Clindamycin Noridem

Package leaflet: Information for the user

Clindamicina Noridem 150 mg/mL injectable solution or solution for infusion

clindamycin
Generic medicine
Please read this leaflet carefully before you are given 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, pharmacist, nurse, or healthcare professional.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, nurse, or healthcare professional. See section 4.

Contents of this leaflet:

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

1. What Clindamicina Noridem is and what it is used for

Clindamicina Noridem contains the active substance clindamycin. Clindamycin is an
antibiotic. It is used to treat infections in adults, adolescents, and children older than 1 month of age.
Clindamicina Noridem is used for the treatment of serious infections, especially when other
antibiotics have failed to eliminate the infection and when the infection is caused by bacteria
susceptible to clindamycin.
Clindamicina Noridem is used to treat:

• Bone and joint infections
• Chronic infections of the paranasal sinuses
• Lower respiratory tract infections
• Abdominal infections (peritonitis)
• Infections of the female reproductive organs
• Skin and soft tissue infections
• Dental infections
• Treatment of bacteraemia occurring in association with, or suspected to be associated with, any of the above-listed infections, and
• Infections caused by Toxoplasma gondii and Pneumocystis jirovecii in adult patients with low immune defences

2. What you need to know before you are given Clindamicina Noridem

Clindamicina Noridem must not be administered to you if:

• you are allergic to clindamycin or lincomycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Clindamicina Noridem:

• if you have reduced kidney or liver function,
• if you have problems with muscle function, for example due to myasthenia gravis (pathological muscle weakness) or Parkinson’s disease (so-called shaking palsy),
• if you have diarrhoea or generally develop diarrhoea when taking antibiotics, or if you have ever suffered from gastrointestinal disorders (e.g. previous inflammation of the colon),
• if you suffer from any type of allergy, for example hypersensitivity to penicillin, because in isolated cases allergic reactions to clindamycin have been reported in people with known hypersensitivity to penicillin,
• if you suffer from asthma, eczema or hay fever.

You should consult your doctor if any of the above-mentioned warnings or precautions apply to you or have applied to you in the past.
Some patients treated with clindamycin have experienced severe hypersensitivity reactions, including severe skin reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP). If you develop signs of hypersensitivity or severe skin reactions during treatment with Clindamicina Noridem, consult your doctor immediately.
Severe allergic reactions may occur even after the first administration. In such a case, your doctor will immediately discontinue treatment with Clindamicina Noridem and implement standard emergency measures.
Rapid intravenous injection causes adverse effects and must be avoided. Your doctor will dilute the medicine before intravenous administration and ensure that it is administered over at least 10–60 minutes.
If you are given Clindamicina Noridem for a prolonged period (more than 10 days), your doctor will regularly monitor your blood count and kidney and liver function.
Acute kidney problems may occur. Inform your doctor about any medicines you are currently taking and if you have kidney problems. If you experience reduced urine output, fluid retention causing swelling in the legs, ankles or feet, shortness of breath or nausea, consult your doctor immediately.
Repeated and long-term use of Clindamicina Noridem may lead to skin and soft mucous membrane infections caused by pathogens not sensitive to clindamycin. It may also lead to the development of fungal infections.
During treatment with clindamycin, a severe colon infection (colitis) may occur. Therefore, you must inform your doctor immediately if you experience severe and persistent diarrhoea during treatment or up to two months afterwards, especially if mucus or blood is present in the stool.

Children and adolescents
This medicine must not be administered to children under 1 month of age, as its safety has not been established.

Other medicines and Clindamicina Noridem
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking:

• Warfarin or similar medicines used to thin the blood. You may bleed more easily. Your doctor may need to perform regular blood tests to monitor blood clotting.
• Erythromycin. Clindamicina Noridem must not be administered concomitantly with medicines containing erythromycin, as a mutual reduction in efficacy cannot be ruled out.
• Lincomycin. Clindamicina Noridem must not be administered after treatment with lincomycin due to cross-resistance.
• Muscle relaxants. Clindamicina Noridem may enhance the effect of muscle relaxants, potentially leading to unexpected and possibly fatal incidents during surgical procedures.
• Use of CYP3A4 inducers such as rifampicin (an antibiotic used to treat tuberculosis) may affect the efficacy of Clindamicina Noridem.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before this medicine is administered to you.
Consult your doctor if:

• you are pregnant or think you may be pregnant. Your doctor will decide how to use Clindamicina Noridem after weighing the risks and benefits of treatment with clindamycin;
• you are breastfeeding. This medicine passes into breast milk and therefore must not be used during breastfeeding.

