Active ingredients: Clofoctol
GRAMPLUS® 750 mg suppositories
GRAMPLUS® 200 mg suppositories
GRAMPLUS® 100 mg suppositories
Why is Gramplus used? What is it for?
PHARMACOTHERAPEUTIC CATEGORY
Antibacterial.
THERAPEUTIC INDICATIONS
Acute and chronic infections of the upper respiratory tract and their annexes. Tracheobronchial infections. Anti-infective treatment after ENT surgery.
Contraindications When Gramplus should not be used
Active diarrhea, hypersensitivity to the active substance or to any of the excipients.
Precautions for use What you need to know before taking Gramplus
Not known.
Interactions Which drugs or foods may change the effect of Gramplus
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Warnings It is important to know that:
Pregnancy and breastfeeding:
During pregnancy, the drug should be used only in case of real need and under the supervision of the doctor. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
Not relevant.
Dose, Method and Time of Administration How to use Gramplus: Posology
Adults: 2 suppositories of 750 mg per day for periods of 5 days.
Children: 2-3 suppositories of 200 mg per day, infants: 2-3 suppositories of 100 mg per day, depending on age and body weight, for periods of 5 days.
In the opinion of the doctor, the therapy can be prolonged or repeated.
Instructions for Use
To extract the suppository, follow the procedures indicated in the figures.
Overdose What to do if you have taken too much Gramplus
WHAT TO DO IF YOU HAVE FORGOTTEN TO TAKE ONE OR MORE DOSES
Do not take a double dose to make up for the forgotten dose.
EFFECTS DUE TO THE SUSPENSION OF THE TREATMENT
If you have any questions about the use of Gramplus, ask your doctor or pharmacist.
Side Effects What are the side effects of Gramplus
Like all medicines, Gramplus can cause side effects, although not everybody gets them. Rare cases of local irritation and diarrheal manifestations have been reported.
There have also been reports of skin reactions such as hives, rash, erythema and pruritus. In such cases, the treatment will be interrupted and specific measures will have to be adopted.
Compliance with the instructions given in this leaflet reduces the risk of undesirable effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
See the expiration date indicated on the package; this date is intended for the product in intact packaging, properly stored.
Keep Gramplus out of the reach and sight of children.
Do not use Gramplus after the expiry date which is stated on the label after "EXP."
The expiry date refers to the last day of the month.
Precautions to be taken for storing the medicinal product
Do not store above 30 ° C.
For a better use of the suppository it is advisable to place the package in the refrigerator before use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
COMPOSITIONS
A 750 mg suppository contains:
Active ingredient: Clofoctol 750 mg.
Excipients: solid semisynthetic glycerides, saturated polyglycolysed glycerides, sodium stearate.
A 200 mg suppository contains:
Active ingredient: Clofoctol 200 mg.
Excipients: Solid semisynthetic glycerides.
A 100 mg suppository contains:
Active ingredient: Clofoctol 100 mg.
Excipients: Solid semisynthetic glycerides.
PHARMACEUTICAL FORM AND CONTENT
Suppositories.
Box of 10 suppositories of 750 mg
Boxes of 10 and 15 suppositories of 200 mg
Boxes of 10 and 15 suppositories of 100 mg
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
GRAMPLUS SUPPOSITORIES
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
A 750 mg suppository contains:
Active ingredient: Clofoctol 750 mg.
A 200 mg suppository contains:
Active ingredient: Clofoctol 200 mg.
A 100 mg suppository contains:
Active ingredient: Clofoctol 100 mg.
For the complete list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Suppositories for rectal use.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Acute and chronic infections of the upper respiratory tract and their annexes. Tracheobronchial infections. Anti-infective treatment after ENT surgery.
04.2 Posology and method of administration
Adults: 2 suppositories of 750 mg per day for periods of 5 days.
Children: 2-3 suppositories of 200 mg per day, infants: 2-3 suppositories of 100 mg per day, depending on age and body weight, for periods of 5 days.
