APRINOX TABLETS 2.5MG

Active substance: BENDROFLUMETHIAZIDE

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Patient Information Leaflet

GB 726-9996-APIL

PSD 2472-01

Aprinox® 2.5 mg and 5 mg Tablets
Bendroflumethiazide

Read all of this leaflet carefully before
you start taking this medicine.
• Please keep this leaflet. You may need to
read it again.
• If you have any further questions, please 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 any of the side effects becomes severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Aprinox 2.5 mg and 5 mg Tablets are and what they
are used for.
2. Before you take Aprinox 2.5 mg and 5 mg Tablets.
3. How to take Aprinox 2.5 mg and 5 mg Tablets.
4. Possible side effects.
5. How to store Aprinox 2.5 mg and 5 mg Tablets.
6. Further information.
1. WHAT APRINOX 2.5 MG AND 5 MG TABLETS ARE AND WHAT
THEY ARE USED FOR
The active ingredient in this medicine is bendroflumethiazide.
Aprinox belongs to a class of medicines known as diuretics. Diuretic medicines
are those that promote the excretion of urine. Aprinox Tablets are used to treat
hypertension (high blood pressure) and oedema (fluid retention). They are
also used to stop the production of breast milk.
2. BEFORE YOU TAKE APRINOX 2.5 MG AND 5 MG TABLETS
Do not take this medicine if:
• you ever had an allergic reaction to Aprinox or any other ingredients of
this medicine (allergic reactions include mild symptoms such as itching
and/or rash. More severe symptoms include swelling of the face, lips,
tongue and/or throat with difficulty in swallowing or breathing);
• you suffer from an imbalance of water and salts in the body;
• you suffer from hypercalcaemia (high levels of calcium in the blood);
• you suffer from elevated levels of uric acid in the blood (hyperuricaemia);
• you have severe liver or kidney problems;
• you suffer from Addison’s disease.
Take special care and tell your doctor or pharmacist if:
• you suffer from gout;
• you are diabetic;
• you suffer from or have a history of a condition called systemic lupus
erythematosus;
• you suffer from alcoholic cirrhosis;
• you suffer from mild to moderate kidney or liver disease as your
doctor may wish to monitor you more frequently.
Tell your doctor before taking this medicine if you have been told that you
have an intolerance to some sugars. This is because Aprinox 2.5 mg
and 5 mg Tablets contains a small amount of lactose, a type of sugar.

Taking other medicines
Tell your doctor if you are taking any other medicines, especially the following:
• medicines for relieving pain and inflammation e.g. non-steroidal
anti-inflammatory drugs;
• ACTH (corticotropin), acetazolamide (used to treat glaucoma) or
carbenoxolone (used to treat ulcers);
• medicines used to reduce inflammation e.g.corticosteroids;
• any other medicine for high blood pressure (including other diuretics
and alpha blockers such as prazosin);
• medicines known as barbiturates (these are used to treat a range of
conditions from severe insomnia to epilepsy) e.g phenobarbital;
• medicines used to treat pain that contain opioids such as codeine or
diamorphine;
• medicines for treating epilepsy e.g. carbamazepine;
• medicines for treating infections e.g. amphotericin;
• calcium salts or vitamin D preparations;
• medicines for treating cancer (particularly cisplatin, toremifene or
aminoglutethimide);
• medicines for treating irregular heart beats e.g disopyramide,
amiodarone, flecainide, quinidine, lidocaine, mexiletine or
calcium-channel blockers e.g. nicardipine (used to treat heart problems);
• medicines which provide contraception e.g. oral contraceptives;
• medicines for treating asthma e.g.theophylline;
• medicines used to treat allergies e.g.terfenadine;
• a medicine called Moxisylyte, which is used to treat Raynaud’s syndrome;
• medicines like pimozide or thioridazine used to treat psychoses (the
term used to describe a broad range of conditions affecting a person’s
mental state, often characterised by symptoms such as delusional
thoughts, hallucinations and agitated behaviour);
• medicines used to treat depression (including lithium, a medicine
called reboxitene or a class of medicines known as monoamine oxidase
inhibitors);
• medicines used to treat a condition known as multiple sclerosis or
spinal injuries (eg. baclofen and tizanide).
Other special warnings
• Be careful when drinking alcohol - it may affect you more than usual.
• If you see another doctor or visit a hospital, remember to tell them
what medicines you are already taking.
• If you are going to have an operation please tell the anaesthetist that
you are taking Aprinox 2.5 mg and 5 mg Tablets as this may affect
some of the drugs he/she may use.
• If you are being treated for depression with tricyclic antidepressants
e.g. amitriptyline, there may be an increased risk of postural
hypotension (fall in blood pressure) whilst taking Aprinox Tablets.
• Colestipol and colestyramine may reduce the absorption of thiazide
diuretics and should therefore be given 2 hours prior to, or after the
ingestion of Aprinox.
• Your doctor may wish to monitor you regularly and carry out blood
tests while you are taking this treatment. This may be the case
especially if you are elderly or are taking the medicine long term.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or if you are breast-feeding.

