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CELIPROLOL HYDROCHLORIDE 400 MG TABLETS

Active substance(s): CELIPROLOL HYDROCHLORIDE

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Celiprolol Hydrochloride 400 mg
Tablets

2371
26.05.15[4]

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
- 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 only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is available using the above name but will be referred to as
Celiprolol Hydrochloride throughout the leaflet. Also available in 200 mg
strength.
What is in this leaflet
1. What Celiprolol Hydrochloride is and what it is used for
2. What you need to know before you take Celiprolol Hydrochloride
3. How to take Celiprolol Hydrochloride
4. Possible side effects
5. How to store Celiprolol Hydrochloride
6. Contents of the pack and other information
1. WHAT CELIPROLOL HYDROCHLORIDE IS AND WHAT IT IS USED
FOR
Your medicine comes as a film-coated tablet.
The active ingredient is celiprolol hydrochloride. The other ingredients are
listed in section 6. Celiprolol Hydrochloride belongs to a family of medicines
known as beta-blockers.
Celiprolol Hydrochloride is used:
- to treat high blood pressure (hypertension)
- to prevent and control angina.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELIPROLOL
HYDROCHLORIDE
Do not take Celiprolol Hydrochloride:
- if you are allergic to celiprolol or any of the other ingredients of this
medicine (listed in section 6). Signs of an allergic reaction include a rash,
swallowing or breathing problems, swelling of your lips, face, throat or
tongue
- if you have suffered an allergic reaction to a beta-blocker in the past
- if you have too much acid in your blood (known as metabolic acidosis),
which may cause an increased rate of breathing
- if you suffer from a very slow heart beat (known as bradycardia)
- if you have low blood pressure (hypotension)
- if 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
- if you have severe kidney problems
- if you suffer from uncontrolled heart failure, missed heart beats (heart
block) or you suffer from hardened arteries
- if you have or have had asthma or wheezing
- if you are using theophylline for the treatment of asthma
- if you are taking or have taken verapamil (used for angina or severe
allergies). If you stop treatment with verapamil, you must wait until at
least 48 hours before you start treatment with Celiprolol Hydrochloride.
After stopping treatment with a Celiprolol Hydrochloride, you must wait at
least 48 hours before you can start treatment with verapamil (by injection
or infusion).
Warnings and precautions
Talk to your doctor or pharmacist before taking Celiprolol Hydrochloride:
- if you have liver problems
- if you have mild to moderate kidney problems
- if you have any heart problems
- if you have Printzmetal's angina (chest pain while resting)
- if you have poor blood circulation eg. Raynaud's disease. Symptoms
include fingers and toes changing colour when cold and tingling or pain
on warming up
- if you have diabetes
- if you have ever had psoriasis
- if you have a history of severe allergies, including anaphylactic reactions
- if you have an overactive thyroid gland, as celiprolol can hide some of the
symptoms associated with this condition
- if you have breathing problems due to long term lung problems (called
bronchitis or emphysema)
- if you have a tumour of the adrenal gland (phaeochromocytoma) and
your high blood pressure is medicine known as an alpha blocker, such as
doxazosin or terazosin
- if you need to have surgery and will be given an anaesthetic; tell your
doctor, dentist or hospital staff.

