{"product_id":"sinufix-cold-treatment-capsules-essential-oils-15-capsules-adult","title":"Sinufix Cold Treatment Capsules (Essential Oils) 15 Capsules – Adult","description":"\u003ch3 data-start=\"73\" data-end=\"87\"\u003eOverview\u003c\/h3\u003e\n\u003cp data-start=\"88\" data-end=\"261\"\u003eSinufix is a \u003cstrong data-start=\"101\" data-end=\"141\"\u003etraditional herbal medicinal product\u003c\/strong\u003e used to help \u003cstrong data-start=\"155\" data-end=\"187\"\u003erelieve common cold symptoms\u003c\/strong\u003e. Its formula combines three plant extracts in the form of essential oils.\u003c\/p\u003e\n\u003ch3 data-start=\"263\" data-end=\"301\"\u003eKey Essential Oils (per capsule)\u003c\/h3\u003e\n\u003cp data-start=\"302\" data-end=\"358\"\u003eEach capsule contains \u003cstrong data-start=\"324\" data-end=\"357\"\u003e11.4 mg of each essential oil\u003c\/strong\u003e:\u003c\/p\u003e\n\u003cul data-start=\"359\" data-end=\"574\"\u003e\n\u003cli data-start=\"359\" data-end=\"419\"\u003e\n\u003cp data-start=\"361\" data-end=\"419\"\u003e\u003cstrong data-start=\"361\" data-end=\"370\"\u003eLemon\u003c\/strong\u003e (\u003cem data-start=\"372\" data-end=\"386\"\u003eCitrus limon\u003c\/em\u003e) essential oil (peel\/pericarp)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"420\" data-end=\"500\"\u003e\n\u003cp data-start=\"422\" data-end=\"500\"\u003e\u003cstrong data-start=\"422\" data-end=\"431\"\u003eThyme\u003c\/strong\u003e (\u003cem data-start=\"433\" data-end=\"450\"\u003eThymus vulgaris\u003c\/em\u003e or \u003cem data-start=\"454\" data-end=\"468\"\u003eThymus zygis\u003c\/em\u003e) essential oil (aerial parts)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"501\" data-end=\"574\"\u003e\n\u003cp data-start=\"503\" data-end=\"574\"\u003e\u003cstrong data-start=\"503\" data-end=\"517\"\u003ePeppermint\u003c\/strong\u003e (\u003cem data-start=\"519\" data-end=\"538\"\u003eMentha x piperita\u003c\/em\u003e) essential oil (fresh aerial parts)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-start=\"576\" data-end=\"599\"\u003eOther Ingredients\u003c\/h3\u003e\n\u003cul data-start=\"600\" data-end=\"736\"\u003e\n\u003cli data-start=\"600\" data-end=\"683\"\u003e\n\u003cp data-start=\"602\" data-end=\"683\"\u003e\u003cstrong data-start=\"602\" data-end=\"638\"\u003eMedium-chain triglycerides (MCT)\u003c\/strong\u003e (RSPO: Roundtable on Sustainable Palm Oil)\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"684\" data-end=\"736\"\u003e\n\u003cp data-start=\"686\" data-end=\"736\"\u003eCapsule shell: \u003cstrong data-start=\"701\" data-end=\"736\"\u003ebovine gelatin, glycerin, water\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-start=\"738\" data-end=\"756\"\u003eWho it’s for\u003c\/h3\u003e\n\u003cul data-start=\"757\" data-end=\"857\"\u003e\n\u003cli data-start=\"757\" data-end=\"782\"\u003e\n\u003cp data-start=\"759\" data-end=\"782\"\u003e\u003cstrong data-start=\"759\" data-end=\"780\"\u003eAdults only (18+)\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"783\" data-end=\"819\"\u003e\n\u003cp data-start=\"785\" data-end=\"819\"\u003e\u003cstrong data-start=\"785\" data-end=\"817\"\u003eNot allowed during pregnancy\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"820\" data-end=\"857\"\u003e\n\u003cp data-start=\"822\" data-end=\"857\"\u003e\u003cstrong data-start=\"822\" data-end=\"857\"\u003eNot allowed while breastfeeding\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-start=\"859\" data-end=\"884\"\u003eDirections (Dosage)\u003c\/h3\u003e\n\u003cul data-start=\"885\" data-end=\"1071\"\u003e\n\u003cli