Clindamycin Kalceks

Package leaflet: Information for the user

Clindamicina Kalceks 150 mg/mL solution for injection or 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 or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

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

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

This medicinal product contains the active substance clindamycin (as clindamycin phosphate), which is an
antibiotic. It is used to treat infections.
Clindamicina Kalceks is used to treat the following serious infections in adults and children from 1 month of age:

• osteoarticular infections
• chronic sinusitis caused by anaerobic microorganisms
• lower respiratory tract infections
• complicated abdominal infections
• pelvic and female genital tract infections
• complicated skin and soft tissue infections.

For patients allergic to beta-lactams, Clindamicina Kalceks may be used for prophylaxis in surgical procedures.

2. What you need to know before Clindamicina Kalceks is administered to you

Clindamicina Kalceks must not be administered to you if:

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

Warnings and precautions
Talk to your doctor or nurse before this medicine is administered to you if:

• you have impaired liver or kidney function;
• you have muscle function problems (e.g., you suffer from muscle weakness called "myasthenia gravis" or Parkinson's disease);
• you have previously had gastrointestinal disorders (e.g., inflammation of the colon);
• you suffer from any type of allergy, such as penicillin hypersensitivity, because in individual cases, allergic reactions to clindamycin have been reported in people with known penicillin hypersensitivity;
• you suffer from asthma, eczema, or hay fever. If you are certain you are affected by any of the conditions described above, consult your doctor.

Immediately inform your doctor or nurse if, during treatment, you experience:

• signs of a severe allergic reaction such as wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching sensation (see section 4). These may occur even after the first administration. In this case, your doctor will immediately stop treatment with clindamycin and initiate standard emergency measures;
• severe skin rash with irregular red patches or blisters filled with pus, peeling of large areas of skin, fever, cough, feeling unwell, and swelling of the gums, tongue or lips (see section 4);
• diarrhoea during or up to 3 weeks after treatment, especially if mucus or blood is present in the stool. This may be a sign of a serious colon infection (colitis). This is more likely to occur in debilitated and/or elderly patients (over 60 years of age).

Acute kidney problems may occur. Inform your doctor about any medicines you are taking and if you have kidney problems. If you urinate less, experience fluid retention causing swelling of the legs, ankles or feet, have shortness of breath or feel nauseous, contact your doctor immediately.

Prolonged and repeated use of clindamycin may lead to skin and mucous membrane infections caused by pathogens not sensitive to clindamycin. It may also result in the development of a fungal infection.

This medicine is not suitable for the treatment of cerebral fever (meningitis).

During long-term treatment, your doctor will regularly monitor your liver and kidney function.

To avoid unwanted effects, clindamycin will be administered as a slow intravenous infusion.

Children
The safety and dosage of clindamycin in neonates under one month of age have not been established.

Other medicines and Clindamicina Kalceks
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.

It is particularly important if you are taking any of the following medicines:

• muscle relaxants (used during surgery to help muscles relax). Concomitant use with clindamycin may lead to unexpected and life-threatening complications during surgery. Therefore, if you are admitted to hospital for surgery or a hospital procedure, inform your doctor that you are taking clindamycin.
• warfarin or similar medicines – used to thin the blood. Bleeding is more likely to occur. Your doctor may require regular blood tests to monitor your blood's clotting ability;
• erythromycin (an antibiotic);
• rifampicin (used to treat tuberculosis);
• cyclosporine/tacrolimus (used after organ transplants).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before this medicine is administered to you.

Your doctor will prescribe clindamycin during pregnancy only if absolutely necessary. This medicine may have a negative effect on the intestinal flora of a breastfed infant. Your doctor will carefully evaluate the benefits of breastfeeding for the infant and the expected benefits and risks of clindamycin treatment for the mother.

Driving and using machines
This medicine has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Clindamicina Kalceks contains sodium
This medicine contains 6.5 mg of sodium (a main component of table salt) per mL of solution. This corresponds to 0.33% of the maximum daily recommended dietary intake for an adult.

