FLAMMAZINE CERIO 10 mg/g + 22 mg/g CREAM

Introduction

Package Leaflet: Information for the Patient

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

Silver sulfadiazine, cerium nitrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Flammazine Cerio and what is it used for
2. What you need to know before you use Flammazine Cerio
3. How to use Flammazine Cerio
4. Possible side effects
5. Storage of Flammazine Cerio
6. Contents of the pack and further information

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

Flammazine Cerio is a combination of silver sulfadiazine, which is an antibiotic from the sulfonamide group (a medicine used to treat bacterial infections), and cerium nitrate, a product that enhances the antimicrobial action of silver sulfadiazine and improves eschar formation and promotes epithelialization.

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

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

Do not use Flammazine Cerio

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

• If you are in the third trimester of pregnancy, or in premature babies, neonates, or infants under 2 months.

Warnings and precautions

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

• you should not expose the treated area with Flammazine Cerio to direct sunlight, as it may cause skin discoloration, as well as a gray coloration of the cream.
• life-threatening skin rashes have been reported with the use of Flammazine Cerio, initially appearing as red spots or patches often with a central blister.
• other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes)
• these life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to generalized blistering or peeling of the skin.
• the period of highest risk of severe skin reactions is during the first few weeks of treatment.
• 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 babies, neonates, or infants under 2 months because sulfonamides can cause kernicterus (a very rare type of brain damage that occurs in a newborn with severe jaundice).

Other medicines and Flammazine Cerio

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought without a prescription.

Flammazine Cerio may alter the effect of medicines that are metabolized by the CYP2C9 enzyme, such as warfarin, phenytoin, tolbutamide, losartan, and some non-steroidal anti-inflammatory drugs.

The use of Flammazine Cerio should be avoided 3 days before and 3 days after the administration of the typhoid vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use Flammazine Cerio in the third trimester of pregnancy. This cream should only be used in other stages of pregnancy and on the advice of a doctor.

Breastfeeding

This cream should be used with caution when breastfeeding premature babies or children with jaundice (yellow color of the skin or the white of the child's eyes). Inform your doctor if you are breastfeeding a child who is suspected or known to have a deficiency of glucose-6-phosphate dehydrogenase, as Flammazine Cerio may harm them.

Driving and using machines

It is unlikely that Flammazine Cerio will affect your ability to drive or use machines.

Flammazine Cerio contains cetyl alcohol and propylene glycol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetyl alcohol.

This medicine contains 70 mg of propylene glycol in each gram. Propylene glycol may cause skin irritation.

3. How to use Flammazine Cerio

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

Instructions for use

Initially, you should wash and clean the wound. Then, with a sterile spatula or with your hand covered with a sterile glove, you should apply a 3 mm thick layer over the affected area, covering it with a suitable dressing.

Normally, the dressing should be changed 1-2 times a day, and may be changed 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 reapplication of the medicine, first remove any remaining application, carefully washing the wound with warm boiled water or isotonic saline solution.

Each container should be used for a single patient.

Instructions for opening the container

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

If you use more Flammazine Cerio than you should

In case of overdose or accidental ingestion, stop using the cream and consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested or used.

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

If you forget 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 make up for forgotten doses.

If you have any further questions on 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 everybody gets them.

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

Very common: (may affect up to 1 in 10 people)

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

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

• Life-threatening skin rashes have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).
• Gray skin discoloration (due to sun exposure).
• Skin reactions such as eczema and dermatitis.

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

• Dry and itchy skin (pruritus) or rash
• Burning sensation or pain in the application area
• Hypersensitivity
• Gray skin discoloration in the application area (due to silver absorption during prolonged periods).
• Alteration of the blood that leads to a lack of oxygen in the tissues (methemoglobinemia) with symptoms that may include paleness, gray or blue discoloration of the skin, lips, or nail beds, difficulty breathing, fatigue, confusion, headache, dizziness.

Other side effects:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flammazine Cerio

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

Do not store above 25°C

Store in the original packaging

Do not use this medicine after the expiry date which is stated on the container after CAD. The expiry date is the last day of the month stated. Once opened, use within 14 days.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Flammazine Cerio

• The active ingredients are silver sulfadiazine and cerium nitrate hexahydrate. Each gram of cream contains 10 milligrams of silver sulfadiazine and 22 milligrams of cerium nitrate (hexahydrate).
• The other ingredients are: liquid paraffin, propylene glycol (E 1520), polysorbate 60 (E 435), polysorbate 80 (E 433), glycerol monostearate, cetyl alcohol, and purified water.

Appearance of the product and contents of the pack

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

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

Marketing authorization holder

Alliance Pharma (Ireland) LTD

United Drug House, Magna Drive,

Magna Business Park, Citywest Road

D24 X0CT- Dublin

Ireland

Manufacturer

Meribel Pharma Parets, S.L.U.

C/ Ramón y Cajal, 2

08150 Parets del Vallès (Barcelona)

Spain

Local representative:

Alliance Pharmaceuticals Spain, S.L.,

Regus Business Center,

Torre de Cristal,

Paseo de la Castellana 259 C, Planta 18,

Cuatro Torres business area,

28046 Madrid-Spain

Date of the last revision of this leaflet: March 2022

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