Zamene 6 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zamene 6 mg tablets

deflazacort

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zamene is and what it is used for

2. What you need to know before taking Zamene

3. How to take Zamene

4. Possible side effects

5. How to store Zamene

6. Contents of the pack and other information

1. What Zamene is and what it is used for

Zamene is a medicine belonging to a group of medicines known as corticosteroids, which have 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 unresponsive to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Ocular diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis.
• Blood disorders: 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.

2. What you need to know before starting to take Zamene

Do not take Zamene:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zamene.

• It is important that your doctor knows about all diseases you currently have or have had in the past before advising you on this treatment. In particular, you must inform them about cardiovascular diseases (heart failure, high blood pressure), conditions related to blood clots (thrombosis, embolism), gastrointestinal or intestinal disorders (stomach ulcer, intestinal inflammation, chronic diarrhea), significant 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 advise you on what to do in such cases. Also inform them if you have recently visited tropical countries.
• Prolonged treatment may lead to ocular disorders, so your doctor may recommend periodic visits to an ophthalmologist.
• The dose of corticosteroids must be adjusted in special situations (such as surgery, infections, and others); therefore, your doctor must be aware of any other illnesses you may have.
• In children, prolonged use of this medicine may impair growth and development.
• After long-term treatment with Zamene, discontinuation should be gradual. Do not stop taking 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 rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in association with the use of deflazacort.

These rashes frequently involve ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes).

Severe skin reactions are often preceded by fever, headache, and body pain (flu-like symptoms). The rash may progress to widespread blisters and skin peeling. If you develop a rash or these skin symptoms, stop taking deflazacort immediately and contact your doctor without delay.

Use in athletes

Patients should be informed that this medicine contains deflazacort, which may result in a positive outcome in doping control tests.

Other medicines and Zamene

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

Some medicines may increase the effects of Zamene, so your doctor will perform careful monitoring if you are taking these drugs (including certain HIV medications: ritonavir, cobicistat).

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

• Medicines for pain or inflammation.
• Medicines for diabetes.
• Diuretics.
• Anti-infective agents.
• Estrogens or oral contraceptives.
• Medicines that cause muscle relaxation.
• Anticholinesterase medicines, used in myasthenia gravis.
• Medicines used to treat heart failure or coagulation disorders.
• Vaccines and toxoids.
• Medicines for epilepsy and psychiatric treatments (phenytoin, phenobarbital).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Human experience is limited; therefore, Zamene should only be used when a prior risk/benefit assessment justifies its use.

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

Driving and use of machines

No data are available. However, until your response to treatment is satisfactory, it is advisable to avoid tasks requiring special attention, such as driving vehicles or operating dangerous machinery.

Zamene contains monohydrate lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Zamene

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

This medicine is administered orally. The tablets must be swallowed whole, with a little liquid.

The dose should be individualized. Therefore, the number and frequency of tablets you must take will be determined by your doctor according to the type and severity of your condition, 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 therefore important that you fully understand your doctor's instructions regarding administration of the medicine, and if in doubt, do not hesitate to consult them.

In special situations (stress, serious infections, severe trauma, or surgical procedures), dose adjustment may be required. Consult your doctor to explain the appropriate course of action in such cases.

Your doctor will advise you on the duration of treatment. Do not stop treatment early or without authorization, and never discontinue abruptly.

After prolonged treatment, administration of this medicine must never be stopped abruptly. Your doctor will instruct you how to gradually reduce the dose. It is also important that you remain in contact with your doctor after completing treatment, so that action can be taken in case of symptom recurrence.

If you take more Zamene than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zamene

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

If you stop treatment with Zamene

Prolonged treatments, if stopped abruptly, may cause: fever, malaise, and muscle and joint pain.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Gastrointestinal disorders: Stomach ulcer, 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: Skin thinning, stretch marks, and acne. With unknown frequency (cannot be estimated from available data): potentially life-threatening skin rashes: 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 levels, and salt retention.

• Endocrine disorders: Adrenal insufficiency, weight gain and moon-shaped face, worsening of diabetes, cessation of menstruation, and growth delay in children.

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

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

During treatment with this medicine, your susceptibility to infections may increase. Therefore, if you notice any symptoms of illness that could be related to taking this medicine, you should contact your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse 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 must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zamene

The active substance is deflazacort.

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

Appearance of the product and contents of the pack:

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

The tablet can be divided into equal parts.

Zamene 6 mg tablets are packed in PVC blisters with an aluminium-PVC foil and are available in packs containing 20 or 500 tablets.

Marketing Authorization Holder

Laboratorios Menarini, S.A.

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

Telephone: +34 934 628 800 – E-mail: [email protected]

Manufacturer:

Laboratorios Menarini, S.A.

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

Telephone: +34 934 628 800 – E-mail: [email protected]

or

Cyndea Pharma, SL

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31, Ólvega 42110 (Soria)

Spain

Date of the most recent 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/