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CELECTOL 400MG TABLETS / CELIPROLOL HYDROCHLORIDE 400MG TABLETS

Active substance(s): CELIPROLOL HYDROCHLORIDE / CELIPROLOL HYDROCHLORIDE

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Celectol® 400mg Tablets
(celiprolol hydrochloride)
Taking Celectol with other medicines
Your medicine is known by the above name but will be referred to as
Please tell your doctor or pharmacist if you are taking or have recently
Celectol throughout this leaflet. This medicine is also available in a 200mg
taken any other medicines, including medicines obtained without a
strength.
Patient Information Leaflet
prescription, including herbal medicines. This is because Celectol can
affect the way some other medicines work. Also, some other medicines
Read all of this leaflet carefully before you start taking this
can affect the way Celectol works.
medicine.
• Keep this leaflet. You may need to read it again.
Tell your doctor if you are taking any of the following:
• If you have further questions, ask your doctor or pharmacist.
• Insulin or tablets to treat diabetes
• This medicine has been prescribed for you. Do not pass it onto
• Medicines, including some cough or cold medicines, containing,
others. It may harm them, even if their symptoms are the same as
ephedrine, pseudoephedrine or adrenaline.
yours.
• Medicines used for mental problems (antipsychotic medicines) –
• If any of the side effects gets serious, or if you notice any side
such as chlorpromazine or other phenothiazines
effects not listed in this leaflet, please tell your doctor or
• Medicines used for asthma (such as theophylline)
pharmacist.
• Medicines for chest pain (angina) – such as verapamil, nifedipine,
and diltiazem
• Medicine used for heart problems – such as lidocaine (also used as
In this leaflet
a local anaesthetic) amiodarone, digitalis, diltiazem, disopyramide,
1) What Celectol is and what it is used for
nifedipine, quinidine and verapamil (also used for severe allergies)
2) Before you take Celectol
• Non-Steroidal Anti-inflammatory Drugs (NSAIDs) – used to relieve
3) How to take Celectol
pain such as ibuprofen and indometacin
4) Possible side effects
• Medicines used to lower blood pressure – such as chlorthalidone,
5) How to store Celectol
hydrochlorothiazide and clonidine
6) Further Information
• Medicines used for the prevention of malaria such as mefloquine
1) What Celectol is and what it is used for
• Medicines to treat depression called MAOIs (monoamine oxidase
inhibitors) or have taken them in the last 2 weeks. MAOIs are
What Celectol is
medicines such as meclobemide, phenelzine or tranylcypromine
Celectol contains a medicine called celiprolol hydrochloride. This belongs
to a group of medicines called beta-blockers.
If you are not sure, talk to your doctor or pharmacist before taking Celectol.
How Celectol works
Taking Celectol with food and drink
It works by slowing your heart rate or lowering your blood pressure.
• Celectol should be taken preferably first thing in the morning, 30
Celectol can be used to
minutes before food or two hours after a meal.
It is used to treat high blood pressure (hypertension).
Pregnancy and breast feeding
Talk to your doctor before taking this medicine if you are pregnant, might
2) Before you take Celectol
become pregnant, or think you may be pregnant.
Do not take this medicine and tell your doctor is:
• You are allergic (hypersensitive) to celiprolol or any of the other
If your doctor cannot find a safer alternative you may be given Celectol. If
ingredients in Celectol (see Section 6: Further Information).
you take Celectol during pregnancy, particularly in the last 3 months, you
Signs of an allergic reaction include: a rash, swallowing or breathing
should tell your midwife. This is because your baby may be affected when
problems, swelling of your lips, face, throat or tongue.
it is born. Any effects usually begin on the first day after birth and can
• You have or have had asthma or wheezing
include lower than normal levels of glucose in the blood (hypoglycaemia),
• You have a very slow heart beat (bradycardia)
slow heart beat, heart failure or having trouble breathing. If your baby has
• You have heart problems – where you have difficulty breathing and
any of these side effects when it is born and you are worried, tell your
swollen ankles
doctor or midwife.
• 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).

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.

3) 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.
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.

4) Possible side effects
Like all medicines Celectol can cause side effects, although not everybody
gets them.
Stopping 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 heartbeat (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 side-effects gets serious or lasts longer than a few days or if you
notice any side-effects not listed in the leaflet, 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.

