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CARBOCISTEINE PHAGECON 250 MG/5 ML SYRUP

Active substance(s): CARBOCISTEINE / CARBOCISTEINE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Carbocisteine Phagecon 250 mg/ 5 ml syrup

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of Carbocisteine Phagecon contains 250 mg of carbocisteine.
Excipient(s) with known effect:
Each 5 ml of Carbocisteine Phagecon contains 7.5 mg of methyl
parahydroxybenzoate.
Each 5 ml of Carbocisteine Phagecon contains 2877.5 mg of sucrose.
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Syrup
Yellow- amber liquid.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Carbocisteine is a mucolytic agent for the adjunctive therapy of respiratory tract
disorders characterised by excessive, viscous mucus, including chronic obstructive
airways disease.

4.2

Posology and method of administration

Posology
Adults
Dosage is based upon an initial daily dosage of 2250 mg carbocisteine in divided
doses, reducing to 1500 mg daily in divided doses when a satisfactory response is
obtained e.g. for normal syrup 15 ml 3 times a day reducing to 10 ml 3 times a day.
Paediatric population
2 - 5 years: 1.25 - 2.5ml, four times a day.
6 - 12 years: 5 ml, three times a day.
Carbocisteine is contraindicated in children aged less than 2 years.
Method of administration
Use the measuring device to measure the appropriate amount, whether its use is for an
adult or a child. The syringe for oral administration is graduated per 0.25ml. One
graduation, 0.25ml corresponds to 12.5mg/ml of carbocisteine.
How to use the syringe:
Step 1: Check the measurements on the side of the syringe to see how much to fill it.
Step 2: Push the syringe's plunger all the way down. Then put the tip of the syringe
into the medicine bottle.
Step 3: Slowly pull back on the plunger until the syringe fills to the appropriate mark.
Make sure there are not any large air bubbles in the syringe. If there are, empty the
syringe and try again.
Step 4: Place the end of the syringe into the mouth against the cheek and carefully
press the plunger down slowly to gently release the medicine. After use replace the
bottle cap. Wash the syringe in warm water and allow to dry. Store out of the reach of
children.

4.3

Contraindications
Use in children less than 2 years of age.
Use in patients with active peptic ulceration.

Hypersensitivity to the active substance or to any of the excipients listed in section
6.1.

4.4

Special warnings and precautions for use
Special precautions:
- Asthmatic patients with a history of bronchospasm;
- Severe respiratory failure;
- Debilitated patients. By decreasing the cough reflex there is a risk of obstruction of
the airways as a consequence of the secretions amount increase.
The use of Carbocisteine Phagecon implies a decrease in the mucus viscosity and
removal, either through the ciliary activity of the epithelium, or by the cough reflex.
Therefore it is expected an increase of cough and sputum. This association of this
medicine with antitussive medication is not recommended.
Caution is advised in the administration of carbocisteine in individuals susceptible to
gastroduodenal ulcers, as mucolytics have the capacity to destroy the gastric mucosal
barrier.
This medicine contains sucrose. Patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
should not take this medicine.
This medicine contains methyl parahydroxybenzoate. May cause allergic reactions
(possibly delayed).

4.5

Interaction with other medicinal products and other forms of interaction
No drug interactions have been identified

4.6

Fertility, pregnancy and lactation
Pregnancy
Although tests in mammalian species have revealed no teratogenic effects, is not
recommended during the first trimester of pregnancy.
Breast-feeding
It is unknown whether carbocisteine/metabolites are excreted in human milk.

Fertility
There is no known relevant data available on the effects of carbocisteine on fertility.

4.7

Effects on ability to drive and use machines
Carbocisteine has no or negligible influence on the ability to drive and use machines.

4.8

Undesirable effects
Adverse reactions listed by System Organ Class. Frequencies are defined using the
following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon
(≥1/1000 to ≤1/100); rare (≥1/10,000 to ≤1/1,000); very rare (≤1/10,000); not known
(cannot be estimated from the available data).

System Organ Class

Frequency

Adverse reaction

Rare

Palpitations

Not known

Hypothyroidism.*

Uncommon

Nausea, vomiting and
diarrhea.

Very rare

Gastrointestinal bleeding.

Not known

Gastric discomfort.

Rare

Urticaria and
bronchospasm.**

Very rare

Rash.

Cardiac disorders

Endocrine Disorders

Gastrointestinal disorders

Immune system disorders

Musculoskeletal and connective tissue disorders
Rare

Muscle pain

Rare

Headache, dizziness, urinary
incontinence, palpitations.

Nervous system disorders

Respiratory, thoracic and mediastinal disorders

Rare

Shortness of breath.

Not known

Bronchorrhea.

Skin and subcutaneous tissue disorders
Not known

Stevens-Johnsons syndrome,
erythema multiforme.

* Special attention in patients with compromised thyroid function due to the risk of
transient hypothyroidism occurrence.
** Special attention in asthmatic patients due to the risk of bronchoconstriction
occurrence (contraction of a muscle of the bronchial wall that leads to a reduction in
airflow). In these cases, treatment discontinuation is recommended.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9

Overdose
Gastrointestinal disturbance (gastralgias, nausea and vomiting) are the most likely
symptoms of Carbocisteine overdosage.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Mucolytic, ATC code: R05CB03
Carbocisteine (S-carboxymethyl L-cysteine) has been shown in normal and bronchitic
animal models to affect the nature and amount of mucus glycoprotein which is
secreted by the respiratory tract. An increase in the acid:neutral glycoprotein ratio of
the mucus and a transformation of serous cells to mucus cells is known to be the
initial response to irritation and will normally be followed by hypersecretion. The
administration of carbocisteine to animals exposed to irritants indicates that the
glycoprotein that is secreted remains normal; administration after exposure indicates
that return to the normal state is accelerated. Several studies have demonstrated that
carbocisteine reduces goblet cell hyperplasia. Carbocisteine can therefore be
demonstrated to have a role in the management of disorders characterised by
abnormal mucus.

5.2

Pharmacokinetic properties
Carbocisteine is rapidly absorbed from the GI tract. Equilibrium pharmacokinetics
were established in healthy volunteers following administration of carbocisteine 375
mg capsules, 2 capsules t.d.s. for seven days. The mean Tmax was 2.0 hours (range
1.0 –3.0); T½ 1.87 hours (range 1.4 – 2.5); KEL 0.387 hour-1 (range 0.28 – 0.50) and
AUC0-7.5 was 39.26 mcg.hr/ml (range 26.0 – 62.4). Values for derived
pharmacokinetic values were CLS 331 ml.min-1; VD 105.2 L and VD 1.4 L/Kg.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to
those already included in other sections of the SmPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sucrose,
Caramel (E150)
Gooseberry flavour
Sodium hydroxide (for pH- adjustment)
Methyl parahydroxybenzoate (E218)
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 years.

After opening, use within 3 months.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
200 ml or 300 ml type III amber glass bottles, with a white plastic inviolable closure
HDPE/LDPE cap and a measuring device (oral syringe with polyethylene plunger and
polypropylene cylinder with 5 ml capacity)

Not all pack sizes may be marketed.

6.6

Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.

7

MARKETING AUTHORISATION HOLDER
Phagecon – Serviços e Consultoria Farmacêutica Lda.
Avenida José Malhoa, n.º2, Edifício Malhoa Plaza
3º piso, escritório 3.7
1070-325 Lisboa
PORTUGAL

8

MARKETING AUTHORISATION NUMBER(S)
PL 36065/0003

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/06/2017

10

DATE OF REVISION OF THE TEXT
01/06/2017

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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