Dioctahedral Smectite
Powder for oral suspension
COMPOSITION
Each sachet contains: Dioctahedral Smectite 3 g
PHARMACOLOGICAL PROPERTIES
Due to its leaflet structure and its plastic viscosity, Smecta possesses a coating property on the gastrointestinal mucosa.
By interacting with glycoproteins of mucus, Smecta increases the resistance of the mucosal gel in response to aggressive agents.
By its action on the gastrointestinal mucus, barrier and its binding capacity, Smecta protects the gastrointestinal mucosa.
Smecta is radiolucent, does not colour the stools and, at usual doses, does not modify the physiological intestinal transit time in a series of animal study.
INDICATIONS
Smecta is indicated for symptomatic treatment of non specific diarrhoea.
POSOLOGY
Take the full recommended starting dose at the first sign of diarrhoea and repeat after each subsequent bowel movement. Do not exceed maximum recommended dose per day. Recommended dose for acute diarrhoea:
| Age | Initial dose | Maximum dose per 24 hours |
|---|---|---|
| Adult and children over 12 years |
3 g
|
9 g
|
| Children 6 - 12 years |
1.5 g
|
4.5 g
|
| Children under 6 years | Only as directed by a physician |
Dissolve 1 sachet into 50 ml water or half glass of water, mix them thoroughly.
Over dosage: In case of accidental over dosage seek professional assistance immediately.
PRECAUTIONS AND WARNINGS
Do not use for more than 2 days or in the presence of fever: or in infants and children under 6 years of age unless directed by a physician.
In case of diarrhoea in the child accompanied by dehydration, the first treatment should be by oral R.T. In this case, Smecta is recommended as follow up treatment.
Caution should be exercised in patients with severe renal insufficiency.
SIDE EFFECTS
No drug incompatibilities have been reported. The only real problem is that of very rare instances of the development of / or the worsening of constipation.
However it has always been possible to continue treatment simply by decreasing the dose.
CONTRAINDICATIONS
Hypersensitivity to one of the components.
DRUG INTERACTIONS
The adsorbent properties of a preparation may interfere with absorption times and / or rates of another substance and it is suggested that all other drugs should be administered separately from Smecta.
STORAGE
To be kept in a dry place Keep out of reach of children
PRESENTATION
Powder, box of 30 sachets, Reg. No. DBL9104112823A1
Powder, box of 10 sachets, Reg. No. DBL9104112823A1
Origin country: France
French Authorization Marketing: 319320.7
FOR FURTHER INFORMATION
PLEASE CONSULT YOUR DOCTOR
Manufactured by :
PT. COMBIPHAR, Bandung, Indonesia
Under license and control of
IPSEN 24 rue Erlanger-75781 Paris,Cedex 16, Perancis
smecta®
Dioctahedral Smectite
Serbuk untuk suspensi oral
KOMPOSISI
Tiap sachet mengandung: Dioctahedral Smectite 3 g
KHASIAT
Karena struktur dan viskositas elastisitasnya, Smecta bekerja melapisi mukosa saluran cerna.
Dengan jalan interaksi dengan glikoprotein di mukosa, Smecta meningkatkan resistensi lapisan gel mukosa sebagai respon terhadap zat-zat yang agresif.
Smecta bekerja pada barrier mukosa gastrointestinal dan karena daya kapasitas ikatnya, Smecta melindungi mukosa gastrointestinal.
Smecta bersifat radiolucent, tidak mewarnai tinja dan pada dosis lazim, tidak merubah waktu transit dari intestinal secara fisiologis pada percobaan menggunakan hewan.
INDIKASI
Smecta diindikasikan untuk pengobatan simptomatik pada diare non spesifik.
DOSIS DAN CARA PEMBERIAN
Pada waktu permulaan gejala diare, ambillah dosis awal sesuai tabel yang dianjurkan di bawah dan ulangi setelah diare berikutnya.
Jangan lampaui dosis maksimum perhari yang dianjurkan. Dosis yang dianjurkan untuk diare akut:
| Umur | Dosis Awal | Dosis Maksimum per 24 jam |
|---|---|---|
| Adult and children over 12 years |
3 g
|
9 g
|
| Children 6 - 12 years |
1.5 g
|
4.5 g
|
| Children under 6 years | Only as directed by a physician |
Dosis berlebih:
Jika terjadi bahaya akibat dosis berlebih, segera minta bantuan dokter.
PERINGATAN DAN PERHATIAN
Jangan gunakan obat lebih dari 2 hari atau jika terjadi demam, atau jangan diberikan pada bayi dan anak di bawah 6 tahun kecuali bila disarankan oleh dokter.
Jika diare pada anak-anak disertai dengan dehidrasi, maka pengobatan awal harus diberikan Oralit. Dalam hal ini, Smecta hanya dianjurkan sebagai pengobatan lanjutan. Hati-hati pada gangguan fungsi ginjal.
EFEK SAMPING
Tidak ada dilaporkan ketidakcocokan pemakaian obat. Satu-satunya problem yang amat jarang terjadi yaitu konstipasi. Tetapi pengobatan selalu bisa diteruskan dengan jalan mengurangi dosis.
KONTRAINDIKASI
Hipersensitif terhadap salah satu komponen.
INTERAKSI OBAT
Daya serap dari Smecta bisa mengganggu waktu atau daya penyerapan dari obat-obat lain, oleh sebab itu dianjurkan agar obat-obat lain diberikan dalam waktu yang terpisah dengan Smecta.
PENYIMPANAN
Simpan di tempat yang kering Jauhkan dari jangkauan anak-anak
KEMASAN
Dus, berisi 30 sachet Smecta, No. Reg. DBL91 04112823A1
Dus, berisi 10 sachet Smecta, No. Reg. DBL9104112823A1
Negara asal: Perancis
Autorisasi Marketing Perancis: 319320.7
KETERANGAN LEBIH LANJUT
DAPAT DIPEROLEH PADA DOKTER ANDA
Dibuat oleh:
PT. COMBIPHAR, Bandung, Indonesia
dengan lisensi dan pengawasan dari
IPSEN 24 rue Erlanger-75781 Paris,Cedex 16, Perancis
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