Package leaflet: Information for the user

CLINDAX

100 mg vaginal ovules
clindamycin
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Clindax is and what it is used for
What you need to know before using Clindax
How to use Clindax
Possible side effects
How to store Clindax
Contents of the pack and other information

1. What Clindax is and what it is used for

The name of the medicine is Clindax 100 mg vaginal ovules. It will be referred to as Clindax in this leaflet.
Clindax is a semi-solid vaginal ovule, i.e. a vaginal suppository. When inserted into the vagina,
it releases a medicine called clindamycin phosphate. This belongs to a class of medicines known as
antibiotics.
Clindax is used in the treatment of a bacterial infection of the vagina called bacterial vaginosis.

2. What you need to know before using Clindax

Do not use Clindax:

if you are allergic to clindamycin, to another antibiotic called lincomycin, or to any of the other ingredients of this medicine (listed in section 6).
if you have previously had inflammation of the colon (colitis) while taking antibiotics.

Warnings and precautions
Inform your doctor or pharmacist before using Clindax

if you suffer from diarrhoea or generally develop diarrhoea when taking antibiotics
if you have a history of inflammatory bowel disease such as Crohn's disease or ulcerative colitis.

If you develop severe or prolonged diarrhoea, or diarrhoea with blood during or after treatment with Clindax,
inform your doctor immediately, as treatment may need to be discontinued.
This could be a sign of intestinal inflammation ( pseudomembranous colitis ), which may occur
following antibiotic treatment.
Consult your doctor to find out whether you can use this medicine in the following cases:

if you have kidney, liver or immune system problems
if you are under 16 or over 65 years of age.

As with all vaginal infections, sexual intercourse during treatment with Clindax is not recommended.
Clindax may reduce the effectiveness of condoms and diaphragms. Contraceptive condoms or diaphragms
should not be considered effective during treatment and for 72 hours after treatment has ended.
The use of other vaginal products such as tampons or douches (vaginal washes) during treatment with the
suppositories is not recommended.
Children
Clindax must not be used in children under 16 years of age.
Other medicines and Clindax
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

medicines used to relax muscles, as Clindax may increase the effect of these medicines.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breast-feeding,
please consult your doctor or pharmacist before using this medicine.
The use of Clindax during the first three months of pregnancy is not recommended, as there is insufficient
evidence regarding its safety.
If you are pregnant, Clindax should only be used after careful consultation with your doctor, who will
decide whether this treatment is suitable for you.
If you are breast-feeding, your doctor will decide whether Clindax is suitable for you, as the active substance
may pass into breast milk.
Although it is unlikely that a breastfed infant would ingest a significant amount of the active substance
through breast milk, if the baby develops diarrhoea with blood or shows any signs of illness, inform your
doctor immediately. If this occurs, you must stop breast-feeding.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or use machinery.

3. How to use Clindax

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Do not use the product if the strips containing the vaginal ovules are torn, opened, or not completely sealed.
Care should be taken to avoid overheating the ovule, as heat may soften and deform it.
The recommended dose of this medicine is one ovule to be inserted into the upper part of the vagina every evening, before going to bed, for three consecutive nights. After insertion, the ovule will dissolve and disappear.

Insertion:

Remove the ovule from its wrapper.
Lie on your back, drawing your knees up to your chest.
Insert the ovule into the vagina using the tip of the middle finger, as deeply as possible, without causing discomfort.

Always wash your hands before and after inserting the ovules.

If you use more Clindax than you should
Contact your doctor. Do not use any further ovules unless instructed to do so by your doctor.

If you forget to use Clindax
If you realize you have forgotten to use the ovule only a few hours late, use it immediately.
If it is almost time for the next ovule, skip the missed dose. Take the next ovule at your usual time.
Continue using the ovules at the scheduled time.
Do not use a double dose to make up for the forgotten dose.

If you swallow Clindax
If the ovule is swallowed, contact your doctor. It is unlikely that the ovules will cause harm, but your doctor will be able to advise you on what to do.

If you have any doubts about how to use this medicine, consult 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 develop severe, persistent diarrhoea, possibly with blood (which may be associated with stomach pain or fever). This is an uncommon side effect that may occur after treatment with antibiotics and could be a sign of serious intestinal inflammation or inflammation of the lining of the large intestine (pseudomembranous colitis).
you experience allergic reactions or very severe skin reactions. These side effects are very rare.

Common (may affect up to 1 in 10 people)

fungal infections, yeast infections
headache
stomach pain, diarrhoea, nausea (feeling unwell)
itching (at a site different from the application site)
vaginal candidiasis, vaginal discomfort, vaginal disorders.

Uncommon (may affect up to 1 in 100 people)

vomiting
skin rash
upper abdominal or back pain
fever or chills, feeling unwell (malaise)
painful urination, blood in the urine, cloudy or foul-smelling urine, increased frequency and urgency to urinate
vaginal infections, vaginal discharge, menstrual irregularities
pain (at the application site), itching, localized swelling.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clindax

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the strips after Exp.
The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clindax contains

The active substance is clindamycin phosphate. Each vaginal suppository contains clindamycin phosphate equivalent to 100 mg of clindamycin.
The other components are solid semisynthetic glycerides.

Description of the appearance of Clindax and pack contents
Clindax is a vaginal suppository of whitish to yellowish colour. It is available in white PVC-PE strips containing 3 suppositories, packaged in a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome, Italy

Manufacturer
Help S.A., Pedini Ioanninon, Ioannina 45500, Greece
QUALIMETRIX S.A., 579 Mesogeion Avenue Agia Paraskevi, Athens 15343, Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark: Clindamycin Terix
Poland: Clindavag
Sweden: Klindamycin Evolan
Germany: Clindamycin Aristo 100 mg Vaginalzäpfchen
Spain: Clindamicina Aristo 100 mg óvulo
Italy: Clindax
Romania: Ovyx 100mg ovule
Belgium: Yenlip 100mg (pessaries/ovules/vaginalzapfchen)
Luxembourg: Yenlip 100mg pessaries