CARVEDILOL 6.25MG TABLETS

Active substance: CARVEDILOL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Carvedilol 3.125 mg, 6.25 mg, 12.5 mg & 25 mg Tablets
(Carvedilol)

4. POSSIBLE SIDE EFFECTS
Like all medicines, Carvedilol can cause side effects, although not everybody gets them. The possible side effects and how likely you
are to get them, will depend on the reason you are being treated with Carvedilol.
Possible side effects when used to treat chronic heart failure

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 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 Carvedilol is and what it is used for
2. Before you take Carvedilol
3. How to take Carvedilol
4. Possible side effects
5. How to store Carvedilol
6. Further information
1. WHAT CARVEDILOL IS AND WHAT IT IS USED FOR
The name of your drug is Carvedilol 3.125 mg or 6.25 mg or 12.5 mg or 25 mg Tablets. Carvedilol Tablets contain the active
ingredient Carvedilol. Carvedilol is one of a group of medicines which act as a beta blocker and it dilates blood vessels
(vasodilator).
Carvedilol is used for the treatment of angina and mild, moderate or severe heart failure. Carvedilol is also used to treat high blood
pressure. Tablets of higher strengths are required when Carvedilol is used to treat high blood pressure or angina.
2. BEFORE YOU TAKE CARVEDILOL
Do not take Carvedilol if
- you are allergic (hypersensitive) to carvedilol or any of the other ingredients of Carvedilol (listed in Section 6)
- you have a history of wheezing due to asthmatic or other lung diseases.
- you have severe fluid retention (swelling of your hands, ankles and feet) which is being treated by medicines given into
one of your veins intravenously.
- you have problems with your liver.
- you have problems with your heart (for example ‘heart block’ or slow heart beat).
- you have very low blood pressure.
- you have a problem with the acid levels in your blood (‘metabolic acidosis’).
- you have agrowth on one of your adrenal glands (‘phaeochromocytoma’)
Do not take Carvedilol if any of the above applies to you. If you are not sure consult your doctor or pharmacist first.
Take special care with Carvedilol if
- you have problems with your kidneys.
- you have diabetes (high blood sugar).
- you wear contact lenses.
- you have ever had problems with your thyroid
- you have ever had a serious allergic reaction (for example, sudden swelling, causing difficulty breathing or swallowing,
swelling of the hands, feet and ankles or a severe rash).
- you have an allergy and are having treatment to desensitise you.
- you have problems with blood circulation in your fingers and toes (‘Raynaud’s phenomenon’).
- you have had a skin disorder called ‘psoriasis’, after taking beta-blocker medicines.
- you have a type of angina called ‘Prinzmetal’s variant angina’.
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Carvedilol.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines. This includes medicines that you buy without
a prescription and herbal medicines. This is because Carvedilol can affect the way some medicines work. Also some other
medicines can affect the way Carvedilol works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Other medicines for your heart or blood pressure, including diuretics (water tablets), calcium channel blockers (e.g.
diltiazem or verapamil), and digoxin
- Monoamine oxidase inhibitors (MAOIs) such as isocarboxide and phenelzine (used to treat depression)
- Medicines for diabetes, such as insulin or metformin.
- Clonidine (used to treat high blood pressure, migraine, flushing in the menopause).
- Rifampicin (used to treat infections)
- Cimetidine (used to treat indigestion, heartburn and stomach ulcers).
- Cyclosporin (used after an organ transplant).
Operations
If you are going to have an operation, tell the doctor that you are taking Carvedilol. This is because some anaesthetics can lower
your blood pressure, and it may become too low.
Pregnancy and breast-feeding
Do not take Carvedilol if you are pregnant, trying to get pregnant or breast-feeding, unless your doctor has told you to.
Driving and using machines
You may feel dizzy while taking Carvedilol. This is more likely when you start treatment or if your treatment is changed, and when
you drink alcohol. If this happens to you, do not drive or use any tools or machines.
Talk to your doctor if you notice any other problems that might affect driving, using tools or machines while you are taking
Carvedilol.
Important information about some of the ingredients of Carvedilol
This medicinal product contains lactose. If you have been told by your doctor that you have intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE CARVEDILOL
It is important to take your medicine as your doctor has told you to. The pharmacist’s label will tell you how many tablets to take.
Carvedilol is not suitable for children under the age of 18 year.
Swallow each tablet with a drink.
Chronic heart failure:
When used for heart failure, treatment with Carvedilol should be started by a specialist doctor.
- You should take your tablets at the same time as eating some food.
- The usual starting dose is one 3.125 mg tablet twice a day for two weeks.
- Your doctor will then increase the dose slowly, over several weeks, up to 25 mg twice a day.
- If you weigh more than 85 kg (187 lb) the dose may be increased up to 50 mg twice a day.
- If you have stopped taking Carvedilol for more than two weeks you should talk to your doctor. They will need you to go
back to the starting dose again (see section ‘If you stop taking Carvedilol’).
High blood pressure:
- The usual starting dose is 12.5 mg once a day for two days.
- After two days the dose is usually 25 mg, once a day.
- If your blood pressure is not under control, your doctor may increase your dose slowly, over several weeks up to 50 mg a day.
- If you are elderly, you may not need any more than 12.5 mg a day to control your blood pressure.
Angina:
Adults
- The usual starting dose is 12.5 mg twice a day for two days.
- After two days the dose is usually 25 mg, twice a day.
Elderly
- Your doctor will decide both your starting dose and the best dose for you to take in the longer term.
- The usual maximum dose is 50 mg each day, taken in smaller amounts (divided doses).
If you take more Carvedilol than you should
- If you take too many tablets (overdose) or someone else takes your Carvedilol tablets, you may feel dizzy, light headed,
breathless, wheezy or extremely tired.
- Contact your nearest hospital casualty department or tell your doctor immediately. Take the medicine pack with you.
If you forget to take your medicine
- If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the
missed dose.
- Do not take a double dose to make up for a forgotten dose.If you are worried, ask your doctor or pharmacist for advice.
If you stop taking Carvedilol
Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you. They may want you to stop taking
Carvedilol slowly over 1 to 2 weeks.