Driving and using machines
You may feel dizzy, tired or suffer from headache when taking this medicine. In such cases, do not drive or operate tools or machinery.

Clindamicina Noridem contains sodium
This medicine contains 7.72 mg of sodium (a key component of table salt) per mL. This corresponds to 0.39% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Clindamicina Noridem is administered

Clindamicina Noridem is administered by intramuscular injection (into a muscle) of the undiluted solution or by intravenous infusion (into a vein) of the diluted solution. It is generally administered by a doctor or nurse.
The doctor will determine the correct dose of clindamycin therapy for you.
For adults and adolescents over 12 years of age, the following doses are administered:
for treatment of less severe infections:
1,200 to 1,300 mg of clindamycin per day,
for treatment of severe infections:
1,800 to 2,700 mg of clindamycin per day,
divided into two to four equal doses.
Normally, the maximum daily dose for adults and adolescents over 12 years of age is 2,700 mg of Clindamicina Noridem in two to four equal doses. In potentially life-threatening infections, doses up to 4,800 mg/day may be administered.

Hepatic and renal impairment
In patients with hepatic or renal disease, clindamycin metabolism is reduced. However, in most cases, dose adjustment is not required. Monitoring of clindamycin blood levels is recommended.
Clindamycin is not dialyzable (removal of waste products from the blood by artificial filtration, used to treat renal failure). Therefore, no additional dose is required before or after hemodialysis.

Use in children
Depending on the severity and site of infection, children aged over 4 weeks and under 12 years are administered 15 to 40 mg of clindamycin per kg of body weight, in three or four equal doses. Clindamycin should be dosed according to total body weight, regardless of obesity.
The duration of treatment depends on the disease and its progression.

If you have been given more Clindamicina Noridem than you should have received
This medicine will always be administered under strictly controlled conditions. Contact your doctor or nurse immediately if you think you have been given too much Clindamicina Noridem.

If a dose of Clindamicina Noridem has been missed
Clindamicina Noridem will be administered by a doctor or nurse. However, if you suspect that a dose has been missed, contact your doctor or nurse.

If you stop treatment with Clindamicina Noridem
Do not stop treatment with Clindamicina Noridem unless instructed by your doctor.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, nurse, or healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact your doctor immediately if you experience:

• signs of a severe allergic reaction such as sudden breathlessness, difficulty breathing, dizziness, swelling of the eyelids, face, lips, throat or tongue, rash or itching (especially if it affects the whole body);
• severe and persistent diarrhoea, or diarrhoea with blood (which may be associated with abdominal pain or fever). This effect may occur with some antibiotics and could be a sign of serious intestinal inflammation;
• signs of serious and potentially life-threatening skin reactions such as blistering and peeling of large areas of skin, fever, cough, feeling unwell, and swelling of gums, tongue or lips;
• yellowing of the skin and whites of the eyes (jaundice);
• fluid retention causing swelling of the legs, ankles or feet, shortness of breath or nausea;
• drop in blood pressure (drowsiness, dizziness, fainting) if the injection is administered too quickly, and, rarely, cardiac arrest;
• increased frequency of infections presenting as fever, severe chills, sore throat or mouth ulcers (infections may indicate a low white blood cell count).

