Mometasone Furoate 0.1% W/W Cream
UItU £1 tutu ££
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.
What is in this leaflet:
The name of your medicine is “Mometasone Furoate
0. 1. w/w Cream” but will mostly be referred to as
“Mometasone Cream” throughout this leaflet.
1. What Mometasone Cream is and what it is used for
2. What you need to know before you use Mometasone Cream
3. How to use Mometasone Cream
4. Possible side effects
5. How to store Mometasone Cream
6. Contents of the pack and other information
1. WHAT MOMETASONE CREAM IS AND WHAT IT IS USED FOR
Mometasone Cream is one of a group of medicines called topical corticosteroids. Mometasone Cream is classified as a “potent corticosteroid”. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.
In adults and children above 6 years, Mometasone Cream is used to reduce redness and itchiness caused by certain skin problems called psoriasis or dermatitis.
Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the elbows, knees, scalp and other parts of the body. Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOMETASONE CREAM
Do not use Mometasone Cream
• if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of Mometasone Cream (listed in section 6), or to similar medicines.
• on any other skin problems as it could make them worse especially:
- rosacea (a skin condition affecting the face)
- acne
- skin atrophy (thinning of the skin)
- dermatitis around the mouth
- genital itching
- nappy rash
- cold sores
- shingles
- chickenpox
- warts
- ulcerated skin
- wounds and
- other skin infections.
Ask your doctor or pharmacist if you are not sure. Warnings and precautions
Talk to your doctor or pharmacist before using Mometasone Cream
• when this medicine is used on psoriasis, as it may make the condition worse (e.g. a pustular form of the disease may occur). You should let your doctor review your progress at regular intervals, as such treatment needs careful supervision.
• if your skin becomes irritated or sensitive after using Mometasone Cream, you should stop using it and tell your doctor
Children and adolescents
Mometasone Cream is not for use in children below 6 years of age.
Other medicines and Mometasone cream
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy, breast-feeding 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. Mometasone Cream contains propylene glycol which may cause skin irritations, and stearyl alcohol and butylated hydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
3. HOW TO USE MOMETASONE CREAM
Always use Mometasone Cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Use in children
Mometasone Cream is not recommended for children under the age of 6.
Usually for adults and children above 6 years, a thin layer of Mometasone Cream should be gently rubbed into the affected areas of skin once a day.
• You only need to use a small amount of this preparation.
• One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand. Never apply more than this quantity or more often than advised by your doctor or pharmacist.
Special care should be used:
• Do not use it on your face for more than 5 days.
• Do not apply the cream to children, on any part of the body, for more than 5 days.
• Do not put the cream under your child’s nappy, as this makes it easier for the active drug to pass through the skin and possibly cause some unwanted effects.
• You should check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face or in children should not be covered with a bandage or plaster.
• You should not use the cream on large areas of the body for a long time (for example every day for many weeks or months).
• Do not use in or around your eyes, including eye-lids.
If you use more Mometasone Cream than you should
If you (or somebody else) accidentally swallow the cream, it should not produce any problems. However, if you are worried, you should see your doctor.
If you use the cream more often than you should, or on large areas of the body, it can affect some of your hormones. In children, this may affect their growth and development.
|
G GLENMARK PHARMACEUTICALS LTD. | |||
|
06.07.2016 |
Black | ||
|
MOMETASONE FURO CRM30G GP-UK |
PKG. DEV.: |
Item code, Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | |
|
ITFM nnnF- VFRSIflN: | |||
|
RA |
Regulatory Text | ||
|
YES NA | |||
|
UK |
QA: |
Entire Text | |
|
LOCATION: | |||
|
PRODUCTION: |
Machine Suitability | ||
|
180x23 MM | |||
|
180X290 MM |
UK/H/2272/001/IA/018/G | ||
|
40 GSM BIBLE PAPER | |||
If you have not used the cream as you were told to do and have used it too often and/or for a long time, you should tell your doctor or pharmacist.
If you forget to use Mometasone Cream If you forget to apply the cream at the right time, use it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop using Mometasone Cream
If you have been using Mometasone Cream for a long time and your skin problems seems to have got better, you should not suddenly stop using the cream. If you do, you may find that your skin becomes red and you may notice stinging or burning. To avoid this, you should speak to your doctor as he will gradually reduce how often you need to use the cream until you stop treatment altogether.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mometasone Cream can cause side effects, although not everybody gets them.
A few people may find that they suffer from some of the following side effects after using Mometasone Cream:
- allergic skin reactions
- bacterial and secondary skin infections
- acne
- inflammation and/or infection of the hair follicles
- thinning of the skin
- red marks with associated prickly heat
- loss of skin colour
- burning
- stinging
- itching
- tingling
- excessive hair growth
- softening of the skin and stretch marks
Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mometasone Furoate 0.1% w/w Cream contains
• The active substance is mometasone furoate. Each gram of Mometasone Furoate 0.1% w/w Cream contains 1mg of mometasone furoate.
