Microsoft word - bendroflumethiazide warning letter.docx

Date: 11/02/2011
Dear Pharmacist
RE: BENDROFLUMETHIAZIDE 2.5MG TABLETS
BENDROFLUMETHIAZIDE 5MG TABLETS
I am writing to inform you that Dr Reddy’s Laboratories (UK) Ltd is issuing a warning in use notice
for Bendroflumethiazide 2.5mg Tablets and Bendroflumethiazide 5mg Tablets.
This warning affects the following batches:
Following an internal audit, it was found that an out of date Patient Information Leaflet (PIL) was included in the packs, which does not contain new safety information. Appendix 1 shows the omitted text and Appendix 2 is copy of the correct PIL. Please cascade this warning notification to your customers, asking them not to distribute the PIL supplied with the bulk dispensing pack. If a patient requires a PIL, the pharmacist may copy the leaflet in Appendix 2. Alternatively, they may request additional copies from our Medical Information service. For medical information enquiries, please contact our Medical Information service on 01753 512500, option 1. For stock enquiries, please contact our Customer Service office on 01753 512500, option 2. The Defective Medicines Report Centre (DMRC) at the MHRA has been notified of this action. We sincerely apologise for any inconvenience that this has caused you and give our reassurance that we will give this matter our utmost attention. Lesley-Anne McGuire Commercial Manager For and on behalf of Dr. Reddy’s Laboratories (UK) Ltd
Appendix 1: Safety information which should have been included in the Patient
Information Leaflet (PIL) for Bendroflumethiazide 2.5mg Tablets and
Bendroflumethiazide 5mg Tablets
The new or revised text is highlighted in italics

Under: “2. Before you take Bendroflumethiazide Tablets”
Taking other medicines

Terfenadine (antihistamine for treating allergies) Calcium salts or Vitamin D preparations Calcium channel blockers (such as amlodipine, diltiazem) Tricyclic antidepressents, reboxetine or monoamine oxidase inhibitors (MAOIs) (used for depression) Moxisylyte (used in Raynaud’s syndrome) Oestrogens and combined oral contraceptives Pimozide or thioridazine (antipyschotics) Colestyramine or colestipol (used to lower cholesterol) Prazosin (used in high blood pressure, heart failure, Raynaud’s syndrome and an enlarged prostate) Muscle relaxants (such as baclofen, tizanidine, tubocurarine, gallamine, alcuronium or pancuronium) Disopyramide, amiodarone, flecainide, quinidine, lidocain or mexiletine (used to control an irregular heartbeat Aminoglutethimide (used in some cancers and Cushing’s syndrome)
Appendix 2: Patient Information Leaflet for Bendroflumethiazide 2.5mg Tablets
and Bendroflumethiazide 5mg Tablets

