Document: leaflet MAH GENERIC_PL 17496-0005 change

• leaflet MAH GENERIC_PL 00142-0381
• leaflet MAH GENERIC_PL 17496-0005

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L900429/8

Patient Information Leaflet

Bendroflumethiazide Tablets BP 5mg

This medicine will be called Bendroflumethiazide Tablets in this leaflet.

In this leaflet:

1.    What Bendroflumethiazide Tablets are and what they are used for

2.    Before you take Bendroflumethiazide Tablets

3.    How to take Bendroflumethiazide Tablets

4.    Possible side effects

5.    How to store Bendroflumethiazide Tablets

6.    Further information

1. What Bendroflumethiazide Tablets are and what they are used for

These tablets contain the active ingredient, bendroflumethiazide. It belongs to a group of medicines called thiazide diuretics. These work by increasing the amount of urine produced by the body. This helps to remove excess fluid from the body.

Bendroflumethiazide Tablets are used to treat high blood pressure (hypertension) or to reduce the swelling caused by fluid build up in the tissues (oedema). They can also be used to help reduce the amount of breast milk produced after pregnancy.

2. Before you take Bendroflumethiazide Tablets

Some people must not take these tablets. Do not

take these tablets if:

•    You know you are allergic to bendroflumethiazide or to any of the other ingredients (these are listed in section 6)

•    You have severe liver or kidney problems

•    You are suffering from hypercalcaemia (an unusually high level of calcium in the blood), hypokalaemia (low level of potassium in the blood), hyponatraemia (low level of sodium in the blood) or hyperuricaemia (high levels of uric acid in the blood)

•    You have Addison’s disease (a problem with the adrenal gland leading to a deficiency of some hormones)

•    You are taking the drug lithium (used in the treatment of mania, bipolar disorder and recurrent depression).

You must be especially careful if:

•    You suffer from diabetes. Taking Bendroflumethiazide Tablets may mean that doses of insulin and/or other diabetes drugs may need to be adjusted

•    You are elderly. Bendroflumethiazide Tablets can affect the balance of salts (electrolytes) in the blood and this can lead to dizziness or feeling faint, or a drop in blood pressure particularly when getting up from sitting or lying down

•    You have any liver or kidney problems

•    You suffer from SLE (systemic lupus erythematosus, a disease which affects the skin and internal organs -symptoms include red, scaly skin and swollen joints).

This may get worse when you are taking these tablets

•    You are pregnant, trying to get pregnant or breastfeeding

•    You suffer from gout or raised levels of uric acid in the blood. These tablets can make these worse

•    You have an intolerance to some sugars. These tablets contain small amounts of lactose and sucrose.

If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.

Taking other medicines

Bendroflumethiazide Tablets can affect some other medicines you may be taking. Make sure your doctor knows if you are taking any of the following:

•    Medicines used for heart problems including amiodarone, digoxin, digitoxin, disopyramide, flecainide, lidocaine, mexiletine, quinidine and sotalol

•    Medicines to treat diabetes such as chlorpropamide, sulphonylureas (e.g. gliclazide) and insulin

•    Medicines to treat muscle spasm and Parkinson’s disease (e.g. baclofen, tizanidine, levodopa)

•    Drugs to increase urine output (e.g. furosemide) or to treat high blood pressure such as beta blockers (e.g. atenolol), ACE inhibitors (e.g. captopril), angiotensin-II antagonists (e.g. losartan), alpha blockers (e.g. doxazosin) and calcium channel blockers (e.g. amlodipine)

•    Non steroidal anti-inflammatory drugs (NSAIDs) used for relief of pain and inflammation (e.g. ibuprofen, indometacin, ketorolac)

•    Corticosteroids (e.g. hydrocortisone or prednisolone) or the drug ACTH. These are used in replacement therapy and to suppress the symptoms of inflammatory and allergic disorders

•    Medicines to treat depression including tricyclic antidepressants (e.g. imipramine), monoamine-oxidase inhibitors (MAOIs e.g. phenelzine) and reboxetine

•    Medicines to treat mental illness such as amisulpride, phenothiazines (e.g. chlorpromazine), pimozide, sertindole, anxiolytics (e.g. diazepam) and hypnotics (e.g. nitrazepam)

•    Medicines to treat asthma such as theophylline and beta-agonists (e.g. salbutamol) or the drug terfenadine (used to treat allergies)

•    Medicines used to lower the body’s normal immune response e.g. ciclosporin

•    Medicines containing platinum compounds used to treat cancer e.g. cisplatin or the drug toremifene (used to treat breast cancer)

•    Oral contraceptives or other drugs containing oestrogens such as hormone replacement therapy (HRT)

•    Acetazolamide (used to treat glaucoma)

•    Carbenoxolone (used to treat ulcers)

•    Aldesleukin (used to treat a type of kidney cancer)

•    Allopurinol (used to treat gout)

•    Alprostadil (used to treat male impotence and heart defects in infants)

•    Amphotericin given by injection (used to treat fungal infections) or lymecycline (used to treat infections)

•    Calcium salts or vitamin D (used in dietary supplements)

•    Colestyramine and colestipol (used to treat high blood cholesterol)

•    Atomoxetine (used for the management of attention deficit hyperactivity disorder (ADHD) in children)

•    Carbamazepine (used to treat epilepsy)

•    Moxisylyte (used to treat Raynaud’s syndrome)

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.

