PACKAGE LEAFLET: INFORMATION FOR THE USER Co-tenidone 50/12.5 mg Film-coated Tablets BP Co-tenidone 100/25 mg Film-coated Tablets BP

(atenolol and chlortalidone)

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.

In this leaflet:

1.    What Co-tenidone Tablets are and what they are used for

2.    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.    Further information

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

Co-tenidone Tablets contain two active ingredients:

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

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

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

2.    BEFORE YOU TAKE CO-TENIDONE TABLETS Do not take Co-tenidone Tablets If you have:

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

•    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)

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.

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)

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.

•    Children - not recommended.

If you take more Co-tenidone Tablets than you should

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.

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.

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

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 Tablets can cause side effects, although not everybody gets them.

STOP taking these tablets and seek medical help immediately if you have any of the following allergic reactions:

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

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

You may experience the following:

•    cold hands and feet

•    slower heartbeat

•    tired and aching muscles

•    sleep disturbances

•    skin rashes and/or dry eyes

•    upset stomach

•    slight dizziness.

There have been rare reports of:

•    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.

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.

6. FURTHER INFORMATION

What Co-tenidone Tablets contain

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

The other ingredients are maize starch, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, povidone K30, sodium starch glycolate (type A), and magnesium stearate. The film coating consists of Hypromellose (E464), Titanium dioxide (EI71), Macrogol, Iron oxide red (E172), Iron oxide yellow (E172) and Iron oxide black (E172).

What Co-tenidone Film-coated Tablets BP (Co-tenidone Tablets) look like and contents of the pack

The 50/12.5mg and 100/25mg 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).

Manufacturer:

Medreich Pic

Warwick House, Plane Tree Crescent Feltham, TW13 7HF, United Kingdom

MA Holder:

Activase Pharmaceuticals Ltd.

11 Boumpoulinas, 3rd floor,

P.C. 1060, Nicosia, Cyprus

This leaflet was last revised in October 2013

Co-tenidone 50/12.5 mg Film-coated Tablets BP PL 28444/0101 Co-tenidone 100/25 mg Film-coated Tablets BP PL 28444/0100

1207773