data-start=\"885\" data-end=\"929\"\u003e\n\u003cp data-start=\"887\" data-end=\"929\"\u003eTake \u003cstrong data-start=\"892\" data-end=\"927\"\u003e1 soft capsule, 3 times per day\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"930\" data-end=\"975\"\u003e\n\u003cp data-start=\"932\" data-end=\"975\"\u003eOral use, with a \u003cstrong data-start=\"949\" data-end=\"973\"\u003elarge glass of water\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"976\" data-end=\"1071\"\u003e\n\u003cp data-start=\"978\" data-end=\"1071\"\u003e\u003cstrong data-start=\"978\" data-end=\"1016\"\u003eMaximum treatment duration: 5 days\u003c\/strong\u003e\u003cbr data-start=\"1016\" data-end=\"1019\"\u003eIf symptoms persist beyond 5 days, consult a doctor.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-start=\"1073\" data-end=\"1101\"\u003eWarnings \/ Precautions\u003c\/h3\u003e\n\u003cp data-start=\"1102\" data-end=\"1133\"\u003eDo not use Sinufix if you have:\u003c\/p\u003e\n\u003cul data-start=\"1134\" data-end=\"1259\"\u003e\n\u003cli data-start=\"1134\" data-end=\"1185\"\u003e\n\u003cp data-start=\"1136\" data-end=\"1185\"\u003eAllergy to \u003cstrong data-start=\"1147\" data-end=\"1165\"\u003eessential oils\u003c\/strong\u003e or any ingredient\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1186\" data-end=\"1259\"\u003e\n\u003cp data-start=\"1188\" data-end=\"1259\"\u003e\u003cstrong data-start=\"1188\" data-end=\"1205\"\u003eLiver disease\u003c\/strong\u003e, \u003cstrong data-start=\"1207\" data-end=\"1222\"\u003echolangitis\u003c\/strong\u003e, \u003cstrong data-start=\"1224\" data-end=\"1240\"\u003eachlorhydria\u003c\/strong\u003e, or \u003cstrong data-start=\"1245\" data-end=\"1259\"\u003egallstones\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-start=\"1261\" data-end=\"1314\"\u003eMedical advice is recommended before use if you have:\u003c\/p\u003e\n\u003cul data-start=\"1315\" data-end=\"1498\"\u003e\n\u003cli data-start=\"1315\" data-end=\"1498\"\u003e\n\u003cp data-start=\"1317\" data-end=\"1498\"\u003e\u003cstrong data-start=\"1317\" data-end=\"1330\"\u003eHeartburn\u003c\/strong\u003e, \u003cstrong data-start=\"1332\" data-end=\"1349\"\u003ehiatal hernia\u003c\/strong\u003e, or \u003cstrong data-start=\"1354\" data-end=\"1383\"\u003eulcers \/ GI tract lesions\u003c\/strong\u003e\u003cbr data-start=\"1383\" data-end=\"1386\"\u003ePregnant or breastfeeding women should seek medical advice (note: product use is not permitted as stated above).\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-start=\"1500\" data-end=\"1515\"\u003ePack size\u003c\/h3\u003e\n\u003cul data-start=\"1516\" data-end=\"1540\"\u003e\n\u003cli data-start=\"1516\" data-end=\"1540\"\u003e\n\u003cp data-start=\"1518\" data-end=\"1540\"\u003e\u003cstrong data-start=\"1518\" data-end=\"1540\"\u003eBox of 15 capsules\u003c\/strong\u003e\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1516\" data-end=\"1540\"\u003e\n\u003cstrong data-start=\"1518\" data-end=\"1540\"\u003e\u003c\/strong\u003e\u003cstrong\u003e\u003cspan style=\"font-family: 'Aptos',sans-serif; mso-ascii-theme-font: minor-latin; mso-hansi-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; color: #ff2a00;\"\u003ePlease read the following full disclosure before purchasing or using this product.