TARLIDOCIN 1.200.000 U.I./25 mg Порошок и раствор для инъекционной суспензии

Содержание инструкции

1. Tarlidocin
   1. What is Tarlidocin and what is it used for
   2. Cosa deve sapere prima di usare Tarlidocin
   3. How to use Tarlidocin
   4. Possible side effects
   5. How to store Tarlidocin
   6. Content of the pack and other information

Tarlidocin

1.2 million IU/25 mg
Powder and solution for injectable suspension
benzylpenicillin benzathine/lidocaine hydrochloride monohydrate

Read this leaflet carefully before using this medicine as 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Tarlidocin and what is it used for

Tarlidocin contains 1 vial of powder with the active ingredient benzathine benzylpenicillin and
1 vial of solution with the active ingredient lidocaine hydrochloride monohydrate.
Tarlidocin is an antibiotic administered to adults and children. It contains a depot penicillin,
administered by injection into a muscle for the treatment of bacterial infections.
Tarlidocin is used for the treatment of:

• erysipelas (skin infection, only as follow-up treatment after initial intravenous antibiotic therapy, after improvement of local signs and symptoms and permanent disappearance of fever)
• syphilis
• infectious tropical diseases of the skin, caused by bacteria of the genus Treponema, yaws or pinta

Tarlidocin is also used for the prevention of the following diseases:

• rheumatic fever
• post-streptococcal glomerulonephritis (a specific form of kidney inflammation)
• erysipelas (skin infection)

This medicine contains a local anesthetic agent (lidocaine hydrochloride monohydrate,
of the injection.

2. Cosa deve sapere prima di usare Tarlidocin

Non usi Tarlidocin

• se è allergico alla benzilpenicillina benzatinica o lidocaina, ad altre penicilline, ad alcuni agenti insensibilizzanti locali (anestetici locali di tipo amide acida), a soia, arachidi o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6)
• se è stato precedentemente trattato con altri prodotti a base di penicillina e ha sviluppato reazione da ipersensibilità (per esempio, eruzioni cutanee, sensazione di prurito, febbre, respiro affannoso, riduzione della pressione arteriosa) a quei medicinali, poiché vi è un rischio di shock anafilattico potenzialmente letale
• se sa di essere ipersensibile ad altri antibiotici beta-lattamici (per esempio cefalosporine, carbapenemi), con l'eccezione dei monobattami (aztreonam), poiché vi è una possibilità di allergia crociata
• se è affetto da un blocco cardiaco completo (un ritmo cardiaco anomalo che insorge quando vengono bloccati gli impulsi elettrici che controllano il battito cardiaco)
• per il trattamento di neonati con sifilide congenita (acquisita prima della nascita)

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima che le venga somministrato Tarlidocin

• se ha avuto in passato reazioni allergiche ad altri antibiotici come la penicillina o altri antibiotici beta-lattamici
• se ha problemi ai reni (è possibile che il medico debba adattare la dose del medicinale)
• se ha problemi al fegato

