Cemidon 60 mg/ml solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cemidon 60 mg/ml injection solution

isoniazid

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Cemidon is and what it is used for

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

Cemidon is indicated for the treatment of tuberculosis and, exceptionally, for the treatment of infections caused by atypical mycobacteria.

In addition, it is used for the prevention of:

• Acute asymptomatic infection identified by tuberculin testing.
• Risk of reactivation of tuberculosis in individuals.
• Contact with a person who has tuberculosis.

2. What you need to know before starting 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 had a severe skin rash, skin peeling, blisters, and/or mouth sores after taking Cemidon.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Cemidon.

Take special care:

• If you have a history of seizures or neurological disorders. Medications to prevent seizures should be administered if there is a risk.
• If you have any liver function disorders. In such cases, your doctor will monitor your liver function weekly during the first month and then monthly throughout treatment. If any liver damage occurs, your doctor will stop treatment.
• If you have alcohol addiction.
• If you have any kidney disease. Your doctor will prescribe the most appropriate dose for you.
• Serious skin reactions have been reported, such as: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acne, lymphadenopathy, and acute generalized exanthematous pustulosis (AGEP), associated with Cemidon treatment. Stop taking Cemidon and seek immediate medical attention if you notice any of the symptoms described in section 4.

Other medicines and Cemidon

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

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

• Medications used to treat epilepsy (phenytoin, carbamazepine). Your doctor may need to adjust the dose of this medication.
• Aluminum salts (medications used to treat gastric acidity). These should be taken at least 2 hours apart from Cemidon.
• Halogenated anesthetics (medications used during surgical procedures). It is recommended to discontinue Cemidon treatment one week before surgery and not restart until 15 days have passed.
• Oral anticoagulants (medications used to prevent blood clots) such as acenocoumarol.
• Glucocorticoids (such as prednisolone).
• Ketoconazole (a medication used to treat fungal infections). Doses of Cemidon should be spaced at least 12 hours apart. Your doctor may adjust the dose of the ketoconazole-containing medication.
• Antibiotic medications used to treat tuberculosis (pyrazinamide, rifampicin); increased clinical and biological monitoring is required.

Taking Cemidon with food, drinks, and alcohol

Isoniazid interacts with foods containing a substance called tyramine, found in foods such as cheese and red wine. Also, if taken with foods containing histamine (e.g., tuna or other tropical fish), it may cause an exaggerated response with headache, sweating, palpitations, flushing, and low blood pressure. Therefore, your doctor will advise you to avoid consuming 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 become pregnant, consult your doctor or pharmacist before using this medicine.

During pregnancy, Cemidon should not be administered except when potential benefits outweigh the possible risks associated with treatment. Your doctor will make this assessment.

Breastfeeding women should consult their doctor before taking this medicine, as isoniazid passes into breast milk.

Driving and using machines

The effect of Cemidon on the ability to drive and operate machinery is significant because it may cause blurred vision and/or dizziness.

Cemidon Injectable contains sodium metabisulfite.

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

3. How to take Cemidon

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents weighing over 45 kg:

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

Use in children and adolescents

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

There are no data available on the use of isoniazid in infants under 3 months of age.

Method of administration

May be administered by intramuscular route or by slow intravenous infusion (3–5 minutes).

If you feel that the effect of Cemidon is too strong or too weak, inform your doctor or pharmacist.

If you take more Cemidon than you should

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

After an overdose of this medicine, nausea, vomiting, dizziness, visual disturbances or hallucinations may occur, along with increased levels of acid in the body, presence of acetone in urine, and high blood sugar levels. With higher doses, respiratory depression and central nervous system depression may occur, potentially leading to seizures and deep coma.

If you forget to take Cemidon

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

If you stop taking Cemidon

Your doctor will advise you on the duration of your treatment with Cemidon. Do not stop treatment prematurely, even if you feel better. If you stop treatment too early, the infection may recur.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• Hepatitis (inflammation of the liver).

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

• Toxic epidermal necrolysis (a skin reaction causing large areas of blistering and peeling skin, which may become life-threatening), drug rash with eosinophilia and systemic symptoms (a severe skin reaction characterized by widespread rash, swollen lymph nodes, and increased levels of certain blood cells such as eosinophils).

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

• Agranulocytosis (reduction in a type of white blood cells, the granulocytes), aplastic anemia (failure of the bone marrow to produce enough blood cells), hemolytic anemia (destruction of red blood cells in the blood), eosinophilia (increase in a type of white blood cells, the eosinophils),
• Acidosis (increased levels of acid 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 in nerves outside the brain and spinal cord), optic neuritis (inflammation of the optic nerve), seizures,
• Visual disturbances, blurred vision,
• Breast enlargement in men,
• Hearing loss, tinnitus (ringing in the ears), dizziness,
• Vasculitis (inflammation of blood vessels),
• Liver failure (severe deterioration of liver function), acute liver disorders, liver damage, jaundice (yellowing of the skin and eyes),
• Constipation, dry mouth, nausea, vomiting, pancreatitis (acute inflammation of the pancreas), stomach ache (abdominal pain),
• Lung injuries causing inflammation or scarring of the lungs (interstitial lung disease),
• Acute skin reactions, Stevens-Johnson syndrome (a severe skin reaction involving blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals), acne, swollen lymph nodes,
• Generalized red, scaly rash with lumps under the skin and blisters,

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

• Systemic lupus erythematosus (a chronic autoimmune disease that may 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 occur: headache, difficulty sleeping, excessive sleepiness, irritability, nervousness.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Cemidon

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

Appearance of the product and contents of the pack

Cemidon Intravenous is supplied in 5 ml colourless neutral glass type I breakable ampoules.

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 the most recent review of this leaflet: August 2025

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