Celiprolol Hydrochloride 400mg Tablets
^ Ref:1664/180716/1/F
Celectol® 400mg Tablets
(celiprolol hydrochloride)
Patient Information Leaflet
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.
Your medicine is called Celectol 400mg Tablets but will be referred to as Celectol throughout the rest of this leaflet. Please note that the leaflet also contains information about the other strength of medicine Celectol 200mg Tablets.
In this leaflet:
What Celectol is and what it is used for ^ Before you take Celectol ^ How to take Celectol Possible side effects How to store Celectol Further Information
^ What Celectol is and what it is used for
What Celectol is
Celectol contains a medicine called celiprolol hydrochloride. This belongs to a group of medicines called beta-blockers.
How Celectol works
It works by slowing your heart rate or lowering your blood pressure. Celectol can be used to
It is used to treat high blood pressure (hypertension).
[2) Before you take Celectol
Do not take this medicine and tell your doctor if:
* You are allergic (hypersensitive) to celiprolol or any of the other ingredients in Celectol (see Section 6: Further Information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
* You have or have had asthma or wheezing
* You have a very slow heart beat (bradycardia)
* You have heart problems - where you have difficulty breathing and swollen ankles
* You have kidney problems
* You have a tumour of the adrenal gland (phaeochromocytoma) and your high blood pressure has not yet been treated with a type of medicine known as an alpha blocker, such as doxazosin or terazosin
* You have low blood pressure (hypotension)
* You have abnormal levels of acid in your blood (metabolic acidosis)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Celectol.
Take special care and check with your doctor or pharmacist before taking Celectol if:
* You have any heart problems
* You have breathing problems due to long term lung problems (called bronchitis or emphysema)
* You have diabetes
* You have liver problems
* You have a tumour of the adrenal gland (phaeochromocytoma) and your high blood pressure is not yet controlled by a type of medicine known as an alpha blocker, such as doxazosin or terazosin
* You have an overactive thyroid gland, as celiprolol can hide some of the symptoms associated with this condition
* You have a history of severe allergies, including anaphylactic reactions
* You have ever suffered from psoriasis
* You suffer from a type of chest pain called Prinzmetal's angina.
* You suffer from very poor circulation (such as Raynaud's disease). Symptoms include fingers and toes changing colour when cold and tingling or painful on warming up
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Celectol. Do this even if they applied only in the past.
Operations or anaesthetics
Tell your doctor or dentist you are taking Celectol if you are going to have an anaesthetic or an operation (including dental surgery).
Taking Celectol with 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, including herbal medicines. This is because Celectol can affect the way some other medicines work. Also, some other medicines can affect the way Celectol works.
Tell your doctor if you are taking any of the following:
* Insulin or tablets to treat diabetes
* Medicines, including some cough or cold medicines, containing, ephedrine, pseudoephedrine or adrenaline.
* Medicines used for mental problems (antipsychotic medicines) - such as chlorpromazine or other phenothiazines
* Medicines used for asthma (such as theophylline)
* Medicines for chest pain (angina) - such as verapamil, nifedipine and diltiazem
* Medicines used for heart problems - such as lidocaine (also used as a local anaesthetic) amiodarone, digitalis, diltiazem, disopyramide, nifedipine, quinidine and verapamil (also used for severe allergies)
* Non-Steroidal Anti-inflammatory Drugs (NSAIDs) - used to relieve pain such as ibuprofen and indometacin
* Medicines used to lower blood pressure - such as chlorthalidone, hydrochlorothiazide and clonidine
* Medicines used for the prevention of malaria such as mefloquine
* Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks MAOIs are medicines such as meclobemide, phenelzine or tranylcypromine
If you are not sure, talk to your doctor or pharmacist before taking Celectol.
Taking Celectol with food and drink
* Celectol should be taken preferably first thing in the morning, 30 minutes before food or two hours after a meal.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
If your doctor cannot find a safer alternative you may be given Celectol. If you take Celectol during pregnancy, particularly in the last 3 months, you should tell your midwife. This is because your baby may be affected when it is born. Any effects usually begin on the first day after birth and can include lower than normal levels of glucose in the blood (hypoglycaemia), slow heart beat, heart failure or having trouble breathing. If your baby has any of these side effects when it is born and you are worried, tell your doctor or midwife.
You should not breast-feed if you are taking Celectol. This is because small amounts may pass into the mothers milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel tired or dizzy whilst taking Celectol. If this happens, do not drive or use any tools or machines.
Drug Tests in sport
Celectol may give a positive result if you have a blood or urine test to check for the presence of drugs.
How to take Celectol
Always take Celectol exactly as your doctor has told you. The dose of Celectol will depend on your needs and the illness being treated.