Tarlidocin non deve essere usato in tessuti con scarso flusso di sangue.
Se si manifestano sintomi allergici (per esempio, eruzione cutanea, sensazione di prurito, respiro
affannoso), si rivolga immediatamente al medico. Se manifesta una reazione allergica, il medico
interromperà il suo trattamento e, se necessario, inizierà una terapia appropriata.
Poiché si deve prendere in considerazione la possibilità di una allergia crociata in pazienti con
ipersensibilità alle cefalosporine e ai carbapenemi, informi il medico se ha già avuto una precedente
reazione allergica ad alcuni antibiotici (cefalosporine, carbapenemi).
Deve informare il medico se le è già stata diagnosticata un'allergia e/o asma allergica o febbre da
fieno. Gravi reazioni allergiche immediate possono manifestarsi anche quando il farmaco è
somministrato per la prima volta. In base ai principi generali, in particolare in alcuni casi, dovrà restare
in osservazione per almeno un'ora dopo la somministrazione del medicinale, in caso dovesse
manifestarsi una reazione allergica acuta. Se dovesse insorgere un'allergia, il medico adotterà le
misure appropriate. Il trattamento con Tarlidocin deve essere interrotto immediatamente.
Durante il trattamento della sifilide, può manifestarsi una reazione corporea alle tossine batteriche, che
perdura per molti giorni (reazione di Jarisch-Herxheimer, vedere paragrafo 4). I sintomi tipici sono
febbre improvvisa (a volte con brividi), pallore seguito da arrossamento cutaneo, mal di testa, muscoli
e articolazioni doloranti o stanchezza. Per sopprimere o alleviare una reazione di Jarisch-Herxheimer,
il medico avvierà la terapia appropriata.
Se accusa diarrea acquosa grave durante o dopo il trattamento che può essere accompagnata da febbre
o dolore addominale, si rivolga immediatamente al medico, poiché potrebbe essere causata da una
grave malattia intestinale (enterocolite pseudomembranosa).
L'uso a lungo termine e ripetuto può portare alla proliferazione eccessiva di batteri e lieviti non
sensibili.
In caso di trattamento a lungo termine, il medico può disporre l'esecuzione di controlli della conta
ematica e della funzionalità renale. Deve fare in modo di presentarsi sempre ai controlli prescritti dal
medico.
Reazioni allergiche possono manifestarsi in pazienti con dermatomicosi (infezione della cute
provocata da funghi) dopo la prima somministrazione di Tarlidocin, a causa dell'antigenicità condivisa
tra penicillina e dermatofiti (funghi che causano le infezioni della cute).
Se è impossibile escludere un coinvolgimento neurologico in pazienti con sifilide congenita, si devono
usare forme di penicillina in grado di raggiungere un livello più elevato nel liquido cerebrospinale.
Si deve prendere in considerazione una ridotta eliminazione di povidone (uno degli eccipienti di
questo farmaco) in caso di compromissione della funzionalità renale. È impossibile escludere che, in
casi molto rari, possano verificarsi un accumulo di povidone o un deposito locale e la comparsa di
granulomi, che potrebbero essere confusi con tumori.
Deve essere preso in considerazione anche un effetto sugli esami diagnostici di laboratorio (vedere
anche paragrafo 4).
Poiché il medicinale contiene lidocaina, Tarlidocin deve essere usato con particolare cautela in
pazienti con:

• malattia renale e/o epatica
• miastenia gravis (malattia che può comportare debolezza muscolare)
• una soglia abbassata del sistema nervoso centrale per le crisi convulsive (per esempio epilessia)
• disturbi cardiaci, compresi i disturbi della conduzione cardiaca
• battito cardiaco lento
• depressione respiratoria (difficoltà nella respirazione e respiro superficiale e lento)
• cattivo stato di salute generale o pazienti anziani

Reazioni emboliche tossiche, probabilmente dovute a occlusione vascolare da parte di grossi cristalli
dei sali di penicillina, possono essere esacerbate dalla lidocaina contenuta in questo medicinale
(sindrome di Hoigné e di Nicolau).
Il trattamento con Tarlidocin deve essere evitato in pazienti con un disturbo della biosintesi del
pigmento rosso che impartisce il suo colore al sangue (porfiria) a causa della lidocaina contenuta in
questo medicinale.
Tarlidocin deve essere usato con particolare cautela in pazienti con disturbi di sanguinamento o trattati
per tali disturbi o trattati con farmaci antinfiammatori non steroidei o sostituti plasmatici, poiché la
lesione accidentale di vasi sanguigni può essere causa di grave sanguinamento.

Altri medicinali e Tarlidocin
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere
qualsiasi altro medicinale. La benzilpenicillina benzatinica può influire o essere influenzata da altri
medicinali.
Cautela è richiesta nella somministrazione contemporanea di Tarlidocin con i seguenti medicinali:
probenecid e sulfinpirazone, medicinali usati nel trattamento della gotta
salicilati, medicinali usati per ridurre il dolore o prevenire coaguli di sangue
indometacina e fenilbutazone, medicinali usati per ridurre il dolore
metotrexato, un medicinale usato in chemioterapia. La combinazione con metotrexato non è
raccomandata
anticoagulanti, medicinali usanti per fluidificare il sangue
La lidocaina può influire o essere influenzata da altri medicinali. In particolare, informi il medico se
assume uno qualsiasi dei seguenti medicinali:
medicinali usati per trattare malattie cardiache, compreso battito cardiaco irregolare, come beta
bloccanti o bloccanti dei canali del calcio
medicinali che restringono i vasi sanguigni (vasocostrittori, per esempio epinefrina o
norepinefrina)
altri anestetici, compresi anestetici locali
sonniferi e medicinali che riducono il livello di coscienza (sedativi)
medicinali usati per rilassare i muscoli (miorilassanti non depolarizzanti)
medicinali che aumentano il rischio di crisi e di crisi convulsive (per esempio tramadolo,
bupropione)
medicinali che riducono il rischio di crisi e di crisi convulsive (per esempio diazepam)

