Hygroton 50 Mg Tablets

Leaflet

Document: leaflet MAH BRAND_PLPI 22961-0178 change

PATIENT INFORMATION LEAFLET

Hygroton® 50 mg Tablets

(chlortalidone)

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

The information in this leaflet has been divided into the following sections:

1. What Hygroton 50 mg Tablets is and what it is taken for

2. Check before you take Hygroton 50 mg Tablets

3. How to take Hygroton 50 mg Tablets

4. Possible side effects

5. How to store Hygroton 50 mg Tablets

6. Further information

1. What Hygroton 50 mg Tablets is and what it is taken for_

Hygroton 50 mg Tablets belongs to a group of medicines called thiazide diuretics.

Thiazide diuretics help to reduce the amount of water in your body. They do this by increasing the amount of water that you pass as urine. They are sometimes called 'water tablets'.

Hygroton 50 mg Tablets is used to:

• treat high blood pressure (hypertension)

• treat heart failure

• help reduce the fluid retention that occurs with some kidney or liver diseases

• treat diabetes insipidus (a condition in which an individual produces large amounts of dilute urine and is constantly thirsty).

2. Check before you take Hygroton 50 mg Tablets_|

Do not take Hygroton 50 mg Tablets:

• if you are allergic (hypersensitive) to chlortalidone, sulphonamides such as sulfamethoxazole or any of the ingredients of Hygroton 50 mg Tablets (see Section 6 Further information)

• if you are not passing any urine at all

• if you have severe kidney or liver problems

• if you have low blood levels of potassium which can cause muscle weakness, muscle twitching or abnormal heartbeat

• if you have low blood levels of sodium which can cause tiredness, confusion, muscle twitching, fits or coma

• if you have high blood levels of calcium which can cause loss of appetite, tiredness or muscle weakness

• if you have ever had gout or kidney stones

• if you have Addison's disease (which is a condition where your adrenal gland is not producing enough steroids)

• if you are taking lithium.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Hygroton 50 mg Tablets. Take special care with Hygroton 50 mg Tablets Before you take Hygroton 50 mg Tablets tell your doctor if:

• you suffer from any other liver or kidney problems

• you are on a low-salt diet

• you suffer from diabetes mellitus (increased levels of sugar in the blood)

• you have high cholesterol levels

• if you have recently had an anaesthetic

• you are elderly.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Hygroton 50 mg Tablets. Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interfere with Hygroton 50 mg Tablets:

• other treatments for high blood pressure or heart problems such as:

- ACE inhibitors (for example, lisinopril)

- beta blockers (for example propranolol hydrochloride)

- methyldopa

- vasodilators (for example bosentan)

- calcium channel blockers (for example amlodipine)

- guanethidine

• corticosteroids such as prednisolone or betamethasone -used to treat allergic and inflammatory diseases and immune reactions

• cytotoxic agents such as cyclophosphamide or methotrexate -used to treat cancer

• asthma treatments such as salbutamol or formoterol

• amphotericin - used to treat infections

• carbenoxolone - used to treat ulcers

• insulin and other treatments for diabetes such as chlorpropamide or glibenclamide

Please tell your doctor or pharmacist if you are taking or have re without a prescription.

• digoxin - for an irregular heartbeat

• lithium - used to treat mental illness

• adrenocorticotropic hormone (ACTH) - used to treat a number of different conditions, including ulcerative colitis, Crohn's disease and rheumatoid arthritis

• anticholinergics such as atropine sulphate or hyoscine butylbromide - for abdominal or stomach spasms or cramps

• colestyramine - used to reduce cholesterol levels and prevent heart disease

• amantadine - used to treat Parkinson's disease or viral infections

• allopurinol - used to treat gout

• calcium salts or vitamin D - used for replacement therapy

• non-steroidal anti-inflammatories (NSAIDs) such as aspirin or indometacin - used for pain relief or rheumatism

• ciclosporin - used to treat rheumatic disease or skin complaints or after a transplant

I taken/used any other medicines, including medicines obtained

Taking with food and drink

It is best to take Hygroton 50 mg Tablets in the morning with food. Swallow your tablets whole with a drink of water. You should avoid low salt diets. Taking Hygroton 50 mg Tablets may reduce the amount of salt in your body.

