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Clindamycin 100mg Pessaries

Active Ingredient:
clindamycin phosphate
Company:  
Aerona Clinical Limited See contact details
ATC code: 
G01AA10
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About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 21 Mar 2023

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 46918/0005.

Clindamycin 100mg pessaries

Package leaflet: Information for the user

Clindamycin 100 mg Pessaries

clindamycin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Clindamycin 100 mg Pessaries are and what they are used for
2. What you need to know before you use Clindamycin 100 mg Pessaries
3. How to use Clindamycin 100 mg Pessaries
4. Possible side effects
5. How to store Clindamycin 100 mg Pessaries
6. Contents of the pack and other information

1. What Clindamycin 100 mg Pessaries are and what they are used for

Clindamycin 100 mg Pessaries are semi-solid pessaries, that is a vaginal suppository. When inserted into the vagina it releases a medicine called clindamycin phosphate. This belongs to a group of medicines called ‘antibiotics’.

Clindamycin 100 mg Pessaries are used in the treatment of a bacterial infection of the vagina called bacterial vaginosis.

2. What you need to know before you use Clindamycin 100 mg Pessaries
Do not use Clindamycin 100 mg Pessaries:
  • If you are allergic to clindamycin, 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) when taking antibiotics.

Warnings and precautions

Talk to your doctor or pharmacist before using Clindamycin 100 mg Pessaries

  • if you have diarrhoea or usually get diarrhoea when you take antibiotics
  • if you have a history of inflammatory bowel disease such as Crohn’s Disease or Ulcerative Colitis

If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin 100 mg Pessaries consult your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.

Please discuss with your doctor if you can use this medicine if the following apply:

  • if you suffer from problems with your kidney, liver or immune system
  • if you are under 16 years old or over 65 years old.

As with all vaginal infections, sexual intercourse during treatment with Clindamycin 100 mg Pessaries is not recommended. Clindamycin 100 mg Pessaries may weaken condoms and diaphragms. Do not rely on condoms or contraceptive diaphragms when using this medicine for 72 hours following treatment.

The use of other vaginal products such as tampons or douches (vaginal washes) during treatment with the pessaries is not recommended.

Children

Clindamycin 100 mg Pessaries are not to be used in children under 16 years old.

Other medicines and Clindamycin 100 mg Pessaries

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

  • Medicines to relax your muscles as Clindamycin 100 mg Pessaries may increase the action of such medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Clindamycin 100 mg Pessaries in the first three months of pregnancy is not recommended as there is insufficient evidence of safety.

If you are pregnant Clindamycin 100 mg Pessaries should only be used after careful discussion with your doctor who will decide if this treatment is appropriate for you.

If you are breast-feeding your doctor will decide if Clindamycin 100 mg Pessaries are appropriate for you as the active substance may be passed into human milk.

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

This medicine is not likely to affect you being able to drive and use machines.

3. How to use Clindamycin 100 mg Pessaries

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Do not use this product if the strips containing the pessaries are torn, opened, or incompletely sealed.

Care should be taken to ensure that the pessary is not heated, since heat may soften and deform it.

The recommended dose of this medicine is one pessary placed high into the vagina each night at bedtime, for three consecutive nights. After insertion the pessary will melt and disappear.

Insertion:
  • Remove the pessary from the strip.
  • Lie on your back with your knees drawn up to your chest.
  • Insert the pessary into the vagina with the tip of your third (middle) finger as far as possible without causing discomfort.

Always wash your hands before and after inserting the pessaries.

If you use more Clindamycin 100 mg Pessaries than you should

Tell your doctor. Do not use any more pessaries until your doctor tells you to.

If you forget to use Clindamycin 100 mg Pessaries

If the forgotten pessary is just a few hours late, use it straight away.

If it is nearly time for your next pessary, miss out the forgotten one. Take your next pessary at the normal time.

Carry on using your pessaries at the usual times.

Do not take a double dose to make up for a forgotten dose.

If you stop using Clindamycin 100 mg Pessaries

Sometimes you may feel better after one or two days treatment. Even if you do feel better, do not stop using the pessaries until you have completed the full course of treatment.

If you swallow Clindamycin 100 mg Pessaries

If a pessary is eaten or swallowed contact your doctor. The pessaries are not likely to cause any harm, but your doctor will be able to give you advice 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.

Tell your doctor immediately if you:

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

Common: (may affect up to 1 in 10 people)

  • fungal infections, yeast infection
  • headache
  • stomach pain, diarrhoea, nausea (feeling sick)
  • itching (non-application site)
  • vaginal thrush, vaginal discomfort, vaginal disorder

Uncommon: (may affect up to 1 in 100 people)

  • vomiting
  • rash
  • upper stomach or back pain
  • fever or chills, feeling sick (malaise)
  • painful urination, blood in the urine, cloudy or foul-smelling urine, increased frequency or urgency of urination
  • vaginal infection, vaginal discharge, irregular periods
  • pain (application site), itching, localized swelling

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: 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.

5. How to store Clindamycin 100 mg Pessaries

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 carton and strips after EXP. The expiry date refers to the last day of that month.

Store below 30°C.

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 protect the environment.

6. Contents of the pack and other information
What Clindamycin 100 mg Pessaries contains
  • The active substance is clindamycin phosphate. Each pessary contains 119 mg of clindamycin phosphate equivalent to 100 mg of clindamycin.
  • The other ingredient is hard fat.

What Clindamycin 100 mg Pessaries look like and contents of the pack

Clindamycin 100 mg Pessaries are off-white to yellowish in colour. They are supplied in white PVC- PE strips of 3 pessaries packed in a carton box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Aerona Clinical Limited
Lafone house
The Leather Market
11-13 Weston Street
Bermondsey
London
SE1 3HN
United Kingdom

Manufacturers

Help S.A.
Pedini Ioanninon
Ioannina 45500
Greece

Lavipharm S.A.
Agias Marinas str. Paiania
Attiki
PO 59
19002
Greece

Qualimetrix S.A.
579 Mesogeion Avenue
Agia Paraskevi
Athens
15343
Greece

This leaflet was last revised in July 2022.

To request a copy of this leaflet in Braille, large print or audio please call 0800 198 5000 (UK only).

Please be ready to give the following information:

Product name: Clindamycin 100 mg Pessaries

Reference number: PLGB 46918/0005

Aerona Clinical Limited
Company image
Address
6 Babbage Way, Exeter Science Park, Clyst Honiton, Exeter, EX5 2FN, UK
Telephone
+44 (0)20 8798 0623
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)20 87980623