Zamene 30 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Zamene 30 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 hepatic diseases: ulcerative colitis, Crohn's disease, and chronic active 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, inform your doctor about cardiovascular diseases (heart failure, high blood pressure), conditions caused by 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 get vaccinated during treatment with this medicine. Your doctor will advise you on what to do in such cases. Also inform your doctor if you have recently visited tropical countries.
• Prolonged treatment may lead to eye disorders; therefore, your doctor may recommend periodic visits to an ophthalmologist.
• The dose of corticosteroids must be adjusted in special situations (such as surgery, infections, and other conditions), so your doctor needs to know if you have suffered from any other illness.
• 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 first consulting your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Serious skin reactions

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

Frequently, these rashes may involve ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red, swollen eyes).

These severe skin reactions are often preceded by fever, headache, and body aches (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 advised that this medicine contains deflazacort, which may result in a positive doping test.

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 medicines (including some used 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:

• 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 for 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 may be pregnant, or are planning 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 during breastfeeding is not recommended.

Driving and use of machines

There are no available data; 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 with him before taking this medicine.

3. How to take Zamene

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

This medicine is administered orally. The tablets should 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 illness, 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 surgery), dose adjustment may be required. Consult your doctor to explain the appropriate course of action in these cases.

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

After prolonged treatment, administration of this medicine must never be stopped abruptly. Your doctor will instruct you on how to gradually reduce the dose. It is also important that you remain in contact with your doctor after completing treatment, so that they can act promptly if symptoms reappear.

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 interrupted 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: Thinning of the skin, stretch marks, and acne. At an unknown frequency (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, absence of menstruation, and growth delay in children.

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

• Eye disorders: Eye disorders (cataracts, increased intraocular pressure). At an unknown frequency (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 they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Zamene Storage

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 Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly discard unused medicines and their packaging. 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:

White, round 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 packed in PVC blisters with aluminum-PVC lidding foil 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

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

Emiliano Revilla Sanz Industrial Estate

Avenida de Ágreda, 31, Ólvega 42110 (Soria)

Spain

Date of the most recent revision of this leaflet: March 2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/