Check with your doctor or pharmacist before taking Celectol.
Taking this medicine
* Swallow the tablets whole with a drink of water
* Take the tablets preferably first thing in the morning, 30 minutes before food, or 2 hours after a meal
* Take your medicine at the same time each day preferably first thing in the morning.
Ref:1664/180716/1/B
(celiprolol hydrochloride)
Patient Information Leaflet (continued)
How much to take Adults
* The usual starting dose is 200mg once daily
* The maximum dose is 400mg once daily.
Children
Celectol should not be given to children.
Elderly patients and patients with kidney problems
Your doctor may decide to lower your dose of Celectol if necessary.
If you take more Celectol than you should
Tell your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any tablets that are left and the pack.
This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, difficulty breathing or wheezing.
If you forget to take Celectol
If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.
Stopping treatment
Keep taking your medicine until your doctor tells you to stop. Do not stop taking Celectol just because you feel better. If you stop taking Celectol, your illness may get worse. When your doctor says that you can stop taking Celectol, you need to do this gradually. Your doctor will help you do this.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines Celectol can cause side effects, although not everybody gets them.
Stop taking Celectol and see a doctor or go to a hospital straight away if:
* You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
This may mean you are having an allergic reaction to Celectol
* You get flu-like symptoms, swollen or painful joints, increased sensitivity to sunlight, hairloss, abdominal pain, anaemia. This may mean you have a condition called Systemic Lupus Erythematosus (SlE). These symptoms will usually go away after Celectol has been stopped.
Tell your doctor as soon as possible if you have any of the following side effects:
* Pain in your chest and feeling weak or dizzy. These could be signs of a heart problem
* Slow heart rate or very fast, uneven or forceful heartbeart (palpitations)
* Feeling dizzy or weak. These could be signs of low blood pressure.
* Stomach pain and diarrhoea
* Difficulty sleeping (insomnia), drowsiness or nightmares
* Feeling that you are losing touch with reality, or are unable to think or judge things clearly. You may also feel more aggressive than usual.
These could be signs of a serious mental health problem (psychoses)
Tell your doctor as soon as possible if you have any of the following side effects:
* Seeing or hearing things that are not there (hallucinations), confusion
* Problems with your eyesight such as blurred vision
* Dryness or redness of the eye
* Changes in behaviour, depression
* Hot flushes
* Skin rashes
* Shakiness (tremor)
* Low blood sugar levels (hypoglycaemia). You may feel a sense of nervousness, shaky or sweaty.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
* Feeling dizzy, tired or light-headed
* Headache
* A cold or numb feeling in your fingers or toes (Raynaud's disease or syndrome)
* Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin
* Feeling sick (nausea) or being sick (vomiting)
* Breathing problems such as asthma
* Difficulty in getting or maintaining an erection, or in ejaculating (impotence)
* Lack of interest in sexual activities (libido)
Blood tests
* The results of some blood tests may show higher levels of liver enzymes than normal.
* Blood tests may also show abnormal levels of glucose in the blood.
If any of the side-effects gets serious or lasts longer than a few days or if you notice any side-effects not listed in the leafet, please tell your doctor or pharmacist.
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.
How to store Celectol
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Store in original package.
Do not use Celectol after the expiry date which is stated on the blister label or carton. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Further information
What Celectol contains
Each film coated tablet contains 400mg celiprolol hydrochloride.
Also contains the following inactive ingredients: Mannitol, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Opadry YS-1-7006 (clear) (contains hypromellose E464 and polyethylene glycol) and Opadry Y-1-7000 (white) (contains titanium dioxide E171, hypromellose E464 and polyethylene glycol).
What Celectol looks like and the contents of the pack
White heart shaped tablets engraved with the Selectol logo on one face with 400 on the other.
Each pack contains 28 tablets.
Manufacturer and Licence Holder
Manufactured by Sanofi Winthrop Industrie, 56 Route de Choisy au Bac, 60205 Compiegne Cedex, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1664 Celectol 400mg Tablets Celectol is a registered trademark of Aventisub LLC.
Revision date: 18/07/16
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Patient Information Leaflet
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.
Your medicine is called Celiprolol hydrochloride 400mg Tablets but will be referred to as Celiprolol hydrochloride throughout the rest of this leaflet. Please note that the leaflet also contains information about the other strength of medicine Celiprolol hydrochloride 200mg Tablets.
In this leaflet:
What Celiprolol hydrochloride is and what it is used for ^ Before you take Celiprolol hydrochloride fa How to take Celiprolol hydrochloride Possible side effects How to store Celiprolol hydrochloride Further Information
^ What Celiprolol hydrochloride is and what it is used for
What Celiprolol hydrochloride is
Celiprolol hydrochloride contains a medicine called Celiprolol hydrochloride. This belongs to a group of medicines called beta-blockers.
How Celiprolol hydrochloride works
It works by slowing your heart rate or lowering your blood pressure.
Celiprolol hydrochloride can be used to
It is used to treat high blood pressure (hypertension).
^ Before you take Celiprolol hydrochloride
Do not take this medicine and tell your doctor if:
* You are allergic (hypersensitive) to celiprolol or any of the other ingredients in Celiprolol hydrochloride (see Section 6: Further Information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
* You have or have had asthma or wheezing
* You have a very slow heart beat (bradycardia)
* You have heart problems - where you have difficulty breathing and swollen ankles
* You have kidney problems
* You have a tumour of the adrenal gland (phaeochromocytoma) and your high blood pressure has not yet been treated with a type of medicine known as an alpha blocker, such as doxazosin or terazosin
* You have low blood pressure (hypotension)
* You have abnormal levels of acid in your blood (metabolic acidosis)
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Celiprolol hydrochloride.
Take special care and check with your doctor or pharmacist before taking Celiprolol hydrochloride if:
* You have any heart problems
* You have breathing problems due to long term lung problems (called bronchitis or emphysema)
* You have diabetes
* You have liver problems
* You have a tumour of the adrenal gland (phaeochromocytoma) and your high blood pressure is not yet controlled by a type of medicine known as an alpha blocker, such as doxazosin or terazosin
* You have an overactive thyroid gland, as celiprolol can hide some of the symptoms associated with this condition
* You have a history of severe allergies, including anaphylactic reactions
* You have ever suffered from psoriasis
* You suffer from a type of chest pain called Prinzmetal's angina.
* You suffer from very poor circulation (such as Raynaud's disease). Symptoms include fingers and toes changing colour when cold and tingling or painful on warming up
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Celiprolol hydrochloride. Do this even if they applied only in the past.
Operations or anaesthetics
Tell your doctor or dentist you are taking Celiprolol hydrochloride if you are going to have an anaesthetic or an operation (including dental surgery).
Taking Celiprolol hydrochloride with 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, including herbal medicines. This is because Celiprolol hydrochloride can affect the way some other medicines work. Also, some other medicines can affect the way Celiprolol hydrochloride works.
Tell your doctor if you are taking any of the following:
* Insulin or tablets to treat diabetes
* Medicines, including some cough or cold medicines, containing, ephedrine, pseudoephedrine or adrenaline.
* Medicines used for mental problems (antipsychotic medicines) - such as chlorpromazine or other phenothiazines
* Medicines used for asthma (such as theophylline)
* Medicines for chest pain (angina) - such as verapamil, nifedipine and diltiazem
* Medicines used for heart problems - such as lidocaine (also used as a local anaesthetic) amiodarone, digitalis, diltiazem, disopyramide, nifedipine, quinidine and verapamil (also used for severe allergies)
* Non-Steroidal Anti-inflammatory Drugs (NSAIDs) - used to relieve pain such as ibuprofen and indometacin
* Medicines used to lower blood pressure - such as chlorthalidone, hydrochlorothiazide and clonidine
* Medicines used for the prevention of malaria such as mefloquine
* Medicines to treat depression called MAOIs (monoamine oxidase inhibitors) or have taken them in the last 2 weeks MAOIs are medicines such as meclobemide, phenelzine or tranylcypromine
If you are not sure, talk to your doctor or pharmacist before taking Celiprolol hydrochloride.
Taking Celiprolol hydrochloride with food and drink
* Celiprolol hydrochloride should be taken preferably first thing in the morning, 30 minutes before food or two hours after a meal.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or think you may be pregnant.
If your doctor cannot find a safer alternative you may be given Celiprolol hydrochloride. If you take Celiprolol hydrochloride during pregnancy, particularly in the last 3 months, you should tell your midwife. This is because your baby may be affected when it is born. Any effects usually begin on the first day after birth and can include lower than normal levels of glucose in the blood (hypoglycaemia), slow heart beat, heart failure or having trouble breathing. If your baby has any of these side effects when it is born and you are worried, tell your doctor or midwife.
You should not breast-feed if you are taking Celiprolol hydrochloride. This is because small amounts may pass into the mothers milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
You may feel tired or dizzy whilst taking Celiprolol hydrochloride. If this happens, do not drive or use any tools or machines.
Drug Tests in sport
Celiprolol hydrochloride may give a positive result if you have a blood or urine test to check for the presence of drugs.
[3) How to take Celiprolol hydrochloride
Always take Celiprolol hydrochloride exactly as your doctor has told you. The dose of Celiprolol hydrochloride will depend on your needs and the illness being treated.
