Acetylcysteine 200mg Powder for Oral Solution

Colonis Pharma Ltd🇬🇧 Electronic Medicines Compendium

Approval Date: N/A
Approval ID: dff7d27975cfed51
Company: Colonis Pharma Ltd
Type: Standard

Approval Details

Approval Id: dff7d27975cfed51
Drug Approval Emc Name: Acetylcysteine 200mg Powder for Oral Solution
Drug Name: Acetylcysteine 200mg Powder for Oral Solution
Company Name: Colonis Pharma Ltd
Company Address: 25 Bedford Square, Bloomsbury, London, WC1B 3HH
Company Website: //www.colonis.co.uk
Company Medical Info Direct Line: +44 (0) 1932 555 026
Company Medical Info Email: medinfo@colonis.co.uk
Atc Code: R05CB01
Legal Category: Prescription only medicine
Authorisation Holder: Colonis Pharma Limited 25 Bedford Square Bloomsbury London WC1B 3HH United Kingdom
Authorisation Number: PLGB 41344/0072
Authorisation Date: 01/11/2024
Instruction Authorisation Holder: Colonis Pharma Limited 25 Bedford Square Bloomsbury London WC1B 3HH United Kingdom
Instruction Authorisation Number: PLGB 41344/0072
Instruction Authorisation Date: 01/11/2024
Instruction Composition: Each sachet contains Acetylcysteine 200 mg. Excipient(s) with known effect: aspartame (E951): 26 mg per sachet sorbitol (E420): 723.34 mg per sachet sunset yellow (E110): 0.66 mg per sachet For the full list of excipients, see section 6.1.
Instruction Dosage Form: Powder for oral solution. White to slightly pink powder.
Instruction Clinical Particulars: 4.1 Therapeutic indications Mucolytic adjuvant in the therapy of respiratory disorders associated with thick, viscous, mucus hypersecretion.4.2 Posology and method of administration \*\*Posology\*\* Adults and adolescents over the age of 12 years 200 mg (1 sachet) 3 times a day. Maximum recommended daily dose 600 mg/day. The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor treating the patient for adults and adolescents. Abundant fluid intake supports the mucolytic effect of acetylcysteine. \*\*Method of administration\*\* Dissolve the contents of one sachet completely in a glass containing a little water just before use, stirring as needed with a teaspoon.4.3 Contraindications Hypersensitivity to the active substance, other chemically similar substance (for example carbocisteine, erdosteine or mecysteine) or to any of the excipients listed in section 6.1. Patients with phenylketonuria, as the product contains aspartame.4.4 Special warnings and precautions for use Patients with bronchial asthma should be closely monitored during therapy; if bronchospasm occurs, treatment with Acetylcysteine 200 mg Powder for Oral Solution should be discontinued immediately. Administration of acetylcysteine, especially at the beginning of treatment, may liquefy bronchial secretions and, at the same time, increase their volume. If the patient is unable to expectorate efficiently, to avoid retention of secretions postural drainage and tracheal suction should be used. Caution is recommended in patients with a history of peptic ulcers, especially in the case of concomitant administration with other medicines that have a known irritation effect on the gastric mucosa. Acetylcysteine can moderately affect histamine metabolism, therefore caution should be taken when administering the drug for a prolonged period of treatment in patients with histamine intolerance, as symptoms of intolerance may appear (headache, vasomotor rhinitis, pruritus). There are no studies on the efficacy and safety of acetylcysteine 200 mg three times daily in adolescent population. However, mild to severe adverse reactions have been reported with the use of IV acetylcysteine in adults and adolescents. This medicine contains 723.34 mg sorbitol in each sachet. Patients with rare hereditary problems of fructose intolerance should not take this medicine.The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. This medicine contains 26 mg of aspartame in each sachet. Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine. This may be harmful to people with phenylketonuria a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. This medicine contains a colouring agent called sunset yellow (E110), which may cause allergic reactions. Acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates. Acetylcysteine can interfere with tests for ketones in urine. Upon opening the sachet the powder may smell of sulphur (rotten egg smell). This is a normal characteristic of the active substance. Upon addition of water the solution will have a citrus odour. Paediatric population Due to the physiological characteristics of the airways in children younger than 2 years, the ability to expectorate may be limited. Therefore, mucolytic substances should not be given to children under 2 years.4.5 Interaction with other medicinal products and other forms of interaction Drug Interactions Antitussive drugs and acetylcysteine should not be administered concomitantly because reducing the cough reflex may lead to a build-up of bronchial secretions. Activated charcoal may reduce the effect of acetylcysteine. It is advisable not to mix Acetylcysteine 200 mg Powder for Oral Solution with other medicinal products. \*In vitro\* tests have shown that when cephalosporin antibiotics and acetylcysteine are mixed, there is a degree of antibiotic inactivation. It is precautionary to advise the administration of oral antibiotics at least two hours before or after acetylcysteine. Concurrent use of nitroglycerin and acetylcysteine causes significant hypotension and leads to temporal artery dilation with possible onset of headache. If concurrent use of nitroglycerin and acetylcysteine is required, patients should be monitored and warned for hypotension that can be severe and accompanied by a headache. Concomitant use of acetylcysteine and carbamazepine may result in sub-therapeutic carbamazepine levels.4.6 Fertility, pregnancy and lactation Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Acetylcysteine 200 mg Powder for Oral Solution during pregnancy. Breastfeeding There is insufficient information on the excretion of acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive or use machines have been performed. Acetylcysteine 200 mg Powder for Oral Solution has no known effect on the ability to drive and use machines.4.8 Undesirable effects Adverse reactions are listed below, by system organ class and frequency. | | | | | | | --- | --- | --- | --- | --- | | \*\*System Organ Class\*\* | \*\*Frequency / Adverse Reactions\*\* | | | | | Uncommon (≥1/1,000, < 1/100) | Rare (≥1/10,000, < 1/1,000) | Very rare (< 1/10,000) | Not known | | Immune system disorders | Hypersensitivity | | Anaphylactic shock, anaphylactic/ anaphylactoid reaction | | | Nervous system disorders | Headache | | | | | Ear and labyrinth disorders | Tinnitus | | | | | Cardiac disorders | Tachycardia | | | | | Vascular disorders | Hypotension | | Haemorrhage | | | Respiratory, thoracic and mediastinal disorders | | Bronchospasm, dyspnoea | | | | Gastrointestinal disorders | Vomiting, diarrhoea, stomatitis, abdominal pain, nausea | Dyspepsia | | | | Skin and subcutaneous tissue disorders | Urticaria, rash, angioedema, pruritus | | | | | General disorders and administration site conditions | Fever | | | Oedema of the face | The occurrence of serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of acetylcysteine. In most of these cases reported at least one other drug was administered at the same time, which may have possibly enhanced the described mucocutaneous effects. In case of the recurrence of skin and mucosal lesions, medical advice should be sought at once and the use of acetylcysteine terminated immediately. A decreased blood platelet aggregation in the presence of acetylcysteine has been confirmed by various studies. The clinical relevance has not yet been clarified to date. 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose An acute overdose of acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea. \*\*Treatment of Overdose\*\* Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition.
Instruction Pharmacology: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Mycolytics, ATC code: R05CB01 N-acetyl-L-cysteine (NAC), the active ingredient in Acetylcysteine 200 mg Powder for Oral Solution exerts an intense mucolytic-fluidizing action on mucous and mucopurulent secretions by depolymerizing the mucoproteic complexes and the nucleic acids which confer viscosity to the vitreous and purulent component of the sputum and other secretions. Furthermore, acetylcysteine exerts a direct antioxidant action, having a free thiol ( SH) nucleophilic group that is able to interact directly with electrophilic groups of oxidant radicals. Of particular interest is the recent finding that acetylcysteine protects α1-antitrypsin enzyme inhibiting elastase from inactivation by hypochlorous acid (HOCl), a powerful oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes. Due to its molecular structure, acetylcysteine can readily cross cell membranes. Inside the cell, NAC is deacetylated to L-cysteine, an amino acid essential for glutathione synthesis (GSH). GSH is a highly reactive tripeptide found ubiquitously in the various tissues of animals and is essential for the maintenance of functional capacity as well as cellular morphological integrity. It is the most important protective intracellular mechanism against oxidant radicals, both exogenous and endogenous, as well as toward numerous cytotoxic substances. These features make Acetylcysteine 200 mg Powder for Oral Solution particularly suitable for the treatment of acute and chronic affections of the respiratory system, characterised by thick, viscous mucous and mucopurulent secretions. There is no evidence on the efficacy and safety of mucolytics including acetylcysteine in acute bronchitis.5.2 Pharmacokinetic properties Absorption Following oral administration, acetylcysteine is rapidly and almost completely absorbed and metabolised in the liver to cysteine (the pharmacologically active metabolite), diacetylcysteine, cysteine and further mixed disulphides. Distribution Due to the high first-pass effect, the bioavailability of orally administered acetylcysteine is very low (approximately 