Clindamycin 2% W/W Cream
PACKAGE LEAFLET: INFORMATION FOR THE USER.
Dalacin® 2%w/w Cream
(clindamycin phosphate)
Read all of this leaflet carefully before you start using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
The name of your medicine is Dalacin 2%w/w Cream, but it will be referred to as Dalacin Cream in this leaflet.
In this leaflet:
1. What Dalacin Cream is and what it is used for
2. Before you use Dalacin Cream
3. How to use Dalacin Cream
4. Possible side effects
5. How to store Dalacin Cream
6. Further Information
1. What Dalacin Cream is and what it is used for
Dalacin Cream is a vaginal cream. It contains clindamycin phosphate which is an antibiotic. It is used in the treatment of bacterial vaginosis (a bacterial infection of the vagina).
2. Before you use Dalacin Cream
Do not use Dalacin Cream
If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this cream.
Do not use if you suffer with a history of inflammatory bowel disease or antibiotic-associated colitis.
Take special care with Dalacin Cream
Before taking this medicine make sure that your doctor knows if
you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe or prolonged or bloody diarrhoea during or after using Dalacin Cream tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
Dalacin cream is not recommended for use in children.
As with all vaginal infections, sexual intercourse during treatment with Dalacin Cream is not recommended. Dalacin Cream may weaken condoms and diaphragms. Do not rely on condoms or contraceptive diaphragms when using this medicine for 72 hours following treatment.
The use of other vaginal products such as tampons or douches (vaginal washes) during treatment with the cream is not recommended.
Taking other medicines
Dalacin Cream may affect other medicines taken at the same time.
Please tell your doctor if you are taking erythromycin (an antibiotic) or have recently taken any other medicines including medicines obtained without a prescription.
Warfarin or similar medicines - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.
Pregnancy
The use of Dalacin Cream in the first three months of pregnancy is not recommended as there is insufficient evidence of safety. Tell your doctor before using this medicine if you are pregnant or think you may be pregnant. If you are pregnant the cream should only be used after careful discussion with your doctor who will decide if this treatment is appropriate for you.
Breast-feeding
Tell your doctor if you will be breast-feeding while using Dalacin Cream as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Dalacin Cream is suitable for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, if your baby gets bloodstained diarrhoea or shows any signs of illness, tell your doctor at once. You should stop breastfeeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with Dalacin Cream.
Important information about some of the ingredients of Dalacin Cream
Dalacin Cream contains propylene glycol and cetostearyl alcohol which may cause local skin irritation and inflammation.
3. How to use Dalacin Cream
Always use Dalacin Cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to use this cream.
The usual dose is one applicator full (approx 5 grams),
which should be placed into the vagina each night at bedtime for seven consecutive nights.
Your doctor may recommend a shorter, three day course of treatment depending on your symptoms.
Always wash your hands before using the cream.
Insertion:
Remove the cap from the tube.
Screw one of the disposable plastic applicators supplied on to the tube where the cap has been removed.
Holding the tube from the bottom, squeeze gently and force the cream into l: the applicator. ’
When the plunger stops moving, the applicator is full.
Unscrew the applicator and replace the cap on the tube.
Lie on your back, firmly grasp the applicator barrel, and insert gently into the vagina as far as possible without causing discomfort.
Still holding the barrel, slowly push the plunger until it stops and all the cream has been expelled.
Carefully withdraw the applicator and dispose of it. It is preferable to wrap it in paper before disposal in a waste container. Do not try to flush it down the toilet.
Wash your hands well after applying the cream.
If you use more Dalacin Cream than you should
Tell your doctor. Do not use any more cream until your doctor tells you to.
If you swallow Dalacin Cream
If you or somebody else swallows some Dalacin Cream contact your doctor. The cream is not likely to cause any harm but your doctor will be able to give you advice on what to do.
If you miss a dose of Dalacin Cream
If the forgotten dose is just a few hours late, use it straight away. If it is nearly time for your next application, miss out the forgotten one. Do the next application at the normal time. Do not use double the amount but carry on using your Cream at the usual times.
