The GCC Guidance for Presenting the SPC, PIL and Labeling ...
The GCC Guidance for Presenting the SPC, PIL and Labeling ...
The GCC Guidance for Presenting the SPC, PIL and Labeling ...
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4. Possible side effects− Describe <strong>the</strong> side effects <strong>and</strong> whenever possible, an estimate of frequency should be provided,expressed in st<strong>and</strong>ard category of frequency (see Appendix 2).− Begin this section with: "Like all medicines, {product name} can cause side effects, althoughnot everybody gets <strong>the</strong>m".− Describe, if necessary, <strong>the</strong> actions to be taken. If <strong>the</strong> patient needs to seek help urgently, <strong>the</strong>use of <strong>the</strong> term is recommended; <strong>for</strong> less urgent conditions, can be used.− Close this section with: "If any of <strong>the</strong> side effects gets serious, or if you notice any side effectsnot listed in this leaflet, please tell your ".5. How to store {product name}− Keep out of <strong>the</strong> reach <strong>and</strong> sight of children.− , − Do not use {product name} after <strong>the</strong> expiry date which is stated on <strong>the</strong> − − Page 16 of 52
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