CEMIDON 60 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Cemidon 60 mg/ml Injectable Solution

isoniazid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Cemidon and what is it used for
2. What you need to know before you take Cemidon
3. How to take Cemidon
4. Possible side effects
5. Storage of Cemidon
6. Contents of the pack and further information

1. What is Cemidon and what is it used for

Cemidon contains isoniazid, an antibiotic belonging to the group of antitubercular medicines.

Cemidon is indicated for the treatment of tuberculosis and, exceptionally, for the treatment of atypical mycobacterial infections.

Additionally, it is used for the prevention of:

• Asymptomatic acute infection identified by tuberculin test.
• People at risk of reactivation of tuberculosis.
• Contact with a person with tuberculosis.

2. What you need to know before you take Cemidon

Do not take Cemidon

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have severe liver problems.
• If you have ever suffered a severe skin rash or peeling, blisters, and/or ulcers in the mouth after taking Cemidon.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Cemidon.

Be particularly careful:

• If you have a history of seizures or neurological problems. Medication to prevent seizures should be administered in case of risk.
• If you have any alteration of liver function. In this case, your doctor will monitor your liver function weekly during the first month and then monthly while treatment lasts. If any injury appears, your doctor will suspend treatment.
• If you have an alcohol addiction problem.
• If you have any kidney disease. Your doctor will prescribe the most suitable dose for you.
• There have been reports of severe skin reactions, such as: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acne, lymph node inflammation, and acute generalized exanthematous pustulosis (AGEP) associated with treatment with Cemidon. Stop taking Cemidon and seek immediate medical attention if you notice any of the symptoms described in section 4.

Other medicines and Cemidon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

In particular, inform your doctor or pharmacist if you are using any of the following medicines:

• Medicines used for the treatment of epilepsy (phenytoin, carbamazepine). Your doctor may adjust the dose of this medicine.
• Aluminum salts (medicines for the treatment of gastric acidity). They should be taken with more than 2 hours of separation between the intake of both products.
• Halogenated anesthetics (medicines used in surgical interventions). It is recommended to interrupt treatment with Cemidon one week before the intervention and not to restart it until 15 days have passed.
• Oral anticoagulants (medicines used to prevent the formation of blood clots) such as acenocoumarol.
• Glucocorticoids (such as prednisolone).
• Ketoconazole (a medicine for the treatment of fungal infections). The intake of Cemidon should be spaced at least 12 hours apart. Your doctor may adjust the dose of the ketoconazole-based medicine.
• Antibiotics used for the treatment of tuberculosis (pyrazinamide, rifampicin) should increase clinical and biological surveillance.

Taking Cemidon with food, drinks, and alcohol

Isoniazid interacts with foods containing a substance called tyramine, which is present in foods such as cheese and red wine. Similarly, if taken with foods containing a substance called histamine (e.g., tuna or other tropical fish), it can cause an exaggerated response with headache, sweating, palpitations, flushing, and decreased blood pressure. Due to this, your doctor will indicate that you should not take foods containing tyramine or histamine during treatment with Cemidon.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In the case of pregnancy, Cemidon should not be administered unless the potential benefits outweigh the possible risks associated with treatment. Your doctor will make this assessment.

Women who are breastfeeding should consult their doctor before taking this medicine, as isoniazid passes into breast milk.

Driving and using machines

Cemidon's influence on the ability to drive and use machines is significant, as it can cause blurred vision and/or dizziness.

Cemidon Injectable contains sodium metabisulfite.

This medicine can cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

3. How to take Cemidon

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents with a weight over 45 kg:

• Treatment:
• 5mg/kg daily up to a maximum of 300 mg.
• or 10 mg/kg three times a week.
• or 15 mg/kg twice a week.
• Prevention: 300 mg daily, for at least six months.

Use in children and adolescents

• Treatment in children and adolescents with a weight of 45 kg or less: the recommended dose is 10 mg/kg daily. The maximum daily dose should not exceed 300 mg.
• Prevention in children under 5 years or immunocompromised: 7-15 mg/kg daily (maximum 300 mg), for at least six months.

