Document: leaflet MAH GENERIC_PL 24780-0002 change

• leaflet MAH GENERIC_PL 20046-0072
• leaflet MAH GENERIC_PL 24780-0002

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clindamycin 150mg/ml, Solution for Injection

Clindamycin phosphate

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or your pharmacist.

•    This medicine has been prescribed for you. Do NOT pass it on to others. It may harm them even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.

The name of your medicine is "Clindamycin 150mg/ml, solution for injection" (referred to as Clindamycin Injection throughout this leaflet).

Your medicine contains the active substance Clindamycin phosphate, which is one of a group of medicines called antibiotics. These are used to kill the bacteria or 'germs' that cause infections. Your doctor has decided to give you Clindamycin Injection because you have an infection.

Clindamycin is usually reserved for the treatment of serious infections, especially when other antibiotics have been unable to clear the infection and when the infection is caused by bacteria that are sensitive to Clindamycin.

Do not take Clindamycin Injection:

•    If you are allergic (hypersensitive) to Clindamycin or Lincomycin

•    If you are allergic to any of the other ingredients of Clindamycin injection (see section 6 "Further Information”)

If you are unsure, talk to your doctor.

Clindamycin should not be used in new born babies.

Before treatment with Clindamycin injection you should tell your doctor:

•    If you develop diarrhoea as this may be a sign of colitis (inflammation of the colon, which is the lower part of your bowel).

•    If you have liver or kidney problems. Your doctor may give you a lower dose.

If you are taking this medicine for a long time, you will have regular tests to check that your liver and kidneys are working properly. Your doctor will also perform these tests if this medicine is given to an infant less than 2 years old.

Taking other medicines:

Please tell your doctor if you are taking any of the following medicines as they may interact with Clindamycin and lead to side effects:

•    "Neuromuscular blocking agents” (these are "muscle relaxants” used mainly during an operation)

•    Erythromycin (an antibiotic used to treat infections).

•    Oral contraceptives. If you are taking oral contraceptives, you should also use barrier protection methods (such as a condom) for at least 7 days after stopping treatment with clindamycin.

•    Warfarin or similar medicines, used to thin blood. You may be more likely to have a bleed. Your doctor may need to take regular blood tests to check how well your blood can clot.

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

Pregnancy and breast-feeding:

If you are pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before you are given this medicine.

Driving and using machines

You may feel dizzy after being given this medicine. If you are affected, do not drive or use any tools or machines.

Important information about some of the ingredients in Clindamycin injection:

This medicine contains less than 1 mmol (23mg) sodium per ampoule i.e. essentially "sodium free” 3x-

INFORMATION FOR THE HEALTHCARE PROFESSIONAL The following information is intended for medical or healthcare professionals only.

Instructions for use and handling:

Do not use Clindamycin injection if you notice any particulate matter in the solution or if there is strong colouration of the solution.

Clindamycin Injection has been shown to be physically and chemically compatible for at least 24 hours in 5% dextrose and sodium chloride injection solutions. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally be no longer than 24 hours at 2-8°C unless dilution has taken place in controlled and validated aseptic conditions.

Clindamycin injection must be diluted prior to intravenous administration and should be infused over at least 10 - 60 minutes.

The minimum time over which infusion should take place depends upon the amount of injection being administered. See following table.

The concentration of clindamycin in diluent for infusion should not exceed 18 mg per mL and infusion rates should not exceed 30mg per minute. The usual infusion rates are as follows:

Dose	Diluent	Time
300 mg	50 mL	10 min
600 mg	50 mL	20 min
900 mg	50-100 mL	30 min
1200 mg	100 mL	40 min

The product should not be admixed with other drug products which are chemically or physically unstable at low pH (see section 6.2 of the Summary of Product Characteristics). The compatibility and duration of stability of drug admixtures will vary depending upon concentration and other conditions.

Storing Clindamycin Injection:

Do not store above 25°C. Do not refrigerate or freeze.

FRONT

Clindamycin Injection will usually be given by a doctor or nurse, either directly into a muscle or by an intravenous infusion ('drip').