10%). In humans, maximum plasma concentrations are achieved after 1-3 hours with the maximum plasma concentration of the metabolite cysteine in the range of approximately 2µmol/l. The protein binding of Acetylcysteine was determined to be about 50%. Biotransformation Acetylcysteine and its metabolites occur in three different forms in the organism: partially in free form, partially bound to proteins via labile disulphide bonds and partially as incorporated amino acid. Acetylcysteine is excreted almost exclusively in the form of inactive metabolites (inorganic sulphates, diacetylcysteine) via the kidneys. The plasma half-life of Acetylcysteine is approximately 1 hour and is mainly determined by the rapid hepatic biotransformation. Impaired hepatic function therefore leads to prolonged plasma half-lives of up to 8 hours. Elimination Pharmacokinetic studies with intravenous administration of acetylcysteine revealed a distribution volume of 0.47 l/kg (in total) or 0.59 l/kg (reduced acetylcysteine); the plasma clearance was determined to be 0.11 l/h/kg (in total) and 0.84 l/h/kg (reduced acetylcysteine), respectively. The elimination half-life after intravenous administration is 30-40 minutes while excretion follows three-phase kinetics (alpha, beta and terminal gamma phase). Acetylcysteine crosses the placenta and is detected in cord blood. No information is available regarding excretion in breast milk. No knowledge is available concerning the behaviour of acetylcysteine at the bloodbrain barrier in humans.5.3 Preclinical safety data Acute toxicity studies in rats and mice, by oral, intraperitoneal and intravenous administration showed acetylcysteine to be of low toxicity. LD50 values greater than 7 g / kg in mice and 6 g / kg in rats have been reported. Chronic toxicity studies with acetylcysteine in rats at doses up to 2000 mg/ kg/ day and dogs at doses up to 300 mg/ kg / day for periods up to 52 weeks demonstrate that acetylcysteine is well tolerated, even at higher doses. In reproductive toxicity studies in rats and rabbits, the oral administration of doses up to 2000 mg / kg / day did not show changes in reproductive capacity, teratogenic effects or peri/postnatal toxicity.
Instruction Pharmaceutical Particulars: 6.1 List of excipients Aspartame (E951) Sorbitol (E420) Lemon flavour (contains maltodextrin, a form of glucose) Sunset yellow (E110)6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.6.3 Shelf life 3 years After reconstitution, the product must be administered immediately.6.4 Special precautions for storage Store in the original package to protect from moisture.6.5 Nature and contents of container Paper/aluminium/polyethylene sachet containing l g powder for oral solution, packaged in a cardboard box, in the following pack sizes: 10, 18, 20, 30 sachets. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling No special requirements for disposal. Any unused product should be disposed of in accordance with local requirements.
Instruction Content: ## Composition Each sachet contains Acetylcysteine 200 mg. Excipient(s) with known effect: aspartame (E951): 26 mg per sachet sorbitol (E420): 723.34 mg per sachet sunset yellow (E110): 0.66 mg per sachet For the full list of excipients, see section 6.1. ## Pharmaceutical Form Powder for oral solution. White to slightly pink powder. ## Clinical Particulars 4.1 Therapeutic indications Mucolytic adjuvant in the therapy of respiratory disorders associated with thick, viscous, mucus hypersecretion.4.2 Posology and method of administration \*\*Posology\*\* Adults and adolescents over the age of 12 years 200 mg (1 sachet) 3 times a day. Maximum recommended daily dose 600 mg/day. The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor treating the patient for adults and adolescents. Abundant fluid intake supports the mucolytic effect of acetylcysteine. \*\*Method of administration\*\* Dissolve the contents of one sachet completely in a glass containing a little water just before use, stirring as needed with a teaspoon.4.3 Contraindications Hypersensitivity to the active substance, other chemically similar substance (for example carbocisteine, erdosteine or mecysteine) or to any of the excipients listed in section 6.1. Patients with phenylketonuria, as the product contains aspartame.4.4 Special warnings and precautions for use Patients with bronchial asthma should be closely monitored during therapy; if bronchospasm occurs, treatment with Acetylcysteine 200 mg Powder for Oral Solution should be discontinued immediately. Administration of acetylcysteine, especially at the beginning of treatment, may liquefy bronchial secretions and, at the same time, increase their volume. If the patient is unable to expectorate efficiently, to avoid retention of secretions postural drainage and tracheal suction should be used. Caution is recommended in patients with a history of peptic ulcers, especially in the case of concomitant administration with other medicines that have a known irritation effect on the gastric mucosa. Acetylcysteine can moderately affect histamine metabolism, therefore caution should be taken when administering the drug for a prolonged period of treatment in patients with histamine intolerance, as symptoms of intolerance may appear (headache, vasomotor rhinitis, pruritus). There are no studies on the efficacy and safety of acetylcysteine 200 mg three times daily in adolescent population. However, mild to severe adverse reactions have been reported with the use of IV acetylcysteine in adults and adolescents. This medicine contains 723.34 mg sorbitol in each sachet. Patients with rare hereditary problems of fructose intolerance should not take this medicine.The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. This medicine contains 26 mg of aspartame in each sachet. Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine. This may be harmful to people with phenylketonuria a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. This medicine contains a colouring agent called sunset yellow (E110), which may cause allergic reactions. Acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates. Acetylcysteine can interfere with tests for ketones in urine. Upon opening the sachet the powder may smell of sulphur (rotten egg smell). This is a normal characteristic of the active substance. Upon addition of water the solution will have a citrus odour. Paediatric population Due to the physiological characteristics of the airways in children younger than 2 years, the ability to expectorate may be limited. Therefore, mucolytic substances should not be given to children under 2 years.4.5 Interaction with other medicinal products and other forms of interaction Drug Interactions Antitussive drugs and acetylcysteine should not be administered concomitantly because reducing the cough reflex may lead to a build-up of bronchial secretions. Activated charcoal may reduce the effect of acetylcysteine. It is advisable not to mix Acetylcysteine 200 mg Powder for Oral Solution with other medicinal products. \*In vitro\* tests have shown that when cephalosporin antibiotics and acetylcysteine are mixed, there is a degree of antibiotic inactivation. It is precautionary to advise the administration of oral antibiotics at least two hours before or after acetylcysteine. Concurrent use of nitroglycerin and acetylcysteine causes significant hypotension and leads to temporal artery dilation with possible onset of headache. If concurrent use of nitroglycerin and acetylcysteine is required, patients should be monitored and warned for hypotension that can be severe and accompanied by a headache. Concomitant use of acetylcysteine and carbamazepine may result in sub-therapeutic carbamazepine levels.4.6 Fertility, pregnancy and lactation Pregnancy Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Acetylcysteine 200 mg Powder for Oral Solution during pregnancy. Breastfeeding There is insufficient information on the excretion of acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.4.7 Effects on ability to drive and use machines No studies on the effects on the ability to drive or use machines have been performed. Acetylcysteine 200 mg Powder for Oral Solution has no known effect on the ability to drive and use machines.4.8 Undesirable effects Adverse reactions are listed below, by system organ class and frequency. | | | | | | | --- | --- | --- | --- | --- | | \*\*System Organ Class\*\* | \*\*Frequency / Adverse Reactions\*\* | | | | | Uncommon (≥1/1,000, < 1/100) | Rare (≥1/10,000, < 1/1,000) | Very rare (< 1/10,000) | Not known | | Immune system disorders | Hypersensitivity | | Anaphylactic shock, anaphylactic/ anaphylactoid reaction | | | Nervous system disorders | Headache | | | | | Ear and labyrinth disorders | Tinnitus | | | | | Cardiac disorders | Tachycardia | | | | | Vascular disorders | Hypotension | | Haemorrhage | | | Respiratory, thoracic and mediastinal disorders | | Bronchospasm, dyspnoea | | | | Gastrointestinal disorders | Vomiting, diarrhoea, stomatitis, abdominal pain, nausea | Dyspepsia | | | | Skin and subcutaneous tissue disorders | Urticaria, rash, angioedema, pruritus | | | | | General disorders and administration site conditions | Fever | | | Oedema of the face | The occurrence of serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of acetylcysteine. In most of these cases reported at least one other drug was administered at the same time, which may have possibly enhanced the described mucocutaneous effects. In case of the recurrence of skin and mucosal lesions, medical advice should be sought at once and the use of acetylcysteine terminated immediately. A decreased blood platelet aggregation in the presence of acetylcysteine has been confirmed by various studies. The clinical relevance has not yet been clarified to date. 