Patient Information Leaflet: Clovate 500 microgram/g Shampoo

Clobetasol propionate

Read this leaflet carefully before you start using this medicine because 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Clovate and what is it used for

2. What you need to know before using Clovate

3. How to use Clovate

4. Possible side effects

5. Storage of Clovate

6. Contents of the pack and additional information

Clovate shampoo contains the active ingredient called clobetasol propionate; it belongs to a group of medications called topical corticosteroids (or steroids). Topical corticosteroids are further classified into groups based on their potency; clobetasol propionate is a very potent topical corticosteroid. “Topical” means it should be applied only to the surface of the skin. Topical steroids reduce redness, itching, and inflammation associated with skin diseases.

Psoriasis of the scalp is caused by an overly rapid production of skin cells on the scalp. This medication is used to treat moderate scalp psoriasis in adults.

Do not use Clovate shampoo

Warnings and precautions

Consult your doctor or pharmacist before starting to use Clovate shampoo if:

• You experience recent bone pain or worsening of previous bone symptoms during treatment with Clovate shampoo, especially if you have been using Clovate shampoo for a prolonged period of time or repeatedly.
• You are using another oral or topical medication containing corticosteroids or immunosuppressive medications (e.g., autoimmune disease or after a transplant). The combination of Clovate shampoo with these medications may result in severe infections.

Be especially careful with Clovate shampoo

• This medication should only be used on the scalp. Do not use it as a daily shampoo or on other areas of the body, and do not use it as a body wash, shower gel, or bath foam.
• When treating your scalp with this medication, do not cover the treated area, for example: do not use a shower cap as it may allow the active ingredient to pass through the skin and affect other parts of the body.
• When using this medication, avoid contact with the face, eyelids, armpits, eroded skin surfaces (skin cracks), and genital areas. Rinse immediately with water if the product spreads to an area outside the scalp.
• If this medication enters the eyes, rinse the affected eye completely with water. If irritation persists, consult your doctor.
• If you do not notice an improvement in your scalp psoriasis, consult your doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents

• If this medication has been prescribed to a child or adolescent under 18 years of age, you must consult with your doctor weekly before continuing to use it.

Other medications and Clovate shampoo

Inform your doctor or pharmacist if you are taking/using or have taken/used recently other medications, including those purchased without a prescription.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using/taking any medication.

Do not use this medication if you are pregnant or breastfeeding, unless your doctor has clearly indicated that you should.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication has little or no influence on the ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The normal daily dose for application is the amount equivalent to approximately half a teaspoonful (approximately 7.5 ml), sufficient to cover the entire scalp.

Unless your doctor has told you otherwise, wash your hands and apply this medication directly to your dry scalp once a day, taking care to cover it well, and massage the affected areas. Avoid using large quantities; use only enough to cover your scalp when it is dry. Wash your hands carefully after application. Leave the product to act on the scalp for 15 minutes, uncovered, so that it can take effect, and then add water, rinse and dry your hair as usual. You can use your regular shampoo if you need more shampoo to wash your hair. Do not add more medication to your hair.

Your doctor will inform you for how long you need to use this medication for the control of your scalp psoriasis. Treatment, normally, should not last more than 4 weeks. However, if your scalp psoriasis improves significantly before the end of treatment, please see your doctor. If, on the other hand, no improvement is seen at the end of treatment, please let your doctor know. This treatment needs to be carefully monitored; you should allow your doctor to evaluate your progress at regular intervals. Do not use this medication for a longer period than indicated by your doctor.

However, your doctor may instruct you to use it again in the future, after a period without using it.

Use in children and adolescents

If the medication has been prescribed to a child or adolescent between the ages of 2 and 18, follow the instructions given by the doctor. You should consult the doctor every week to continue treatment.

If you use more Clovate shampoo than you should

If you use more medication than you should, see your doctor. It is only used on the scalp. Do not ingest it. If you ingest it accidentally, small amounts are not harmful. If you are unsure, see your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

If you forgot to use the Clovate shampoo

If you forgot to use this medication, do not use a double dose to compensate for the missed doses. Continue with the treatment indicated by your doctor. If you have forgotten to use it several times, inform your doctor.

If you interrupt treatment with the Clovate shampoo

If you interrupt treatment with this medication, see your doctor. It may occur that, when stopping using it, your disease worsens, especially if it has been used for a long period of time. Inform your doctor if you observe this worsening of your scalp psoriasis.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It may cause the following side effects:

Frequent (may affect up to 1 in 10 people):

• Burning sensation of the skin
• Inflammation of one or more hair follicles

Less frequent (may affect up to 1 in 100 people):

• Endocrine disorders (such as adrenal suppression, Cushing's syndrome); have been observed with potent topical steroids, especially when applied to large areas or for prolonged periods
• Itching or burning in the eyes, eye irritation
• Sensation of eye tension
• Glaucoma
• Hypersensitivity
• Headache
• Pain in the skin, skin discomfort, skin edema, skin atrophy (skin thinning), skin irritation, skin tension
• Itching
• Acne
• Telangiectasia (the veins under the surface of your skin may become more visible)
• Worsening of psoriasis
• Hair loss
• Skin dryness
• Urticaria
• Contact dermatitis
• Erythema
• Rash

Irritation, itching, urticaria, small visible veins or skin thinning around treated areas are generally mild to moderate in nature.

Rare:

• Opportunistic infections (caused by bacteria, viruses, when the immune system is weakened); immunosuppression (your immune system does not function as it should)

Frequency not known (cannot be estimated from available data):

• Worsening of diabetes mellitus
• Blurred vision
• Cataracts
• Perioral dermatitis (rash in the form of red patches around the mouth), if applied to the face

• Worsening of rosacea (erythema facial associated with skin redness and possible appearance of papulopustules)
• Pustular eruptions (large pimples) and changes in hair growth and skin color, or loss of skin color; stretch marks (stretch marks) and purpura (bruises) may be seen. This may occur, on occasion, with repeated treatments with topical steroids over a long period of time
• Generalized pustular psoriasis (appearance of pustules and plaques all over the body)

• If you have any signs of local intolerance such as burning sensation or redness in the areas that have been treated, do not use this medicine until these symptoms have disappeared.
• If your condition worsens during treatment (this is more likely to occur if you use this medicine for longer than indicated), or you experience swelling of the eyelids, face, or lips, indicating that you may be allergic to the product or have a skin infection, discontinue use and inform your doctor as soon as possible.
• Using more of the medicine or keeping it on the scalp for more than 15 minutes may:

• Make the skin thinner and, as a result, more easily damaged.
• Allow the active ingredient to pass through the skin; this may affect other parts of the body, especially in children (may cause growth retardation, frequency not known) and during pregnancy.

• Your application to the skin may cause skin thinning, so it should never be used on the face or other areas of skin other than the scalp.
• To avoid interaction with hair dyes, such as changes in hair color, this medicine should be completely cleared.
• If you experience any unusual discomfort that you cannot explain, inform your doctor as soon as possible.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD.:. The expiration date is the last day of the month indicated.

Dispose of the bottle 4 weeks after the first opening.

Do not store above 86°F (30°C). Store in the original packaging to protect it from light.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Clovate Composition

• The active ingredient is clobetasol propionate.

Each gram of shampoo contains 500 micrograms of clobetasol propionate. 1 gram of shampoo is equivalent to 1 milliliter.

• The other components are: ethanol, coco alkyldimethyl beta-ine, sodium lauryl sulfate, poliquaternium-10, sodium citrate dihydrate, citric acid monohydrate, and purified water.

Product appearance and packaging contents

Viscous, transparent, colorless to pale yellow liquid shampoo with an alcohol odor.

It is packaged in high-density polyethylene (HDPE) bottles with a polypropylene screw cap.

Packaging size: 125 ml.

Marketing Authorization Holder and Responsible Manufacturer

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía 30

La Concha de Villaescusa

39690 Cantabria (Spain)

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy: Clobecare

Portugal: Clobetasol Cantabria 500 micrograms/g Shampoo

Spain: Clovate 500 micrograms/g shampoo

Denmark: Clobetasolpropionat IFC

Last review date of this leaflet:March 2021

Further detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es