Neo-Naclex 2.5mg Tablets
PATIENT LEAFLET: INFORMATION FOR THE USER
NEO-NACLEX 2.5 MG TABLETS (Bendroflumethiazide)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further queries, 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.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Neo-Naclex 2.5 mg Tablets are and what they are used for
2. What you need to know before you take Neo-Naclex 2.5 mg tablets
3. How to take Neo-Naclex 2.5 mg Tablets
4. Possible Side Effects
5. How to store Neo-Naclex 2.5 mg Tablets
6. Contents of the pack and other information.
1. What Neo-Naclex 2.5 mg Tablets are and what they are used for
The name of your medicine is Neo-Naclex 2.5 mg Tablets. The active ingredient is Bendroflumethiazide.
Neo-Naclex 2.5 mg Tablets belong to a group of medicines called thiazide diuretics (water tablets). They may be used to:
• reduce fluid retention (oedema) particularly in the heart, kidneys,
liver or that caused by medication, by increasing the flow of urine.
• reduce high blood pressure alone or with other medication.
2. What you need to know before you take Neo-Naclex 2.5 mg Tablets
Do not take Neo-Naclex 2.5 mg Tablets and tell your doctor if you
have:
• an allergy (hypersensitivity) to thiazides or any of the other ingredients in Neo-Naclex 2.5 mg Tablets (see section 6).
• severely impaired kidney or liver function.
• high blood levels of calcium (hypercalcaemia).
• low blood levels of sodium (hyponatraemia).
• low blood levels of potassium which has not responded to treatment (refractory hypokalaemia).
• or have had gout (high levels of uric acid in the blood), causing crystals to deposit in joints of hands or feet causing pain (hyperuricaemia).
• Addison's disease (syndrome due to low level of corticosteroid hormones secretion, symptoms include weakness, loss of energy, low blood pressure and dark pigmentation of the skin).
Warnings and Precautions
Check with your doctor or pharmacist before taking Neo-Naclex
2.5 mg Tablets if you have:
• mild or moderate impaired kidney or liver function.
• liver disease caused by alcohol (alcoholic cirrhosis).
• or may have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage.
• systemic lupus erythematosus (SLE) (an inflammatory disease of connective tissue causing large areas of red scaly patches on the face, hair loss, weight loss, painful joints and fever).
• an inherited disorder of the red blood pigment haemoglobin causing skin blisters, abdominal pain and brain or nervous system disorders (porphyria).
Other medicines and Neo-Naclex 2.5 mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially:
• allopurinol (used in gout)
• colestyramine or colestipol (used to lower cholesterol)
• disopyramide, amiodarone, flecainide, quinidine, lidocaine or mexiletine (used to control an irregular heart beat)
• tricyclic antidepressants, reboxetine or monoamineoxidase inhibitors (MAOIs) (used for depression)
• sulfonylureas (used in diabetes to control blood sugar levels)
• carbamazepine (used in epilepsy)
• amphotericin (used to treat fungal infections)
• prazosin (used in high blood pressure, heart failure, Raynaud’s syndrome and an enlarged prostate)
• ACE inhibitors (e.g. enalapril) or angiotensin-II antagonists (e.g. losartan) used to lower blood pressure
• pimozide or thioridazine (antipsychotics)
• calcium salts
• calcium channel blockers e.g. amlodipine or diltiazem
• moxisylyte (used in Raynaud’s syndrome)
• corticosteroids e.g. prednisolone
• cisplatin (used to treat cancer)
• digoxin (used to treat some heart problems)
• aminoglutethamide (used in some cancers and Cushing’s syndrome)
• toremifene (used in some cancers)
• lithium (used for mental health problems)
• muscle relaxants such as baclofen, tizanidine, tubocurarine, gallamine, alcuronium or pancuronium
• NSAIDs (non-steroidal anti-inflammatory drugs) such as indometacin, ketorolac, ibuprofen, piroxicam or naproxen
• oestrogens and combined oral contraceptives
• sympathomimetics (used as decongestant, asthma or heart medicine)
• theophylline (used in breathing problems such as asthma)
• carbenoxolone (an ulcer healing drug)
• vitamin D
• terfenadine (antihistamine medicine for allergy and hay fever)
• acetazolamide, which is used to treat glaucoma (increased pressure in the eye), epilepsy or for preventing altitude sickness.
• if you are receiving adrenocorticotropic (ACTH) hormone
• beta-agonists and xanthines (medicines used to treat asthma)
• opioids (strong-pain relieving medicines)
• barbiturates (medicines used to treat either fits or to help you sleep)
Pregnancy, breast-feeding and fertility
Neo-Naclex 2.5 mg Tablets should not be used in pregnant or breast-feeding women. Speak to your doctor or pharmacist before taking any medicine.
