Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Pseudoephedrine hydrochloride 60mg; ; ;
PSM Healthcare Ltd trading as API Consumer Brands
Pseudoephedrine hydrochloride 60 mg
60 mg
Tablet
Active: Pseudoephedrine hydrochloride 60mg Excipient: Lactose monohydrate Magnesium stearate Maize starch
Blister pack, (not marketed), 30 tablets
Class B2 Controlled Drug
Class B2 Controlled Drug
BASF PharmaChemikalien GmbH & Co KG
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, glass, - 500 tablets - 36 months from date of manufacture stored at or below 25°C
1974-06-12
1 SUDOMYL _Pseudoephedrine hydrochloride 60mg Tablet_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Sudomyl. This leaflet answers some common questions about Sudomyl. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits . Your doctor has weighed the risks of you using Sudomyl against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT SUDOMYL IS USED FOR Sudomyl is for the effective relief of:_ _ Runny nose, Sinus and nasal congestion, Sinus pain due to congestion. Sudomyl reduces the swelling and secretions in the nose and sinuses, allowing you to breathe more easily. It relieves the pressure behind the nose and eyes, which is the cause of sinus pain and headache. Your doctor may have prescribed Sudomyl for another reason. Ask your doctor if you have any questions about why Sudomyl has been prescribed for you. This medicine is only available with a doctor’s prescription. BEFORE YOU USE SUDOMYL _WHEN YOU MUST NOT USE IT _ DO NOT USE SUDOMYL IF YOU HAVE AN ALLERGY TO: any medicine containing pseudoephedrine any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin. DO NOT TAKE SUDOMYL IF Preberite celoten dokument
NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 1 of 6 1. PRODUCT NAME Sudomyl, Tablet, 60 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Name and strength of the active substance Pseudoephedrine Hydrochloride 60mg Excipient(s) with known effect For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral - tablet Presentation Sudomyl is a white biconvex circular tablet with a diameter of about 8.5 mm. Each tablet contains 60mg of Pseudoephedrine Hydrochloride. Tablets cannot be halved. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Sudomyl is indicated for the effective relief of • runny nose; • sinus and nasal congestion; and • sinus pain due to congestion. Sudomyl reduces the swelling and secretions in the nose and sinuses, allowing the patient to breathe more easily. It relieves the pressure behind the nose and eyes, which is the cause of sinus pain and headache. 4.2 Dose and method of administration Adults and children over 12 years: One tablet if necessary, up to 3 times daily at intervals of not less than 4 hours, with a maximum of 3 tablets in 24 hours. Children under 12 years: Must not be used in children under 12 years of age. Elderly: There is no need for dosage reduction in the elderly. NEW ZEALAND DATA SHEET New Zealand Data Sheet Page 2 of 6 Do not exceed the recommended dose. Do not halve the tablet. If symptoms do not improve within seven days, consult your doctor. 4.3 Contraindications Sudomyl is contraindicated for use in children under 12 years of age. Pseudoephedrine is contraindicated for use in patients: • with known hypersensitivity or idiosyncratic reaction to pseudoephedrine (or any of the other ingredients in the product); • with severe hypertension or coronary artery disease; • taking monoamine oxidase inhibitors (MAOIs) or who have taken MAOIs within the previous 14 days. Refer to ‘INTERACTIONS’ for additional information. 4.4 Special warnings and precautions for use Pseudoephedrine should be used with caution in patients with: • hypertension Preberite celoten dokument