Cymex Ultra
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Active ingredient: Aciclovir
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Lipsore 5% w/w Cream carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or does not improve after 10 days.
• If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Lipsore 5% w/w Cream is and what it is used for
2. Before you use Lipsore 5% w/w Cream
3. Howto use Lipsore 5% w/w Cream
4. Possible side effects
5. How to store Lipsore 5% w/w Cream
6. Further information
1. What Lipsore 5% w/w Cream is and what it is used for
Aciclovir belongs to a group of medicines called antivirals. Aciclovir works in cells that are infected by certain viruses, including the herpes simplex virus. It interferes with virus DNA, si owing down virus growth. Aciclovir is not harmful to human DNA.
What is Lipsore 5% w/w Cream is used for?
Lipsore 5% w/w Cream is used to treat cold sores of the lips and face caused by the herpes simplex virus. Aciclovir has been shown to speed up the healing of cold sore blisters if it is used soon enough.
2. Before you use Lipsore 5% w/w Cream
If you are not sure that your symptoms are caused by a cold sore then please consult your doctor or pharmacist before use.
Do not use Lipsore 5% w/wCream:
• If you are allergic to Aciclovir, valaciclovir, propylene glycol or any other ingredients of the preparation (see section 6 for a complete list of ingredients).
• inside your mouth, to treat mouth ulcers and in the eyes or genital areas.
Take special care with Lipsore 5% w/wCream:
Tell your doctor or pharmacist before you start using the cream:
If you are pregnant, plan to become pregnant or are breastfeeding.
• If you have a weak immune system, for example after chemotherapy or radiotherapy or due to immune deficiency disease or following transplant surgery. Consult your doctor first if you have an infection.
• People with severe recurrent infection of the face and lips should contact their doctor or pharmacist.
• Lipsore cream is not for use with eye infections.
• Lipsore cream is not to be used to treat genital herpes.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking any of the following medicines:
• Probenecid used to prevent kidney problems associated with cidofovir.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without prescription.
Pregnancy and Breastfeeding:
Tell your doctor if you are pregnant or planning to become pregnant. A small amount of this drug does pass into breast milk. If you are breast-feeding or are planningto breast-feed your baby tel I your doctor.
Driving and using machines:
This medicine should not affect your ability to drive or operate machinery.
Important information about some of the ingredients of Lipsore cream
Lipsore 5% w/w cream contains cetyl alcohol and propylene glycol which may cause local skin reactions (skin irritation and redness).
3. Howto use Lipsore 5% w/wCream
Lipsore 5% w/w Cream is for use on the skin only. It is not to be taken internally.
• To work at its best, Lipsore 5% w/wCream should be started as soon as possible after the first symptoms of infection appear.
• People who suffer from cold sores can often tell when they are about to get a cold sore by a tingling or itching sensation. Lipsore 5% w/w Cream should be used at this tingling stage or just after skin bl isters appear.
• If you get cold sores often, it may be useful to keep a pack ready foryour next one.
The following instructions will tell how to use Lipsore 5% w/w Cream:-
1. Wash your hands.
2. Apply a thin film of Lipsore 5% w/w Cream to the infected skin, and the skin immediately next to it, using your fingertip. Take care not to rub the infected skin any more than you need to.
3. You should apply Lipsore 5% w/w Cream to the infected area 5 times each day, at intervals of about 4 hours, nighttime application can be omitted.
4. Wash your hands again. Herpes simplex is infectious and you should try to avoid touching the infected skin with your hands or with towels, etc. to prevent spreadingthe infection.
• Never apply Lipsore 5% w/w Cream to an area of the body called the mucous membranes, as the cream can cause irritation. These areas to avoid include the inside of the mouth and nose and the inside of the vagina.
• Treatment should be continued for at least 4 days. If the infection has not healed after this time, treatment can be continued for up to 5 days more.
• If your skin infection does not get better after 10 days of treatment or gets worse at any time tell your doctor as soon as possible.
If you use more Lipsore 5% w/w Cream than you should:
Lipsore 5% w/w Cream is not to be used in the mouth as it may irritate the skin in this area. If it is accidentally swallowed, do not worry, but contact your doctor or pharmacist for advice.
Lipsore 5% w/w Cream should not be used in the eyes. If it gets in the eyes, wash it out with plenty of water. If your eye gets sore tell your doctor or pharmacist.
If you forget to use Lipsore 5% w/w Cream:
If you forget to use your cream, apply some as soon as you remember, then go on as before.
If you have any further questions on the use of Lipsore 5% w/w Cream askyour doctor or pharmacist.
4. Possible side Effects
Like all medicines Lipsore 5% w/w Cream can cause side effects, although not everybody gets them.
Very rarely there is an allergic (hypersensitive) reaction with symptoms of swelling of the face, throat and mouth and itching. Contact your doctor or hospital emergency department immediately.
Uncommon (>1/1000 and <1/100)
• Mild drying or flaking of the skin.
• After application of the cream there may be some burning or stinging of the treated skin areas.
• Itching
These may occur at the beginning of the treatment. If these signs do not get better after a few days then contact the doctor.
Rare: (> 1/10,000 and < 1/1000)
• Contact dermatitis with symptoms of a red rash or bumps, itching which may be severe with skin blistering, cracking and possibly bleeding.
In this case let your doctor know immediately. He will decide if you should continue with Lipsore 5% w/w Cream.
Very Rare (< 1/10,000):
• an allergic or hypersensitive reaction (see start of section).
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 the yellow card scheme at "htt p://www. mh ra.gov. uk/ye 11owcard11.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lipsore 5% w/w Cream
Keep out of the sight and reach of children.
Do not use Lipsore 5% w/w Cream after the expiry or 'use by1 date shown on the container.
Use within 6 weeks of opening.
Keep Lipsore 5% w/w Cream in its original container and store at a temperature below 25°C but do not refrigerate or freeze.
6. Further information What the cream contains:
The active ingredient is Aciclovir. Each gram of the cream contains 50 mg of Aciclovir.
The other ingredients are stearoyl macrogolglycerides, dimethicone, cetyl alcohol, liquid paraffin, white soft paraffin, propylene glycol and purified water.
What Lipsore 5% w/w Cream looks like and contents of the pack
Lipsore 5% w/w cream is available from your pharmacist without prescription in a2gtube.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited, Cheshire House, Gorsey Lane, Wid nes, Cheshire, WA8 0RR UK.
Date leaflet last revised: December 2013 | GSL PL20395/0001