Leaflet: information for the patient

Flammazine 10mg/g cream

Silver sulfadiazine

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 is Flammazine and what it is used for

2. What you need to know before starting to use Flammazine

3. How to use Flammazine

4. Possible side effects

5. Storage of Flammazine

6. Contents of the pack and additional information

Flammazine contains silver sulfadiazine, which is an antibiotic from the sulfonamides group (a medication useful for the treatment of bacterial infectionsbacterial infections).

Flammazine 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 as well as varicose and decubitus ulcers.

Do not use Flammazine

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

- If you are in the third trimester of pregnancy, or in premature, neonatal, or lactating infants less than 2 months old.

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 that your liver enzymes metabolize medications more slowly than usual.
• If you have a reduced number of white blood cells in your blood, your doctor will perform regular counts.
• If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase.
• If you are pregnant or breastfeeding.
• Do not expose the treated area to direct sunlight, as it may cause skin discoloration and grayish discoloration of the cream.
• Severe skin reactions that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of Flammazine 10 mg/g cream, 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) lesions.
• These life-threatening skin reactions often accompany flu-like symptoms. The rash may progress to widespread blistering or skin peeling.
• The highest risk period 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 10 mg/g cream, do not use Flammazine 10mg/g cream again at any time.
• If you develop a rash or these symptoms on your skin, seek immediate medical attention and inform your doctor that you are taking this medication.
• The use of Flammazine 10mg/g cream 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 less than 2 months old, as sulfonamides may cause kernicterus (a rare type of brain damage that occurs in a newborn with severe jaundice).

Other medications and Flammazine

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 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 10mg/g cream 3 days before and 3 days after administration of the typhoid vaccine.

Pregnancy and lactation

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

Pregnancy

Do not use Flammazine 10mg/g cream in the third trimester of pregnancy. It should only be used in other stages of pregnancy and under the recommendation of a doctor.

Lactation

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 may harm them.

Driving and operating machinery:

It is unlikely that Flammazine 10 mg/g cream will affect your ability to drive vehicles or operate machinery.

Flammazine 10 mg/g cream contains cetomacrogol and propylene glycol:

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of 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.

Usage instructions

Initially, the wound should be washed and cleaned. Then, with a sterile spatula or with a hand covered with a sterile glove, a layer of 3 mm thickness should be applied to the affected area, covering it with an appropriate dressing.

Normally, the dressing change 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 duration of treatment 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 should be removed first, carefully washing the wound with warm boiled water or isotonic saline solution.

Each package should be used for a single patient.

Instructions for opening the package

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

If you use more Flammazine 10 mg/g cream than you should

In case of overdose or accidental ingestion, stop using the cream and consult 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 10 mg/g cream

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 this medication, ask your doctor or pharmacist.

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

If you observe any of the following reactions, stop using Flammazine 10mg/g cream and inform your doctor immediately:

Very common: (may affect 1 in 10 patients)

• Reduction in the number 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)
• Skin reactions such as eczema and dermatitis
• Grey discoloration of the skin (due to sun exposure)

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 (due to prolonged silver absorption)
• Blood disorder leading to tissue hypoxia (methemoglobinemia) with symptoms that may include pallor, grey or bluish discoloration of the skin, lips, or nail beds, difficulty breathing, fatigue, confusion, headache, dizziness.

Other adverse effects:

• The absorption of propylene glycol 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 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.

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

Composition of Flammazine 10 mg/g cream

- The active ingredient is silver sulfadiazine. Each 1 gram of cream contains 10 milligrams of silver sulfadiazine.

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

Appearance of the product and content of the container

Flammazine 10 mg/g cream is a white or bone-white, sterile cream.

Flammazine 10 mg/g cream is available in tubes with 50 grams of cream and in jars with 500 grams of cream (clinical container)

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)

Local representative:

Alliance Pharmaceuticals Spain, S.L.,

Regus Business Center,

Torre de Cristal,

Paseo de la Castellana 259 C, Floor 18,

Cuatro Torres business area,

28046 Madrid (Spain)

Date of the last review 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