PATIENT INFORMATION LEAFLET NEO-NACLEX®-K 2.5mg/630mg TABLETS Bendroflumethiazide 2.5mg and Potassium Chloride 630mg

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. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Neo-Naclex-K 2.5mg/630mg Tablets are and what they are used for

2.    Before you take Neo-Naclex-K 2.5mg/630mg Tablets

3.    How to take Neo-Naclex-K 2.5mg/630mg Tablets

4.    Possible side effects

5.    How to store Neo-Naclex-K 2.5mg/630mg Tablets

6.    Further information

1.    What Neo-Naclex-K 2.5mg/630mg Tablets are and what they are used for

Neo-Naclex-K 2.5mg/630mg Tablets belong to a group of medicines called diuretics. They make the kidneys remove water from the body.

Neo-Naclex-K 2.5mg/630mg Tablets are used to treat:

•    Oedema, which is a build-up of fluid in the body. This may occur in many situations, for instance with liver and kidney problems or with heart failure (when the heart doesn’t pump efficiently)

•    Raised blood pressure (hypertension).

2.    Before you take Neo-Naclex-K 2.5mg/630mg Tablets DO NOT take Neo-Naclex-K 2.5mg/630mg Tablets if you:

•    know that you are allergic to bendroflumethiazide or potassium chloride or any of the other ingredients of Neo-Naclex-K 2.5mg/630mg Tablets (see section 6 of this leaflet)

•    have a serious liver or kidney disorder (your doctor will advise you)

•    have high levels of potassium (hyperkalaemia) or calcium (hypercalcaemia) in your blood.

Your doctor will advise you

•    suffer from serious complications from diabetes (diabetic keto-acidosis)

•    have a disease of the adrenal glands causing weakness, weight loss and a deficiency of hormones in the blood (Addison’s disease)

•    are taking the medicine lithium (used for severe mental illness)

•    have gastrointestinal problems involving a blockage in your gut.

Take special care with Neo-Naclex-K 2.5mg/630mg Tablets if you:

•    have diabetes

•    have problems with your liver or kidneys or heart

•    have prostate problems (males only)

•    are elderly

•    have abnormal levels of potassium or calcium in your blood or you have high cholesterol (you doctor will advise you)

•    have a chronic skin disease (such as lupus erythematosus).

If any of the above applies to you, make sure your doctor is aware of this.

Your doctor may monitor your blood or urine, especially if you are elderly or have problems with your kidneys.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effects of these medicines may change, especially if you are taking:

•    Vitamin B12

•    Medicines used as anaesthetics

•    Medicines to treat ulcers (carbenoxolone)

•    Corticosteroids to treat inflammatory conditions such as arthritis or asthma

•    Medicines to treat heart problems

•    Antidepressants such as Monoamine Oxidase Inhibitors (MAOIs) e.g. phenelzine

•    Other medicines that treat high blood pressure (e.g. atenolol, enalapril)

•    Medicines to treat diabetes

•    Medicines that act as central nervous system (CNS) depressants (barbiturates)

•    Analgesics and narcotics (medicines for pain relief) including non-steroidal anti inflammatory drugs (NSAIDs) or muscle relaxants

•    Medicines to treat gout (painful inflammation of the joints, e.g. allopurinol).

Pregnancy and breast feeding:

Neo-Naclex-K 2.5mg/630mg Tablets should not be used during pregnancy or breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

Neo-Naclex-K 2.5mg/630mg Tablets should not affect your ability to drive or use machinery. However, you may experience dizziness whilst taking the tablets. If you are affected do not drive or operate machinery.

Taking with food and drink:

You should avoid drinking alcohol whilst you are taking this medicine as it may change the effects of Neo-Naclex-K 2.5mg/630mg Tablets.

Important information about some of the ingredients of Neo-Naclex-K 2.5mg/630mg Tablets:

This medicine also contains:

•    Lactose, which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

•    Carmoisine E122, which may cause allergic reactions.

3. How to take Neo-Naclex-K 2.5mg/630mg Tablets

Always take Neo-Naclex-K 2.5mg/630mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will decide the best dose for you and may change it depending on how you respond to treatment. You may also be given other medicines.

You should swallow the tablets whole with a glass of water.

Adults:

To treat high blood pressure

The usual dose is one tablet a day, alone or with other medicines.

