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CO-TENIDONE 50/12.5MG TABLETS BP

Active substance: CHLORTALIDONE

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second or third degree heart block (irregular heartbeat) or cardiogenic shock (shock
caused by cardiac arrest)



severe kidney or liver failure



a history of wheezing or asthma.



sick sinus syndrome (heart conduction or rhythm problems)



untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney)



Bradycardia (slow heart rate)



Hypotension (low blood pressure)



severe peripheral blood circulation problems (which may cause your fingers and toes
to tingle or turn pale or blue)



metabolic acidosis (an increased acidity of the blood)

Pregnancy and breast-feeding
Do not take Co-Tenidone Tablets if you are pregnant or breast-feeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Co-Tenidone Tablets are not expected to affect your ability to drive or operate machinery.
3. HOW TO TAKE CO-TENIDONE TABLETS
Always take Co-Tenidone Tablets exactly as your doctor has told you. The
pharmacist's label should tell you how much to take and how often.
The tablets must be swallowed with a drink of water.
Dosage

Adults - take one 50/12.5mg tablet or one 100/25mg tablet a day.

Elderly or patients with kidney disease - your doctor may prescribe a reduced dose.

23.09(RK)/01.10(MA)/04(MA)/24.11.10(MA)/
20.01.11(MA)
WIN\artworks\Medreich\UK Products\Co-tenidone\PIL\1207773.ai

CD issued on

CQA:

Check on Label claim, License, Codes aspects:

QC:
Technical services:

4

Check on Dimensions
& OPD aspects:

72%
Artwork made to

280 x 240 mm (Open Size) 140 x 40 mm (Folded Size)

NA

Internal Approval issued on 07.01.11(MA)
Format No.: CO-QA005-F06-00



MED/Co-T/PIL/05

an allergy (hypersensitivity) to atenolol, chlortalidone or any of the other ingredients in
the product (see Section 6)

IBD:



Regulatory :

Do not take Co-Tenidone Tablets If you have:

PDC

BEFORE YOU TAKE CO-TENIDONE TABLETS

Check on design and
adequacy of text matter:

2.

100% check
on text matter:

These tablets are prescribed for adults only to treat high blood pressure.

Check for all aspects

chlortalidone belongs to a group of medicines called thiazide diuretics which remove
excess water and salt.

Dimensions & Colour Shade: Confirmed by PDC



Artwork No.:

atenolol belongs to a group of medicines called beta-blockers which help the heart
beat more slowly and with less force

1207773 (WOA)



Item Code

Co-Tenidone Tablets contain two active ingredients:

No. of Folds

WHAT CO-TENIDONE TABLETS ARE AND WHAT THEY ARE USED FOR

Dimensions:

1.

Taking other medicines
Please inform your doctor if you are taking or have recently taken any other medicines,
including those obtained without a prescription, particularly:

drugs affecting the heart (e.g. digoxin, clonidine, disopyramide, amiodarone)

blood pressure lowering medicines (e.g. verapamil, nifedipine, diltiazem)

ergotamine (for migraines)

adrenaline, used to treat shock

cancer chemotherapy

anti-diabetic medication

lithium (used in the treatment of depression)

certain medicines for arthritis or inflammation (e.g. indometacin).

aminoglycosides

anaesthetics (patient should be advised to tell hospital staff if they are taking the
medicine and are due to have an operation)

NA

Further information

Layout No.

How to store Co-Tenidone Tablets

6.

Single - Black

5.

Colours:

Possible side effects

PIF - 136/10 & 137/10
New Product

How to take Co-Tenidone Tablets

4.

MEDREICH PLC, UK

Before you take Co-Tenidone Tablets

3.

Reason
for Issue

What Co-Tenidone Tablets are and what they are used for

2.

Customer

1.

Specification: Printed on 56-60 gsm maplitho paper

In this leaflet:

Co-Tenidone Tablets -100/25 & 50/12.5mg - SL - Eng - PIL

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.

Take special care with Co-Tenidone Tablets if you:

have a tight, painful feeling in the chest in periods of rest (Prinzmetal's angina)

have poor liver function/liver disease

intermittent claudication (episodic muscle pain or cramp when taking exercise)

suffer from Reynauds syndrome (discoloration of the fingers,toes and occasionally
other areas)

If you have a history of allergic reactions, as you may become more sensitive to
allergens or experience more serious allergic reactions.