If you stop taking Dalacin Cream
Sometimes you may feel better after only a few days treatment. Even if you do feel better, do not stop using the cream until you have completed the full course of treatment.
If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dalacin Cream can cause side effects, although not everybody gets them.
Tell your doctor immediately if you:
• develop severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.
• experience an allergic reaction or skin reaction such as hives or a measles-like rash. These are very rare side effects.
Very common side effects (likely to occur in more than 1 in 10 patients):
• Effects on your genital area: irritation of the vagina or cervix
Uncommon side effects (likely to occur in less than 1 in 100 patients):
• Effects on your nervous system: dizziness, vertigo, headaches.
• Effects on your stomach and intestines: heartburn, nausea (feeling sick), vomiting, diarrhoea, stomach pain and constipation.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Dalacin Cream
• Keep out of the sight and reach of children.
• Do not use Dalacin Cream after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
• Do not store above 25°C. Do not freeze.
• If your medicine shows any signs of deterioration, seek the advice of your pharmacist.
• 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.
What Dalacin Cream contains
• The active substance is clindamycin phosphate.
Each 1 gram of cream contains 20mg of clindamycin.
• The other ingredients are: sorbitan stearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, liquid paraffin, benzyl alcohol and water.
What Dalacin Cream looks like and contents of the pack
Dalacin Cream is a white, semi-solid cream. It is supplied in a laminated tube. Each tube contains 40g of cream, packed in a cardboard carton together with the leaflet and 7 applicators.
Manufactured by: Pharmacia & Upjohn Company, Kalamazoo, Michigan, USA. Or
Pfizer Service Company BVBA, Zaventem, Belgium.
Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Limited,
956 Buckingham Avenue, Slough Trading Estate, Slough,
SL1 4NL, UK.
Dalacin® 2%w/w Cream, p0M PL: 39352/0008 -
Dalacin® is a registered trademark of Pfizer Ltd.
Leaflet date: 05/07/2016
Clindamycin 2%w/w Cream
(clindamycin phosphate)
Read all of this leaflet carefully before you start using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
The name of your medicine is Clindamycin 2%w/w Cream, but it will be referred to as Clindamycin Cream in this leaflet.
In this leaflet:
1. What Clindamycin Cream is and what it is used for
2. Before you use Clindamycin Cream
3. How to use Clindamycin Cream
4. Possible side effects
5. How to store Clindamycin Cream
6. Further Information
1. What Clindamycin Cream is and what it is used for
Clindamycin Cream is a vaginal cream. It contains clindamycin phosphate which is an antibiotic. It is used in the treatment of bacterial vaginosis (a bacterial infection of the vagina).
2. Before you use Clindamycin Cream
Do not use Clindamycin Cream
If you are allergic (hypersensitive) to clindamycin, lincomycin or to any of the other ingredients in this cream.
Do not use if you suffer with a history of inflammatory bowel disease or antibiotic-associated colitis.
Take special care with Clindamycin Cream
Before taking this medicine make sure that your doctor knows if
you have diarrhoea or usually get diarrhoea when you take antibiotics. If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin Cream tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
Clindamycin cream is not recommended for use in children.
As with all vaginal infections, sexual intercourse during treatment with Clindamycin Cream is not recommended. Clindamycin Cream may weaken condoms and diaphragms. Do not rely on condoms or contraceptive diaphragms when using this medicine for 72 hours following treatment.
The use of other vaginal products such as tampons or douches (vaginal washes) during treatment with the cream is not recommended.
Taking other medicines
Clindamycin Cream may affect other medicines taken at the same time.
Please tell your doctor if you are taking erythromycin (an antibiotic) or have recently taken any other medicines including medicines obtained without a prescription.
Warfarin or similar medicines - used to thin the blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.
Pregnancy
The use of Clindamycin Cream in the first three months of pregnancy is not recommended as there is insufficient evidence of safety.
Tell your doctor before using this medicine if you are pregnant or think you may be pregnant. If you are pregnant the cream should only be used after careful discussion with your doctor who will decide if this treatment is appropriate for you.
