CLOVATE 500 micrograms/g SHAMPOO

Introduction

Package Leaflet: Information for the Patient

Clovate 500 micrograms/g shampoo

Clobetasol, propionate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Clovate is and what it is used for
2. What you need to know before you use Clovate
3. How to use Clovate
4. Possible side effects
5. Storing Clovate
6. Contents of the pack and other information

1. What Clovate is and what it is used for

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

Scalp psoriasis is caused by an overly rapid production of skin cells on your scalp. This medicine is used to treat moderate scalp psoriasis in adults.

2. What you need to know before you use Clovate

Do not use Clovate shampoo

• If you are allergic (hypersensitive) to clobetasol propionate or any of the other ingredients of this medicine (listed in section 6). Please review the list of ingredients in this leaflet carefully. If you are allergic to any ingredient on this list, inform your doctor before starting treatment.
• If you have skin infections, bacterial, viral, fungal, or parasitic, such as herpes, chickenpox, shingles (herpes), impetigo (type of rash on the face), ringworm, athlete's foot, thrush, cutaneous tuberculosis, or a skin disease caused by syphilis.
• If you have ulcerative wounds (suppurating wounds) on your scalp.
• In children under 2 years of age.
• Do not apply the medicine to the eyes or eyelids (risk of glaucoma, which is high tension in the eye, and risk of cataract, which is a loss of transparency of the lens in the eye).

Warnings and precautions

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

• you experience recent onset 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 or repeatedly.
• you are using another oral or topical medicine that contains corticosteroids or medicines for controlling your immune system (e.g., autoimmune disease or after a transplant). The combination of Clovate shampoo with these medicines may result in serious infections.

Be careful with Clovate shampoo

• This medicine 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 shower gel, body soap, or bath foam.
• When treating your scalp with this medicine, do not cover the area being treated, for example: do not use a shower cap, as this can cause the active ingredient to pass through the skin and affect other parts of the body.
• When using this medicine, avoid contact with the face, eyelids, armpits (underarms), eroded skin surface (cracked skin), and genital areas. Rinse immediately with water if the product spreads to an area outside the scalp.
• If the medicine gets into your eye(s), 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 medicine has been prescribed to a child or adolescent under 18 years of age, they should consult their doctor weekly before continuing to use it.

Other medicines and Clovate shampoo

Tell your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, including those obtained without a prescription.

Pregnancy, Breastfeeding, and Fertility

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

Do not use this medicine if you are pregnant or breastfeeding, unless your doctor has clearly indicated it.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive or use machines.

3. How to use Clovate

Follow your doctor's instructions for using this medicine exactly. If in doubt, consult your doctor or pharmacist.

The normal daily dose per application is approximately half a tablespoon (approximately 7.5 ml), enough to cover the entire scalp.

Unless your doctor has indicated otherwise, wash your hands and apply this medicine directly to your dry scalp, once a day, taking care to cover it well, and massage the affected areas. Avoid using large amounts; use only enough to cover your scalp when it is dry. Wash your hands carefully after application. Leave the product on the scalp for 15 minutes, without covering, to allow it to 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 of this medicine to your hair.

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

However, your doctor may indicate that you can use it again in the future, after a period without using it.

Use in children and adolescents

If the medicine has been prescribed to a child or adolescent between 2 and 18 years of age, they should follow the instructions given by the doctor. They should consult their doctor every week to continue treatment.

If you use more Clovate shampoo than you should

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

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

If you forget to use Clovate shampoo

If you forget to use this medicine, do not use a double dose to make up for the forgotten doses. Continue with the treatment indicated by your doctor. If you have forgotten to use it on several occasions, inform your doctor.

If you stop using Clovate shampoo

If you stop using this medicine, consult your doctor. It may happen that when you stop using it, your disease worsens, especially if you have been using it for a long time. Inform your doctor if you notice this worsening of your scalp psoriasis.

If you have any other questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

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

Uncommon (may affect up to 1 in 100 people):

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

Irritation, itching, hives, small visible veins, or thinning of the skin around the 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 is not working as it should)

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

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

• Worsening of rosacea (facial erythema 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; striae (stretch marks) and purpura (bruises) may occur. This can happen, occasionally, with repeated treatments with topical steroids for a long period
• Generalized pustular psoriasis (appearance of pustules and plaques all over the body)

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

• make the skin thinner and more easily damaged.
• allow the active ingredient to pass through the skin; this can affect other parts of the body, especially in children (may cause growth retardation, with unknown frequency) and during pregnancy.

• Its application to the skin may cause thinning of the skin, so it should never be used on the face or other skin areas different from the scalp.
• To avoid interaction with hair dyes, such as changes in hair color, this medicine should be rinsed completely.
• 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 side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Clovate

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 carton after EXP. The expiry date is the last day of the month shown.

Discard the bottle 4 weeks after first opening.

Do not store above 30°C. Store in the original package to protect from light.

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 protect the environment.

6. Contents of the pack and other information

Composition of Clovate

• 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 ingredients are: ethanol, coco alkyl dimethyl betaaine, sodium lauryl ether sulfate, polyquaternium-10, sodium citrate dihydrate, citric acid monohydrate, and purified water.

Appearance of the product and contents of the pack

Viscous liquid shampoo, translucent, colorless to pale yellow, with an alcohol smell.

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

Package size: 125 ml.

Marketing Authorization Holder and 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 under the following names:

Italy: Clobecare

Portugal: Clobetasol Cantabria 500 micrograms/g shampoo

Spain: Clovate 500 micrograms/g shampoo

Denmark: Clobetasolpropionat IFC

Date of last revision of this leaflet:March 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es