Nidrazid

Package Leaflet: Information for the User

Nidrazid, 100 mg, Tablets

Isoniazid

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.
• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nidrazid and what is it used for

Isoniazid (the active substance of Nidrazid) acts on tuberculosis bacteria.
Nidrazid is indicated for the treatment of all forms of pulmonary and extrapulmonary tuberculosis, as well as for the prevention of pulmonary tuberculosis.
During tuberculosis treatment, Nidrazid is used in combination with other anti-tuberculosis medicines to prevent the development of resistance to this medicine (loss of efficacy).
For prevention, Nidrazid is usually used as a single medicine.
The medicine is indicated for use in adults and children over 3 years of age who are able to swallow a tablet (if there are difficulties with swallowing, the tablet can be crushed).

2. Important information before taking Nidrazid

When not to take Nidrazid

• if you are allergic to isoniazid or any of the other ingredients of this medicine (listed in section 6).
• if you have severe liver failure or drug-induced liver failure.

Warnings and precautions

Before starting treatment with Nidrazid, you should discuss it with your doctor if you have any of the following conditions:

• epilepsy,
• psychosis,
• tendency to bleeding,
• neuritis,
• liver function disorders (current or past); your doctor may discontinue the medicine or modify the dosage,
• kidney function disorders; your doctor may modify the dosage; in patients with severe kidney function disorders, the use of the medicine should be carefully monitored,
• AIDS;
• diabetes.

Particular caution is required in patients:

• of advanced age;
• who consume alcoholic beverages daily;
• who take intravenous drugs;
• who are malnourished;
• who require high doses of Nidrazid; this may lead to a deficiency of vitamin B, which may increase the frequency of certain side effects. If neuritis occurs, your doctor will recommend increasing the dose of vitamin B to 50 mg per day.
• During treatment (even several months after starting treatment), severe liver inflammation may develop, sometimes leading to death. In patients over 35 years of age, liver inflammation and monitoring for signs of liver inflammation, such as fatigue, weakness, malaise, loss of appetite, nausea, or vomiting, are more common. If these symptoms occur, the medicine should be discontinued immediately;
• Each adult patient should have liver function tests and blood tests before starting treatment with Nidrazid.
• During treatment, the patient should remain under medical supervision and visit the doctor at least once a month for check-ups.
• In patients over 35 years of age, liver function tests should be performed regularly, at least once a month.
• If abnormal parameters are detected in a patient, they will be re-evaluated and the doctor may recommend repeating laboratory tests if necessary.
• If the patient has not had liver disease in the past, liver function tests are performed if symptoms such as fever, vomiting, jaundice, or other symptoms indicating a worsening condition occur. If these symptoms occur during treatment with Nidrazid, the doctor should be informed.
• In patients with liver function disorders, treatment is used only when necessary, with special caution and under close medical supervision; the doctor will order liver function tests before starting treatment, then every 2 to 4 weeks throughout the treatment period.
• The medicine should be discontinued if signs of liver failure occur during treatment. The doctor will consider an alternative method of treating tuberculosis. When liver test results return to normal, the doctor may consider re-administering Nidrazid, ordering daily laboratory tests (monitoring liver function parameters).
• The medicine should be used with caution in black and Latino women.
• In children (except for children with a confirmed risk of hepatotoxicity), routine liver function tests are not necessary.
• If a patient develops a progressive rash (often with blisters or mucosal lesions), they should contact their doctor immediately, as these may be symptoms of severe skin reactions called Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) (see section 4).
• If a patient suddenly develops fever or lymph node enlargement, they should consult their doctor immediately, as these may be symptoms of multi-organ disorders of hypersensitivity known as drug reaction with eosinophilia and systemic symptoms (DRESS) (see section 4).