PHARMACODE
AREA

Carvedilol
Tablets

PHARMACODE
AREA

Carvedilol
Tablets

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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Very common (affect more than 1 in 10 people):
- Feeling dizzy.
- Headache (this is usually mild and happens at the start of your treatment).
- Feeling weak and tired.
Common (affect less than 1 in 10 people):
- Increase in weight.
- Increase in cholesterol levels (shown by a blood test).
- Loss of control of blood sugar in people with diabetes.
- A slow heart beat.
- Low blood pressure. The signs include feeling dizzy or light-headed, in particular after you stand 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.
- Feeling sick or being sick.
- Diarrhoea.
- Problems with your sight.
Uncommon (affect less than 1 in 100 people)
- Fainting.
- Problems with your heart when increasing the dose of Carvedilol.
Rare (affect less than 1 in 1,000 people):
- Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
- Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat and lungs.
- Kidney problems. The signs include feeling tired, bruising easily and passing water (urinating) less often.
Other side effects that can happen when you take Carvedilol for chronic heart failure include:
- Increased sweating and a skin rash.
- Some women may have difficulty with bladder control when they pass water (urinary incontinence).This normally will get
better when treatment is stopped.
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
Possible side effects when used to treat high blood pressure or angina
Common (affect less than 1 in 10 people):
- Feeling dizzy, tired and having a headache (usually these effects are mild and happen at the start of your treatment).
- A slow heart beat and feeling dizzy or light-headed after standing up. (These effects are more common at the start of your
treatment).
- Breathing problems. The signs include wheezing, shortness of breath and chest tightness.
- Stomach upset. The signs include feeling sick, stomach ache and diarrhoea.
- Pain in your hands and feet.
- A feeling of dryness in your eye because fewer tears are made.
Uncommon (affect less than 1 in 100 people)
- Feeling depressed.
- Disturbed sleep.
- Tingling or numbness of your hands or feet.
- Feeling weak and tired.
- Fainting.
- Low blood pressure. The signs include feeling dizzy or light-headed.
- Problems with blood circulation in your arms and legs. The signs include cold hands and feet, whiteness, tingling and pain
in your fingers and a pain in your leg which gets worse when you walk.
- Problems with your heart. The signs include chest pains, tiredness, shortness of breath and swelling of your arms and legs.
- Constipation.
- Being sick.
- Increased sweating.
- 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.
- Problems with your sight.
- Being unable to get an erection (erectile dysfunction).
Rare (affect less than 1 in 1,000 people):
- Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
- Low numbers of all types of white blood cells. The signs include infections of the mouth, gums, throat
- Changes in your blood shown up by a blood test.
- A stuffy nose, wheezing and flu-like symptoms.
- A dry mouth.
- Sore eyes.
- Changes to how often you pass urine.
- Allergic 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.
Other possible side effects that can happen when you take Carvedilol for high blood pressure and angina include:
- Difficulty controlling your blood sugar if you have diabetes.
- Developing the signs of diabetes in people who have a very mild form of diabetes called ‘latent diabetes’.
- Some women may have difficulty with bladder control when they pass water (urinary incontinence). This normally will get
better when treatment is stopped
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE CARVEDILOL
- Keep out of the reach and sight of children.
- Do not use Carvedilol after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day
of that month.
- Store in the original package in order to protect from moisture.
- Carvedilol tablets do not require any special storage conditions.
- Do not throw away any leftover tablets. Instead, return any leftover tablets to the pharmacist so that they can dispose of
them properly. Only keep them if your doctor tells you to.
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 Carvedilol contains
- The active substance is Carvedilol
- The other ingredients are Lactose monohydrate, Microcrystalline cellulose (Avicel PH 102), Low-Substituted hydroxypropyl
cellulose (E463), Maize starch, Yellow iron oxide (E172), Colloidal anhydrous silica, Purified talc, Magnesium stearate
(E572)
This leaflet does not contain the complete information on Carvedilol. If you have any questions, or are not sure about anything, ask
your doctor or pharmacist.
Remember: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even
if their symptoms are the same as yours.
What Carvedilol looks like and contents of the pack
Carvedilol 3.125 mg tablets are cream coloured, circular, biconvex tablets, marked ‘C3’ on one face and plain onthe reverse face.
Carvedilol 6.25 mg tabletsare cream coloured, circular, biconvex tablets, marked ‘C6’ on one face and plain on the reverse face.
Carvedilol 12.5 mg tablets are cream coloured, circular, biconvex tablets, marked ‘C12’ on one face and plain on the reverse face.
Carvedilol 25 mg tablets are cream coloured, circular, biconvex tablets, marked ‘C25’ on one face and plain on the reverse face.
Carvedilol 3.125 mg and 6.25 mg tablets are available in packs of 28 and 56 tablets.
Carvedilol 12.5 mg and 25 mg tablets are available in packs of 14, 28, 30, 56 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, CP House, 97 – 107 Uxbridge Road, Ealing, London W5 5TL.
Marketed and Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Ltd., 9th floor, CP House, 97 – 107 Uxbridge Road, Ealing, London W5 5TL.
This leaflet was last revised in August 2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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