If you have a history of allergic reactions.

have a heart condition

have any breathing difficulties, in case of bronchospasm (tightening of muscles in your
airways)

are a diabetic or have abnormally low blood sugar levels - the amount of sugar in your
urine should be monitored with longer treatment

are on a low potassium diet, have high blood potassium levels or an imbalance of
other electrolytes (salts) in your blood. Your fluid and electrolyte levels should be
regularly monitored during your treatment with this medicine.

have gout or excess uric acid in your blood

are elderly.

Product

Co-Tenidone 50/12.5 mg Tablets BP
Co-Tenidone 100/25 mg Tablets BP
(atenolol and chlortalidone)

MEDREICH LIMITED

PACKAGE LEAFLET: INFORMATION FOR THE USER

Title: Art Work Approval Form

PC - 3037

change in the number of certain blood cells; if you notice you are bruising easily, have
frequent nose bleeds, sore throats or infections, tell your doctor immediately.



abnormally low concentrations of sodium in the blood (this can be detected by a
blood test).

If any of the side effects get serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor.
5.

HOW TO STORE CO-TENIDONE TABLETS

Keep out of the reach and sight of children.
Do not use Co-Tenidone Tablets after the expiry date (refers to the last day of the month
stated) stated on the label.
The tablets should be stored below 25°C in their original package, protected from light and
moisture.

1207773

23.09(RK)/01.10(MA)/04(MA)/24.11.10(MA)/
20.01.11(MA)
WIN\artworks\Medreich\UK Products\Co-tenidone\PIL\1207773.ai

CD issued on

CQA:

Check on Label claim, License, Codes aspects:

QC:
Technical services:

4

Check on Dimensions
& OPD aspects:

72%

280 x 240 mm (Open Size) 140 x 40 mm (Folded Size)
Dimensions:

Artwork made to

Single - Black
Colours:

NA

Internal Approval issued on 07.01.11(MA)
Format No.: CO-QA005-F06-00



MED/Co-T/PIL/05

slight dizziness.

There have been rare reports of:

IBD:

upset stomach



Regulatory :

skin rashes and/or dry eyes



PDC

sleep disturbances



Check on design and
adequacy of text matter:

tired and aching muscles



100% check
on text matter:



This leaflet was last approved in January 2011

Check for all aspects

slower heartbeat

Dimensions & Colour Shade: Confirmed by PDC

cold hands and feet



MEDREICH LIMITED



Artwork No.:

severe itching of the skin, with a red rash or raised lumps.

You may experience the following:

1207773 (WOA)



MA Holder & Batch Release site:
MEDREICH PLC
9, Royal Parade, Kew Gardens,
Surrey TW9 3QD, England.

Item Code

difficulty breathing or swallowing, swelling of the face, lips, tongue or throat

No. of Folds



NA

the following allergic reactions:

What Co-Tenidone Tablets look like and contents of the pack
The 50mg/12.5mg and 100mg/25mg tablets are brownish pink, round, biconvex and
film-coated, marked CT/50 or CT/100 on one side.
They are available in blister packs of 28s, 30s, 56s and 60s (not all pack sizes may be
marketed).

Layout No.

STOP taking these tablets and seek medical help immediately if you have any of

The other ingredients are maize starch, calcium hydrogen phosphate dihydrate,
microcrystalline cellulose, povidone K30, sodium starch glycollate (type A), magnesium
stearate and water. The film coating consists of hydroxypropylmethylcellulose (E464),
titanium dioxide (El71), macrogol and iron oxides (E172) for Co-Tenidone 50mg/12.5mg
Tablets and Co-Tenidone 100mg/25mg Tablets

PIF - 136/10 & 137/10
New Product

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

The active ingredients are atenolol (50 or 100mg) and chlortalidone (12.5 of 25mg), per
tablet.

MEDREICH PLC, UK

4. POSSIBLE SIDE EFFECTS

What Co-Tenidone Tablets contain

Reason
for Issue

If you have any further questions on the use of this product, ask your doctor or pharmacist.

FURTHER INFORMATION

Customer

Do NOT stop taking Co-Tenidone Tablets without seeking medical advice first.

Specification: Printed on 56-60 gsm maplitho paper

If you forget to take Co-Tenidone Tablets
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose,
skip the forgotten dose and just carry on as before; do not take a double dose to make up
for the one you have forgotten.

6.

Co-Tenidone Tablets -100/25 & 50/12.5mg - SL - Eng - PIL

If you accidentally take too many of these tablets, contact your doctor or nearest accident
and emergency department immediately (take any remaining medicine in its original
package with you if you can). Symptoms of overdose include a slow heart rate, low blood
pressure, nausea (feeling sick), weakness, dizziness and imbalance of electrolytes.

Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

Product

Children - not recommended.

If you take more Co-Tenidone Tablets than you should

Title: Art Work Approval Form



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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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