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CANESTEN HC CREAM - Patient leaflet, side effects, dosage

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Patient leaflet - CANESTEN HC CREAM

Canesten®


IHC



Colours

PANTONE485C

PANTONE Cool Gray 11C

Process Black

LTH

2.

LTH

3

LTH



Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


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Read all of this leaflet carefully 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. Do not give it to anyone else under any circumstances.
  • If you have any unusual effects after using this product, tell your doctor or pharmacist.
  • 1. What is Canesten HC Cream and what is it used for?

  • 2. Before you use Canesten HC Cream

  • 3. How to use Canesten HC Cream

  • 4. Possible side effects

  • 5. How to store Canesten HC Cream

  • 6. Further Information

  • 1. WHAT IS CANESTEN® HC CREAM AND WHAT IS IT USED FOR?

Canesten HC Cream is used to treat fungal skin infections when there are additional symptoms of inflammation (such as swelling, redness and itching). Canesten HC Cream treats the fungal skin infection and reduces the swelling and itching caused by it.

Canesten HC Cream is used for the treatment of infection and irritation of the vulva or end of the penis (glans) caused by thrush. It is also used to treat nappy rash and fungal infection of the breast fold (intertrigo), as well as infections such as ringworm and athlete’s foot.

The active substances in Canesten HC Cream are clotrimazole and hydrocortisone acetate. Clotrimazole belongs to a group of medicines called imidazoles which destroy the fungi and some bacteria that cause skin infections. Hydrocortisone acetate is a mild steroid which reduces swelling, redness and itching associated with inflammation of the skin.

2. before you use canesten® hc creamido not use canesten hc cream:

  • If you (or your baby if treating nappy rash) are allergic (hypersensitive) to clotrimazole, hydrocortisone or any of the other ingredients, including cetostearyl alcohol or benzyl alcohol, of Canesten HC Cream.
  • On areas of broken skin.
  • On large areas of skin (more than 5–10% of body surface).
  • For longer than 7 days.
  • To treat cold sores or acne.
  • On any untreated bacterial skin infection, such as syphilis or tuberculosis.
  • On vaccination reactions.
  • On shingles, chicken pox, rosacea or herpes.

Cream ;

Clotrimazole & Hydrocortisone acetate

Warnings and precautions:

  • As with all steroids, long-term, continuous use on large areas of skin should be avoided, particularly in infants and children.
  • Do not cover the area being treated with a dressing or bandage.
  • In infants, care should be taken not to fasten nappies too tightly over the treated area, as this may increase the absorption of the hydrocortisone acetate.
  • Wash your hands immediately after applying the cream.
  • As with other creams, this product may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms. Consequently, if you are using this cream on the vulva or penis, you should use alternative precautions for at least five days after using this product.
  • Contact your doctor if you experience blurred vision or other visual disturbances.
  • Talk to your doctor or pharmacist or nurse before using Canesten HC Cream.
  • 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.

Pregnancy and breast-feeding:

If you are pregnant, breast-feeding or trying fora baby, tell your doctor or midwife before using Canesten HC cream. If you have informed your doctor or midwife already, follow his/her instructions carefully.

Important information about some of the ingredients:

This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). The medicine also contains 20mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.

3. HOW TO USE CANESTEN® HC CREAM

Unless directed otherwise by your doctor, follow these directions closely:

  • Before use, pierce the tube seal by inverting the cap over the end of the tube and press.
  • If feet are infected; before applying the cream, they should be washed and dried thoroughly, especially between the toes.
  • Canesten HC cream should be applied thinly and evenly to the affected areas two or three times daily and rubbed in gently. Approximately 1cm of cream per application should be sufficient.
  • Do not cover the area being treated with a dressing or bandage.
  • As with all products containing hydrocortisone, you should wash your hands immediately after applying the cream.


