Important safety information and consumer warnings you should know about topical clindamycin.
The risk information provided here is not comprehensive. To learn more, talk about any new medicine with your healthcare provider and pharmacist. The full FDA-approved product labeling can be found at https://www.fda.gov/ or 1-800-555-DRUG. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Clindamycin Phosphate (Cleocin T, Clindagel)
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 your 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
- What topical clindamycin is and what it is used for
- What you need to know before you use topical clindamycin
- How to use topical clindamycin
- Possible side effects
- How to store topical clindamycin
- Contents of the pack and other information
1. What topical clindamycin is and what it is used for
Topical clindamycin contains an antibiotic called clindamycin phosphate and comes as either a solution or lotion. The solution and the lotion are used on the skin to treat acne.
2. What you need to know before you use topical clindamycin
Do not use topical clindamycin:
- if you are hypersensitive (allergic) to clindamycin, lincomycin or to any of the other ingredients of this medicine (listed in section 6).
- if you have a history of inflammatory bowel disease or antibiotic-associated colitis.
Warnings and precautions
Talk to your doctor or pharmacist before using topical clindamycin 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 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.
Topical clindamycin solution contains alcohol, which can cause burning or irritation of your eyes. Keep it away from your eyes, mouth, and cuts or grazes on your skin. If you get any of these sensitive areas, wash it away with plenty of cool water. Take care when using the lotion or the topical solution around your mouth as they each have an unpleasant taste.
Topical clindamycin solution is flammable. Do not use the solution near flames or while you are smoking.
Other medicines and topical clindamycin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are using any skin treatments that contain benzoyl peroxide. These medicines should not be used at the same time as topical clindamycin.
If you are going to hospital for a surgical procedure, tell your doctor and/or anaesthetist if you are taking drugs that cause paralysis of muscle (neuromuscular blocking agents).
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 and breast-feeding
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Tell your doctor if you will be breast-feeding while using topical clindamycin as the active substance in this medicine may be passed into breast milk. Your doctor will decide if topical clindamycin 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 topical clindamycin.
Topical clindamycin solution contains propylene glycol
This may cause skin irritation.
Topical clindamycin lotion contains cetostearyl alcohol and methyl parahydroxybenzoate
Cetostearyl alcohol may cause local skin reactions such as dermatitis (an inflammation of the skin). Methyl parahydroxybenzoate may cause allergic reactions that can be delayed.
3. How to use topical clindamycin
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Usually, you should use this medicine twice a day, shake the bottle well before use. Wash the affected area and put on a thin film of solution or lotion.
The topical clindamycin solution bottle has an automatic pad dispenser. Gently apply a thin film onto your skin using the pad on the applicator.
The topical clindamycin lotion bottle has a dispensing cap. Wash your hands before and after use and dry them, apply a thin film of the lotion by gently rubbing it into your skin, you may use a cotton pad for this or you can use your fingers. Always replace the cap after use.
If you forget to apply topical clindamycin
Do not worry if you miss one or two applications; just carry on as soon as you remember.
If you stop using topical clindamycin
Do not stop using topical clindamycin as soon as your acne starts to get better. Ask your doctor when you should stop the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 or pseudomembranous colitis.
Side effects that have been seen with topical clindamycin lotion and topical clindamycin solution are:
Very common: may affect more than 1 in 10 people
- Skin irritation (may cause symptoms such as burning, itching, peeling), hives, dryness of skin
Common: may affect up to 1 in 10 people
- Oily skin
Uncommon: may affect up to 1 in 100 people (only seen with topical clindamycin solution)
- Gastrointestinal disturbances (may cause symptoms such as diarrhoea, and nausea) Frequency not known, but may also occur
- Severe acne (also known as gram-negative folliculitis), stinging of the eye, stomach pain, inflammation of the skin caused by contact with irritants or allergens
- Topical clindamycin lotion may cause gastrointestinal disturbances (with symptoms such as diarrhoea and nausea)
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store topical clindamycin
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the bottle and carton after expiration. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispense away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What topical clindamycin contains
The active ingredient is clindamycin phosphate. Each ml of topical clindamycin lotion or solution contains 10 mg of clindamycin.
The other ingredients are:
- lotion: glycerol, sodium lauroyl sarcosinate, stearic acid, tegin, cetostearyl alcohol, isostearyl alcohol, methylparaben and water.
- solution: isopropyl alcohol, propylene glycol, hydrochloric acid, sodium hydroxide and water.
What topical clindamycin looks like and contents of the pack
Topical clindamycin lotion is a white to off-white aqueous emulsion in a plastic bottle with a dispensing cap. Bottles contain 30 ml or 60 ml of topical clindamycin lotion.
Topical clindamycin solution is a clear colourless solution in a plastic bottle with an automatic pad dispenser and cap. Bottles contain either 30 ml, 50 ml or 60 ml of topical clindamycin solution.
Not all pack sizes may be marketed.