\u003c\/span\u003e\u003c\/strong\u003e\u003cspan style=\"font-family: 'Arial',sans-serif;\"\u003e\u003c\/span\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"1516\" data-end=\"1540\"\u003e\n\u003cdiv class=\"flex flex-col text-sm pb-25\"\u003e\n\u003carticle class=\"text-token-text-primary w-full focus:outline-none [--shadow-height:45px] has-data-writing-block:pointer-events-none has-data-writing-block:-mt-(--shadow-height) has-data-writing-block:pt-(--shadow-height) [\u0026amp;:has([data-writing-block])\u0026gt;*]:pointer-events-auto scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]\" dir=\"auto\" data-turn-id=\"request-WEB:0fcb13a0-8855-4e01-9f7b-c8aea10a6590-28\" data-testid=\"conversation-turn-4\" data-scroll-anchor=\"true\" data-turn=\"assistant\" tabindex=\"-1\"\u003e\n\u003cdiv class=\"text-base my-auto mx-auto pb-10 [--thread-content-margin:--spacing(4)] @w-sm\/main:[--thread-content-margin:--spacing(6)] @w-lg\/main:[--thread-content-margin:--spacing(16)] px-(--thread-content-margin)\"\u003e\n\u003cdiv class=\"[--thread-content-max-width:40rem] @w-lg\/main:[--thread-content-max-width:48rem] mx-auto max-w-(--thread-content-max-width) flex-1 group\/turn-messages focus-visible:outline-hidden relative flex w-full min-w-0 flex-col agent-turn\" tabindex=\"-1\"\u003e\n\u003cdiv class=\"flex max-w-full flex-col grow\"\u003e\n\u003cdiv data-message-author-role=\"assistant\" data-message-id=\"6de1bca0-986b-451c-8c38-5e50cd97512f\" dir=\"auto\" class=\"min-h-8 text-message relative flex w-full flex-col items-end gap-2 text-start break-words whitespace-normal [.text-message+\u0026amp;]:mt-1\" data-message-model-slug=\"gpt-5-2-thinking\"\u003e\n\u003cdiv class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[1px]\"\u003e\n\u003cdiv class=\"markdown prose dark:prose-invert w-full wrap-break-word light markdown-new-styling\"\u003e\n\u003cp data-start=\"0\" data-end=\"38\"\u003e\u003cstrong data-start=\"0\" data-end=\"38\"\u003eSUMMARY OF PRODUCT CHARACTERISTICS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"40\" data-end=\"71\"\u003eANSM – Last updated: 30\/07\/2024\u003c\/p\u003e\n\u003cp data-start=\"73\" data-end=\"250\"\u003eIN THIS ANNEX, THE TERM “MARKETING AUTHORISATION” IS TO BE UNDERSTOOD AS “REGISTRATION OF A TRADITIONAL HERBAL MEDICINAL PRODUCT” AND THE TERM “AUTHORISATION” AS “REGISTRATION”.\u003c\/p\u003e\n\u003chr data-start=\"252\" data-end=\"255\"\u003e\n\u003ch2 data-start=\"257\" data-end=\"292\"\u003e1. NAME OF THE MEDICINAL PRODUCT\u003c\/h2\u003e\n\u003cp data-start=\"294\" data-end=\"319\"\u003e\u003cstrong data-start=\"294\" data-end=\"319\"\u003eSINUFIX, soft capsule\u003c\/strong\u003e\u003c\/p\u003e\n\u003chr data-start=\"321\" data-end=\"324\"\u003e\n\u003ch2 data-start=\"326\" data-end=\"372\"\u003e2. QUALITATIVE AND QUANTITATIVE COMPOSITION\u003c\/h2\u003e\n\u003cp data-start=\"374\" data-end=\"743\"\u003eLemon (\u003cstrong data-start=\"381\" data-end=\"414\"\u003eCitrus limon (L.) Burman fil.\u003c\/strong\u003e) (essential oil from peel\/pericarp) .................................... \u003cstrong data-start=\"488\" data-end=\"499\"\u003e11.4 mg\u003c\/strong\u003e\u003cbr data-start=\"499\" data-end=\"502\"\u003eThyme (\u003cstrong data-start=\"509\" data-end=\"531\"\u003eThymus vulgaris L.\u003c\/strong\u003e or \u003cstrong data-start=\"535\" data-end=\"554\"\u003eThymus zygis L.\u003c\/strong\u003e) (essential oil from aerial parts) ............... \u003cstrong data-start=\"606\" data-end=\"617\"\u003e11.4 mg\u003c\/strong\u003e\u003cbr data-start=\"617\" data-end=\"620\"\u003ePeppermint (\u003cstrong data-start=\"632\" data-end=\"656\"\u003eMentha x piperita L.\u003c\/strong\u003e) (essential oil from fresh aerial parts) ................................. \u003cstrong data-start=\"732\" data-end=\"743\"\u003e11.4 mg\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp data-start=\"745\" data-end=\"766\"\u003ePer one soft capsule.