In the opinion of the doctor, the therapy can be prolonged or repeated.
Instructions for Use
To extract the suppository follow the procedures indicated in the package leaflet.
04.3 Contraindications
Active diarrhea, hypersensitivity to the active substance or to any of the excipients.
04.4 Special warnings and appropriate precautions for use
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
Do not report.
04.6 Pregnancy and lactation
Animal studies have shown the absence of teratogenic and embryotoxic effects on the investigated species.
During pregnancy, the drug should be used only in case of real need and under the supervision of the doctor.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
Rare cases of local irritation and diarrheal manifestations have been reported. There have also been reports of skin reactions such as hives, rash, erythema and pruritus. In such cases, the treatment will be interrupted and specific measures will have to be adopted.
04.9 Overdose
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antibacterial. ATC code: J01XX03.
Clofoctol, the active ingredient of the Gramplus specialty, is a synthetic antibacterial with specific activity on Gram + germs and in particular on staphylococci, pneumococci and streptococci. The antibacterial activity is carried out at doses very close to bacteriostatic doses.
05.2 Pharmacokinetic properties
Clofoctol is very well absorbed by the rectal mucosa. Bioavailability is in fact rapid and total: 98% in two hours. The maximum blood peak is reached within half an hour from administration thus ensuring a rapid therapeutic action. Clofoctol spreads rapidly in the organism thanks to essentially plasma transport and reaches high concentrations in the respiratory tree, thus justifying its indications, particularly in bronchopulmonary, ENT and stomatological diseases of infectious origin. Elimination occurs mainly via the biliary route, partly in the form of conjugated glucuronide derivatives; urinary elimination is modest. The risk of tissue accumulation is negligible as excretion is almost complete within 72 hours.
05.3 Preclinical safety data
The oral LD50 in mice and rats was found to be> 5 g / kg, while rectally in the rat was> 2 g / kg. These doses, in relation to the recommended therapeutic doses, give Gramplus a large safety margin. Rectal treatment in rabbits for 4 weeks did not reveal any particular signs of systemic and rectal mucosal toxicity. Rectal treatment in the dog for 14 weeks and in the rat for 24 weeks showed no particular signs of toxicity. Regarding fetal toxicity, no signs of effects on fertility, reproductive function and pregnancy, nor teratogenic effects emerged.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Gramplus 750 mg suppositories: solid semisynthetic glycerides, saturated polyglycolysed glycerides, sodium stearate.
Gramplus 200 mg suppositories and Gramplus 100 mg suppositories: solid semisynthetic glycerides.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
The period of validity indicated refers to the product in intact packaging, correctly stored.
06.4 Special precautions for storage
storage
Do not store above 30 ° C.
For a better use of the suppository it is advisable to place the package in the refrigerator before use.
06.5 Nature of the immediate packaging and contents of the package
Internal packaging: alveoli in coupled PVC / PE. External packaging: printed cardboard box.
Gramplus 750 mg suppositories - box of 10 suppositories
Gramplus 200 mg suppositories - box of 10 suppositories
Gramplus 100 mg suppositories - box of 10 suppositories
Gramplus 200 mg suppositories - box of 15 suppositories
Gramplus 100 mg suppositories - box of 15 suppositories
06.6 Instructions for use and handling
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Chiesi Farmaceutici S.p.A., Via Palermo 26 / A - Parma
08.0 MARKETING AUTHORIZATION NUMBER
Gramplus 750 mg suppositories - 10 suppositories: 025703012
Gramplus 200 mg suppositories - 10 suppositories: 025703024
Gramplus 100 mg suppositories - 10 suppositories: 025703036
Gramplus 200 mg suppositories - 15 suppositories: 025703048
Gramplus 100 mg suppositories - 15 suppositories: 025703051
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
13/05/1985
10.0 DATE OF REVISION OF THE TEXT
November 2011