Other possible side effects include:
Very common: may affect more than 1 in 10 people

• Diarrhoea, abdominal pain, vomiting, nausea

Common: may affect up to 1 in 10 people
Disorders of blood vessels such as thrombophlebitis (inflammation of the veins).
Skin disorders such as rash (widespread rash with small bumps), urticaria.
Liver function tests may be altered.
Uncommon: may affect up to 1 in 100 people
Nervous system disorders such as neuromuscular blockade (blockage of nerve impulse transmission to a muscle) and distortion of taste sensation (dysgeusia).
General disorders and administration site conditions such as pain and abscess at the injection site.
Rare: may affect up to 1 in 1,000 people
Itching
Vaginitis (inflammation of the vaginal mucosa)
Very rare: may affect up to 1 in 10,000 people
Inflammation of the joints (polyarthritis)
Not known: frequency cannot be estimated from the available data
Vaginal infection
Drowsiness
Dizziness
Headache
Jaundice
Irritation at the injection site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, nurse or other healthcare professional. You can also report side effects directly via the national reporting system at the following address
.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Clindamicina Noridem

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 vial label after Scad./EXP. The expiry date refers to the last day of that month.
Store below 25 °C.

Period of validity after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C and at 2-8 °C in solutions of sodium chloride 9 mg/mL (0.9%) and glucose 50 mg/mL (5%), with clindamycin concentrations of 6 and 18 mg/mL in polypropylene infusion bags.

From a microbiological standpoint, unless the dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the times and conditions of storage during use are the responsibility of the user.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Clindamicina Noridem Contains
The active substance is clindamycin.
Each mL of injectable or infusion solution contains 150 mg of clindamycin (as phosphate).
Each 2 mL vial contains 300 mg of clindamycin (as phosphate).
Each 4 mL vial contains 600 mg of clindamycin (as phosphate).
Each 6 mL vial contains 900 mg of clindamycin (as phosphate).
The other components are disodium edetate, sodium hydroxide 5 N (for pH adjustment), hydrochloric acid 5 N (for pH adjustment), and water for injections.

Description of the Appearance of Clindamicina Noridem and Contents of the Package
Clindamicina Noridem is a transparent, colourless to almost colourless injectable or infusion solution, free from visible particles, supplied in glass vials containing 2 mL, 4 mL, or 6 mL of solution.
Clindamicina Noridem is available in packages containing 1, 5, 10, or 25 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3, Office 115
1065 Nicosia, Cyprus

Manufacturer:
DEMO S.A. INDUSTRIA FARMACEUTICA
21st Km National Road Athens–Lamia,
14568 Krioneri, Attiki, Greece
T: +30 210 8161802

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Clindamycin Noridem 150 mg/ml Injektions-/Infusionslösung
Greece Clindamycin/DEMO
Sweden Clindamycin Noridem 150 mg/ml Injektions-/infusionsvätska, lösning
Norway Clindamycin Noridem
Finland Clindamycin Noridem 150 mg/ml Injektio-/infuusioneste, liuos
Czech Republic Clindamycin Noridem
Slovakia Clindamycin Noridem 150 mg/ml Injekčný/infúzny roztok
Hungary Klindamicin Noridem 150 mg/ml, Oldatos injekció/infúzió
Romania Clindamicină Noridem 150 mg/ml Soluţie injectabilă/perfuzabilă
Poland Clindamycin Noridem
Ireland Clindamycin 150 mg/ml Solution for injection/infusion
Austria Clindamycin Noridem 150 mg/ml Injektions-/Infusionslösung
Belgium Clindamycin Noridem 150 mg/ml solution injectable/pour perfusion / Injektions-/Infusionslösung / oplossing voor injectie / infusie
Cyprus Clindamycin Noridem 150 mg/ml διάλυμα για ένεση/έγχυση
Denmark Clindamycin Noridem
Spain Clindamycina Noridem 150 mg/ml solución inyectable y para perfusión EFG
France CLINDAMYCINE NORIDEM 150 mg/ml, solution injectable/pour perfusion
Italy Clindamicina Noridem
Netherlands Clindamycin Noridem 150 mg/ml oplossing voor injectie / infusie
Portugal Clindamicina Noridem 150 mg/ml solução injetável ou para perfusão

<------------------------------------------------------------------------------------------------------------------------>
The following information is intended exclusively for physicians or healthcare professionals:

Incompatibilities
The following active substances are physically incompatible with clindamycin: ampicillin, aminophylline, barbiturates, calcium gluconate, ceftriaxone sodium, ciprofloxacin, phenytoin, idarubicin hydrochloride, magnesium sulfate, sodium phenytoin, and ranitidine hydrochloride. Solutions of clindamycin salts have a low pH, and it is therefore reasonably expected that they are incompatible with alkaline preparations or with drugs unstable at low pH.