Breast-feeding
Tell your doctor if you will be breast-feeding while using Clindamycin Cream as the active substance in this medicine may be passed into breast milk. Your doctor will decide if Clindamycin Cream is suitable for you. Although it is not likely that a nursing infant will take in very much of the active substance from the milk it drinks, if your baby gets blood stained diarrhoea or shows any signs of illness, tell your doctor at once. You should stop breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with Clindamycin Cream.
Important information about some of the ingredients of Clindamycin Cream
Clindamycin Cream contains propylene glycol and cetostearyl alcohol which may cause local skin irritation and inflammation.
3. How to use Clindamycin Cream
Always use Clindamycin Cream exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure how to use this cream.
The usual dose is one applicator full (approx 5 grams),
which should be placed into the vagina each night at bedtime for seven consecutive nights.
Your doctor may recommend a shorter, three day course of treatment depending on your symptoms.
Always wash your hands before using the cream.
Insertion:
Remove the cap from the tube.
Screw one of the disposable plastic applicators supplied on to the tube where the cap has been removed.
Holding the tube from the bottom, squeeze gently and force the cream into the applicator.
When the plunger stops moving, the applicator is full.
Unscrew the applicator and replace the cap on the tube.
Lie on your back, firmly grasp the applicator barrel, and insert gently into the vagina as far as possible without causing discomfort.
Still holding the barrel, slowly push the plunger until it stops and all the cream has been expelled.
Carefully withdraw the applicator and dispose of it. It is preferable to wrap it in paper before disposal in a waste container. Do not try to flush it down the toilet.
Wash your hands well after applying the cream.
If you use more Clindamycin Cream than you should
Tell your doctor. Do not use any more cream until your doctor tells you to.
If you swallow Clindamycin Cream
If you or somebody else swallows some Clindamycin Cream contact your doctor. The cream is not likely to cause any harm but your doctor will be able to give you advice on what to do.
If you miss a dose of Clindamycin Cream
If the forgotten dose is just a few hours late, use it straight away. If it is nearly time for your next application, miss out the forgotten one. Do the next application at the normal time. Do not use double the amount but carry on using your Cream at the usual times.
If you stop taking Clindamycin Cream
Sometimes you may feel better after only a few days treatment. Even if you do feel better, do not stop using the cream until you have completed the full course of treatment.
If you have any further questions on how to take this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Clindamycin Cream can cause side effects, although not everybody gets them.
Tell your doctor immediately if you:
• develop severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.
• experience an allergic reaction or skin reaction such as hives or a measles-like rash. These are very rare side effects.
Very common side effects (likely to occur in more than 1 in 10 patients):
• Effects on your genital area: irritation of the vagina or cervix
Uncommon side effects (likely to occur in less than 1 in 100 patients):
• Effects on your nervous system: dizziness, vertigo, headaches.
• Effects on your stomach and intestines: heartburn, nausea (feeling sick), vomiting, diarrhoea, stomach pain and constipation.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or 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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Clindamycin Cream
• Keep out of the sight and reach of children.
• Do not use Clindamycin Cream after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
• Do not store above 25°C. Do not freeze.
• If your medicine shows any signs of deterioration, seek the advice of your pharmacist.
• 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.
What Clindamycin Cream contains
• The active substance is clindamycin phosphate.
Each 1 gram of cream contains 20mg of clindamycin.
• The other ingredients are: sorbitan stearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, liquid paraffin, benzyl alcohol and water.
What Clindamycin Cream looks like and contents of the pack
Clindamycin Cream is a white, semi-solid cream. It is supplied in a laminated tube. Each tube contains 40g of cream, packed in a cardboard carton together with the leaflet and 7 applicators.
Manufactured by: Pharmacia & Upjohn Company, Kalamazoo, Michigan, USA. Or
Pfizer Service Company BVBA, Zaventem, Belgium.
Procured from within the EU & repackaged by Product Licence holder: Kosei Pharma UK Limited,
956 Buckingham Avenue, Slough Trading Estate, Slough, SL1 4NL, UK.
Clindamycin 2%w/w Cream, PL: 39352/0008
Leaflet date: 05/07/2016
POM