Patient leaflet - Metoprolol Tartrate 100 mg tablets

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

Metoprolol tartrate, belongs to a group of medicines called beta blockers.

It is used to treat:

high blood pressure
angina pectoris (pain in the chest caused by blockages in the arteries to the heart)
irregular heart rhythm (arrhythmia)
the symptoms caused by an overactive thyroid gland (thyrotoxicosis)

It is used to prevent:

heart damage and death due to heart attacks
migraine

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

Do not take Metoprolol Tartrate tablets if you:

are allergic to metoprolol, other beta-blockers or any other ingredients of this medicine (listed in section 6).
suffer with heart conduction or rhythm problems
have severe or uncontrolled heart failure
are in shock caused by heart problems
suffer with blocked blood vessels, including blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)
have a slow heart rate or have suffered a heart attack which has been complicated by a significantly slow heart rate
suffer from a tight, painful feeling in the chest in periods of rest (Prinzmetal’s angina)
have or have had breathing difficulties or asthma including COPD (Chronic Obstructive Pulmonary Disease causing cough, wheezing or breathlessness, phlegm or increase in chest infections)
sufferwith untreated phaeochromocytoma( high blood pressure due to a tumour near the kidney)
suffer from increased acidity of the blood (metabolic acidosis)
have low blood pressure
suffer with diabetes associated with frequent episodes of low blood sugar (hypoglycaemia)
have liver or kidney disease or failure
are given other medicines for blood pressure by injection especially verapamil, diltiazem or disopyramide.

Warnings and precautions

Talk to your doctor or pharmacist before using Metoprolol Tartrate 50 mg tablets if you:
have a history of allergic reactions, for example to insect stings, foods or other substances,
have diabetes mellitus (low blood sugar levels may be hidden by this medicine)
have controlled heart failure.
have a slow heart rate or blood vessel disorder.
suffer from treated phaeochromocytoma (high blood pressure due to tumour near the kidney)
have or have suffered from psoriasis (severe skin rashes)
have liver cirrhosis
are elderly
have myasthenia gravis.
If you suffer from dry eyes

Anaesthetics and surgery

If you are going to have an operation or an anaesthetic, please tell your doctor or dentist that you are taking Metoprolol Tartrate tablets, as your heart beat might slow down too much.

Taking other medicines

Do not take Metoprolol Tartrate tablets if you are already taking:

monoamine oxidase inhibitors (MAOIs) for depression
other blood pressure lowering medicines such as verapamil, nifedipine and diltiazem
disopyramide or quinidine (to treat irregular heartbeat (arrhythmia)

Children

Do not give this medicine to children.

Other medicine and Metoprolol Tartrate tablets

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

medicines used to treat stomach ulcers such as cimetidine
medicines used to treat high blood pressure such as hydralazine, clonidine or prazosin
medicines used to treat irregular heart rhythm such as amiodarone and propafenone
medicines used to treat depression such as tricyclic or SSRI antidepressants
medicines used to treat epilepsy such as barbiturates
medicines used to treat mental illness such as phenothiazines
- anaesthetics such as cyclopropane or
  trichloroethylene
- medicines used to treat some cancers, particularly cancer of the kidney such as aldesleukin
- medicines used to treat erectile dysfunction such as alprostadil
- anxiolytics or hypnotics (e.g. temazepam, nitrazepam, diazepam)
- indometacin or celecoxib (Non-Steroidal Anti-Inflammatory Drugs (NSAIDs))
- rifampicin (antibiotic) or terbinafine (antifungal)
- oestrogens such as a contraceptive pill or hormone replacement therapy
- corticosteroids (e.g. hydrocortisone, prednisolone)
- other beta-blockers e.g. eye drops.
- adrenaline (epinephrine) or noradrenaline (norepinephrine), used in anaphylactic shock or other sympathomimetics
- medicines used to treat diabetes. Metoprolol tartrate tablets could increase the risk of severe hypoglycaemia when used with certain type of antidiabetic drugs called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide)
- lidocaine (a local anaesthetic)
- moxisylyte (used in Raynaud’s syndrome)
- medicines used to treat malaria such as mefloquine
- medicines used to prevent nausea and vomiting such as tropisetron
- medicines used to treat asthma such as xanthines such as aminophylline or theophylline
- medicines to treat migraines such as ergotamine
- medicines used to treat heart conditions such as cardiac glycosides e.g. digoxin
- medicines used to treat rheumatoid arthritis such as hydroxychloroquine
- diphenydramine (sedative antihistamine).

Metoprolol Tartrate tablets and alcohol You are advised to avoid alcohol whilst taking this medicine. Alcohol may increase the blood pressure lowering effect of Metoprolol Tartrate tablets.