\u003c\/p\u003e\n\u003cp data-start=\"768\" data-end=\"817\"\u003eFor the full list of excipients, see section 6.1.\u003c\/p\u003e\n\u003chr data-start=\"819\" data-end=\"822\"\u003e\n\u003ch2 data-start=\"824\" data-end=\"849\"\u003e3. PHARMACEUTICAL FORM\u003c\/h2\u003e\n\u003cp data-start=\"851\" data-end=\"864\"\u003eSoft capsule.\u003c\/p\u003e\n\u003chr data-start=\"866\" data-end=\"869\"\u003e\n\u003ch2 data-start=\"871\" data-end=\"897\"\u003e4. CLINICAL PARTICULARS\u003c\/h2\u003e\n\u003ch3 data-start=\"899\" data-end=\"931\"\u003e4.1. Therapeutic indications\u003c\/h3\u003e\n\u003cp data-start=\"932\" data-end=\"1027\"\u003eTraditional herbal medicinal product used for the \u003cstrong data-start=\"982\" data-end=\"1026\"\u003esymptomatic treatment of the common cold\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"1029\" data-end=\"1124\"\u003eUse is reserved for the specified indication \u003cstrong data-start=\"1074\" data-end=\"1123\"\u003eexclusively on the basis of long-standing use\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"1126\" data-end=\"1175\"\u003e\u003cstrong data-start=\"1126\" data-end=\"1175\"\u003eSINUFIX, soft capsule is indicated in adults.\u003c\/strong\u003e\u003c\/p\u003e\n\u003ch3 data-start=\"1177\" data-end=\"1223\"\u003e4.2. Posology and method of administration\u003c\/h3\u003e\n\u003cp data-start=\"1225\" data-end=\"1281\"\u003e\u003cstrong data-start=\"1225\" data-end=\"1237\"\u003ePosology\u003c\/strong\u003e\u003cbr data-start=\"1237\" data-end=\"1240\"\u003eAdults: \u003cstrong data-start=\"1248\" data-end=\"1280\"\u003e1 soft capsule 3 times daily\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"1283\" data-end=\"1406\"\u003e\u003cstrong data-start=\"1283\" data-end=\"1308\"\u003ePaediatric population\u003c\/strong\u003e\u003cbr data-start=\"1308\" data-end=\"1311\"\u003eUse in children and adolescents under 18 years of age is \u003cstrong data-start=\"1368\" data-end=\"1387\"\u003enot recommended\u003c\/strong\u003e (see section 4.4).\u003c\/p\u003e\n\u003cp data-start=\"1408\" data-end=\"1523\"\u003e\u003cstrong data-start=\"1408\" data-end=\"1436\"\u003eMethod of administration\u003c\/strong\u003e\u003cbr data-start=\"1436\" data-end=\"1439\"\u003eOral use.\u003cbr data-start=\"1448\" data-end=\"1451\"\u003eSwallow the capsule whole, without chewing, with a large glass of water.\u003c\/p\u003e\n\u003cp data-start=\"1525\" data-end=\"1650\"\u003e\u003cstrong data-start=\"1525\" data-end=\"1550\"\u003eDuration of treatment\u003c\/strong\u003e\u003cbr data-start=\"1550\" data-end=\"1553\"\u003e\u003cstrong data-start=\"1553\" data-end=\"1564\"\u003e5 days.\u003c\/strong\u003e\u003cbr data-start=\"1564\" data-end=\"1567\"\u003eIf symptoms persist beyond 5 days of use, a doctor or pharmacist must be consulted.\u003c\/p\u003e\n\u003ch3 data-start=\"1652\" data-end=\"1678\"\u003e4.3. Contraindications\u003c\/h3\u003e\n\u003cp data-start=\"1679\" data-end=\"1848\"\u003eHypersensitivity to the active substances, to extracts from the following botanical genera \u003cstrong data-start=\"1770\" data-end=\"1796\"\u003eCitrus, Thymus, Mentha\u003c\/strong\u003e, or to any of the excipients listed in section 6.1.