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CELIPROLOL HYDROCHLORIDE TABLETS 200MG

Active substance(s): CELIPROLOL HYDROCHLORIDE

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Celiprolol
Hydrochloride
200 mg Tablets
Celiprolol
Hydrochloride
400 mg Tablets
(celiprolol hydrochloride)

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.
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
The name of your medicine is Celiprolol
Hydrochloride 200 mg and 400 mg Tablets
(referred to as Celiprolol Hydrochloride
throughout this leaflet).
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

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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.

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Package leaflet: Information for the patient

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 this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on the label, blister or carton
after ‘EXP’. The expiry date refers to the last day
of that month.
There are no special storage requirements for
this medicine.
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. Contents of the pack and
other information
What Celiprolol Hydrochloride tablets contains
Each film-coated tablet contains either 200 mg
or 400 mg of the active ingredient celiprolol
hydrochloride.
The other ingredients are cellulose,
microcrystalline; mannitol (E421);
croscarmellose sodium; magnesium stearate;
hypromellose (E464) and macrogol. The
200 mg tablet coating also contains lactose
monohydrate; titanium dioxide (E171); iron
oxide yellow (E172); quinoline yellow lake (E104)
and glycerol triacetate.
What Celiprolol Hydrochloride tablets look like
and contents of the pack
The 200 mg film-coated tablets are yellow and
marked ‘CL/200’ and the 400 mg film-coated
tablets are white and marked ‘CL 400’, on one side.
All tablets are round with a ‘G’ on the other side.
Celiprolol Hydrochloride is available in blister
packs of 5, 7, 10, 14, 15, 20, 21, 28, 30, 50,
56, 60, 84, 90 & 100 film-coated tablets and
polypropylene bottle with polyethylene cap s in
packs of 30 & 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturers
Gerard Laboratories, 35/36 Baldoyle, Industrial
Estate, Grange Road, Dublin 13, Ireland.
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Mylan Hungary Kft, H-2900 Komárom,
Mylan utca 1, Hungary.

This leaflet was last revised in
12/2014

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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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