Patient leaflet - Dalacin 2% cream, Clindamycin 2% w/w cream
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. 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 250mg propylene glycol in each 5g applicator which is equivalent to 50mg/g.
This medicine contains 160.5mg cetostearyl alcohol in each 5g applicator, which is equivalent to 32.1mg/g. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 50mg of benzyl alcohol in each 5g applicator which is equivalent to 10mg/g. Benzyl alcohol may cause allergic reactions and mild local irritation.
3. 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.
Package leaflet: Information for the patient
Dalacin® 2% Cream
(clindamycin phosphate) 
RECTUM VAGINA
CERVIX 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 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.
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
Frequency not known, but may also occur
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 in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.
5. How to store Dalacin Cream
Keep out of the sight and reach of children.
Do not store above 25°C. Do not freeze. Store in the original package.
Do not use any pack that is damaged or is open.
Do not use the cream after the expiry date which is stated on the carton and tube label after ‘Exp’. The expiry date refers to the last day of that month.
If the cream becomes discoloured or show 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.
6. Contents of the pack and other information
What Dalacin Cream contains
The active ingredient in Dalacin Cream is clindamycin phosphate. Each gram of cream contains 20mg clindamycin (as the phosphate).
The other ingredients are: sorbitan monostearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, purified water, mineral oil and benzyl alcohol (1%) as preservative.
What Dalacin Cream looks like and contents of the pack Dalacin Cream is a white, semi-solid cream.
It is supplied in tubes containing 40g (7 doses) of cream. Pack also contains 7 applicators to measure the correct dose and facilitate application.
Manufactured by: Pfizer Service Company bvba, Hoge Wei, 10 1930, Zaventem, Belgium.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Dalacin® 2% Cream; PL 18799/2222
Leaflet date: 24.09.2021
Dalacin is a registered trademark of Pfizer Inc.
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POM