CO-TENIDONE TABLETS BP 100MG/25MG

Active substance: CHLORTHALIDONE

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Ref:

231-30-85919-V LEA CO-TENIDONE A/S TAB TUK

Version:

2

12 August 2013

202136

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

231-10-38177, 231-10-38185
N/A
21 (0110)
N/A
N/A
Univers
8 Pt

217621

PL 00289/0736-37. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva UK Limited, Eastbourne.
Packing line: Uhlmann.
V1: Text update. V2: Text update.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:
Base Font Size:

Child:

Dimensions:
L:
W:
D

323 mm
160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)
Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

PANTONE® GREEN C
BLACK
D5 (PANTONE® 123 C)
S3 (PANTONE® 232 C)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 1: FRONT FACE (INSIDE OF REEL)

PACKAGE LEAFLET: INFORMATION
FOR THE USER

Pharma code 21

• Read all of this leaflet carefully before you start
taking this medicine.
• 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.
IN THIS LEAFLET:
1. What Co-Tenidone is and what it is used for
2. Before you take Co-Tenidone
3. How to take Co-Tenidone
4. Possible side effects
5. How to store Co-Tenidone
6. Further information

1

WHAT CO-TENIDONE IS AND WHAT IT IS
USED FOR

Co-Tenidone is a combination of two drugs.
Atenolol is a beta blocker and chlorthalidone is a
diuretic. Beta blockers have an action on the
heart; to slow the pulse rate and reduce the force
of contraction of the heart muscle. Diuretics
increase urine output and so reduce fluid
retention. This combined action leads to a
lowering of your blood pressure.
Co-Tenidone is used to treat people with high
blood pressure.

2

BEFORE YOU TAKE CO-TENIDONE

Do NOT take Co-Tenidone if you:
• are allergic (hypersensitive) to atenolol or
chlorthalidone or any of the other ingredients of
this medicine
• are pregnant or breast-feeding
• have an unusually slow heart beat or low blood
pressure sometimes causing dizziness,
faintness or lightheadness on standing
• have a phaeochromocytoma (adrenal gland
tumor) unless adequately controlled by
medication
• have metabolic acidosis (acidification of the
blood)
• have a second or third degree heart block (a
conduction defect of the heart) or a weak heart
(cardiogenic shock)
• have sick-sinus syndrome (slow and irregular
heart beat due to sino-atrial block)
• have unstable/uncontrolled heart failure
• have severe hardening of the arteries affecting
the circulation in your legs or feet.
• have severe kidney failure.
Take special care with Co-Tenidone
Tell your doctor before you start to take this
medicine if you:
• have a history of asthma, wheezing or have
other problems with your breathing
• have liver or kidney problems
• have gout
• have first degree heart block, controlled heart
failure or Printzmetal’s angina (chest pain) or
any type of heart disease.
• have history of allergic reactions (swelling of
the lips, face or neck leading to severe difficulty
in breathing; skin rash or hives)
• have diabetes as your low blood sugar “hypo”
warning signs may be less obvious than usual.
Your doctor may want to test your blood sugar
level at the beginning of this treatment
• have thyroid problems
• are elderly
• have a diet low in potassium
• suffer from stomach problems.
Tell your doctor or dentist you are taking
Co-Tenidone tablets if you are to have an
operation requiring an anaesthetic.

Your doctor may test the level of potassium in
your blood if you are taking digoxin or digitoxin,
are on a low potassium diet or if you have any
stomach complaints.
If you take Co-Tenidone for a long time your urine
will be tested regularly for sugar.
Co-Tenidone can affect or be affected by other
medicines you are using, including eye drops for
the treatment of glaucoma.
Taking other medicines
Talk to your doctor if you are taking any of the
following:
• insulin or tablets to treat diabetes
• digoxin or digitoxin (used to treat heart
problems)
• non-steroidal anti-inflammatory drugs (NSAIDs)
e.g. indometacin or ibuprofen
• sympathomimetic (heart stimulating) drugs
such as dopamine, terbutaline, salmeterol,
salbutamol, ephedrine, adrenaline and
phenylpropranolamine. Ephedrine and
phenylpropranolamine may be present in
medicines for colds and nasal stuffiness
• lithium (use to treat manic depression)
• calcium channel blockers e.g. diltiazem,
verapamil or nifedipine
• medication to treat an irregular heart beat such
as disopyramide, amiodarone
• clonidine (another drug used to treat high
blood pressure)
• baclofen (used for relaxation of muscle)
• anaesthetics (medicines used for temporary
loss of bodily sensation).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Taking Co-Tenidone with food and drink
Do not drink alcohol while taking Co-Tenidone.
Pregnancy, breast-feeding and fertility
Do not take Co-Tenidone if you are pregnant,
planning to become pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Co-Tenidone may cause dizziness or tiredness, if
affected do not drive or operate machinery.

