Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
SODIUM PICOSULPHATE MONOHYDRATE
Boehringer Ingelheim Limited
A06AB08
SODIUM PICOSULPHATE MONOHYDRATE
2.5 Milligram
Capsules, Soft
Product not subject to medical prescription
Contact laxatives
Authorised
1999-04-01
Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy, or generally “off colour”. Sometimes it causes headaches. These healthy tips are recommended to try to prevent constipation happening: • Eat a balanced diet including fresh fruit and vegetables • Drink enough water so that you do not become dehydrated • Keep up your exercise and stay fit • Make time to empty your bowels when your body tells you 2. BEFORE YOU TAKE DULCOLAX PICO PERLES DO NOT TAKE DULCOLAX PICO PERLES IF: • You are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients in the product (listed in Section 6: Further information) • You have severe dehydration • You have a bowel condition called “ileus” (blockage in the intestine) • You have a serious abdominal condition such as appendicitis • You have severe abdominal pain with nausea and vomiting and/or fever • You have a blocked bowel (intestinal obstruction) • You have inflammation of the bowel (small or large intestine) Do not take this medicine if any of the above applies to you. If you are not sure, talk to your pharmacist or doctor before taking this medicine. TAKING OTHER MEDICINES Please tell your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because DULCOLAX PICO PERLES can affect the way some other medicines work. Also, some other medicines can affect the way DULCOLAX PICO PERLES works. In particular, tell your pharmacist or doctor if you are taking: • Water tablets (diuretics) such as bendrof Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dulcolax Pico Perles 2.5 mg Capsules, soft 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 2.5 mg sodium picosulfate as Sodium Picosulfate Monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft Round, colourless, clear capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term management of constipation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. The following dosages are recommended to be taken at night to produce evacuation the following morning. It is recommended to start with the lowest dose. The dose may be adjusted up to the maximum recommended dose to produce regular stools. The maximum recommended daily dose should not be exceeded. _Adults and children over 10 years of age_ Two to four capsules (5 - 10 mg) per day. _Children under 10 years of age_ Not to be taken by children under 10 years of age without medical advice. _Children aged 4 - 10 years_ One to two capsules (2.5 - 5 mg) per day. _Children under 4 years of age_ Not recommended for children under 4 years of age. Once regularity has been restarted, dosage should be reduced and can usually be stopped. The capsules should be swallowed with adequate fluid. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/05/2015_ _CRN 2160729_ _page number: 1_ 4.3 CONTRAINDICATIONS DULCOLAX PICO is contraindicated in patients with: Ileus or intestinal obstruction Severe painful and/or feverish acute abdominal conditions (e.g. appendicitis) potentially associated with nausea and vomiting Acute inflammatory bowel diseases Severe dehydration Known hypersensitivity Pročitajte cijeli dokument