Medine.co.uk

Co-Tenidone 50/12.5mg Film- Coated Tablets

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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)


Read all of this leaflet carefully before you start to take this medicine.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please 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 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


The name of your medicine is Co-Tenidone tablets.

This medicine contains two active ingredients, atenolol and chlortalidone. Atenolol belongs to a group of medicines called beta blockers which help in reducing blood pressure. Chlortalidone belongs to a group of medicines called diuretics which remove excess water from the body and help in reducing blood pressure.

Co-Tenidone tablets are used to treat high blood pressure.


2. Before you take Co-Tenidone tablets


You should not take Co-Tenidone tablets if you:

•    are allergic (hypersensitive) to atenolol, chlortalidone or to any of the other ingredients in this medicine (see Section 6, further information)

•    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

•    suffer from liver disease

•    suffer from kidney disease

•    you have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure

•    you have been told that you have higher than normal levels of acid in your blood (metabolic acidosis)

•    you are pregnant, trying to become pregnant or are breast-feeding.

Talk to your doctor before taking this medicine if you:

•    have history of heart failure

•    have diabetes

•    have risk of developing gout (sudden unexpected burning pain in the joints)

•    have asthma, wheezing or any other similar breathing problems, or get allergic reactions, for example to insect stings. If you have ever had asthma or wheezing, do not take this medicine without first checking with your doctor.

•    have problems with your kidneys

•    have a type of chest pain (angina) called Prinzmetal’s angina


•    have poor blood circulation or controlled heart failure

•    have first degree heart block

•    have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster

•    have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis.

During your treatment with this medicine you may undergo regular tests to check the level of glucose in your urine, and also to check the level of fluids and salts in your body.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines can affect or can be affected by this medicine:

•    calcium or aluminium hydroxide drugs, such as antacids (medicines used to treat acidity)

•    aminoglycosides, such as gentamycin or erythromycin (a medicine used to treat bacterial infection)

•    nifedepine, diltiazem and verapamil (medicines used to treat diseases of the heart and blood pressure)

•    clonidine (a medicine used to treat high blood pressure)

•    lithium (a medicine used to treat bipolar disorder)

•    sympathomimetic drugs, such as adrenaline (medicines used to treat heart disease, low blood pressure or delay premature labour)

•    ergotamine (a medicine used to treat migraine)

•    amphetamine (a medicine used to treat a disease called ADHD)

•    disopyramide or amiodarone (for an uneven heart beat)

•    adrenaline (a drug that stimulates the heart)

•    baclofen (a medicine used for muscle relaxation)

•    ibuprofen or indometacin (for pain and inflammation)

•    digoxin (for heart problems)

•    insulin or medicines you take by mouth for diabetes.

Speak to your doctor if you are due for a surgery as this medicine interacts with anaesthetic agents (medicines used during surgery).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding you should not take this medicine.

Driving and using machinery

This medicine does not affect your ability to drive.


3. How to take Co-Tenidone tablets


Always take Co-Tenidone tablets as your doctor has told you. Your doctor will decide the right dose for you. This will be on the pharmacist’s label.

This medicine is to be swallowed with water.

Adults

•    one tablet daily.

Elderly

•    one tablet daily.

Children

•    this medicine is not recommended for use in children.

In patients with kidney disease:

•    your doctor may decide to reduce your dose, or how often you take this medicine.

If you take more Co-Tenidone tablets than you should

If you (or anybody else, including a child), takes more of this medicine than you should, contact your nearest hospital casualty department or your doctor immediately. Always take the remaining tablets in the pack and this leaflet with you. Symptoms of overdose includes slower heart rate, abnormally slow pulse rate, low blood pressure, feeling sick, weakness, feeling dizzy and excessive loss of body fluids (excessive diuresis).

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If you forget to take Co-Tenidone tablets

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

Do not stop taking this medicine suddenly without consulting your doctor.

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.

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 (affects less than 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

-    an increase in the amount of uric acid

Your doctor may take blood samples every so often to check on these levels.

Uncommon (affects less than 1 in 100 people)

•    disturbed sleep

Rare (affects less than 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)

•    you may get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)

•    you may bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia)

•    low levels of potassium in the blood (hyponatraemia) which can cause muscle weakness, twitching or abnormal heart rhythm

•    tired and aching muscles

Very rare (affects less than 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 (cannot be estimated from the data available)

•    constipation

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 less than 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

If you experience any side effects not listed in this leaflet or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

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 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 take your medicine after the expiry date on the label; the expiry date refers to the last day of the month.

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 protect the environment.


6. Further 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 03/2015.

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