There is no data available on the use of isoniazid in children under 3 months of age.

Method of administration

It can be administered intramuscularly or by slow intravenous injection (3-5 minutes).

If you think the action of Cemidon is too strong or too weak, tell your doctor or pharmacist.

If you take more Cemidon than you should

If you have been given more Cemidon than you should, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 562 04 20, indicating the medicine and the amount taken.

After an overdose of this medicine, you can expect the appearance of nausea, vomiting, dizziness, visual disturbances, or hallucinations, increased levels of acid in the body, appearance of acetone in urine, and high blood sugar levels. With higher doses, respiratory depression and central depression may occur, leading to convulsions and deep coma.

If you forget to take Cemidon

Do not take a double dose to make up for forgotten doses.

If you stop taking Cemidon

Your doctor will indicate the duration of your treatment with Cemidon. Do not stop treatment before, even if you feel better. If you stop taking the treatment too soon, the infection could reappear.

If you have any further questions on 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.

Uncommon side effects(may affect up to 1 in 100 people):

• Hepatitis (inflammation of the liver).

Rare side effects(may affect up to 1 in 1,000 people):

• Toxic epidermal necrolysis (skin reaction that causes large areas of skin with blisters and peeling, potentially life-threatening), drug reaction with eosinophilia and systemic symptoms (severe skin reaction characterized by widespread skin rash, lymph node inflammation, and increased number of certain blood cells, such as eosinophils).

Frequency not known(cannot be estimated from the available data):

• Agranulocytosis (decrease in a type of white blood cell, granulocytes), aplastic anemia (bone marrow failure to produce enough blood cells), hemolytic anemia (destruction of red blood cells in the blood), eosinophilia (increase in a type of white blood cell, eosinophils),
• Acidosis (increase in acid levels in the body), low blood glucose levels, nicotinic acid deficiency (vitamin B3), anorexia,
• Hyperactivity, euphoria, insomnia, manic episodes, acute delirium, depression,
• Peripheral neuropathy (nerve damage outside the brain and spinal cord), optic neuritis (inflammation of the optic nerve), seizures,
• Visual disturbances, blurred vision,
• Gynecomastia (breast enlargement in men),
• Deafness, tinnitus, vertigo,
• Vasculitis (inflammation of blood vessels),
• Liver failure (severe liver damage), acute liver disorders, liver damage, jaundice (yellowing of the skin and eyes),
• Constipation, dry mouth, nausea, vomiting, pancreatitis (inflammation of the pancreas), stomach pain (abdominal pain),
• Lung injuries that cause inflammation or scarring (interstitial lung disease),
• Acute skin reactions, Stevens-Johnson syndrome (severe skin reaction that causes blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals), acne, lymph node inflammation,
• Generalized exanthematous pustulosis (skin rash with blisters and pus),

accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis),

• Systemic lupus erythematosus (chronic autoimmune disease that can affect joints, skin, brain, lungs, kidneys, and blood vessels), lupus-like syndrome (causing symptoms such as joint inflammation, fatigue, and skin rashes), shoulder-hand syndrome, joint pain, muscle pain,
• Pain or discomfort when urinating,
• Fever,
• Increased liver enzymes.

When treatment is discontinued or interrupted, the following symptoms may appear: headache, difficulty sleeping, excessive sleepiness, irritability, nervousness.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cemidon

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine should be stored in a cool and dry place. Store protected from light at a temperature not exceeding 25°C.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cemidon

• The active substance is isoniazid.
• The other ingredients (excipients) are: sodium metabisulfite (E-223) and water for injectable preparations.

Appearance of the product and pack contents

Cemidon Intravenous is presented in 5 ml glass ampoules of neutral type I.

Each pack contains 5 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares

Madrid (Spain)

Date of last revision of this leaflet:August 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es