Deflamol Ointment (18 g)

Dosage form

Deflamol in the form of an ointment is a dermatological product.

Contraindications

In which cases it should not be used?

Do not use in case of hypersensitivity to any of the ingredients of the product.

Precautions for use:

Deflamol is not placed in the eyes or on open wounds and mucous membranes.

Warning! The product contains parabens (methyl parahydroxybenzoate, propyl parahydroxybenzoate) as excipients, which may cause allergies. These are usually a fun type of reaction. Rarely, they cause an immediate reaction with urticaria and bronchospasm.

Pregnancy and lactation:

There are no restrictions on the use of the product during pregnancy and lactation.

Drug interactions:

No adverse drug interactions are known.

Storage instructions:

In original packaging in a dry and protected from light place at a temperature below 25 °C.

Keep out of reach of children!

The tolerance to the product is very good. Does not cause irritation at the application site. Due to its topical application does not lead to the development of hypervitaminosis A and D and related complications. Rarely, hypersensitivity reactions such as itching, burning or rash may occur.

Overdose:

To date, there are no data on topical administration of Deflamol.

DEFLAMOL ungvent 18 g SOPHARMA

PACKAGE LEAFLET: INFORMATION FOR THE USER

Deflamol 350IU/400 IU/g ointment

Deflamol 350 IU/400 IU/g ointment

retinol palmitate/ergocalciferol

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist. 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.
• If after 7 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet

1. What Deflamol is and what it is used for

2. What you need to know before you use Deflamol

3. How to use Deflamol

4. Possible side effects

5. How to store Deflamol

6. Contents of the pack and other information

1. What Deflamol is and what it is used for

Deflamol ointment is a combined medicinal product with a pronounced epithelotonic effect. When applied to the skin, it has a softening, stimulating and regenerative effect on the epithelial cells of the skin.

It is used as a protective and softening agent for dry and irritated skin (including drainage, ileostoma or colostomia, dermatitis and diaper rash), superficial skin damage from solar, thermal and chemical influences, superficial wounds and ulcers (abrasion, cracking, chafing).

If after 7 days you do not feel better or your condition worsens, you should seek medical attention.

2. What you need to know before you use Deflamol

Do not use Deflamol

• if you are allergic (hypersensitive) to the active substances, to peanuts and soya or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Do not apply Deflamol in the eyes, as well as on deep, secreting and infected wounds, mucous membranes and large skin areas.

Children and adolescents

Deflamol can be used in children.

Other medicines and Deflamol

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

No adverse drug and other interactions are known.

Pregnancy and breast-feeding

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

Deflamol ointment can be used during pregnancy and in the period of lactation.

Driving and using machines

Deflamol ointment is a medicinal product for application to the skin. Has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Deflamol

The composition of the product as excipients contain methyl- and propyl parahydroxybenzoates, which can cause inflammation of the skin and rashes. It also contains lanolin, Peruvian balm and macrogol, which can cause local skin irritation.

3. How to use Deflamol

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Deflamol ointment is applied in a thin layer on the damaged skin surfaces 1-2 times a day. In the absence of improvement within 7 days, treatment should be reevaluated after consulting a doctor.

If you take more Deflamol than you should

When applied to the skin of the product, there is no evidence of overdose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, deflamol ointment can cause side effects, although not everybody gets them.

In rare cases, it is possible to observe itching, burning or rashes at the site of application in patients with increased sensitivity.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Deflamol

Keep out of the reach of children.
Store in the original package in order to protect from light at a temperature below 25°C.

Shelf life after opening the tube: 6 months.

Do not use Deflamol after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.

6. Additional information

What Deflamol contains

– 1 g ointment contains active substances:

retinol palmitate 0.3 mg (5 IU, respectively);

ergocalciferol (ergocalciferol) 0.01 mg (400 IU, respectively).

– The other ingredients are:

• cod liver oil;
• Peruvian balm; liquid paraffin;
• hard paraffin;
• white soft paraffin;
• Lanolin; polysorbate 80;
• polysorbate 60;
• sorbitan oleate;
• macrogol 4000;
• methyl parahydroxybenzoate (E218);
• propyl parahydroxybenzoate (E216);
• Epgilgalat;
• purified water.

What Deflamol looks like and contents of the pack

Tan homogeneous ointment with a specific smell of Peruvian balm.

18 g ointment in membrane aluminum tubes with polypropylene caps, 1 tube in a cardboard box, together with a leaflet.

40 g ointment in membrane aluminum tubes with polypropylene caps, 1 tube in a cardboard box, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria