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CEMIDON B6 300 MG/50 MG TABLETS

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About the medicine

How to use CEMIDON B6 300 MG/50 MG TABLETS

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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

Patient Information Leaflet

Cemidon B6300 mg/50 mg tablets

isoniazid/pyridoxine

Read this leaflet carefully before starting to take 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, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

  1. What is Cemidon B6 and what is it used for
  2. What you need to know before taking Cemidon B6
  3. How to take Cemidon B6
  4. Possible side effects
  5. Storage of Cemidon B6
  6. Package contents and additional information

1. What is Cemidon B6 and what is it used for

Cemidon B6 is a combination of two medicinal substances. It contains isoniazid, an antibiotic belonging to the group of antitubercular medicines, and vitamin B6.

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

It is essential to follow the instructions regarding dosage, administration, and treatment duration 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 medicines down the drain or in the trash.

Cemidon B6 is indicated for the treatment of tuberculosis and, exceptionally, for the treatment of atypical mycobacterial infections.

It is also used for the prevention of:

  • Asymptomatic acute infection identified by tuberculin test.
  • People at risk of reactivating tuberculosis.
  • Contact with a person with tuberculosis.
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2. What you need to know before taking Cemidon B6

Do not take Cemidon B6

  • If you are allergic to the active substances or any of the other components of this medicine (listed in section 6).
  • If you have severe liver problems.
  • If you have ever suffered from 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 to take Cemidon B6.

Be particularly careful:

  • If you have a history of seizures or neurological problems. Medicines to prevent seizures should be administered in case of risk.
  • If you have any liver function disorders. In this case, your doctor will monitor your liver function weekly for the first month and then monthly during treatment. If any damage occurs, 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 generalized acute pustular exanthema (GPE), 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 B6

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 to treat 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 a separation of more than 2 hours between the administration 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). Cemidon doses should be spaced at least 12 hours apart. Your doctor may adjust the dose of the ketoconazole-based medicine.
  • Antibiotics used to treat tuberculosis (pyrazinamide, rifampicin) should be closely monitored clinically and biologically.

Taking Cemidon B6with 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. Therefore, your doctor will indicate that you should not take foods containing tyramine or histamine during treatment with Cemidon B6.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In case of pregnancy, Cemidon B6 should not be administered unless the 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

Cemidon B6 may affect your ability to drive and use machines, as it can cause blurred vision and/or dizziness.

Cemidon B6300 mg/50 tablets contain tartrazine.

This medicine may cause allergic reactions because it contains tartrazine. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Cemidon B6

Follow the administration instructions for this medicine indicated by your doctor or pharmacist. If you are unsure, 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 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 weighing 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 is recommended to take the medicine in the morning on an empty stomach, at least 30 minutes before or 2 hours after meals.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Due to its size, Cemidon tablets are not suitable for the treatment of adults, children, or adolescents who cannot swallow the tablets.

If you think the effect of Cemidon B6 is too strong or too weak, tell your doctor or pharmacist.

If you take more Cemidon B6than you should

If you have taken more Cemidon B6 than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 562 04 20, indicating the medicine and the amount ingested.

After an overdose of this medicine, you may expect the appearance of nausea, vomiting, dizziness, visual disturbances, or hallucinations, increased acid levels in the body, presence 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 B6

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

If you stop taking Cemidon B6

Your doctor will indicate the duration of your treatment with Cemidon B6. Do not stop treatment before this, even if you feel better. If you stop treatment too early, the infection may recur.

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

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 (a skin reaction that causes large areas of skin with blisters and peeling, potentially life-threatening), drug reaction with eosinophilia and systemic symptoms (a severe skin reaction characterized by a generalized rash, lymph node inflammation, and increased blood cell counts).

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

  • Agranulocytosis (decrease in a type of white blood cell), aplastic anemia (bone marrow failure to produce enough blood cells), hemolytic anemia (destruction of red blood cells), eosinophilia (increase in a type of white blood cell),
  • Acidosis (increased acid levels in the body), low blood glucose levels, nicotinic acid deficiency (vitamin B3 deficiency), 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), abdominal pain (stomach pain),
  • Lung injuries that cause inflammation or scarring (interstitial lung disease),
  • Acute skin reactions, Stevens-Johnson syndrome (a severe skin reaction characterized by blisters and peeling, especially around the mouth, nose, eyes, and genitals), acne, lymph node inflammation,
  • Generalized pustular exanthema (a skin reaction with pus-filled bumps and peeling),

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

  • Systemic lupus erythematosus (a chronic autoimmune disease that can affect the joints, skin, brain, lungs, kidneys, and blood vessels), drug-induced 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 stopped or interrupted, the following symptoms may appear: headache, difficulty sleeping, excessive sleepiness, irritability, nervousness.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cemidon B6

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

Do not use this medicine after the expiration date stated on the carton after EXP. The expiration date is 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 should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Cemidon B6composition

  • The active substances are isoniazid and pyridoxine.
  • The other components (excipients) are: gum arabic (E-414), hydroxyethyl methylcellulose, talc, magnesium stearate, tartrazine (E-102).

Product appearance and package contents

Cemidon B6 300 mg/50 mg tablets are biconvex, yellow, scored on one side, and marked with IS/3 on the other, with a diameter of 11 mm.

Each package contains 30 tablets in a PVC-PVDC-aluminum blister pack.

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

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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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.

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Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

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Frequently Asked Questions

Is a prescription required for CEMIDON B6 300 MG/50 MG TABLETS?
CEMIDON B6 300 MG/50 MG TABLETS 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 B6 300 MG/50 MG TABLETS?
The active ingredient in CEMIDON B6 300 MG/50 MG TABLETS is isoniazid, combinations. This information helps identify medicines with the same composition but different brand names.
How much does CEMIDON B6 300 MG/50 MG TABLETS cost in pharmacies?
The average pharmacy price for CEMIDON B6 300 MG/50 MG TABLETS is around 5.07 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CEMIDON B6 300 MG/50 MG TABLETS?
CEMIDON B6 300 MG/50 MG TABLETS 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 B6 300 MG/50 MG TABLETS 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 B6 300 MG/50 MG TABLETS 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 B6 300 MG/50 MG TABLETS?
Other medicines with the same active substance (isoniazid, combinations) include CEMIDON B6 150 MG/25 MG TABLETS, CEMIDON B6 50 MG/15 MG TABLETS, CEMIDON 60 mg/ml INJECTABLE SOLUTION. 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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