Package Insert: Information for the Patient

Cemidon B6150 mg/25 mg Tablets

isoniazid/pyridoxine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.

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

Cemidon B6is a combination of two medicinal substances. It contains isoniazid,a bacteriostatic antibiotic belonging to the group of antitubercular medications and vitamin B6.

Cemidon B6is indicated for the treatment of tuberculosis and, exceptionally, for the treatment of atypical mycobacterial infections.

It is also used for the prevention of:

• Acute asymptomatic infection identified by tuberculin test.
• Individuals at risk of reactivating tuberculosis.
• Contacts with a person with tuberculosis.

Do not take Cemidon B6

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have severe liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cemidon B6.

Be especially careful:

• If you have a history of seizures or neurological problems. Medications to prevent seizures should be administered if there is a risk.
• If you have any liver function abnormalities. Your doctor will monitor your liver function weekly for the first month and monthly thereafter while you are taking the treatment. If any damage appears, your doctor will suspend the treatment.
• If you have a problem with alcohol addiction.
• If you have any kidney disease. Your doctor will prescribe the most suitable dose for you.

Other medications and Cemidon B6

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Particularly, inform your doctor or pharmacist if you are using any of the following medications:

• Medications used to treat epilepsy (phenytoin, carbamazepine). Your doctor may adjust the dose of this medication.

• Aluminum salts (medications for the treatment of acid reflux). They should be taken more than 2 hours apart from the intake of both products.
• Halogenated anesthetics (medications used in surgical interventions). It is recommended to interrupt the treatment with Cemidon 1 week before the intervention and not to resume it until 15 days have passed.
• Oral anticoagulants (medications used to prevent the formation of blood clots) such as acenocoumarol.
• Glucocorticoids (such as prednisolone).
• Ketoconazole (medication 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 medication.
• Antibiotics used to treat tuberculosis (pyrazinamide, rifampicin). Increased clinical and biological monitoring is required.

Taking Cemidon B6with food, drinks, and alcohol

Isoniazid interacts with foods containing a substance called tyramine, found in foods such as cheese and red wine. Additionally, if taken with foods containing a substance called histamine (for example, tuna or other tropical fish), an exaggerated response may occur, including headache, sweating, palpitations, flushing, and decreased blood pressure. Therefore, your doctor will advise you not to take foods containing tyramine or histamine during your treatment with Cemidon B6.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

In the case of pregnancy, Cemidon B6should not be administered except when the potential benefits outweigh the possible risks associated with the treatment. Your doctor will make this evaluation.

Women who are breastfeeding should consult their doctor before taking this medication, as isoniazid passes into breast milk.

Driving and operating machinery

The influence of CemidonB6on the ability to drive and operate machinery is important, as it may cause blurred vision and/or dizziness.

Cemidon B6150 mg/25 mg tablets contain tartrazine.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents with a weight of more than 45 kg:

• Treatment:
• 5mg/kg per day 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 per day, 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 per day. The maximum daily dose should not exceed 300 mg.
• Prevention in children under 5 years or immunocompromised: 7-15 mg/kg per day (maximum 300 mg), for at least six months.

No data are available on the use of isoniazid in children under 3 months of age.

Administration form

The medication should be administered in the morning with an empty stomach, at least 30 minutes before or 2 hours after meals.

The groove is only for breaking the tablet if it is 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 estimate that the action of Cemidon B6is too strong or too weak, inform your doctor or pharmacist.

If you take more Cemidon B6than you should

If you have taken more Cemidon B6than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: (91) 562 04 20, indicating the medication and the amount ingested.

After an excessive intake of this medication, nausea, vomiting, dizziness, visual disturbances, or hallucinations, increased levels of acid in the body, appearance of acetone in urine, and high blood sugar levels may be expected. With higher doses, respiratory depression and central depression may occur, potentially leading to convulsions and deep coma.

If you forgot to take Cemidon B6

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Cemidon B6

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 may reappear.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Rare side effects(may affect up to 1 in 100 people):

• Hepatitis (liver inflammation).

Very 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, which can be life-threatening), drug eruption syndrome with eosinophilia and systemic symptoms (severe skin reaction characterized by generalized skin eruption, lymph node inflammation, and increased numbers of certain blood cells, such as eosinophils).

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

• Agranulocytosis (decrease in a type of white blood cell, granulocytes), aplastic anemia (bone marrow insufficiency to produce sufficient 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, niacin deficiency (vitamin B3), anorexia,
• Hypervigilance, euphoria, insomnia, manic crises, acute delirium, depression,
• Peripheral neuropathy (damage to nerves outside the brain and spinal cord), optic nerve inflammation, seizures,
• Visual disturbances, blurred vision,
• Male breast enlargement,
• Deafness, tinnitus, vertigo,
• Vasculitis (inflammation of blood vessels),
• Acute liver insufficiency (severe liver deterioration), acute liver disorders, liver damage, jaundice (yellowing of the skin and eyes),
• Constipation, dry mouth, nausea, vomiting, pancreatitis (acute inflammation of the pancreas), abdominal pain,
• Pulmonary interstitial disease (lung inflammation or scarring caused by lesions),
• Acute skin reactions, Stevens-Johnson syndrome (severe skin reaction characterized by blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals), acne, lymph node inflammation,
• Systemic lupus erythematosus (chronic autoimmune disease that can affect joints, skin, brain, lungs, kidneys, and blood vessels), lupus-like syndrome, 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

This medication must 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 through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cemidon B6

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

Appearance of the product and content of the packaging

Cemidon B6150 mg/25 mg tablets are biconvex, yellow, scored, and approximately 8.2 mm in diameter.

Each package contains 50 tablets in a PVC-PVDC-Aluminum blister.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CHIESI ESPAÑA, S.A.U.

Plaça d’Europa, 41-43, 10th floor

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Responsible for manufacturing

LABORATORIOS ALCALA FARMA S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares

Madrid (Spain)

Last review date of this leaflet:May 2023

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