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CELECTOL 400MG TABLETS

Active substance(s): CELIPROLOL HYDROCHLORIDE

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®

Celectol 400mg Tablets / Celiprolol Hydrochloride 400mg Tablets

Ref:0159/300316/1/F

(celiprolol hydrochloride)
Please note that the leaflet also contains information about other strengths
of the medicine Celectol 200mg Tablets or Celiprolol Hydrochloride 200mg
Tablets.

Patient Information Leaflet

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.

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.

* Insulin or tablets to treat diabetes
* Medicines, including some cough or cold medicines, containing, ephedrine,

In this leaflet:
1 What Celectol is and what it is used for

*
*

2

Before you take Celectol

3

How to take Celectol

4

Possible side effects

5

How to store Celectol

6

Further Information

Tell your doctor if you are taking any of the following:

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1

What Celectol is and what it is used for

What Celectol is
The name of your medicine is Celectol 400mg Tablets or Celiprolol
Hydrochloride 400mg Tablets (called Celectol throughout this leaflet).
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).

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 breastfeeding
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.

Ref:0159/300316/1/B

®

Celectol 400mg Tablets / Celiprolol Hydrochloride 400mg Tablets
(celiprolol hydrochloride)
Patient Information Leaflet (continued)
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 nit 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.
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.

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

Expiry date
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist for safe disposal. Only keep this medicine, if your
doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Storing your medicine
this medicine out of the sight and reach of children.
* Keep
not store above 25°C.
* Do
not take your tablets out of the blister strip until it is time to take your
* Do
dose.
Important
Remember this medicine is for you. Only a doctor can prescribe it.
Never give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional
information about this medicine and will be able to advise you.

6

Further information

What Celectol contains
Each tablet contains 400mg of the active ingredient celiprolol hydrochloride.
Your medicine also contains the following inactive ingredients:
Tablet core: Mannitol, microcrystalline cellulose, croscarmellose sodium,
magnesium stearate,
Film coating: Opadry Y-IR-7000 (hypromellose, polyethylene glycol, titanium
dioxide E171) - Opadry YS-1-7006 (hypromellose, polyethylene glycol)
What Celectol looks like and the contents of the pack
Each white heart shaped film-coated tablet is marked with ‘400’ on one side
and an ‘s’ shape on the other side. They are available in blister packs of 28
tablets (2 blisters of 14).
Manufacturer and Licence Holder
The tablets are 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 15184/0159

Celectol is a registered trademark of Aventisub LLC.
Revision date: 30/03/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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