\u003c\/p\u003e\n\u003cp data-start=\"1850\" data-end=\"1999\"\u003eDue to the presence of \u003cstrong data-start=\"1873\" data-end=\"1896\"\u003eterpene derivatives\u003c\/strong\u003e, this medicinal product is contraindicated in patients with a history of \u003cstrong data-start=\"1970\" data-end=\"1998\"\u003eepilepsy and\/or seizures\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"2001\" data-end=\"2096\"\u003eDue to the presence of \u003cstrong data-start=\"2024\" data-end=\"2052\"\u003epeppermint essential oil\u003c\/strong\u003e, this medicinal product is contraindicated:\u003c\/p\u003e\n\u003cul data-start=\"2097\" data-end=\"2224\"\u003e\n\u003cli data-start=\"2097\" data-end=\"2123\"\u003e\n\u003cp data-start=\"2099\" data-end=\"2123\"\u003ein \u003cstrong data-start=\"2102\" data-end=\"2120\"\u003eliver diseases\u003c\/strong\u003e,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"2124\" data-end=\"2201\"\u003e\n\u003cp data-start=\"2126\" data-end=\"2201\"\u003ein \u003cstrong data-start=\"2129\" data-end=\"2143\"\u003egallstones\u003c\/strong\u003e, \u003cstrong data-start=\"2145\" data-end=\"2160\"\u003echolangitis\u003c\/strong\u003e, or other \u003cstrong data-start=\"2171\" data-end=\"2198\"\u003ebiliary tract disorders\u003c\/strong\u003e,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"2202\" data-end=\"2224\"\u003e\n\u003cp data-start=\"2204\" data-end=\"2224\"\u003ein \u003cstrong data-start=\"2207\" data-end=\"2223\"\u003eachlorhydria\u003c\/strong\u003e.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch3 data-start=\"2226\" data-end=\"2275\"\u003e4.4. Special warnings and precautions for use\u003c\/h3\u003e\n\u003cp data-start=\"2276\" data-end=\"2327\"\u003eFollow the recommended dose and treatment duration.\u003c\/p\u003e\n\u003cp data-start=\"2329\" data-end=\"2470\"\u003eIn the event of \u003cstrong data-start=\"2345\" data-end=\"2354\"\u003efever\u003c\/strong\u003e, \u003cstrong data-start=\"2356\" data-end=\"2382\"\u003ebreathing difficulties\u003c\/strong\u003e, \u003cstrong data-start=\"2384\" data-end=\"2403\"\u003epurulent sputum\u003c\/strong\u003e, or \u003cstrong data-start=\"2408\" data-end=\"2430\"\u003eworsening symptoms\u003c\/strong\u003e during use, a doctor must be consulted.\u003c\/p\u003e\n\u003cp data-start=\"2472\" data-end=\"2555\"\u003eThis product contains \u003cstrong data-start=\"2494\" data-end=\"2517\"\u003eterpene derivatives\u003c\/strong\u003e which, at excessive doses, may cause:\u003c\/p\u003e\n\u003cul data-start=\"2556\" data-end=\"2650\"\u003e\n\u003cli data-start=\"2556\" data-end=\"2604\"\u003e\n\u003cp data-start=\"2558\" data-end=\"2604\"\u003eseizure-type events in infants and children,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"2605\" data-end=\"2650\"\u003e\n\u003cp data-start=\"2607\" data-end=\"2650\"\u003erespiratory pauses and collapse in infants.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-start=\"2652\" data-end=\"2836\"\u003ePatients with \u003cstrong data-start=\"2666\" data-end=\"2679\"\u003eheartburn\u003c\/strong\u003e or \u003cstrong data-start=\"2683\" data-end=\"2700\"\u003ehiatal hernia\u003c\/strong\u003e may sometimes experience worsening of symptoms after taking peppermint essential oil. Treatment must be discontinued in these patients.\u003c\/p\u003e\n\u003cp data-start=\"2838\" data-end=\"2967\"\u003ePeppermint essential oil should be used with caution in people with \u003cstrong data-start=\"2906\" data-end=\"2966\"\u003einflammation or ulceration of the gastrointestinal tract\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"2969\" data-end=\"3124\"\u003e\u003cstrong data-start=\"2969\" data-end=\"2994\"\u003ePaediatric population\u003c\/strong\u003e\u003cbr data-start=\"2994\" data-end=\"2997\"\u003eIn the absence of sufficient data in this population, use in children and adolescents under 18 years of age is not recommended.