Carvedilol 6.25mg Tablets
PATIENT INFORMATION LEAFLET: Information for the user
CARVEDILOL 3.125 mg, 6.25 mg, 12.5 mg & 25 mg TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others; it may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
In this leaflet:
1. What Carvedilol Tablets are and what they are used for
2. What you need to know before you take Carvedilol Tablets
3. How to take Carvedilol Tablets
4. Possible side effects
5. How to store Carvedilol Tablets
6. Contents of the pack and further information
1. WHAT CARVEDILOL TABLETS ARE AND WHAT THEY ARE USED FOR
Carvedilol is a type of medicine called a beta blocker and vasodilator.
Carvedilol Tablets are used for the treatment of angina (pains in the chest caused by blockages in the arteries leading to the heart) and mild to moderate heart failure (when the heart cannot pump blood properly to the rest of the body). Carvedilol is also used to treat hypertension (high blood pressure).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARVEDILOL TABLETS
Do not take Carvedilol Tablets if you:
• are allergic (hypersensitive) to carvedilol, other beta blockers or any of the other ingredients in the tablets (these are listed in Section 6, Further Information)
• have a history of wheezing due to asthma or other lung diseases
• have severe fluid retention (swelling of your hands, ankles and feet) which is being treated by medicines given into your veins (intravenously)
• have very severe heart failure and are breathless even when sitting
• have liver disease
• suffer from a condition called phaeochromocytoma (high blood pressure due to a tumour near the kidney) unless this is already being controlled by a medicine known as an alpha blocker
• have a conduction defect of the heart
• have or have been told you have a very slow heart beat (less than 55 beats per minute)
• have very low blood pressure
• have severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)
• have problems with the acid levels in your blood (metabolic acidosis)
Take special care with Carvedilol Tablets:
Warnings and Precautions
Talk to your doctor or pharmacist before taking Carvedilol Tablets if you:
• have a condition called Prinzmetal’s angina
• suffer from any other heart problems
• have any problems with your kidneys
• suffer from any lung diseases
• have a thyroid problem
• have diabetes and are taking insulin or anti-diabetic tablets. You may need to monitor your glucose (sugar) levels more closely when you take Carvedilol Tablets.
• have psoriasis (a skin condition)
• suffer from Reynaud’s disease (very poor circulation in the hands and feet) or another form of peripheral vascular disease
• suffer from serious allergic reactions (abnormal sensitivity to insect bites or stings, severe eczema, hayfever)
• have an allergy and are having treatment to desensitise you
• wear contact lenses. Carvedilol can make your eyes become drier Carvedilol Tablets can affect the results of some blood, urine or other tests. If you have a blood or urine test done, tell the doctor or medical staff that you are taking Carvedilol Tablets
Taking other medicines
Tell your doctor or pharmacist if you are taking ©r ,have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Carvedilol Tablets can affect the way some medicines work. Also some medicines can affect the way carvedilol works.
In particular you should tell your doctor if you are taking or have taken any of the following:
• other medicines for treating high blood pressure or angina including diuretics (water tablets) calcium channel blockers (diltiazem, amodipine or verapamil), digoxin and amiodarone
• catecholamine-depleting agents (for example reserpine) and Monoamine oxidase inhibitors (MAOIs, such as isocarboxide and phenelzine (used to treat depression))
• fluoxetine (used to treat depression)
• medicines for diabetes, such as insulin or metformin
• cimetidine (an ulcer medicine)
• rifampicin (an antibiotic for tuberculosis)
• clonidine (for migraine, menopausal flushing, hypertension or Tourette syndrome)
• ciclosporin (used following an organ transplant)
• non-steroidal anti-inflammatory drugs (NSAIDs, for example aspirin, indomethacin and ibuprofen)
• beta-agonist bronchodilators (used to treat chest tightness and wheezing due to asthma or other chest conditions (for example salbutamol and terbutaline sulphate))
• anaesthetics may cause an abnormal drop in blood pressure. Therefore you must tell medical or dental staff that you are taking Carvedilol Tablets at least 24 hours before undergoing any forms of surgery.
It may still be alright for you to take Carvedilol Tablets and your doctor will be able to decide what is suitable for you.
Carvedilol Tablets with food and drink
It is recommended that Carvedilol Tablets should be taken with fluid. Drinking alcohol during treatment with Carvedilol Tablets may make you feel excessively drowsy. If you are affected you should avoid drinking alcohol.
Pregnancy,breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be-pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking his medicine.
If you are taking Carvedilol Tablets, it may appear in your breast milk. Therefore, you should not breast-feed while taking Carvedilol Tablets.
Driving and using machines
Carvedilol Tablets may make you feel sleepy, dizzy or light-headed, particularly at the beginning of treatment or if you change your treatment. Do not drive or operate machinery until you are sure that you are not affected.
What Carvedilol Tablets contain
This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE CARVEDILOL TABLETS
Method of Administration
Carvedilol Tablets should be swallowed whole with a drink of water. Do not crush, chew or suck them.
Dosage
Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Do not change your dose unless your doctor tells you to do so.
Always take Carvedilol Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. The recommended dose is on the label on the carton which will tell you how many tablets you should take and when.
The usual doses for carvedilol are as follows:
Heart Failure
If you have been given Carvedilol Tablets for the treatment of heart failure it is likely that a hospital specialist will have started your treatment.
The usual starting dose is 3.125 mg tablets twice a day (every 12 hours). You should try to take the tablets with food. However you should still take your tablets even if you do not have much appetite. Your doctor may gradually increase the strength of your tablets until you find a dose that suits you best.
Carvedilol may worsen your symptoms of heart failure. Please tell your doctor if you notice any such change. While taking Carvedilol Tablets, make sure that you continue with any other treatments you may already be taking for heart failure as advised by your doctor.
High Blood Pressure
The usual starting dose is 12.5 mg once a day. Your doctor will gradually increase the strength of tablets you take until you receive the dose that suits you best. The normal dosage is one 25 mg tablet once a day.
Angina
The usual starting dose is 12.5 mg twice a day for the first two days of your treatment. From then on the usual dose is one 25 mg tablet twice a day.
Use in children and adolescents
Carvedilol Tablets are not suitable for children and adolescents under 18 years of age.
Do not take more Carvedilol Tablets then you should:
If you have accidentally taken more than your prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The most common signs and symptoms of overdose are a fall in blood pressure (causing dizziness and lightheadedness) accompanied by a drop in heart rate, feeling breathless, wheezy or extremely tired.
If you forget to take Carvedilol Tablets
It is important that you take your medicine every day. However, if you forget to take one or more doses, take another as soon as you remember and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.
If you stop taking Carvedilol Tablets
Do not suddenly stop taking your Carvedilol Tablets before you have spoken to your doctor about it. You may have side effects if you suddenly stop the tablets. Your doctor will tell you how to reduce and then stop this medicine.
If you are also taking clonidine, do not stop taking it unless you are told to do so by 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 Carvedilol Tablets can cause side effects although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. If you get any of the following symptoms after taking these tablets, you should stop taking the tablets and contact your doctor immediately:
• swelling of the face, lips or throat
• difficulty in swallowing or breathing
• an itchy skin rash or hives
These symptoms could be due to a serious allergic reaction to Carvedilol Tablets although this is rare.
The most common side effects, reported by more than one in 10 people receiving Carvedilol Tablets are:
• Dizziness
• Headache
• Feeling weak and tired
• Problems with your heart. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs
• Low blood pressure. The signs include feeling dizzy or light headed
Feeling dizzy, having a headache and feeling weak and tired are usually mild and more likely to happen at the beginning of your treatment.
The following side effects are common and have been reported by less than one in 10 people:
• Infections of the airway (bronchitis), lung (pneumonia), nose and throat (upper respiratory tract). The signs include wheezing, shortness of breath, chest tightness and sore throat
• Infections in the urinary tract which can cause problems passing water
• Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, a fluttering sensation in your heart (palpitations) and shortness of breath
• Increase in weight
• Increase in cholesterol levels (shown by a blood test)
• Loss of control of blood sugar levels in people with diabetes
• Feeling depressed
• Problems with your sight, sore or dry eyes due to fewer tears being made
• A slow heart beat
• Feeling dizzy or light headed when standing up
• Fluid retention. The signs include overall swelling of your body, swelling of parts of your body for example your hands, feet, ankles and legs and an increase in how much blood you have in your body.
• Problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain in your fingers, pain in your leg which gets worse on walking.
• Breathing problems
• Feeling sick or being sick
• Diarrhoea
• Stomach upset/indigestion
• Pain, possibly in the hands and feet
• Problems with your kidneys including changes to how often you pass urine
The following side effects are uncommon and have been reported by less than one in 100 people:
• Disturbed sleep
• Feeling lightheaded
• Fainting
• Tingling or numbness in your hands and feet
• Problems with your skin including skin rashes which may cover a lot of your body, a lumpy rash (hives), feeling itchy and dry skin patches
• Flair loss
• Being unable to get an erection (erectile dysfunction)
• Heart problems such as angina
The following side effects are rare and have been reported by less than one in 1,000 people:
• Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds
• A stuffy nose
The following side effects are very rare and have been reported by less than one in 10,000 people:
• Low numbers of all types of white blood cells. The signs include infection of the mouth, gums, throat and lungs
• Allergic (hypersensitivity) reactions. The signs may include difficulty breathing or swallowing caused by sudden swelling of the throat or face or swelling of your hands, feet and ankles
• Severe skin reactions possibly accompanied by fever, sore throat and fatigue.
• Liver problems which show up in a blood test
• Some women have difficulty with bladder control when they pass water (urinary incontinence). This normally will get better when treatment is stopped.
• Carvedilol Tablets can also cause development of the signs of diabetes in people who have a very mild form of diabetes called ‘latent diabetes’.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
5. HOW TO STORE CARVEDILOL TABLETS
Store in the original package. Do not take this medicine after the expiry date which is stated on the carton.
The expiry date is the last day of that month.
Keep all medicines out of the reach and sight of children.
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. CONTENTS OF THE PACK AND FURTHER INFORMATION
What Carvedilol Tablets contain:
The active substance is carvedilol. Each tablet contains either: 3.125, 6.25, 12.5 or 25 mg of carvedilol. The other ingredients are lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, maize starch, yellow iron oxide (E172), colloidal anhydrous silica, talc and magnesium stearate.
What Carvedilol Tablets look like and the contents of the pack:
Carvedilol 3.125 mg Tablets are cream coloured and round marked with ‘NEO’ on one face and C3 on the reverse face
Carvedilol 6.25 mg Tablets are cream coloured and round marked with ‘NEO’ on one face and C6 on the reverse face
Carvedilol 12.5 mg Tablets are cream coloured and round marked with ‘NEO’ on one face and C12 on the reverse face
Carvedilol 25 mg Tablets are cream coloured and round marked with ‘NEO’ on one face and C25 on the reverse face
Your medicine is available in packs of 28 tablets.
Marketing Authorisation Holder: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough,
Northamptonshire, NN8 6GT, UK
Manufacturer responsible for batch release: Fannin (UK) Limited 57 High Street, Odiham, Hampshire, RG29 1LF.
This leaflet was prepared in December 2013