Daivobet 50 micrograms/0.5 mg/g gel
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Daivobet 50 micrograms/0.5 mg/g gel
calcipotriol/betamethasone
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Daivobet is and what it is used for
- What you need to know before using Daivobet
- How to use Daivobet
- Possible adverse effects
- How to store Daivobet
Contents of the pack and other information
1. What Daivobet is and what it is used for
Daivobet is used as a topical treatment for scalp psoriasis in adults and to treat mild to moderate plaque psoriasis (psoriasis vulgaris) on the skin of other body areas in adults. Psoriasis is caused by an abnormally rapid production of skin cells. This leads to redness, scaling, and thickening of the skin.
Daivobet contains calcipotriol and betamethasone. Calcipotriol helps normalize the rate of skin cell growth, and betamethasone reduces inflammation.
2. What you need to know before starting to use Daivobet
Do not use Daivobet:
- if you are allergic (hypersensitive) to calcipotriol, betamethasone, or to any of the other ingredients of this medicine (listed in section 6)
- if you have problems with calcium levels in your body (consult your doctor)
- if you suffer from certain types of psoriasis: such as erythrodermic, exfoliative, or pustular psoriasis (consult your doctor).
Since Daivobet contains a potent steroid, DO NOT use it on skin affected by:
- skin infections caused by viruses (for example, herpes or chickenpox)
- skin infections caused by fungi (for example, athlete’s foot or ringworm)
- skin infections caused by bacteria
- skin infections caused by parasites (for example, scabies)
- tuberculosis
- perioral dermatitis (red rash around the mouth)
- thin skin, fragile blood vessels, stretch marks
- ichthyosis (dry, scaly skin)
- acne (spots)
- rosacea (intense redness or flushing of the facial skin)
- ulcers or damaged skin.
Warnings and precautions
Consult your doctor/nurse/pharmacist before and during treatment with Daivobet if:
- you are using other medicines containing corticosteroids, as you may experience adverse effects
- you have used this medicine for a long time and plan to stop using it (since there is a risk that your psoriasis may worsen or 'rebound' when steroids are suddenly discontinued)
- you have diabetes mellitus (diabetes), as your blood sugar/glucose levels may be affected by the steroid
- a skin infection develops, as it may be necessary to interrupt treatment
- you suffer from a type of psoriasis called guttate psoriasis
- you experience blurred vision or other visual disturbances.
Special precautions
- Avoid use on more than 30% of your body surface or more than 15 grams per day
- Avoid using occlusive dressings such as bathing caps, bandages, or gauze, as these increase steroid absorption
- Avoid use on large areas of damaged skin, mucous membranes, or skin folds (groin, armpits, under the breasts), as these increase steroid absorption
- Avoid use on the face or genitals (genital organs), as these areas are highly sensitive to steroids
- Avoid excessive sun exposure, excessive use of artificial tanning, and other forms of light therapy.
Children
The use of this medicine is not recommended in children under 18 years of age.
Use of Daivobet with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. If your doctor agrees that you may breastfeed, take care not to apply Daivobet to the breast area.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.
Daivobet contains butylhydroxytoluene (E321)
Daivobet may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene (E321).
3. How to use Daivobet
Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.
How to use Daivobet: Cutaneous use.
Bottle
Instructions for proper use
- Use it only on areas of psoriasis and do not apply it to skin without psoriasis.
- Shake the bottle before use and remove the cap.
- Apply the gel onto a clean fingertip or directly onto the psoriatic area.
- Apply Daivobet with the fingertip to the affected area and gently massage until the psoriatic area is covered with a thin layer of gel.
- Do not apply a dressing, or cover or wrap the treated skin area.
- Wash your hands thoroughly after using Daivobet. This will help prevent accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes).
- Do not worry if a small amount of gel is accidentally applied to healthy skin near your psoriasis, but clean it off if it has spread excessively.
- To achieve optimal effect, it is recommended not to shower or bathe immediately after applying Daivobet gel.
- After applying the gel, avoid contact with fabrics that may be easily stained by grease (e.g., silk).
If you have psoriasis on the scalp
- Before applying Daivobet to the scalp, brush your hair to remove loose scales. Tilt your head to prevent Daivobet from running onto your face. It may be helpful to part the hair in the area to be treated before using Daivobet. Apply Daivobet with the fingertip to the affected area and gently massage.
It is not necessary to wash your hair before applying Daivobet.
