50 micrograms / g + 0.5 mg / g calcipotriol / betamethasone ointment 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Calcipotriol / Betamethasone Sandoz is and what it is used for 
2. What you need to know before you use Calcipotriol / Betamethasone Sandoz 
3. How to use Calcipotriol / Betamethasone Sandoz 
4. Possible side effects 
5. How to store Calcipotriol / Betamethasone Sandoz 6. Contents of the pack 
and other information 

What Calcipotriol / Betamethasone Sandoz is and what it is used for

Calcipotriol / Betamethasone Sandoz ointment is used for the local treatment of plaque – psoriasis ( psoriasis Vulgaris) in adults. Psoriasis is caused by the formation of new skin cells far too quickly. This causes redness, flaking, and an increase in the thickness of the skin.

Calcipotriol / Betamethasone Sandoz ointment contains calcipotriol and betamethasone. Calcipotriol helps to normalize the growth rate of skin cells and betamethasone relieves inflammation.

Calcipotriol and betamethasone contained in Calcipotriol / Betamethasone Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Calcipotriol / Betamethasone Sandoz

Do not use Calcipotriol / Betamethasone Sandoz

  • if you are allergic to calcipotriol, betamethasone, or any of the other ingredients of this medicine (listed in section 6)
  • if you have any disturbance in your body’s calcium metabolism (ask your doctor)
  • if you have certain types of psoriasis: these are erythrodermic, exfoliative, and pustular psoriasis (ask your doctor).

Because Calcipotriol / Betamethasone Sandoz contains strong cortisone, DO NOT use the ointment on the skin

  • skin infections caused by viruses (eg herpes or chickenpox)
  • skin infections caused by fungi (eg athlete’s foot or ringworm )
  • skin infections caused by bacteria
  • skin infections caused by parasites (eg scabies)
  • tuberculosis (TB)
  • perioral dermatitis (red rash around the mouth)
  • thin skin, blood vessels that break easily, stretch marks in the skin
  • ichthyosis (dry, fish-skin-like skin)
  • acne (pimples)
  • rosacea (violent flushing or reddening of the face)
  • sore or damaged skin.

Warnings and cautions

Talk to your doctor or pharmacist before taking Calcipotriol / Betamethasone Sandoz if:

  • Using other medicines containing cortisone , because you can get side-effect s
  • you have been using this medicine for a long time and plan to stop (because there is a risk that your psoriasis will get worse or “flare-up” if you suddenly stop using cortisone )
  • you have diabetes mellitus (diabetes), as your blood sugar level can be affected by cortisone a
  • your skin becomes infected, as you may need to discontinue your treatment
  • you have a special type of psoriasis, so-called gutted psoriasis.

Special care

  • Avoid using more than 30% of your body or using more than 15 grams per day.
  • Avoid use under bandages or covering dressings, as it increases the uptake of steroid one.
  • Avoid use on large areas of damaged skin, on mucous membranes, or in skin folds (groin, armpits, under the breasts), as it increases the uptake of cortisone.
  • Avoid use on the face or abdomen, as these areas are very sensitive to cortisone .
  • Avoid excessive sunbathing, excessive use of solariums, or other forms of light therapy.

Contact a doctor if you experience blurred vision or other visual disturbances.

Children

Calcipotriol / Betamethasone Sandoz is not recommended for the treatment of children under 18 years of age.

Other medicines and Calcipotriol / Betamethasone Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

Do not use Calcipotriol / Betamethasone Sandoz if you are pregnant (or could be pregnant) or breastfeeding without consulting your doctor first. If your doctor thinks you can breast-feed, be careful, and do not apply Calcipotriol / Betamethasone Sandoz to your breasts.

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 any medicine.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Calcipotriol / Betamethasone Sandoz

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How to use Calcipotriol / Betamethasone Sandoz: For topical use.