Driving and using machines
Neo-Naclex 2.5 mg Tablets can cause dizziness, make sure you are not affected before driving or operating machinery.
Neo-Naclex 2.5 mg Tablets with food, drink and alcohol
It is recommended not to take alcohol with Neo-Naclex 2.5 mg Tablets as it may aggravate dizziness on standing due to low blood pressure.
Tests
During treatment with Neo-Naclex 2.5 mg Tablets, your doctor may want to monitor your kidney function. If you are elderly or on long term treatment with Neo-Naclex 2.5 mg Tablets, your doctor may want to monitor the level of chemicals in your body, by carrying out tests.
Bendroflumethiazide may interfere with a number of laboratory tests including estimation of serum protein-bound iodine and tests of parathyroid function.
Neo-Naclex 2.5 mg Tablets contain Lactose
This medicine contains lactose. If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.
3. How to take Neo-Naclex 2.5 mg Tablets
• Always take these tablets exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• The number of tablets you need will depend on your condition.
• Swallow the tablets with water in the morning (to avoid frequent urination at night).
Doses:
Adults and children 12 years and over:
• High blood pressure: 2.5 mg to 5 mg once a day.
• Oedema: Initially 5-10mg once a day or once every other day. The maintenance dose is 5-10mg one to three times a week.
Elderly:
Your doctor may prescribe you a lower dose especially if you have impaired kidney function.
Children under 12 years:
A more appropriate formulation may be used.
Initially 400micrograms per kilogram of body weight, a day.
The maintenance dose is 50-100micrograms per kilogram of body weight, a day.
If you take more Neo-Naclex 2.5 mg Tablets than you should
If you accidently take too many tablets, tell your doctor immediately or contact your nearest Hospital Casualty/ Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.
Symptoms of an overdose include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, muscle cramps, increase in the
frequency and amount of urination, thirst, decreased volume within blood vessels, low blood pressure, circulation problems (peripheral circulatory failure), low blood levels of potassium (hypokalaemia) and sodium (hyponatraemia), low blood sugar levels (hypoglycaemia) and central nervous system depression (drowsiness, tiredness and coma).
If you forget to take Neo-Naclex 2.5 mg Tablets
If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Neo-Naclex 2.5 mg Tablets can cause side effects, although not everybody gets them.
Contact your doctor at once if you experience the following:
• Allergic reaction (hypersensitivity): rashes including skin that is red, flaky and peeling (exfoliative dermatitis), sensitivity to sunlight or artificial light (e.g. sun beds), inflammation of the lungs which causes breathlessness, cough and raised temperature (pneumonitis), fluid in the lungs (pulmonary oedema).
• Blood: altered numbers and types of blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.
Tell your doctor or pharmacist if you notice any of the following side effects, they get worse or you notice any not listed.
• Metabolism: decreased carbohydrate tolerance, worsening of existing diabetes, increased blood levels of uric acid, worsening of gout, changes in blood lipid (fat) levels and high blood sugar levels
.• Chemicals within the body: low blood potassium levels (hypokalaemia) (which may cause an increase in the frequency and
amount of urination, a feeling of general discomfort and illness, muscle weakness or cramp, dizziness, feeling or being sick and loss of appetite), low blood magnesium and sodium levels, high blood levels of calcium (hypercalcaemia), low blood levels of chloride ion with high level of bicarbonate ion-decreased blood acidity (hypochloraemic alkalosis).
• Stomach and intestines: feeling or being sick, diarrhoea, constipation, stomach irritation.
• Other: inflammation of the pancreas, blocked bile flow within the liver, inability to maintain an erection, dizziness on standing due to low blood pressure (postural hypotension), dizziness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.
5. How to store Neo-Naclex 2.5 mg Tablets
• Keep the medicine out of the sight and reach of children.
• Containers and blister carton: Do not store above 250C.
• Store in the original packaging and keep the packaging tightly closed.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Neo-Naclex 2.5 mg Tablets contain
• The active substance is Bendroflumethiazide. This is the new name for bendrofluazide. The ingredient itself has not changed.
• Each tablet contains either 2.5mg of the active ingredient.
• The other ingredients are: lactose, pregelatinised starch, talc and stearic acid.
What Neo-Naclex 2.5 mg Tablets look like and contents of the pack.
• Neo-Naclex 2.5 mg Tablets are white to off white circular, biconvex, uncoated tablets.
• Neo-Naclex 2.5 mg Tablets come in blister packs containing 14, 28, 56 or 84 tablets and containers containing 50, 100, 250, 500 or 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,
HP4 1EG, United Kingdom Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Neo-Naclex 2.5 mg Tablets; PL 17907/0082 This leaflet was last revised in June 2015
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V1 19-06-15 D0