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1. Ratiopharm Cold & Flu Lemon Flavour 1000mg/12.2mg Powder For Oral Solution
2. Ratiopharm Cold & Flu Lemon Flavour 1000mg/12.2mg Powder For Oral Solution

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Ratiopharm Cold & Flu Lemon Flavour 1000mg/12.2mg Powder for Oral Solution

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

1 Sachet contains:

Paracetamol    1000 mg

Phenylephrine hydrochloride* 12.2 mg (*Equivalent to phenylephrine (base) 10.0 mg)

Excipients:

Sucrose 3.8g Aspartame (E951) 35 mg

Sorbitol (E420) 1 mgFor a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Powder for oral solution, sachet White powder

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of the symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion and fever.

Ratio Pharm 1000mg/12.2mg Cold & Flu Lemon Flavour is indicated in adults and children over 16 years of age.

4.2 Posology and method of administration

Oral administration after dissolution in water

Adults who weigh more than 50 kg:

One sachet dissolved by stirring in hot water.

The dose may be repeated in 8 hours.

No more than three doses should be taken in 24 hours.

Children over 16 years of age who weigh more than 50kg: One sachet dissolved by stirring in hot water.

The dose may be repeated in 8 hours.

No more than three doses should be taken in 24 hours.

Children under 16 years of age:

Ratio Pharm 1000mg/12.2mg Cold & Flu Lemon Flavour is not recommended for use in children below the age of 16 without medical advice.

Elderly:

There is no indication that dosage needs to be modified in the elderly.

Doses depend on body weight and age with a maximum of 75 mg/kg body weight for maximum paracetamol daily dose.

4.3 Contraindications

Hypersensitivity to the active substances paracetamol or phenylephrine or any of the excipients.

Severe coronary heart disease.

Hypertension.

Glaucoma.

Hyperthyroidism.

Acute hepatitis

Severe impairment of liver function

Use in patients taking tricyclic antidepressants.

Use in patients who are currently taking ore have taken monoamine oxidase inhibitors (MAOis)within the last 2 weeks.

4.4 Special warnings and precautions for use

Use with caution in patients with

•    Raynaud's phenomenon

•    Diabetes

•    Moderate and severe renal insufficiency

•    Liver function disorders:

mild to moderate hepatocellular insufficiency (including Gilbert’s syndrome), concomitant treatment with medicinal products affecting hepatic functions

•    haemolytic anaemia,

•    dehydration

•    alcohol abuse

•    chronic malnutrition

•    glutathione depletion due to metabolic deficiencies

•    prostatic hypertrophy

•    pheochromocytoma

This product should not be combined with other medicinal products that contain paracetamol. Higher doses than recommended may lead to severe liver damage. Clinical signs of liver damage normally become evident 2 days after ingestion. Antidote should be given as soon as possible. See also section 4.9.

Each sachet contains approximately 3.9 g of carbohydrates. This should be taken into account in patients with diabetes mellitus.

Contains sucrose and sorbitol (E420). Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Contains aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria.

Medical supervision is recommended if symptoms are not relieved or deteriorate within 3 days of therapy with Ratio Pharm 1000mg/12.2mg Cold & Flu Lemon Flavour.

Aspirin-hypersensitive asthmatics may also be hypersensitive to Ratio Pharm 1000mg/12.2mg Cold & Flu Lemon Flavour.

4.5 Interaction with other medicinal products and other forms of interaction

Paracetamol

Drugs which induce hepatic microsomal enzymes, such as alcohol, barbiturates, anticonvulsants such as phenytoine, phenobarbital, methylphenobarbital and primidone, rifampicin, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage.

The speed of absorption of paracetamol may be decreased by anticholinergic drugs (e.g. glycopyrronium, propantheline), and increased by metoclopramide or domperidone and absorption reduced by cholestyramine. Isoniazide reduces paracetamol clearance with possible potentiation of its action and/or toxicity, by inhibiton of its metabolism in the liver. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Probenecid reduces clearance of paracetamol by inhibiting conjugation with glucuronic acid.

Regular use of paracetamol possibly reduces metabolism of zidovudine (increased risk of neutropenia).

Other known effects in concomitant use of paracetamol:

Concomitant use of lamotrigine and paracetamol may result in decreased lamotrigine effectiveness.

Phenylephrine

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta-blockers and other antihypertensives.

The vasopressor effects of phenylephrine can be potentiated by digoxin, MAO inhibitors, tricyclic antidepressants such as amitryptiline, amoxapine, clomipramine, desipramine and doxepine or tetracyclics such as maprotiline; antidepressants such as phenelzine, isocarboxylic acid, nialamide, tranylcipromine, moclobemide; Parkinson's disease drugs such as selegiline, and others such as furazolidone.

Contraindicated for patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.

Patients currently using local decongestive drops containing phenylephrine and ephedrine (e.g. nasal drops) should not take <Paracetamol/Phenylephrine> at the same time.