Instructions for use

  • Use only on areas affected by psoriasis and not on healthy skin.
  • Remove the cap and check that the tube seal is not broken before using the ointment for the first time.
  • Use the tip on the back of the cap to break the seal.
  • Squeeze the ointment on a clean finger.
  • Gently lubricate the skin so that the affected area is covered until most of the ointment has been absorbed by the skin.
  • Do not use bandages, opaque covers, or wraps on the treated skin area.
  • Wash your hands thoroughly after using Calcipotriol / Betamethasone Sandoz (unless you use the ointment to treat psoriasis of the hands) to avoid accidental contact with other parts of the body (especially the face, scalp, mouth, and eyes).
  • Do not worry if the ointment accidentally comes in contact with healthy skin near the psoriasis spots, but wipe off the excess if it spreads too far
  • For optimal effect, it is recommended not to shower or bathe immediately after applying Calcipotriol / Betamethasone Sandoz ointment.
  • Avoid putting the ointment in contact with textiles that are easily stained by grease (eg silk) after application.

Treatment time

  • Use the ointment once a day, it can be most practical in the evening.
  • The recommended treatment time, to begin with is 4 weeks, but your doctor may prescribe another treatment time.
  • Your doctor may prescribe repeated treatment.
  • Use a maximum of 15 grams per day.

If you are taking any other medicines containing calcipotriol, the total amount of medicines containing calcipotriol should not exceed 15 grams per day and the treated area should not exceed 30% of the total body surface area.

What can I expect when I use Calcipotriol / Betamethasone Sandoz?

Most patients see a clear effect after 2 weeks of treatment, even if their psoriasis has not completely disappeared.

If you use more Calcipotriol / Betamethasone Sandoz than you should

Contact your doctor if you have used more than 15 grams in one day.

Excessive use of Calcipotriol / Betamethasone Sandoz can cause problems with blood calcium levels, which usually return to normal when treatment is stopped.

Your doctor may need to take blood samples to rule out problems with high blood calcium levels caused by using too much ointment.

Excessive, prolonged use can also cause the adrenal glands do not function normally (the adrenal glands are close to the kidneys and produce hormones ).

.

If you forget to use Calcipotriol / Betamethasone Sandoz

Do not take a double dose to make up for a forgotten dose.

If you stop using Calcipotriol / Betamethasone Sandoz

Treatment with Calcipotriol / Betamethasone Sandoz should be discontinued according to your doctor’s instructions. It may be necessary to gradually reduce the treatment, especially if you have used the ointment for a long time.

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.

Serious side effects are

Tell your doctor/nurse immediately or as soon as possible if any of the following occur. You may need to stop treatment.

The following serious side effects have been reported with calcipotriol/betamethasone:

Uncommon (may affect up to 1 in 100 people)

  • Exacerbation of your psoriasis. If your psoriasis gets worse, tell your doctor as soon as possible. Rare (may affect up to 1 in 1,000 people)
  • Pustular psoriasis can occur (red skin patches with yellowish, blistered blisters, usually on the hands or feet). If this happens, stop taking Calcipotriol / Betamethasone Sandoz and tell your doctor as soon as possible.


Some serious side effects may occur with treatment with betamethasone (a strong steroid ), which is one of the ingredients in Calcipotriol / Betamethasone Sandoz. Tell your doctor as soon as possible if you get any serious side effects. These side effects are more common with long-term use, use in skin folds (eg groin, armpits, or under the breasts), when used under cover bandages or when used on large areas of the skin.

Side effects include the following:

  • Your adrenal glands may stop functioning normally. Symptoms are fatigue, depression, and anxiety.
  • Cataract (symptoms are blurred or blurred vision, impaired night vision, and photosensitivity) or increased pressure inside the eye (symptoms are eye pain, red eyes, impaired or blurred vision).
  • The infection you (because your immune system that fights infection can be inhibited or weakened).
  • Pustular psoriasis (red patches of skin with yellowish, full-blown blisters, usually on the hands or feet). If this happens, stop the treatment and contact your doctor as soon as possible.
  • Effects on the metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in your blood sugar).