Children and adolescents
Celiprolol Hydrochloride should not be given to children.
Other medicines and Celiprolol Hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Do not take Celiprolol Hydrochloride if you are already taking any of the
following:
- theophylline (for the treatment of asthma)
- medicines for chest pain (angina) such as verapamil (also used for
severe allergies), nifedipine and diltiazem or medicines used for heart
problems such as digitalis
- disopyramide, quinidine or amiodarone given by injection to treat
abnormal heart rhythm
- medicines used to lower blood pressure such as clonidine or diuretics
('water' tablets) e.g. chlorthalidone and hydrochlorothiazide
- medicines to treat depression called MAOIs (Monoamine Oxidase
Inhibitors) such as moclobemide, phenelzine or tranylcypromine, or if you
have taken them in the last 2 weeks.
Tell your doctor if you are already taking any of the following as they may
interact with your medicine:
- medicines used to treat heart problems such as lidocaine (also used as
local anaesthetic), disopyramide, nifedipine, quinidine, amiodarone,
sotalol, hydroquinidine, ibutilide, dofetilide and propafenone
- medicine used for the prevention of malaria such as mefloquine
- other medicines to treat heart conditions or high blood pressure e.g.
reserpine, alpha-methyldopa, guanfacine, moxonidine, rilmenidine
- medicines which cause a heart rhythm condition known as torsades de
pointes (except sultopride), including the following:
* some medicines for mental illness (antipsychotic medicine) including
chlorpromazine, cyamemazine, levomepromazine, thioridazine,
trifluoperazine, amisulpiride, sulpiride, tiapride, droperidol, haloperidol,
pimozide
* bepridil, cisapride, diphemanil, spiramycin or erythromycin (by injection),
halofantrine, antibacterial medicines such as moxifloxacin or pentamidine
and vincamycin (by injection), astemizole, terfenadine, mizolastine
- medicine to treat urinary retention such as alfuzosin, doxazosin, prazosin,
tamsulosin and terazosin
- insulin or tablets to treat diabetes; your blood sugar may need to be
monitored closely
- antidepressants or other medicines to treat mental illness (antipsychotic
medicines) such as barbiturates or other phenothiazines
- anti-inflammatory painkillers (NSAIDs such as ibuprofen etoricoxib,
aspirin (in high doses) and indometacin
- cough and cold remedies containing, ephedrine, pseudoephedrine or
adrenaline bought over the counter (including nose and eye drops).
Celiprolol Hydrochloride with food, drink and alcohol
If you take this medicine with food it may not work as well: Celiprolol
Hydrochloride should be taken 30 minutes before food or two hours after it.
Drinking alcohol can increase the effect of this medicine and you may feel
dizzy.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before
taking this medicine.
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 to 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 your baby if you are taking Celiprolol
Hydrochloride as small amounts of Celiprolol Hydrochloride may pass into
your breast milk.
Driving and using machines
You may feel dizzy or tired, have problems seeing, shaking or headaches
whilst taking this medicine. If this happens, do not drive or use tools or
machines.
Celiprolol Hydrochloride 200 mg contains lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE CELIPROLOL HYDROCHLORIDE
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Adults including the elderly
The recommended starting dose is 200 mg of Celiprolol Hydrochloride once
a day. If needed, your doctor will increase the dose to 400 mg once a day.
Patients with kidney problems
If you have kidney problems, your doctor will give you a lower dose than
stated above.
Use in children and adolescents
Celiprolol Hydrochloride must not be given to children.
Method of administration
- 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.
If you take more Celiprolol Hydrochloride than you should
If you take more Celiprolol Hydrochloride than you should, contact your
doctor or go to the nearest hospital casualty department immediately. Take
the container and any remaining tablets with you. 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.
If you stop taking Celiprolol Hydrochloride
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 to do this.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Celiprolol Hydrochloride and contact your doctor or go to your
nearest hospital emergency department immediately if you think you may
have any of the following side effects.
Rare (may affect up to 1 in 1,000 people):
- swelling of the hands, feet, ankles, face, lips or throat which may cause
difficulty in swallowing or breathing. You could also notice itchy, lumps
rash (hives) or nettle rash (urticaria). This may mean you are having an
allergic reaction to Celiprolol Hydrochloride
- pain in your chest and feeling weak or dizzy with breathlessness and
swollen ankles. These could be signs of heart problems.
Very rare (may affect up to 1 in 10,000 people)
- 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).
Not known (frequency cannot be estimated from the available data):
- flu like symptoms, swollen or painful joints, increased sensitivity to
sunlight, hair loss, abdominal pain, anaemia. This may mean you have a
condition called Systemic Lupus Erythematous (SLE). These symptoms
will usually go away after Celiprolol Hydrochloride has been stopped.
Other side effects
Tell your doctor as soon as possible if you have any of the following
side effects:
Common (may affect up to 1 in 10 people):
- headache
- dizziness
- sleep problems
- nightmares
- tremor
- cold fingers and toes
- slowing of the heart beat
- an irregular heart rhythm or missed beats (palpitations)
- low blood pressure causing dizziness or lightheadedness, including when
standing up
- feeling or being sick
- stomach pain or discomfort
- muscle cramps
- feeling tired.

Rare (may affect up to 1 in 1,000 people):
- feeling depressed
- ringing in the ears
- tingling or numbness in the arms and legs
- diarrhoea or constipation
- muscle weakness
- difficulty in getting or maintaining an erection or in ejaculating (impotence)
- painful cold fingers and toes and worsening of patients with circulation
problems e.g. Raynaud's disease
- wheezing, coughing, difficulty in breathing or worsening of existing
asthma, sometimes with fever, chills, dry cough and a tight feeling in your
chest (pneumonitis).
Very rare (may affect up to 1 in 10,000 people):
- seeing or hearing things that are not there (hallucinations), confusion
- problems with eyesight such as blurred vision
- dryness or redness of the eye
- psoriasis or worsening of psoriasis.
Not known (frequency cannot be estimated from the available data):
- nervousness
- hot flushes
- low blood sugar level (hypoglycaemia). You may feel a sense of
nervousness, shaky or sweaty
- lack of interest in sexual activities (libido)
- unusual weakness.
Blood Tests:
- the result of some blood tests may show higher level of liver enzymes
than normal
- blood tests may also show abnormal levels of glucose in the blood
- blood tests may also show abnormal levels of antinuclear antibodies
(ANA) in the blood.
Celiprolol hydrochloride may worsen diabetes.
Patients with diabetes or an overactive thyroid gland should be aware that
the symptoms of low blood sugar (hypoglycaemia) or an overactive thyroid
gland (thyrotoxicosis) may be hidden by beta-blocker medicines.
If you feel more thirsty than usual, feel unusually tired or pass more urine
than usual, tell your doctor as celiprolol hydrochloride may be affecting the
amount of glucose (sugar) in your blood, which can lead to diabetes.
Taking Celiprolol Hydrochloride may lead to an increase in the risk of heart
rhythm disorders. Your doctor may want to monitor you.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 HYDROCHLORIDE
- Keep out of the sight and reach of children
- Do not take this medicine after the expiry date stated on the pack. The
expiry date refers to the last day of that month.
- There are no special storage requirements for this medicine. Medicine
should not be disposed of via wastewater or household waste
- If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
- Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Celiprolol contains
Each film-coated tablet contains 400 mg celiprolol hydrochloride.
The other ingredients are microcrystalline cellulose, mannitol (E421),
croscarmellose sodium, magnesium stearate, hypromellose (E464) and
macrogol.
What Celiprolol looks like and the contents of the pack
Celiprolol are white film-coated, round biconvex tablets, imprinted ‘CL 400’
on one side and ‘G’ on the other.
Available in blister packs of 28 tablets.
Manufacturer and Product Licence Holder
Manufactured by Mc Dermott Laboratories Ltd, 35-36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.Procured from the EU by Product
Licence holder Star Pharmaceuticals Ltd., 5 Sandridge close, Harrow,
Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636 / 2371

Leaflet revision and issue date (Ref) 26.05.15[4]

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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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