Patient leaflet - BENDROFLUMETHIAZIDE 2.5 MG TABLETS
1. What Bendroflumethiazide is and what it is used for
2. What you need to know before you take Bendroflumethiazide
3. How to take Bendroflumethiazide
4. Possible side effects
5. How to store Bendroflumethiazide
6. Contents of the pack and other information
1. what bendroflumethiazide is and what it is used for
- Bendroflumethiazide tablets contain the active substance bendroflumethiazide.
Bendroflumethiazide belongs to a group of medicines known as the thiazide diuretics (water tablets). It may be used to reduce:
- a build-up of excess fluid in the body (oedema) particularly caused by heart, kidney, liver disease or that caused by medication, by increasing the flow of urine
- high blood pressure (hypertension), alone or with other medication.
You must talk to your doctor if you do not feel better or if you feel worse.
2. what you need to know before you take bendroflumethiazide
Do not take Bendroflumethiazide and tell your doctor if you:
- are allergic to bendroflumethiazide, or any of the other ingredients of this medicine (listed in section 6) or to other thiazide diuretics
- have severe liver or kidney problems
- have low blood levels of potassium or sodium
- have high blood levels of calcium or uric acid
- have Addison’s disease (underactive adrenal glands causing tiredness, weight loss and low blood pressure and dark pigmentation of the skin)
Warnings and precautions
Talk to your doctor or pharmacist before you take this medicine if you:
- have or have had mild or moderate liver or kidney problems
- have liver disease caused by alcohol (alcoholic cirrhosis)
- have diabetes
- have or have had gout (pain and swelling of the joints)
- have Systemic Lupus Erythematosus (an inflammatory disease which causes joint pain, skin rashes and fever)
- have porphyria (an inherited iron disorder)
- are receiving digoxin (digitalis treatment)
- are taking pimozide or thioridazine
- have an intolerance to some sugars, including lactose
- If you experience a decrease in vision or eye pain.
These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Bendroflumethiazide. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy, you can be at higher risk of developing this.
Other medicines and Bendroflumethiazide 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 to lower cholesterol
- carbenoxolone (used to treat stomach ulcers)
- disopyramide, amiodarone, flecainide, quinidine, lidocaine or mexiletine (used to control an irregular heartbeat)
- colestipol or
- tricyclic antidepressants, reboxetine or monoamine oxidase inhibitors (MAOIs) (used to treat depression)
- carbamazepine (used in epilepsy)
- amphotericin (used to treat fungal infections)
- prazosin (used in high blood pressure, heart failure, Raynaud’s syndrome and enlarged prostate)
- ACE inhibitors (e.g. enalapril)
- angiotensin-II receptor antagonists (e.g. losartan) used to lower blood pressure
- moxisylyte (used in Raynaud’s syndrome)
- calcium-channel blockers e.g. amlodipine or diltiazem
- medicines used in diabetes to lower blood sugar levels, such as sulfonylureas
- acetazolamide to treat glaucoma (increased eyeball pressure)
- lithium (used for mental health problems)
- pimozide or thioridazine (antipsychotics)corticosteroids e.g. prednisolone
- digoxin (used to treat some heart problems)
- amino-glutethimide (used in some cancers and Cushing’s syndrome)
- toremifene (used to treat cancers)
- Oestrogens and combined oral contraceptives
- NSAIDs (non-steroidal anti-inflammatory drugs) such as indometacin, ketorolac, ibuprofen, and piroxicam or naproxen muscle relaxants such as baclofen, tizanidine, tubocurarine
- cisplatin (used to treat cancer)
- such as aldesleukin, aminoglutethamide, toremifene
- sympathomimetics such as salbutamol, terbutaline theophylline (used in breathing problems such as asthma)
- vitamin D
Bendroflumethiazide with food, drink and Alcohol Alcohol should be avoided when taking this medicine.
Tests
During treatment with Bendroflumethiazide tablets, your doctor may want to monitor your kidney function. If you are elderly or on long-term treatment with Bendroflumethiazide tablets, your doctor may want to monitor the levels of certain chemicals in your body, by carrying out tests.
If you go into hospital or have treatment for other conditions, tell the doctor that you are taking Bendroflumethiazide.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine Bendroflumethiazide should be avoided during pregnancy, as there is no sufficient evidence of its safety.
Because Bendroflumethiazide passes into the breast milk it should be avoided in mothers who wish to breast-feed.
New born infants whose mothers have taken bendroflumethiazide during pregnancy may suffer from a blood condition known as thrombocytopenia.
Driving and using machines
Bendroflumethiazide tablets can cause dizziness, you should ensure you are not affected before attempting to drive or operate machinery.
Bendroflumethiazide tablets contains lactose
This medicine contains lactose. If you know you have an intolerance to lactose or other sugars, contact your doctor before taking this medicine.
3. how to take bendroflumethiazide
Always take Bendroflumethiazide exactly as your doctor has told you. check with your doctor or pharmacist If you are not sure.
Take these tablets in the morning (to avoid having to pass urine at night), with a glass of water.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition.
Adults and children 12 years and over:
Oedema – Initially the recommended dose is 5 – 10 mg once a day, or once every other day.
This may then be reduced to 2.5 – 10 mg 2 to 3 times a week.
Hypertension – The recommended dose is 2.5 – 5 mg per day.
Elderly: If you have kidney problems you may require smaller doses. Follow your doctor’s advice.
Children under 12 years: Initially 400 micrograms per kilogram of body weight, a day. The maintenance dose is 50–100 micrograms per kilogram of body weight a day. The doctor will decide the dose for your child, as it depends on their bodyweight.
A more appropriate formulation may need to be used.
If you take more Bendroflumethiazide than you should Contact your doctor or the nearest hospital casualty department immediately. Show them the package.
Symptoms of an overdose can include feeling or being sick, diarrhoea, dehydration, dizziness, weakness, muscle cramps, increased frequency and volume of urination, thirst, decreased volumes within blood vessels, low blood pressure, circulation problems, low blood levels of potassium and sodium, low blood sugar levels and central nervous system depression (drowsiness, tiredness or coma).
If you forget to take Bendroflumethiazide
Don’t worry, just take it as soon as you remember and then take your next scheduled dose at the correct time. 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, although not everybody gets them.
If you get any of the following serious side effects, stop taking Bendroflumethiazide and tell your doctor or go to the nearest hospital emergency department immediately:
- Allergic reaction (frequency: Not known – frequency cannot be estimated from the available data) which may cause skin rashes, itching, sensitivity to sunlight, a viral infection of the lungs (pneumonitis) or fluid in the lungs (pulmonary oedema).
- Blood disorders (frequency: Rare – frequency may affect up to 1 in 1,000 people) which may cause you to have unexplained bleeding, bruising and sore throats. Regular blood and urine tests may be needed.
The following side effects have been reported under frequency Not known (frequency cannot be estimated from the available data)
- nausea, vomiting, diarrhoea, constipation, stomach irritation
- a fall in blood pressure on standing up, (postural hypotension), which causes dizziness, light-headedness or fainting
- inability to maintain an erection (reversible once the tablets are stopped)
- a decrease in blood levels of potassium, which may cause increased frequency and volume of urination, a feeling discomfort or unease, muscle weakness or cramp, dizziness, feeling or being sick and loss of appetite
- a decrease in blood levels of sodium or magnesium
- an increase in blood levels of calcium
- an increase in uric acid levels in the blood and worsening of gout
- an increase in blood sugar levels and worsening of diabetes
- decreased carbohydrate tolerance
- changes in blood lipid (fat) levels
- low blood levels of chloride ions with increased alkalinity in the body (hypochloraemic alkalosis)
- blockage within the liver, which causes itching, yellowing of the skin or whites of the eyes (jaundice), dark urine and pale stools
- inflammation of the pancreas, which causes severe pain in the abdomen and back
- Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle- closure glaucoma).
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card scheme at: or search for MHRA Yellow Card Google play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store bendroflumethiazide
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date which is stated on the package or container after EXP. 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 Bendroflumethiazide tablets contains
The active substance is bendroflumethiazide. This is the new name for bendrofluazide. The ingredient itself has not changed.
The other ingredients are lactose, maize starch, pregelatinised starch, sodium starch glycollate and magnesium stearate.
What Bendroflumethiazide tablets looks like and contents of the pack
Bendroflumethiazide 2.5 mg tablets are round white tablets of 5.5 mm diameter with the marking MP18 on one side.
Bendroflumethiazide 5 mg tablets are round white tablets of 6.5 mm diameter with the marking MP19 on one side.
The tablets come in blister packs and containers of 28, 30, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41 – 43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus
Manufacturer
DDSA Pharmaceuticals Limited,
-
84 Pembroke Road, London, W8 6NX, UK
This leaflet was last revised in 07/2020.
GE0012–0013/O/PIL/GE4