5) How to store Celectol





Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Further Information
What Celectol contains:
The active substance is celiprolol hydrochloride. Each tablet contains
400mg of celiprolol hydrochloride.
The other ingredients are:
Tablet core: mannitol, microcrystalline cellulose, croscarmellose sodium,
magnesium stearate.
Film-coating: Opadry Y-1-7000 (hypromellose, polyethylene glycol,
titanium dioxide (E171)), Opadry YS-1-7006 (hypromellose, polyethylene
glycol).
What Celectol look like and the contents of the pack
Celectol 400mg Tablets are white, film coated, biconvex, heart shaped
tablets engraved with

on one face with 400 on the other.

They come in blister packs containing 28 tablets.
PL 10383/2194 Celectol 400mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Sanofi Winthrop Industrie, 56 Route de
Choisy au Bac, 60205 Compiègne Cedex, France.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 22.08.2016
Celectol is a registered trademark of Aventisub LLC, USA.

Celiprolol Hydrochloride 400mg Tablets
Your medicine is known by the above name but will be referred to as
celiprolol throughout this leaflet. This medicine is also available in a 200mg
strength.
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
• Your doctor may have given you this medicine before from another
company. It may have looked slightly different. However, either
brand will have the same effect.
In this leaflet
1) What celiprolol is and what it is used for
2) Before you take celiprolol
3) How to take celiprolol
4) Possible side effects
5) How to store celiprolol
6) Further Information

1) What celiprolol is and what it is used for
What celiprolol is
Celiprolol contains a medicine called celiprolol hydrochloride. This belongs
to a group of medicines called beta-blockers.
How celiprolol works
It works by slowing your heart rate or lowering your blood pressure.
Celiprolol can be used to
It is used to treat high blood pressure (hypertension).

2) Before you take celiprolol
Do not take this medicine and tell your doctor is:
• You are allergic (hypersensitive) to celiprolol or any of the other
ingredients in celiprolol (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.
Take special care and check with your doctor or pharmacist before
taking celiprolol 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.
Operations or anaesthetics
Tell your doctor or dentist you are taking celiprolol if you are going to have
an anaesthetic or an operation (including dental surgery).

Taking celiprolol 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 can
affect the way some other medicines work. Also, some other medicines
can affect the way celiprolol 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
• Medicine 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.
Taking celiprolol with food and drink
• Celiprolol 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. If
you take celiprolol 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. 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. If this happens, do not
drive or use any tools or machines.
Drug Tests in sport
Celiprolol 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
Always take celiprolol exactly as your doctor has told you. The dose of
celiprolol will depend on your needs and the illness being treated. Check
with your doctor or pharmacist before taking celiprolol.
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.
How much to take
Adults
• The usual starting dose is 200mg once daily
• The maximum dose is 400mg once daily.
Children
Celiprolol should not be given to children.

Elderly patients and patients with kidney problems
Your doctor may decide to lower your dose of celiprolol if necessary.
If you take more celiprolol 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
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 just because you feel better. If you stop taking celiprolol,
your illness may get worse. When your doctor says that you can stop
taking celiprolol, 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 can cause side effects, although not
everybody gets them.
Stopping taking celiprolol 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
• 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 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 heartbeat (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 side-effects gets serious or lasts longer than a few days or if you
notice any side-effects not listed in the leaflet, 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.

5) How to store celiprolol





Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the
carton and blister. The expiry date refers to the last day of the month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

6) Further Information
What celiprolol contains:
The active substance is celiprolol hydrochloride. Each tablet contains
400mg of celiprolol hydrochloride.
The other ingredients are:
Tablet core: mannitol, microcrystalline cellulose, croscarmellose sodium,
magnesium stearate.
Film-coating: Opadry Y-1-7000 (hypromellose, polyethylene glycol,
titanium dioxide (E171)), Opadry YS-1-7006 (hypromellose, polyethylene
glycol).
What celiprolol look like and the contents of the pack
Celiprolol 400mg Tablets are white, film coated, biconvex, heart shaped
tablets engraved with on one face with 400 on the other.
They come in blister packs containing 28 tablets.
PL 10383/2194 Celiprolol Hydrochloride 400mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Sanofi Winthrop Industrie, 56 Route de
Choisy au Bac, 60205 Compiègne Cedex, France.
Procured from within the EU and repackaged by Product Licence Holder:
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex UB5 5QS.
Leaflet date: 22.08.2016

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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