Contains clindamycin penicillin

Clindamycin AL 300

Patient information for Clindamycin AL 300

1. What is Clindamycin AL 300 and what is it used for?

1.1 What are the properties of the medicinal product?

Clindamycin AL 300 contains the active ingredient clindamycin, a drug from the group of so-called antibiotics and lincomycins.

Clindamycin is usually used in salt form as clindamycin hydrochloride or clindamycin-2-palmitate hydrochloride.

Clindamycin requires a prescription and should only be used on medical advice.

1.2 What strengths and dosage forms are there?

Oral clindamycin is commonly available

- as capsules or film-coated tablets containing 150 mg, 300 mg, 450 mg or 600 mg clindamycin,

- Juice / granules for the preparation of an oral solution containing 75 mg clindamycin in 5 ml (15 mg / ml), as clindamycin-2-palmitate hydrochloride.

Your doctor will determine which strength and dosage form are suitable for your treatment.

1.3 Clindamycin is used for

acute and chronic bacterial infections (diseases caused by contagion) caused by pathogens sensitive to clindamycin, such as

- infections of the bones and joints,

- ear, nose and throat infections,

- infections of the tooth and jaw area,

- upper or lower respiratory tract infections,

- infections of the pelvic and abdominal cavity,

- infections of the female genital organs,

- infections of the skin and soft tissues,

- Scarlet fever.

In the case of severe clinical pictures, treatment with clindamycin-containing drugs, which are slowly administered into a blood vessel (infusions), should be started.

2.1 Clindamycin AL 300 must not be taken

- if you are hypersensitive (allergic) to the active substance clindamycin, lincomycin (you are allergic to both substances at the same time) or one of the other ingredients of clindamycin AL 300.

2.2 Special care is required when taking Clindamycin AL 300

Talk to your doctor or pharmacist before taking Clindamycin AL 300, if

- you have impaired liver function,

- you have neuromuscular transmission disorders (e.g. myasthenia gravis: pathological muscle weakness; Parkinson's disease: so-called shaking paralysis),

- you have a history of gastrointestinal disorders (e.g. previous inflammation of the colon).

If you have severe, persistent diarrhea during or in the first few weeks after taking Clindamycin AL 300, inform your doctor immediately. It could be pseudomembranous enterocolitis, a serious bowel disease. This bowel disease can be life threatening and requires immediate adequate treatment. Do not take medicines for diarrhea that inhibit bowel movement.

- you are prone to hypersensitivity reactions,

- you have or have had allergies or asthma in the past.

Some patients treated with clindamycin have had severe hypersensitivity reactions, including severe skin reactions such as a drug rash with an increase in eosinophils (a type of blood cell) in the blood and symptoms that affect the whole body (DRESS syndrome), Stevens -Johnson's Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Pustular Rash (AGEP). If you should show signs of hypersensitivity or severe skin reactions during treatment with Clindamycin AL 300, please contact your doctor immediately.

Treatment with Clindamycin AL 300 is a possible treatment alternative for penicillin allergies (penicillin hypersensitivity). A cross allergy between clindamycin and penicillin is not known and, due to the structural differences between the substances, is not to be expected. In individual cases, however, there is information about anaphylaxis (hypersensitivity) to clindamycin in people with a pre-existing penicillin allergy. This should be taken into account when treating patients with penicillin allergy during clindamycin treatment. If severe, acute allergic reactions (e.g. anaphylactic shock) occur, treatment with Clindamycin AL 300 must be stopped immediately and the usual appropriate emergency measures (e.g. antihistamines, corticosteroids, sympathomimetics and, if necessary, ventilation) initiated.

In the case of long-term treatment (longer than 10 days), your doctor will check the blood count and the liver and kidney function at regular intervals. Long-term and repeated use of Clindamycin AL 300 can lead to infection of the skin and mucous membranes with pathogens against which Clindamycin AL 300 is ineffective, and to colonization with fungi.

Clindamycin AL 300 should not be used in acute respiratory infections caused by viruses. Clindamycin AL 300 is not suitable for the treatment of meningitis because the concentrations that can be achieved in the cerebrospinal fluid (cerebrospinal fluid) are too low.

Animal studies have shown no evidence of impaired fertility or childbearing ability. Studies in humans on the effects of clindamycin on fertility are not available.

Note on other ingredients: Oral medicines can contain different types of sugar. Therefore, please only take this after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

2.2.a) Children

Clindamycin is dosed in children depending on body weight (and on the location and severity of the infection).

Ask your pediatrician for advice before using any medicine.

2.2.b) Elderly patients

The side effects could be more severe in elderly or debilitated patients. A dose adjustment is usually not necessary.

