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231-30-20143-B LEA CLOTRIMAZOLE CREAM 1% 20g GENERIC

Version:

2

24 April 2012

Artwork Originator; Sign & Date:

PL 00289/1490. TEVA UK Ltd. (Responsible Regulatory Officer = Annette Huggett), PL Number(s), MA Holder & Packer: packed at Thornton & Ross.

Reason for revision: V1: Amendment of product name and excipients. Requested by Annette via Trackwise 27.3 12 at 07:01.

V2: Dimensions changed from 206x145mm to 210x148 at the request of T&R. 13.4.12.

Digitally signed by Elizabeth Morgan DN: cn=Elizabeth Morgan, o=TEVA UK Ltd, ou=Origination, email=elizabeth.morga n@tevauk.com, c=GB Date: 2012.04.24 11:17:53 Z

Neil MacGilli vray

Artwork Checker; Sign & Date:

Digitally signed by Neil MacGillivray DN: cn=Neil MacGillivray, o=TEVA UK Ltd, ou=Artwork Origination, email=Neil.MacGillivray@te vauk.com, c=GB Date: 2012.04.25 14:06:38 Z

Approved for Regulatory submission into MHRA/IMB; Sign & Date:

Final approval by MA Holder confirming receipt of MHRA/IMB approval; Sign & Date:

Packing Site Approval (where not TEVA UK Limited) Sign & Date:

Annette Huggett

Digitally signed by Annette Huggett DN: dc=Corp, dc=Teva, dc=UK, ou=EBN, ou=REG, cn=Annette Huggett, email=annette. huggett@tevauk.com Date: 2012.12.17 17:22:12 Z

paronychia (an infection of the fingernail or toenail) pityriasis versicolor (a rash caused PACKAGE LEAFLET: by a yeast fungus) INFORMATION FOR THE USER erythrasma (reddish brown scaly The name of your medicine is patches on the skin) Clotrimazole 1 % w/w cream, which intertrigo (a rash in body folds) will be referred to as Clotrimazole or fungal nappy rash Clotrimazole cream throughout this candidal vulvitis (thrush of the vulva) leaflet. candidal balanitis (thrush of the penis). Read all of this leaflet carefully before you start using this medicine 2 BEFORE YOU USE because it contains important THIS MEDICINE information for you. Do NOT use Clotrimazole cream if: Always use this medicine exactly as You are allergic (hypersensitive) to described in this leaflet or as your clotrimazole or any of the other doctor or pharmacist has told you. ingredients of Clotrimazole cream (see list of ingredients in Section 6). Keep this leaflet. You may need to An allergic reaction may include read it again. rash, itching, difficulty breathing or Ask your pharmacist if you need swelling of the face, lips, throat or more information or advice. tongue. If you get any side effects, talk to Do not use this cream to treat scalp or your doctor or pharmacist. This nail infections without advice from a includes any possible side effects pharmacist or doctor. not listed in this leaflet. You must talk to a doctor if you do Take special care with Clotrimazole not feel better, or if you feel worse, cream: after 7 days. The cream contains cetyl alcohol and stearyl alcohol, which may IN THIS LEAFLET: cause a skin reaction (e.g. contact 1. What Clotrimazole cream is and dermatitis) what it is used for If you are using Clotrimazole cream 2. Before you use Clotrimazole cream for thrush of the vulva or penis, the 3. How to use Clotrimazole cream cream may cause damage to condoms. 4. Possible side effects You should take other precautions 5. How to store Clotrimazole cream to prevent pregnancy for at least 6. Further information five days after using the cream. WHAT CLOTRIMAZOLE CREAM Taking other medicines 1 IS AND WHAT IT IS USED FOR Please tell your doctor or pharmacist if Clotrimazole cream is a cream that is you are taking, or have recently taken, any other medicines, including applied to the skin. It contains medicines obtained without a clotrimazole as the active ingredient, prescription. which is an antifungal. Clotrimazole cream is used for the Pregnancy and breast-feeding treatment of skin infections caused If you are pregnant or breast-feeding by dermatophytes (a group of fungi tell your doctor or midwife and they that cause skin diseases). will decide if Clotrimazole cream is Clotrimazole cream can be used to right for you. Follow their instructions treat: carefully. Ask your doctor or ringworm infections pharmacist for advice before taking any medicine.

CLOTRIMAZOLE 1 % w/w CREAM

Driving and using machines Clotrimazole cream does not affect your ability to drive or use machines.

5 HOW TO STORE

CLOTRIMAZOLE CREAM

Clotrimazole cream should be kept out of the reach and sight of children. CLOTRIMAZOLE CREAM Do not use Clotrimazole after the Dosage expiry date which is stated on the Always use Clotrimazole cream exactly carton. The expiry date refers to the as your doctor or pharmacist has told last day of that month. you. You should check with your doctor Medicines should not be disposed of or pharmacist if you are unsure. via wastewater or household waste. Adults, children and elderly: Ask your pharmacist how to dispose The cream is applied to the affected of medicines no longer needed. These area two or three times daily. measures will help to protect the The duration of treatment depends on environment. the infection being treated: Thrush infections need to be treated 6 FURTHER INFORMATION for at least two weeks. What Clotrimazole cream contains: Other infections need to be treated The active substance is Clotrimazole for at least one month. 1 % w/w. The other ingredients are: Accidental ingestion Sorbitan Stearate, Polysorbate 60, If Clotrimazole cream is accidentally Cetyl Palmitate, Stearyl Alcohol, Cetyl swallowed, you should consult a Alcohol, 2-Octyldodecanol, Benzyl doctor immediately. Alcohol and Purified Water. If you have any further questions on What Clotrimazole cream looks like the use of this product, ask your and contents of the pack doctor or pharmacist. Clotrimazole cream comes in an aluminium tube with a plastic 4 POSSIBLE SIDE EFFECTS screw-on cap. It contains 20 g, 30 g, or Like all medicines, Clotrimazole cream 50 g of cream. can cause side effects, although not Not all pack sizes may be marketed. everybody gets them. All medicines can cause allergic Marketing Authorisation Holder reactions, although serious allergic TEVA UK Limited, Eastbourne, reactions are very rare. BN22 9AG. Tell your doctor straight away if you get Manufacturer any sudden wheeziness, difficulty in Thornton & Ross Ltd. breathing, swelling of the eyelids, face Linthwaite, Huddersfield, or lips, rash or itching (especially affecting your whole body), or you feel West Yorkshire, HD7 5QH, UK dizzy or faint. This leaflet was last revised: March 2012 The following side effects have also been reported: PL 00289/1490 blisters, itching, burning, stinging, discomfort, swelling, rash, irritation or peeling of skin. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

3 HOW YOU USE

20143-B

Dimensions:

L: W:

210 mm 148 mm

Fonts: Variants of Univers Base Font Size: 9.5 Pt

N/A

Pharma Code (top to bottom on the front face when reading the text design right way up):

Colours:

(PANTONE is a registered trademark of Pantone, Inc.)

BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Suppliers Proof before approval to print will be granted.

3rd Party Code: N/A

Please refer to the latest version of the full base material specification: 92655

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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