Gravidanza e allattamento
Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando con
latte materno chieda consiglio al medico o al farmacista prima di prendere questo medicinale.
Gravidanza
I dati relativi all’uso di benzilpenicillina benzatinica e lidocaina, i componenti farmacologicamente
attivi di Tarlidocin, in donne in gravidanza non sono adeguati. Pertanto Tarlidocin deve essere
utilizzato durante la gravidanza solo se assolutamente necessario.
Allattamento
Benzilpenicillina e lidocaina sono escrete nel latte materno.
Quando Tarlidocin è usato durante l'allattamento con latte materno, è impossibile escludere
sensibilizzazione e interferenza con la normale flora batterica intestinale nel lattante.
Il lattante deve essere monitorato per segni di diarrea e colonizzazione della mucosa da parte di lieviti.

Guida di veicoli e utilizzo di macchinari
Considerato che questo medicinale contiene lidocaina, è impossibile escludere che, in casi singoli, la
capacità di guidare veicoli (prendere una parte attiva nel traffico stradale), di usare macchinari o di
lavorare in quota possa essere compromessa per un breve periodo di tempo dopo l'iniezione.
Pertanto, nel suo caso particolare, il medico deve decidere se lei può guidare veicoli (prendere una
parte attiva nel traffico stradale) o usare macchinari.

Tarlidocin contiene povidone
L'escrezione ritardata di povidone deve essere tenuta in considerazione in pazienti con
compromissione renale. Poiché questo medicinale contiene povidone, è impossibile escludere che l'uso
frequente o prolungato possa, in casi molto rari, portare all'accumulo di povidone nel sistema
reticoloendoteliale (RES) o a depositi locali e alla formazione di granulomi da corpo estraneo, che
potrebbero essere confusi con tumori.

Tarlidocin contiene sodio
Questo medicinale contiene 26,19 mg di sodio per dose di 1,2 milioni UI. Questo equivale a 1,3%
dell'assunzione massima giornaliera raccomandata con la dieta di un adulto.

3. How to use Tarlidocin

Tarlidocin is generally administered by a healthcare professional. If you have any doubts about how this medicine is administered, consult your doctor or pharmacist.
The recommended dose is:

General treatment (for example, follow-up treatment for erysipelas):
Adults and adolescents: 1.2 million IU once a week
Children > 30 kg body weight: 1.2 million IU once a week
Children 3.5 kg–30 kg body weight: 600,000 IU once a week

Syphilis treatment:
Primary and secondary stage
Adults and adolescents: 1 x 2.4 million IU
Children: 50,000 IU/kg body weight, however not exceeding 2.4 million IU
The treatment should be repeated if clinical symptoms reappear or if laboratory results
remain strongly positive.
Duration of treatment: single dose

Late-stage syphilis (seropositive latent syphilis)
Adults and adolescents: 2.4 million IU once a week
Children: 50,000 IU/kg body weight, however not exceeding 2.4 million IU
Duration of treatment: 3 weeks

Treatment of congenital syphilis: without neurological involvement
Infants: 1 x 50,000 IU/kg body weight
Duration of treatment: single dose

Treatment of yaws, pinta:
Adults and adolescents: 1 x 1.2 million IU
Children > 30 kg body weight: 1 x 1.2 million IU
Children 3.5 kg–30 kg body weight: 1 x 600,000 IU
Duration of treatment: single dose

Prophylaxis of rheumatic fever, post-streptococcal glomerulonephritis and erysipelas:
Adults and adolescents: 1 x 1.2 million IU every 2-4 weeks
Children > 30 kg body weight: 1 x 1.2 million IU every 3-4 weeks
Children 3.5 kg–30 kg body weight: 1 x 600,000 IU every 3-4 weeks
Duration of treatment:
a) without cardiac involvement: at least 5 years or until the age of 21
b) transient cardiac involvement: at least 10 years or until the age of 21
c) persistent cardiac involvement: at least 10 years or until the age of 40; sometimes prophylaxis is
necessary throughout life.

Special patient groups (with kidney or liver problems or with heart failure)
Dose and frequency of administration will be determined by the doctor. If you require clarification on
dosage, consult your doctor.