2.2.c) Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

When taking it during pregnancy, the benefit and risk must be carefully weighed against each other. Observations on humans have so far not given any evidence of teratogenic effects.

2.2.d) Breastfeeding

When taking it during breastfeeding, the benefit and risk must be carefully weighed against each other. Clindamycin is excreted in breast milk. In the breastfed infant, sensitization (generation of hypersensitivity), diarrhea and fungus colonization of the mucous membranes cannot be ruled out.

2.2.e) Ability to drive and use machines

Clindamycin has minor or moderate influence on the ability to drive and use machines. Some side effects (e.g. dizziness, drowsiness) may affect your ability to concentrate and react and affect the ability to drive and use machines.

2.3 Which interactions with other medicinal products have to be considered?

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or may take / use any other medicines.

In some cases, medicines can affect the way some other medicines work.

This can be the case when Clindamycin AL 300 is used together with the following medicines:

- Erythromycin-containing antibiotics, since a mutual reduction in effectiveness cannot be ruled out.

- Lincomycin-containing antibiotics, as this can lead to cross-resistance of the pathogens to clindamycin, the active ingredient of clindamycin AL 300, and lincomycin.

- Medicines to relax muscles during anesthesia (e.g. ether, tubocurarine, pancuronium halide).

Because of its neuromuscular blocking properties, Clindamycin AL 300 may increase the effects of these drugs and unexpected life-threatening incidents may occur during an operation. For this reason, you should be used with caution when you receive Clindamycin AL 300 when receiving such medicines.

- Medicines to thin the blood (e.g. phenprocoumon, warfarin): the likelihood of bleeding may be increased. Regular blood tests may be needed to check blood clotting.

- The active ingredient of Clindamycin AL 300 (clindamycin) is metabolized in the human body with the help of enzymes after ingestion. Various inhibitors, which may also include medicinal products used at the same time, can influence the metabolism of Clindamycin AL 300 and weaken or intensify the effect.

If the drug rifampicin is administered at the same time, the active substance levels of clindamycin in the blood may be too low, as rifampicin increases the excretion of clindamycin. Your doctor should check the effectiveness of Clindamycin AL 300 by regularly checking your blood levels.

2.4 What should be thought of when taking Clindamycin AL 300 together with food, beverages and tobacco?

Clindamycin AL 300 can be taken with food and drink.

3. How to take Clindamycin AL 300

The following information applies unless your doctor has prescribed Clindamycin AL 300 otherwise. Please adhere to the instructions for use, otherwise the drug cannot work properly!

3.1 Type and duration of application

To protect the esophagus, please always take capsules or film-coated tablets with a full glass of water! This can be done regardless of meals.

The granulate is usually prepared by gradually filling it up with water up to the marking line and shaking the bottle; Shake the bottle well before each use; it can be taken independently of meals.

The duration of treatment depends on the underlying disease and the course of the disease. Your doctor will tell you how long your clindamycin treatment will last. Take the film-coated tablets for as long as your doctor has told you.

For infections caused by certain pathogens - beta-hemolytic streptococci - treatment should last at least 10 days.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Adults, elderly patients and adolescents over 14 years of age

Depending on the location and severity of the infection, 600 mg to 1800 mg clindamycin / day.

The daily intake is divided into 3 to 4 individual earnings. As a rule, preference is given to 4 individual income. Capsules or film-coated tablets of different strengths are available for this.

3.2.b) Children over 4 weeks to 14 years of age

Depending on the location and severity of the infection, 8 mg to 25 mg clindamycin per kilogram of body weight / day.

This corresponds, for example, to the following amounts of juice consumed (granules 75 mg / 5 ml):

10 kg body weight: 3 measuring spoons or 15 ml juice, equivalent to 225 mg clindamycin / day.

20 kg body weight: 4 to 6 measuring spoons or 20 to 30 ml of juice, corresponding to 300 to 450 mg clindamycin / day.

30 kg body weight: 4 to 10 measuring spoons or 20 to 50 ml of juice, corresponding to 300 to 750 mg clindamycin / day.

This daily intake is divided into 3 to 4 individual earnings. As a rule, 4 gifts are preferable.

Film-coated tablets or capsules with a higher active ingredient content are available for higher intake quantities as well as for adults and adolescents over 14 years of age.

3.2.c) Dosage in liver diseases

In patients with moderate to severe liver disease, the elimination half-life (measure of the metabolic function of the liver) of clindamycin is increased. A dose reduction is usually not necessary if Clindamycin AL 300 is given every 8 hours. However, the plasma level (blood concentration of clindamycin) should be monitored in patients with severe hepatic insufficiency (severely impaired liver function). Depending on the results of this measure, it may be necessary to reduce the dose or to extend the dosing interval.

