Document: document 0 change

• document 0
• document 1

---

e

MercuryPharma

PATIENT INFORMATION LEAFLET

Navispare® 0.25mg/2.5mg Tablets

Cyclopenthiazide/Amiloride Hydrochloride 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.

The name of your medicine is Navispare 0.25mg/2.5mg Tablets. It will be referred to as Navispare Tablets for ease hereafter.

In this leaflet:

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

2.    Before you take Navispare Tablets

3.    How to take Navispare Tablets

4.    Possible side effects

5.    How to store Navispare Tablets

6.    Further information

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

Navispare Tablets belong to a group of medicines called diuretics. They make the kidneys remove water from the body and they have the effect of lowering the blood pressure.

Navispare Tablets are used to treat mild to moderate high blood pressure (hypertension).

2. Before you take Navispare Tablets

DO NOT take Navispare Tablets if you:

•    know you are are allergic to cyclopenthiazide and amiloride hydrochloride, or other sulphonamide derivatives or any of the other ingredients of Navispare Tablets (see section 6 of this leaflet)

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

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

•    are unable to pass water

•    are diabetic and have kidney damage

Take special care with Navispare Tablets if you:

•    are going to have a general anaesthetic, tell the doctor or dentist in charge that you are taking Navispare®.

•    are going to have a glucose tolerance test tell your doctor that you are taking Navispare®.

•    are diabetic, take particular care with your blood sugar control since this medicine may make you less aware of low blood sugar levels.

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

•    have too much fat in your blood (your doctor will advise you and may want to monitor you).

•    suffer from gout (painful joints, especially the big toe)

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:

•    Medicines used as anaesthetics

•    Other medicines that treat high blood pressure

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

•    Sleeping tablets or sedatives (e.g. barbiturates)

Pregnancy and breast feeding:

Navispare Tablets should be avoided while pregnant or breast feeding.

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

Driving and using machines:

If you feel dizzy or sleepy or have problems with vision when you start taking these tablets, do not drive or work machinery until these effects have worn off.

Taking with food and drink:

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

Important information about some of the ingredients of Navispare Tablets:

This medicine also contains:

•    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.

•    Polyethoxylated hydrogenated castor oil which may cause stomach upset and diarrhoea.

•    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.

3. How to take Navispare Tablets

Always take Navispare 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.

The usual dose is one or two tablets taken once a day in the morning.

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

Do not give Navispare Tablets to children under 12 years.

Keep taking Navispare Tablets even if you feel well. Do not stop taking Navispare Tablets unless your

^{doctor tells you to}.    22824000/06

1111861/13

MercuryPharma	Date of Approval: N/A To be implemented by: N/A	PROOF 1 11/09/2014
Product Description:	Originated by Date:	Tech Approved Date:
Navispare 0.25mg/2.5mg Tablets	N/A 02/04/2012	No
Component:	Revised by	Version:
Leaflet	SMT	100066/LF/3
Manufacturer:	File Name:	CRF No.:
Riemser	100066LF Navispare Tablets v3_1	AMCO.CRF.286.2014
Market:	Software Package:	Barcode:
UK	Quark Xpress 10	N/A
Minimum Font Size & Typeface:	Dimensions:	Pharma Code:
8.5pt Swiss 721BT	160 x 315mm	N/A
	Colours: 1 Black	Key Line:

If you take more Navispare 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 Navispare Tablets:

If you miss taking Navispare 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 Navispare 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.

Navispare Tablets are generally well tolerated. But, like all medicines, Navispare Tablets can cause side effects, although not everybody gets them.

If you notice any of the following effects stop taking your tablets and speak to your doctor immediately: Increased or irregular heart rate, chest pain or dizziness when raising from a sitting or lying position Unusual bleeding or bruising Persistent sore throat or high temperature Breathing difficulties

Inflammation of the pancreas gland causing abdominal pain and brain damage Occurrence or worsening of diabetes (high levels of sugars in your blood)

Any sign of bleeding in the stomach or intestine, e.g. passing black stools Feeling weak or dizzy and/or have muscle cramps or joint pain Loss of appetite

Yellowing of the skin or whites of the eyes (signs of jaundice)

Mood changes or problems with sleeping Tingling in your hands or feet, tremor Hair loss Stomach ache

Feeling sick (nausea) or being sick (vomiting)

Constipation or diarrhoea.

Other effects which may occur include:

•    Feeling thirsty or dry mouth

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

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

•    Problems with passing urine

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

•    Attacks of gout

•    Flatulence or heartburn

•    Headache, dizziness or light-headedness

•    Reduced sex drive

•    Cough, wheezing, blocked up nose or ringing in the ears

•    Unusual tiredness

•    Increase in blood fat levels

As Navispare 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 Navispare Tablets.

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 Navispare Tablets

Keep this medicine out of the sight and reach of children.

Do not use Navispare Tablets after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. 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 original package in order to protect from moisture.

6. Further information

Each Navispare® Tablet contains the active ingredients cyclopenthiazide and amiloride hydrochloride. Navispare Tablets also contains wheat starch (gluten), lactose, povidone, stearic acid, talc, sodium starch glycollate, titanium dioxide (E171), yellow iron oxide (E172), polyethoxylated castor oil, hydroxypropylmethylcellulose.

What Navispare Tablets look like and contents of the pack:

Navispare Tablets are film coated tablets. Each tablet contains 0.25mg cyclopenthiazide and 2.5mg amiloride hydrochloride.

They are supplied in blister packs of 28.

Marketing Authorisation Holder & Manufacturer:

Mercury Pharmaceuticals Ltd.,

Capital House, 85 King William Street, London EC4N 7BL, UK Alternate Manufacturer:

Riemser Specialty production GmbH,

Mittelstrafe 18, D - 88471 Laupheim, Germany.

This leaflet was last revised in September 2014.

Navispare is the registered trademark of Mercury Pharma Group Limited.    100066/LF/3

22824000/06

1111861/13

MercuryPharma	Date of Approval: N/A To be implemented by: N/A	PROOF 1 11/09/2014
Product Description:	Originated by Date:	Tech Approved Date:
Navispare 0.25mg/2.5mg Tablets	N/A 02/04/2012	No
Component:	Revised by	Version:
Leaflet	SMT	100066/LF/3
Manufacturer:	File Name:	CRF No.:
Riemser	100066LF Navispare Tablets v3_1	AMCO.CRF.286.2014
Market:	Software Package:	Barcode:
UK	Quark Xpress 10	N/A
Minimum Font Size & Typeface:	Dimensions:	Pharma Code:
8.5pt Swiss 721BT	160 x 315mm	N/A
	Colours: 1 Black	Key Line: