NUMARK MAX STRENGTH SINUS RELIEF

Route of administration:

Oral Swallow whole with water. Do not chew.

For all indications:

Adults, the elderly and children aged 16 years and over: Two capsules every 4 to 6 hours when necessary to a maximum of 8 capsules (4 doses) in 24 hours. Dosage should not be continued for longer than 3 days without consulting a doctor.

Children under 16 years:

Not to be used unless recommended by a doctor.

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 (incidence cannot be assessed on the basis of the available data).

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class.

Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Paracetamol Body System Undesirable effect Blood and lymphatic system disorders Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol. Immune system disorders Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis Respiratory, thoracic and mediastinal disorders Bromchospasm* Hepatobiliary disorders Hepatic dysfunction Metabolism and nutrition disorders High anion gap metabolic acidosis (Frequency Unknown) * There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. Caffeine Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.

Central Nervous system Nervousness and anxiety Irritability, Restlessness and Excitability Dizziness When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

Phenylephrine The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events. Body System Undesirable effect Psychiatric disorders Nervousness Nervous system disorders Headache, dizziness, insomnia Cardiac disorders Increased blood pressure Gastrointestinal disorders Nausea, vomiting, diarrhoea Adverse reactions identified during post-marketing use are listed below.

The frequency of these reactions is unknown. g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions – including cross-sensitivity with other sympathomimetics may occur Renal and urinary disorders Dysuria, urinary retention.

This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy. Very rare cases of serious skin reactions have been reported. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Use with caution in patients with Raynaud’s Phenomenon and diabetes mellitus.

The following warnings will appear on the pack: - CONTAINS PARACETAMOL Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor. Keep out of the sight and reach of children.

The Label shall say:

Talk to a doctor at once if you take much of this medicine, even if you feel well.

The Leaflet shall say:

Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per 2 capsules, that is to say essentially ‘sodium-free’.

g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended.

The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.

Paracetamol:

Hypersensitivity to paracetamol or any of the other constituents.

Caffeine:

Should be given with care to patients with a history of peptic ulcer.

Phenylephrine Hydrochloride:

Severe coronary heart disease and cardiovascular disorders. Hypertension. Hyperthyroidism. Contraindicated in patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors. Not to be used in children under the age of 16 years.

Avoid in patients with prostatic enlargement.