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose An acute overdose of acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea. \*\*Treatment of Overdose\*\* Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition. ## Pharmacological Properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Mycolytics, ATC code: R05CB01 N-acetyl-L-cysteine (NAC), the active ingredient in Acetylcysteine 200 mg Powder for Oral Solution exerts an intense mucolytic-fluidizing action on mucous and mucopurulent secretions by depolymerizing the mucoproteic complexes and the nucleic acids which confer viscosity to the vitreous and purulent component of the sputum and other secretions. Furthermore, acetylcysteine exerts a direct antioxidant action, having a free thiol ( SH) nucleophilic group that is able to interact directly with electrophilic groups of oxidant radicals. Of particular interest is the recent finding that acetylcysteine protects α1-antitrypsin enzyme inhibiting elastase from inactivation by hypochlorous acid (HOCl), a powerful oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes. Due to its molecular structure, acetylcysteine can readily cross cell membranes. Inside the cell, NAC is deacetylated to L-cysteine, an amino acid essential for glutathione synthesis (GSH). GSH is a highly reactive tripeptide found ubiquitously in the various tissues of animals and is essential for the maintenance of functional capacity as well as cellular morphological integrity. It is the most important protective intracellular mechanism against oxidant radicals, both exogenous and endogenous, as well as toward numerous cytotoxic substances. These features make Acetylcysteine 200 mg Powder for Oral Solution particularly suitable for the treatment of acute and chronic affections of the respiratory system, characterised by thick, viscous mucous and mucopurulent secretions. There is no evidence on the efficacy and safety of mucolytics including acetylcysteine in acute bronchitis.5.2 Pharmacokinetic properties Absorption Following oral administration, acetylcysteine is rapidly and almost completely absorbed and metabolised in the liver to cysteine (the pharmacologically active metabolite), diacetylcysteine, cysteine and further mixed disulphides. Distribution Due to the high first-pass effect, the bioavailability of orally administered acetylcysteine is very low (approximately 10%). In humans, maximum plasma concentrations are achieved after 1-3 hours with the maximum plasma concentration of the metabolite cysteine in the range of approximately 2µmol/l. The protein binding of Acetylcysteine was determined to be about 50%. Biotransformation Acetylcysteine and its metabolites occur in three different forms in the organism: partially in free form, partially bound to proteins via labile disulphide bonds and partially as incorporated amino acid. Acetylcysteine is excreted almost exclusively in the form of inactive metabolites (inorganic sulphates, diacetylcysteine) via the kidneys. The plasma half-life of Acetylcysteine is approximately 1 hour and is mainly determined by the rapid hepatic biotransformation. Impaired hepatic function therefore leads to prolonged plasma half-lives of up to 8 hours. Elimination Pharmacokinetic studies with intravenous administration of acetylcysteine revealed a distribution volume of 0.47 l/kg (in total) or 0.59 l/kg (reduced acetylcysteine); the plasma clearance was determined to be 0.11 l/h/kg (in total) and 0.84 l/h/kg (reduced acetylcysteine), respectively. The elimination half-life after intravenous administration is 30-40 minutes while excretion follows three-phase kinetics (alpha, beta and terminal gamma phase). Acetylcysteine crosses the placenta and is detected in cord blood. No information is available regarding excretion in breast milk. No knowledge is available concerning the behaviour of acetylcysteine at the bloodbrain barrier in humans.5.3 Preclinical safety data Acute toxicity studies in rats and mice, by oral, intraperitoneal and intravenous administration showed acetylcysteine to be of low toxicity. LD50 values greater than 7 g / kg in mice and 6 g / kg in rats have been reported. Chronic toxicity studies with acetylcysteine in rats at doses up to 2000 mg/ kg/ day and dogs at doses up to 300 mg/ kg / day for periods up to 52 weeks demonstrate that acetylcysteine is well tolerated, even at higher doses. In reproductive toxicity studies in rats and rabbits, the oral administration of doses up to 2000 mg / kg / day did not show changes in reproductive capacity, teratogenic effects or peri/postnatal toxicity. ## Pharmaceutical Particulars 6.1 List of excipients Aspartame (E951) Sorbitol (E420) Lemon flavour (contains maltodextrin, a form of glucose) Sunset yellow (E110)6.2 Incompatibilities In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.6.3 Shelf life 3 years After reconstitution, the product must be administered immediately.6.4 Special precautions for storage Store in the original package to protect from moisture.6.5 Nature and contents of container Paper/aluminium/polyethylene sachet containing l g powder for oral solution, packaged in a cardboard box, in the following pack sizes: 10, 18, 20, 30 sachets. Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling No special requirements for disposal. Any unused product should be disposed of in accordance with local requirements.

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