Leaflet: information for the patient

Flammazine Cerio 10 mg/g + 22 mg/g cream

Silver sulfadiazine, cerium nitrate

Read this leaflet carefully before you start using this medicinebecause 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyou experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Flammazine Cerio is and what it is used for

2. What you need to know before using Flammazine Cerio

3. How to use Flammazine Cerio

4. Possible side effects

5. Storage of Flammazine Cerio

6. Contents of the pack and additional information

Flammazine Cerio is the association of silver sulfadiazine, which is an antibiotic from the sulfonamides group (a medication useful for the treatment of bacterial infections), along with cerium nitrate, a product that potentiates the antimicrobial action of silver sulfadiazine and improves the formation of the eschar and promotes epithelialization.

Flammazine Cerio is indicated for adults, adolescents, children, infants from 2 months to 23 months of age for the treatment and prevention of infections in second- and third-degree burns.

Do not use Flammazine Cerio

If you are allergic (hypersensitive) to silver sulfadiazine, cerium nitrate, or any of the other components of this medication (listed in section 6).

-Do not use in the third trimester of pregnancy, in premature, neonatal, or lactating infants under 2 months..

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication:

• If you are hypersensitive to sulfonamides
• If you have any liver or kidney disease, avoid applying the cream to large or open wounds, especially ulcers.
• If you are a slow acetylator, meaning your liver enzymes metabolize medications more slowly than usual
• If you have a reduced white blood cell count, your doctor will perform regular blood counts.
• If you have a deficiency of the glucose-6-phosphate dehydrogenase enzyme.
• If you are pregnant or breastfeeding.
• Do not expose the treated area to direct sunlight, as it may cause skin discoloration and a grayish color of the cream.
• Severe skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of Flammazine Cerio, initially appearing as red circular spots often with a central blister.
• Additional signs that may appear include mouth, throat, nose, genital, and conjunctivitis (swollen and red eyes)
• These life-threatening skin reactions often accompany flu-like symptoms. The rash may progress to widespread blistering or skin peeling.
• The period of highest risk for severe skin reactions is during the first weeks of treatment.
• If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Flammazine Cerio, do not use Flammazine Cerio again at any time.
• If you develop a rash or these symptoms on your skin, go immediately to a doctor and inform them that you are taking this medication
• The use of Flammazine Cerio to treat large areas of the body may increase the likelihood of adverse effects

Children

Do not use this cream in premature, neonatal, or lactating infants under 2 months because sulfonamides can cause kernicterus (a rare type of brain damage that occurs in a newborn with severe jaundice).

Other medications and Flammazine Cerio

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Flammazine Cerio may alter the effect of medications metabolized by the CYP2C9 enzyme, such as warfarin, phenytoin, tolbutamide, losartan, and some nonsteroidal anti-inflammatory drugs.

Avoid using Flammazine Cerio 3 days before and 3 days after administration of the typhoid vaccine..

Pregnancy and breastfeeding

If you are pregnant orbreastfeeding,believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use Flammazine Cerio in the third trimester of pregnancy. It should only be used in other stages of pregnancy and under the recommendation of a doctor.

Breastfeeding

Use with caution when breastfeeding premature or jaundiced infants. Inform your doctor if you are breastfeeding a child suspected or known to have a deficiency of glucose-6-phosphate dehydrogenase, as Flammazine Cerio may harm them.

Driving and operating machinery:

It is unlikely that Flammazine Cerio will have any effect on your ability to drive vehicles or operate machinery.

FlammazineCerio contains cetomacrogol and propylene glycol:

This medication may cause local skin reactions (such as contact dermatitis) because it contains cetomacrogol.

This medication contains 70 mg of propylene glycol per gram. Propylene glycol may cause skin irritation.

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

Usage Instructions

Initially, you must wash and clean the wound. Then, with a sterile spatula or with a hand covered with a sterile glove, you must apply a layer of 3 mm thickness over the affected area, covering it with an appropriate dressing.

Normally, the dressing renewal will be performed 1-2 times a day, and it can be renewed every 4-6 hours in the case of highly contaminated wounds. The treatment duration depends on the underlying disease. Ask your doctor for advice after 2 weeks.

At each dressing change and medication replacement, the remnants of the previous application must be removed first, carefully washing the wound with warm boiled water or isotonic saline solution.

Each package must be used for a single patient.

Instructions for Opening the Package

The tube is sealed to ensure the sterility of the cream.Follow the instructions below to open it:

If you use more Flammazine Cerio than you should

In case of overdose or accidental ingestionstop using the cream andconsult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested or used.

High doses of silver sulfadiazine may cause symptoms affecting the brain, liver, kidneys, lungs, digestive system, and blood.

If you forgot to use Flammazine Cerio

If you forget to apply a dose, apply it as soon as you remember. Do not use a double dose to compensate for the missed doses.

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

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

If you observe any of the following reactions, stop using Flammazine Cerio and inform your doctor immediately:

Very common: (may affect 1 in 10 patients)

• Reduction of white blood cells in the blood (leucopenia)

Very rare: (may affect 1 in 10,000 people)

• Severe skin eruptions that may threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).
• Grey discoloration of the skin (due to sun exposure).
• Skin reactions such as eczema and dermatitis.

Frequency not known: (the frequency cannot be estimated from available data)

• Dry, itchy skin (pruritus) or rash
• Burning or pain sensation in the application area
• Hypersensitivity Grey discoloration of the skin in the application area (due to silver absorption during prolonged periods).
• Blood alteration leading to a lack of oxygen in tissues (methemoglobinemia) with symptoms that may include paleness, grey or bluish skin, lips, or nail beds, difficulty breathing, fatigue, confusion, headache, dizziness.

Other adverse effects:

The absorption of propylene glycol contained in the cream may increase serum osmolality, which may interfere with some laboratory tests.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25°C

Store in the original packaging

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, use within 14 days.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at your local pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Flammazine Cerio

- The active principles are silver sulfadiazine and cerium nitrate hexahydrate. Each 1 gram of cream contains 10 milligrams of silver sulfadiazine and 22 milligrams of cerium nitrate (hexahydrate).

- The other components are: liquid paraffin, propylene glycol (E 1520), polisorbate 60 (E 435), polisorbate 80 (E 433), monoestearate of glycerol, cetyl alcohol, and purified water.

Appearance of the product and contents of the packaging

Flammazine Cerio is a white or off-white sterile cream.

Flammazine Cerio is available in 50-gram tubes of cream and 500-gram jars of cream. (Clinical packaging)

Holder of the marketing authorization

Alliance Pharma (Ireland) LTD

United Drug House, Magna Drive,

Magna Business Park, Citywest Road

D24 X0CT- Dublin

Ireland

Responsible for manufacturing

Reciphar .Parets, S.L.

C/ Ramón Cajal, 2

08150 Parets del Valles (Barcelona)

Spain

Local Representative:

Alliance Pharmaceuticals Spain, S.L.,

Regus Business Center,

Torre de Cristal,

Paseo de la Castellana 259 C, 18th floor,

Cuatro Torres business area,

28046 Madrid-Spain

Last review date of this leaflet: March 2022

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