Summary of medicine characteristics - CENTOREZE TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Centoreze tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg of extract (as dry extract) from Pelargonium root (Pelargonium sidoides DC and/or Pelargonium reniforme Curt. (4–7:1) Extraction solvent: Ethanol 14% (v/v).
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Red-brown, smooth round, biconvex
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product used to relieve the symptoms of upper respiratory tract infections including the common cold, such as sore throat, cough and blocked or runny nose, based on traditional use only
4.2 Posology and method of administration
For oral use only.
Adult, elderly and adolescents above 12 years of age:
Take 1 tablet three times daily (morning, midday, evening).
Tablets should be swallowed whole with a little water. The tablets should not be chewed.
The use in children under 12 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”)
Duration of use:
After relief of symptoms, it is recommended to continue treatment for a further 2–3 days in order to prevent a relapse. However, treatment duration should not exceed 10 days.
If the symptoms worsen, or persist after 7 days, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Severe hepatic or renal disease.
4.4 Special warnings and precautions for use
Do not exceed the stated dose
A doctor or qualified healthcare practitioner should be consulted if symptoms worsen, or do not improve after one week.
If fever, shortness of breath or blood in the sputum occurs, a doctor or qualified healthcare practitioner should be consulted.
Hepatotoxicity and hepatitis cases were reported in association with the administration of the medicinal product.
Patients shouls stop taking this product immediately and consult their doctor if they develop signs and symptoms that suggest liver dysfunction (fatigue, anorexia, yellowing of the skin and eyes or severe stomach pain with nausea and vomiting or dark urine).
The use in children under 12 years of age has not been established and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established. Due to lack of sufficient data, the use during pregnancy and lactation is not recommended.
No studies on the effect on fertility have been performed.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed
4.8 Undesirable effects
The following adverse reactions have been reported.
Gastrointestinal complaints such as stomach pain, heartburn, nausea, vomiting, dysphagia or diarrhoea may occur uncommonly.
Mild bleeding from the gums or nose and hypersensitivity reactions(e.g. exanthema, urticaria, pruritus of skin and mucous membranes) have been reported in rare cases.
In very rare cases serious hypersensitivity reactions with swelling of the face, dyspnoea and decrease in blood pressure have been reported.
Hepatotoxicity and hepatitis have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
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 website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
Symptomatic and supportive measures should be taken as appropriate.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c (1) (a) (iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
5.3 Preclinical safety dataThe extract was negative in an Ames test for mutagenicity.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6.1 List of excipients
Extract:
Cellulose powder
Silica, colloidal anhydrous
Tablet core:
Cellulose, microcrystalline
Silica, colloidal anhydrous
Magnesium stearate
Film coating:
Hypromellose
Macrogol, type 6000
Iron oxide yellow E172
Iron oxide red E172
Titanium dioxide E171
Talc
6.2 Incompatibilities
Not applicable
6.3 Shelf life
5 years
6.4 Special precautions for storage
This product does not require any special storage conditions.
Store in the original packaging.
6.5 Nature and contents of container
This product is available in packs with 30 tablets.
The tablets are sealed into PVC/PVDC-aluminium blisters. The blisters are packed into folding cartons.