Nidrazid 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.
If your doctor recommends starting any other medicine, inform them that you are taking Nidrazid. Do not take any over-the-counter medicines without consulting your doctor while taking Nidrazid.
Isoniazid may affect the action of some medicines, and some medicines may affect the action of Nidrazid. If you are taking any of the following medicines, tell your doctor before starting treatment with Nidrazid, as dosage modification may be necessary:

• oral anticoagulants,
• antiepileptic drugs (phenytoin, carbamazepine, valproic acid, ethosuximide, primidone, barbiturates),
• benzodiazepines (drugs used to treat mental disorders),
• stavudine, zalcitabine (drugs used to treat HIV infections)
• rifampicin (antibiotic),
• cycloserine (antibiotic),
• disulfiram (drug used to treat alcoholism),
• ketoconazole, itraconazole (antifungal drugs),
• alfentanil (drug used in anesthesia for operations),
• antacids (used for hyperacidity) containing aluminum - these drugs reduce the absorption of isoniazid, so it is recommended to take Nidrazid one hour before taking antacids,
• p-aminosalicylic acid (anti-tuberculosis drug).

Nidrazid with food, drink, and alcohol

A patient taking isoniazid should avoid consuming foods and drinks containing tyramine (such as cheese, red wine) and histamine (such as bonito, tuna, other tropical fish).
Alcoholic beverages should not be consumed while taking Nidrazid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The decision to use the medicine during pregnancy or breastfeeding will be made by your doctor.
Isoniazid passes into breast milk. However, its concentration in milk is low.
Women should not breastfeed while taking isoniazid, unless the potential benefit to the mother outweighs the risk to the infant, as assessed by the doctor.

Driving and using machines

When taken in recommended doses, Nidrazid does not affect the ability to concentrate. However, in case of overdose, psycho-physical performance may decrease due to side effects such as headaches, dizziness, mental disorders, or psychoses.

Nidrazid contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Nidrazid

This medicine should always be taken according to the doctor's recommendations. If you have any doubts, consult your doctor or pharmacist.
Tuberculosis treatment should be started and supervised by doctors specializing in the diagnosis and treatment of tuberculosis, according to current standards.
The doctor will determine the dose of the medicine. Always follow the doctor's recommendations, as different dosing schedules may be possible.
Treatment is long-term.
Adults

• Once-daily administration: the therapeutic dose is usually 5 mg/kg body weight per day; do not take more than 3 tablets (300 mg) per day.
• Twice-weekly administration: the single dose is 15 mg/kg body weight, not more than 9 tablets (900 mg).
• Prevention of pulmonary tuberculosis: take 3 tablets (300 mg) per day.

Children over 3 years of age
The doctor will determine the dose of the medicine based on the child's body weight.

• Once-daily administration: the dose for children is usually 5 to 10 mg/kg body weight per day, up to a maximum of 3 tablets (300 mg) per day.
• Twice-weekly administration: the single dose is 15 mg/kg body weight, not more than 9 tablets (900 mg).
• Prevention of pulmonary tuberculosis: take 5 to 10 mg/kg body weight per day, up to a maximum of 3 tablets (300 mg) per day.

Prevention of neuropathy
To prevent the occurrence of a side effect - neuropathy, take vitamin B (pyridoxine) at a dose of 10 mg daily. If neuritis occurs, the dose of vitamin B should be increased to 50 mg per day.
Patients with kidney function disorders
The doctor may decide to use a lower dose of Nidrazid.
Method of administration
Nidrazid is recommended to be taken once daily, on an empty stomach, at least 30 minutes before a meal or 2 hours after a meal.

Using a higher than recommended dose of Nidrazid

In case of overdose or accidental ingestion by a child, contact your doctor.
Symptoms of isoniazid overdose include: nausea, vomiting, dizziness, blurred speech and vision, ataxia, visual hallucinations (including seeing in bright colors and strange patterns), skin rash; in severe cases, respiratory failure, CNS depression, rapidly progressing from stupor to deep coma, as well as severe seizures resistant to treatment. Laboratory tests show metabolic acidosis, presence of ketone bodies (acetonuria), and hyperglycemia.