Packaging Site Approval:

Name:

Date:

Action:

Country Approval:

Name:

Date:

Action:



BAYER ARTWORK PANEL

Bayer Ref No:

BAY447540

Trident Reference No:

TR2043551

Brand:

Canesten

Range:

Cream

Product:

Clotrimazole and Hydrocortisone

Pack Type:

Leaflet

Pack Size:

30 g

Action:

B

Date:

23/11 /20

Country:

UK

Finished Goods Code:

80179936

Synaps Request Code:

OTH009216

Component Code:

00000

CAD Ref No:

PIL 148 × 210 (P041)

Printer:

Generic Bayer

Packaging Site:

Kern Pharma [ES]

Substrate:

White Paper

Barcode 1 Type:

N/A

Barcode 1 Mag:

N/A

Barcode 2 Type:

N/A

Barcode 2 Mag:

N/A

Pharmacode No/NE:

010001100(651)

Technical & Non Printing Items

Cutter Guides

Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100

Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.

UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.

STUDIO USE ONLY CarolineP-Wells v1.0

Sm^Art check results: G=1; O=0; R=0; – CP – 23/1 1/20 16:33:58

FONT SIZE PANEL

Main Text (body copy): 7.75 pt

Height (based on lower case x): 1.5 mm

ARTWORK APPROVAL PANEL

Treatment should be continued for no more than 7 days.

The symptoms of skin infection, such as itching or soreness, should improve within a few days of treatment, although signs such as redness and scaling may take longer to disappear. If the symptoms persist or do not start to improve after 7 days, consult your doctor.

Canesten HC Cream is for external use only: Do not put the cream in your mouth or swallow it.

If the cream is swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.

If you accidentally get cream in your eyes or mouth, wash immediately with water and contact your doctor.

If you forget to use Canesten HC Cream:

Apply the cream as soon as possible and then continue the rest of your treatment as usual.

You can help the treatment to work if you follow these simple self-help tips:

  • Although the infected area will itch, try not to scratch. Scratching will damage the surface of the skin and cause the infection to spread further.
  • Keep the affected skin areas clean.
  • Pay particular attention to drying the skin, including between the toes, but avoid excessive rubbing.
  • Do not share towels, bath mats, etc. with other people as you could spread the infection to them.
  • Always wash your hands after treating the infection to prevent it from spreading.

If you have Athlete’s Foot:

  • Remember to dry the skin between the toes thoroughly.
  • Wash your socks, stockings and tights thoroughly in hot water to remove any shed skin or fungal spores.
  • Change your footwear daily if possible.

4. possible side effects

Like all medicines, Canesten HC Cream can cause side effects, although not everybody gets them.

  • As with all medicines, some people may be allergic to the cream. If you or your baby are allergic, a reaction will occur soon after you start using it. If you or your baby experience an allergic reaction, stop using Canesten HC Cream and tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital. Signs of an allergic reaction may include: Rash.
  • Swallowing or breathing problems.
  • Swelling of your lips, face, throat or tongue.
  • Weakness, feeling dizzy or faint.
  • Nausea.

I

After you apply the cream, you might experience the following symptoms:

  • Itching, rash, blisters, burning, discomfort, swelling, irritation, redness or peeling of skin, blurred vision.

Treatment should be limited to 7 days unless advised otherwise by your doctor. If you apply the cream to a large area or under a dressing, or if you use the cream for more than 2 weeks, you may experience skin reactions such as:

  • Broken veins.
  • Excess hair growth.
  • Stretch marks.
  • Thinning or whitening of skin.
  • Secondary infections.
  • An acne-like rash.

If you or your baby experience any of the above effects or react badly to the cream in any other way not listed in this leaflet, tell your doctor immediately.

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 via the Yellow Card Scheme at: 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 canesten® hc cream

Keep out of the sight and reach of children.

This product should be stored in the original carton.

Do not store above 25°C.

Do not use Canesten HC cream after the expiry date which is stated at one end of the carton and on the end of the tube of cream. The expiry date refers to the last day of that month.

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. FURTHER INFORMATION

  • The active substances are clotrimazole and hydrocortisone acetate. Each gram of cream contains 10mg clotrimazole and 11.2mg hydrocortisone acetate (equivalent to 10mg hydrocortisone).
  • The other ingredients are benzyl alcohol,cetostearyl alcohol, triceteareth-4-phosphate, medium chain triglycerides, purified water, sodium hydroxide and hydrochloric acid.

