Metoprolol

• Beta-blocker
• For high blood pressure and heart problems
• Can also be used to prevent migraine attacks
• May affect your reaction time
• Avoid drinking alcohol while taking this medicine

About Metoprolol

Metoprolol belongs to a class of medicines called beta-blockers. Metoprolol lowers blood pressure and heart rate.

This medicine is used to treat various conditions, including:

• High blood pressure.
• Cardiac arrhythmia.
• Angina pectoris (chest pain).
• Heart attack prophylaxis.
• Overactive thyroid gland.
• Migraine prophylaxis.

How to use Metoprolol

Always take this medicine exactly as your doctor has told you. The tablet should be swallowed whole with some water. Metoprolol prolonged release tablets can be taken with or without food.

Dosage

The doctor will tell you how many Metoprolol tablets to take and when to take them. The dose you are prescribed will depend on your symptoms. The recommended dose in adults and children is:

For high blood pressure (hypertension):

• Adults: the usual starting dose is one tablet Metoprololsuccinaat Sandoz retard 50 once a day. This dose may be increased to a maximum of 100-200 mg once a day.
• Children aged 6 or older: the dose depends on the body mass of the child. The usual starting dose is 0.5 mg/kg once a day, but not more than 50 mg.

For chest tightness or pain (angina pectoris):

• Adults: 100-200 mg once a day. Maximum two tablets of Metoprololsuccinaat Sandoz retard 200 a day.

For heart rhythm disorders (arrhythmia):

• Adults: 100-200 mg spread out over the day. Your doctor may increase the dose if necessary.

For an overactive thyroid (hyperthyroidism):

• Adults: 100-200 mg spread out over the day. Your doctor may increase the dose if necessary.

For migraine prophylaxis:

• Adults: 100-200 mg once a day.

Alcohol/driving

This medicine may cause side effects such as dizziness or tiredness. If you experience these side effects, you should avoid driving until the symptoms have passed.

Avoid drinking alcohol while taking this medicine as this is likely to trigger or worsen the side effects.

Taken too much/forgot to take/stop taking Metoprolol

If you take more tablets than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take a tablet, you may take it as soon as you remember unless it is almost time for your next scheduled dose. Never take a double dose to make up for the forgotten one.

Do not stop taking Metoprolol without consulting a doctor first. If stopping the treatment is necessary, the dosage should be gradually decreased.

When not to use Metoprolol

Metoprolol is not suitable for everyone. and should not be used if:

• You are allergic any of the ingredients of this medicine (see section ‘What Metoprolol contains').
• You are allergic to other blood pressure reducers that belong to a class of medicines called beta-blockers.
• You have a disease of the cardiac conduction system (second- and third-degree AV block).
• You have had acute heart failure or have uncontrolled heart failure, with fluid retention in the lungs (pulmonary oedema) or low blood pressure (hypotension).
• You suffer from septic shock with considerably impaired cardiac pump function.
• You have severe blood circulation problems.
• You have a slow resting heart rate (bradycardia).
• You are being treated continuously or intermittently with medicines that help to improve the heart's pumping action (so-called bèta-2-agonists).
• You have a type of heart rhythm disorder called sick sinus syndrome.
• You have a history of myocardial infarction in combination with a slow heart rate, low blood pressure and heart failure.
• You are being treated with verapamil by injection into a vein. This may lower your blood pressure and cause disturbance of cardiac conduction or heart failure.
• You suffer from lung problems such as asthma or other respiratory disorders.
• You have a tumour of the adrenal gland (phaeochromocytoma), which may cause irregular bursts in blood pressure, severe headache, sweating and a faster than normal heartbeat.

When should this medicine be used with caution?

In some cases, you should take special care when using Metoprolol. For instance, if you have:

• Diabetes.
• Surgery planned.
• A faster than normal heartbeat (tachycardia).
• A blood circulation disorder, such as Raynaud’s syndrome.
• Asthma or any other breathing disorder.

For a complete list of warnings and explanations, see the package leaflet. Always consult a doctor if any of the warnings apply to you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, ask your doctor for advice before using this medicine. Metoprolol may not be suitable for you. You may need to switch to another medicine.

