ZAMENE 30 mg TABLETS

2. What you need to know before you take Zamene

Do not take Zamene:

• If you are allergic to deflazacort or any of the other ingredients of this medicine (listed in section 6).
• If you have a stomach ulcer.
• If you have bacterial infections (active tuberculosis) and viral infections (simple herpes, herpes zoster, chickenpox) or generalized fungal infections.
• If you are in a pre- or post-vaccination period.

Warnings and precautions

Consult your doctor or pharmacist before taking Zamene.

• It is essential that your doctor knows about all the diseases you have or have had before they can advise you on this treatment. Especially, you should inform them about cardiovascular diseases (heart failure, high blood pressure), blood clotting disorders (thrombosis, embolism), gastrointestinal or intestinal diseases (stomach ulcers, intestinal inflammation, chronic diarrhea), severe liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid gland insufficiency, muscle weakness, and certain acute or chronic infections.
• You should not be vaccinated during treatment with this medicine. Your doctor will tell you what to do in these cases. Also, inform them if you have recently been to tropical countries.
• In prolonged treatments, eye disorders may appear, so your doctor may advise you to visit an ophthalmologist periodically.
• It is necessary to adjust the dose of corticosteroids in special situations (surgery, infections, and others) and therefore the doctor must know if the patient has suffered from any other disease.
• In children, prolonged use of this medicine can stop their growth and development.
• After a long treatment with Zamene, it should be gradually discontinued. Do not stop this medicine without consulting your doctor first.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Severe skin reactions

In post-marketing experience, severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in association with the use of deflazacort.

These skin reactions often involve ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes).

These severe skin reactions are often preceded by fever, headache, and body pain (flu-like symptoms). The rash can evolve into generalized blisters and skin peeling. If you develop a rash or these skin symptoms, stop taking deflazacort and contact your doctor immediately.

Use in athletes

Patient should be warned that this medicine contains deflazacort, which may produce a positive result in doping tests.

Other medicines and Zamene

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may increase the effects of Zamene, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as Zamene may interact with them:

• Pain or anti-inflammatory medicines.
• Diabetes medicines.
• Diuretics.
• Antibiotics.
• Estrogens or oral contraceptives.
• Muscle relaxants.
• Anticholinesterase medicines used in myasthenia gravis.
• Medicines for heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medicines for epilepsy and those used in psychiatric treatments (phenytoin, phenobarbital).

Pregnancy, breastfeeding, and fertility

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.

Human experience is limited, so Zamene will only be used in cases where the risk-benefit assessment advises its use.

Zamene is excreted in breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

No data are available, but it is advisable that, until the response to treatment is satisfactory, you do not perform tasks that require special attention, such as driving vehicles or operating hazardous machinery.

Zamene contains lactose monohydrate

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

3. How to take Zamene

Follow exactly the administration instructions of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine is administered orally. The tablets should be swallowed without chewing, with a little liquid.

The dose must be individualized. Therefore, the number and frequency of tablets you should take will be determined by your doctor based on the type and severity of your disease, as well as your response to treatment.

In adults, the dose may range from 6 to 90 mg per day, and in children from 0.25 to 1.5 mg/kg. It is essential that you fully understand your doctor's instructions regarding the administration of the medicine, and if in doubt, do not hesitate to consult them.

In special situations (stress, significant infections, severe trauma, or surgical interventions), it may be necessary to adjust the dose. Consult your doctor to explain the procedure to follow in these cases.

Your doctor will indicate the duration of the treatment. Do not stop it before, or without authorization, and never stop it abruptly.

After prolonged treatment, the administration of this medicine should never be stopped abruptly. Your doctor will indicate how to gradually decrease the dose. It is also important that you remain in contact with your doctor at the end of the treatment so that they can act in case of symptom recurrence.

If you take more Zamene than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone +34 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Zamene

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

If you stop taking Zamene

Prolonged treatments that are stopped abruptly can cause: fever, discomfort, and muscle and joint pain.

If you have any further questions on 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.

In short-term treatments, this medicine is well tolerated, and side effects are rare. However, in prolonged treatments, the following have been observed:

• Gastrointestinal disorders: Stomach ulcers, bleeding, indigestion, acute pancreatitis (especially in children).

• Nervous system disorders: Headache, dizziness, agitation, insomnia, mood changes (depression, euphoria), and increased intracranial pressure.

• Skin and subcutaneous tissue disorders: Thinning of the skin, stretch marks, and acne. With an unknown frequency (cannot be estimated from the available data): potentially fatal skin reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis.

• Cardiac and vascular disorders: Increased blood pressure, fluid retention in tissues (edema), heart failure, complications caused by blood clots (thromboembolism), decreased potassium, and salt retention.

• Endocrine disorders: Adrenal insufficiency, weight gain, and moon face, worsening of diabetes, disappearance of menstruation, and growth retardation in children.

• Musculoskeletal and connective tissue disorders: Muscle disorders or weakness, osteoporosis.

• Eye disorders: Eye disorders (cataracts, increased intraocular pressure). With an unknown frequency (cannot be estimated from the available data): blurred vision.

During treatment with this medicine, your tendency to infections may increase, so if you notice any symptoms of disease that may be related to taking this medicine, you should contact your doctor.

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: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zamene

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If in doubt, 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 Zamene

The active substance is deflazacort.

The other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and pack contents:

Round, white tablets with a cross engraved on one side and the number 30 on the other.

The tablet can be divided into equal parts.

Zamene 30 mg tablets are packaged in PVC and aluminum-PVC blisters and are available in packs containing 10 or 500 tablets.

Marketing authorization holder

Laboratorios Menarini, S.A.

C/Alfons XII, 587 – E 08918 Badalona (Barcelona) Spain

Phone: +34 934 628 800 – Email: [email protected]

Manufacturer

Laboratorios Menarini, S.A.

C/Alfonso XII, 587 – E 08918 Badalona (Barcelona) Spain

Phone: +34 934 628 800 – Email: [email protected]

or

Cyndea Pharma, SL

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31, Ólvega 42110 (Soria)

Spain

Date of the last revision of this leaflet:March 2023.

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/