3.2.d) Dosage in kidney disease

In kidney disease, the elimination half-life (measure of kidney function) of clindamycin is prolonged; however, a dose reduction is not necessary in the case of mild to moderately severe impairment of kidney function. However, plasma levels (blood concentrations of clindamycin) should be monitored in patients with severe renal insufficiency (severe renal impairment) or anuria (lack of urine excretion). Depending on the results of this measure, a dose reduction or, alternatively, a longer dosing interval of 8 or even 12 hours may be necessary.

3.2.e) Dosage for hemodialysis ("blood washing")

Clindamycin is not hemodialysable. No additional dose is therefore required before or after dialysis.

3.3 If you take more Clindamycin AL 300 than you should

Symptoms of overdose have not yet been observed. Gastric lavage is indicated if necessary. Hemodialysis (so-called blood washing) and peritoneal dialysis (lavage) are not effective. A specific antidote is not known.

3.4 If you forget to take Clindamycin AL 300

As a rule, forgetting to take a dose does not lead to any symptoms of illness. The application continues unchanged, i. H. a dose forgotten the day before will not be made up. Please note, however, that Clindamycin AL 300 can only work safely and adequately if it is taken regularly!

3.5 Effects when treatment with Clindamycin AL 300 is stopped

In the event of side effects, your doctor will discuss with you what countermeasures are available and whether other medicines can be used for the treatment.

Please do not stop taking the medicine without asking, as the success of the treatment can be endangered!

4. What are the possible side effects?

Like all medicines, Clindamycin AL 300 can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100 but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

The following side effects require immediate medical attention

- severe allergic reactions to the medicine including: (high) fever, joint pain, swelling of the throat, eyelids, face or lips,

- severe skin reactions such as: severe skin rash with peeling affecting the eyes, mouth, throat and genitals,

- severe diarrhea or blood in the diarrhea.

Other possible side effects are:

4.1.a) Very common

Esophageal irritation, inflammation of the esophagus, inflammation of the oral mucosa, diarrhea, abdominal pain, vomiting, nausea.

4.1.b) Often

Pseudomembranous colitis, agranulocytosis, neutropenia, thrombocytopenia, leukopenia, eosinophilia, blotchy rash with small, raised nodules (maculopapular rash), measles-like rash, hives, abnormal liver function test.

4.1.c) Occasionally

Taste disorders, neuromuscular blocking effect (blocking the transmission of nerve stimuli to the muscle).

4.1.d) Rarely

Drug fever, life-threatening skin disorder, e.g. Sometimes with blistering, death of the uppermost skin layers or extensive lifting of the skin (toxic epidermal necrolysis [TEN]), skin diseases (Stevens-Johnson syndrome (SJS), Lyell syndrome, Quincke / angioedema, exfoliative or bullous dermatitis , Erythema multiforme), itching, inflammation of the vagina.

4.1.e) Very rare

Allergic (anaphylactic) reaction, temporary inflammation of the liver with jaundice caused by biliary congestion, rash and blistering (hypersensitivity reactions), inflammation of the joints (polyarthritis).

4.1.f) Frequency not known (cannot be estimated from the available data)

Clostridium difficile colitis, vaginal infections, anaphylactic shock, anaphylactoid reaction, hypersensitivity, dizziness, drowsiness, headache, esophageal ulcer, jaundice, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), acute generalizing pustular exanthema (AGEP).

4.2 What countermeasures should be taken if side effects occur?

If you notice any of the serious side effects described above, call your nearest doctor for help. In the case of other undesirable effects, please talk to your treating doctor about further treatment.

Treatment of pseudomembranous enterocolitis: Here the doctor must consider discontinuing treatment with Clindamycin AL 300 depending on the indication and, if necessary, immediately initiate appropriate treatment (e.g. taking special antibiotics / chemotherapeutic agents whose effectiveness has been clinically proven). Medicines that inhibit bowel movement (peristalsis) must not be used.

Severe acute hypersensitivity reactions (e.g. anaphylactic shock): In this case, treatment with Clindamycin AL 300 must be stopped immediately and the usual appropriate emergency measures (e.g. antihistamines, corticosteroids, sympathomimetics and, if necessary, ventilation) initiated.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn (website: www.bfarm.de). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Clindamycin AL 300

Store Clindamycin AL 300 at normal room temperature and keep the medicine in the original packaging protected from light and moisture, unless the manufacturer specifies otherwise.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Granules 75 mg / 5 ml: The ready-to-use solution should usually be stored at 20 ° C to 25 ° C and can be used for 2 weeks. Shake well before each use. Do not store the prepared solution in the refrigerator!

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; March 2019 (5)