The correct dose will be decided by your doctor and depends on the type of infection and your weight and age.

Adults:

The usual adult dose is 600mg to 1.2g per day given in two, three or four equal doses either directly into a muscle or by infusion into a vein. Larger doses are sometimes needed for more severe infections.

Children:

For infants and children, the dose is usually based on how much they weigh and is usually between 15mg to 25mg per kilogram weight of the child per day, divided into three or four separate doses. Larger doses are sometimes needed for more severe infections.

Your doctor will decide how long you need to be treated with this medicine. You may need to be treated for at least 10 days.

Like all medicines, Clindamycin Injection can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden swelling of the hands, feet, ankles, or swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing, should be reported to a doctor immediately.

Common side effects (probably affecting fewer than 1 in 10 people)

•    nausea (feeling sick), vomiting (being sick), stomach ache and diarrhoea

•    abnormal results in blood tests of liver function

Uncommon side effects (probably affecting fewer than 1 in 100 people)

•    pain, inflammation, itching or swelling at the site of injection

•    reduction in the number of white blood cells which makes infections more likely

•    reduction in blood platelets which increases risk of bleeding or bruising

Rare side effects (probably affecting fewer than 1 in 1,000 people)

•    inflammation of the vagina

•    scaling, itching, and redness of the skin (dermatitis)

•    itching (pruritus) and rash

Very rare side effects (probably affecting fewer than 1 in 10,000 people)

•    yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)

•    serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)

•    red patches on the skin, often on the back of the hands and arms (Eythema multiforme)

If the injection is given too quickly, this may lead to low blood pressure and in rare cases to cardiac arrest (heart stops working).

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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the reach and sight of children. Do not use Clindamycin Injection after the expiry date which is printed on the label and carton. Do not store above 25°C. Do not refrigerate or freeze. Your doctor, pharmacist or nurse will know how to store Clindamycin Injection properly.

What Clindamycin lnjection contains

•    The active substance is Clindamycin 150mg/ml as Clindamycin phosphate

•    The other ingredients are disodium edetate, sodium hydroxide and water for injections.

What Clindamycin lnjection looks like and contents of the pack:

Clindamycin lnjection is a clear, colourless solution in an ampoule.

Each 2ml ampoule contains 300mg Clindamycin as Clindamycin phosphate. Each 4ml ampoule contains 600mg Clindamycin as Clindamycin phosphate. Each carton contains 1,5, 10, 20 or 50 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Villerton lnvest S.A., 40 Avenue Monterey, L-2163 Luxembourg Manufacturer:

Lisapharma S.p.A., Via Licinio 11,22036 Erba - Como, Italy This leaflet was last revised in June 2014.

Dosage instructions

Adults:

Serious infections: 600 mg - 1.2 g/day in two, three or four equal doses.

More severe infections: 1.2 - 2.7 g/day in two, three or four equal doses.

Single i.m. injections of greater than 600 mg are not recommended nor is administration of more than 1.2 g in a single one hour infusion.

For more serious infections, these doses may have to be increased. In life-threatening situations, doses as high as 4.8 g daily have been given intravenously to adults. Alternatively, the drug may be administered in the form of a single rapid infusion of the first dose followed by continuous IV. infusion.

Renal and/or hepatic insufficiency

The dosage may require reduction in patients with renal and/or hepatic insufficiency due to prolongation of the serum half life.

Children (over 1 month of age):

Serious infections: 15 - 25 mg/kg/day in three or four equal doses.

More severe infections: 25 - 40 mg/kg/day in three or four equal doses. In severe infections it is recommended that children be given no less than 300 mg/day regardless of body weight.

Elderly patients: The half-life, volume of distribution and clearance, and extent of absorption after administration of clindamycin phosphate are not altered by increased age. Analysis of data from clinical studies has not revealed any age-related increase in toxicity. Dosage requirements in elderly patients should not be influenced, therefore, by age alone.

Treatment for infections caused by beta-haemolytic streptococci should be continued for at least 10 days to guard against subsequent rheumatic fever or glomerulonephritis.

02LE01336/02

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