Co-Tenidone 50/12.5 Mg Tablets
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Patient Information Leaflet
CO-TENIDONE 50/12.5MG TABLETS CO-TENIDONE 100/25 MG TABLETS (Atenolol & Chlortalidone)
This medicine will be called Co-tenidone Tablets
_in this leaflet._
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.
• If you have any further questions, please ask your doctor or pharmacist.
• If any of the side effects gets 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
These tablets are available in two different strengths and your doctor will have decided which is the most suitable for you. Co-tenidone 50/12.5 mg Tablets contain 50 mg of atenolol and 12.5 mg of chlortalidone as the active ingredients. Co-tenidone 100/25 mg Tablets contain 100 mg of atenolol and 25 mg of chlortalidone as the active ingredients.
Atenolol belongs to a group of medicines known as beta blockers which work on receptors in the heart to lower blood pressure, and chlortalidone belongs to a group of medicines known as diuretics which work by increasing the amount of urine passed (a diuretic action), also helping to lower blood pressure.
Co-tenidone Tablets are used to treat hypertension (high blood pressure).
Some people must not take these tablets.
Do not take these tablets if you:
• Know you are allergic to atenolol, chlortalidone or to any of the other ingredients (these are listed in section 6). (An allergic reaction may be recognised as shortness of breath, blocked nose, rash, itching, swollen face or lips)
• Have heart problems such as bradycardia or sick sinus syndrome (causing slow or abnormal heart rhythms), second or third degree heart block, uncontrolled heart failure or cardiogenic shock
• Suffer from low blood pressure or you have very poor circulation
• Have phaeochromocytoma (tumour of the adrenal gland) unless you are being treated with another medicine for this, or you have metabolic acidosis (too much acid in the body)
• Suffer from hypercalcaemia (an unusually high level of calcium in the blood), hypokalaemia (low level of potassium
in the blood), hyponatraemia (low level of sodium in the blood) or hyperuricaemia (high levels of uric acid in the blood)
• Are pregnant or breastfeeding
• Have Addison’s disease (a condition in which the adrenal gland does not work properly causing weakness, tiredness, weight loss and low blood pressure)
You must be especially careful if you:
• Have ever had asthma or wheezing unless you have discussed these symptoms with the prescribing doctor.
• Have heart failure which is being controlled, first degree heart block or you suffer from heart disease
• Suffer from portal hypertension (high blood pressure in the large vein to the liver)
• Have myasthenia gravis (a disease causing muscle weakness)
• Suffer from diabetes
• Suffer from hyperthyroidism (an overactive thyroid gland)
• Suffer from Prinzmetal’s angina
• Are prone to allergic reactions
• Have impaired liver or kidney function
• Suffer from poor circulation.
If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.
Taking other medicines
Co-tenidone Tablets and other medicines you may be taking may affect how each other work. Make sure your doctor knows if you are taking any of the following:
• Other medicines being used to treat high blood pressure or angina such as verapamil, diltiazem or nifedipine
• Medicines used for heart problems such as digoxin, disopyramide or amiodarone
• Adrenaline (heart stimulant)
• Baclofen (a muscle relaxant)
• Insulin and oral medicines used in the treatment of diabetes
• Medicines used for pain relief such as ibuprofen or indometacin
• Medicines containing lithium (for treating depression)
• Clonidine (used in high blood pressure or migraine). Do not stop taking clonidine unless instructed by your doctor. If you need to stop taking it your doctor will give you careful instructions on how to do this.
• Medicines to treat nose or sinus congestion or other cold remedies (including those you can buy in the pharmacy).
• Betaxolol, carteolol, levobunolol and timolol (eye drops for glaucoma).
Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as those you have on prescription from your doctor.
Other special warnings
If you are having an operation requiring an anaesthetic, you must ensure the doctor in charge is aware you are taking Co-tenidone Tablets.
Your doctor may take blood samples whilst you are taking this medicine, particularly if you are elderly, on a low potassium diet, being treated for cardiac failure, or you have a stomach problem.
Driving and using machinery
Co-tenidone Tablets may occasionally make some patients feel dizzy or tired. Do not drive or operate machinery if they have this effect on you. If you feel dizzy or tired when taking this medicine, ask your doctor for advice.
Pregnancy and breast-feeding
Do not take Co-Tenidone if you are pregnant or trying to get pregnant. Do not take Co-Tenidone if you are breast-feeding.
The tablets should be swallowed with a drink of water.
Your doctor will decide what dose you need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist’s label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.
The usual dose is as follows:
Adults: Take one tablet daily.
Children: Your medicine must not be given to children.
People with kidney problems
If you have problems with your kidneys, your doctor may give you a lower dose or ask you to take this medicine less often.