Other special warnings

•    This medicine can increase the effects of muscle relaxants given during general anaesthesia. If you are going to have a general anaesthetic, make sure you tell the hospital staff that you are taking bendroflumethiazide

•    This medicine may also interfere with a number of laboratory tests. If you are going to have any blood or other tests tell the doctor or nurse you are taking these tablets

Continued, please turn over.

•    If you need to take these tablets for a long time, or if you are elderly, you may need to have blood tests from time to time to monitor the levels of salts (electrolytes) in your blood, and possibly to determine that your kidneys are working properly

•    Drinking alcohol, taking barbiturates to help you sleep (e.g amobarbital sodium), or taking opioids to relieve pain (e.g. morphine, codeine phosphate) whilst taking these tablets may make you feel faint when you stand up.

Driving and using machinery

You may feel dizzy or faint while using Bendroflumethiazide Tablets. They might also affect your eyesight. Do not drive or operate machinery if you are affected.

3. How to take Bendroflumethiazide Tablets

The tablets should be swallowed with a drink of water.

The doctor will decide what dose of tablets you need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.

The usual doses are as follows:

Adults:

To treat high blood pressure: Take half a tablet each morning. Higher doses are rarely necessary.

To reduce fluid build up in the tissues: To start, take 1 or 2 tablets each morning. Your doctor may then want you to continue with a dose of 2.5 mg - 10 mg three times a week.

To reduce production of breast milk: Take 1 tablet each morning and 1 tablet at midday for about five days.

Elderly

Elderly patients may need a lower dose, particularly if they have kidney problems.

Children

The doctor will decide what dose is needed. It depends on the body weight of the child.

If you take more tablets than you should

You should contact your doctor or your pharmacist straightaway. Take your tablets or the pack with you.

If you forget to take a dose of Bendroflumethiazide Tablets

If you are late with your morning dose, do not take it later than midday. Miss this dose and carry on with the normal routine the next day.

4. Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Tell your doctor immediately if you notice any of the

following effects:

•    Breathing difficulty, coughing up blood, excessive sweating, anxiety and pale skin

•    Breathlessness, cough or raised temperature

•    Severe skin reactions.

The symptoms listed above may be signs of an allergic

reaction.

•    Severe pain in the abdomen and back (indicating inflammation of the pancreas).

Less than 1 in 1,000 people have experienced:

•    Blood disorders which can cause fever, tiredness, bruising and sometimes abnormal bleeding or make infections more likely.

Other effects which have been reported are:

•    Irregular heartbeat

•    Yellowing of the skin or whites of the eyes, pale stools, dark urine, itching

•    Reduced levels of blood electrolytes (salts) e.g. low potassium, sodium, chloride and/or magnesium levels or increased blood levels of calcium. Symptoms include an abnormal heartbeat, muscle weakness, numbness, loss of appetite, nausea or vomiting (feeling or being sick), constipation, abdominal pain, muscle spasms, twitching, tiredness, confusion, fits, coma

•    Increased skin sensitivity to sunlight

•    Change in blood lipid (fat) levels

•    Raised levels of glucose in the blood. This can lead to symptoms of diabetes (e.g. frequent urination, increased thirst and increased appetite) or worsening of existing diabetes

•    Raised levels of uric acid in the blood which can cause worsening of gout in some people

•    Temporary blurred vision, worsening of short sightedness

•    Impotence (inability to achieve or maintain an erection)

•    A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting

•    Diarrhoea

•    Headache, numbness or tingling anywhere in the body

•    Blood vessel damage.

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 Bendroflumethiazide Tablets

Keep out of the sight and reach of children.

Blisters: Do not store above 25°C. Store in the original package and keep blister in the outer carton to protect the tablets from moisture.

Tablet containers: Do not store above 25°C. Store in the original container and keep the container tightly closed, in order to protect the tablets from moisture.

Do not use the tablets after the expiry date shown on the carton or label.

If your doctor tells you to stop taking the tablets, please take any unused medicine back to your pharmacist to be destroyed.

6. Further Information

Ingredients

Each tablet contains 5 mg of the active ingredient, bendroflumethiazide. The other ingredients are lactose, pregelatinised maize starch, sucrose, stearic acid and magnesium stearate.

What the medicine looks like

The tablets are white, flat and round. They are supplied to your pharmacist in packs of 28, 56, 500 or 1000 tablets. Not all pack sizes may be available.

Product licence holder and manufacturer

The product licence holder is

Dalkeith Laboratories Ltd., 2 Park Street, Woburn,

Bedfordshire, MK17 9PG, UK.

Manufactured by Surepharm Services Ltd., Bretby, Burton upon Trent, Staffs, DE15 0YZ, UK.

Product Licence Number:

PL 17496/0005

Date of revision: May 2015

If you would like the leaflet in a different format, please contact the licence holder at the above address.

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