Interactions with other drugs.

Local application of the drug causes no interactions with other drugs.

Dosage and administration. For adults and infants since 1^st day of life, instill 4 drops 2-3 times per day into the external auditory passage. In order to avoid contact of a cold solution with the pinna, the vial before use should be warm in hands.

The course of treatment should not exceed 10 days.

Before instillation of the drug should unscrew the white cap of the vial, invert the vial and instill 4 drops. After using, screw in the white cap on the dropper and put the vial into the packaging.

Overdose. No overdose should be mentioned when using the drug according to the instructions.

Side effects. The preparation is generally well tolerated. Local reaction as irritation, itches and hyperemia are very rare.

Storage conditions. Store at temperature below 25°C, in the original package.

Keep this medicine out of the sight and reach of children.

Shelf-life is 3 years from the manufacturing date and 1 month after first opening.

Package. Carton box with a LDPE bottle, fitted with LDPE plug dropper, contains 15 ml (17 g) of eardrops, solution.

CREON® 25000 CAPSULES

Composition

Each capsule contains pancreatin PhEur 300 mg equivalent to:

Lipase 25,000 PhEur units

Amylase 18,000 PhEur units

Protease 1,000 PhEur units

Indications

For the treatment of pancreatic exocrine insufficiency.

Dosage and Administration

Adults (including the elderly) and children: Initially one or two capsules during or immediately after each meal. Dose increases, if required, should be added slowly, with careful monitoring of response and symptomatology. The capsules can be swallowed whole, or for ease of administration they may be opened and the granules taken with acidic fluid or soft food, but without chewing. This could be apple sauce or yoghurt or any fruit juice with a pH less than 5.5, e.g. apple, orange or pineapple juice. If the granules are mixed with fluid or food, it is important that they are taken immediately and the mixture not stored, otherwise dissolution of the enteric coating may result. In order to protect the enteric coating, it is important that the granules are not crushed or chewed. Crushing and chewing of the mini microspheres or mixing with food or fluid with a pH greater than 5.5 can disrupt the protective enteric coating. It is important to ensure

adequate hydration of patients at all times whilst dosing Creon 25000.

Contraindications

Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

Undesirable effects

The incidence of drug-related adverse effects is very low (<1%). Diarrhoea, constipation, gastric discomfort, nausea and skin reactions have been reported occasionally in patients receiving enzyme replacement therapy.

Overdose

Excessive doses of pancreatin may actuate hyperuricosuria and hyperuricaemia.

Special warnings and precautions for use

Structures of the ileo-caecum and large bowel (fibrosing colonopathy) have been reported in patients with cystic fibrosis taking high doses of pancreatin preparations. As a precaution, unusual abdominal symptoms or changes in abdominal symptoms should be medically assessed to exclude the possibility of fibrosing colonopathy, especially if the patient is taking in excess of 10 000 units of lipase/kg/day.

Storage

Do not store above 25°C. Keep container tightly closed.

Shelf Life

2 years

ORALDENE

COMPOSITION

ORALDENE contains 0.1% w/v hexetidine.

INDICATIONS

ORALDENE is indicated for use in minor mouth infections including thrush, as an aid in the prevention and treatment of gingivitis, and in the management of sore throat and recurrent aphthous ulcers. ORALDENE is also of value in the alleviation of halitosis and pre- and postdental surgery.

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