If you are on a low salt diet check with your doctor first before taking Hygroton 50 mg Tablets.

Pregnancy and breast-feeding

Do not take Hygroton 50 mg Tablets if you are pregnant or trying to become pregnant.

Do not take Hygroton 50 mg Tablets if you are breast-feeding because Hygroton 50 mg Tablets passes into breast milk and could harm your baby.

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

Driving and using machines

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

3. How to take Hygroton 50 mg Tablets

Always take Hygroton 50 mg Tablets exactly as your doctor has told you to.

It is important to take your tablets at the right time. You should check with your doctor or pharmacist if you are not sure.

Your doctor will choose a suitable starting dose for your particular condition and monitor your progress. If necessary, this dose can be increased or reduced.

Whilst you are taking Hygroton 50 mg Tablets, your doctor may want to carry out a number of tests from time to time. This is quite usual and nothing to worry about.

It is best to take Hygroton 50 mg Tablets in the morning with food. Swallow your tablets whole with a drink of water. Ref: 761

Adults

The usual doses for adults are as follows:

• High blood pressure:

The starting dose is 25 mg (half a tablet) a day. Your doctor may increase this to 50 mg (one tablet) a day if necessary.

• Heart failure:

The starting dose is 25 mg (half a tablet) a day. Your doctor may increase this up to 200 mg (four tablets) a day if necessary.

• Fluid retention associated with kidney or liver disease:

Up to 50 mg (one tablet) a day.

• Diabetes insipidus (a disease in which an individual produces large amounts of dilute urine and is constantly thirsty):

The starting dose is 100 mg (two tablets) twice a day. Your doctor may reduce your dose to 50 mg (one tablet) a day.

Children

Your doctor will choose a suitable dose based on your child's age and weight.

Elderly patients or those with kidney problems

Your doctor may give you a lower dose because your body may not get rid of Hygroton 50 mg Tablets as quickly as normal.

If you are not sure how many tablets to take, ask your doctor or pharmacist. Do not stop taking your tablets suddenly. Ask your doctor first.

What to do if you take more Hygroton 50 mg Tablets than you should

If you accidentally take too many tablets, or someone else takes any of your medicine, you should tell your doctor immediately or contact your nearest accident and emergency department because you may need urgent treatment. Show any left-over medicines or the empty packet to the doctor.

If you forget to take Hygroton 50 mg Tablets

If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do not take a double dose. Then go on as before.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

| 4. Possible side effects

Do not worry. Like all medicines, Hygroton 50 mg Tablets can cause side effects, although not everyone gets them.

Rare side effects (that affect less than 1 person in 1000)

• increased calcium in the blood which can cause agitation, sore eyes, abdominal pain

• sugar in the urine (this would show up when your doctor or nurse tests your urine)

• worsening of diabetes

• yellowing of the skin or eyes caused by liver or blood problems (jaundice)

• increased sensitivity of your skin to sunlight

• abnormal heartbeat the symptoms of which include palpitations and fainting

• pins and needles

• headache

• feeling or being sick

• stomach pain

• constipation

• diarrhoea

• reduction in blood platelets which increases the risk of bruising or bleeding

• severe reduction in the number of white blood cells which makes infection more likely

• an abnormally high amount of eosinophils (type of white blood cell) in the blood

• breathing problems

• problems with your kidneys.

If you get any of the following tell your doctor or pharmacist immediately as they may tell you to stop taking Hygroton 50 mg Tablets:

• muscles feel weak or will not work properly

• irregular heartbeat.

Very common side effects (that affect more than 1 person in 10)

• low blood levels of potassium which can cause muscle weakness, muscle twitching or abnormal heartbeat

• increased blood levels of uric acid

• increased blood levels of cholesterol.