Shake the bottle before use. | Place one drop of Daivobet onto the fingertip. | Apply directly to the areas of the scalp affected by thickened plaques and massage the Daivobet gel into the skin. Depending on the affected area, 1–4 g (up to a teaspoonful) is usually sufficient. |
To achieve an optimal effect, it is recommended not to wash your hair immediately after applying Daivobet. Allow Daivobet to remain on the scalp overnight or during the day. When you wash your hair after application, the following instructions may be helpful:
Apply a gentle shampoo to dry hair, especially in those areas where the gel has been applied. | Leave the shampoo on the scalp for a few minutes before proceeding with washing. | Wash your hair as usual. |
If necessary, repeat steps 4 to 6 once or twice.
Duration of treatment
- Use the gel once daily. It may be more convenient to apply the gel at night.
- The usual initial treatment period is 4 weeks for scalp areas and 8 weeks for other areas.
- Your doctor may decide on a different treatment duration.
- Your doctor may decide that you should repeat the treatment.
- Do not use more than 15 grams in one day.
If you are using other medications containing calcipotriol, the total amount of medications containing calcipotriol should not exceed 15 grams per day, and the treated area should not exceed 30% of the total body surface area.
Applicator
Read the instructions for using the Daivobet gel applicator, included at the end of this leaflet, carefully before starting to use it.
The Instructions for Use contain information on the assembly, use, cleaning, and storage of the Daivobet gel applicator.
Daivobet gel with applicator will be referred to as "the applicator" throughout this leaflet.
Instructions for proper use of Daivobet
- Use it only on your psoriasis-affected skin and do not apply it to skin not affected by psoriasis.
- Apply Daivobet using the applicator to the affected area and gently massage until the psoriatic area is covered with a thin layer of gel.
- Do not apply a dressing, or cover or wrap the treated skin area.
- Wash your hands thoroughly after using Daivobet if the gel has come into contact with your fingers. This will help prevent accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes).
- Do not be concerned if a small amount of gel is accidentally applied to healthy skin near your psoriasis, but clean it off if it has spread excessively.
- To achieve optimal effect, it is recommended not to shower or bathe immediately after applying Daivobet gel.
- After applying the gel, avoid contact with fabrics that may be easily stained by grease (e.g., silk).
It is not necessary to wash your hair before applying Daivobet.
To achieve optimal effect, it is recommended not to wash your hair immediately after applying Daivobet. Leave Daivobet on the scalp overnight or during the day. When you do wash your hair after application, the following instructions may be helpful:
Apply a gentle shampoo to dry hair, especially in those areas where the gel has been applied. | Leave the shampoo on the scalp for a few minutes before proceeding with washing. | Wash your hair as usual. |
If necessary, repeat steps 1 to 3 once or twice.
Duration of treatment
- Use the gel once daily. It may be more convenient to apply the gel at night.
- The usual initial treatment period is 4 weeks for scalp areas and 8 weeks for other areas.
- Your doctor may decide on a different treatment duration.
- Your doctor may decide that you should repeat the treatment.
- Do not use more than 15 grams in one day. This means that one 60 g applicator should last at least 4 days.
- Normally, a daily amount between 1 g and 4 g is sufficient for treatment of the scalp.
If you are using other medications containing calcipotriol, the total amount of calcipotriol-containing medicines should not exceed 15 grams per day, and the treated area should not exceed 30% of the total body surface area.
One full pump press releases 0.05 g of Daivobet gel.
What should I expect when using Daivobet?
Most patients notice obvious results within 2 weeks, even though the psoriasis may not have completely cleared by then.
If you use more Daivobet than you should
Consult your doctor if you have used more than 15 grams in one day.
Excessive use of Daivobet may cause a problem with calcium levels in your blood, which usually returns to normal once treatment is stopped.
Your doctor may need to perform blood tests to check whether excessive use of the gel has caused any problem with your blood calcium levels.
Prolonged and excessive use may also cause your adrenal glands to stop functioning properly (the adrenal glands are located near the kidneys and produce hormones).
Contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount used.
If you forget to use Daivobet
Do not apply a double dose to make up for the missed dose.
If you stop using Daivobet
Treatment with Daivobet should be discontinued as directed by your doctor. You may need to stop using this medicine gradually, especially if you have been using it for a long time.
If you have any further questions about using this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Serious adverse effects
Inform your doctor/nurse immediately or as soon as possible if you experience any of the following adverse effects. You may need to stop your treatment.
The following serious adverse effects have been reported with Daivobet:
Uncommon (may affect up to 1 in 100 people)
- Worsening of your psoriasis. If your psoriasis worsens, inform your doctor as soon as possible.
