Document: leaflet MAH GENERIC_PL 17907-0130 change

• leaflet MAH GENERIC_PL 16363-0328
• leaflet MAH GENERIC_PL 17907-0130

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180 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metoprolol Tartrate 50mg and 100mg Film-Coated 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 any further questions, ask your doctor or pharmacist

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are 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. See section 4.

What is in this leaflet

1.    What Metoprolol tartrate tablets are and what they are used for

2.    What you need to know before you take Metoprolol tartrate tablets

3.    How to take Metoprolol tartrate tablets

4.    Possible side effects

5.    How to store Metoprolol tartrate tablets

6.    Contents of the pack and other information

1. What Metoprolol tartrate tablets are and what they are used for

Metoprolol tartrate, the active ingredient in Metoprolol tartrate 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.

•    Metoprolol tartrate tablets are used to treat a number of different conditions including:

-    High blood pressure

-    Angina (chest pain)

-    Some heart disorders, for example, heart attack or irregular heart beats.

•    They can also be used as part of the treatment for an overactive thyroid gland.

•    Metoprolol tartrate tablets can be taken to help prevent migraine attacks.

•    Metoprolol is for use in adults

2. What you need to know before you take Metoprolol tartrate tablets

Do not take Metoprolol tartrate tablets and tell your doctor if:

•    you are allergic to metoprolol or to any of the other ingredients of Metoprolol tartrate tablets (listed in Section 6)

•    you have a condition affecting the conduction of electrical impulses in the heart (second and third degree heart block)

•    you have severe heart failure

•    you are suffering from shock due to your heart not pumping properly

•    you have seriously poor circulation

•    you have a very slow heart rate (less than 50 beats a minute)

•    you are receiving a group of drugs called beta-agonists which are used to help the heart pump more strongly

•    you are suffering from heart rhythm problems known as sick sinus syndrome

•    you are receiving verapamil or diltiazem by intravenous injection.

•    you are allergic to any other beta blocker drugs

•    you have severe asthma or severe attacks of wheezing

•    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).

Warnings and Precautions

Take special care and talk to your doctor or pharmacist if you:

•    suffer from asthma, bronchitis or any similar lung disorder

•    have problems with your heart (such as slow heart rate) or circulation. (Taking this medicine may make these worse.)

•    have diabetes

•    suffer from any serious liver disease

•    are pregnant or breast feeding

•    ever had a severe allergic reaction to anything

•    suffer from a rare form of angina called Prinzmetal’s angina

•    will be having an operation which requires a general anaesthetic; please tell your anaesthetist that you are taking metoprolol tartrate tablets

•    have psoriasis

•    want to discontinue treatment; you should not stop suddenly, as this can aggravate chronic heart failure and increase the risk of a heart attack.

•    have a tumour near the kidney (phaeocromocytoma)

•    have an overactive thyroid (symptoms such as increased heart rate, sweating, tremor, anxiety, increased appetite or weight loss may be hidden by this medicine)

•    suffer from dry eyes.

Other medicines and Metoprolol tartrate tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Make sure your doctor knows if you are taking any of the following because you may need to change your treatment:

•    Medicines used to lower blood pressure including:

-    Calcium antagonists e.g. verapamil, nifedipine and diltiazem

-    Centrally acting agents e.g. guanfacin, moxonidine, methyldopa and rilmenidine

-    Alpha blockers e.g. prazosin, tamsulosin, terazosin, doxazosin

The effects of metoprolol and other blood pressure lowering drugs on blood pressure are usually additive.

•    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 used to treat serious mental illness (antipsychotics)

•    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

•    Rifampicin, which is used to treat tuberculosis

•    Atropine, which is used for treating certain eye conditions

•    Anaesthetics

•    Medicines used to treat diabetes

•    Baclofen, which is used to treat spastic conditions

•    Antacids, which is used for stomach upsets

Metoprolol tartrate tablets with alcohol

Be careful when drinking alcohol-it may affect you more than usual. Alcohol may increase the blood pressure lowering effect of this medicine.

Pregnancy, breast-feeding and fertility

Metoprolol Tartrate is not generally recommended during pregnancy although your doctor may decide to use metoprolol in late pregnancy under close supervision including any effects on the newborn infant.

Please inform your doctor if you are pregnant.

Breast-feeding

Breast-feeding should be generally be discontinued during treatment with metoprolol although your doctor may decide to use metoprolol in a nursing mother with close supervision of the infant.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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. This applies to a greater extent at the beginning of the treatment.

Other special warnings

•    If you are going to have general anaesthetic, tell the doctor or dentist in charge that you are taking metoprolol tartrate.

•    If you are diabetic, take particular care with your blood sugar control since metoprolol tartrate 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 metoprolol tartrate. You might also need regular eye examinations.

Metorprolol tartrate tablets contain 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 Metoprolol tartrate tablets

The doctor will tell you how many Metoprolol tartrate tablets to take and when to take them. The dose you are prescribed will depend on the condition you have and how severe is it. 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, g ask your doctor or pharmacist. Keep taking your tablets for as

SAME SIZE ARTWORK 180 x 350 mm Front

long as you have been told, unless you have any problems. In that case, check with your doctor.