Common side effects (that affect less than 1 person in 10)

• low levels of sodium which can cause tiredness, confusion, muscle twitching, fits or coma

• low levels of magnesium

• high blood sugar levels which can cause tiredness, weakness or feeling thirsty

• nettle rash

• skin rash

• low blood pressure which may make you feel dizzy when you stand up

• dizziness

• loss of appetite

• upset stomach

• impotence in men.

Uncommon side effects (that affect less than 1 person in 100)

• gout which causes pain and swelling in the joints.

Very rare side effects (that affect less than 1 person in 10 000)

• low levels of chloride in the blood, symptoms include dry mouth, thirst, gastrointestinal disturbances (including nausea, vomiting), weakness, lethargy, drowsiness, restlessness, seizures, confusion, headache, muscle pains or cramps, hypotension

• inflammation of the pancreas which causes severe stomach and back pain.

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 Hygroton 50 mg Tablets

Keep out of the sight and reach of children.

Protect from moisture.

Do not take Hygroton 50 mg Tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Should your tablets become discoloured, or show any other signs of deterioration, contact your pharmacist who will advise you what to do. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist on how to dispose of medicines no longer required. These measures will help protect the environment.

| 6. Further information

What is in Hygroton 50 mg Tablets?

Each tablet contains 50 mg of chlortalidone.

The other ingredients are maize starch, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, yellow iron oxide (E172) and sodium carboxymethylcellulose.

What Hygroton 50 mg Tablets looks like and contents of the pack

Pale yellow, round, flat tablets with bevelled edges, impressed with letter ‘Z' and ‘A' on either side of a break line, and plain on the other side.

Hygroton 50 mg Tablets comes in blister packs of 30 tablets.

Manufacturer: CENEXI SAS, 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-Sous-Bouis, France.

Procured from within the EU by the Product Licence Holder: Expono Ltd, Cornwall Road, Smethwick, B66 2JT, UK. Repackaged by: N.G. Ltd, West Midlands, B66 2JT, UK. [poM

PL 22961/0178 - Hygroton® 50 mg Tablets -

Revision Date: 10.10.2016

Hygroton® is a registered trademark of Alliance Pharmaceuticals Ltd.

PATIENT INFORMATION LEAFLET

Chlortalidone 50 mg Tablets

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

The information in this leaflet has been divided into the following sections:

1. What Chlortalidone 50 mg Tablets is and what it is taken for

2. Check before you take Chlortalidone 50 mg Tablets

3. How to take Chlortalidone 50 mg Tablets

4. Possible side effects

5. How to store Chlortalidone 50 mg Tablets

6. Further information

1. What Chlortalidone 50 mg Tablets is and what it is taken for

Chlortalidone 50 mg Tablets belongs to a group of medicines called thiazide diuretics.

Thiazide diuretics help to reduce the amount of water in your body. They do this by increasing the amount of water that you pass as urine. They are sometimes called 'water tablets'.

Chlortalidone 50 mg Tablets is used to:

• treat high blood pressure (hypertension)

• treat heart failure

• help reduce the fluid retention that occurs with some kidney or liver diseases

• treat diabetes insipidus (a condition in which an individual produces large amounts of dilute urine and is constantly thirsty).

2. Check before you take Chlortalidone 50 mg Tablets_

Do not take Chlortalidone 50 mg Tablets:

• if you are allergic (hypersensitive) to chlortalidone, sulphonamides such as sulfamethoxazole or any of the ingredients of Chlortalidone 50 mg Tablets (see Section 6 Further information)

• if you are not passing any urine at all

• if you have severe kidney or liver problems

• if you have low blood levels of potassium which can cause muscle weakness, muscle twitching or abnormal heartbeat

• if you have low blood levels of sodium which can cause tiredness, confusion, muscle twitching, fits or coma

• if you have high blood levels of calcium which can cause loss of appetite, tiredness or muscle weakness

• if you have ever had gout or kidney stones

• if you have Addison's disease (which is a condition where your adrenal gland is not producing enough steroids)

• if you are taking lithium.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Chlortalidone 50 mg Tablets. Take special care with Chlortalidone 50 mg Tablets Before you take Chlortalidone 50 mg Tablets tell your doctor if:

• you suffer from any other liver or kidney problems

• you are on a low-salt diet

• you suffer from diabetes mellitus (increased levels of sugar in the blood)

• you have high cholesterol levels

• if you have recently had an anaesthetic

• you are elderly.