To treat fluid retention (oedema)

The usual dose is two tablets a day in the morning. The dose can be increased to 4 tablets if needed.

After some time, your doctor may tell you to take just 1 or 2 tablets a day on only two or three days in a week.

Elderly:

If you are elderly, your doctor may give you a lower dose.

Children:

Do not give Neo-Naclex-K 2.5mg/630mg Tablets to children under 12 years.

Keep taking Neo-Naclex-K 2.5mg/630mg Tablets even if you feel well. Do not stop taking Neo-Naclex-K 2.5mg/630mg Tablets unless your doctor tells you to.

Your doctor will give you regular urine tests (to check your kidneys) or blood tests during treatment.

If you take more Neo-Naclex-K 2.5mg/630mg Tablets than you should:

If you think that you, or any other person, have taken too many Tablets, contact your doctor or hospital casualty department immediately. Take any remaining Tablets and this leaflet with you so that the medical staff know exactly what you have taken.

If you forget to take your Neo-Naclex-K 2.5mg/630mg Tablets:

If you miss taking Neo-Naclex-K 2.5mg/630mg Tablets in the morning, then take it as soon as you remember and carry on taking the Tablets as normal on the following morning. Do not take a double dose to make up for the missed one.

4. Possible side effects

Like all medicines, Neo-Naclex-K 2.5mg/630mg Tablets can sometimes cause side-effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

As Neo-Naclex-K 2.5mg/630mg Tablets remove excess water from your body, the number of times that you need to pass urine will increase. This will be most noticeable when you first start taking Neo-Naclex-K 2.5mg/630mg Tablets.

If you have any of the following unwanted effects, stop taking this medicine and tell your doctor:

•    Pass blood in your stools/motions or black tarry stools

•    Vomit any blood or dark particles that look like coffee grounds

•    Some people may have stomach ache, feel or be sick and have diarrhoea

•    Some people may feel weak or dizzy and/or have muscle cramps and headaches

•    Loss of appetite

•    A few people may feel thirsty or have a dry mouth

•    Very rarely, some patients may develop a skin rash especially when the skin is exposed to daylight

•    Males may suffer from impotence. This problem resolves after you stop taking the medicine.

Certain other unwanted effects on the pancreas, kidneys or liver or changes in the blood levels of chemicals and salts can only be detected by your doctor. To check for this your doctor may occasionally want to do some blood tests.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Neo-Naclex-K 2.5mg/630mg Tablets

Keep out of the reach and sight of children.

Do not use Neo-Naclex-K 2.5mg/630mg Tablets after the expiry date which is stated on the packaging. If your Tablets are out of date, take them to your pharmacist who will get rid of them safely.

Securitainer:

Do not store above 30°C. Store in the original container in order to protect from light and moisture. Blister:

Do not store above 25°C. Store in the original package in order to protect from light and moisture.

6.    Further information

Each Neo-Naclex-K 2.5mg/630mg Tablet contains the active ingredients bendroflumethiazide and potassium chloride.

Neo-Naclex-K 2.5mg/630mg Tablets also contains magnesium stearate, lactose, maize starch, silicon dioxide, methanol, methylene chloride, cellulose acetate phthalate, ethylcellulose 100, indigo carmine E132, carmoisine E122, polyethylene glycol 6000, purified water, hydroxypropylmethylcellulose, ethylcellulose 50, acetylated monoglyceride, propylene glycol, polysorbate 80, methylene chloride, isopropyl alcohol.

What Neo-Naclex-K 2.5mg/630mg Tablets look like and contents of the pack:

Neo-Naclex-K 2.5mg/630mg Tablets are film coated, two-layered white and pink tablets. Each tablet contains 2.5mg bendroflumethiazide in the white layer and 630mg potassium chloride in the pink layer, providing 330mg elemental potassium.

They are supplied in blister packs of 28, 56 or 112 Tablets.

They are also supplied in polypropylene vials containing 30, 100, 250 and 500 Tablets.

Marketing Authorisation Holder: Mercury Pharma Group Ltd., Capital House, 85 King William Street,

London EC4N 7BL, UK

Manufacturer:

Dales Pharmaceuticals Ltd., Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, UK.

This leaflet was last revised in December 2013.

Neo-Naclex is a registered trade mark of Mercury Pharma Group Limited.