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CEMIDON 60 mg/ml INJECTABLE SOLUTION

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About the medicine

How to use CEMIDON 60 mg/ml INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

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.
Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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

Online doctors for CEMIDON 60 mg/ml INJECTABLE SOLUTION

Discuss questions about CEMIDON 60 mg/ml INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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  • headache, dizziness, migraine symptoms
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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

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  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
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Additional care areas:

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Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
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Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
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  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
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  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
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  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Frequently Asked Questions

Is a prescription required for CEMIDON 60 mg/ml INJECTABLE SOLUTION?
CEMIDON 60 mg/ml INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CEMIDON 60 mg/ml INJECTABLE SOLUTION?
The active ingredient in CEMIDON 60 mg/ml INJECTABLE SOLUTION is isoniazid. This information helps identify medicines with the same composition but different brand names.
How much does CEMIDON 60 mg/ml INJECTABLE SOLUTION cost in pharmacies?
The average pharmacy price for CEMIDON 60 mg/ml INJECTABLE SOLUTION is around 12.11 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CEMIDON 60 mg/ml INJECTABLE SOLUTION?
CEMIDON 60 mg/ml INJECTABLE SOLUTION is manufactured by Chiesi España S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CEMIDON 60 mg/ml INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CEMIDON 60 mg/ml INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CEMIDON 60 mg/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (isoniazid) include CEMIDON B6 150 MG/25 MG TABLETS, CEMIDON B6 300 MG/50 MG TABLETS, CEMIDON B6 50 MG/15 MG TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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