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CURATODERM 4 MICROGRAMS / G LOTION - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - CURATODERM 4 MICROGRAMS / G LOTION

1. what curatoderm lotion is and what it is used for

Curatoderm Lotion contains tacalcitol which is a drug that belongs to a group of medicines called antipsoriatics and is a vitamin D derivative.

Curatoderm Lotion is used to treat a condition known as psoriasis vulgaris especially on the scalp. Psoriasis is a skin disorder in which itchy, red, flaky patches appear on the skin or scalp. Within affected areas of skin, new cells are being produced faster than normal, but old dead cells are only being shed at the normal rate. As live skin cells accumulate, the skin becomes thickened and inflamed. Curatoderm Lotion works by slowing down cell production and bringing it back to normal and helps to reduce inflammation.

2. what you need to know before you use curatoderm lotion do not use curatoderm lotion

  • if you are allergic to tacalcitol or any of the other ingredients of this medicine (listed in section 6).
  • If you suffer with psoriasis punctata which are individual lesions, each red in colour and tipped with a single white scale.
  • If you suffer with psoriasis pustulosa which is inflammation of the skin and small white or yellow pus-filled blisters.
  • If you suffer with severe liver, kidney or heart disease.
  • if you have ever had problems with too much calcium in your blood (hypercalcaemia or other disorders of calcium metabolism).

If this applies to you, do not use this medicine and speak to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before using Curatoderm Lotion.

When applying Curatoderm Lotion to the face do not allow the lotion to come in contact with the eyes. If it does, rinse thoroughly with water.

Tell your doctor if:

  • you have or have had problems with your kidneys,
  • you have a particular type of psoriasis called generalized pustular psoriasis or erythrodermic exfoliative psoriasis,
  • you are taking high doses of vitamin D (more than 500IU).

Your doctor may want to check the level of calcium in your blood if you have any of these conditions.

Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Other medicines and Curatoderm Lotion

Tell your doctor or pharmacist if you are taking or using, have recently taken or used or might take or use any other medicines, including medicines obtained without a prescription.

Especially:

  • Multivitamin products or vitamin D
  • Other treatments for psoriasis

If you are receiving ultraviolet (UV) therapy, this should be given in the morning and Curatoderm Lotion used at bedtime.

Pregnancy and breast-feeding

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

The potential risk to the baby if Curatoderm Lotion is used during pregnancy is unknown. Therefore treatment with Curatoderm Lotion during pregnancy should be avoided.

It is not known if Curatoderm Lotion passes into breast milk. Therefore treatment with Curatoderm Lotion whilst breastfeeding is not recommended.

Driving and using machines

No particular precautions are required.

Curatoderm Lotion contains propylene glycol and dodecyl gallate

This medicine contains 100 mg propylene glycol and 0.2 mg dodecyl gallate in each gram.

Due to its propylene glycol content this medicine may cause skin irritation. It may also induce slight irritation to the skin, eyes and mucous membranes due to its dodecyl gallate content.

3. how to use curatoderm lotion

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

Use in children

Curatoderm Lotion is not recommended for use in children, as there is limited experience.

Curatoderm Lotion is for use by adults including the elderly.

Curatoderm Lotion can be used on all areas of the body including face, hairline, scalp, armpits, elbows and knees.

Follow your doctor’s instruc­tions for use exactly. The following are general guidelines:

  • Apply Curatoderm Lotion once a day, preferably at bedtime.
  • Do not use more than 10ml of lotion (equivalent to 2 teaspoons) each day.
  • Spread the lotion over the areas of skin affected by psoriasis and then rub it in.
  • To treat the scalp, part your hair and place the nozzle close to the affected area, apply a few drops, then rub the lotion in gently.
  • Avoid transfer of the lotion to other areas of the body not affected by psoriasis.
  • Avoid contact with the eyes. When Curatoderm Lotion accidentially comes into contact with your eyes, rinse them thoroughly with water
  • Wash your hands as soon as you have finished applying the lotion.

Duration of treatment

  • Your doctor will tell you for how long you need to use the lotion.

If you also use Curatoderm Ointment

  • Curatoderm is also available as an ointment. If you are also using Curatoderm Ointment, take into account that the quantity of applied tacalcitol adds up. You should not use more than 280 micrograms of tacalcitol per week. That is for example equivalent to 30ml Curatoderm Lotion plus 40g Curatoderm Ointment per week.

If you use more Curatoderm Lotion than you should

If you have used too much Curatoderm Lotion, tell your doctor as it may be necessary to check the amount of calcium in your blood.

If you forget to use Curatoderm Lotion

If you forget to use Curatoderm Lotion at the usual time, use it as soon as you remember, then carry on as before.

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

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rarely (may affect up to 1 in 1,000 people)

Local skin reactions such as itching, burning or redness may be experienced.

These are usually mild effects and don’t last very long.