The recommended dose is:

•    High blood pressure

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

•    Angina (Chest pain)

The usual dose is 50-100 mg taken two or three times a day.

For other conditions, the usual total daily dose is between 100 and 200 mg. Your doctor will choose a suitable starting dose and monitor your progress.

The maximum recommended dose is 400mg/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.

•    The tablets can be divided into equal halves.

Children

Metoprolol tartrate tablets is not recommended for children. Patients with impaired liver function

In such cases the dose should be adjusted. Always follow your doctor’s advice.

If you forget to take Metoprolol tartrate tablets

If you forget to take a dose, take it when you remember and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you take too many Metoprolol tartrate tablets than you should

If you accidently take too many Metoprolol tartrate 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.

If you stop taking Metoprolol Tartrate tablets

Never suddenly stop taking Metoprolol Tartrate tablets. If you suddenly stop taking the medicine, then your physical condition may deteriorate immediately, abnormalities in your heart rhythm may develop or you may develop high blood pressure. Discontinuing metoprolol treatment should always be undertaken in consultation with your doctor who will direct you how to gradually reduce the dose until the treatment is stopped altogether. If you suffer problems during the tapering-off period, consult your doctor.

4. Possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them.

Stop treatment and contact a doctor at once if you have the following symptoms:

-    an allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue

-    very slow heart rate and blood pressure (you may feel very dizzy or weak) or in case of breathing difficulties.

The side effects listed below have been reported.

Very common (may affect more than 1 in 10 people)

•    Fatigue

Common (may affect up to 1 in 10 people)

•    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.

•    Irregular heart beat

•    Poor blood circulation which makes the toes and fingers numb and pale

•    Breathlessness or wheeziness (bronchospasm)

•    Abdominal pain

•    Diarrohea or constipation

Uncommon (may affect upto 1 in 100 people)

•    Weight gain

•    Depression

•    Reduced alertness

•    Drowsiness

•    Difficulty in sleeping

•    Nightmares

•    Abnormal skin sensations (tingling, tickling, itching or burning)

•    Muscle weakness and cramps

•    an aggravation of heart failure

•    water retention (oedema)

•    chest pain

•    wheezing

•    vomiting

•    skin rash

•    increased sweating

Rare (may affect up to 1 in 1,000 people)

•    Nervousness

•    Anxiety

•    Impotence or loss of libido

•    Eye problems (blurred vision, dry and/or irritated eyes, inflammation)

•    Runny nose, dry mouth

•    Changes in results of liver function tests

•    Reversible hair loss

Very rare (may affect up to 1 in 10,000 people)

•    Hallucinations or personality disorders.

•    Tinnitus or hearing problems.

•    Gangrene.

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

•    Painful joints.

•    Severe reduction in number of white blood cells which makes infections more likely

•    Reduction in blood platelets, which increases risk of bleeding or bruising

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

•    Low blood sugar in diabetics taking insulin

•    Memory impairment

•    Confusion

•    Hallucination

•    Personality changes

•    Taste disorders

•    Hepatitis

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

Not known (frequency cannot be estimated from the available data)

•    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.

Reporting of side effects

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. 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 Metoprolol tartrate tablets

•    Do not store above 25⁰C. Store in the original package.

•    Keep out of the sight and reach of children.

•    Do not take Metoprolol tartrate tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. 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 Metoprolol tartrate tablets contain

Each tablet contains 50mg or 100mg of Metoprolol tartrate Ph. Eur as the active ingredient.

The other ingredients are Lactose Monohydrate, Cellulose Microcrystalline, Sodium Starch Glycolate, Silica Colloidal Anhydrous, Crosscarmellose Sodium, Starch Pregelatinised, Magnesium Stearate, Hypromellose, Talc, Macrogol, Titanium Dioxide (E171).

Metoprolol tartrate 50mg tablets also contain Ferric Oxide red (E172).

What Metoprolol tartrate tablets look like and contents of the pack

Metoprolol tartrate 100mg tablets are white to off-white, round, biconvex film-coated tablets with ‘B’ & ‘L’ separated by notch break line on one side and ‘100’ embossed on other side. Metoprolol tartrate 50mg tablets are pink, round, biconvex film-coated tablets with ‘B’ & ‘L’ separated by notch break line on one side and ‘50’ embossed on other side.

Both the 50mg and 100mg tablets are available in blister packs containing 28 and 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge road, Berkhamsted, Hertfordshire, HP4 1EG UK

Telephone:    0044(0) 1442 200922

Fax:    0044(0) 1442 873717

Email:    info@bristol-labs.co.uk

Metoprolol Tartrate 50mg Film-coated Tablets;

PL 17907/0129

Metoprolol Tartrate 100mg Film-coated Tablets;

PL 17907/0130

a

This leaflet was last revised in July 2015

To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.    V2 30-07-15 D0

SAME SIZE ARTWORK 180 x 350 mm Back

For other conditions, the usual total daily dose is between 100 and 200 mg. Your doctor will choose a suitable starting dose and monitor your progress.