Pregnancy and breast-feeding

Metoprolol Tartrate tablets are not recommended during pregnancy or breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Metoprolol Tartrate tablets may make you feel tired and dizzy. If affected, patients should not drive or operate machinery.

3. How to take Metoprolol Tartrate tablets

Always take Metoprolol Tartrate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not

sure.

Recommended dose:

Recommended dose should not exceed

400 mg/day in any of below mentioned

conditions.

High blood pressure:
Initially 100 mg metoprolol tartrate daily. The dose may be increased to 200mg daily in single or divided doses.
Angina:
50 to 100 mg metoprolol tartrate two or three times daily.
Irregular heart beats:
50mg metoprolol tartrate two or three times daily. The dose may be increased to 300mg daily in divided doses.
Heart attack:
50mg metoprolol tartrate every six hours. The usual maintenance dose is 200mg daily in divided doses. The medicine should be taken for at least 3 months.
Prevention of migraine:
100 to 200 mg metoprolol tartrate daily in divided doses (in the morning and evening).
Overactive thyroid gland (thyrotoxicosis): 50mg metoprolol tartrate four times daily.
Children:
Not recommended.
Patients with impaired kidney or liver function: In such cases the dose should be adjusted. Always follow your doctor’s advice.

Swallow the tablet whole. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Metoprolol Tartrate tablets than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Symptoms of overdose are low blood pressure (fatigue and dizziness), slow pulse, heart conduction problems, shortness of breath, unconsciousness, coma, cardiac arrest, feeling and being sick, blue colouring of the skin, low blood sugar levels and high levels of potassium in the blood.

If you forget to take Metoprolol Tartrate tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Metoprolol Tartrate tablets Do not suddenly stop taking Metoprolol Tartrate tablets as this may cause worsening of heart failure and increase the risk of heart attack. Only change the dose or stop the treatment in consultation with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Package leaflet: Information for the patient

Metoprolol Tartrate 50 mg tablets Metoprolol Tartrate 100 mg tablets

Metoprolol tartrate

Front Side

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 of an:

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

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Common (may affect up to 1 in 10 people):

tiredness
dizziness
headache
a slow heart rate
feeling faint on standing due to low blood pressure
shortness of breath with or without strenuous physical activity
feeling or being sick
stomach pain

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

depression
nightmares
nervousness
anxiety
sexual dysfunction or reduced sex drive
inability to think clearly
sleepiness or difficulty in sleeping
tingling or ‘pins and needles’
difficulty breathing
heart failure
irregular heart rate
palpitation
water retention causing swelling
Raynaud’s phenomenon (causing pain, numbness, coldness and blueness of the fingers)
diarrhoea or constipation
skin rash
muscle cramps

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

changes in the results of blood tests
effects on blood clotting causing easy or unexplained bruising
changes in personality
confusion
hallucinations
visual disturbances
dry or irritated eyes
ringing in the ears
loss of hearing with high doses
heart conduction problems
chest pain
gangrene in patients with severe poor circulation
runny nose
dry mouth
weight gain sensitivity to light
increased sweating
hair loss
worsening or new psoriasis
joint inflammation (arthritis)
disturbances of sexual desire and performance
changes in liver function tests
taste disorders

Not known (frequency cannot be estimated from the

available data):

worsening or development of limping
hepatitis (symptoms include fever, sickness and yellowing of the skin or whites of the eyes)
Peyronie’s syndrome (bending of the penis)
symptoms of high levels of the thyroid hormone or low blood sugar may be hidden
increase in blood fats or decrease in cholesterol
retroperitoneal fibrosis (symptoms include lower back pain, high blood pressure)
occurrence of antinuclear antibodies not associated with systemic lupus erythematosus (SLE).

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, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metoprolol Tartrate tablets

Keep out of the sight and reach of children.
Do not use Metoprolol Tartrate tablets after the expiry date, which is stated on the blister and the carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Metoprolol Tartrate tablets contains

The active substance is Metoprolol tartrate.

Each tablet contains 50/100 mg Metoprolol tartrate.

The other ingredients are:

Cellulose microcrystalline (E460), Gelatin (E441), Sodium starch glycolate, Silica colloidal hydrated (E551), Stearic acid

What Metoprolol Tartrate tablets looks like and contents of the pack

50 mg tablets: White to off-white, approximately 8 mm round, biconvex tablet marked on one side and a scoreline on the other side.

100 mg tablets: White to off-white, approximately 10 mm round, biconvex tablet marked on one side and a scoreline on the other side.

Metoprolol Tartrate tablets are available in PVC/PVdC-Aluminium blister packs containing 10, 20, 28, 30, 50, 56, 60, 84 and 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation holder

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom

Manufacturer