Missing a dose of Nidrazid

Do not take a double dose to make up for a missed dose.
Take the missed dose as soon as possible. If it is almost time for the next dose, do not take the missed dose, just take the next dose and continue with the prescribed schedule.

Stopping treatment with Nidrazid

Do not stop taking Nidrazid without consulting your doctor, even if you think your condition has improved.
If you have any further 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.
If you experience symptoms of liver function disorders, such as fatigue, loss of appetite, nausea, vomiting, itching, or yellowing of the skin or whites of the eyes, discontinue the medicine and consult your doctor immediately.

If you experience any of the following side effects, contact your doctor immediately.

• Pancreatitis (inflammation of the pancreas) causing severe abdominal and back pain, frequency not known.
• Severe, widespread skin damage (exfoliation and mucosal lesions) - toxic epidermal necrolysis (Lyell's syndrome, TEN), may occur in 1 in 1000 people.
• Drug reaction causing rash, fever, inflammation of internal organs, blood disorders, and systemic disease (DRESS syndrome, drug rash with eosinophilia and systemic syndrome), may occur in 1 in 1000 people.
• Severe disease characterized by blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome, frequency not known).
• Yellowing of the skin or whites of the eyes or darker urine and lighter stools, fatigue, weakness, malaise, loss of appetite, nausea, or vomiting due to liver disease (hepatitis), may occur in 1 in 100 people.

The following side effects may occur during treatment with Nidrazid, presented according to their frequency of occurrence.
Very common (may occur in more than 1 in 10 people):increased liver enzyme activity.
Common (may occur in up to 1 in 10 people):vitamin B deficiency, mental disorders (irritability, anxiety), psychosis (mania, catatonia, paranoia), headache, dizziness, tingling, itching (peripheral neuropathy), nausea, vomiting, indigestion.
Uncommon (may occur in up to 1 in 100 people):jaundice, hepatitis (usually occurring 4-8 weeks or even several months after starting treatment), fatigue, weakness, fever.
Rare (may occur in up to 1 in 1000 people):loss of appetite, pellagra (niacin or vitamin B deficiency), muscle cramps, optic neuritis (e.g., blurred vision), allergic skin reactions, hives, itching, rash, erythema, pellagrous skin changes, toxic epidermal necrolysis (Lyell's syndrome), DRESS syndrome (systemic symptoms of eosinophilia), urinary disorders.
Very rare (may occur in less than 1 in 1000 people):changes in blood morphology (decreased red blood cell count, decreased platelet count, changes in white blood cell count), lymph node enlargement, immune system disorders (serum sickness-like reaction), gynecomastia (breast enlargement in men and women), increased bilirubin or glucose levels in the blood, metabolic acidosis.
Frequency not known (frequency cannot be estimated from available data):anaphylactic reactions, increased glucose levels in the blood, metabolic acidosis, psychotic disorders (noted especially in patients with poor general condition, metabolic disorders: diabetes, hyperthyroidism; with alcoholism, epilepsy), toxic encephalopathy, memory disorders, loss of reflexes, joint pain, muscle weakness, muscle pain, muscle breakdown, optic nerve atrophy, vasculitis, pancreatitis, abdominal discomfort, constipation or diarrhea, dry mouth, severe liver inflammation (in extreme cases leading to death), Stevens-Johnson syndrome, pemphigus, glomerulonephritis (usually reversible).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Nidrazid

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nidrazid contains

The active substance of Nidrazid is isoniazid. Each tablet of Nidrazid contains 100 mg of isoniazid.
Other ingredients are: cornstarch, aluminum stearate, sodium carboxymethylcellulose, gelatin, talc.

What Nidrazid looks like and contents of the pack

Flat tablets with a diameter of 7 mm, white or slightly yellowish in color, with a dividing line on one side.
Packaging contains 250 tablets in glass bottles.

Marketing authorization holder and manufacturer

Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, 102 37 Prague, Czech Republic.
For more detailed information about this medicine, please contact the local representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
Bonifraterska Street 17
00-203 Warsaw
phone: +48 22 375 92 00

Date of last revision of the leaflet: