Diacold Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DiaCold 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 curved
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 two weeks.
If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.3 Contraindications
DiaCold is not to be used in the following cases:
-hypersensitivity to the active substance or to any of the excipients, -increased tendency to bleeding,
-patients using coagulation-inhibiting drugs,
-severe hepatic and renal diseases
4.4 Special warnings and precautions for use
Do not exceed the stated dose
A doctor should be consulted if the condition does not improve within one week, in case of fever lasting for several days or in case of shortness of breath or blood in the sputum.
Based on theoretical reasons, DiaCold should not be used in cases of an increased tendency to bleeding or use of coagulation-inhibiting drugs.
DiaCold should not be used in cases of severe hepatic and renal diseases, due to lack of adequate data.
This formulation is not suitable for children under 12 years of age and medical advice should be sought
4.5 Interaction with other medicinal products and other forms of interaction
Drug interactions have not been reported
However, due to the potential influence of DiaCold on coagulation parameters, this product may enhance the effect of coagulation-inhibiting drugs such as warfarin. Therefore, it should not be taken concomitantly with these drugs (see section 4.3 “Contraindications”).
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. The frequency is not known.
|
Gastrointestinal disorders |
Stomach pain, heartburn, nausea, diarrhoea | ||
|
Skin and subcuteanous disorders |
mild bleeding from the gums or nose; hypersensitivity reactions (e. g. exanthema, urticaria, pruritus of skin and mucous membranes) | ||
|
Vascular disorders |
Swelling of the face | ||
|
Respiratory, thoracic and mediastnal disorders |
Dyspnoea | ||
|
Cardiac disorders |
Hypotension | ||
|
Hepatobiliary disorders |
Disturbances of the liver function (any causal relationship between this effect and the use of the product has not been demonstrated) | ||
|
If other adverse reactions not mentioned above occur, a doctor shoulc |
be consulted. | ||
4.9 Overdose
No 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
The extract was negative in an Ames test for mutagenicity.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
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
2 years
6.4 Special precautions for storage
Do not store above 25° C.
6.5 Nature and contents of container
DiaCold is available in packs with 30, 50, 60, 90 or 100 tablets.
The tablets are sealed into PVC/PVDC-aluminium blisters. The blisters are packed into folding cartons.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Diapharm GmbH & Co. KG Hafenweg 18-20 48155 Munster Germany
8 MARKETING AUTHORISATION NUMBER(S)
THR 42340/0017
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
02/06/2011
DATE OF REVISION OF THE TEXT
30/07/2013