<br><b><font color = "blue">The tablets contain 23.75mg, 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 50, 100 and 200 mg of metoprolol tartrate, USP,tablets are scored and can be cut in half</b></font><br>
Toprol XL/Betaloc CR tablets are used for:
. lowering high blood pressure, also called hypertension, and to reduce the risk of complications due to high blood pressure such as stroke, heart attack or early death.
. preventing angina (heart or chest pain brought on by stress or exercise in patients with coronary heart disease).
. treating or preventing heart attacks, or to reduce your risk of heart complications following a heart attack.
. treating heart failure (symptomatic mild to severe chronic heart failure in addition to other heart failure medicine), to help increase survival, reduce hospitalisation, improve symptoms, and Quality of Life.
. treating disturbances of heart rate in patients with heart disease, especially rapid heart beat.
. treating symptoms of rapid or irregular heart beat in patients without heart disease.
. prevention of migraine headaches.
. overactive thyroid (hyperthyroidism).
Toprol XL/Betaloc CR may be used either alone or in combination with other medicines to treat your condition.
Toprol XL/Betaloc CR belongs to a group of medicines called beta-blockers. It works by affecting the body's response to some nerve impulses, especially in the heart. As a result, it decreases the heart's need for blood and oxygen and therefore reduces the amount of work the heart has to do. It also widens the blood vessels in the body, as well as helping the heart to beat more regularly.
Toprol XL/Betaloc CR is a controlled release tablet that releases its drug content in a time controlled manner. Controlled release tablets ensure a more even effect over 24 hours.
When you must not use it
Do not take Toprol XL/Betaloc CR tablets if you are pregnant or intend to become pregnant or if you are breast-feeding unless your doctor says to do so.
As with all medicines used to lower blood-pressure, metoprolol may cause unwanted effects, e.g. slow heart rate, in the foetus and in the new-born baby. You should tell your doctor as soon as possible if you become pregnant while using Toprol XL/Betaloc CR. The effect of using Toprol XL/Betaloc CR on the baby, if you are breast-feeding is negligible if the mother is taking doses within the normal range of the recommended treatment.
Do not use Toprol XL/Betaloc CR if the expiry date (EXP) printed on the pack has passed. It may have no effect at all, or worse, an entirely unexpected effect if it is used after the expiry date.
Do not use Toprol XL/Betaloc CR if the packaging is torn or shows signs of tampering.
Do not give Toprol XL/Betaloc CR to children. The safety and effectiveness of Toprol XL/Betaloc CR in children has not been established.
Before you start to take it
You must tell your doctor if:
1. you have any allergies to
. Toprol XL/Betaloc CR or any of the ingredients listed at the end of this leaflet.
. any other medicine or other beta-blocker medicines
. any other substances, such as foods, preservatives or dyes
. insect stings.
2. you have any other health problems relating to your
. lungs
. liver
. kidneys or adrenal glands
. heart
. blood circulation
Also tell your doctor if you have diabetes and / or if you have had symptoms of low blood sugar (hypoglycaemia).
If you have not told your doctor about any of these things, tell them before you take Toprol XL/Betaloc CR.
Using Toprol XL/Betaloc CR
Toprol XL/Betaloc CR tablets should be swallowed with liquid. The tablets and the divided halves should not be chewed or crushed. Generally Toprol XL/Betaloc CR is recommended to be taken once a day together with the morning meal. Your doctor will tell you how much Toprol XL/Betaloc CR you need to take. Take the dose your doctor prescribes so that you get full benefit from this medicine.
How much to take
For high blood pressure:
The recommended dose in patients with mild to moderate high blood-pressure is 47.5 mg taken once a day. If you do not adequately respond to 47.5 mg, your doctor may increase the dose to 90-190 mg once a day or combine Toprol XL/Betaloc CR with other medicines.
Long term treatment with Toprol XL/Betaloc CR in daily doses of 95-190 mg has been shown to reduce the risk of complications due to high blood-pressure (stroke, myocardial infarction, sudden cardiac death).
Follow your doctor's instructions carefully.
For angina pectoris:
The recommended dose is 95-190 mg taken once a day. Your doctor may Toprol XL/Betaloc CR with other medicines used for treatment of angina pectoris.
Maintenance treatment after myocardial infarction:
The usual dose for patients treated for a long time is 190 mg taken once a day. Long term treatment with Toprol XL/Betaloc CR in daily doses of 190 mg has been shown to reduce the risk of death and to reduce the risk of reinfarction.
Heart Failure:
The recommended starting dose is 23.75 mg or half a 23.75 mg tablet once daily during the first one to two weeks. It is then recommended to double the dose every second week up to a maximum dose of 190 mg once daily or the highest tolerated dose.
