Label: information for the patient

Zamene 22.75 mg/ml oral suspension drops

deflazacort

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Zamene is a medication belonging to a group of medications 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 that does not respond to conventional treatment.
• Pulmonary diseases: sarcoidosis, organic dust pneumoconiosis, idiopathic pulmonary fibrosis.
• Eye diseases: choroiditis, chororetinitis, 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. Especially, you must 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 gland 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. Also, inform them if you have recently been to tropical countries.
• In prolonged treatments, eye alterations 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 your doctor must know if you have had any other disease.
• 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 this medication without consulting your doctor first.
• Contact your doctor if you experience blurred vision or other visual alterations.

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 often precede 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

Inform patients 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).

Especially 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.
• Estrogens or oral contraceptives.
• Medications that cause muscle relaxation. 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 for use during breastfeeding.

Driving and operating machinery

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

Zamene contains sorbitol, benzyl alcohol, and sodium

This medication contains 100 mg of sorbitol in each ml of oral suspension.

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

This medication contains 0.01 mg of benzyl alcohol in each 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 diseases. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks of age) unless your doctor recommends it.

This medication should not be used for more than a week in children under 3 years of age, unless your doctor or pharmacist advises it.

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

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

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

The usual dose in adults can 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 from 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.

Instructions for correct administration:

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

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

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

After a 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 doubts 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).

• Central 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 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 sodium retention.

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

• Musculoskeletal and Connective Tissue Disorders: Muscle alterations or weakness, osteoporosis.

• Eye 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, 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 not listed 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 product does not require special conditions for conservation.

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.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Zamene

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

Appearance of the product and contents of the packaging

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

It is packaged in amber glass bottles of 20 ml with a screw cap with aluminium seal, and includes a glass dropper.

The contents of the packaging are 13 ml of oral drops in suspension.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

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

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

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

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