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THIRD PARTY SUPPLY ARTWORK

3742 Finished pack SAP code: 76142 210x297mm PACKAGE LEAFLET: INFORMATION FOR THE USER D04610 3. How to take • Description: PIL Phenylephrine 0.1mg/ml • tissue damage at the site of the injection Phenylephrine 0.1 mg/ml, solution for injection The administration will be performed by a health•care professional with appropriate training and relevant • muscle weakness • phenylephrine experience. Market: UK • Use in Adults Supplier: Unimedic • Your doctor or nurse will give you Phenylephrine into a using this because it contains important vein (intravenously). Your doctor will decide the right dose Development artwork number: D04610 information for you. In patients with serious heart failure phenylephrine may for you and when and how it should be injected. TWONA number: 35818 Yellow Card Scheme at: worsen the heart failure as a consequence of blood vessel Use in patients with impaired renal function Replaces code: N/A • If you have any further questions, ask your doctor, constriction. Website: www.mhra.gov.uk/yellowcard Lower doses of phenylephrine may be needed in patients Template/style number: As supplied pharmacist or nurse. The blood pressure in your arteries will be monitored with impaired renal function. • This medicine has been prescribed for you only. during treatment. If you have heart disease, additional information on the safety of this medicine. Dimensions: 148 x 210mm Do not pass it on to others. It may harm them, even if monitoring of vital functions will be performed. Use in patients with impaired liver function their signs of illness are the same as yours. Higher doses of phenylephrine may be needed in patients 5. How to store Phenylephrine Version number: 01 Date: 15/03/19 By: NF Children with cirrhosis of the liver. The medicine is not recommended for use in children Keep the ampoules in the outer carton in order to protect Date of previous revision: 05/12/19 pharmacist or nurse. This includes any possible side Use in older people from light. EAN barcode (if applicable): N/A recommendations. Treatment in older people should be carried out with care. Keep this medicine out of the sight and reach of children. Min point size (legal text): 8pt Use in children Other and Phenylephrine Colours: PMS Black C Tell your doctor, pharmacist or nurse if you are taking, have It is not recommended for use in children due to Do not use this medicine after the expiry date which is 1. What Phenylephrine is and what it is used for stated on the carton after EXP. The expiry date refers to the 2. What you need to know before you use Phenylephrine recently taken or might take any other medicines. recommendations. last day of that month. 3. How to use Phenylephrine Do not use Phenylephrine with: Martindale Pharma Artwork Dept 4. • iproniazide, nialamide (for depression) If you use more Phenylephrine than you should Do not throw away any medicines via wastewater or To confirm that all artwork checks have been completed prior to circulation 5. How to store Phenylephrine Signs that indicates that you have received too much household waste. Ask your pharmacist how to throw away Name: 6. Contents of the pack and other information Phenylephrine is a faster and irregular heart beat, medicines you no longer use. These measures will help concomitant use: headache, nausea, vomiting, paranoid psychosis, protect the environment. Signature: 1. What Phenylephrine is and what it is used • , , methylergometrine, hallucinations and . for (for ) It is unlikely that this will happen because you will get this 6. Contents of the pack and other Date: • linezolid (an antibiotic) medicine at a hospital. information Comments: This drug belongs to a group called adrenergic or • , , , (for What Phenylephrine contains dopaminergic agents. Phenylephrine is used to treat low Parkinson’s disease) 4. • The active substance is phenylephrine as • , , , moclobemide, phenylephrine hydrochloride 0.1 mg/ml anaesthesia. toloxatone, minalcipram, venlafaxine (for depression) although not everybody gets them. • The other ingredients are sodium chloride, sodium • 2. What you need to know before you use The following adverse reactions have been reported: citrate, citric acid, water for injection and hydrochloric Phenylephrine acid and sodium hydroxid for pH adjustment • medicine used to treat high blood pressure away if you get any of the following: Name: What Phenylephrine looks like and contents of the Do not use Phenylephrine if: (guanethidine) • chest pain or pain due to the angina pack Signature: • you are allergic (hypersensitive) to phenylephrine or any • medicines used to treat heart failure and certain irregular • irregular heartbeat Clear and colourless solution. of the other ingredients of this medicine (listed in section heartbeats (cardiac glycosides) • feeling the heart pumping in the chest Phenylephrine 0.1 mg/ml, solution for injection, is available Date: 6). • medicine used to treat abnormal heart rhythm • bleeding in the brain (speech disorder, dizziness, in glass ampoules of 5 ml and 10 ml. • () paralysis of one side of the body) Comments: • • medicine used during labour (). • psychosis (losing contact with reality) The ampoules are packaged in trays of plastic and then in blood circulation) Pregnancy, breast•feeding and fertility cartons of 5, 10, 20, 50 and 100 ampoules. • you take a non•selective monoamine oxidase inhibitor If you are pregnant or breast•feeding, think you may be • reaction of hypersensitivity (allergy) Not all pack sizes may be marketed. (MAOI) (or within 2 weeks of their withdrawal) for pregnant or are planning to have a baby, ask your doctor, Quality • excessive dilation of the pupils treatment of depression (iproniazide, nialamide). pharmacist or nurse for advice before taking this medicine. Marketing Authorisation Holder • • increased pressure in the eye (aggravation of glaucoma) Unimedic Pharma AB Name: (hyperthyroidism) Pregnancy • excitability (excessive sensitivity of an organ or body PO Box 6216 This medication should not be used during pregnancy part) SE-102 34 Stockholm Signature: Warnings and precautions unless absolutely necessary. • agitation (restlessness) Talk to your doctor, pharmacist or nurse before using Sweden • anxiety Date: Phenylephrine : Breast•feeding Manufacturer This medication should not be used during breast•feeding • confusion • if you are elderly Unimedic AB, Storjordenvägen 2 Comments: unless it is absolutely necessary. However, in the event of • headache • if you have an overactive thyroid gland • nervousness, SE•864 31 Matfors, Sweden • a single administration during childbirth, breast•feeding is possible. • Distributor heart block (partial), heart muscle disease, poor blood • shaking (tremor) Martindale Pharmaceuticals Ltd, Driving and using machines circulation in the heart, severe peripheral vascular • burning of the skin (Trading as Martindale Pharma) Software/platform: Adobe Indesign CC Not relevant. • prickling of the skin Bampton Road, Harold Hill, Romford, RM3 8UG, Fonts: Myriad Pro heart rate), bradycardia (low heart rate), angina pectoris Phenylephrine contains sodium • itching or tingling skin sensation (paraesthesia) United Kingdom. File name: D04610-01 • if you have poor blood circulation in the brain • Each 10 ml ampoule contains 1,6 mmol (36,8 mg) • slow or high heart rate • if you have atherosclerosis (hardening and thickening of sodium per dose. This should be considered by patients • high blood pressure Varnish free area: N/A the blood vessel walls) on a controlled sodium diet. • Braille: N/A • if you have diabetes mellitus • Each 5 ml ampoule contains 0,8 mmol (18,4 mg) sodium • • per dose. This means that it contains less than 1 mmol • nausea me&you vessels can be enhanced and cause very high blood sodium (23 mg) per dose, which means it is almost free • vomiting 1 Blighs Road, Sevenoaks, Kent, TN13 1DA, UK pressure and stroke in the period immediately after from sodium. • sweating t: +44 (0) 1732 749 748 childbirth 04610 e: [email protected] Continued overleaf • pallor or skin blanching (pale colour of the skin) D e: [email protected] www.meandyou.co.uk

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