PEPTI-CALM Oral suspension (2014)
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Περιεχόμενα
1. Name of the medicinal product
Pepti-Calm 525.6mg/30ml Oral Suspension or Almus Pepti-Calm Suspension Bismuth Subsalicylate 525.6mg/30ml.
2. Qualitative and quantitative composition
Active ingredient mg/30ml Bismuth subsalicylate 525.6 For excipients, see 6.1.
3. Pharmaceutical form
Oral suspension. Thick pink suspension.
4.1. Therapeutic indications
For the relief of indigestion, dyspepsia, nausea, upset stomach and diarrhoea.
4.2. Posology and method of administration
<u>Adults and children over 16 years:</u> 30ml to be taken every 30-60 minutes as required up to a maximum of eight doses in 24 hours. Do not give to children under 16 years. For oral administration. ...
4.3. Contraindications
Hypersensitivity to any of the ingredients, aspirin or other nonsteroidal antiinflammatory drugs and patients with renal disorders. Pregnancy and breastfeeding (see section 4.6, Pregnancy and lactation). ...
4.4. Special warnings and precautions for use
There is a possible association between salicylates and Reyes syndrome when given to children. Reyes syndrome is a very rare disease which affects the brain and liver and can be fatal. For this reason ...
4.5. Interaction with other medicinal products and other forms of interaction
Salicylates may enhance the effect of coumarin anticoagulants and oral hypoglycaemics of the sulphonylurea type. Salicylates diminish the action of uricosurics.
4.6. Pregnancy and lactation
The safety of Pepti-Calm during pregnancy and lactation has not been established and therefore use during these periods is not recommended. Animal studies are insufficient with respect to effects on pregnancy. ...
4.7. Effects on ability to drive and use machines
No adverse effects known.
4.8. Undesirable effects
Nausea and vomiting have been reported as well as darkening or blackening of the faeces and tongue. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of ...
4.9. Overdose
The effects of bismuth intoxication include gastrointestinal disturbances, skin reactions, stomatitis and discolouration of the mucous membranes. A characteristic blue line may appear on the gums. Salicylate ...
5.1. Pharmacodynamic properties
Bismuth has weak antacid properties. Bismuth subsalicylate may exert its antidiarrhoeal action not only by stimulating absorption of fluid and electrolytes across the intestinal wall but also when hydrolysed ...
5.2. Pharmacokinetic properties
Following oral administration, the amount of bismuth absorbed is negligible, whereas the salicylate component is absorbed completely and rapidly from the small intestine. Bismuth subsalicylate is believed ...
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6.1. List of excipients
Maltitol liquid Glycerin Dispersible cellulose (containing microcrystalline cellulose and sodium carboxymethylcellulose) Xanthan gum Citric acid monohydrate Sodium citrate Sodium benzoate Rootbeer flavour ...
6.2. Incompatibilities
None.
6.3. Shelf life
18 months.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
A 150ml, 180ml or 300ml white flint glass bottle with a roll on aluminium closure and expanded polyethylene liner.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
The Boots Company PLC, 1 Thane Road West, Nottingham NG2 3AA Trading as: BCM
8. Marketing authorization number(s)
PL 00014/0615
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 02 November 2000
10. Date of revision of the text
16 December 2014
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