It is known that some serious adverse effects are caused by betamethasone (a potent steroid), one of the components of Daivobet. If you experience any of these serious adverse effects, inform your doctor as soon as possible. These adverse effects are more likely to occur after long-term use, when applied to skin folds (e.g. groin, armpits or under the breasts), when the treated area is covered, or when used over large areas of skin.
The adverse effects include the following:
- Your adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety.
- Cataracts (symptoms include blurred or cloudy vision, reduced night vision, and light sensitivity) or increased pressure inside the eye (symptoms include eye pain, red eye, blurred vision, or reduced vision).
- Infections (because your immune system, which fights infections, may be suppressed or weakened).
- Pustular psoriasis (a red area with yellowish pustules, usually on the hands or feet). If this occurs, stop using Daivobet and inform your doctor as soon as possible.
- Effect on the metabolic control of diabetes mellitus (if you have diabetes, you may experience changes in blood glucose levels).
Serious adverse effects caused by calcipotriol
- Allergic reactions with severe swelling of the face or other parts of the body such as the hands or feet. Swelling of the mouth/throat and breathing difficulties may occur. If you experience an allergic reaction, stop using Daivobet and inform your doctor immediately or go to the nearest hospital emergency department.
- Treatment with this gel may cause an increase in calcium levels in your blood or urine (usually when too much gel is used). Symptoms of elevated blood calcium include excessive urination, constipation, muscle weakness, confusion, and coma. This can be serious and you must contact your doctor immediately. However, calcium levels return to normal once treatment is stopped.
Less serious adverse effects
The following less serious adverse effects have been reported with Daivobet:
Common (may affect up to 1 in 10 people)
- Itching.
Uncommon (may affect up to 1 in 100 people)
- Eye irritation
- Burning sensation of the skin
- Pain or irritation of the skin
- Inflammation or swelling at the hair root (folliculitis)
- Skin rash with skin inflammation (dermatitis)
- Redness of the skin due to dilation of small blood vessels (erythema)
- Acne (spots)
- Dry skin
- Skin rash (rash)
- Pustular rash
- Skin infection.
Rare (may affect up to 1 in 1,000 people)
- Allergic reactions
- Stretch marks (striae)
- Skin peeling
- Rebound effect: Worsening of symptoms/psoriasis after stopping treatment.
Frequency not known (frequency cannot be estimated from available data)
- When used on the scalp, white or grey hair may temporarily turn yellowish at the application site.
- Blurred vision.
Less serious adverse effects caused by the use of betamethasone, especially with prolonged use, include the following. If you notice any of these, inform your doctor or nurse as soon as possible:
- Thinning of the skin
- Appearance of superficial veins or stretch marks (striae)
- Changes in hair growth
- Red rash around the mouth (perioral dermatitis)
- Skin rash with inflammation or swelling (allergic contact dermatitis)
- Golden-yellow papules (miliaria colloid)
- Skin discoloration (depigmentation)
- Inflammation or swelling at the hair root (folliculitis).
Less serious adverse effects caused by calcipotriol include:
- Dry skin
- Skin sensitivity to light leading to a skin rash
- Eczema
- Itching
- Skin irritation
- Burning sensation and itching
- Redness of the skin due to dilation of small blood vessels (erythema)
- Skin rash (rash)
- Skin rash (rash) with skin inflammation (dermatitis)
- Worsening of psoriasis.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Daivobet
- Keep this medicine out of the sight and reach of children.
Bottle
- Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
- Do not refrigerate. Store the bottle in the outer packaging to protect it from light.
- Discard the bottle with any remaining gel 6 months after first opening.
Applicator
- Do not use this medicine after the expiry date stated on the cartridge after EXP. The expiry date refers to the last day of the month indicated.
- Do not refrigerate.
- The applicator is disposable. Discard the applicator with any remaining gel 6 months after first opening.
Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Daivobet
The active substances are:
Calcipotriol and betamethasone.
One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
The other components are:
- liquid paraffin
- poloxipropylene stearate ether
- hydrogenated castor oil
- butylhydroxytoluene (E321)
- all-rac-α-tocopherol.
Appearance of Daivobet and contents of the pack
Bottle
Daivobet is a nearly transparent, colourless or slightly whitish gel supplied in high-density polyethylene bottles with a low-density polyethylene nozzle and a high-density polyethylene screw cap.
The bottles are packed in cardboard boxes.
Pack sizes: 15 g, 30 g, 60 g, 80 g, 2 x 60 g, 2 x 80 g, and 3 x 60 g.
