Summary of Product Characteristics (SmPC) - Frisium 10 mg tablets
1. Trade Name of the Medicinal Product
Not applicable.
2. Qualitative and Quantitative Composition
Not applicable.
3. Pharmaceutical Form
Not applicable.
Clinical Particulars
4.1. Therapeutic Indications
Not applicable.
4.2. Posology and Method of Administration
Not applicable.
4.3. Contra-indications
Not applicable.
4.4. Special Warnings and Precautions for Use
Not applicable.
4.5. Interactions with other Medicaments and other forms of Interaction
Not applicable.
4.6. Pregnancy and Lactation
Not applicable.
4.7. Effects on Ability to Drive and Use Machines
Not applicable.
4.8. Undesirable Effects
Not applicable.
4.9. Overdose
Not applicable.
Pharmacological Properties
5.1. Pharmacodynamic Properties
Not applicable.
5.2. Pharmacokinetic Properties
Not applicable.
5.3. Preclinical Safety Data
Not applicable.
Pharmaceutical Particulars
6.1. List of Excipients
Not applicable.
6.2. Incompatibilities
Not applicable.
6.3. Shelf Life
Not applicable.
6.4. Special Precautions for Storage
Not applicable.
6.5. Nature and Contents of Container
Not applicable.
6.6. Instruction for Use/Handling
Not applicable.
SUMMARY OF PRODUCT CHARACTERISTICS
Product Summary
- 1.
NAME OF THE MEDICINAL PRODUCT
Not applicable
- 2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Not applicable
- 3.
PHARMACEUTICAL FORM
Not applicable
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Not applicable
4.2. Posology and method of administration
Not applicable
4.3. Contraindications
Not applicable
4.4. Special warnings and precautions for use
Not applicable
4.5. Interactions with other medicinal products and other forms of interaction
Not applicable
4.6. Pregnancy and lactation
Not applicable
4.7. Effects on ability to drive and use machines
Not applicable
4.8. Undesirable effects
Not applicable
4.9. Overdose
Not applicable
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Not applicable
5.2. Pharmacokinetic properties
Not applicable
5.3. Preclinical safety data
Not applicable
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Not applicable
6.2. Incompatibilities
Not applicable
6.3. Shelf life
Not applicable
6.4. Special precautions for storage
Not applicable
6.5. Nature and contents of container
Not applicable
6.6. Instruction for use and handling (, and disposal)
Not applicable
Administrative Data
7. MARKETING AUTHORISATION HOLDER
Not applicable
8. MARKETING AUTHORISATION NUMBER
Not applicable
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Not applicable
10. DATE OF REVISION OF THE TEXT
Not applicable