DOSAGE AND ADMINISTRATION. Dosage and administration

Usual dosage in adults and children 6 years and over:

Shake well before use. Rinse the mouth, or gargle with at least 15 ml of undiluted solution, two or three times a day. Do not swallow the solution but spit out after use.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

ORALDENE mouthwash is for external use only; the solution must therefore not be swallowed.

UNDESIRABLE EFFECTS

ORALDENE is generally very well tolerated with a low potential for causing irritation, or sensitisation reactions. Prolonged use of ORALDENE is also well tolerated.

Possible adverse reactions:

Immune System Disorders: Hypersensitivity reactions; Angioedema

Nervous System Disorders: Dysgeusia

Respiratory, Thoracic and Mediastinal Disorders: Cough; Dyspnoea

Gastrointestinal Disorders: Dry mouth; Dysphagia; Nausea; Salivary gland enlargement; Vomiting

General Disorders and Administration Site Conditions: Transient anaesthesia, Application site reactions.

OVERDOSE

Symptoms

Acute alcoholic intoxication is extremely unlikely, however, it is theoretically possible that, if a

massive dose were swallowed by a small child, alcoholic intoxication may occur due to the ethanol content.

No adverse effects have been reported in overdose other than those seen in normal use.

Hexetidine, at the strength present in ORALDENE, is unlikely to be toxic when used as directed.

Ingestion of sufficient quantities of hexetidine in alcoholic solution may lead to signs/symptoms of alcohol intoxication.

Management

Treatment of overdose is symptomatic, but rarely required. In the event of accidental ingestion of the contents of a bottle by a child, a doctor should be consulted immediately. Gastric lavage should be considered within two hours of ingestion and management should relate to treatment of alcoholic intoxication.

ACECLOFENAC

Composition:

Each film-coated tablet contains100 mg of Aceclofenac.

Indication

Ankylosing spondylitis; Rheumatoid arthritis; Osteoarthritis

Dosage and administration

Adult: 100 mg bid, in the morning and in the evening. Should be taken with food. Take w/or immediately after meals.

Contraindications

Hypersensitivity to aceclofenac or other NSAIDs. Active or history of peptic ulcer/haemorrhage,

history of active bleeding or bleeding disorders, history of bleeding or perforation related to previous NSAID therapy, ischaemic heart disease, peripheral arterial disease, cerebrovascular disease, severe heart failure. Moderate to severe renal and severe hepatic impairment. Pregnancy (3rd trimester).

Special Precautions

Patient w/ulcerative colitis, Crohn's disease, bleeding diathesis or haematological abnormalities.

Patient w/or previous history of asthma. Hepatic and mild renal impairment. Pregnancy and lactation.

Patient Counselling: This drug may cause dizziness, vertigo, drowsiness, fatigue, and visual disturbances, if affected, do not drive or operate machinery.

Monitoring Parameters: Monitor for GI bleeding regularly. Closely monitor cardiac, hepatic, and renal function.

Adverse Drug Reactions

GI disorders (e.g. dyspepsia, abdominal pain, nausea, vomiting, diarrhoea, flatulence, constipation), rash, ruber, urticaria, enuresis, headache, dizziness, paraesthaesia, drowsiness; asthma, bronchospasm, dyspnoea, pruritus, purpura, angioedema. MI, stroke, acute coronary syndrome, oedema, cardiac failure; nephritis, nephritic syndrome, renal failure; abnormal liver function, hepatitis, jaundice; visual disturbance, optic neuritis; thrombocytopenia, neutropenia, agranulocytosis, aplastic and haemolytic anaemias.

Potentially Fatal: GI bleeding, ulceration or perforation.

Overdosage

Symptoms: Headache, nausea, vomiting, epigastric pain, GI irritation and bleeding, diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, resp depression, fainting, convulsions, renal failure, liver damage.

Management: Symptomatic and supportive treatment. Employ gastric lavage or activated charcoal w/in 1 hr of ingestion. IV diazepam may be used for prolonged convulsions.

Storage

Store at or below 30°C.

POLYGYNAX

Product Polygynax® vaginal capsules

Composition:

Neomycin sulphate 35,000 IU • Polymyxin B sulphate 35,000 IU • Nystatin 100,000 IU

Therapeutic category:

Topical anti-infectious agent (G. genitourinary tract).

Indication:

Topical treatment of vaginal infections.

Contra indications:

Allergy to one of its ingredients or another substance of the same family. Use of latex diaphragms or condoms. Inform your physician or your pharmacist about all medication you are using with Polygynax® at the same time.

Special Warnings:

Polygynax® contains soybean oil. If you are allergic to peanut or soya, do not use this medicinal product. Stop treatment in case of local intolerance or allergic reactions. In case of local allergy, the subsequent use of the same antibiotic or related antibiotics via the oral route may be compromised.

Precautions:

Inform your physician in case of renal failure. Do not exceed the treatment duration recommended by your physician.

Interactions: Do not use with spermicidal products (risk of inactivation) and condoms

Adverse effects:

Possibility of contact allergic eczema or away from the site of application in case of prolonged use.

Report any unwanted and bothersome effects not mentioned in this insert to your physician or pharmacist.

Pregnancy Lactation:

The use of his drug is not recommended during pregnancy. This drug must not be taken while breast-feeding. In general, pregnant women and nursing mothers should always ask their physician or pharmacist for advice before taking any drugs.

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