Lopresor Sr 200mg Tablets
S961 LEAFLET Lopresor 20150814
PACKAGE LEAFLET: INFORMATION FOR THE USER LOPRESOR® SR 200mg TABLETS
(metoprolol tartrate)
Your medicine is known as Lopresor SR 200mg Tablets but will be referred to as Lopresor SR Tablets throughout the following patient information leaflet.
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.
If you have any other questions, or if there is something you don't understand, please ask your doctor or pharmacist.
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.
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.
They are used to treat high blood pressure and angina (chest pain). They can also be taken to help prevent migraine attacks.
2. THINGS TO CONSIDER BEFORE YOU START TO TAKE LOPRESOR SR TABLETS
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.)
• 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,
• 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).
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.
• Do you suffer from asthma, bronchitis or any similar lung disorder?
• Do you have problems with your heart (such as slow heart rate) or circulation? (Taking Lopresor SR tablets may make these worse.)
• Do you have diabetes?
• Do you have problems with your thyroid?
• Do you suffer from any serious liver disease?
• Are you pregnant or breast-feeding?
• 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?
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:
• Medicines for high blood pressure (including prazosin, clonidine and drugs called calcium channel blockers such as verapamil or diltiazem)
• 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.
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?
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.
Other special warnings
• 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 might also need regular eye examinations.
3. HOW TO TAKE LOPRESOR SR TABLETS
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.
The usual doses are:
High blood pressure One tablet in the morning.
The usual starting dose is 100 mg a day. This can be increased by your doctor if necessary.
Angina (Chest pain)
The usual starting dose is 1 tablet a day. This may be increased to 2 tablets once a day if necessary.
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.
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.
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.
• Depression.
• Muscle cramps
• Heart failure or irregular heart beat.
• Water retention (oedema).
• Breathlessness or wheeziness (bronchospasm).
• Diarrhoea or constipation.
• Skin rash and/or itching.
Up to 1 in 10,000 people have experienced:
• Weight gain.
• Hallucinations or personality disorders.
• Dry or sore eyes or problems with vision.
• Tinnitus or hearing problems.
• Gangrene.
• Runny nose, dry mouth.
• 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.
• Impotence or loss of libido.
• 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.
Do not be alarmed by this list - most people take Lopresor SR tablets without any problems.
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.
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).
What Lopresor SR Tablets looks like and contents of the pack
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.
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.
Manufacturer
This product is manufactured by
• Daiichi Sankyo Europe GmbH, Pfaffenhofen (D), Germany.
• Hennig Arzneimittel GmbH & Co. KG, Florsheim am Main (D), Germany.
POM PL No: 19488/0961
Leaflet revision date: 14 August 2015
Lopresor is a registered trade mark of Novartis AG, Switzerland.
S961 LEAFLET Lopresor 20150814