The maximum recommended dose is 400mg/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.

•    The tablets can be divided into equal halves.

Children

Metoprolol tartrate tablets is not recommended for children.

Patients with impaired liver function

In such cases the dose should be adjusted. Always follow your doctor’s advice.

If you forget to take Metoprolol tartrate tablets

If you forget to take a dose, take it when you remember and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you take too many Metoprolol tartrate tablets than you should

If you accidently take too many Metoprolol tartrate 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.

If you stop taking Metoprolol Tartrate tablets

Never suddenly stop taking Metoprolol Tartrate tablets. If you suddenly stop taking the medicine, then your physical condition may deteriorate immediately, abnormalities in your heart rhythm may develop or you may develop high blood pressure. Discontinuing metoprolol treatment should always be undertaken in consultation with your doctor who will direct you how to gradually reduce the dose until the treatment is stopped altogether.

If you suffer problems during the tapering-off period, consult your doctor.

Like all medicines this medicine can cause side effects, although not everybody gets them.

Stop treatment and contact a doctor at once if you have the following symptoms:

-    an allergic reaction such as itching, difficulty breathing or swelling of the face, lips, throat or tongue

-    very slow heart rate and blood pressure (you may feel very dizzy or weak) or in case of breathing difficulties.

The side effects listed below have been reported.

Very common (may affect more than 1 in 10 people)

•    Fatigue

Common (may affect up to 1 in 10 people)

•    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.

•    Irregular heart beat

•    Poor blood circulation which makes the toes and fingers numb and pale

•    Breathlessness or wheeziness (bronchospasm)

•    Abdominal pain

•    Diarrohea or constipation

Uncommon (may affect upto 1 in 100 people)

•    Weight gain

•    Depression

•    Reduced alertness

•    Drowsiness

•    Difficulty in sleeping

•    Nightmares

•    Abnormal skin sensations (tingling, tickling, itching or burning)

•    Muscle weakness and cramps

•    an aggravation of heart failure

•    water retention (oedema)

•    chest pain

•    wheezing

•    vomiting

•    skin rash

•    increased sweating

Rare (may affect up to 1 in 1,000 people)

•    Nervousness

•    Anxiety

•    Impotence or loss of libido

•    Eye problems (blurred vision, dry and/or irritated eyes, inflammation)

•    Runny nose, dry mouth

•    Changes in results of liver function tests

•    Reversible hair loss

Very rare (may affect up to 1 in 10,000 people)

•    Hallucinations or personality disorders.

•    Tinnitus or hearing problems.

•    Gangrene.

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

•    Painful joints.

•    Severe reduction in number of white blood cells which makes infections more likely

•    Reduction in blood platelets, which increases risk of bleeding or bruising

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

•    Low blood sugar in diabetics taking insulin

•    Memory impairment

•    Confusion

•    Hallucination

•    Personality changes

•    Taste disorders

•    Hepatitis

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

Not known (frequency cannot be estimated from the available data)

•    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.

Reporting of side effects

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. 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.

•    Do not store above 25⁰C. Store in the original package.

•    Keep out of the sight and reach of children.

•    Do not take Metoprolol tartrate tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Metoprolol tartrate tablets contain

Each tablet contains 50mg or 100mg of Metoprolol tartrate Ph. Eur as the active ingredient.

The other ingredients are Lactose Monohydrate, Cellulose Microcrystalline, Sodium Starch Glycolate, Silica Colloidal Anhydrous, Crosscarmellose Sodium, Starch Pregelatinised, Magnesium Stearate, Hypromellose, Talc, Macrogol, Titanium Dioxide (E171).

Metoprolol tartrate 50mg tablets also contain Ferric Oxide red (E172).

What Metoprolol tartrate tablets look like and contents of the pack

Metoprolol tartrate 100mg tablets are white to off-white, round, biconvex film-coated tablets with ‘B’ & ‘L’ separated by notch break line on one side and ‘100’ embossed on other side. Metoprolol tartrate 50mg tablets are pink, round, biconvex film-coated tablets with ‘B’ & ‘L’ separated by notch break line on one side and ‘50’ embossed on other side.

Both the 50mg and 100mg tablets are available in blister packs containing 28 and 56 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge road, Berkhamsted, Hertfordshire, HP4 1EG, UK Telephone:    0044(0) 1442 200922

Fax:    0044(0) 1442 873717

Email:    info@bristol-labs.co.uk

Metoprolol Tartrate 50mg Film-coated Tablets;

PL 17907/0129

Metoprolol Tartrate 100mg Film-coated Tablets;

PL 17907/0130

This leaflet was last revised in July 2015

To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the address (or telephone, fax, email) above.

a

V2 30-07-15 D1    ^

SAME SIZE ARTWORK 180 x 430 mm Back