Skip to Content

CO-TENIDONE 50/12.5MG FILM- COATED TABLETS

Active substance(s): ATENOLOL / CHLORTALIDONE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user
Co-Tenidone 50/12.5mg Tablets
Co-Tenidone 100/25mg Tablets
(Referred to as Co-Tenidone tablets in the leaflet)

8th fold

(26.25mm)

7th fold

(26.25mm)

6th fold

(26.25mm)

5th fold

(26.25mm)

4th fold

(26.25mm)

3rd fold

(26.25mm)

2nd fold

(26.25mm)

1st fold

(26.25mm)

Neutral code not required on the leaflet artworks.

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 Co-Tenidone tablets are and what they are used for
2. What you need to know before you take Co-Tenidone tablets
3. How to take Co-Tenidone tablets
4. Possible side effects
5. How to store Co-Tenidone tablets
6. Contents of the pack and other information
1. What Co-Tenidone tablets are and what they are used
for
Co-tenidone is used to treat high blood pressure (hypertension).
It contains two different medicines atenolol and chlortalidone.
These medicines work together to lower your blood pressure.
• Atenolol belongs to a group of medicines called
beta-blockers. It works by making your heart beat more
slowly and with less force.
• Chlortalidone belongs to a group of medicines called
diuretics. It works by increasing the amount of urine
produced by your kidneys.
2. What you need to know before you take Co-Tenidone
tablets
Do not take Co-Tenidone tablets:
• if you are allergic to atenolol, chlortalidone or to any of the
other ingredients in this medicine (listed in section 6)
• have ever had any of the following heart problems:
- heart failure which is not under control (this usually makes
you breathless and causes your ankles to swell)
- second- or third-degree heart block (a condition which may
be treated by a pacemaker)
- very slow or very uneven heart beats, very low blood
pressure or very poor circulation
• if you have a tumour called phaeochromocytoma that is not
being treated. This is usually near your kidney and can cause
high blood pressure
• if you have problems with your kidneys
• if you have been told that you have higher than normal levels
of acid in your blood (metabolic acidosis)
• if you are pregnant, are trying to become pregnant or are
breast-feeding.
Do not take Co-tenidone tablets if any of the above apply to
you. If you are not sure, talk to your doctor or pharmacist
before taking Co-tenidone tablets.
Warnings and precautions
Talk to your doctor before taking this Co-tenidone tablets:
• if you have asthma, wheezing or any other similar
breathing problems, or you get allergic reactions, for
example to insect stings. If you have ever had asthma or
wheezing, do not take this medicine without checking
with your doctor.
• if you have a risk of developing gout (sudden unexpected

burning pain in the joints)
• if you have a type of chest pain (angina) called Prinzmetal’s
angina
• if you have poor blood circulation or controlled heart failure
• if you have first-degree heart block
• if you have diabetes. Your medicine may change how you
respond to having low blood sugar. You may feel your heart
beating faster
• if you have thyrotoxicosis (a condition caused by an
overactive thyroid gland). Your medicine may hide the
symptoms of thyrotoxicosis.
• if you have problems with your adrenal glands.
• if you have liver problems
If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking Co-tenidone tablets.
Children
This medicine is not for use in children.
Other medicines and Co-Tenidone tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This includes
medicines that you buy without a prescription and herbal
medicines. This is because Co-tenidone tablets can affect the
way some other medicines work and some medicines can
have an effect on Co-tenidone tablets.
In particular, tell your doctor if you are taking any of the
following medicines:
• clonidine (for high blood pressure or migraine). If you are
taking clonidine and Co-tenidone tablets together, do not
stop taking clonidine unless your doctor tells you to do so. If
you have to stop taking clonidine, your doctor will give you
careful instructions on how to do so.
• verapamil, diltiazem and nifedipine (for high blood pressure
or chest pain)
• disopyramide or amiodarone (for an uneven heart beat)
• digoxin (for heart problems)
• adrenaline, also known as epinephrine (a medicine that
stimulates the heart)
• baclofen (a medicine used for muscle relaxation)
• ibuprofen or indomethacin (for pain and inflammation)
• insulin or medicines that you take by mouth for diabetes.
• lithium (for certain mental illnesses)
• medicines to treat nose or sinus congestion or other cold
remedies (including those you can buy in the pharmacy)
• betaxolol, carteolol, levobunolol and timolol (eye drops for
glaucoma)
Operations
If you go into hospital to have an operation, tell the
anaesthetist or medical staff that you are taking Co-tenidone
tablets. This is because you can get low blood pressure
(hypotension) if you are given certain anaesthetics while you
are taking Co-tenidone tablets.
Pregnancy and breast-feeding
• Do not take Co-tenidone tablets if you are pregnant or trying
to get pregnant, ask your doctor for advice before using this
medicine.
• Do not take Co-tenidone tablets if you are breast-feeding,
ask your doctor for advice before using this medicine.
Driving and using machines
• Your medicine is not likely to affect you being able to drive or
use any tools or machines. However, it is best to wait to see
how your medicine affects you before trying these activities.
• If you feel dizzy or tired when taking this medicine, ask your
doctor for advice.
3. How to take Co-Tenidone tablets
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor if you are not sure.
• Your doctor will tell you how many tablets to take each day
and when to take them. Read the label on the carton to
remind you what the doctor said.
• Swallow your Co-tenidone tablets with a drink of water.

