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Clindavasin V vaginal cream 40 g.

Product Code: Clindavasin V vaginal cream 40 g.
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What Clindavasin V vaginal cream is and what it is used for
Clindavasin B vaginal cream contains the antibiotic clindamycin. It is used to treat bacterial vaginosis (bacterial infections of the vagina).

2. What you need to know before you use Clindavasin V vaginal cream
Do not use Clindavasin V vaginal cream:
if you are allergic to clindamycin or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to lincomycin;
if you have had inflammatory bowel disease or colitis associated with the use of antibiotics in the past.
Warnings and precautions
Talk to your doctor or pharmacist before using Clindavasin V vaginal cream:

If you have previously had diarrhea or colitis after taking another antibiotic, tell your doctor;
If severe or prolonged diarrhea occurs during treatment with Clindavasin B, the drug should be stopped and you should be provided with appropriate diagnostic procedures and treatment;
Tell your doctor if you suffer from an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
You may need some tests before and after starting treatment with Clindavasin B to determine the exact cause of the infection;
During treatment with Clindavasin B, you should avoid sexual contact and not use other vaginal products (such as tampons or douches);
Clindavasin B contains ingredients that can reduce the strength of condoms and vaginal diaphragms and make them less effective as methods of preventing pregnancy or sexually transmitted diseases. The use of condoms and diaphragms is not recommended until 72 hours after the administration of Clindavasin B;
The use of Clindavasin B, like other antibiotics, can lead to overgrowth of non-susceptible microorganisms, including fungi.
The use of Clindavasin B in children is not recommended, as the safety and efficacy of this medicine in them has not been established.

Use of other drugs and Clindavasin B vaginal cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking:
muscle relaxants used for surgery (neuromuscular blockers) - clindamycin may increase their effect.
warfarin or similar medicines used to thin the blood - you are more likely to have bleeding. Your doctor may need to do regular blood tests to check how well your blood is clotting.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Clindavasin B vaginal cream should not be used to treat pregnant women during the first trimester of pregnancy.

Clindavasin B vaginal cream can be used to treat pregnant women during the second and third trimesters of pregnancy, as well as breastfeeding women, only in cases of proven need.

It is not known whether clindamycin can pass into breast milk in humans after vaginal administration. When administered orally or by injection, clindamycin can be excreted in human milk and may cause adverse reactions in the nursing infant, such as diarrhea, blood in the stool, or a rash. Your doctor will consider whether to stop breastfeeding or to stop the administration of the drug, due to the risk of possible side effects for your child.

Driving and using machines
There is no evidence of an adverse effect of Clindamycin B on the ability to drive and operate machinery.

Clindavasin B vaginal cream contains cetostearyl alcohol, propylene glycol, benzyl alcohol and liquid paraffin
Cetostearyl alcohol may cause local skin reactions (eg contact dermatitis). One full applicator of Clindavasin B (approximately 5 g of vaginal cream) contains 1 g of propylene glycol. Propylene glycol may cause skin irritation.

One full applicator of Clindavasin B (approximately 5 g of vaginal cream) contains 50 mg of benzyl alcohol. Benzyl alcohol can cause mild local irritation and allergic reactions.

In addition, Clindavasin B vaginal cream contains liquid paraffin, which reduces the strength of latex or rubber products, such as condoms or vaginal diaphragms, so their integrity may be affected. The use of these products is not recommended until 72 hours after treatment with Clindavasin B vaginal cream.

3. How to apply Clindavasin V vaginal cream
Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults and adolescents over 16 years of age
The recommended dose is one full applicator (approximately 5 g cream equivalent to 100 mg clindamycin) daily. It is applied in the vagina, preferably after going to bed

If you forget to apply Clindavasin B vaginal cream
Continue treatment as usual. Do not use a double dose to make up for a missed dose.

If you have stopped using Clindavasin V vaginal cream
If you stop the treatment, the desired effect will not be achieved or the symptoms may worsen again. Consult your doctor before stopping treatment.
If you have any further questions related to 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.

Contact your doctor immediately if you experience:

severe, persistent or bloody diarrhea (which may be associated with stomach pain or fever). This is an uncommon side effect that may occur during or after antibiotic treatment is completed and may be a sign of serious inflammation of the bowel (pseudomembranous colitis).
allergic reaction with rash and itching (especially affecting the whole body).
The following adverse drug reactions are possible during treatment with this drug:

Very common side effects (may affect more than 1 in 10 people):
Fungal infection of the external genitalia and vagina (vulvovaginal candidiasis).
Common side effects (may affect 1 to 10 in 100 people):
Fungal infection, candidiasis of the body;
Headache, dizziness, altered taste;
Upper respiratory tract infection;
Stomach pains and cramps, diarrhea, nausea, vomiting, constipation;
Itching (unrelated to the site of application), rash;
Back pain;
Urinary tract infection, sugar in the urine, protein in the urine;
Complicated birth;
Inflammation of the external genitalia and vagina (vulvovaginitis), vulvovaginal disorder, itching and irritation in the external genitalia, menstrual disorder, pain in the external genitalia and vagina, uterine bleeding unrelated to the monthly cycle (metrorrhagia), vaginal discharge .
Uncommon side effects (may affect 1 to 10 in 1,000 patients):
Bacterial infection;
Alergic reaction;
Bleeding from the nose;
Abdominal pain, bad breath, gas, bloating, dyspepsia, heartburn;
Hives, reddening of the skin (erythema);
Burning and pain when urinating;
Inflammation of the vagina (trichomonial vulvovaginitis), vaginal infection, pelvic pain;
Deviations in microbiological research.
Adverse reactions with an unknown frequency (cannot be estimated from the available data):
Fungal infection of the skin (candidiasis);
Increased function of the thyroid gland (hyperthyroidism);
Pseudomembranous colitis (serious inflammation of the intestines), gastrointestinal complaints;
Skin rash with small, flat and raised red spots (maculopapular rash)
A condition with severe pain before menstruation, infertility, disorders in the menstrual cycle (endometriosis);
Inflammation, pain, swelling.
5. How to store Clindavasin V vaginal cream
Keep out of the reach of children.
To be stored below 25°C.
Do not freeze.
Shelf life after first opening the package: 7 (seven) days.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date corresponds to the last day of the month indicated.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Clindavasin V vaginal cream contains:
The active substance is clindamycin as clindamycin phosphate. 1 g of vaginal cream contains 20 mg of clindamycin.
The other ingredients are: benzyl alcohol, sorbitan stearate, polysorbate 60, propylene glycol, stearic acid, cetostearyl alcohol, cetyl palmitate, liquid paraffin, purified water, sodium hydroxide (for pH adjustment).
What Clindavasin V vaginal cream looks like and contents of the pack: A white to off-white homogeneous cream.

Aluminum tube with HDPE screw cap containing 40 g Clindavasin B 20 mg/g vaginal cream.
One tube with patient leaflet and seven disposable applicators packed in a cardboard box.


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