Patient leaflet - Metoprolol Tartrate Dawa 1 mg / ml solution for injection

1. What Metoprolol Tartrate Injection is and what it is used for

The name of your medicine is Metoprolol Tartrate DAWA 1 mg/ml solution for injection (called Metoprolol Tartrate Injection in the rest of this leaﬂet). Metoprolol Tartrate Injection contains a medicine called metoprolol tartrate. This belongs to a group of medicines called beta-blockers.

Metoprolol Tartrate Injection is used: Ÿ To treat uneven heart beats (arrhythmias). Ÿ After a heart attack (myocardial infarction).

It works by making your heart beat more slowly and with less force.

2. What you need to know before you use Metoprolol Tartrate Injection

Do not have Metoprolol Tartrate Injection

Ÿ If you are allergic to metoprolol tartrate or

any of the other ingredients of this medicine (listed in Section 6).

Ÿ If you are allergic to any other beta-blocker

medicines (such as atenolol or propranolol). Ÿ If you have ever had any of the following

heart problems:

heart attack with shock
heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)
second- or third-degree heart block (a condition which may be treated by a pacemaker)
very slow or very uneven heart beats (unless a permanent pacemaker is in place).

Ÿ If you have low blood pressure which may

make you feel faint.

Ÿ If you have very poor circulation.

Ÿ If you have a tumour called

phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure. If you are being treated for phaeochromocytoma your doctor will give you another medicine called an alpha-blocker, to take as well as your Metoprolol Tartrate Injection.

Ÿ If you have been told that you have higher

than normal levels of acid in your blood (metabolic acidosis).

If any of the above apply to you, do not have Metoprolol Tartrate Injection. If you are not sure, talk to your doctor or nurse before having Metoprolol Tartrate Injection.

Warnings and precautions

Talk to your doctor or nurse before using Metoprolol Tartrate Injection if:

Ÿ You have asthma, wheezing or any other

similar breathing problems, or you get allergic reactions, for example to insect stings, foods or other substances. If you have ever had asthma or wheezing, do not have this medicine without ﬁrst checking with your doctor.

Ÿ You have a type of chest pain (angina) called

Prinzmetal's angina.

Ÿ You have poor blood circulation or controlled

heart failure.

Ÿ You have ﬁrst-degree heart block. Ÿ You have problems with your liver. Ÿ You have diabetes. Your treatment for

diabetes may need to be adjusted. Ÿ You have thyrotoxicosis (a condition caused

by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis.

Ÿ You have or have ever had psoriasis (a skin

condition).

If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before having Metoprolol Tartrate Injection.

Other medicines and Metoprolol Tartrate Injection

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Metoprolol Tartrate Injection can aﬀect the way some other medicines work and some medicines can have an eﬀect on Metoprolol Tartrate Injection.

In particular, tell your doctor or nurse if you are taking any of the following medicines: Ÿ Clonidine (for high blood pressure or

migraine). If you are taking clonidine and Metoprolol Tartrate Injection together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine or Metoprolol Tartrate Injection, your doctor will give you careful instructions about how to do it.

Ÿ Medicines called Mono-Amine Oxidase

Inhibitors (MAOIs).

Ÿ Verapamil, diltiazem or nifedipine (for high blood pressure or chest pain).

Ÿ Quinidine, amiodarone or digoxin (for heart problems).

Ÿ Hydralazine (for high blood pressure). Ÿ Medicines for stomach ulcers (such as cimetidine).

Ÿ Medicines for infections caused by bacteria

(such as rifampicin).

Ÿ Adrenaline, also known as epinephrine (a medicine that stimulates the heart). Ÿ Medicines for pain, inﬂammation and arthritis

(such as indometacin and celecoxib). Ÿ Medicines for depression.

Ÿ Medicines for mental illness (such as phenothiazine).

Ÿ Barbiturates (a type of sedative).

Ÿ Antihistamines (medicines for hay fever and allergies).

Ÿ Other beta-blocker medicines used as eye drops (such as timolol).

Ÿ Insulin or medicines that you take by mouth for diabetes. Your doctor may need to adjust your dose of these medicines. Metoprolol Tartrate Injection could increase the risk of severe hypoglycaemia when used with certain types of antidiabetic drugs called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).

Ÿ Lidocaine (a local anaesthetic).

Ÿ Ergotamine medicines (for migraines).

Operations

If you go into hospital or to the dentist to have an operation, tell the anaesthetist, medical staﬀ or dentist that you are having Metoprolol Tartrate Injection. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are having Metoprolol Tartrate Injection.

Metoprolol Tartrate Injection with food, drink and alcohol

Before having Metoprolol Tartrate Injection, inform your doctor or nurse if you have recently had alcohol. This is because alcohol can aﬀect how the medicine works.

Pregnancy, breast-feeding and fertility

Ÿ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine. Beta-blockers including Metoprolol Tartrate Injection may cause harm to the foetus and early labour. Ÿ If you become pregnant while having

Metoprolol Tartrate Injection, talk to your doctor as soon as possible.

Driving and using machines

If you feel dizzy or tired after having this medicine, do not drive or use any tools or machines.