3. How Clindamicina Kalceks is administered

Your doctor will decide the correct dose of clindamycin to administer to you.
The medicine will be given to you by a doctor or nurse as an injection into a muscle or as a slow intravenous infusion (through an IV drip). The medicine will be diluted before intravenous infusion. The infusion will last from 10 to 60 minutes.

Adults

• For treatment of less severe infections: the usual dose is 1200–1800 mg per day, administered in 3 or 4 equal doses.
• For treatment of serious infections: the usual dose is 2400–2700 mg per day, administered in 2, 3, or 4 equal doses.

In life-threatening infections, the intravenous dose may be increased up to 4800 mg per day.
The dose for prophylaxis of postoperative infections will be determined by the doctor. It depends on the type and duration of the surgical procedure.
For intramuscular administration, the maximum recommended single dose is 600 mg.
For intravenous administration, the maximum recommended dose for a single one-hour infusion is 1200 mg.

Elderly

In elderly patients with normal hepatic and renal function, no dose adjustment is required.

Patients with hepatic and/or renal impairment

In general, dose adjustment is not necessary in cases of mild to moderate hepatic or renal impairment.
Your doctor will monitor renal function in patients with severe renal impairment.
In patients with severe hepatic impairment, your doctor will monitor liver function and, where possible, plasma levels of the medicine. If necessary, your doctor may adjust the dose or dosing intervals.

Use in children and adolescents

Children from 1 month to 12 years of age
20 to 40 mg per kg of body weight per day, administered in 3 or 4 equal doses.
The clindamycin dose in children must be based on total body weight, regardless of obesity. In serious infections, it is recommended to administer children at least 300 mg per day, regardless of body weight. The total daily dose must not exceed the maximum recommended daily dose for adults.

Adolescents over 12 years of age
Doses in adolescents over 12 years of age should be the same as in adults, taking into account any necessary dose adjustments based on hepatic function. In underweight adolescents between 12 and 18 years of age, it is recommended not to exceed the maximum dose of 40 mg per kg of body weight per day. The total daily dose must not exceed the maximum recommended daily dose for adults.

If you are given more Clindamicina Kalceks than you should

This medicine is always administered under closely monitored conditions. However, if you think you have been given too much medicine, inform your doctor or nurse immediately.

If you forget to take Clindamicina Kalceks

This medicine will be administered to you by a doctor or nurse. However, if you think you have missed a dose, inform your doctor or nurse.

If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious side effects
Tell your doctor or nurse immediately if you experience any of the following side effects, as you may need immediate medical attention:

Common (may affect up to 1 in 10 people)

• Stomach and intestinal problems Severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This may occur during or after treatment with antibiotics and could be a sign of serious intestinal inflammation (pseudomembranous colitis).

Uncommon (may affect up to 1 in 100 people)

• Heart and blood vessel problems Low blood pressure (feeling dizzy, lightheaded or fainting) or sudden chest pain or tightness, shortness of breath, dizziness, fainting, nausea or vomiting (signs of cardiac arrest). These may occur if the medicine is administered too quickly.

Frequency not known (frequency cannot be estimated from the available data)

• Allergic reactions Signs of a severe allergic reaction such as wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching (especially if affecting the whole body).
• Skin problems Signs of serious, potentially life-threatening skin reactions, such as severe rash with irregular red patches or pus-filled blisters, peeling of large areas of skin, fever, cough, feeling unwell, and swelling of the gums, tongue or lips.
• Liver problems Yellowing of the skin and whites of the eyes (jaundice).
• Kidney problems Fluid retention causing swelling of the legs, ankles or feet, shortness of breath or nausea.
• Changes in blood counts Increased susceptibility to infections, which may present as fever, severe chills, sore throat or mouth ulcers (this may indicate a low number of white blood cells in the body).

