CEMIDON B6 300 MG/50 MG TABLETS

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.

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.

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.

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