Dosage
Adults and adolescents over 12 years of age

• For the treatment of severe infections: 1,800 to 2,700 mg of clindamycin per day in two to four divided doses, in combination with an antibiotic active against Gram-negative aerobic bacteria.
• For the treatment of less severe infections: 1,200 to 1,800 mg of clindamycin administered in three or four equal doses.

Normally, the maximum daily dose for adults and adolescents over 12 years of age is 2,700 mg of clindamycin in two to four divided doses. Doses up to 4,800 mg/day have been administered in potentially life-threatening infections.

Paediatric population
Children (aged 1 month to 12 years):
Severe infections: 15–25 mg/kg/day in three or four divided doses.
More severe infections: 25–40 mg/kg/day in three or four divided doses. In severe infections, it is recommended to administer at least 300 mg/day to children regardless of body weight.
Clindamycin should be dosed based on total body weight regardless of obesity.
The maximum daily dose should not exceed that recommended for adults.

Elderly patients:
Half-life, volume of distribution, clearance, and absorption after administration of clindamycin phosphate are not altered by advanced age. Analysis of clinical study data has not revealed any age-related increase in toxicity. Therefore, dosage adjustments are not required in elderly patients with normal hepatic and normal renal function (based on age).

Patients with hepatic impairment:
In patients with moderate to severe liver disease, the elimination half-life of clindamycin is prolonged. Dose reduction is generally not necessary if clindamycin is administered every 8 hours. However, plasma concentrations of clindamycin should be monitored in patients with severe hepatic insufficiency. Depending on the results, this may necessitate a reduction in dose or an increase in dosing intervals.

Patients with renal impairment:
In the presence of renal disease, the elimination half-life is prolonged; however, dose reduction is not necessary in cases of mild to moderate renal impairment. Plasma concentrations of clindamycin should be monitored in patients with severe renal impairment or anuria. Depending on the results, this may necessitate a reduction in dose or an increase in dosing intervals to 8 or even 12 hours.

Dosing in haemodialysis:
Clindamycin cannot be removed by haemodialysis. Therefore, no additional dose is required before or after haemodialysis.

Duration of Treatment
In cases of confirmed or even suspected infections caused by β-haemolytic streptococci, treatment with clindamycin should be continued for at least 10 days to prevent the development of rheumatic fever or glomerulonephritis.

Method of Administration
Clindamicina Noridem is administered by intramuscular injection or intravenous infusion.
Clindamicina Noridem must be diluted prior to intravenous administration and infused over at least 10–60 minutes. The concentration must not exceed 18 mg of clindamycin per mL of solution.
For intramuscular administration, Clindamicina Noridem should be used undiluted.
For instructions on dilution of the medicinal product prior to administration, see section "Instructions for Handling".
Single intramuscular (i.m.) injections exceeding 600 mg are not recommended, nor is the administration of more than 1.2 g in a single one-hour infusion.
Alternatively, the medicinal product may be administered as a rapid single infusion of the first dose followed by continuous intravenous (i.v.) infusion.

Disposal
Unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

Overdose
Symptoms of overdose have not been observed. Haemodialysis and peritoneal dialysis are ineffective. No specific antidote is known. Clindamicina Noridem is administered by i.m. or i.v. route; therefore, gastric lavage is not useful.

Instructions for Handling
Clindamicina Noridem must be diluted prior to intravenous administration (not exceeding 18 mg of clindamycin per mL) and infused over at least 10–60 minutes (without exceeding 30 mg/min). It must never be injected as an intravenous bolus.

Clindamicina Noridem may be diluted with a sodium chloride solution 9 mg/mL (0.9%) or a glucose solution 50 mg/mL (5%).
After dilution:
Refer to section 5 of the package leaflet for storage conditions after dilution.
Intramuscular administration is indicated when intravenous infusion is not possible for any reason.
For single use only.
The medicinal product must be inspected visually before use and also after dilution.
Only clear solutions free from visible particles should be used.