CLINDAX 100 mg Vaginal Suppository

Зміст інструкції

1. CLINDAX
   1. What is Clindax and what is it used for
   2. What you need to know before you use Clindax
   3. How to use Clindax
   4. Possible side effects
   5. How to store Clindax
   6. Contents of the pack and other information

CLINDAX

100 mg vaginal ovules
clindamycin
Generic medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
• 1. What Clindax is and what it is used for
• 2. What you need to know before you use Clindax
• 3. How to use Clindax
• 4. Possible side effects
• 5. How to store Clindax
• 6. Contents of the pack and other information

1. What is Clindax and what is it used for

The name of the medicine is Clindax 100 mg vaginal ovules. It is called Clindax in this leaflet.
Clindax is a semi-solid vaginal ovule, meaning a vaginal suppository. When inserted into the vagina,
it releases a medicine called clindamycin phosphate. This belongs to the category of
antibiotics.
Clindax is used in the treatment of a bacterial infection of the vagina called bacterial vaginosis.

2. What you need to know before you use 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 suffered from inflammation of the colon (colitis) while taking antibiotics.

Warnings and precautions
Tell your doctor or pharmacist before using Clindax

• if you suffer from diarrhoea or if you generally experience 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 with traces of blood during or after using Clindax,
tell your doctor immediately, as you may need to stop treatment.
This could be a sign of intestinal inflammation ( pseudomembranous colitis), which can
occur following treatment with antibiotics.
Consult your doctor to find out if you can use the medicine in the following cases:

• if you suffer from kidney, liver or immune system problems
• if you are under 16 years of age 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. Do not consider condoms or diaphragms to be effective for contraception during use of the medicine for the 72 hours following
treatment.
The use of other vaginal products such as tampons or douches (vaginal washes) during treatment with the
ovules is not recommended.

Children
Clindax should not be used in children under 16 years of age.

Other medicines and Clindax
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking:

• medicines to relax muscles as Clindax may increase the action of these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.
The use of Clindax in the first three months of pregnancy is not recommended, as there is insufficient evidence
of 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 breastfeeding, your doctor will decide whether Clindax is suitable for you as the active ingredient may
pass into breast milk.
Although it is unlikely that an infant could take a significant amount of the active ingredient
through the milk they drink, if the baby develops diarrhoea with traces of blood or shows any
sign of discomfort, tell your doctor immediately. If this happens, you should stop
breastfeeding.

Driving and using machines
It is unlikely that this medicine will impair the ability to drive and use machines.

3. How to use Clindax

Use this medicine following exactly the instructions of 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, open or not
completely sealed.
You must be careful that the ovule does not overheat, because heat can soften and deform it.
The recommended dose for this medicine is one ovule to be inserted into the upper part of the vagina every
evening, before going to bed, for three consecutive evenings. After insertion, the ovule will dissolve and
disappear.

Insertion:

• Remove the ovule from its packaging.
• Lie on your back, drawing your knees up to your chest.
• Insert the ovule into the vagina with the tip of your 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 other ovule until your doctor tells you to do so.

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

If you swallow Clindax
If the ovule is ingested or 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 further questions on 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.
Immediately inform your doctor if:

• you develop severe, persistent diarrhea, or diarrhea containing blood (which may be associated with stomach pain or fever). This is an uncommon side effect that can occur after treatment with antibiotics and may be a sign of serious intestinal inflammation or inflammation of the lining of the large intestine (pseudomembranous colitis).
• you experience allergic reactions or very serious skin reactions. These side effects are very rare.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help to 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 which is stated on the package and on the blisters after Exp.
The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clindax contains

• The active ingredient is clindamycin phosphate. Each vaginal ovule contains clindamycin phosphate equivalent to 100 mg of clindamycin.
• The other ingredients are solid semi-synthetic glycerides.

Description of the appearance of Clindax and contents of the pack
Clindax is a vaginal ovule ranging in color from whitish to yellowish. It is available in white PVC-PE strips
containing 3 ovules, packaged in a cardboard box.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Farmitalia S.r.l.
Viale Alcide De Gasperi 165/B
95127 Catania - Italy

Manufacturer
Help S.A., Pedini Ioanninon, Ioannina 45500, Greece
LAVIPHARM S.A., Agias Marinas str. PO 59, Paiania 19002, Attiki, 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 with the
following denominations:
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 ovules
Belgium: Yenlip 100mg (pessaries/ovules/vaginalzapfchen)
Luxembourg: Yenlip 100mg pessaries