Teva Carvedilol 12.5mg Tablets
Package Leaflet: Information for the user
CARVEDILOL 3.125, 6.25, 12.5 and 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Carvedilol is and what it is used for
2. What you need to know before you take Carvedilol
3. How to take Carvedilol
4. Possible side effects
5. How to store Carvedilol
6. Contents of the pack and other information
1. What Carvedilol is and what it is used for
Carvedilol belongs to a group of drugs called beta-blockers. Beta-blockers make your blood vessels relax and widen and slows your heart rate, thus causing the heart to beat more calmly and lower blood pressure.
Carvedilol is used to:
• treat angina
• control high blood pressure.
• Carvedilol can also be used in combination with other therapies to treat heart failure.
2. What you need to know before you take Carvedilol
Do not take Carvedilol if you:
• are allergic (hypersensitive) to Carvedilol or any of the other ingredients of this medicine (listed in section 6).
• have a history of asthma or other lung diseases unless you have consulted your doctor or pharmacist first
• have problems with your heart (for example ‘heart block’ or unstable heart failure), as Carvedilol is not suitable for some people with certain types of heart problem
• have an unusually slow heart beat (<50 bpm) or very low blood pressure (systolic blood pressure below 85 mmHg) sometimes causing dizziness, faintness or lightheadness on standing
• are receiving verapamil or diltiazem by injection or as an infusion (with a drip)
• have a problem with the acid levels in your blood (‘metabolic acidosis’).
• have liver problems
Warnings and precautions
Tell your doctor before you start to take this medicine if you:
• have diabetes, as your low blood sugar (hypo) warning signs may be less obvious than usual
• have kidney problems
• have Raynaud’s syndrome or peripheral vascular disease causing cold hands and feet or pins-and-needles
• have thyroid problems
• have previously suffered from serious allergic reactions or you are undergoing desensitisation therapy to prevent allergy e.g. to wasp or bee stings
• have psoriasis (patches of thickened and sore skin)
• wear contact lenses, as Carvedilol may cause dry eyes
• have had problems taking debrisoquine (used to treat high blood pressure)
• have a phaeochromocytoma (a growth on one of your adrenal glands) unless adequately controlled by medication
• have a certain type of chest pain called Prinzmetal’s angina
• severe bradycardia (<50 bpm).
Other medicines and Carvedilol
Please tell your doctor or pharmacist if you are taking ,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 can affect the way some medicines work. Also some other medicines can affect the way Carvedilol works.
Talk to your doctor if you are taking any of the following:
• other medicines for your heart or high blood pressure particularly;
• antiarrhythmics e.g. amiodarone
• calcium channel blockers e.g. amlodipine, diltiazem, verapamil, nifedipine
• digitalis drugs e.g. digoxin
• nitrates e.g. glyceryl trinitrate
• guanethidine, reserpine, methyldopa
• clonidine
• monoamine oxidase inhibitors (used to treat depression) e.g. moclobemide
• barbiturates e.g. amylobarbitone (sleeping drug)
• phenothiazines e.g. prochlorperazine (to help stop vomiting and nausea)
• antidepressants e.g. amitriptyline, fluoxetine (used to treat depression)
• ciclosporin (used following an organ transplant)
• insulin or tablets to treat diabetes
• non-steroidal anti-inflammatory drugs (NSAIDs) e.g. ibuprofen (used for pain, stiffness and inflammation of painful bones, joints and muscles)
• corticosteroids (used to reduce inflammation) e.g. beclometasone
• oestrogen therapies (used as contraception or hormone replacement therapy)
• rifampicin (used to treat tuberculosis)
• cimetidine (used to treat ulcers)
• ketoconazole (used to treat fungal infections)
• haloperidol (used in mental illness)
• erythromycin (an antibiotic used for bacterial infections)
• sympathomimetics (used for the nervous system) e.g. ephedrine, or beta agonist bronchodilators
• ergotamine (used to treat migraine)
• neuromuscular blocking agents (muscle relaxants used in anaesthesia) e.g. atracurium besilate.