Other side effects
Common (may affect up to 1 in 10 people)

• Infection or inflammation of leg veins (thrombophlebitis)
• Increase in certain white blood cells (eosinophilia)
• Inflammation of the inner lining of the mouth
• Diarrhoea
• Raised red rash
• Hardening at the injection site (after intramuscular injection)
• Changes in liver function (detected in blood tests)

Uncommon (may affect up to 1 in 100 people)

• Low number of white blood cells in the body (granulocytopenia)
• Disturbance of taste sensation
• Muscle weakness
• Abdominal pain
• Inflammation of the oesophageal lining
• Nausea
• Vomiting
• Hives
• Inflammation and redness of the skin (erythema multiforme)
• Itching
• Pain at injection site
• Abscess at injection site (after intramuscular injection)

Rare (may affect up to 1 in 1,000 people)

• Swelling, especially of the face and throat, wheezing and/or difficulty breathing (angioedema)

Very rare (may affect up to 1 in 10,000 people)

• Indigestion

Frequency not known (frequency cannot be estimated from the available data)

• Intestinal infection of the large intestine (colon) caused by a bacterium
• Vaginal infection
• Unexplained bruising or prolonged bleeding or small red-purple spots on the skin (may indicate a low number of platelets in the blood)
• Allergic reactions
• Changes in sense of smell
• Flat or slightly raised pink-red rash
• Irritation at injection site

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clindamicina Kalceks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton after EXP/Exp.. The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not refrigerate or freeze.
Keep the vials in the outer packaging to protect the medicine from light.
Shelf life after opening of the vial: the product must be used immediately.
Shelf life after dilution
Chemical and physical in-use stability has been demonstrated for 48 hours at a temperature of 25°C and at 2-8 °C.
From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times in use and storage conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2-8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Clindamicina Kalceks contains:

• The active substance is clindamycin. Each mL of solution contains 150 mg of clindamycin (as clindamycin phosphate). Each 2 mL vial of solution contains 300 mg of clindamycin (as clindamycin phosphate). Each 4 mL vial of solution contains 600 mg of clindamycin (as clindamycin phosphate).
• The other components are disodium edetate, sodium hydroxide (for pH adjustment), water for injections.

Description of the appearance of Clindamicina Kalceks and contents of the package
Clear, colourless to almost colourless solution, practically free from visible particles.
2 mL or 4 mL of solution in colourless glass vials with a break point.
Each pack contains 1, 5 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark Clindamycin Kalceks
Austria, Germany Clindamycin Kalceks 150 mg/ml Injektions-/Infusionslösung
Croatia Klindamicin Kalceks 150 mg/ml otopina za injekciju/infuziju
Finland, Norway Clindamycin Kalceks
France CLINDAMYCINE KALCEKS 600 mg/4 mL, solution injectable/pour perfusion
Hungary Clindamycin Kalceks 150 mg/ml oldatos injekció vagy infúzió
Ireland Clindamycin 150 mg/ml solution for injection/infusion
Italy Clindamicina Kalceks
Latvia Clindamycin Kalceks 150 mg/ml šķīdums injekcijām/infūzijām
Netherlands Clindamycine Kalceks 150 mg/ml oplossing voor injectie/infusie
Slovenia Klindamicin Kalceks 150 mg/ml raztopina za injiciranje/infundiranje
Spain Clindamicina Kalceks 150 mg/ml solución inyectable y para perfusión EFG

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------\

For compatible diluents, see "Instructions for use, handling and disposal".
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in
the section "Instructions for use, handling and disposal".
The following medicinal products are physically incompatible with clindamycin phosphate: ampicillin, sodium phenytoin, barbiturates, aminophylline, calcium gluconate, magnesium sulfate, sodium ceftriaxone, ciprofloxacin, idarubicin hydrochloride and ranitidine hydrochloride.
Instructions for use, handling and disposal
For single use only. Discard unused solution.
The medicinal product should be inspected visually prior to use. Do not use if there are visible signs of deterioration (e.g. particulate matter). Use only clear solutions free from visible particles.
It may be diluted with:

• sodium chloride 9 mg/mL (0.9%) infusion solution
• glucose 50 mg/mL (5%) infusion solution.

Instructions for opening the vial

1. Position the vial with the coloured tip facing upwards. If solution is present in the upper part of the vial, gently tap with the finger to bring all the solution to the lower part of the vial.
2. Use both hands to open; hold the lower part of the vial with one hand and, with the other hand, break off the top part of the vial in the direction opposite to the coloured mark (see figures below).

Any unused medicinal product and waste material derived from this medicinal product should be disposed of in accordance with local regulations.