• The other ingredients are hexylene glycol, water, white beeswax (E901), propylene glycol monopamitostearate, stearyl alcohol, ceteareth-20, titanium dioxide (E171), aluminium starch octenylsuccinate, phosphoric acid, and white soft paraffin which contains traces of butylated hydroxytoluene (E321).
What Mometasone Furoate 0.1% w/w Cream looks like and contents of the pack
Mometasone Furoate 0.1% w/w Cream is a white to off-white smooth cream.
It is available in tubes containing 10g, 15g, 20g, 30g, 50g, 60g or 100 g of cream.
Not all packs sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited, Laxmi House,
2 B Draycott Avenue, Kenton, Middlesex HA3 0BU,
United Kingdom
Manufacturer(s)
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben, Germany
Glenmark Pharmaceuticals Europe Limited, Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA, United Kingdom
Glenmark Pharmaceuticals s.r.o., Fibichova 143,
566 17 Vysoke Myto, Czech Republic
This leaflet was last revised in July 2016
5. HOW TO STORE MOMETASONE CREAM
Keep this medicine out of the sight and reach of children. Do not use Mometasone Cream after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not refrigerate or freeze.
PExxxxxxxxxxx UK
Discard the opened tube with any remaining cream after 12 weeks.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
|
G GLENMARK PHARMACEUTICALS LTD. |
06.07.2016 |
Black | |
|
MOMETASONE FURO CRM30G GP-UK ITEM CODE: VERSION: YES NA |
PKG. DEV.: |
Item code. Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | |
|
RA |
Regulatory Text | ||
|
UK |
QA: |
Entire Text | |
|
LOCATION: 180x23 MM | |||
|
PRODUCTION: |
Machine Suitability | ||
|
180X290 MM |
UK/H/2272/001/IA/018/G | ||
SPECIFICATION: 40 gsm bible paper
PACKAGE LEAFLET: INFORMATION FOR THE USER
MOMETASONE FUROATE 0.1% W/W CREAM
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.
What is in this leaflet:
The name of your medicine is “Mometasone Furoate
0. 1. w/w Cream” but will mostly be referred to as
“Mometasone Cream” throughout this leaflet.
1. What Mometasone Cream is and what it is used for
2. What you need to know before you use Mometasone Cream
3. How to use Mometasone Cream
4. Possible side effects
5. How to store Mometasone Cream
6. Contents of the pack and other information
1. WHAT MOMETASONE CREAM IS AND WHAT IT IS USED FOR
Mometasone Cream is one of a group of medicines called topical corticosteroids. Mometasone Cream is classified as a “potent corticosteroid”. These medicines are put on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.
In adults and children above 6 years, Mometasone Cream is used to reduce redness and itchiness caused by certain skin problems called psoriasis or dermatitis.
Psoriasis is a skin disease in which itchy, scaly, pink patches develop on the elbows, knees, scalp and other parts of the body. Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MOMETASONE CREAM
Do not use Mometasone Cream
• if you are allergic (hypersensitive) to mometasone furoate, any of the other ingredients of Mometasone Cream (listed in section 6), or to similar medicines.
• on any other skin problems as it could make them worse especially:
- rosacea (a skin condition affecting the face)
- acne
- skin atrophy (thinning of the skin)
- dermatitis around the mouth
- genital itching
- nappy rash
- cold sores
- shingles
- chickenpox
- warts
- ulcerated skin
- wounds and
- other skin infections.
Ask your doctor or pharmacist if you are not sure. Warnings and precautions
Talk to your doctor or pharmacist before using Mometasone Cream
• when this medicine is used on psoriasis, as it may make the condition worse (e.g. a pustular form of the disease may occur). You should let your doctor review your progress at regular intervals, as such treatment needs careful supervision.
• if your skin becomes irritated or sensitive after using Mometasone Cream, you should stop using it and tell your doctor
Children and adolescents
Mometasone Cream is not for use in children below 6 years of age.
Other medicines and Mometasone cream
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Pregnancy, breast-feeding 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. Mometasone Cream contains propylene glycol which may cause skin irritations, and stearyl alcohol and butylated hydroxytoluene (E321) which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
3. HOW TO USE MOMETASONE CREAM
Always use Mometasone Cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Use in children
Mometasone Cream is not recommended for children under the age of6.
Usually for adults and children above 6 years, a thin layer of Mometasone Cream should be gently rubbed into the affected areas of skin once a day.
• You only need to use a small amount of this preparation.
• One fingertip unit (a line from the tip of an adult index finger to the first crease) is enough to cover an area twice the size of an adult hand. Never apply more than this quantity or more often than advised by your doctor or pharmacist.