\u003c\/p\u003e\n\u003ch3 data-start=\"3126\" data-end=\"3207\"\u003e4.5. Interaction with other medicinal products and other forms of interaction\u003c\/h3\u003e\n\u003cp data-start=\"3208\" data-end=\"3251\"\u003eNo interaction studies have been performed.\u003c\/p\u003e\n\u003ch3 data-start=\"3253\" data-end=\"3296\"\u003e4.6. Fertility, pregnancy and lactation\u003c\/h3\u003e\n\u003cp data-start=\"3298\" data-end=\"3581\"\u003e\u003cstrong data-start=\"3298\" data-end=\"3311\"\u003ePregnancy\u003c\/strong\u003e\u003cbr data-start=\"3311\" data-end=\"3314\"\u003eThis medicinal product contains \u003cstrong data-start=\"3346\" data-end=\"3369\"\u003eterpene derivatives\u003c\/strong\u003e. There are no or limited data on the use of terpene derivatives in pregnant women.\u003cbr data-start=\"3452\" data-end=\"3455\"\u003e\u003cstrong data-start=\"3455\" data-end=\"3516\"\u003eSINUFIX, soft capsule is not recommended during pregnancy\u003c\/strong\u003e, and in women of childbearing potential not using contraception.\u003c\/p\u003e\n\u003cp data-start=\"3583\" data-end=\"3850\"\u003e\u003cstrong data-start=\"3583\" data-end=\"3601\"\u003eBreast-feeding\u003c\/strong\u003e\u003cbr data-start=\"3601\" data-end=\"3604\"\u003eThere are no data on the excretion into breast milk of the essential oil components contained in SINUFIX and\/or their metabolites. A risk to newborns\/infants cannot be excluded.\u003cbr data-start=\"3781\" data-end=\"3784\"\u003eThis medicinal product \u003cstrong data-start=\"3807\" data-end=\"3849\"\u003emust not be used during breast-feeding\u003c\/strong\u003e.\u003c\/p\u003e\n\u003cp data-start=\"3852\" data-end=\"3900\"\u003e\u003cstrong data-start=\"3852\" data-end=\"3865\"\u003eFertility\u003c\/strong\u003e\u003cbr data-start=\"3865\" data-end=\"3868\"\u003eNo fertility data are available.\u003c\/p\u003e\n\u003ch3 data-start=\"3902\" data-end=\"3955\"\u003e4.7. Effects on ability to drive and use machines\u003c\/h3\u003e\n\u003cp data-start=\"3956\" data-end=\"4027\"\u003eEffects on the ability to drive and use machines have not been studied.\u003c\/p\u003e\n\u003ch3 data-start=\"4029\" data-end=\"4057\"\u003e4.8. Undesirable effects\u003c\/h3\u003e\n\u003cp data-start=\"4058\" data-end=\"4156\"\u003eDue to the presence of essential oils and if the indication or recommended doses are not followed:\u003c\/p\u003e\n\u003cul data-start=\"4157\" data-end=\"4320\"\u003e\n\u003cli data-start=\"4157\" data-end=\"4190\"\u003e\n\u003cp data-start=\"4159\" data-end=\"4190\"\u003erisk of seizures in children,\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"4191\" data-end=\"4271\"\u003e\n\u003cp data-start=\"4193\" data-end=\"4271\"\u003epossibility of digestive disorders, in particular stomach pain (gastralgia),\u003c\/p\u003e\n\u003c\/li\u003e\n\u003cli data-start=\"4272\" data-end=\"4320\"\u003e\n\u003cp data-start=\"4274\" data-end=\"4320\"\u003erisk of contact allergy or allergic reactions.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp data-start=\"4322\" data-end=\"4524\"\u003eContact allergy to peppermint oil has been reported in patients with intra-oral symptoms associated with burning mouth syndrome, recurrent oral ulceration, or a lichenoid reaction. Frequency is unknown.\u003c\/p\u003e\n\u003cp data-start=\"4526\" data-end=\"4702\"\u003eAllergic reactions to menthol have been reported, including headache, bradycardia, muscle tremors, ataxia, anaphylactic shock, and erythematous skin rash. Frequency is unknown.