Navispare 0.25mg/2.5mg Tablets

Document: leaflet MAH GENERIC_PL 12762-0216 change

Patient Information Leaflet

Cyclopenthiazide 0.25mg and Amiloride Hydrochloride 2.5mg Tablets

This leaflet will provide you with important information about your medicine. Please read it carefully before you take your medicine. The leaflet contains a summary but not all of the information about your medicine. If you require any further information or if you are unsure about any thing, ask your doctor or pharmacist.

What’s in your medicine

Description: Cyclopenthiazide 0.25mg and Amiloride Hydrochloride 2.5mg Tablets are orange yellow, round slightly biconvex, film coated tablets, imprinted with GS on one face and 053 on the other.

Each film coated tablet contains Cyclopenthiazide 0.25mg and Amiloride Hydrochloride 2.5mg.

Also contains inactive ingredients. These are: Wheat Starch (Gluten), Lactose, Povidone K90, Stearic Acid, Talc, Sodium Starch Glycollate, Titanium Dioxide (E171), Yellow Iron Oxide (E172), Polyethoxylated Castor Oil, Hydroxypropylmethylcellulose and Purified Water.

Pack Size: The tablets come in blister packs containing 28 tablets.

Type of medicine: This medicine belongs to a group of medicines called diuretics (‘water tablets’) Product License Holder:

Mercury Pharmaceuticals Ltd

Capital House, 85 King William Street, London EC4N 7BL, UK PL 12762/0216

Company Responsible for Manufacture:

Mercury Pharmaceuticals Ltd

Capital House, 85 King William Street, London EC4N 7BL, UK Riemser Specialty production GmbH,

MittelstraPe 18, D - 88471 Laupheim, Germany.

What is this medicine used for

This medicine is used to treat high blood pressure (hypertension).

Before you take your medicine

• Have you ever had a rash or other possible allergic reaction whilst taking diuretics or sulphonamides?

• Do you suffer from Addison’s disease?

• Do you suffer from serious liver or kidney disease?

• Do you suffer from gout or kidney stones?

• Do you have low blood levels of Sodium or Potassium?

• Do you have high blood levels of Calcium or Potassium?

• Are you taking any other diuretics or potassium-containing medicines?

• Are you taking lithium tablets?

If the answer to any of these questions is YES, do not take the tablets without talking to your doctor again.

• This medicinal product contains Wheat Starch. Patients with wheat allergy (different from coeliac disease) should not take this medicine.

• This medicinal product contains Castor Oil, which may cause stomach upset and diarrhoea.

• This medicinal product contains Lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

• Are you diabetic and taking insulin or anti-diabetic tablets?

• Do you have high levels of cholesterol in your blood?

• Do you have or have you ever had lupus erythematosus (LE)

• Are you pregnant or breast feeding?

• Do you suffer from any serious blood vessel disorders?

If the answer to any of these questions is YES, tell your doctor or pharmacist.

Are you taking any of the following

• Medicines for high blood pressure or heart problems, e.g. ACE inhibitors, beta-blockers, calcium antagonists, which your doctor does not know about?

• Medicines used to relieve pain or inflammation, e.g. non-steroidal anti-inflammatory agents (NSAIDs)?

• Sleeping tablets or sedatives?

• Any other medicines which your doctor does not know about?

If the answer to any of these questions is YES, tell your doctor or pharmacist.

Other special warnings

• Be careful when drinking alcohol - it may affect you more than usual.

• 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.

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

• If you are going to have a glucose tolerance test, tell your doctor that you are taking this medicine.

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

• When taking this medicine for a long time, your doctor may wish to do regular tests, e.g. check the salt level in your blood.

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

• Cyclopenthiazide 0.25mg and Amiloride Hydrochloride 2.5mg Tablets are not suitable for children. How to take your medicine

It is important to take your medicine at the right time. You must take them as instructed by your doctor. The usual dosage is 1 or 2 tablets taken once a day in the morning.

Elderly patients may need lower doses.

If you are not sure how many tablets to take, ask your doctor or pharmacist.

• Swallow your tablets whole with a drink of water.

• Do not stop taking your tablets suddenly. Ask your doctor first.

• If you forget to take a dose, take the next dose at the usual time. DO NOT take a double dose.

• If you accidentally take too many Cyclopenthiazide 0.25mg and Amiloride Hydrochloride 2.5mg Tablets, tell your doctor at once or contact your nearest hospital casualty department.

Whilst taking your medicine

These tablets sometimes cause unwanted effects in some people. If you get any of the following tell your doctor:

• Skin rash, itching or blistering of the skin

• Muscle pains or cramps, joint pain

• A persistent sore throat and/or raised temperature

• Any unusual bleeding or bruising

• Any yellow discolouration of the whites of your eyes or your skin

• Increased sensitivity of the skin to sunlight

• Increased or irregular heart rate, chest pain or dizziness when raising from a sitting or lying position

• Problems with passing urine

• Breathing difficulties

• Pancreatitis, encephalopathy

• Attacks of gout

• Occurrence or worsening of diabetes

• Any sign of bleeding in the stomach or intestine, e.g. passing black stools

Other effects which may occur include:

• Stomach upset including stomach pain, diarrhoea, constipation, flatulence, heartburn or

• sickness

• Headache, dizziness or light-headedness

• Problems with vision

• Impotence or reduced sex drive

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

• Mood changes or problems with sleeping

• Tingling in your hands or feet, tremor

• Loss of appetite, dry mouth, increased thirst

• Hair loss

• Unusual tiredness or weakness

• Increase in blood fat levels

If unwanted effects are severe or last for more than a few days, tell your doctor.

If you suffer from any side effects not mentioned in this leaflet you should also tell your doctor or pharmacist.

It is important to take your medicine at the right time.

Storing your medicine

• The expiry date for these tablets is given on the carton. Do not take the tablets after this date.

• Store in the original package in order to protect from moisture.

• Do not store above 25°C

• Keep out of the reach and sight of children.

• Return any unused tablets to your pharmacist.

REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to somebody else. It may harm them even if they have the same symptoms as you. The information in this leaflet applies only to Cyclopenthiazide 0.25mg and Amiloride Hydrochloride 2.5mg Tablets.