Driving and using machines
Aprinox should not normally affect your ability to drive or operate machinery.
If you find that you do get drowsy, do not drive or operate machinery.
3. HOW TO TAKE APRINOX 2.5 MG AND 5 MG TABLETS
Always take your medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure. He or she will tell
you how many to take and how often to take them.
The doses commonly prescribed are listed below. Your doctor may prescribe
different doses depending on your needs.
High blood pressure: The usual dose is 2.5 mg taken once daily in the
morning. Higher doses are rarely necessary.
Fluid retention: The usual starting dose is 5 to 10 mg once daily or every
other day. The usual maintenance dose is 5 to 10 mg one to three times
weekly.
Suppression of breast milk: The usual dose is 5 mg taken in
the morning and 5 mg taken at midday. Treatment usually lasts for
approximately five days.
Children: The dose in children depends on how much they weigh. The
starting dose is up to 400 micrograms per kilogram of body weight. The
maintenance dose is 50-100 micrograms per kilogram of body weight.
Your doctor will tell you how many tablets your child will have to take.
Elderly: The dose of Aprinox Tablets may need to be reduced in some elderly
patients when there is the possibility of salt imbalance in the blood.
It is important that you keep taking these tablets until your doctor tells
you to stop. Do not stop just because you feel better. If you stop taking
the tablets too soon your condition may get worse.
If you take more tablets than you should
If you accidentally take too much of your medicine, you should contact a
doctor immediately or go to the nearest hospital casualty department.
Take your medicine and this leaflet with you.
If you forget to take your medicine
If you forget to take a dose, just take the next dose at the usual time,
DO NOT take a double dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines Aprinox 2.5 mg and 5 mg Tablets can cause unwanted
side effects in some people, although it is generally well tolerated. You
are unlikely to get any of the following, but if you do, tell your doctor
immediately:
• Hypersensitivity reactions (including severe skin reactions, which
include swelling of the face, lips, tongue and/or throat which may be
accompanied by difficulty in swallowing or breathing; inflammation
of the lungs (pneumonitis) or fluid retention on the lungs
(pulmonary oedema))
• If you feel very tired, experience unexpected bruising or bleeding,
or more infections (e.g. colds and sore throats) than usual, please
tell your doctor immediately. Your doctor may decide to conduct
tests on your blood periodically as a result of these symptoms.

Other side effects may include:
• Skin rashes, sensitivity to light, blood disorders of various types
including anaemia;
• A rise in the level of uric acid in the blood which can result in swelling
of the joints (gout) may occur;
• Problems with the pancreas and liver have been reported;
• Like other water tablets, Aprinox may occasionally affect the level of
sugar in the blood;
• Dizziness or faintness on standing which may be due to a lowering of
your blood pressure;
• Impotence has been reported occasionally, although this is reversible
once your treatment with Aprinox Tablets is over or stopped;
• Dry mouth, thirst, weakness, lethargy, drowsiness, restlessness and
anxiety, muscle pain and cramps, seizures, changes in heart rate and
blood pressure, diarrhoea and gastro-intestinal problems may be
signs and symptoms of salt imbalance. This is caused by a lowering of
the levels of potassium or sodium in the blood;
• If you are an insulin-dependent diabetic patient, you may need to have
your dose of insulin adjusted as your body’s ability to deal with the insulin
may be affected if you are taking Aprinox at the same time.
If any of the side effects become severe, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist immediately.
5. HOW TO STORE APRINOX 2.5 MG AND 5 MG TABLETS
Do not store above 25° C. Keep the container tightly closed and store in the
original container. Do not use after the expiry date that is stated on the carton.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF
CHILDREN
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION
What Aprinox 2.5 mg and 5 mg Tablets contain
Each tablet contains 2.5 mg or 5 mg of the active substance
bendroflumethiazide.
The other ingredients are: lactose, maize starch, stearic acid
and French chalk.
What Aprinox 2.5 mg and 5 mg Tablets look like and the contents
of the pack:
The tablets are round and white and are available in two different strengths
containing either 2.5 mg or 5 mg.
Aprinox 2.5 mg and 5 mg Tablets are available in blister packs containing
28 tablets and bulk packs of 100 or 500 tablets.
Marketing Authorisation Holder and Manufacturer:
Waymade Plc trading as Sovereign Medical, Sovereign House, Miles Gray
Road, Basildon, Essex, SS14 3FR.
This leaflet does not contain all the available information about your
medicine. If you have any questions or are not sure about anything,
ask your doctor or pharmacist.
The information in this leaflet applies only to Aprinox 2.5 mg and 5 mg
Tablets
Date of preparation of the leaflet: October 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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