If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take Chlortalidone 50 mg Tablets. Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines as they may interfere with Chlortalidone 50 mg Tablets:

• other treatments for high blood pressure or heart problems such as:

- ACE inhibitors (for example, lisinopril)

- beta blockers (for example propranolol hydrochloride)

- methyldopa

- vasodilators (for example bosentan)

- calcium channel blockers (for example amlodipine)

- guanethidine

• corticosteroids such as prednisolone or betamethasone -used to treat allergic and inflammatory diseases and immune reactions

• cytotoxic agents such as cyclophosphamide or methotrexate -used to treat cancer

• asthma treatments such as salbutamol or formoterol

• amphotericin - used to treat infections

• carbenoxolone - used to treat ulcers

• insulin and other treatments for diabetes such as chlorpropamide or glibenclamide

Please tell your doctor or pharmacist if you are taking or have re without a prescription.

• digoxin - for an irregular heartbeat

• lithium - used to treat mental illness

• adrenocorticotropic hormone (ACTH) - used to treat a number of different conditions, including ulcerative colitis, Crohn's disease and rheumatoid arthritis

• anticholinergics such as atropine sulphate or hyoscine butylbromide - for abdominal or stomach spasms or cramps

• colestyramine - used to reduce cholesterol levels and prevent heart disease

• amantadine - used to treat Parkinson's disease or viral infections

• allopurinol - used to treat gout

• calcium salts or vitamin D - used for replacement therapy

• non-steroidal anti-inflammatories (NSAIDs) such as aspirin or indometacin - used for pain relief or rheumatism

• ciclosporin - used to treat rheumatic disease or skin complaints or after a transplant

I taken/used any other medicines, including medicines obtained

Taking with food and drink

It is best to take Chlortalidone 50 mg Tablets in the morning with food. Swallow your tablets whole with a drink of water. You should avoid low salt diets. Taking Chlortalidone 50 mg Tablets may reduce the amount of salt in your body.

If you are on a low salt diet check with your doctor first before taking Chlortalidone 50 mg Tablets.

Pregnancy and breast-feeding

Do not take Chlortalidone 50 mg Tablets if you are pregnant or trying to become pregnant.

Do not take Chlortalidone 50 mg Tablets if you are breast-feeding because Chlortalidone 50 mg Tablets passes into breast milk and could harm your baby.

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

Driving and using machines

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

3. How to take Chlortalidone 50 mg Tablets

Always take Chlortalidone 50 mg Tablets exactly as your doctor has told you to.

It is important to take your tablets at the right time. You should check with your doctor or pharmacist if you are not sure.

Your doctor will choose a suitable starting dose for your particular condition and monitor your progress. If necessary, this dose can be increased or reduced.

Whilst you are taking Chlortalidone 50 mg Tablets, your doctor may want to carry out a number of tests from time to time. This is quite usual and nothing to worry about.

It is best to take Chlortalidone 50 mg Tablets in the morning with food. Swallow your tablets whole with a drink of water. Ref: 760

Adults

The usual doses for adults are as follows:

• High blood pressure:

The starting dose is 25 mg (half a tablet) a day. Your doctor may increase this to 50 mg (one tablet) a day if necessary.

• Heart failure:

The starting dose is 25 mg (half a tablet) a day. Your doctor may increase this up to 200 mg (four tablets) a day if necessary.

• Fluid retention associated with kidney or liver disease:

Up to 50 mg (one tablet) a day.

