Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Clindamycin phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Dalacin Cream 2% 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).
e Dalacin Cream Do not use Dalacin Cream
The use of other vaginal products such as tampons or douches (vaginal washes) during treatment with this medicine 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 recently 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 this medicine 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, benzyl alcohol and polysorbate 60. 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. This medicine contains 250 mg polysorbate 60 in each 5 g applicator which is equivalent to 50 mg/g. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergies.
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.
Page 2 of 6
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, threeday course of treatment depending on your symptoms. Always wash your hands before using this medicine. 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 this medicine. If you use more Dalacin Cream than you should Tell your doctor. Do not use any more of this medicine until your doctor tells you to. If you swallow Dalacin Cream If you or somebody else swallows this medicine, contact your doctor. It 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 to make up for a forgotten dose. 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 this medicine 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. Page 3 of 6
4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you:
• • • • • • • • •
Upset stomach Bad breath Passing wind Reddening of the skin A nettle-like rash, hives Painful urination Vaginal infection Pelvic pain Abnormal laboratory test results
Not known: frequency cannot be estimated from the available data
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.
Dalacin Cream • • • •
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25oC. Do not freeze. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Dalacin Cream contains
•
The other ingredients are: benzyl alcohol (E1519), sorbitan stearate, polysorbate 60, propylene glycol (E1520), stearic acid, cetostearyl alcohol, cetyl palmitate, liquid paraffin and water (see section 2 "Dalacin Cream contains propylene glycol, cetostearyl alcohol, benzyl alcohol, and polysorbate 60").
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 either 7.8 g, 20 g or 40 g of cream, packed in a cardboard carton together with 7 single-use applicators and a leaflet. Not all pack sizes may be marketed. Marketing Authorisation Holder Pfizer Limited, Ramsgate Rd, Sandwich, Kent, CT13 9NJ, UK. Manufacturer Pfizer Service Company BV, Hermeslaan 11, 1932 Zaventem , Belgium. Company Contact Address: For further information on your medicine contact Medical Information at Pfizer Limited in Walton Oaks, Tadworth, Surrey. Tel: 01304 616161. This leaflet was last revised in 01/2026. Ref: DA 26_1
Page 6 of 6
Dalacin Cream 2% comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Dalacin Cream 2% is clindamycin phosphate.
This leaflet reproduces the patient information leaflet approved for Dalacin Cream 2%, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Antibiotic for the treatment of bacterial vaginosis.
Posology
One applicator full intravaginally at bedtime for 7 consecutive days.
In patients for whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective.
Paediatric population
Safety and efficacy in paediatric patients have not been established (see section 4.4).
Elderly
No clinical studies have been conducted in populations older than 60.
This medicine is contra-indicated in patients with a history of hypersensitivity to clindamycin, lincomycin, or to any of the excipients listed in section 6.1.
This medicine is also contraindicated in individuals with a history of inflammatory bowel disease or a history of antibiotic-associated colitis.
Before or after initiation of therapy with clindamycin, other infections including Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and gonococcal infections may need to be investigated by adequate laboratory tests.
The use of clindamycin may result in the overgrowth of non-susceptible organisms, particularly yeasts.
Onset of symptoms suggestive of pseudomembranous colitis may occur during or after antimicrobial treatment (see section 4.8). Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Therefore, it is important that this is considered in patients who present with diarrhoea subsequent to the administration of antibacterial agents. Moderate cases may improve following withdrawal of the drug.
Clindamycin treatment must be stopped if pseudomembranous diarrhoea occurs. An adequate antibacterial therapy should be prescribed. Drugs inhibiting peristalsis are contraindicated in this situation.
Caution is advised in patients when prescribing clindamycin to individuals with inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
As with all vaginal infections, sexual intercourse during treatment with clindamycin vaginal cream is not recommended. Latex condoms and diaphragms may be weakened if exposed to the suppository base used in clindamycin vaginal cream. The use of such products within 72 hours following treatment with clindamycin vaginal cream is not recommended as such use could be associated with diminished contraceptive efficacy or protection against sexually transmitted disease.
The use of other vaginal products (such as tampons and douches) during the treatment with clindamycin vaginal cream is not recommended.
Paediatric population
Safety and efficacy in paediatric patients have not been established (see section 4.2).
Excipient information
This medicine contains propylene glycol, cetostearyl alcohol, benzyl alcohol and polysorbate 60 (see section 2).
Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Benzyl alcohol may cause allergic reactions and mild local irritation.
Polysorbate 60 may cause hypersensitivity reactions.
Systemic clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving such agents (see section 4.9).
No information is available on the concomitant use of other vaginal medications with clindamycin.
Pregnancy
Use of clindamycin is not recommended during the first trimester, as there are no adequate and well-controlled studies in pregnant women over this period.
In clinical trials, intravaginal use of clindamycin vaginal products in pregnant women during second trimester and systemic use of clindamycin phosphate during the second and third trimester has not been associated with congenital abnormalities.
Clindamycin may be used to treat pregnant women if clearly necessary during the second and third trimester of pregnancy.
Reproduction studies performed in rats and mice using oral and parenteral doses of clindamycin, ranging from 100 to 600 mg/kg/day, have revealed no evidence of harm to the fetus due to clindamycin (see section 5.3). In one mouse strain, cleft palates were observed in species treated fetuses; this response was not produced in other mouse strains or in other species, and is therefore considered to be a strain specific effect. Animal reproduction studies are not always predictive of human response.
In a clinical trial in pregnant women during the second trimester, this medicine was effective in treating bacterial vaginosis, and no drug-related medical events were reported in the neonates. However, as with any drug used during pregnancy, a careful risk-benefit assessment should take place beforehand.
Breast-feeding
It is not known if clindamycin is excreted in human breast milk following the use of vaginally administered clindamycin vaginal cream. Clindamycin has been reported to appear in human breast milk in ranges from <0.5 to 3.8 µg/ml following systemic use. Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal flora such as diarrhoea or blood in the stool, or rash. If oral or intravenous clindamycin is required by a nursing mother, it is not a reason to discontinue breastfeeding, but an alternate drug may be preferred. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition.
Fertility
Fertility studies in rats treated orally with clindamycin revealed no effects on fertility or mating ability. No animal fertility studies have been performed using the vaginal route of administration.
The effect of clindamycin on the ability to drive or operate machinery has not been systematically evaluated.
The table below lists the adverse reactions identified through clinical trial experience and post-marketing surveillance by system organ class and frequency. Adverse reactions identified from post-marketing experience are included in italics. The frequency grouping is defined using the following convention: Very common (≥1/10); Common (≥ 1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The safety of clindamycin vaginal cream was evaluated in both non pregnant patients and patients during their second and third trimesters of pregnancy.
Adverse Drug Reactions Table for Clindamycin Vaginal Cream
System Organ Class
Very Common
≥ 1/10
Common
≥ 1/100 to <1/10
Uncommon
≥ 1/1000 to <1/100
Rare
≥ 1/10, 000 to <1/1000
Very Rare
< 1/10, 000
Frequency not known
(cannot be estimated from available data)
Infections and infestations
Fungal infection, candida infection
Bacterial infection
Skin candida
Immune System Disorders
Hypersensitivity
Endocrine disorders
Hyperthyroidism
Nervous System Disorders
Headache, dizziness, dysgeusia
Ear and labyrinth disorders
Vertigo
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
Epistaxis
Gastrointestinal Disorders
Abdominal pain, constipation, diarrhea, nausea, vomiting
Abdominal distension, breath odour, flatulence
Gastrointestinal disorder, Pseudomembranous colitis*, dyspepsia
Skin and Subcutaneous Tissue Disorders
Pruritus (non-applicable site), rash
Erythema, urticaria urticaria
Rash maculopapular
Musculoskeletal and connective tissue disorders
Back pain
Renal and urinary disorders
Urinary tract infection, glycosuria, proteinuria
Dysuria
Pregnancy, puerperium and perinatal conditions
Abnormal labour
Reproductive system and breast disorders
Vulvovaginal candidiasis
Vulvovaginitis, vulvovaginal disorder, menstrual disorder, vulvovaginal pain, metrorrhagia, vaginal discharge
Vulvovaginitis trichomonal, vaginal infection, pelvic pain
Endometriosis
General disorders and administration site conditions
Pain, inflammation
Investigations
Microbiology test abnormal
* ADRs identified post-marketing.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store.
There are no reports of overdose with clindamycin. When applied vaginally, this medicine can be absorbed in sufficient amounts to produce systemic effects.
In the event of overdosage, general symptomatic and supportive measures are indicated as required.
Accidental oral intake can lead to effects comparable with those of therapeutic concentrations of orally administered clindamycin.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Dalacin Cream 2%. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.