Use in children
Tarlidocin should not be used in children with a body weight of less than 3.5 kg to avoid
exceeding the maximum dose of lidocaine.
Tarlidocin should be used with particular caution in children under 4 years of age due to its
lidocaine content.
Method of administration

For intramuscular use only(the preparation can only be injected into a muscle)
Tarlidocin is not suitable for injection under the skin, into blood vessels or into the spinal canal.
In case of repeated intramuscular administration, the injection site must be changed.
Serious local reactions may occur during intramuscular administration, in
particular in small children. For this reason, if possible, other treatments may be used, for example a different formulation of penicillin.
Important information for doctors/healthcare professionals regarding the method of administration is

If you use more Tarlidocin than you should
At extremely high doses, penicillins can induce neuromuscular excitability or epileptiform seizures.
If you suspect an overdose, seek immediate medical advice.
A lidocaine overdose mainly affects the central nervous system. If you start to
experience dizziness or mental confusion, numbness of the tongue, ringing in the ears, vomiting or
tremors, you should immediately inform the person administering the injection. The doctor will know how
to manage these symptoms and will provide you with any necessary treatment.
Important information for doctors/healthcare professionals regarding symptoms of overdose/use

If you forget to use Tarlidocin
If you believe that a dose has not been administered to you, inform your doctor immediately.

If you stop using Tarlidocin
You should not stop treatment with Tarlidocin without first consulting your doctor. Otherwise there is a risk that your illness has not been completely cured and that you may experience
a relapse.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
li manifestino.

Important side effects to watch out for:
Severe allergic reaction (may affect up to 1 in 10,000 people)
If you have a severe allergic reaction (anaphylaxis), tell your doctor immediately.
The signs may include: shock with circulatory failure, sweating and impaired consciousness
(potentially fatal, see also paragraph 2 "Warnings and precautions")
Severe skin rashes
If you have a severe skin reaction, tell your doctor immediately.
The signs may include:

• very rare (may affect up to 1 in 10,000): skin rash with blisters, usually involving the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Frequency not known: increased number of certain blood cells due to hypersensitivity (eosinophilia), hives causing intense itching (urticaria), swelling of the skin and mucous membranes, especially on the face, mouth, throat and larynx (angioedema), inflammation of blood vessels with bleeding of the skin and mucous membranes (leucocytoclastic vasculitis, Henoch-Schönlein purpura), painful skin nodules (erythema nodosum) Any immediate-type reaction with hives causing intense itching (urticaria) must always be considered a serious sign and strictly requires discontinuation of therapy.

Benzylpenicillin can cause the following side effects:

Common (may affect up to 1 in 10 people)

• hypersensitivity reactions (it is impossible to estimate the frequency of numerous individual symptoms of allergic reactions with sufficient accuracy based on the available data)
• skin rash (morbilliform or scarlatiniform)
• hardening at the injection site, fever
• Changes in some tests and investigations, such as: falsely positive direct Coombs test in tests to determine the presence of protein in the urine using precipitation techniques (Folin-Ciocalteu-Lowry method, biuret method) falsely positive tests to determine the presence of protein in the urine (ninydrin method) simulation of pseudohypoalbuminemia [transient changes in the properties of blood proteins (albumin)] when electrophoresis methods are used to determine albumin falsely positive tests for non-enzymatic detection of glucose in urine and urobilinogen increased levels during the determination of 17-ketosteroids (using the Zimmermann reaction) in urine (see paragraph 2)

Uncommon (may affect up to 1 in 100 people)

• inflammation of the tongue and oral mucosa, black hairy tongue, feeling unwell (nausea), feeling sick (vomiting), diarrhea

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

• severe watery diarrhea during or after treatment that may be accompanied by fever or abdominal pain, caused by a serious intestinal disease (pseudomembranous colitis) (see also paragraph 2 "Warnings and precautions")
• serum sickness (symptoms include, but are not limited to, fever, joint swelling and rash)
• kidney disease (nephropathy), inflammation of the kidneys (interstitial nephritis)