What Canesten HC Cream looks like and contents of the pack:

Canesten HC Cream is available in tubes containing 5g or 30g of white cream. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK.

Manufacturer:

Kern Pharma S.L.,

Poligon Industrial Colon II, Calle Venus 72, 08228 Terrassa, Barcelona, Spain.

Remember: This medicine has been prescribed for you. Do not give it to anyone else under any circumstances. If you have any doubts about using Canesten ® HC Cream correctly, seek the advice of your doctor or pharmacist.

For UK residents only: if you have any questions or would like more information, call our Canesten Advice Line on 0845 758 5030­. Calls charged at local rate.

This leaflet was last revised in September 2020. Canesten is a registered trademark of Bayer AG, Germany.

Bayer |

00000


Packaging Site Approval:

Name:

Date:

Action:

Country Approval:

Name:

Date:

Action:



MOCKUP

not for production

Frequently Asked Questions

What is Canesten HC Cream used for?

Canesten HC Cream is used to treat fungal skin infections, such as athlete's foot, jock itch, and ringworm. It also contains hydrocortisone to reduce inflammation and itching.

How does Canesten HC Cream work?

Canesten HC Cream combines an antifungal agent that kills fungi causing the infection and a corticosteroid that reduces redness and swelling.

Can I use Canesten HC Cream for vaginal yeast infections?

No, Canesten HC Cream is for external use only. For vaginal yeast infections, please consult your doctor about appropriate treatments.

How should I apply Canesten HC Cream?

Apply a thin layer of Canesten HC Cream to the affected area usually twice a day unless directed otherwise by your doctor.

How long should I use Canesten HC Cream?

It's typically recommended to use it for 2 to 4 weeks, but follow your doctor’s advice for the best results.

Can I use Canesten HC Cream on my face?

It's best to avoid using Canesten HC Cream on your face unless directed by a healthcare professional, as sensitive skin may be irritated.

Are there any side effects of using Canesten HC Cream?

Some people may experience mild side effects like burning or stinging at the application site. If you notice severe reactions, stop using it and consult your doctor.

Can I use other medications with Canesten HC Cream?

Always inform your doctor about any other medications you're taking before using Canesten HC Cream to avoid interactions.

Is it safe to use Canesten HC Cream during pregnancy?

Consult your healthcare provider before using Canesten HC Cream if you're pregnant or breastfeeding to ensure it's safe for you.

What should I do if I miss an application of Canesten HC Cream?

If you miss an application, apply it as soon as you remember, unless it's time for your next dose. Do not double up.

How do I store Canesten HC Cream?

Store the cream at room temperature away from moisture and heat. Keep it out of reach of children.

Can I use sunscreen after applying Canesten HC Cream?

Yes, you can apply sunscreen after the cream has been absorbed into your skin. Just ensure not to mix them together directly.

What if my symptoms do not improve after using Canesten HC Cream?

If there is no improvement within 2 weeks, or if symptoms worsen, contact your healthcare provider for further evaluation.

Is it normal for the cream to feel greasy on my skin?

Yes, some patients find that antifungal creams can feel greasy. It usually absorbs over time.

Can children use Canesten HC Cream?

Consult with a pediatrician before using this cream on children under 12 years old.

Are there any specific precautions while using Canesten HC Cream?

Avoid covering the treated area with tight bandages unless instructed by a doctor. Keep the area clean and dry.

Is there a generic version of Canesten HC Cream available?

Yes, there are generic versions of clotrimazole/hydrocortisone cream available that might be more affordable.

What happens if I accidentally ingest Canesten HC Cream?

If ingested, seek immediate medical advice or contact poison control for assistance.

Can sunlight affect the effectiveness of Canesten HC Cream?

While sunlight shouldn't affect its effectiveness directly, it’s best to avoid prolonged sun exposure on affected areas during treatment.