500 micrograms / g shampoo
clobetasol propionate
1. What Clobex shampoo is and what it is used for
Clobex shampoo contains the active substance clobetasol propionate, which belongs to the group of drugs topical corticosteroids (or steroids ). Topical corticosteroids are further divided into groups depending on their strength. Clobetasol propionate is an extra strong corticosteroid .
“Topical” means that it is only for external use on the skin. Topical steroid s reduces redness , itching and inflammation associated with various skin diseases.
Psoriasis of the scalp is caused by the formation of skin cells in the scalp too quickly. Clobex shampoo is used to treat moderate psoriasis of the scalp in adults.
Clobetasol propionate contained in Clobex shampoo 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.
2. What you need to know before using Clobex shampoo
Do not use Clobex shampoo
- if you are allergic to clobetasol propionate or any of the other ingredients of Clobex shampoo (listed in section 6). If you are allergic, you must inform your doctor before starting treatment.
- if you have bacterial , viral , fungal or parasitic infections of the skin such as cold sores, varicella (chickenpox), herpes zoster ( shingles ), impetigo (type of skin rash on the face), ringworm , athlete’s foot , cod, skin tuberculosis or skin disease caused by syphilis .
- if you have exuding sores on your scalp.
- for children under 2 years.
- do not use Clobex shampoo in the eyes or on the eyelids (risk of glaucoma , ie high pressure in the eye and risk of cataracts, ie cloudiness of the eye lens).
Warnings and cautions
Take special care with Clobex shampoo
- Clobex shampoo should only be used on the scalp. Do not use it as a regular shampoo or on other areas of the body. Do not use Clobex shampoo as shower gel, soap or bath foam.
- When you treat the scalp with Clobex shampoo , you must not cover the area being treated. For example, a shower cap must not be used, as it may cause the active ingredient to be absorbed by the skin and affect other parts of the body.
- Make sure that Clobex shampoo does not come into contact with the face, eyelids, armpits, abdomen or chapped and cracked skin. Rinse immediately with water, if the medicine runs from the scalp.
- If you get Clobex shampoo in your eyes, wash your eyes thoroughly with water. If irritation persists, consult a physician.
- If you do not see any improvement in your psoriasis of the scalp, consult your doctor.
- Contact a doctor if you experience blurred vision or other visual disturbances.
Children and young people
- If this medicine has been prescribed for a child or adolescent under the age of 18, consult a doctor every week before continuing treatment.
Other medicines and Clobex shampoo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
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.
Driving and using machines
Clobex shampoo has no or very little effect on the ability to drive or use machines.
3. How to use Clobex shampoo
Always use Clobex shampoo exactly as your doctor has told you . Ask your doctor or pharmacist if you are unsure. The usual daily dose is an amount equivalent to about half a tablespoon (about 7.5 ml) per application, which is enough to cover the entire scalp.
Wash your hands and apply Clobex shampoo thoroughly directly on dry scalp and massage the affected areas once a day, unless your doctor has prescribed otherwise. Avoid using large amounts of Clobex shampoo . Use only enough to cover the scalp when it is dry. Wash hands thoroughly after application. Let the medicine work for 15 minutes without covering the hair . Then add water, rinse and dry your hair as usual. If more shampoo is needed to wash your hair, use your regular shampoo . Do not add more Clobex shampoo to your hair.
Your doctor will tell you how long you need to use Etrivex shampoo on your psoriasison the scalp. The treatment should usually not last for more than 4 weeks. If your psoriasis of the scalp improves significantly before the end of treatment, consult your doctor. If no improvement is seen at the end of treatment, tell your doctor. The treatment requires close monitoring. You should have your doctor evaluate your treatment regularly. Do not use Clobex shampoo for longer than your doctor has prescribed.
Your doctor may prescribe Clobex shampoo again, after a period of no use.
Use for children and adolescents
If this medicine has been prescribed for children or adolescents between 2 and 18 years of age, the instructions of the doctor must be followed. Consult your doctor every week, before continuing treatment.
If you use too much Clobex shampoo
See your doctor if you have been using Clobex shampoo for much longer than you should. The drug may only be used on the scalp. Do not swallow it. If you do this unintentionally, small amounts are not harmful. If you are unsure, seek medical advice immediately.
If you forget to use Clobex shampoo
If you forget to use Clobex shampoo , do not take a double dose at the next application to make up for a forgotten dose . Just follow your usual prescription . Tell your doctor if you miss several doses .
