Geloprom Oral Powder

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

GeloProm Oral Powder

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet (1635 mg) contains:

Paracetamol 1000 mg

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

Excipients:

Each sachet contains:

20.0 mg Aspartame - a source of phenylalanine

23.8 mg Sodium

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral Powder

GeloProm is a white powder in single dose sachets for oral application.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the relief of the symptoms of colds and influenza (aches and pains, headache, sore throat and fever) when associated with nasal congestion.

4.2 Posology and method of administration

Oral administration. The powder should be placed directly onto the tongue where it will dissolve and can then be swallowed without water.

Adults, the elderly and adolescents 12 years and over: The content of one sachet is directly poured onto the tongue.

The dose may be repeated in 4 - 6 hours. No more than three doses should be taken in 24 hours.

Not to be given to children under 12 years of age.

This product must not be used longer than 3 days (short term treatment).

4.3 Contraindications

• Hypersensitivity to paracetamol, phenylephrine or any of the excipients

• Severe coronary heart disease

• Hypertension or pheochromocytoma

• Hyperthyroidism

• Patients currently receiving, or within two weeks of stopping, therapy with monoamine oxidase inhibitors.

• Severe impairment of liver function

• Alcohol abuse

4.4 Special warnings and precautions for use

Use with caution in patients with

• Raynaud's phenomenon

• Diabetes mellitus

• Moderate and severe renal insufficiency

• mild to moderate hepatocellular insufficiency (including Gilbert’s syndrome)

• concomitant treatment with medicinal products affecting hepatic functions

• haemolytic anaemia

• dehydration

• chronic malnutrition

• glutathione depletion due to metabolic deficiencies

• prostatic hypertrophy

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.

This medicinal product contains 1 mmol (or 23.8 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

It also contains a source of phenylalanine. May be harmful for people with phenylketonuria.

Label warnings (UK only): Do not exceed the stated dose. Keep out of the reach and sight of children. Contains paracetamol. If symptoms persist consult your doctor. If you are being prescribed medicine by your doctor, seek his advice before taking this product.

Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Leaflet warnings (UK only): In the event of an overdose talk to a doctor straight away as there is a risk of delayed, serious liver damage even if you feel well.

4.5 Interaction with other medicinal products and other forms of interaction

Paracetamol:

The rate of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption may be reduced by cholestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Phenylephrine:

Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta-blockers. Drugs which inhibit hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibtors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors because of a risk of hypertensive crisis.

4.6 Fertility, pregnancy and lactation

Fertility:

The effects of paracetamol and phenylephrine on male and female fertility have not been studied.

Pregnancy:

Paracetamol: Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Phenylephrine:

Due to vasoconstrictive properties of phenylephrine, the product should be used with caution in patients with a history of pre-eclampsia.

Phenylephrine may reduce placental perfusion. As a precautionary measure, it is recommended to avoid the use of GeloProm during pregnancy.

Lactation:

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

There is no information on use of phenylephrine in lactation.

As a precautionary measure, GeloProm should not be used during breast-feeding.

4.7 Effects on ability to drive and use machines

None known.

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)

Paracetamol

Blood and lymphatic system with the frequency “rare”: Blood dyscrasias including platelet disorders, agranulocytosis, leucopenia, thrombocytopenia, haemolytic anaemia, pancytopenia

Skin and subcutaneous tissue disorders with the frequency „rare“: Hypersensitivity including skin rash and urticaria, pruritus, sweating, purpura, angioedema.

Very rare cases of serious skin reactions have been reported.

Immune system disorders with the frequency “rare”: Allergic or hypersensitivity reactions including skin rashes, urticaria, anaphylaxis and bronchospasm

Hepato-biliary disorders with the frequency “rare”: Abnormal hepatic function (increase in hepatic transaminases), hepatic failure, hepatic necrosis, jaundice.

Renal and urinary disorders with the frequeny “very rare”: Interstitcial nephritis after prolonged use of high doses of paracetamol , sterile pyuria (cloudy urine)

Isolated cases oedema of the larynx, anaphylactic shock, anaemia, liver alteration and hepatitis, renal alteration (severe renal impairment, haematuria, anuresis), gastro intestinal effects and vertigo have been reported with a not known frequency.

Paediatric population

Frequency, type and severity of adverse reactions in children over the age of 16 years are expected to be the same as in adults.

Phenylephrine

Nervous system disorders with the frequency “very rare”: Insomnia, nervousness, tremor, anxiety, restlessness, confusion, irritability, dizziness and headache may occur

Cardiac disorders with the frequency “rare”: Tachycardia, palpitation

Vascular disorders with the frequency “rare”: Blood pressure increase

Gastrointestinal disorders with the frequency “common”: Anorexia, nausea and vomiting

Immune system disorders with the frequency “rare”: Allergic or hypersensitivity reactions including skin rash, urticaria, anaphylaxis and bronchospasm.

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; Website: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Paracetamol: Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion 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, promidone, rifampicin, St. John’s Wort or other drugs that induce liver enzymes, or

(b) Regularly consumes ethanol in excess of recommended amounts, or

Symptoms

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.

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 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 NPIS or a liver unit.

Phenylephrine hydrochloride: Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor-blocking agent.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic properties

Paracetamol: Paracetamol is absorbed rapidly and completely from the small intestine, producing peak plasma levels after 15 - 20 minutes 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 T1/2 of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80 %) which are excreted in urine.

Phenylephrine hydrochloride: 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 the 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

There are no findings of relevance to the prescriber other than those already mentioned elsewhere in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ascorbic acid Xylitol

Ethyl cellulose

Sodium carbonate, anhydrous

Tartaric acid

Magnesium citrate, anhydrous

Aspartame

Magnesium stearate

6.2 Incompatibilities

None known.

6.3 Shelf life

Three years

6.4 Special precautions for storage

Do not store above 25 °C.

Store in the original package.

6.5 Nature and contents of container

Heat sealed sachet of an ionomer resin-aluminium foil-paper laminate in an outer cardboard carton.

Pack size: 10 sachets

6.6 Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

G. Pohl-Boskamp GmbH & Co. KG Kieler StraBe 11 25551 Hohenlockstedt Germany

Telefon: +49 4826 59-0 Telefax: +49 4826 59-109

8 MARKETING AUTHORISATION NUMBER(S)

PL 04719 / 0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/07/2012

10 DATE OF REVISION OF THE TEXT

02/05/2014