occurs with unknown frequency.

Reporting Side Effects

If you experience any side effects, including any 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.
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By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Rifamazid

Keep the medicine out of sight and reach of children.
Store in a temperature not exceeding 25°C. Keep the container tightly closed to protect from light and moisture.
Do not use the medicine after the expiry date (EXP) 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 Pack and Other Information

What Rifamazid Contains

• The active substances of the medicine are rifampicin and isoniazid. Rifamazid, 150 mg+100 mg -one hard capsule contains 150 mg of rifampicin and 100 mg of isoniazid. Rifamazid, 300 mg+150 mg -one hard capsule contains 300 mg of rifampicin and 150 mg of isoniazid.
• Other ingredients (excipients) are: colloidal silica, sodium lauryl sulfate, magnesium stearate, talc, sodium carboxymethylcellulose (type A), and azorubine (E 122), indigo carmine (E 132), titanium dioxide (E 171), gelatin.

What Rifamazid Looks Like and What the Pack Contains

Cherry-colored capsules.
Packaging:100 hard 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 number: 22 811-18-14
In order to obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder.

Date of Last Revision of the Leaflet:

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