• vasodilating agents (these drugs open blood vessels)
• guanfacine (used to treat high blood pressure)
Tell your hospital or dentist you are taking Carvedilol Tablets if you are going to have an operation needing an anaesthetic.
Carvedilol with food and drink
Do not drink alcohol while you are taking Carvedilol.
Pregnancy and Breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding, you should not take this medicine, unless your doctor has told you to.
Driving and using machines
Carvedilol may reduce your alertness and 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 affected do not drive or operate machinery.
Important information about some of the ingredients of Carvedilol:
Patients who are intolerant to lactose should note that Carvedilol Tablets contain a small amount of 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
Always take Carvedilol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• The tablets should be swallowed preferably with a glass of water.
• Your doctor may monitor you at the start of treatment or if your dose is increased. This may involve urine and blood tests.
The usual dose is:
High blood pressure
• Adults: The usual starting dose is 12.5 mg once a day for the first two days after which the recommended dose is 25 mg once a day. If necessary your doctor may gradually increase your dose. The maximum dose taken at one time is 25 mg and the maximum dose taken in one day is 50 mg.
• Older people: The usual starting dose is 12.5 mg once a day. If necessary your doctor may increase your dose.
Angina
• Adults: The usual starting dose is 12.5 mg twice a day for two days after which the recommended dose is 25 mg twice a day. If necessary your doctor may gradually increase your dose. The maximum daily
dose is 50 mg twice a day.
• Older people: The usual starting dose is 12.5 mg twice a day for two days after which the recommended dose is 25 mg twice a day, which is the maximum daily dose.
Heart failure
The tablets should be taken with food to reduce the risk of a fall in blood pressure when standing up, which causes dizziness, light-headedness or fainting.
• Adults: The usual starting dose is 3.125 mg twice a day for 2 weeks. Your doctor may gradually increase your dose to 25 mg twice a day. The maximum dose is 25 mg twice a day for patients with a body weight of less than 85 kg. For patients with a body weight above 85 kg, a maximum dose of 50 mg twice a day can be taken.
Liver or Kidney problems
If you have either liver or kidney problems your doctor may prescribe a lower dose.
Older people
Your doctor may want to monitor you more closely if you are elderly.
Use in Children and adolescents (under 18 years old)
Carvedilol is not recommended for use in children and adolescents under 18 years old.
If you take more Carvedilol than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose can cause low blood pressure (leading to feeling faint, shaky and weak), wheezing, vomiting, fits, very slow heartbeat, heart failure/attack, breathing problems and loss of consciousness.
If you forget to take Carvedilol
If you forget to take a dose, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.
If you stop taking Carvedilol
Do not suddenly stop taking your tablets as side effects may occur. If treatment is to be stopped your doctor will gradually reduce your dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are less likely if you are being treated for angina or hypertension than if you are being treated for heart failure.
Possible side effects in patients being treated for heart failure:
Very common (may affect more than 1 in 10 people):
• Dizziness
• Headache
• Problems with your heart
• Feeling weak or tired
• Low blood pressure (feeling dizzy or light-headed)
• slow heartbeat, dizziness or faintness on standing up (due to lowered blood pressure)
Common (may affect up to 1 in 10 people):
• infection of the airway (bronchitis), lungs (pneumonia), nose and throat
• urinary infections
• anaemia
• weigt gain
• increase in the cholesterol (fat) content of the blood
• Loss of control of blood sugar in people with diabetes
• Feeling depressed
• Problems with vision, sore or dry eyes, eye irritation
• slow heartbeat
• swelling of hands, ankles or feet
• problems with circulation, fluid retention
• faintness or dizziness on standing up (due to lowered blood pressure)
• worsening of cold extremities in patients who have Raynaud’s disease or circulation problems.