3

HOW TO TAKE CO-TENIDONE

Always take Co-Tenidone exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure. The tablets
should be swallowed preferably with a glass of
water.
The usual dose is:
Adults
One Co-Tenidone 50 mg/12.5 mg tablet daily. This
may be increased to 100 mg/25 mg daily.
Elderly
Dosage may be reduced.
Kidney problems
You may be prescribed a lower dose or you may
need to take your medicine less frequently.Please
speak to your doctor before taking this medicine if
you have severe kidney problems.
Children and adolescents < 18 years
Co-Tenidone is not recommended for use in
children and adolescents < 18 years.
If you take more Co-Tenidone than you should
If you (or someone else) take too many tablets all
together, or if you think a child has swallowed any
of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
An overdose is likely to cause low blood pressure
(feeling faint, dizzy, shaky and weak), slow heart
beat, difficulty in breathing and heart
failure/attack. Please take this leaflet, any
remaining tablets and the container with you to
the hospital or doctor so that they know which
tablets were consumed.

Top of page cut-off to middle of registration mark: 44 mm.

CO-TENIDONE 50 mg/12.5 mg and
100 mg/25 mg TABLETS

Ref:

231-30-85919-V LEA CO-TENIDONE A/S TAB TUK

Version:

2

12 August 2013

202136

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

231-10-38177, 231-10-38185
N/A
21 (0110)
N/A
N/A
Univers
8 Pt

217621

PL 00289/0736-37. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Teva UK Limited, Eastbourne.
Packing line: Uhlmann.
V1: Text update. V2: Text update.

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:
Base Font Size:

Child:

Dimensions:
L:
W:
D

323 mm
160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

D5 (PANTONE® 123 C)
S3 (PANTONE® 232 C)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you forget to take Co-Tenidone
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one. Do not take a double dose to make up
for a forgotten tablet.
If you stop taking Co-Tenidone
Do not suddenly stop taking your tablets as side
effects can occur. If your treatment is to be stopped
your doctor will gradually reduce your dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Co-Tenidone can cause side
effects, although not everybody gets them.

Very rare side effects (occurring in less than 1 in
10,000 patients):
• increase in anti-nuclear antibody.
Side effects with frequency not known
• constipation.
If you have these, or any other effects whilst
taking Atenolol, tell your doctor immediately.
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.

5

HOW TO STORE CO-TENIDONE

Keep out of the reach and sight of children. Store
in a cool dry place at or below 25°C. Protect from
light. Do not use Co-Tenidone after the expiry
If the following happens, stop taking the tablets
date that is stated on the outer packaging. The
and tell your doctor immediately or go to the
expiry date refers to the last day of that month.
casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or Medicines should not be disposed of via
wastewater or household waste. Ask your
neck leading to severe difficulty in breathing;
pharmacist how to dispose of medicines no
skin rash or hives).
This is a very serious but rare side effect. You may longer required. These measures will help to
need urgent medical attention or hospitalisation. protect the environment.
If you have a history of asthma or psoriasis
(patches of flaky, thickened and sore skin) you
may experience a worsening of the symptoms of
these conditions.
Tell your doctor if you experience any of the
following:
Common side effects (occurring in more than 1 in
100 patients but in less than 10 in 100 patients):







slow heart beat
cold hands and feet
stomach upset
feeling unwell
tiredness
high uric acid in blood (this can be detected
from a blood test)
• low blood levels of potassium which can cause
muscle weakness, twitching or abnormal heart
rhythm
• low blood levels of sodium which can cause
tiredness and confusion, muscle twitching, fits
and coma
• sugar intolerance.

6

FURTHER INFORMATION

What Co-Tenidone contains:
• The active ingredients in Co-Tenidone
50 mg/12.5 mg tablets are: atenolol 50 mg and
chlorthalidone 12.5 mg
• The active ingredients in Co-Tenidone
100 mg/25 mg Tablets are: atenolol 100 mg and
chlorthalidone 25 mg
• The other ingredients are magnesium
carbonate, maize starch, povidone (E1201),
sodium starch glycolate and magnesium
stearate (E572). The tablet coating contains
hypromellose (E464), purified talc (E553b),
polyethylene glycol (E1520), yellow, red and
black iron oxides (E172) and titanium dioxide
(E171).

What Co-Tenidone looks like and contents of the
pack:
• The 50 mg/12.5 mg are brown, film-coated,
round, biconvex tablets, engraved: 3H2.
• The 100 mg/25 mg are brown, film-coated,
round, biconvex tablets, engraved: 4H2.
• The product comes in packs of 10, 20, 28, 30,
56, 60, 100, 250, 500 and 1000 tablets.
Uncommon side effects (occurring in more than 1
Not all pack sizes may be marketed.
in 1000 patients but in less than 10 in 1000 patients):
• sleep disturbances
• elevated liver function test.
• Rare side effects (occurring in more than 1 in
10,000 patients but in less than 10 in 10,000
patients):




























Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: July 2013

low white blood cell and platelet count in blood PL 00289/0736 & 0737
bleeding underneath the skin
unusual bleeding or unexplained bruising
mood changes
nightmares
confusion
abnormal condition of mind
seeing and hearing things that are not real
dizziness
headache
abnormal sensation of skin
dry eyes
disturbed vision
heart failure deterioration
heart block
rapid fall of blood pressure when standing up
feeling faint
asthma
difficulty in breathing or wheezing
dry mouth
liver disease
inflammation of the pancreas that may cause
intense, persistent pain in the upper abdomen.
Symptoms may include nausea, constipation,
and jaundice
hair loss
skin rash
patchy inflamed skin
inability to develop or maintain an erection of
the penis.

85919-V
160 x 323

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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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