Metoprolol Tartrate Injection contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially 'sodium-free'.

3. How to take Metoprolol Tartrate Injection

Adults

Metoprolol Tartrate Injection will be given to you by a doctor or a nurse. It will be given to you as an injection into your vein. Your doctor will decide how much to give you. The amount depends on your illness.

Use in children

Your medicine must not be given to children.

If you use more Metoprolol Tartrate Injection than you should

If you think you have been given too much of this medicine, talk to your doctor or nurse straight away.

If you stop using Metoprolol Tartrate Injection

Your doctor or nurse will let you know when to stop having this medicine. You may need to stop having it gradually.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side eﬀects

Like all medicines, this medicine can cause side eﬀects, although not everybody gets them. The following side eﬀects may happen with this medicine.

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

Ÿ Feeling tired.

Common (may aﬀect up to 1 in 10 people)

Ÿ You may notice that your pulse rate becomes

slower while you are having Metoprolol Tartrate Injection. If this happens tell your doctor as soon as possible. Your doctor may need to lower your dose of Metoprolol Tartrate Injection or you may need to stop having it gradually.

Ÿ Pounding heartbeat.

Ÿ Dizziness (particularly when standing up,

may sometimes cause fainting).

Ÿ Headache.

Ÿ Shortness of breath on eﬀort.

Ÿ Feeling sick (nausea).

Ÿ Stomach ache.

Ÿ Diarrhoea or constipation.

Ÿ Cold hands and feet

Uncommon (may aﬀect up to 1 in 100 people).

Ÿ Depression.

Ÿ Diﬃculty going to sleep.

Ÿ Nightmares.

Ÿ Diﬃculty concentrating.

Ÿ Feeling sleepy.

Ÿ Sensation of burning, prickling or numbness. Ÿ Heart changes shown on an ECG. Ÿ Severe drop in blood pressure during a heart

attack (cardiogenic shock).

Ÿ Feeling of tightness in the airways. Ÿ Being sick (vomiting).

Ÿ Skin rash.

Ÿ Increased sweating.

Ÿ Muscle cramps.

Ÿ Chest pain.

Ÿ Swelling.

Ÿ Weight gain.

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

Ÿ Feeling anxious or nervous.

Ÿ Disturbances of vision.

Ÿ Dry or irritated eyes.

Ÿ Uneven heartbeat.

Ÿ Numbness and spasm in your ﬁngers

(Raynaud's disease).

Ÿ Allergic reactions. The signs may include

runny nose and red or watery eyes. Ÿ Dry mouth.

Ÿ Thinning of your hair.

Ÿ Being unable to get an erection (impotence). Ÿ Liver problems (shown in a blood test).

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

Ÿ Changes to some of the cells or other parts

of your blood. Your doctor may take blood samples every so often to check whether Metoprolol Tartrate Injection has had any eﬀect on your blood.

Ÿ Reduced numbers of platelets in the blood.

This may make you bruise more easily. Ÿ Confusion.

Ÿ Hallucinations.

Ÿ Loss of memory or problems with memory. Ÿ Changes to taste.

Ÿ Ringing in the ears.

Ÿ Inﬂammation of the liver (hepatitis). Ÿ Skin reaction due to increased sensitivity to

sunlight.

Ÿ Pain in joints.

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to have your medicine:

Ÿ Being short of breath, feeling tired or having

swollen ankles (if you have heart failure) may get worse for a while. This is uncommon aﬀecting less than 1 in 100 people. Ÿ Psoriasis (a skin condition) and poor

circulation may get worse. This is very rare aﬀecting less than 1 in 10,000 people.

Reporting of side eﬀects

If you get any side eﬀects, talk to your doctor or pharmacist. 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 Injection

Ÿ The doctor and hospital pharmacist are responsible for storing, using and disposing of Metoprolol Tartrate Injection correctly. Ÿ Keep this medicine out of the sight and reach of children.

Ÿ Do not use this medicine after the expiry date which is stated on the carton and ampoule label after EXP. The expiry date refers to the last day of that month.

Ÿ The medicinal product does not require any special storage conditions.

Ÿ Do not take this medicine if the packaging is torn or damaged.

Ÿ Metoprolol Tartrate DAWA 1 mg/ml solution for injection is a clear, colourless liquid. Do not use this medicine if it does not match this description.

Ÿ Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

What Metoprolol Tartrate Injection contains The active substance is metoprolol tartrate. Each 1 ml of solution contains 1 mg metoprolol tartrate. Each ampoule of 5 ml contains 5 mg metoprolol tartrate.

The other ingredients are sodium chloride and water for injections.

What Metoprolol Tartrate Injection looks like and contents of the pack

Metoprolol Tartrate Injection is a clear, colourless liquid and sterile aqueous solution which comes in a type I clear glass ampoule of 5 ml ﬁll volume.

Pack size: Carton of 1 ampoule, 5 ampoules or 10 ampoules.

Marketing Authorisation Holder

Dawa Limited

5 Sandridge Close,

Harrow, Middlesex,

HA1 1XD, United Kingdom.

Manufacturer

Drugsrus Limited