4.6 Fertility, pregnancy and lactation

Pregnancy

Paracetamol

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

Phenylephrine

There are limited data on the use of phenylephrine in pregnant women. Vasoconstriction of uterine vessels and reduced uterine blood flow associated with use of phenylephrine may result in fetal hypoxia. Until more information is available, use of phenylephrine should be avoided during pregnancy.

Breast-feeding

Paracetamol

Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Phenylephrine

There are no data available on whether phenylephrine is released into breast milk and no reports on the effects of phenylephrine on the nursing infant. Until more data are available, use of phenylephrine should be avoided in lactating woman.

Fertility

There is no evidence from non-clinical studies indicating effects of paracetamol on male or female fertility at clinically relevant doses. The effects of phenylephrine on male or female fertility have not been studied.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. No such effects have been described to date.

4.8 Undesirable effects

The frequency of occurrence of undesirable effect is usually classified as follows Very common (>1/10)

Common (>1/100 to <1/10)

Uncommon (>1/1,000 to <1/100)

Rare (>1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data)

Frequency	System	Symptoms
Rare (>1/10,000 -< 1/1,000	Blood and lymphatic system disorders	Blood dyscrasias including platelet disorders, agranulocytosis, leucopenia, thrombocytopenia, haemolytic anaemia, pancytopenia
Rare	Skin and	Hypersensitivity including skin rash and urticaria,

(>1/10,000 -< 1/1,000	subcutaneous tissue disorders	pruritus, sweating, purpura, angioedema
Rare (>1/10000 -< 1/1000	Immune system disorders	Allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis and bronchospasm
Rare (>1/10,000 -< 1/1,000	Hepato-biliary disorders	Abnormal hepatic function (increase in hepatic transaminases), hepatic failure, hepatic necrosis, jaundice.
Very Rare (< 10,000)	Renal and urinary disorders	Interstitial nephritis after prolonged use of high doses of paracetamol, Sterile pyuria (cloudy urine)
Very Rare (< 10,000)	Gastrointestina l disorders	Acute pancreatitis

Isolated cases of epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme, edema of the larynx, anaphylactic shock, anemia, liver alteration and hepatitis, renal alteration (severe renal impairment, haematuria, anuresis), gastro intestinal effects and vertigo have been reported.

Frequency	System	Symptoms
Common (> 1/100 to <1/10)	Gastrointestinal disorders	Anorexia, nausea and vomiting
Rare (>1/10,000 -< 1/1,000	Cardiac disorders	Tachycardia, palpitation
Rare (>1/10,000 -< 1/1000)	Vascular disorders	Blood pressure increase
Rare (>1/10000 -< 1/1000	Immune system disorders	Allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis and bronchospasm
Very Rare(< 10,000)	Nervous system disorders	Insomnia, nervousness, tremor, anxiety, restlessness, confusion, irritability, dizziness and headache may occur

4.9 Overdose

Liver damage is possible in adults who have taken a single dose of 10 g or more of paracetamol. Ingestion of a single dose of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors If the patient:

(a)    Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John's Wort or other drugs that induce liver enzymes.

Or

(b)    Regularly consumes ethanol in excess of recommended amounts.

Or

(c)    Is likely to be glutathione deplete, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Or

(d)    is a young child.

Or

(e)    has a liver disease.

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

After prolonged use of high doses of paracetamol hypokalemia may develop.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the specialised services or a liver unit.

Hypertensive effects may be treated with an i.v. alpha-receptor blocking agent.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group:    paracetamol combinations excl. psycholeptics

ATC- Code:    N02BE51

Paracetamol: Paracetamol has both analgesic and antipyretic activity which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.

Phenylephrine: Phenylephrine is a post-synaptic alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.

5.2 Pharmacokinetic properties

Paracetamol: Paracetamol is absorbed rapidly and completely mainly from the small intestine and, depending on the formulation, produces peak plasma levels after 30 minutes to 2 hours following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a t./₂ of approximately 2 hours. Plasma protein binding is about 10%. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.

Phenylephrine: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.

5.3 Preclinical safety data

Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use in the product and which have not already been mentioned elsewhere in this Summary.

6.1    List of excipients

Ascorbic acid Sucrose

Aspartame (E951),

Lemon flavours (containing: natural lemon oils and natural and nature identical flavouring substances, maltodextrin, mannitol (E421), gluconolactone, acacia gum, sorbitol (E420), a - tocopherol (E307)and silica colloidal anhydrous)

Saccharin sodium

Silica colloidal

Citric acid

Sodium citrate.

6.2    Incompatibilities

Not applicable

6.3    Shelf life

2 years.

The reconstituted solution in hot water is stable for 60 minutes at room temperature.

6.4    Special precautions for    storage

Store in the original container and keep the sachet tightly closed in order to protect from moisture.

6.5    Nature and contents    of    container

The sachet foil is composed of paper, glue or polyethylene, aluminium and ethylene methacrylic acid copolymer.

10 or 20 sachets are contained in a cardboard carton.

Not all pack sizes may be marketed.