Applicator
Daivobet is a nearly transparent, colourless or slightly whitish gel supplied in a polypropylene cartridge (with a screw cap and a high-density polyethylene plunger). The cartridge and the applicator head (outer cover made of polypropylene, lever made of polyoxymethylene, and nozzle made of thermoplastic elastomer) are assembled before first use. The polypropylene cap is for storage after use.
The cartridge(s), applicator head(s), and cap(s) are included in a cardboard box.
Pack sizes: 60 g (equivalent to 68 ml) and 2 x 60 g (equivalent to 2 x 68 ml).
Only some pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
The manufacturers are:
LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark
or
LEO Laboratories Ltd. (LEO Pharma)
285 Cashel Road
Dublin 12
Ireland
Instructions for Use of the applicator are provided at the end of this leaflet.
This medicinal product is authorised in the European Economic Area member states under the following names:
Daivobet: Austria, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
Dovobet: Belgium, Cyprus, Greece, Ireland, Italy, Luxembourg, the Netherlands, United Kingdom
Date of the most recent revision of this leaflet: October 2019.
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
Instructions for Use
of the Daivobet gel applicator
Read this entire leaflet and the Instructions for Use carefully before you start using this medicine – even if you have used Daivobet gel before.
The Daivobet gel applicator is designed to apply Daivobet gel to your skin and scalp affected by psoriatic plaques. By using the Daivobet gel applicator, you can apply the gel without it coming into contact with your fingers.
Always follow your doctor's instructions regarding treatment of your psoriasis.
Do not share Daivobet gel or the applicator with other people.
Keep this medicine out of the sight and reach of children.
Your Daivobet gel
Preparing your Daivobet gel | |
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Check the expiry date shown on the label of the cartridge. Do not use it if expired. The expiry date on the cartridge refers to the last day of the month indicated. Write on the cartridge label the date when you attach the dispenser. Do not use the dispenser after 6 months from this date. |
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Holding the cartridge vertically, turn the cap counterclockwise to remove it. Do not tilt the cartridge, as the gel may leak out. Dispose of the cap after removal. |
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Hold the cartridge vertically and attach the applicator head. Screw the applicator head clockwise until it is securely fitted. You will hear several clicks when it is properly secured. Note: Do not disassemble the applicator. Attempting to do so may break the applicator. |
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To prime: Ensure that the applicator head and cartridge are securely attached. Press carefully on the center of the bottom of the cartridge while simultaneously pressing the lever, until product appears at the tip of the nozzle. |
If you travel by airplane with the Daivobet gel applicator assembled, you may need to press the lever several times to re-prime it before use.
Applying Daivobet gel to the affected area | |
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Place the applicator nozzle close to the affected area and press the lever once or more to dispense Daivobet gel. Release the lever completely between each press to ensure a full dose is delivered. One complete press releases 0.05 g of Daivobet gel. |
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Use the designated spreading surfaces to gently massage Daivobet gel into the affected skin. Take care not to press the lever while spreading the gel. |
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Before applying Daivobet to the scalp, brush your hair to remove loose scales. Tilt your head to prevent Daivobet from running into your face. It may be helpful to part the hair in the area to be treated before using Daivobet. Locate the treatment area with your fingers and part the hair. Use the nozzle directly on the scalp to dispense and massage in the Daivobet gel. |
- After application
Check that the affected areas are sufficiently covered with the gel.
If necessary, ask someone to help you apply Daivobet gel to areas that you cannot reach or see.
Wash your hands after use, if Daivobet gel has come into contact with your fingers or those of the person who applied the gel.
This will prevent accidental contact of the gel with other parts of your body (especially the face, mouth, and eyes).
After use | |
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After use, clean the applicator tip with a clean, dry tissue. Avoid pressing the lever while cleaning. Note:
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Replace the cap after each use to keep the applicator tip clean. Always ensure the cap is properly secured (you will hear a click) to prevent leakage of Daivobet gel during storage and transport. |
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To estimate the remaining amount of Daivobet gel, look at the bottom of the cartridge to see the position of the plunger. The plunger moves upward as the gel is used. |
Before using again | |
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Before use, always check the expiration date shown on the cartridge label. Do not use if the expiration date has passed or if more than 6 months have elapsed since the cartridge was first opened. The expiration date printed on the cartridge refers to the last day of the month indicated. |
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Remove the cap by lifting the tab. |
Storage
Always ensure the cap is properly secured (you will hear a click) to prevent the gel from leaking during storage and transport.
For additional information regarding product storage, refer to section 5, 'Storage of Daivobet'.
Disposal
For information on disposal of the product, refer to section 5, 'Storage of Daivobet'.