BETALOC® CR

Metoprolol succinate, 23.75 mg, 47.5 mg, 95 mg, 190 mg controlled release
tablets

What is in this leaflet

This leaflet answers some of the common questions people ask about Betaloc
CR. It does not contain all the information that is known about Betaloc
CR.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the
risks of you taking Betaloc CR against the benefits they expect it will
have for you.

If you have any concerns about taking this medicine, ask your doctor or
pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Betaloc CR is used for

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).

Your doctor may have prescribed this medicine for another reason.

Your doctor will have explained why you are being treated with Betaloc CR
and told you what dose to take.

Betaloc CR may be used either alone or in combination with other
medicines to treat your condition.

Follow all directions given to you by your doctor carefully. They may
differ from the information contained in this leaflet.

Ask your doctor if you have any questions about why Betaloc CR has
been prescribed for you.

Betaloc CR is not addictive

How Betaloc works

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.

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.

Before you use Betaloc

When you must not use it

Do not take 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 Betaloc CR. The effect of using 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 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 Betaloc CR if the packaging is torn or shows signs of
tampering.

Do not give Betaloc CR to children. The safety and effectiveness of
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
   
   • 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 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
  digitalis/digoxin, 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 Betaloc CR at the same time and your clonidine
  treatment is to be discontinued, 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 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 Betaloc CR.

If you have not told your doctor about any of these things, tell them before
you take any Betaloc CR.

Using Betaloc CR

Betaloc CR tablets should be swallowed with liquid. The tablets and
the divided halves should not be chewed or crushed. Generally Betaloc CR
is recommended to be taken once a day together with the morning meal. Your
doctor will tell you how much 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 Betaloc CR
with other medicines.

Long term treatment with 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
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 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 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.

If you forget to take it

If you miss a dose of Betaloc CR and your next dose is about 12 hours
away, take the missed dose, or half of it right away. If you remember sooner,
take the full dose but if it is closer to your next dose, take only half. Then,
take your next dose on time.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your
pharmacist for some hints.

Overdose

Telephone your doctor or the National Poisons and Hazardous Chemicals
Information Centre Ph 0800 POISON (0800 764 766) or go to Accident & Emergency
at your nearest hospital immediately if you think that you or anyone else may
have taken too much Betaloc. Even if there are no signs of discomfort or
poisoning.

If you take too many Betaloc CR tablets your blood pressure may drop
too far. You will feel faint or faint, and your heart rate will also slow down.
You may also have nausea, vomiting, and convulsions. In extreme cases, serious
heart and lung problems may occur.

The first signs of overdosage may be observed 20 minutes to 2 hours after you
have taken the medicine. If you experience any of these symptoms contact your
doctor/pharmacist or hospital immediately.

While you are using Betaloc

Things you must do

Be sure to keep all of your doctor's appointments so that your progress can
be checked.

If you become pregnant while taking Betaloc CR, tell your doctor.

If you develop an increasingly slow heart beat when taking Betaloc CR,
information your doctor as soon as possible. The doctor may give you a lower
dose of Betaloc CR or withdraw your medicine gradually.

You may feel light-headed or dizzy when you begin to take Betaloc CR.
This is because your blood pressure has fallen suddenly. Standing up slowly,
especially when you get up from bed or chairs, will help your body get used to
the change in position and blood pressure. If this problem gets worse or
continues, talk to your doctor.

If you plan to have surgery (even at the dentist) that needs a general
anaesthetic, tell your doctor or dentist that you are taking Betaloc CR.
Your blood pressure may drop suddenly if Betaloc CR interacts with the
anaesthetic.

If you are being treated for diabetes, make sure you check your blood
suger level regularly and report any changes to your doctor.

If you have to have any medical tests while you are taking Betaloc CR,
tell your doctor. Betaloc CR may affect the results of some tests.

Tell any doctors, dentists, and pharmacists who are treating you that you
are taking Betaloc CR.

Things you must not do

Do not stop taking Betaloc CR without checking with your doctor. Your
doctor may want you to gradually reduce the amount of Betaloc CR you are
taking before stopping completely. If possible this should be done over at least
2 weeks. Doses should be reduced to half a 23.75 mg tablet once a day for at
least 4 days before stopping completely. This may help reduce the possibility of
your condition getting worse.

Do not give Betaloc CR to anyone else even if they have the same condition
as you.

Do not use Betaloc CR to treat any other complaints unless your doctor
tells you to.

Things to be careful of

You should know how you react to this medicine before you drive or use
machines because dizziness or fatigue may occur.

Be careful drinking alcohol while you are taking Betaloc CR. Dizziness
or light-headedness may be worse.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking 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
• fatigue or swollen ankles my temporarily worsen
• during a heart attack blood pressure may be severely decreased
  (cardiogenic shock)
• minor ECG changes which do not affect heart performance
• 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 Betaloc CR.

After using it

Storage

Keep your tablets in the blister pack until it is time to take them.
If you take Betaloc CR out of the blister pack it will not keep well.

Keep the tablets in a cool dry place where the temperature stays below
30°C.

Do not store it or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it. A locked cupboard at
least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave it in the car on hot days.

Disposal

Ask your pharmacist what to do with any tablets you have left over if your
doctor tells you to stop taking them, or you find that the expiry date has
passed.

Product description

What Betaloc CR looks like

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/β on one side.

Ingredients

Each 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