If you stop using Clobex shampoo
Consult your doctor before stopping treatment with Clobex shampoo . The disease may worsen when treatment is stopped, especially if Clobex shampoo has been used for a long time. Tell your doctor if you notice a worsening of your psoriasis on the scalp.
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. Etrivex shampoo can cause the following side effects are
Common side effects (may affect up to 1 in 10 people)
- Hudsveda
- Inflammation in one or more hair follicles
Uncommon side effects (may affect up to 1 in 100 people)
- Hormone disorders (such as adrenal suppression, Cushing’s syndrome) has been observed with strong topical steroids s, particularly when used on large areas of skin or for long periods
- Tingling or burning in the eyes
- Eye irritation
- Feeling of tightness in the eyes
- Glaucoma
- Hypersensitivity
- Headache
- Skin pain
- Skin problems
- Itching
- Acne
- Skin swelling
- Telangiectasia (veins under the skin become more visible)
- Exacerbated psoriasis
- Hair loss
- Dry skin
- Hives
- Skin atrophy (thinned skin)
- Skin irritation
- Skin tension
- Allergic contact dermatitis
- Reddening of the skin
- Rash
No known frequency (cannot be calculated from the available data)
- Dimsyn
Skin irritation, itching , hives , visible small vessels or thinner skin around the treated areas are usually mild to moderate.
- If you experience signs of local intolerance, such as a burning sensation or redness in areas that have been treated, do not use Clobex shampoo again until the symptoms have disappeared.
- Stop using the medicine and tell your doctor as soon as possible if your condition worsens during treatment (it is more likely if you have used Clobex shampoo for longer than prescribed) or if you experience swelling of the eyelids, face or lips. Then you may be allergic to the drug or have a skin infection.
- Using large amounts of the medicine or having the medicine on the scalp for more than 15 minutes can:
- make the skin thinner so that it is more easily damaged.
- cause the active ingredient to be absorbed by the skin, which can affect other parts of the body, especially in children and during pregnancy.
- Repeated use of topical steroid s over a long time can sometimes cause pustular rash (large pimples) and changes in hair growth and skin color. Streaks on the skin (stretch marks) and purpura (many small bruises) may become more visible.
- If you have rosacea (spotty redness on the face and sometimes permanent rashes), using Clobex facial shampoo can worsen your skin condition.
- Using Clobex facial shampoo can cause perioral dermatitis (mottled red rash around the mouth).
- Using Clobex shampoo on the skin can lead to thinning of the skin, and therefore Clobex shampoo should never be used on the face or on other skin areas than the scalp.
- To avoid reactions with hair coloring products, such as changing hair color, Clobex shampoo must be rinsed off thoroughly.
- If you experience any discomfort that you do not understand, tell your doctor as soon as possible.
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 Clobex shampoo
Keep this medicine out of the sight and reach of children.
Use Clobex shampoo before the expiry date stated on the bottle and carton. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light.
Discard the bottle 6 months after first opening.
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 substance is clobetasol propionate.One gram (one milliliter) of Clobex shampoo contains 500 micrograms of the active substance clobetasol propionate.
- The other ingredients are ethanol , cocobetaine, sodium lauret sulphate, polyquaternium-10, sodium citrate, citric acid monohydrate and purified water.
What the medicine looks like and the contents of the pack
Clobex shampoo is a thick, translucent liquid shampoo that is colorless to pale yellow with an alcohol odor.
Clobex shampoo is available by prescription and is delivered in 60 ml or 125 ml white high density polyethylene (HDPE) plastic bottles with polypropylene caps. The 30 ml HDPE bottle has a polypropylene screw cap. The bottles contain 30 ml, 60 ml or 125 ml of shampoo (not all pack sizes may be marketed).
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Galderma Nordic AB, Seminariegatan 21, 752 28 Uppsala,
Tel: 018-444 0330, Fax: 018-444 0335, Email: nordic@galderma.com.
Manufacturer
Laboratories Galderma, ZI Montdésir, 74540 Alby-sur-Chéran, France
This medicinal product is authorized under the European Economic Area under the names:
United Kingdom, Italy, Ireland and Portugal: Etrivex 500 micrograms / g shampoo
France, Germany, Belgium, Poland, Spain, Hungary, Netherlands, Denmark, Austria, Luxembourg, Iceland, Czech Republic, Norway, Greece, Slovakia and Finland: Clobex 500 micrograms / g shampoo