Special care should be used:
• Do not use it on your face for more than 5 days.
• Do not apply the cream to children, on any part of the body, for more than 5 days.
• Do not put the cream under your child’s nappy, as this makes it easier for the active drug to pass through the skin and possibly cause some unwanted effects.
• You should check with your doctor before covering the treated areas with a bandage or plaster. Treated areas on the face or in children should not be covered with a bandage or plaster.
• You should not use the cream on large areas of the body for a long time (for example every day for many weeks or months).
• Do not use in or around your eyes, including eye-lids.
If you use more Mometasone Cream than you should
If you (or somebody else) accidentally swallow the cream, it should not produce any problems. However, if you are worried, you should see your doctor.
If you use the cream more often than you should, or on large areas of the body, it can affect some of your hormones. In children, this may affect their growth and development.
|
G GLENMARK PHARMACEUTICALS LTD. | |||
|
06.07.2016 |
Black | ||
|
MOMETASONE FURO CRM100G GP-U |
PKG. DEV.: |
Item code, Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | |
|
ITFM nnnF- VFRSIflN: | |||
|
RA |
Regulatory Text | ||
|
YES NA | |||
|
UK |
QA: |
Entire Text | |
|
LOCATION: | |||
|
PRODUCTION: |
Machine Suitability | ||
|
180x29 MM | |||
|
180X290 MM |
UK/H/2272/001/IA/018/G | ||
|
40 GSM BIBLE PAPER | |||
If you have not used the cream as you were told to do and have used it too often and/or for a long time, you should tell your doctor or pharmacist.
If you forget to use Mometasone Cream If you forget to apply the cream at the right time, use it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop using Mometasone Cream
If you have been using Mometasone Cream for a long time and your skin problems seems to have got better, you should not suddenly stop using the cream. If you do, you may find that your skin becomes red and you may notice stinging or burning. To avoid this, you should speak to your doctor as he will gradually reduce how often you need to use the cream until you stop treatment altogether.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mometasone Cream can cause side effects, although not everybody gets them.
A few people may find that they suffer from some of the following side effects after using Mometasone Cream:
- allergic skin reactions
- bacterial and secondary skin infections
- acne
- inflammation and/or infection of the hair follicles
- thinning of the skin
- red marks with associated prickly heat
- loss of skin colour
- burning
- stinging
- itching
- tingling
- excessive hair growth
- softening of the skin and stretch marks
Other side effects that may occur with topical corticosteroids are dry skin, skin irritation, dermatitis, dermatitis around the mouth, and small dilated blood vessels.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Mometasone Furoate 0.1% w/w Cream contains
• The active substance is mometasone furoate. Each gram of Mometasone Furoate 0.1% w/w Cream contains 1mg of mometasone furoate.
• The other ingredients are hexylene glycol, water, white beeswax (E901), propylene glycol monopamitostearate, stearyl alcohol, ceteareth-20, titanium dioxide (E171), aluminium starch octenylsuccinate, phosphoric acid, and white soft paraffin which contains traces of butylated hydroxytoluene (E321).
What Mometasone Furoate 0.1% w/w Cream looks like and contents of the pack
Mometasone Furoate 0.1% w/w Cream is a white to off-white smooth cream.
It is available in tubes containing 10g, 15g, 20g, 30g, 50g, 60g or 100 g of cream.
Not all packs sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited, Laxmi House,
2 B Draycott Avenue, Kenton, Middlesex HA3 0BU,
United Kingdom
Manufacturer(s)
Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben, Germany
Glenmark Pharmaceuticals Europe Limited, Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA, United Kingdom
Glenmark Pharmaceuticals s.r.o., Fibichova 143,
566 17 Vysoke Myto, Czech Republic
This leaflet was last revised in July 2016
5. HOW TO STORE MOMETASONE CREAM
Keep this medicine out of the sight and reach of children. Do not use Mometasone Cream after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Do not refrigerate or freeze.
PExxxxxxxxxxx UK
Discard the opened tube with any remaining cream after 12 weeks.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
|
G GLENMARK PHARMACEUTICALS LTD. |
06.07.2016 |
Black | |
|
MOMETASONE FURO CRM100G GP-U ITEM CODE: VERSION: YES NA |
PKG. DEV.: |
Item code. Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | |
|
RA |
Regulatory Text | ||
|
UK |
QA: |
Entire Text | |
|
LOCATION: 180x29 MM | |||
|
PRODUCTION: |
Machine Suitability | ||
|
180X290 MM |
UK/H/2272/001/IA/018/G | ||
SPECIFICATION: 40 gsm bible paper
Temple Packaging Pvt. Ltd. Font: Times New Roman / Size: 9 pts. Sap code: 30100010393 File: 43643 Ver: 01 / george