pg 1/2
ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :
Process
Black

Co-Tenidone 50/12.5mg & 100/25mg - 28 Tabs
Wockhardt UK
FP1682; FP1683
L1
(w)148 x (h)210mm
2596
222874
7.5 pt. (10% condensation)
Co-tenidone_Leaflet_104550-7.ai
Adobe Illustrator CS5
Arial Regular / Bold
23rd & 28th June, 2017
R 1st PDF sent on - 28TH JUNE 2017
R 2nd PDF sent on - 28TH JUNE 2017
R 3rd PDF sent on - 11TH AUG. 2017

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • New regulatory text

Non-Regulatory

104550/7
222874

pg 2/2

1st fold

(26.25mm)

2nd fold

(26.25mm)

3rd fold

(26.25mm)

4th fold

(26.25mm)

5th fold

(26.25mm)

6th fold

(26.25mm)

7th fold

6. Contents of the pack and other information
What Co-tenidone Tablets contain
The active ingredients are: atenolol and chlortalidone.
The other ingredients are: maize starch, calcium hydrogen
phosphate, microcrystalline cellulose, povidone K30, sodium
starch glycollate, magnesium stearate, purified water. Film
coating: opadry OY-6954
What Co-Tenidone tablets look like and the contents of the
pack
Co-Tenidone tablets are brownish pink, round, biconvex
film-coated tablets marked CTE 50 or CTE 100 on one side
and CP on the other.
These tablets are available in blister packs of white opaque
PVC film and hard tempered aluminium foil. They are available
in the pack size of 28, 30, 56 and 60. Not all pack sizes may
be marketed.
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print
or audio please call, free of charge: 0800 198 5000 (UK Only).
Please be ready to give the following information:
Product Name
Reference number
Co-Tenidone tablets
29831/0056
29831/0057
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in 08/2017.

(26.25mm)

5. How to store Co-Tenidone tablets
Keep out of the sight and reach of children.
• Co-Tenidone tablets should be stored below 25°C. Store in
the original package to protect from light and moisture.
• do not use this medicine after the expiry date on the label.
The expiry date refers to the last day of that 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.

8th fold

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Allergic reactions:
If you have an allergic reaction, see a doctor straight away.
The signs may include raised lumps on your skin (weals) or
swelling of your face, lips, mouth, tongue or throat.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• cold hands and feet
• you may notice that your pulse rate becomes slower while
you are taking the tablets. This is normal, but if you are
concerned please tell your doctor about it.
• diarrhoea
• feeling sick (nausea)
• feeling tired
• changes in the amount of certain substances in your blood.
It can cause:
- higher levels of sugar (glucose) than normal
- low levels of sodium, which may cause weakness, being
sick (vomiting) and cramps
- low levels of potassium, which can cause muscle
weakness, twitching or abnormal heart rhythm
- an increase in the amount of uric acid
Your doctor may take blood samples every so often to check
on these levels.
Uncommon (may affect up to 1 in 100 people)
• disturbed sleep
Rare (may affect up to 1 in 1,000 people)
• heart block (which can cause an abnormal heart beat,
dizziness, tiredness or fainting)
• numbness and spasm in your fingers which is followed by
warmth and pain (Raynaud’s disease)
• dizziness (particularly when standing up)
• headache
• feeling confused
• changes in personality (psychoses) or hallucinations
• mood changes
• nightmares
• dry mouth
• thinning of your hair
• dry eyes
• skin rash
• tingling of your hands
• disturbances of vision
• bruising more easily or purplish marks on your skin
• being unable to get an erection (impotence)
• jaundice (causing yellowing of the skin or the whites of your eyes)
• pancreatitis (inflammation of a large gland behind the stomach)
• a reduced number of white blood cells. You may get more
infections than usual.
Very rare (may affect up to 1 in 10,000 people)
Changes to some of the cells or other parts of your blood. Your
doctor may take blood samples every so often to check

whether Co-tenidone has had any effect on your blood.
Not known (frequency cannot be estimated from the data
available)
• constipation
• Lupus-like syndrome (a disease where the immune system
produces antibodies that attacks mainly skin and joints)
Conditions that may get worse
If you have any of the
following conditions,
they may get worse
when you start to take
your medicine. This
happens rarely
affecting up to
1 in 1,000 people:
• psoriasis (a skin
condition)
• being short of breath
or having swollen
ankles (if you have heart failure)
• asthma or breathing problems
• poor circulation
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.

(26.25mm)

Adults
The recommended dose for an adult is one tablet each day.
People with kidney problems
If you have problems with your kidneys, your doctor may give
you a lower dose or ask you to take this medicine less often.
Use in Children
Your medicine must not be given to children
If you take more Co-Tenidone tablets than you should
If you take more Co-tenidone tablets than prescribed by your
doctor, talk to a doctor or go to a hospital straight away. Take
the medicine pack with you so that the tablets can be identified.
If you forget to take Co-Tenidone tablets
If you forget to take a dose, take it as soon as you remember.
However, if it is almost time for the next dose, skip the missed
dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Co-tenidone tablets
Do not stop taking Co-tenidone tablets without talking to your
doctor. In some cases, you may need to stop taking it gradually.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

+ Expand Transcript

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.

Hide