Package Insert: Information for the Patient

Zamene 6 mg Tablets

deflazacort

Read this package insert carefully before taking 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 for you only, and you should not give it to others who 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.

6. Contents of the pack and additional information

Zamene is a medication belonging to a group of medications known as corticosteroids, which has anti-inflammatory and antiallergic properties.

Zamene is indicated for the treatment of:

• Rheumatic and collagen diseases: such as rheumatoid arthritis, psoriatic arthritis, and systemic lupus erythematosus.
• Skin diseases: such as pemphigus, generalized exfoliative dermatitis, and severe psoriasis.
• Allergic diseases: bronchial asthma that does not respond to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Eye diseases: choroiditis, choroidoretinitis, iritis, and iridocyclitis.
• Blood diseases: idiopathic thrombocytopenia, hemolytic anemias, and palliative treatment of leukemias and lymphomas.
• Gastrointestinal and liver diseases: ulcerative colitis, Crohn's disease, and active chronic hepatitis.
• Kidney diseases: nephrotic syndrome.

Do not take Zamene:

• If you are allergic to deflazacort or any of the other components of this medication (listed in section 6).
• If you have a stomach ulcer.
• If you have bacterial infections (active tuberculosis) and viral infections (herpes simplex eye, herpes zoster, varicella) or generalized infections caused by fungi.
• If you are in the pre- or post-vaccination period.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zamene.

• It is essential that your doctor knows all the diseases you have or have had before they can advise you on this treatment. You must especially inform them of cardiovascular diseases (heart failure, high blood pressure), those caused by blood clots (thrombosis, embolism), digestive or intestinal diseases (stomach ulcer, intestinal inflammation, chronic diarrhea), important liver or kidney diseases, diabetes, osteoporosis, behavioral disorders (mood changes, insomnia), epilepsy, glaucoma, thyroid insufficiency, muscle weakness, and certain acute or chronic infections.
• You should not be vaccinated during treatment with this medication. Your doctor will indicate what you should do in these cases. Inform them also if you have recently been to tropical countries.
• In prolonged treatments, ocular alterations may appear, so your doctor may advise you to visit an ophthalmologist periodically.
• The dose of corticosteroids needs to be adjusted in special situations (surgery, infections, and others), and therefore your doctor must know if you have had any other diseases.
• In children, the prolonged use of this medication may stop their growth and development.
• After a long treatment with Zamene, it should be gradually discontinued. Do not stop taking this medication 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 severe 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 aches (similar to flu symptoms). The rash may evolve into widespread blisters and skin peeling. If you develop a rash or these skin symptoms, stop taking deflazacort and contact your doctor immediately.

Use in athletes

You should be advised that this medication contains deflazacort, which may produce a positive result in doping control tests.

Other medications and Zamene

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Some medications may increase the effects of Zamene, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.The experience in humans is limited, so Zamene should only be used in cases where the risk-benefit assessment recommends its use.

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

Driving and operating machinery

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

Zamene contains lactose monohydrate

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

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

This medication is administered orally. The tablets should be swallowed without chewing, with the help of a little liquid.

The dose must be individualized. Therefore, the number and frequency of tablets that you should take will be set 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 understand perfectly the instructions given by your doctor regarding the administration of the medication, and in case of doubt, do not hesitate to consult them.

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

Your doctor will indicate the duration of treatment. Do not stop it before, nor without authorization, and never discontinue it abruptly.

After prolonged treatment, the administration of this medication should never be stopped abruptly. Your doctor will indicate how to gradually reduce the dose. It is also essential that you maintain contact with your doctor at the end of treatment to act in case of reappearance of symptoms.

If you take more Zamene than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Zamene

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

If you interrupt treatment with Zamene

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

In short-term treatments, this medication is well tolerated and adverse effects are infrequent. However, in prolonged treatments, the following have been observed:

• Gastrointestinal disorders: Stomach ulcer, hemorrhage, heavy digestion, acute pancreatitis (especially in children).

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

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

• Cardiovascular 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, cessation of menstruation and delayed growth in children.

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

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

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

Reporting Adverse Effects

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

This medication does not require special storage conditions.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Zamene

The active principle is deflazacort.

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

Appearance of the product and content of the packaging:

Round white tablets, with a cross engraved on one face and the number 6 on the other.

The tablet can be divided into equal parts.

Zamene 6 mg tablets are packaged in PVC blister and aluminum-PVC foil and are presented in containers containing 20 or 500 tablets.

Holder of the marketing authorization

Laboratorios Menarini, S.A.

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

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

Responsible for manufacturing:

Laboratorios Menarini, S.A.

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

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

or

Cyndea Pharma, SL

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda, 31, Ólvega 42110 (Soria)

Spain

Last review date of this leaflet:March 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/