• Diabetes insipidus (a disease in which an individual produces large amounts of dilute urine and is constantly thirsty):

The starting dose is 100 mg (two tablets) twice a day. Your doctor may reduce your dose to 50 mg (one tablet) a day.

Children

Your doctor will choose a suitable dose based on your child's age and weight.

Elderly patients or those with kidney problems

Your doctor may give you a lower dose because your body may not get rid of Chlortalidone 50 mg Tablets as quickly as normal.

If you are not sure how many tablets to take, ask your doctor or pharmacist. Do not stop taking your tablets suddenly. Ask your doctor first.

What to do if you take more Chlortalidone 50 mg Tablets than you should

If you forget to take Chlortalidone 50 mg Tablets

If you forget to take a dose, take it as soon as possible, unless it is almost time to take the next dose. Do not take a double dose. Then go on as before.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

| 4. Possible side effects

Do not worry. Like all medicines, Chlortalidone 50 mg Tablets can cause side effects, although not everyone gets them.

Rare side effects (that affect less than 1 person in 1000)

• increased calcium in the blood which can cause agitation, sore eyes, abdominal pain

• sugar in the urine (this would show up when your doctor or nurse tests your urine)

• worsening of diabetes

• yellowing of the skin or eyes caused by liver or blood problems (jaundice)

• increased sensitivity of your skin to sunlight

• abnormal heartbeat the symptoms of which include palpitations and fainting

• pins and needles

• headache

• feeling or being sick

• stomach pain

• constipation

• diarrhoea

• reduction in blood platelets which increases the risk of bruising or bleeding

• severe reduction in the number of white blood cells which makes infection more likely

• an abnormally high amount of eosinophils (type of white blood cell) in the blood

• breathing problems

• problems with your kidneys.

If you get any of the following tell your doctor or pharmacist immediately as they may tell you to stop taking Chlortalidone 50 mg Tablets:

• muscles feel weak or will not work properly

• irregular heartbeat.

Very common side effects (that affect more than 1 person in 10)

• low blood levels of potassium which can cause muscle weakness, muscle twitching or abnormal heartbeat

• increased blood levels of uric acid

• increased blood levels of cholesterol.

Common side effects (that affect less than 1 person in 10)

• low levels of sodium which can cause tiredness, confusion, muscle twitching, fits or coma

• low levels of magnesium

• high blood sugar levels which can cause tiredness, weakness or feeling thirsty

• nettle rash

• skin rash

• low blood pressure which may make you feel dizzy when you stand up

• dizziness

• loss of appetite

• upset stomach

• impotence in men.

Uncommon side effects (that affect less than 1 person in 100)

• gout which causes pain and swelling in the joints.

Very rare side effects (that affect less than 1 person in 10 000)

• inflammation of the pancreas which causes severe stomach and back pain.

Reporting of side effects

| 5. How to store Chlortalidone 50 mg Tablets

Keep out of the sight and reach of children.

Protect from moisture.

Do not take Chlortalidone 50 mg Tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

| 6. Further information

What is in Chlortalidone 50 mg Tablets?

Each tablet contains 50 mg of chlortalidone.

The other ingredients are maize starch, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, yellow iron oxide (E172) and sodium carboxymethylcellulose.

What Chlortalidone 50 mg Tablets looks like and contents of the pack

Pale yellow, round, flat tablets with bevelled edges, impressed with letter ‘Z' and ‘A' on either side of a break line, and plain on the other side.

Chlortalidone 50 mg Tablets comes in blister packs of 30 tablets.

Manufacturer: CENEXI SAS, 52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-Sous-Bouis, France.

Procured from within the EU by the Product Licence Holder: Expono Ltd, Cornwall Road, Smethwick, B66 2JT, UK. Repackaged by: N.G. Ltd, West Midlands, B66 2JT, UK. [poM

PL 22961/0178 - Chlortalidone 50 mg Tablets -

Revision Date: 10.10.2016

Ref: 760