Revised final version 21.04.2010 Package Leaflet: Information for the User Bendroflumethiazide 2.5mg & 5mg Tablets Bendroflumethiazide is the new name for Bendrofluazide. If you have been taking Bendrofluazide tablets, do not worry, as this is the same medicine Read all of this leaflet carefully before you start taking this medicine: - Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours. What Bendroflumethiazide Tablets are and what they are used for Before you take Bendroflumethiazide Tablets 1. What Bendroflumethiazide Tablets are and what they are used for Bendroflumethiazide belongs to a group of medicines called thiazide diuretics (‘water tablets’). They are used to increase the flow of urine to reduce the build-up of fluid in tissue below the skin (oedema). 2. Before you take Bendroflumethiazide Tablets Do not take Bendroflumethiazide Tablets if you: are allergic to Bendroflumethiazide, other thiazide diuretics or have high levels of calcium in the blood ( hypercalcaemia) to any of the other ingredients in the tablets (see Section 6) have low levels of blood potassium (hypokalaemia) or low have gout or an increase in uric acid in the blood have Addison’s disease (when the adrenal glands above the • are taking lithium (for some mental disorders) kidneys do not work properly, resulting in a lack of adrenal are pregnant, planning to become pregnant or are Check with your doctor before taking Bendroflumethiazide Tablets if you: are over 60, as older adults are more sensitive to the effects have an inflammatory disease called systemic lupus erythematosus, as Bendroflumethiazide may make have diabetes, as Bendroflumethiazide can make diabetes worse and can reduce the effect of some drugs to control diabetes have a blood disorder known as porphyria • have kidney problems including kidney stones or gallstones. Taking other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription, (as these may alter the effects of Bendroflumethiazide or of the other medicine) especially: barbiturates or opioid drugs such as codeine non steroidal anti-inflammatory drugs such as aspirin, ibuprofen and indomethacin (used to treat pain pimozide or thioridazine (antipsychotics) • amphotericin (used to treat fungal infections) colestyramine or colestipol (used to lower cholesterol) prazosin (used in high blood pressure, heart failure, Raynaud’s • terfenadine (antihistamine for treating allergies) • calcium salts or Vitamin D preparations muscle relaxants (such as baclofen, tizanidine, tubocurarine, • calcium channel blockers (such as amlodipine, diltiazem) disopyramide, amiodarone, flecainide, quinidine, lidocaine • tricyclic antidepressants, reboxetine or monoamine oxidase or mexiletine (used to control an irregular heartbeat) inhibitors (MAOIs) (used for depression) aminoglutethimide (used in some cancers and Cushing’s • moxisylyte (used in Raynaud’s syndrome) • oestrogens and combined oral contraceptives If you are going to have an anaesthetic, tell your doctor or surgeon that you are taking Bendroflumethiazide tablets. Pregnancy and breast-feeding Bendroflumethiazide tablets should not be taken during pregnancy. Expectant mothers who take Bendroflumethiazide may be at an increased risk of pancreatic bleeding and the newborn infant may suffer from a blood condition (thrombocytopenia) that can result in serious bleeding. Bendroflumethiazide can also pass into breast milk, therefore it should not be used during breast-feeding. If you become pregnant whilst taking these tablets, tell your doctor straight away. Blood tests Diuretics can cause salt imbalances in the blood to occur. If you are over 60 years of age, taking high doses or are taking this medicine for a long time, your doctor should carry out regular blood tests to check for such imbalances. 3. How to take Bendroflumethiazide Tablets You will be prescribed the lowest dose needed to control your symptoms. If you are not sure, check with your doctor or pharmacist. Do not stop taking the medicine or change the dose unless your doctor tells you to. Swallow the tablets with a glass of water. Usual doses Adults over 60 years: Dosage may need to be reduced, particularly High blood pressure: 2.5mg a day in the morning. Oedema: 5mg a day in the morning. If required, this dose can be increased to 10mg. Many patients will respond to a lower dose of 2.5mg Children: 100 micrograms per kilo of bodyweight, at the discretion or 5mg on 2 or 3 days per week. In some cases, a single dose once a of the doctor. week may be sufficient. If you take more than you should If you accidentally take more tablets than you should, or somebody else takes any tablets, contact a doctor or go to your nearest hospital casualty department at once. Take any remaining tablets and the container or packaging with you so they can be identified. If you forget to take the tablets If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose. 4. Possible side effects Like all medicines Bendroflumethiazide can cause side effects. Do not be alarmed by this list of side effects. Most people take Bendroflumethiazide without any problems. Tell your doctor at once if you notice any of the following side effects or any other unusual or worrying effects: • mild loss of appetite, indigestion (this may be avoided by taking skin rashes and increased sensitivity to sunlight increase in uric acid levels in the blood (with or without the • fall of blood pressure when moving from lying down or sitting to development of gout), increased concentration of blood fats a standing position (postural hypotension) • salt imbalances in the blood causing dizziness, light headedness, inflammation of the pancreas causing severe abdominal pain dryness of the mouth, increased thirst, mood changes, confusion, liver disorders that could be indicated by jaundice (yellowing of muscle cramps or muscle pain, nausea, vomiting, unusual tiredness or weakness and rarely abnormal heart rhythms. a blood disorder known as porphyria causing skin blisters, • types of anaemia. If you suffer from bruising or have an unusually abdominal pain and brain/nervous system disorders severe sore throat, be sure to tell your doctor, as these could be severe allergic reactions including severe skin reactions. inflammation of the lung (pneumonitis), an increase in fluid in 5. How to store Do not store above 25°C. Store in a dry place, protect from light. Keep the container tightly closed. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging. Return any unused tablets to your pharmacist for safe disposal. 6. Further information What the tablets contain The active ingredient (which makes the tablets work) is bendroflumethiazide. The 2.5mg tablets contain 2.5mg of bendroflumethiazide. The 5mg tablets contain 5mg of bendroflumethiazide. The tablets also contain lactose, maize starch, pregelatinised starch, sodium starch glycollate and magnesium stearate. What the tablets look like and contents of pack The tablets are round, white tablets. Both 2.5mg and 5mg strengths are available in pack sizes of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000. Marketing authorisation holder and manufacturer Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK. Bendroflumethiazide 2.5mg Tablets: PL 08553/0066 Leaflet revised 21.04.10 Dr Reddy’s Laboratories (UK) Ltd Bendroflumethiazide 5mg Tablets: PL 08553/0067

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