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If you take more tablets than you should
You should contact your doctor or go to your nearest hospital casualty department immediately. Take your tablets or the pack with you so that the doctor knows what you have taken.
If you forget to take a dose of Co-tenidone Tablets
If you miss a dose, take the missed dose as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for the forgotten dose; just carry on with the normal routine.
If you stop taking Co-Tenidone
Do not stop taking Co-Tenidone without talking to your doctor. In some cases, you may need to stop taking it gradually.
Co-tenidone Tablets are suitable for most people, but, like all
medicines they can sometimes cause side effects.
Some side effects can be serious.
Stop taking the tablets and tell your doctor straightaway if
you notice any of the following effects:
• Raised lumps on your skin (weals) or swelling of your face, lips, mouth, tongue or throat.
• Shortness of breath, wheezing or breathing difficulties (may be more likely to occur in patients who have asthma or a history of an asthmatic condition)
• Skin rash, hives, itching or other serious skin reactions.
These may be signs of a severe allergic reaction.
Tell your doctor straight away if you notice any of the
following effects:
• Cough, coughing up blood, high temperature, excessive sweating, anxiety, pale skin, problems in urinating, lower back pain, swelling (particularly of the ankles), high blood pressure, increased skin sensitivity to sunlight. (These may be signs of conditions caused by an allergic reaction)
• Slow or irregular heartbeat, dizziness or fainting upon standing up (caused by very low blood pressure), increased shortness of breath or ankle swelling. (These may be symptoms of heart or circulatory problems and worsening of heart failure)
• Severe pain in the abdomen and back (indicating inflammation of the pancreas)
• Fever, tiredness and sometimes abnormal bleeding. (These may be symptoms of a blood disorder which may make infections more likely)
• Muscle weakness or spasms, twitching, abnormal heart rhythm, confusion, fits, coma, loss of appetite, feeling or being sick, constipation and abdominal pain.
The following side effects have also been reported:
Less than 1 in 10 people have experienced:
• Nausea and stomach/gastro-intestinal disturbances
• Weariness or tiredness
• Unusually high levels of uric acid in the blood
• Impaired glucose tolerance
• 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.
• 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.
Less than 1 in 100 people have experienced:
• Sleep disturbances; increased transaminase levels.
Less than 1 in 1000 people have experienced:
• Pancreatitis (inflammation of a large gland behind the stomach).
• A reduced number of white blood cells
• Mood changes, changes in personality, hallucinations, nightmares, confusion
• Dizziness, headache, tingling or numbness in the skin (like pins and needles)
• Problems with vision, dry eyes; dry mouth
• Hair loss, skin rash or a skin disorder resembling psoriasis (red scaly patches on the skin) or worsening of psoriasis
• Impotence (inability to achieve or maintain an erection)
• Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud’s disease).
• Jaundice (causing yellowing of your skin or the whites of your eyes).
• Bruising more easily or purplish marks on your skin.
• Pain and/or tightening of the muscles in the calf, thigh or buttock during walking or exercise.
Less than 1 in 10,000 people have experienced:
• Increased levels of a type of antibody (known as ANAs) in the blood.
• Changes to some of the cells or other parts of your blood.
Other side effects reported include:
• Feeling of dizziness or spinning;
• Changes in blood lipid (fat) levels, raised levels of glucose in the blood
• Gout (symptoms include painful and swollen joints).
Not known (cannot be estimated from 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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.
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect the tablets from light and moisture.
Do not use your medicine after the expiry date shown on the carton.
If your doctor tells you to stop taking the tablets, please take any unused medicine back to your pharmacist to be destroyed.
Ingredients
Co-tenidone 50/12.5 mg Tablets contain 50 mg of atenolol and 12.5 mg of chlortalidone as the active ingredients.
Co-tenidone 100/25 mg Tablets contain 100 mg of atenolol and 25 mg of chlortalidone as the active ingredients.
The tablets also contain magnesium carbonate (heavy), maize starch, sodium laurilsulfate, gelatin, magnesium stearate, hypromellose, titanium dioxide (E171), ethylcellulose and diethyl phthalate.
What the medicine looks like
The 50/12.5 mg tablets are round, white, film-coated tablets and the 100/25mg tablets are round, white, film-coated tablets with a break-line.
They are supplied to your pharmacist in packs containing 28, 56, 84, 112, 140, 168, 196, 224, 252 or 280 tablets.
Not all pack sizes may be available.
MA Holder:
Special Concept Development (UK) Ltd,
Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR
Manufacturer: KLEVA S.A. Parnithos Ave. 189, Acharnai Attiki, 13675, Greece
Product licence numbers: PL 36722/0005 & PL 36722/0006 Date of revision: January 2015.
If you would like this leaflet in a different format, please contact the licence holder at the above address.
210mm