• Problems with breathing
• Feeling sick, upset stomach, vomiting
• Diarrhoea
• Pain in your hands, feet
• Problems with your kidney, including changes in passing urine
Uncommon ((may affect up to 1 in 100 people)
• problems with sleeping
• feeling faint, fainting
• tingling or numbness
• problems with heart, chest pain
• problems with your skin (skin rashes, itchiness, dry skin patches)
• loss of hair
• impotence (difficulty getting or maintaining an erection).
Rare (may affect up to 1 in 1,000 people):
• decreased number of platelets in your blood (causing unusual bleeding or unexplained bruising)
• stuffy nose
Very rare (may affect up to 1 in 10,000 people):
• low number of white blood cells in your blood
• allergic reactions
• changes in liver function (detected by tests)
• problems keeping urine (incontinence in women)
• blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome: rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals), or severe blistering and peeling of large areas of the skin (toxic epidermal necrolysis: severe skin reaction which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell , or erythema multiforme: severe condition of the skin that may affect the mouth and other parts of the body. It is seen as red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body. The spots may blister or may progress to form raised, red, pale-centred marks. Those affected may have fever, sore throat, headache and/or diarrhea
Changes in blood sugar levels and a worsening of blood sugar control in patients with diabetes can occur.
You should report to your doctor if your symptoms or condition worsen, as the dose of your other medications or Carvedilol may need to be changed.
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 Carvedilol
Keep this medicine out of sight and reach of children.
Do not store above 25 oC.
Do not use Carvedilol after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. An abbreviation for expiry date (e.g. Exp) may be present on the carton and blister.
Do not throw away any medicines via wastewater or household waster. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Carvedilol Tablets contain:
• The active ingredient is Carvedilol.
• Each 3.125mg tablet contains 3.125mg of the active ingredient Carvedilol.
• Each 6.25mg tablet contains 6.25mg of the active ingredient Carvedilol.
• Each 12.5mg tablet contains 12.5mg of the active ingredient Carvedilol.
• Each 25mg tablet contains 25mg of the active ingredient Carvedilol.
• The other ingredients are lactose monohydrate, povidone, crospovidone, colloidal silica anhydrous and magnesium stearate. The tablets contain the following colourings:
• 3.125 mg tablets: yellow and red iron oxide (E172)
• 6.25 mg tablets: yellow iron oxide (E172)
• 12.5 mg tablets: red iron oxide (E172).
What Carvedilol Tablets look like and contents of the pack:
Carvedilol tablets are round, flat tablets, scored on one side and debossed on the other side with “CVL” at the top. Additionally:
• The 3.125 mg tablets are light peach, and have “Tl” at the bottom
• The 6.25 mg tablets are light yellow to yellow and have “T2” at the bottom
• The 12.5 mg tablets are mottled light brick red, and have “T3” at the bottom
• The 25 mg tablets are white to off-white, and have “T4” at the bottom.
• The 3.125 mg tablets are available in pack sizes1 of 28, 30, 50 and 100 tablets
• The 6.25 mg, 12.5 mg and 25 mg tablets are available in pack sizes1 of 14, 28, 30, 50, 56 and 100 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom.
Company responsible for manufacture:
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom OR2
Teva UK Ltd, 18 Bruntcliffe Way, Morely, Leeds, West Yorkshire LS27 0JG, United Kingdom OR2
Pharmachemie B.V. Swensweg 5, PO Box 552, 2003 RN, Haarlem, Netherlands OR2
Teva Pharmaceutical Works Ltd, 13 Pallagi St, H-4042 Debrecen, Hungary.
OR2
Teva Operations Poland Sp. z o.o.,Mogilska 80 Str. 31-546 Krakow This leaflet was last revised: January 2014
Not all pack sizes may be marketed.
Only the paragraph containing the details of the current batch release site will be included in the printed version of the PIL