Serious side effects can be caused by calcipotriol

  • Allergic reactions with deep swelling of the face or other parts of the body such as hands or feet. Swelling of the mouth or throat and difficulty breathing may occur. If you experience an allergic reaction, stop treatment with Calcipotriol / Betamethasone Sandoz and contact your doctor immediately or go to the nearest emergency department.
  • Treatment with this ointment may cause elevated levels of calcium in the blood or urine (usually when too much ointment has been used). Symptoms of high blood calcium levels include increased urinary excretion, constipation, muscle weakness, confusion, and coma. This can be serious and you should contact your doctor immediately. However, the values ​​are normalized when the treatment is stopped.

Minor side effects are

The following minor adverse reactions have been reported with calcipotriol/betamethasone:

Common (may affect up to 1 in 10 people)

  • Itching
  • Skin flaking.

Uncommon (may affect up to 1 in 100 people)

  • Skin pain and skin irritation
  • Rash with dermatitis ( dermatitis )
  • Reddening of the skin due to dilation of external blood vessels ( erythema )
  • Inflammation or swelling of the hair follicle ( folliculitis )
  • Changed skin color in the area that you treated with ointment
  • Rash
  • Skin infections
  • Skin thinning
  • The occurrence of red or purple discoloration on the skin (purpura or ecchymosis ).

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

  • Hair follicle infection caused by bacteria or fungus (boils)
  • Allergic reactions
  • Elevated calcium levels in the blood (hypercalcemia)
  • Stretch marks
  • Sensitivity to light that can cause a rash
  • Acne (pimples)
  • Dry skin
  • Rebound effect: Exacerbation of psoriasis/symptoms after discontinuation of treatment.

Has been reported (occurs in an unknown number of users)

  • Dimsyn.

Less serious side effects with the use of betamethasone, especially with long-term use, may be any of the following. You should inform your doctor or nurse as soon as possible if you experience any of them.

  • Skin thinning
  • Prominent vessels under the skin or streaks in the skin
  • Altered hair growth
  • Red rash around the mouth (perioral dermatitis )
  • Inflamed or swollen skin rash (allergic contact dermatitis )
  • Gold-colored jelly-filled bumps (colloidal milia)
  • Lighter skin color (loss of skin pigment)
  • Inflammation or swelling of the hair follicle ( folliculitis ).

Other less serious side effects that can be caused by calcipotriol are

  • Dry skin
  • Sensitivity to light that can cause a rash
  • Eczema
  • Itching
  • Skin irritation
  • Burning and tingling
  • Skin redness due to dilation of small blood vessels ( erythema )
  • Rash
  • Rash with inflammation of the skin ( dermatitis )
  • Exacerbation of psoriasis.

Reporting of side effects

If you get 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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Calcipotriol / Betamethasone Sandoz

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

Do not use this medicine after the expiry date which is stated on the label/carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in a cold place. Do not freeze.

The tube should be discarded 1 year after it was first opened. Make a note of the date when the tube was opened in the place indicated on the box.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are calcipotriol and betamethasone.
    1 gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg betamethasone (as dipropionate).
  • The other ingredients are all-rac-α-tocopherol (E307), oleyl alcohol, liquid paraffin, white petrolatum.

What the medicine looks like and the contents of the pack

Calcipotriol / Betamethasone Sandoz is an off-white ointment.

The ointment is packaged in an aluminum/epoxy phenol tube with a screw cap made of polyethylene or polypropylene.

Pack sizes: tube with 15 g, 30 g, 60 g, and 120 g ointment.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Lek Pharmaceuticals dd, Verovskova 57, 1526 Ljubljana, Slovenia

or

Salutas Pharma GmbH, Betriebsstaette Osterweddingen, Lange Goehren 3, D-39171, Suelzetal, Germany

or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

Muhammad Nadeem

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