Disturbances of cardiac rhythm:
The recommended dose is 95-190 mg taken once a day.
Functional heart disorders with palpitations:
The recommended dose is 95 mg taken once a day. If necessary, your doctor may increase the dose to 190 mg.
For migraine prevention or hyperthyroidism:
The recommended dose is 95-190 mg taken once a day.
Do not stop taking Toprol XL/Betaloc CR tablets suddenly. The dose needs to be reduced slowly over 7 to 14 days to make sure that your condition does not get worse.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Toprol XL/Betaloc CR.
Tell your doctor if any of the following side effects bother you or continue.
Very common
• tiredness (fatigue)
Common
• dizziness
• headache
• slow heart rate
• dizziness related to change of position of the body
• cold hands and feet
• feeling sick (nausea)
• stomach ache
• diarrhoea
• constipation
• shortness of breath on effort
• feeling of heart pounding in the chest.
Uncommon
• sensation of burning/ prickling/ numbness
• muscle cramps
• symptoms of heart disease such as shortness of breath
• swelling
• chest pain
• depression
• concentration impaired
• feeling sleepy
• difficulty going to sleep
• nightmares
• skin rash
• feeling of tightness in the airways
• being sick (vomiting)
• increased sweating
• weight gain
Tell you doctor if you notice anything else that is making you feel unwell or bothering you.
Important: This leaflet alerts you to some of the situations when you should call your doctor. Other situations, which cannot be predicted, may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about using Toprol XL/Betaloc CR.
Taking other medicines
Tell your doctor if you are taking any other medicines, including
• Medicines used in the treatment of heart and blood vessels (such as calcium antagonists, antiarrhythimic agents, sympathetic ganglion blockers, hydralazine.
• Other medicines such as mono amine oxidase (MAO) inhibitors, inhalation anaesthestics, antibacterial drugs (rifampicin), antiulcer drugs (cimetidine), anti-inflammatory drugs (indomethacin, celecoxib), certain antidepressants and antipsychotic medicines, antihistamines, other beta-blockers (including eye drops) and other substances (alcohol, some hormones).
• If you take clonidine and Toprol XL/Betaloc CR at the same time and your clonidine treatment is to be discontinued, Toprol XL/Betaloc CR should be withdrawn several days before clonidine.
• If you take oral antidiabetic, your doctor may need to adjust your dose.
These medicines may be affected by Toprol XL/Betaloc CR or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Toprol XL/Betaloc CR.
If you have not told your doctor about any of these things, tell them before you take any Toprol XL/Betaloc CR.
What Toprol XL/Betaloc CR looks like
Toprol XL/Betaloc CR tablets (47.5, 95 and 190 mg) are white to off-white, biconvex, circular, scored on one side and marked on the other side. The 47.5 mg is marked A/mO, the 95 mg is marked A/mS and the 190 mg is marked A/mY.
The 23.75 mg tablet is white, to off-white, oval, and scored on both sides and marked A/ß on one side.
Ingredients
Each Toprol XL/Betaloc CR tablet contains:
Metoprolol succinate 23.75 mg, 47.5 mg, 95 mg or 190 mg as the active ingredient,
plus
• ethylcellulose
• hydroxypropyl cellulose
• hydroxypropyl methylcellulose
• microcrystalline cellulose
• paraffin
• polyethylene glycol
• silicon dioxide
• sodium stearyl fumarate
• titanium dioxide
Toprol-XL, metoprolol succinate, is a beta1-selective (cardioselective) adrenoceptor blocking agent, for oral administration, available as extended release tablets. Toprol-XL has been formulated to provide a controlled and predictable release of metoprolol for once daily administration. The tablets comprise a multiple unit system containing metoprolol succinate in a multitude of controlled release pellets. Each pellet acts as a separate drug delivery unit and is designed to deliver metoprolol continuously over the dosage interval. The tablets contain 47.5 mg, 95 mg and 190 mg of metoprolol succinate equivalent to 50, 100 and 200 mg of metoprolol tartrate, USP, respectively. Its chemical name is (±) 1-(isopropylamino)-3-[p-(2-methoxyethyl) phenoxy]-2-propanol succinate (2:1) (salt).
Metoprolol succinate is a white crystalline powder with a molecular weight of 652.8. It is freely soluble in water; soluble in methanol; sparingly soluble in ethanol; slightly soluble in dichloromethane and 2- propanol; practically insoluble in ethyl-acetate, acetone, diethylether and heptane. Inactive ingredients: silicon dioxide, cellulose compounds, sodium stearyl fumarate, polyethylene glycol, titanium dioxide, paraffin.
BRAND NAMES: Betaloc; Betaloc CR; Toprol Xl