Patient Information Leaflet

Clindavag, 100 mg, globules
Clindamycinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Clindavag is and what it is used for
Important information before using Clindavag
How to use Clindavag
Possible side effects
How to store Clindavag
Contents of the pack and other information

1. What Clindavag is and what it is used for

The name of this medicine is Clindavag, 100 mg, globules. The medicine described in this leaflet is called Clindavag.
Clindavag is a semi-solid preparation in the form of globules intended for vaginal use. Once inserted into the vagina, it releases a substance called clindamycin phosphate. This belongs to a group of medicines known as antibiotics.
Clindavag is used in the treatment of a bacterial vaginal infection called bacterial vaginosis.

2. Important information before using Clindavag

When not to use Clindavag

If the patient is allergic to clindamycin, another lincosamide antibiotic, or any of the other ingredients of this medicine (listed in section 6).
If the patient has previously experienced colitis following antibiotic treatment.

Warnings and precautions
Before starting treatment with Clindavag, discuss this with your doctor.

If the patient has diarrhoea or usually develops diarrhoea when taking antibiotics.
If the patient has previously suffered from inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

If the patient develops severe, persistent, or bloody diarrhoea during or after treatment with Clindavag, medical advice should be sought immediately, as treatment may need to be discontinued. These symptoms may indicate intestinal inflammation (pseudomembranous colitis), which may occur as a consequence of antibiotic therapy. Discuss with your doctor the use of this medicine if:

The patient has impaired kidney, liver, or immune system function.
The patient is under 16 years of age or over 65 years of age.

As with all vaginal infections, sexual intercourse is not recommended during treatment with Clindavag. Clindavag may weaken the effect of condoms and vaginal diaphragms. Do not rely on the effectiveness of condoms or vaginal contraceptive diaphragms if used within 72 hours after treatment.
The use of other vaginal products, such as tampons or intimate hygiene washes, is not recommended during treatment with the suppositories.
Children
Clindavag must not be used in children under 16 years of age.
Clindavag and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take.
In particular, inform your doctor if the patient is taking:

Muscle relaxants, because Clindavag may enhance the effect of such medicines.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The use of Clindavag is not recommended during the first three months of pregnancy, as data on safety during this period are limited.
If the patient is pregnant, Clindavag should only be used after careful discussion with her doctor, who will decide whether treatment is appropriate.
If the patient is breastfeeding, her doctor will decide whether Clindavag is suitable, as the active substance may pass into breast milk.
Although it is unlikely that a breastfed infant will receive a large amount of the active substance from the milk, if the child develops bloody diarrhoea or any signs of illness, this should be reported to the doctor immediately. In such a case, breastfeeding should be discontinued.
Driving and operating machinery
It is unlikely that this medicine will affect the ability to drive or operate machinery.

3. How to use Clindavag

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Do not use this medicine if the blister pack containing the ovules is torn, open, or not completely sealed.
Take care to avoid overheating the ovule, as heat may cause softening and deformation of the ovule.
The recommended dose of this medicine is one ovule to be inserted deeply into the vagina every evening
at bedtime for 3 consecutive days. After application, the ovule will dissolve and disappear.

Insertion of the ovule into the vagina:

Remove the ovule from the blister pack.
Lie on your back with your knees drawn up towards your chest.
Using the tip of the middle finger, insert the ovule as deeply as possible into the vagina, without causing discomfort.

Always wash your hands before and after inserting the ovule.

Use of more than the recommended dose of Clindavag
If you have used more than the recommended dose, contact your doctor immediately.
Do not use more ovules than recommended without consulting your doctor.

Missed dose of Clindavag
If several hours have passed since the missed dose, apply the ovule as soon as possible. If it is almost time for the next dose, skip the missed dose. Take the next dose at the usual time.
Try to use the ovules at the same time each day.
Do not use a double dose to make up for a missed dose.

If Clindavag is swallowed
If the ovule has been ingested or swallowed, contact your doctor. It is unlikely that the ovule will cause any harm, but your doctor will advise you on what to do in such a case.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should inform your doctor immediately if:

Severe, persistent or bloody diarrhoea develops (which may be associated with abdominal pain or fever). This is an uncommon adverse reaction that may occur during or after antibiotic treatment and may be a sign of a serious intestinal inflammation or inflammation of the lining of the large intestine (pseudomembranous colitis).
Very severe allergic reactions or skin reactions occur. These are very rare adverse reactions.

Common (may occur in up to 1 in 10 patients):

fungal infections, yeast infections
headache
abdominal pain, diarrhoea, nausea
itching (in areas other than the application site)
vaginal candidiasis, vaginal discomfort, vaginal disorders.

Uncommon (may occur in up to 1 in 100 patients):

vomiting
rash
upper abdominal pain or back pain
fever or chills, nausea (feeling unwell)
pain during urination, blood in urine, cloudy or foul-smelling urine, increased frequency of urination or sudden urge to urinate
vaginal infection, vaginal discharge, irregular menstrual bleeding
pain (at application site), itching, local swelling.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can
be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Clindavag

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the package and other information

What Clindavag contains

The active substance is clindamycin phosphate. Each ovule contains clindamycin phosphate equivalent to 100 mg of clindamycin.
Other components of the medicine are: hard fat.

What Clindavag looks like and contents of the pack
Clindavag is a white to yellowish ovule. 3 vaginal ovules in a white PVC/PE blister pack,
packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Manufacturer
HELP S.A.
Pedini Ioanninon
45500 Ioannia
Greece
QUALIMERIX S.A.
579 Mesogeion Avenue
15343 Agia Paraskevi Athens
Greece
Other sources of information
Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products http://urpl.gov.pl