Clindamycin 150mg/ml Solution for Injection or Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• 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

Talk to your doctor, pharmacist or nurse before you are given Clindamycin Injection :

• if you have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines (bowel disease). If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin Injection tell 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 even after 2 to 3 weeks following treatment with antibiotics.
• if you have any allergies such as hayfever, asthma or eczema;
• if you have problems with your kidneys. Acute kidney disorders may occur. Please inform your doctor about any medication you currently take and if you have any existing problems with your kidneys. If you experience decreased urine output, fluid retention causing swelling in your legs, ankles or feet, shortness of breath, or nausea you should contact your doctor immediately;
• if you have problems with your liver.

Clindamycin Injection does not get into the brain and is therefore not suitable for treating serious infections in and around the brain. Your doctor may need to give you another antibiotic if you have these infections.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can affect the way Clindamycin Injection works, or Clindamycin Injection itself can reduce the effectiveness of other medicines taken at the same time. These include:

• erythromycin an antibiotic used to treat infection: Clindamycin Injection and erythromycin may not work as well when they are used together.
• oral contraceptive pill: the pill may not work and may not prevent pregnancy. Use additional contraception, such as a condom, while receiving Clindamycin Injection and for 7 days after your last dose of Clindamycin Injection.
• warfarin or other similar medicines used to thin the blood: you may bleed more than usual when taking these medicines together with Clindamycin Injection. Your doctor may need to perform regular blood tests to check how well your blood clots.
• CYP3A4 or CYP3A5 inducers like Rifampicin may impact effectiveness of the medicine.

If you are in hospital to have an operation or a hospital procedure tell your doctor you are taking Clindamycin Injection. Clindamycin Injection may increase the effect of certain medicines (such as those given to help your muscles relax).

Tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy

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

Breast-feeding

Tell your doctor if you will be breast-feeding while taking Clindamycin Injection as clindamycin may be passed into breast milk. Your doctor will decide if Clindamycin Injection is appropriate for you. 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.

No effects on the ability to drive or use machines have been seen with Clindamycin Injection.

This medicine contains less than 1 mmol sodium (23 mg) per 2 ml ampoule, (prior to dilution) that is to say essentially ‘sodium-free’.

This medicine contains 26 mg sodium (main component of cooking/table salt) in each 4 ml ampoule (prior to dilution). This is equivalent to 1.3% of the recommended maximum daily dietary intake of sodium for an adult.

• The usual dose is 600-1200mg clindamycin per day. This will be given in 2, 3 or 4 equal doses over a 24-hour period.
• If you have a very severe infection your doctor may increase your dose to a maximum of 2700mg per day. This will be given in 2, 3 or 4 equal doses over a 24-hour period.

Doses up to 4800mg per day have been given in life-threatening cases.

The dose for children is based on your child’s body weight.

• The doctor will decide how much to give your child.
• The usual dose is 15 to 25mg per kg of body weight. This will be given in 3 or 4 equal doses over a 24-hour period.
• If your child has a very severe infection your doctor may increase the dose to at least 300mg. The dose is not related to the weight of your child. This will be given in 3 or 4 equal doses over a 24-hour period.

Normally Clindamycin Injection is only given to patients in hospital. The medical staff will be keeping a close eye on you during your treatment. If you need to have more than one course of treatment with clindamycin, your doctor may want to check that the clindamycin is not having any effect on the way your kidneys and liver are working.

Long term use can also make you more likely to get other infections that do not respond to Clindamycin Injection treatment

If you think you have been given too much Clindamycin Injection tell a doctor or a nurse.

Clindamycin Injection will be given to you by a doctor or nurse. If you think you have missed a dose tell your doctor or nurse.

Common: may affect up to 1 in 10 people

• blood clot (vein inflammation)
• abnormalities in liver function tests
• rash characterised by a flat, red area on the skin that is covered with small bumps

Uncommon: may affect up to 1 in 100 people

• change of sense of taste
• low blood pressure (feeling lightheaded, dizzy or faint)
• feeling sick, diarrhoea
• itchy skin
• hives
• pain, abscess (boil)

Not known: frequency cannot be estimated from available data

• reduced numbers of blood cells which may cause bruising or bleeding or weaken the immune system
• an increase in the number of white blood cells (eosinophilia)
• stomach pain, being sick (throwing up)
• inflammation of the lining of the oesophagus (gullet) open sores or lesions in the lining of the oesophagus (gullet)
• infection inside and around the vagina
• irritation at the site of the injection

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.

• The active substance is clindamycin phosphate. Each ml contains 150mg clindamycin.
• The other ingredients are disodium edetate, sodium hydroxide and water for injections.

Clindamycin Injection is a clear solution in a glass ampoule containing 2ml or 4ml of the solution for injection. This product is available in cartons containing 1 x 2ml, 1 x 4ml, 5 x 2ml or 5 x 4 ml ampoules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

For information in large print, audio CD or Braille please telephone + 44 (0)208 588 9131 or email [email protected].