\u003c\/p\u003e\n\u003cp data-start=\"4704\" data-end=\"5191\"\u003e\u003cstrong data-start=\"4704\" data-end=\"4748\"\u003eReporting of suspected adverse reactions\u003c\/strong\u003e\u003cbr data-start=\"4748\" data-end=\"4751\"\u003eReporting suspected adverse reactions after registration is important. It allows continued monitoring of the benefit\/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres – Website: \u003ca data-start=\"5149\" data-end=\"5190\" rel=\"noopener\" class=\"decorated-link\" href=\"https:\/\/signalement.social-sante.gouv.fr\/\"\u003ehttps:\/\/signalement.social-sante.gouv.fr\/\u003cspan aria-hidden=\"true\" class=\"ms-0.5 inline-block align-middle leading-none\"\u003e\u003csvg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"20\" height=\"20\" aria-hidden=\"true\" data-rtl-flip=\"\" class=\"block h-[0.75em] w-[0.75em] stroke-current stroke-[0.75]\"\u003e\u003cuse fill=\"currentColor\" href=\"\/cdn\/assets\/sprites-core-mxwopdm6.svg#304883\"\u003e\u003c\/use\u003e\u003c\/svg\u003e\u003c\/span\u003e\u003c\/a\u003e.\u003c\/p\u003e\n\u003ch3 data-start=\"5193\" data-end=\"5210\"\u003e4.9. Overdose\u003c\/h3\u003e\n\u003cp data-start=\"5211\" data-end=\"5486\"\u003eOverdose may cause severe gastrointestinal symptoms (such as nausea, diarrhea, rectal ulceration), central nervous system disorders (such as seizures, ataxia, loss of consciousness), urinary disorders, and cardiac rhythm disturbances, probably due to the presence of menthol.\u003c\/p\u003e\n\u003cp data-start=\"5488\" data-end=\"5585\"\u003eIn the event of massive overdose, treatment consists of gastric lavage and symptomatic treatment.\u003c\/p\u003e\n\u003chr data-start=\"5587\" data-end=\"5590\"\u003e\n\u003ch2 data-start=\"5592\" data-end=\"5624\"\u003e5. PHARMACOLOGICAL PROPERTIES\u003c\/h2\u003e\n\u003ch3 data-start=\"5626\" data-end=\"5661\"\u003e5.1. Pharmacodynamic properties\u003c\/h3\u003e\n\u003cp data-start=\"5662\" data-end=\"5677\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch3 data-start=\"5679\" data-end=\"5714\"\u003e5.2. Pharmacokinetic properties\u003c\/h3\u003e\n\u003cp data-start=\"5715\" data-end=\"5730\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch3 data-start=\"5732\" data-end=\"5764\"\u003e5.3. Preclinical safety data\u003c\/h3\u003e\n\u003cp data-start=\"5765\" data-end=\"5878\"\u003eThe in vitro genotoxicity study conducted with Sinufix, soft capsule showed no mutagenic effect in the Ames test.\u003c\/p\u003e\n\u003cp data-start=\"5880\" data-end=\"5976\"\u003eNo carcinogenicity studies or reproduction and development toxicity studies have been performed.\u003c\/p\u003e\n\u003chr data-start=\"5978\" data-end=\"5981\"\u003e\n\u003ch2 data-start=\"5983\" data-end=\"6015\"\u003e6. PHARMACEUTICAL PARTICULARS\u003c\/h2\u003e\n\u003ch3 data-start=\"6017\" data-end=\"6044\"\u003e6.1. List of excipients\u003c\/h3\u003e\n\u003cp data-start=\"6045\" data-end=\"6115\"\u003eMedium-chain triglycerides (RSPO: Roundtable on Sustainable Palm Oil).\u003c\/p\u003e\n\u003cp data-start=\"6117\" data-end=\"6176\"\u003eCapsule shell composition: bovine gelatin, glycerol, water.\u003c\/p\u003e\n\u003ch3 data-start=\"6178\" data-end=\"6204\"\u003e6.2. Incompatibilities\u003c\/h3\u003e\n\u003cp data-start=\"6205\" data-end=\"6220\"\u003eNot applicable.\u003c\/p\u003e\n\u003ch3 data-start=\"6222\" data-end=\"6241\"\u003e6.3. Shelf life\u003c\/h3\u003e\n\u003cp data-start=\"6242\" data-end=\"6250\"\u003e3 years.\u003c\/p\u003e\n\u003ch3 data-start=\"6252\" data-end=\"6292\"\u003e6.4. Special precautions for storage\u003c\/h3\u003e\n\u003cp data-start=\"6293\" data-end=\"6339\"\u003eStore at a temperature not exceeding \u003cstrong data-start=\"6330\" data-end=\"6338\"\u003e30°C\u003c\/strong\u003e.