CEMIDON B6 50 MG/15 MG TABLETS

Introduction

Package Leaflet: Information for the Patient

Cemidon B650 mg/15 mg tablets

isoniazid/pyridoxine

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 get 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 pack

1. What is Cemidon B6 and what is it used for
2. What you need to know before you take Cemidon B6
3. How to take Cemidon B6
4. Possible side effects
5. Storage of Cemidon B6
6. Contents of the pack and other 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.

Additionally, it is 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 you take Cemidon B6

Do not take CemidonB6

• 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 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 disorder. In this case, your doctor will monitor your liver function weekly during the first month and then monthly while the treatment lasts. If any injury appears, your doctor will suspend the 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 Cemidon treatment. Stop taking Cemidon and seek immediate medical attention if you notice any of the symptoms described in section 4.

Other medicines and CemidonB6

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 more than 2 hours of separation 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 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 administration of Cemidon should be spaced at least 12 hours apart. Your doctor may adjust the dose of the ketoconazole-based medicine.
• Antibiotic medicines used to treat tuberculosis (pyrazinamide, rifampicin) should increase clinical and biological monitoring.

Taking CemidonB6with 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 your 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, do not administer Cemidon B6 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 B6's influence on the ability to drive and use machines is significant, as it can cause blurred vision and/or dizziness.

Cemidon B650 mg/15 mg tablets contain wheat starch, lactose, and tartrazine.

This medicine contains very low levels of gluten (from wheat starch). One tablet does not contain more than 0.006 mg (6 micrograms) of gluten.

If you have a wheat allergy (different from celiac disease), you should not take this medicine.

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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 exactly the administration instructions of this medicine 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:
• 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 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 is recommended to administer 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 action of Cemidon B6 is too strong or too weak, tell your doctor or pharmacist.

If you take more CemidonB6than 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 can expect the appearance of nausea, vomiting, dizziness, visual disturbances or hallucinations, increased acid levels 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 CemidonB6

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

If you stop taking CemidonB6

Your doctor will indicate the duration of your treatment with Cemidon B6. Do not stop treatment before, even if you feel better. If you stop treatment too soon, the infection could 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 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 (insufficiency 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 cell, eosinophils),
• Acidosis (increase in 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 (damage to the nerves outside the brain and spinal cord), optic neuritis (inflammation of the optic nerve), seizures,
• Visual disturbances, blurred vision,
• Increased breast tissue 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 pus-filled bumps),

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

• Systemic lupus erythematosus (chronic autoimmune disease that can affect the 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 while 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, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's 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 expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

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 medicinal products in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicinal products. This will help protect the environment.

6. Contents of the pack and other information

Composition of CemidonB6

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

Appearance of the product and pack contents

Cemidon B6 50 mg/15 mg tablets are yellow, biconvex, and scored, with a diameter of approximately 7.4 mm.

Each pack contains 100 tablets in PVC-PVDC-Aluminum blisters.

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 last revision of this leaflet:August 2025.

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