Space for PC No.:

PACKAGE LEAFLET: INFORMATION FOR THE USER Co-Tenidone 50/12.5 mg Tablets BP Co-Tenidone 100/25 mg 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 heart beat)

•    sick-sinus syndrome (heart condition or rhythm problems)

•    bradycardia (slow heart rate)

•    uncontrolled heart failure

•    cardiogenic shock (shock caused by cardiac arrest)

•    hypotension (low blood pressure)

•    severe peripheral arterial circulatory disturbances (which may cause your fingers and toes to tingle or turn pale or blue)

•    severe renal failure

•    metabolic acidosis (an increased acidity of the blood)

•    untreated phaechromocytoma (a rare tumour of the adrenal gland near the kidney)

•    pregnancy and lactation

Do not take this medicine if you have a history of wheezing or asthma 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) or poor circulation

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

•    have a heart condition

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

•    Have diabetes, this medication can alter warning signs of hypoglycaemia (abnormal rapid heart rate, palpitations and sweating) and change your glucose tolerance, your sugar levels should be monitored regularly

•    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

•    if you are prescribed ophthalmic beta blockers (eye drops).

•    if you are being treated for phaeochromocytoma (a rare tumour of the adrenal gland near the kidney)

•    if you have the skin condition    psoriasis

•    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. ibuprofen, indometacin).

•    aminoglycosides

•    anaesthetics (you must tell hospital staff if you are taking the medicine and are due to have an operation)

•    baclofen (a muscle relaxant)

•    antacids containing calcium or aluminum hydroxide 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 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.

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 bloodpressure, other heart problems and difficulty breathing.

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:

Common - less than 1 in 10 but more than 1 in 100 patients

•    slow heart rate

•    cold hands and feet

•    nausea (feeling sick)

•    stomach or intestine discomfort or pain

•    fatigue

•    increased uric acid in the blood which may lead to gout

•    decreased sodium and potassium in the blood

•    diabetic patients may find their reaction to sugar changes Uncommon - less than 1 in 100 but more than 1 in 1,000 patients

•    problems sleeping

•    changes to liver enzymes

Rare - less than 1 in 1000 but more than 1 in 10,000 patients

•    a dark rash

•    reduction in platelets which may increase bruising and bleeding

•    reduction in white blood cells which may make infections more likely

•    dizziness

•    headache

•    tingling or ‘pins and needles' sensation

•    changes in mood

•    nightmares

•    confusion

•    delusions and seeing, hearing or feeling things that are not present

•    dry eyes

•    changes to eyesight

•    worsening of heart failure

•    problems with the way the heart beats (heart block)

•    low blood pressure when moving which may cause dizziness or fainting

•    patients with intermittent claudication (muscle cramps due to poor blood flow) may find their symptoms getting worse

•    patients with Raynaud's phenomenon (poor circulation causing fingers and toes to go pale or blue) may find their symptoms getting worse

•    patients with a history of asthma or asthma like problems may experience breathing problems

•    dry mouth

•    problems with the liver including problems releasing bile

•    problems with the pancreas

•    alopecia

•    inflammation of the skin looking like psoriasis

•    worsening of psoriasis

•    skin rashes

•    Impotence

Very rare - less than 1 in 10,000 patients

•    changes to antibodies measured in blood tests Not known (cannot be estimated from available data):

•    constipation

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

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

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 10Omg) and chlortalidone (12.5 of 25mg), per tablet. 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 (EI71), macrogol and iron oxides (E172) for Co-Tenidone 50mg/12.5mg Tablets and Co-Tenidone 100mg/25mg Tablets

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).

MA Holder & Batch Release site:

MEDREICH PLC, Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

This leaflet was last approved in July 2015

Co-tenidone 50/12.5mg Tablets PL No.: 21880/0102 Co-tenidone 100/25mg Tablets PL No.: 21880/0103

0102-0103/0/PIL/001 /I