\u003c\/p\u003e\n\u003ch3 data-start=\"6341\" data-end=\"6382\"\u003e6.5. Nature and contents of container\u003c\/h3\u003e\n\u003cp data-start=\"6383\" data-end=\"6455\"\u003e15 soft capsules in blisters (PVC\/PVDC\/Aluminium) in a cardboard carton.\u003c\/p\u003e\n\u003ch3 data-start=\"6457\" data-end=\"6517\"\u003e6.6. Special precautions for disposal and other handling\u003c\/h3\u003e\n\u003cp data-start=\"6518\" data-end=\"6542\"\u003eNo special requirements.\u003c\/p\u003e\n\u003chr data-start=\"6544\" data-end=\"6547\"\u003e\n\u003ch2 data-start=\"6549\" data-end=\"6585\"\u003e7. MARKETING AUTHORISATION HOLDER\u003c\/h2\u003e\n\u003cp data-start=\"6587\" data-end=\"6656\"\u003e\u003cstrong data-start=\"6587\" data-end=\"6602\"\u003eSYLVEOS SAS\u003c\/strong\u003e\u003cbr data-start=\"6602\" data-end=\"6605\"\u003e12 Avenue de la Grande Armée\u003cbr data-start=\"6633\" data-end=\"6636\"\u003e75017 Paris\u003cbr data-start=\"6647\" data-end=\"6650\"\u003eFrance\u003c\/p\u003e\n\u003chr data-start=\"6658\" data-end=\"6661\"\u003e\n\u003ch2 data-start=\"6663\" data-end=\"6702\"\u003e8. MARKETING AUTHORISATION NUMBER(S)\u003c\/h2\u003e\n\u003cul data-start=\"6704\" data-end=\"6801\"\u003e\n\u003cli data-start=\"6704\" data-end=\"6801\"\u003e\n\u003cp data-start=\"6706\" data-end=\"6801\"\u003e\u003cstrong data-start=\"6706\" data-end=\"6727\"\u003e34009 302 303 1 2\u003c\/strong\u003e: 15 soft capsules in blisters (PVC\/PVDC\/Aluminium) in a cardboard carton.\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003chr data-start=\"6803\" data-end=\"6806\"\u003e\n\u003ch2 data-start=\"6808\" data-end=\"6870\"\u003e9. DATE OF FIRST AUTHORISATION\/RENEWAL OF THE AUTHORISATION\u003c\/h2\u003e\n\u003cp data-start=\"6871\" data-end=\"6908\"\u003e[To be completed later by the holder]\u003c\/p\u003e\n\u003chr data-start=\"6910\" data-end=\"6913\"\u003e\n\u003ch2 data-start=\"6915\" data-end=\"6950\"\u003e10. DATE OF REVISION OF THE TEXT\u003c\/h2\u003e\n\u003cp data-start=\"6951\" data-end=\"6988\"\u003e[To be completed later by the holder]\u003c\/p\u003e\n\u003chr data-start=\"6990\" data-end=\"6993\"\u003e\n\u003ch2 data-start=\"6995\" data-end=\"7011\"\u003e11. DOSIMETRY\u003c\/h2\u003e\n\u003cp data-start=\"7012\" data-end=\"7027\"\u003eNot applicable.\u003c\/p\u003e\n\u003chr data-start=\"7029\" data-end=\"7032\"\u003e\n\u003ch2 data-start=\"7034\" data-end=\"7093\"\u003e12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS\u003c\/h2\u003e\n\u003cp data-start=\"7094\" data-end=\"7109\"\u003eNot applicable.\u003c\/p\u003e\n\u003chr data-start=\"7111\" data-end=\"7114\"\u003e\n\u003ch2 data-start=\"7116\" data-end=\"7156\"\u003eCONDITIONS OF PRESCRIPTION AND SUPPLY\u003c\/h2\u003e\n\u003cp data-start=\"7158\" data-end=\"7193\" data-is-last-node=\"\" data-is-only-node=\"\"\u003eNon-prescription medicinal product.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"z-0 flex min-h-[46px] justify-start\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003cdiv class=\"mt-3 w-full empty:hidden\"\u003e\n\u003cdiv class=\"text-center\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/article\u003e\n\u003c\/div\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Pharmarcie.com","offers":[{"title":"Default Title","offer_id":45347658498220,"sku":"P3400930230312","price":23.29,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0604\/4047\/7868\/files\/Alisting3_995da450-f1cf-4846-97ab-8018dbbde98f.jpg?v=1771746250","url":"https:\/\/pharmarcie.com\/products\/sinufix-cold-treatment-capsules-essential-oils-15-capsules-adult","provider":"Pharmarcie.com","version":"1.0","type":"link"}