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Navidrex 0.5mg Tablets

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PATIENT INFORMATION LEAFLET Navidrex® 0.5mg Tablets (cyclopenthiazide)

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 Navidrex® 0.5mg Tablets are and what they are used for

2.    Before you take Navidrex® 0.5mg Tablets

3.    How to take Navidrex® 0.5mg Tablets

4.    Possible side effects

5.    How to store Navidrex® 0.5mg Tablets

6.    Further information

1.    What Navidrex 0.5mg Tablets are and what they are used for

Navidrex® 0.5mg Tablets belong to a group of medicines called diuretics. They make the kidneys remove water from the body.

Navidrex® 0.5mg Tablets are used to treat high blood pressure and some types of heart problems. They are also used to help reduce fluid retention associated with the pre-menstrual syndrome and some kidney or liver diseases.

2.    Before you take Navidrex® 0.5mg Tablets DO NOT take Navidrex® 0.5mg Tablets if you:

•    know that you are allergic to cyclopenthiazide, other diuretics or sulphonamides or any of the other ingredients of Navidrex® 0.5mg Tablets (see section 6 of this leaflet).

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

•    have gout (painful joints, especially the big toe) or kidney stones

•    raised blood pressure during pregnancy

•    have low blood levels of sodium or potassium

•    have high levels of calcium in your blood (hypercalaemia). Your doctor will advise you

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

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Take special care with Navidrex 0.5mg Tablets and tell your doctor if you:

•    suffer from diabetes

•    problems with your liver or kidneys or heart

•    are being sick (vomiting) or have diarrhoea

•    are unwell or have a fever

•    are elderly

•    have high cholesterol (your doctor will advise you)

•    suffer from any serious blood vessel disorders

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

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 D or calcium salts

•    Medicines for infections (amphotericin)

•    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), eg phenelzine

•    Medicines for ulcers (carbenoxolone)

•    Medicines to treat cancer (cyclophosphamide or methotrexate)

•    Medicines for stomach and gut problems (anticholinergics)

•    Medicines for Parkinsons’s or viral infections (amantadine)

•    Medicines to treat rheumatic disease or skin problems or for transplants (cyclosporine)

•    Medicines for severe mental illness such as lithium

•    Medicines for high cholesterol levels

•    Other medicines that treat high blood pressure (e.g. methyldopa or diazoxide (used for severe high blood pressure)

•    Medicines to treat diabetes

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

•    Medicines to treat gout (painful inflammation of the joints)

Pregnancy and breast feeding

Navidrex® 0.5mg 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

If you feel you feel dizzy or have problems with your vision when you start taking these tablets, do not drive or work machines until these effects wear off.

Taking with food and drink

You should avoid drinking alcohol whilst you are taking this medicine as it may change the effects of Navidrex® 0.5mg Tablets.

Since these tablets may reduce the amount of salt in the body, you should avoid strict low salt diets.

Important information about some of the ingredients of Navidrex® 0.5mg 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.

•    Wheat starch (gluten). This medicine is suitable for people with celiac disease. Patients with wheat allergy (different from celiac disease) should not take this medicine.

3. How to take Navidrex 0.5mg Tablets

Always take Navidrex® 0.5mg 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.

It is best to take your tablets in the morning. You should swallow the tablets whole with a glass of water.

USUAL DOSE:

The usual adult dose is half of one tablet, or one whole tablet a day, alone or with other medicines. This can be increased by your doctor, if necessary.

To treat heart conditions, the maximum recommended dose is two tablets a day.

If you are elderly or have kidney problems, your doctor may give you a lower dose.

Keep taking Navidrex® 0.5mg Tablets even if you feel well. Do not stop taking Navidrex® 0.5mg Tablets unless your doctor tells you to.

Your doctor will give you regular blood or urine tests during treatment.

Do not give Navidrex® 0.5mg Tablets to children under 12 years.

If you take more Navidrex 0.5mg 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 Navidrex® 0.5mg Tablets:

If you miss taking Navidrex® 0.5mg Tablets in the morning, then take it as soon as you remember and carry on taking the Tablets as normal on the following morning.

4. Possible side effects

Like all medicines Navidrex® 0.5mg 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 Navidrex® 0.5mg 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 Navidrex® 0.5mg Tablets.

Other side effects include:

•    Some people may have loss of appetite, stomach ache or feel or be sick and have diarrhoea.

•    Some people may feel weak or dizzy and/or have muscle cramps, headaches, mood changes or problems with sleeping.

•    Yellowing of the skin or whites of the eyes (jaundice).

•    Problems with your sight, usually when first starting treatment with these tablets.

•    Unusual bleeding or bruising.

•    Persistent sore throat or high temperature.

•    Increased or irregular heart beat.

•    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 such as 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 Navidrex 0.5mg Tablets

Keep out of the reach and sight of children.

Do not use Navidrex® 0.5mg 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.

Do not store above 25°C. Store in the original package.

Protect from light and moisture

6.    Further information

Each Navidrex® 0.5mg Tablets contains the active ingredient cyclopenthiazide.

Navidrex® 0.5mg Tablets also contains lactose, wheat starch, gelatin, stearic acid and talc What Navidrex® 0.5mg Tablets look like and contents of the pack

Navidrex® 0.5mg Tablets are white, round, flat tablets with bevelled edges, impressed ‘055’ on one side and ‘GS’ either side of a breakline on the other.

They are supplied in blister packs of 28 tablets.

Marketing Authorisation Holder

Mercury Pharmaceuticals Ltd,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

Manufacturer

Mercury Pharmaceuticals Ltd,

No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK

®Navidrex is a registered trademark This leaflet was last revised in March 2012