Contact dermatitis or a worsening of the skin condition may occur.

The following side effects have also been reported (frequency not known, cannot be estimated from the available data)

Elevated calcium levels in the blood (hypercalcaemia).

Hypersensitivity reactions (including swelling, oedema and face oedema).

Rash (erythematous, macular, papular, vesicular).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. You can also report side effects directly via or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store curatoderm lotion

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

Keep the bottle in the outer carton in order to protect it from light.

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the label after “EXP”.

The expiry date refers to the last day of that month.

Do not use for longer than 6 months after first opening the container, write the date of first opening the container bottle on the carton label.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other information- the active substance is tacalcitol.

  • 1 g of lotion contains 4 micrograms of tacalcitol (as monohydrate).

  • – The other ingredients are purified water, light liquid paraffin, medium-chain triglycerides, propylene glycol, octyldodecanol, macrogol (21) stearylether, diisopropyl adipate, phenoxyethanol, disodium phosphate dodecahydrate, xanthan gum, potassium dihydrogen phosphate, disodium edetate, dodecyl gallate.

What Curatoderm Lotion looks like and contents of the pack

Curatoderm Lotion is a white, thin emulsion for use on the skin.

Your medicinal product comes in either 20 ml, 30 ml or 50 ml HDPE plastic bottle and with HDPE screw cap.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Almirall Hermal GmbH

Scholtzstrasse 3, 21465 Reinbek, Germany

Tel: +49–40/72704–0

Fax: +49–40/7229296

This leaflet was last revised in 11/2021

00000000 / GB / 1021

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is CURATODERM lotion used for?

CURATODERM 4 micrograms / G lotion is primarily used for the treatment of certain skin conditions like eczema and psoriasis. It helps to reduce inflammation and soothe irritated skin.

How often should I apply CURATODERM lotion?

It is generally recommended to apply CURATODERM lotion once or twice daily, or as directed by your healthcare provider. Make sure to follow their instructions for the best results.

Can I use CURATODERM on my face?

Yes, CURATODERM can be used on the face, but it’s essential to do so with caution. Consult your doctor before applying it to sensitive areas like the face.

Is CURATODERM suitable for children?

CURATODERM can be prescribed for children, but it’s crucial to seek advice from a pediatrician or healthcare professional to ensure safety and appropriate use.

What should I do if I miss a dose of CURATODERM lotion?

If you miss a dose, apply it as soon as you remember. If it's almost time for your next dose, skip the missed one and continue with your regular schedule.

Can I use CURATODERM along with other skin medications?

It's important to consult your healthcare provider before combining CURATODERM with other skin treatments to avoid potential interactions or side effects.

What side effects should I be aware of when using CURATODERM lotion?

Common side effects may include skin irritation, burning sensation, or dryness. If these persist or worsen, contact your healthcare provider immediately.

How long can I use CURATODERM lotion safely?

The duration of use should be determined by your healthcare provider. Long-term use may require regular evaluations to monitor skin response and side effects.

Can pregnant or breastfeeding women use CURATODERM?

If you are pregnant or breastfeeding, consult your healthcare provider before using CURATODERM to weigh potential risks and benefits.

Does CURATODERM lotion have any alcohol in it?

CURATODERM does not contain alcohol but always check the ingredients list or consult your pharmacist if you have concerns about specific components.

Can I use moisturizer along with CURATODERM lotion?

Yes, you can apply a moisturizer after using CURATODERM. However, allow some time for the lotion to absorb before applying other products.

Is it normal for my skin to feel warm after applying CURATODERM?

Some users may experience a warming sensation after application; however, if this feels uncomfortable or excessive, consult your healthcare provider.

Can I expose my skin to sunlight after using CURATODERM lotion?

It's advisable to protect treated areas from direct sunlight as they may be more sensitive; consider using sunscreen if you're going outdoors.

What should I do if I have an allergic reaction to CURATODERM lotion?

If you experience symptoms like hives, swelling, or difficulty breathing after using CURATODERM, seek medical attention immediately.

Is there a specific way to apply CURATODERM lotion effectively?

Apply a thin layer of CURATODERM gently on the affected area and massage it in until absorbed. Avoid rubbing harshly on inflamed skin.

How should I store CURATODERM lotion?

Store CURATODERM at room temperature away from moisture and heat. Keep it out of reach of children and never use past its expiration date.

Will using CURATODERM affect my daily activities?

Generally, using CURATODERM should not interfere with daily activities. However, some initial irritation might occur; monitor how your skin reacts during use.

What happens if I accidentally ingest CURATODERM lotion?

If ingested accidentally, contact poison control or seek medical help immediately as this may cause adverse effects depending on the amount ingested.

Are there any lifestyle changes that can help alongside using CURATODERM lotion?

Maintaining hydrated skin by drinking plenty of water and avoiding known irritants (like certain soaps) can enhance treatment effectiveness alongside using CURATODERM.