Hygroton 50mg Tablets
Patient Information Leaflet
Hygroton® 50mg 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 name of this medicine is Hygroton® 50mg Tablets but it will be referred to as Hygroton throughout the remainder of this leaflet.
The information in this leaflet has been divided into the following sections:
1) What Hygroton is and what it is taken for
2) Check before you take Hygroton
3) How to take Hygroton
4) Possible side effects
5) How to store Hygroton
6) Further information
1) WHAT HYGROTON IS AND WHAT IT IS TAKEN FOR
Hygroton 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 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 Do not take Hygroton:
• if you are allergic (hypersensitive) to chlortalidone, sulphonamides such as sulfamethoxazole or any of the ingredients of Hygroton (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.
Take special care with Hygroton
Before you take Hygroton 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
• 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.
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:
• 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
• 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
Please tell your doctor or pharmacist if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription.
Taking with food and drink
It is best to take Hygroton in the morning with food. Swallow your tablets whole with a drink of water.
You should avoid low salt diets. Taking Hygroton 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.
Pregnancy and breast-feeding
Do not take Hygroton if you are pregnant or trying to become pregnant. Do not take Hygroton if you are breast-feeding because Hygroton 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
Always take Hygroton 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, 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 in the morning with food. Swallow your tablets whole with a drink of water.
POM
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 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 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
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 can cause side effects, although not everyone gets them.
If you get any of the following tell your doctor or pharmacist immediately as they may tell you to stop taking Hygroton:
• 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.
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.
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
• Keep out of the sight and reach of children.
• Protect from moisture.
• Do not take Hygroton after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• If your tablets become discoloured or show any signs of deterioration, return them to your pharmacist.
• 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 Hygroton contains
Each tablet contains 50mg of chlortalidone.
The other ingredients are colloidal anhydrous silica, microcrystalline cellulose, yellow iron oxide (E172), magnesium stearate, maize starch and sodium carboxymethyl cellulose.
What Hygroton looks like and contents of the pack
Hygroton tablets are pale yellow, round tablets, which are plain on one side and on the other side have a scoreline down the middle with letters Z and A on either side.
Hygroton comes in blister packs of 30 tablets.
Manufactured by
Cenexi SAS, 52, rue Marcel et Jacques Gaucher,
94120 Fontenay-sous-Bois, France.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd. PL 33532/0655
The information in this leaflet applies only to Hygroton.
If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.
Leaflet dated 16th May 2016
Leaflet code xxxxxxxx
Hygroton® is a registered trademark of Novartis AG.
Chlortalidone 50mg 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 50mg Tablets are and what they are taken for
2) Check before you take Chlortalidone 50mg Tablets
3) How to take Chlortalidone 50mg Tablets
4) Possible side effects
5) How to store Chlortalidone 50mg Tablets
6) Further information
1) WHAT CHLORTALIDONE 50MG TABLETS ARE AND WHAT THEY ARE TAKEN FOR
Chlortalidone 50mg 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 50mg Tablets are 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 50MG TABLETS
Do not take Chlortalidone 50mg Tablets:
• if you are allergic (hypersensitive) to chlortalidone, sulphonamides such as sulfamethoxazole or any of the ingredients of Chlortalidone 50mg 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 50mg Tablets.
Take special care with Chlortalidone 50mg Tablets
Before you take Chlortalidone 50mg 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
• 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 50mg 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 50mg 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
• 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
Please tell your doctor or pharmacist if you are taking or have recently taken/used any other medicines, including medicines obtained without a prescription.
Taking with food and drink
It is best to take Chlortalidone 50mg Tablets in the morning with food. Swallow your tablets whole with a drink of water.
You should avoid low salt diets. Taking Chlortalidone 50mg 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 50mg Tablets.
Pregnancy and breast-feeding
Do not take Chlortalidone 50mg Tablets if you are pregnant or trying to become pregnant.
Do not take Chlortalidone 50mg Tablets if you are breast-feeding because Chlortalidone 50mg 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 50MG TABLETS
Always take Chlortalidone 50mg 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 50mg 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 50mg Tablets in the morning with food. Swallow your tablets whole with a drink of water.
POM
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 50mg 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 50mg 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 Chlortalidone 50mg 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 50mg Tablets can cause side effects, although not everyone gets them.
If you get any of the following tell your doctor or pharmacist immediately as they may tell you to stop taking Chlortalidone 50mg 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.
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.
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 CHLORTALIDONE 50MG TABLETS
• Keep out of the sight and reach of children.
• Protect from moisture.
• Do not take Chlortalidone 50mg Tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• If your tablets become discoloured or show any signs of deterioration, return them to your pharmacist.
• 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 Chlortalidone 50mg Tablets contain
Each tablet contains 50mg of chlortalidone.
The other ingredients are colloidal anhydrous silica, microcrystalline
cellulose, yellow iron oxide (E172), magnesium stearate, maize starch
and sodium carboxymethyl cellulose.
What Chlortalidone 50mg Tablets look like and contents of the pack
Chlortalidone 50mg Tablets are pale yellow, round tablets, which are plain on one side and on the other side have a scoreline down the middle with letters Z and A on either side.
Chlortalidone 50mg Tablets come in blister packs of 30 tablets. Manufactured by
Cenexi SAS, 52, rue Marcel et Jacques Gaucher,
94120 Fontenay-sous-Bois, France.
Procured from within the EU by Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd. PL 33532/0655
The information in this leaflet applies only to Chlortalidone 50mg Tablets. If you have any questions or you are not sure about anything, ask your doctor or a pharmacist.
Leaflet dated 16th May 2016 Leaflet code xxxxxxxx