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

• certain blood diseases (so-called hemolytic anemia, leukopenia, thrombocytopenia, agranulocytosis)
• liver cell damage, blockage of bile flow. These reactions have occurred in association with shock, rash, exfoliative dermatitis, fever and/or increased number of certain blood cells due to hypersensitivity (eosinophilia) or serum sickness syndrome Not known (frequency cannot be estimated based on available data)
• infections from antibiotic-resistant bacteria and fungal infections (candidiasis)
• allergic swelling, Jarisch-Herxheimer reaction (this reaction can occur during the treatment of syphilis (usually 2-12 hours after the first dose) and is characterized by fever, chills, general and focal symptoms)
• blockage of blood vessels (arteries)
• swelling of the larynx, spasmodic narrowing of the bronchi with shortness of breath, allergic lung disease (pulmonary eosinophilia)
• toxic embolic reactions, probably due to vascular occlusion by large crystals of penicillin salts (Hoigné and Nicolau syndrome), pain at the injection site, which can occur even if the injection is performed with the correct technique. The local anesthetic contained in this medicine initially provides pain relief. Once the analgesic effect has worn off, the pain may persist for some time.

Other side effects/further information
Neurotoxic reactions, possible with penicillin-based therapy at high doses, do not occur,
because the levels reached with Tarlidocin in the blood are low.
Lidocaine can cause the following side effects:
Due to the low lidocaine content and the low frequency of use of Tarlidocin, the risk of systemic
lidocaine-related adverse reactions related to the dose is low when the product is used as intended. Despite the low lidocaine content (the active analgesic principle), attention should be paid to the side effects of lidocaine. Reactions affecting the
whole body may occur, for example after accidental injection into a vein.

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

• allergic reactions

Not known (frequency cannot be estimated based on available data)

• dizziness, mental confusion, seizures (convulsions), tingling around the mouth, numbness of the tongue, feeling sleepy
• abnormally slow heartbeat, irregular heartbeat, cessation of normal blood circulation due to heart failure, cardiac arrest, slight increase in blood pressure, low blood pressure, circulatory shock
• respiratory depression
• nausea, vomiting
• rash, edema

This medicine contains phospholipids from soybean seeds ((3-sn-phosphatidyl)choline), caution is required
in light of the risk of allergic reactions.
It is impossible to exclude, in very rare cases and considering the content of povidone, the possibility of
accumulation of povidone in the reticuloendothelial system (RES) or local deposits and the appearance of
foreign body granulomas, which could be mistaken for tumors.
Important information for doctors/healthcare professionals regarding possible serious side effects in

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
Website: 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 Tarlidocin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label of the vial and on the
pack after "Exp.". The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
The reconstituted injectable suspension must be prepared fresh immediately before use.
Do not dispose of any medicine in wastewater . Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Tarlidocin contains

• The active ingredients are benzathine benzylpenicillin and lidocaine hydrochloride monohydrate.

1 vial of powder contains 916.7 mg of benzathine benzylpenicillin (as tetrahydrate),
equivalent to 1,200,000 IU of benzathine benzylpenicillin.
1 glass vial of 5 ml solution contains 25 mg of lidocaine hydrochloride monohydrate.

• The other ingredients in the powder vial are: povidone K17, soya lecithin, polysorbate 80, sodium citrate (anhydrous), citric acid, mannitol (E421), simethicone.
• The other ingredients in the solution vial are: sodium hydroxide, water for injections

Description of the appearance of Tarlidocin and content of the pack
Tarlidocin consists of a vial containing a powder from white to cream-colored and a vial
containing a clear, colorless solution.
After reconstitution, the medicinal product ready for use is a homogeneous injectable suspension of milky
white color.
Tarlidocin is available in packs containing 1 vial and 1 ampoule and in multiple packs
containing 5 boxes each with 1 vial and 1 ampoule.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Tarlidocin
France: Tarlidocin
Germany: Tarlidocin
Netherlands: Tarlidocin
United Kingdom: Cindolin

