Patient leaflet - DALACIN 2% CREAM
Dalacin® Cream 2%
Ref: 1559/101121/1/F
(clindamycin phosphate)
Patient Information Leaflet
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 onto others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, tell your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
Your medicine is called Dalacin Cream 2% but will be referred to as Dalacin Cream throughout the leaflet.
What is in this leaflet
What Dalacin Cream is and what it is used for
^2| what you need to know before you use
Dalacin Cream
How to use Dalacin Cream
Possible side effects
How to store Dalacin Cream
r61 Contents of the pack and other information
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).
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What you need to know before you use Dalacin Cream
Do not use Dalacin Cream
- if you are allergic to clindamycin, lincomycin or to any of the other ingredients of this medicine (listed in section 6).
- if you suffer with a history of inflammatory bowel disease or antibiotic-associated colitis.
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if you have diarrhoea or usually get diarrhoea when you take antibiotics.
If you develop severe, 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.
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.
The use of other vaginal products such as tampons or douches (vaginal washes) during treatment with the cream is not recommended.
Children
Dalacin Cream is not recommended for use in children.
Other medicines and Dalacin Cream
Tell your doctor or pharmacist if you are taking, have taken or might take any other medicines.
Dalacin Cream may affect other medicines taken at the same time. Tell your doctor if you are taking erythromycin (an antibiotic) or have recently taken any other medicines including medicines obtained without a prescription.
Pregnancy and breast-feeding Pregnancy
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.
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 breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines have been seen with Dalacin Cream.
Dalacin Cream contains propylene glycol, cetostearyl alcohol and benzyl alcohol.
This medicine contains 250 mg propylene glycol in each 5 g applicator which is equivalent to 50 mg/g. This medicine contains 160.5 mg cetostearyl alcohol in each 5 g applicator, which is equivalent to 32.1 mg/g. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 50 mg of benzyl alcohol in each 5 g applicator which is equivalent to 10 mg/g. Benzyl alcohol may cause allergic reactions and mild local irritation.
How to use Dalacin Cream
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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 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 forget to use 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 using 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 the use of this medicine, ask your doctor or pharmacist.
Q 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
- 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 , (affecting more than 1 in every 10 patients):
- Inflammation of the cervix
Common side effects , (affecting less than 1 in every 10 patients):
- Vaginal thrush
- Infection or inflammation of the vulva and vagina
- Itching
- Vaginal disorder, vaginal discomfort, vaginal discharge
- Stomach cramps
Uncommon (affecting less than 1 in every 100 patients)
- Inflammation of the vagina
- Vaginal infection, urinary tract infection
- Yeast infection ( body)
- Fungal infection
- Allergic reactions
- Headache, dizziness
- A sensation of whirling and loss of balance, nosebleed
- Bad breath, diarrhoea, feeling sick (nausea), vomiting, change of sense of taste
- Constipation, stomach ache
- Upset stomach or indigestion
- Passing wind
- Rash, reddening of the skin, hives
- Painful urination, excess of sugar in the urine, protein in the urine
- Vaginal pain
- Inflammation of the vagina, generalised abdominal pain, back pain, pelvic pain, bacterial infection, head and chest infection caused by virus, skin infection
- Overactive thyroid, pain in a specific area of the abdomen, abdominal swelling
- Rash with red spots, irregular periods, abnormal bleeding from the uterus, endometriosis, abnormal labour, swelling, body pain, abnormal blood culture and sensitivity
- Inflammation of the lining of large intestine (pseudomembranous colitis)
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, pharmacist or nurse. This includes any possible side effects not listed on this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Q How to store Dalacin Cream
- Do not store above 25°C.
- Do not freeze.
- 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 label. The expiry date refers to the last day of that month.
- If your medicine becomes discoloured or shows any signs of deterioration, ask your pharmacist who will advise you what to do.
- Medicines should not be disposed of via water waste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Q Contents of the pack and other information
What Dalacin cream contains
The active substance is clindamycin phosphate. Each 1g of cream contains 20mg clindamycin (as phosphate).
The other ingredients sorbitan stearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, liquid paraffin and benzyl alcohol and purified water.
What Dalacin creame looks like and contents of the pack
Dalacin Cream is a white, semi solid cream. Each tube contains either 40g of cream.
Manufacturer and Licence Holder
Manufactured by Pfizer Manufacturing Belgium N.V., Puurs, Belgium and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE is a registered trademark of Allergan, Inc.
POM PL 15184/1559
Leaflet revision date: 10/11/21
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Ref: 1559/101121/1/B