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LOPRESOR SR 200MG TABLETS

Active substance(s): METOPROLOL TARTRATE

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Do you have diabetes?



Do you have problems with your thyroid?

LOPRESOR SR 200mg TABLETS
(metoprolol tartrate)



Do you suffer from any serious liver disease?



Are you pregnant or breast-feeding?

Your medicine is known as Lopresor SR 200mg Tablets but will be
referred to as Lopresor SR Tablets throughout the following patient
information leaflet.



Have you ever had a severe allergic reaction to anything?



Do you suffer from a rare form of angina called Prinzmetal's
angina?



Will you be having an operation which requires a general
anaesthetic?

S961 LEAFLET Lopresor 20150814

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

What you need to know about Lopresor SR tablets
Your doctor has decided that you need this medicine to help treat
your condition.
Please read this leaflet carefully before you start to take your
medicine. It contains important information. Keep the leaflet in a
safe place because you may want to read it again.

Are you taking other medicines?
Lopresor SR interacts with a large number of other medicines.
Make sure your doctor knows if you are taking any of the following
because you may need to change your treatment:


If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.

Medicines for high blood pressure (including prazosin, clonidine
and drugs called calcium channel blockers such as verapamil or
diltiazem)



This medicine has been prescribed for you. Never give it to
someone else. It may not be the right medicine for them even if
their symptoms seem to be the same as yours.

Other beta-blockers (including those used in the form of eye
drops)



Drugs which affect the peripheral circulation (fingers and toes)
such as ergotamine which can be used to treat migraine



Medicines to treat depression



Medicines to treat other mental illnesses



Antiretroviral drugs used to treat AIDS and some other
conditions



Antihistamines (including medicines that you can buy without a
prescription for hayfever and other allergies, colds and other
conditions)



Drugs to prevent malaria



Medicines to treat fungal infections



Medicines which affect liver enzymes, such as cimetidine used
to treat stomach ulcers and rifampicin used to treat tuberculosis



Medicines for heart problems including angina, such as
amiodarone, digoxin, nitrates and anti-arrhythmic drugs



Insulin and other drugs to treat diabetes



Drugs called NSAIDs used to treat pain and inflammation



A local anaesthetic called lignocaine.

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 Lopresor SR tablets are and what they are used for
2. Things to consider before you start to take Lopresor SR tablets
3. How to take Lopresor SR tablets
4. Possible side effects
5. How to store Lopresor SR tablets
6. Further information
1. WHAT LOPRESOR SR TABLETS ARE AND WHAT THEY
ARE USED FOR
Metoprolol tartrate, the active ingredient in Lopresor SR tablets, is
one of a group of medicines called beta-blockers. Beta-blockers
slow the heart beat, lessen the force with which the heart muscle
contracts and reduce blood vessel contraction in the heart, brain,
and throughout the body.
Lopresor SR tablets are specially formulated to release the active
ingredient slowly.

Always tell your doctor or pharmacist about all the medicines you
are taking. This means medicines you have bought yourself as well
as medicines on prescription from your doctor.
Will there be any problems with driving or using machinery?

They are used to treat high blood pressure and angina (chest pain).
They can also be taken to help prevent migraine attacks.

If you feel dizzy or sleepy, or if you have problems with your eyes
when you start to take these tablets, do not drive or use machinery
until these effects have worn off.

2. THINGS TO CONSIDER BEFORE YOU START TO TAKE
LOPRESOR SR TABLETS

Other special warnings

Some people MUST NOT take Lopresor SR tablets. Talk to your
doctor if:


you think you may be allergic to metoprolol or to any of the
other ingredients of Lopresor SR tablets, (These are listed at
the end of the leaflet.)



Be careful when drinking alcohol - it may affect you more than
usual.



If you are going to have a general anaesthetic, tell the doctor or
dentist in charge that you are taking Lopresor SR.



If you are diabetic, take particular care with your blood sugar
control since Lopresor SR tablets may make you less aware of
low blood sugar levels.



The doctor will want to keep an eye on your heart and thyroid
function while you are taking Lopresor SR tablets.



you are allergic to any other beta-blocker drugs,



you have severe asthma or severe attacks of wheezing,



you have certain serious heart or blood vessel disorders which
shouldn’t be treated with beta-blockers (your doctor should be
aware of these),



you have low blood pressure,

3. HOW TO TAKE LOPRESOR SR TABLETS



you been told that you have high blood pressure due to a
tumour near your kidney (phaeochromocytoma),



you have been told that your blood is more acidic than normal
(a condition called metabolic acidosis).

