ZAMENE 22.75 mg/ml ORAL SUSPENSION DROPS

Introduction

Patient Information Leaflet

Zamene 22.75 mg/ml oral drops in suspension

deflazacort

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

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

Contents of the Leaflet

1. What is Zamene and what is it used for
2. What you need to know before taking Zamene
3. How to take Zamene
4. Possible side effects
5. Storage of Zamene
6. Package contents and additional information

1. What is Zamene and what is it used for

Zamene is a medicine belonging to a group of medicines known as corticosteroids, which have anti-inflammatory and anti-allergic 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.
• Ocular diseases: choroiditis, chorioretinitis, iritis, and iridocyclitis.
• Blood diseases: 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 taking Zamene

Do not take Zamene

• If you are allergic to deflazacort or 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) 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 starting to take 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 ulcer, 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 indicate what conduct to follow 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 may 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, 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 medicine.

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 the treatment of 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 plan to become pregnant, consult your doctor or pharmacist before using 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 sorbitol, benzyl alcohol, and sodium

This medicine contains 100 mg of sorbitol per ml of oral suspension.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

This medicine contains 0.01 mg of benzyl alcohol per ml of oral suspension.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist has indicated it.

This medicine contains less than 23 mg of sodium (1 mmol) per ml of oral suspension, which is essentially "sodium-free".

3. How to take Zamene

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the daily dose. The dosage is individual for each patient, depending on the type and severity of their disease, as well as their response to treatment.

The usual dose in adults 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 you have any doubts, do not hesitate to consult them.

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

Instructions for correct administration:

This medicine is administered orally. The bottle should be shaken before use. The suspension to be administered can be diluted, immediately before administration, in sugared water or non-carbonated beverages.

1. To release the dropper from its protection, hold A and pull B upwards at the same time.
2. Unscrew the metal cap from the bottle and place and screw the dropper.
3. To open the bottle containing the dropper, press the cap firmly and unscrew at the same time. CHILD SAFETY LOCK.

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

After a prolonged treatment, the administration of this medicine should never be interrupted 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 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 forgotten doses.

If you interrupt treatment with Zamene

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

If you have any other doubts about 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 everyone will experience 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 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. With an unknown frequency (cannot be estimated from available data): potentially fatal skin reactions: 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, disappearance of menstruation, and growth retardation in children.

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

• Ocular disorders: Ocular disorders (cataracts, increased intraocular pressure). With an unknown frequency (cannot be estimated from 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) 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 sight and reach of children.

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

Once opened, the bottle can be stored below 30°C for 3 months.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Zamene composition

• The active ingredient is deflazacort. One ml contains 22.75 mg of deflazacort. One drop contains 1 mg of deflazacort.
• The other ingredients are: aluminum and magnesium silicate, sodium carboxymethylcellulose, benzyl alcohol, sorbitol 70%, polysorbate 80 (E-433), acetic acid, and purified water.

Appearance of the product and package contents

Zamene 22.75 mg/ml oral drops in suspension is a slightly viscous and whitish suspension.

It is packaged in 20 ml amber glass bottles with an aluminum cap and a glass dropper.

The package contents are 13 ml of oral drops in suspension.

Marketing authorization holder and manufacturer

Laboratorios Menarini, S.A.

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

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

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

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/