Check with your doctor or pharmacist before taking Celiprolol hydrochloride. Taking this medicine
* Swallow the tablets whole with a drink of water
* Take the tablets preferably first thing in the morning, 30 minutes before food, or 2 hours after a meal
* Take your medicine at the same time each day preferably first thing in the morning.
Patient Information Leaflet (continued)
How much to take Adults
* The usual starting dose is 200mg once daily
* The maximum dose is 400mg once daily.
Children
Celiprolol hydrochloride should not be given to children.
Elderly patients and patients with kidney problems
Your doctor may decide to lower your dose of Celiprolol hydrochloride if necessary.
If you take more Celiprolol hydrochloride than you should
Tell your doctor or go to the nearest hospital casualty department straight away. Remember to take with you any tablets that are left and the pack.
This is so the doctor knows what you have taken. The following effects may happen: feeling dizzy or weak, difficulty breathing or wheezing.
If you forget to take Celiprolol hydrochloride
If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.
Stopping treatment
Keep taking your medicine until your doctor tells you to stop. Do not stop taking Celiprolol hydrochloride just because you feel better. If you stop taking Celiprolol hydrochloride, your illness may get worse. When your doctor says that you can stop taking Celiprolol hydrochloride, you need to do this gradually. Your doctor will help you do this.
If you have any further questions about this medicine, ask your doctor or pharmacist.
[4 Possible side effects
Like all medicines Celiprolol hydrochloride can cause side effects, although not everybody gets them.
Stop taking Celiprolol hydrochloride and see a doctor or go to a hospital straight away if:
* You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
This may mean you are having an allergic reaction to Celiprolol Hydrochloride
* You get flu-like symptoms, swollen or painful joints, increased sensitivity to sunlight, hairloss, abdominal pain, anaemia. This may mean you have a condition called Systemic Lupus Erythematosus (SLE). These symptoms will usually go away after Celiprolol hydrochloride has been stopped.
Tell your doctor as soon as possible if you have any of the following side effects:
* Pain in your chest and feeling weak or dizzy. These could be signs of a heart problem
* Slow heart rate or very fast, uneven or forceful heartbeart (palpitations)
* Feeling dizzy or weak. These could be signs of low blood pressure.
* Stomach pain and diarrhoea
* Difficulty sleeping (insomnia), drowsiness or nightmares
* Feeling that you are losing touch with reality, or are unable to think or judge things clearly. You may also feel more aggressive than usual.
These could be signs of a serious mental health problem (psychoses)
Tell your doctor as soon as possible if you have any of the following side effects:
* Seeing or hearing things that are not there (hallucinations), confusion
* Problems with your eyesight such as blurred vision
* Dryness or redness of the eye
* Changes in behaviour, depression
* Hot flushes
* Skin rashes
* Shakiness (tremor)
* Low blood sugar levels (hypoglycaemia). You may feel a sense of nervousness, shaky or sweaty.
Tell your doctor or pharmacist if any of the following side effects gets serious or last longer than a few days:
* Feeling dizzy, tired or light-headed
* Headache
* A cold or numb feeling in your fingers or toes (Raynaud's disease or syndrome)
* Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin
* Feeling sick (nausea) or being sick (vomiting)
* Breathing problems such as asthma
* Difficulty in getting or maintaining an erection, or in ejaculating (impotence)
* Lack of interest in sexual activities (libido)
Blood tests
* The results of some blood tests may show higher levels of liver enzymes than normal.
* Blood tests may also show abnormal levels of glucose in the blood.
If any of the side-effects gets serious or lasts longer than a few days or if you notice any side-effects not listed in the leafet, please tell your doctor or pharmacist.
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.
[p How to store Celiprolol hydrochloride
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C. Store in original package.
Do not use Celiprolol hydrochloride after the expiry date which is stated on the blister label or carton. The expiry date refers to the last day of the month. If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist (chemist) for safe disposal. Only keep this medicine if your doctor tells you to.
If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
[p Further information
What Celiprolol hydrochloride contains
Each film coated tablet contains 400mg celiprolol hydrochloride.
Also contains the following inactive ingredients: Mannitol, Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Opadry YS-1-7006 (clear) (contains hypromellose E464 and polyethylene glycol) and Opadry Y-1-7000 (white) (contains titanium dioxide E171, hypromellose E464 and polyethylene glycol).
What Celiprolol hydrochloride looks like and the contents of the pack
White heart shaped tablets engraved with the Selectol logo on one face with 400 on the other.
Each pack contains 28 tablets.
Manufacturer and Licence Holder
Manufactured by Sanofi Winthrop Industrie, 56 Route de Choisy au Bac, 60205 Compiegne Cedex, France and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1664 Celiprolol hydrochloride 400mg Tablets
Revision date: 18/07/16