Other medicines and Metoprolol

Metoprolol may interact with other medicines, including:

• Calcium antagonists, such as verapamil or diltiazem.
• Rifampicin.
• Medicines for allergy relief (antihistamines).
• Medicines used to treat or prevent psychoses (antipsychotics) and states of depression (antidepressants).
• Certain group of anti-inflammatory painkillers (selective COX-2 inhibitors).
• Ganglionic blockers (used in neurological diseases).
• Monoamine oxidase inhibitors (MAOIs) for depression and other beta-blockers (including those used in the form of eyedrops).
• Clonidine.
• Medicines for heart problems including angina pectoris (e.g., amiodarone, quinidine).
• Anaesthetics.
• Indometacin.
• Insulin and other oral medicines to treat diabetes.
• Licodiane, a local anaesthetic.
• Digitalis, a medicine that helps a weakened heart pump more efficiently.
• Nitroglycerin, a medicine for heart problems including angina pectoris.
• Prazosin, a medicine for high blood pressure and Raynaud’s syndrome.

Talk to your doctor if you are taking any of these medicines. The doctor will know what medicines you should avoid mixing Metoprolol with. See the package leaflet for more information.

Side effects

Medicines can cause side effects, although some people may not experience any. The side effects of Metoprolol include:

Very common:

• Tiredness.

Common:

• Slow heartbeat, palpitations.
• Feeling dizzy, especially when getting up from a sitting or lying down position (sometimes with loss of consciousness).
• Dizziness and headache.
• Shortness of breath with exertion.
• Nausea, vomiting, abdominal pain.
• Tiredness.

Uncommon:

• Severe blood circulation problems (cardiogenic shock) in patients with acute myocardial infarction.
• Disturbances of cardiac conduction (first-degree AV block).
• Pain in the chest below the breastbone.

Rare:

• Heart failure (reduced pumping ability of the heart).
• Heart rhythm disturbances.
• Depression, decreased alertness, sleepiness or insomnia and nightmares, nervousness, anxiety.
• Fluid retention (oedema), pale or bluish colour skin of the fingers or toes (Raynaud's syndrome).
• Abnormal sensation of the skin (tingling, pricking, itching) with no apparent physical cause (paresthesia).
• Shortness of breath caused by tightening of the muscles that line the airways (bronchospasm).
• Diarrhoea or constipation.
• Hepatic impairment, abnormalities in liver function tests.
• Skin rash, possibly with severe itching and lumps (hives), psoriasis-like skin eruptions and skin growth problems.
• Muscle cramps.

For more uncommon and rare side effects, please see the package leaflet. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this package leaflet.

What Metoprolol contains

The active substance is metoprolol succinate.

• Metoprololsuccinaat Sandoz retard 25: one tablet contains 23.75 mg metoprolol succinate, equivalent to 25 mg metoprolol tartrate.
• Metoprololsuccinaat Sandoz retard 50: one tablet contains 47.5 mg metoprolol succinate, equivalent to 50 mg metoprolol tartrate.
• Metoprololsuccinaat Sandoz retard 100: one tablet contains 95 mg metoprolol succinate, equivalent to 100 mg metoprolol tartrate.
• Metoprololsuccinaat Sandoz retard 200: one tablet contains 190 mg metoprolol succinate, equivalent to 200 mg metoprolol tartrate.

The other ingredients are: sucrose, maize starch, glucose (liquid), polyacrylate, talc (E553B), magnesium stearaat (E470b), cellulose microcrystalline (E460), crospovidone, colloidal anhydrous silica (E551), lactose, hypromellose (E464), titanium dioxide (E171), macrogol 4000.

Metoprololsuccinaat Sandoz retard 100 also contains yellow iron oxide (E172).

The manufacturers of Metoprololsuccinaat Sandoz Retard are:

Salutas Pharma GmbH Otto-von-Guericke Allee 1
39179 Barleben
Germany

Sandoz B.V. Postbus 10332
1301 AH Almere
The Netherlands

Package leaflet

Read the package leaflet before use. The official package leaflet of Metoprololsuccinaat Sandoz Retard is available for download here.