The doctor will tell you how many Lopresor SR tablets to take and
when to take them. The dose you are prescribed will depend on the
condition you have and how severe it is. Always follow the doctor’s
instructions carefully. The dose will be on the pharmacist’s label.
Check the label carefully. If you are not sure, ask your doctor or
pharmacist. Keep taking your tablets for as long as you have been
told, unless you have any problems. In that case, check with your
doctor.

You should also ask yourself these questions before taking
Lopresor SR tablets. If the answer to any of these questions is
YES, discuss your treatment with your doctor or pharmacist
because Lopresor SR tablets might not be the right medicine
for you.



You might also need regular eye examinations.

The usual doses are:

Do you suffer from asthma, bronchitis or any similar lung
disorder?

High blood pressure

Do you have problems with your heart (such as slow heart rate)
or circulation? (Taking Lopresor SR tablets may make these
worse.)

The usual starting dose is 100 mg a day. This can be increased by
your doctor if necessary.

One tablet in the morning.

Angina (Chest pain)

Do not be alarmed by this list - most people take

The usual starting dose is 1 tablet a day. This may be increased to
2 tablets once a day if necessary.

Lopresor SR tablets without any problems.

To prevent migraine
One tablet a day.


Swallow your tablets whole with a drink of water.



Do not stop taking your tablets suddenly as this may cause your
condition to get worse. Ask your doctor first.



Lopresor SR is not recommended for children.



People with liver problems may be told to take a lower dose.

What if you forget to take a dose?
If you forget to take a dose, take it when you remember and then
take your next dose at the usual time. However, it is important not
to take two doses at the same time.
What if you take too many tablets?
If you accidentally take too many Lopresor SR tablets, tell your
doctor at once or contact your nearest hospital casualty
department. Take your medicine pack with you so that people can
see what you have taken.
4. POSSIBLE SIDE EFFECTS
Lopresor SR tablets are suitable for most people, but, like all
medicines, they can sometimes cause side effects.

If any of the symptoms become troublesome, or if you notice
anything else not mentioned here, please go and see your
doctor. He/she may want to give you a different medicine.
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 LOPRESOR SR TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

The side effects listed below have been reported.
Up to 1 in 10 people have experienced:


Headache, dizziness, or unusual tiredness.



Slow heart beat.



Low blood pressure which might make you faint or dizzy.



Feeling short of breath when exercising.



Feeling or being sick, stomach ache.

6. FURTHER INFORMATION
What Lopresor SR Tablets contain


Each film-coated tablet contains 200mg of the active ingredient,
metoprolol tartrate in a sustained release formulation.



Lopresor SR Tablets also contain the following inactive
ingredients:silicon dioxide, cellulose, calcium phosphate,
methacrylic acid copolymer, magnesium stearate, gylceryl
palmitostearate, hydroxypropyl methylcellulose, polysorbate,
talc, titanium dioxide (E171) and yellow iron oxide (E172).

Up to 1 in 1,000 people have experienced:


Sleep disorders such as sleepiness, sleeplessness or
nightmares.



Feeling less alert.



Coldness, numbness or tingling in your hands and feet.



What Lopresor SR Tablets looks like and contents of the pack

Depression.



Muscle cramps



Heart failure or irregular heart beat.

The tablets are pale yellow, capsule-shaped, biconvex and
engraved ‘CG’ on either side of a breakline on one side and ‘CDC’
on either side of a breakline on the other side.



Water retention (oedema).



Breathlessness or wheeziness (bronchospasm).



Diarrhoea or constipation.



Skin rash and/or itching.

Up to 1 in 10,000 people have experienced:

Lopresor SR Tablets are available as blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



Weight gain.



Hallucinations or personality disorders.

Manufacturer



Dry or sore eyes or problems with vision.

This product is manufactured by



Tinnitus or hearing problems.



Daiichi Sankyo Europe GmbH, Pfaffenhofen (D), Germany.



Gangrene.





Runny nose, dry mouth.

Hennig Arzneimittel GmbH & Co. KG, Flörsheim am Main (D),
Germany.



Changes in the results of liver function tests.



Bruising or increased sensitivity of the skin to sunlight,
worsening of psoriasis.



Increased sweating, loss of hair.

Leaflet revision date: 14 August 2015



Impotence or loss of libido.

Lopresor is a registered trade mark of Novartis AG, Switzerland.



Painful joints.



Chest pain.

The following have also been reported:


Confusion.



Abnormal levels of certain types of fats such as cholesterol or
triglycerides in the blood.



Abnormal curvature of the penis with painful erections (known
as Peyronie’s disease)



Retroperitoneal fibrosis where abnormal scar tissue occurs
behind the membrane that lines the cavity of the abdomen. This
may present with pain in the back, groin or the lower abdomen.



Hepatitis.

POM

PL No: 19488/0961

S961 LEAFLET Lopresor 20150814

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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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