The following information is intended exclusively for physicians or healthcare professionals:
Method of administration
The preparation is strictly for intramuscular injection. The injection must not be
administered into tissues with reduced perfusion.
Reconstitution of the intramuscular injectable suspension
The powder from one vial must be reconstituted with the solution from the ampoule.
To open the glass ampoule, the top must be broken at the defined breaking point
on the neck of the ampoule.
Use a sterile syringe fitted with a needle to completely aspirate the solution contained in the
ampoule.
To reconstitute the injectable suspension, the needle of the syringe must be inserted through the rubber stopper
of the vial, so that the end of the needle is only in the upper part of the
vial.
Then the solution must be injectedcompletely and slowly into the vial, which must
be shaken with a rotary movement. Avoid shaking the vial vigorously.
The procedure described above helps to avoid leakage of the solution or the formation of
foam.
The medicinal product ready for use is a homogeneous injectable suspension, milky white in color. After
reconstitution with the solution provided in this pack, the volume of the injectable suspension
ready for use is 6 ml.
Administration of 1.2 million IU (equivalent to 1 vial)
The contents of one vial must be completely aspirated and then administered.
Administration of lower doses, for example 600,000 IU (equivalent to ½ vial)
The contents of one vial must be completely aspirated. Half of the contents must be
discarded immediately and the second half of the contents must be administered.
The injectable suspension is for single use only. The product must be used
immediately after opening the ampoule and reconstituting the injectable suspension.
The remaining medicinal product after administering the single dose must be discarded.
Injection
Using a long, large-gauge needle (cannula diameter 0.90 mm), Tarlidocin must be
injected by deep intramuscularinjection into the upper-outer quadrant of the gluteus muscle, in
the direction of the iliac crest, or by the von Hochstetter technique. The needle must be inserted as
perpendicularly as possible to the skin and the injection must be given as far as
possible from the larger vessels. Always aspirate before injecting. The injection must be stopped if
blood is aspirated or if the patient experiences pain during the injection.
In children, the medio-lateral muscles of the thigh (quadriceps femoris muscle) are recommended as the injection site. The deltoid muscle is only suitable if it is well-formed; in this case, care must be taken with the radial nerve.
In infants and young children, the peripheral area of the upper-outer quadrant
of the gluteal region should only be selected as the injection site in exceptional cases (e.g., extensive burns), to avoid
injury to the sciatic nerve.
The injection must not be administered into tissues with reduced blood flow (see also
section 2 "Do not use Tarlidocin"). In case of repeated administration, the injection site must be changed.
The injection must be given as slowly as possible and with only slight pressure. It
must be avoided to massage the area after the injection.
Serious local reactions may occur during intramuscular administration, in
particular in young children. If possible, taking into account in particular the therapeutic indications
and dosage regimens and assessing the benefit/risk ratio, alternative treatments such as intravenous therapy with a suitable penicillin product should be considered.
During long-term treatment with depot penicillins (e.g. for the treatment of
syphilis), repeated injections into a very circumscribed area of muscle tissue can lead to
tissue trauma and proliferation of blood vessels, consequently increasing the probability
that the injected material enters the circulation, either by direct injection into a blood vessel or
by pushing the material into the circulation due to the injection pressure or even spreading
the deposit due to the effect of massage. During long-term treatment, it is therefore recommended to
administer each injection as far as possible from the previous injection site.

Note
For reasons of possible adverse reactions (Nicolau syndrome or Hoigné syndrome in
association with the effects of lidocaine), it is absolutely necessary to exclude that the needle is in a
intravascular position by performing an aspiration test with an empty injection syringe.
The injection must be stopped if blood is aspirated or if the patient experiences pain during the injection.
Tarlidocin is notindicated for subcutaneous, intravenous or intralumbar injections.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Symptoms of overdose/misuse
At extremely high doses, penicillins can induce neuromuscular excitability or epileptiform convulsions.
If an overdose is suspected, clinical monitoring and symptomatic measures are indicated.
Lidocaine poisoning following inappropriate administration of an excessive amount of
lidocaine manifests in two phases. Initially, patients exhibit central and cardiac excitatory symptoms: agitation, restlessness, dizziness, visual and auditory disturbances, tingling around the mouth,
slurred speech, nausea, vomiting, tremors and muscle contractions, which may be signs of
an impending seizure. Cardiovascular symptoms may include arrhythmia, tachycardia,
hypertension and flushing. As the poisoning progresses, patients develop depression of
central and cardiac functions, leading to coma, respiratory and circulatory arrest. Hypotension
is a frequent prodrome. Accidental intravascular administration of lidocaine does not always
generate excitatory symptoms. Acidosis, hyperkalemia, hypocalcemia and hypoxia increase and prolong the
toxic effects of local anesthetics.
Emergency procedures and antidotes
Benzathine benzylpenicillin is hemodialyzable.
At the first signs of a lidocaine overdose, the administration of Tarlidocin must be
stopped immediately. Oxygen administration is recommended. Additional treatment
must be symptomatic in response to the signs of poisoning: a seizure indicates the need to administer diazepam intravenously, while respiratory and circulatory arrest must be
managed with the usual cardiopulmonary resuscitation procedures.
Central nervous system stimulants are contraindicated in local anesthetic poisoning.