Document: Metoprolol ratiopharm prolonged-release tablet ENG PL change

• Metoprolol Teva prolonged-release tablet PL
• Metoprolol ratiopharm prolonged-release tablet ENG PL

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PACKAGE LEAFLET:INFORMATION FOR THE USER

Metoprolol ratiopharm 25 mg prolonged-release tablets

Metoprolol ratiopharm 50 mg prolonged-release tablets

Metoprolol ratiopharm 100 mg prolonged-release tablets

Metoprolol ratiopharm 200 mg prolonged-release tablets

Metoprolol succinate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

What is in this leaflet:

1. What Metoprolol ratiopharm is and what it is used for

Metoprolol ratiopharm belongs to a group of medicines known as beta blocking agents. Metoprolol reduces the effect of stress hormones on the heart in connection with physical and mental exertion.This results in the heart beating slower (pulse rate is reduced).

Metoprolol ratiopharm prolonged-release tablets are used:

Adults:

• for the treatment of high blood pressure

• to prevent angina pectoris

• for the treatment of heart failure

• for the treatment of palpitation (unduly rapid or irregular heart beat) in some cases

• for the treatment of certain types of arrhythmia (irregular heart beat)

• for prophylactic treatment after an acute heart attack

• prophylactic treatment for migraine.

Children and adolescents from 6-18 years:

2. What you need to know before you take Metoprolol ratiopharm

Do not take Metoprolol ratiopharm

• if you are allergic (hypersensitive) to metoprolol succinate, any of the other ingredients of this medicine (listed in section 6)

• if you are suffering from shock due to severe heart problems,

• if you suffer from a diseased sinus node in the heart (sick sinus syndrome),

• if you have a serious heart block (conduction disorder)

• if you suffer from untreated heart insufficiency,

• if you have very low blood pressure and/or a very low heart rate,

• if you have recently suffered a heart attack and have the following special conditions (heart rate less than 45 beats per minute, abnormal ECG, the upper value of your blood pressure is less than 100 mmHg).

• if you suffer from heart insufficiency and your upper value of your blood pressure is less than 100 mmHg at lying,

• if you suffer from advanced blood circulation disorder in the arms or/and legs

Warnings and precautions

Talk to your doctor or pharmacist before taking Metoprolol ratiopharm if you have any one of the following conditions:

• asthma

• considerable problems with narrowing of the bronchi

• severe acute conditions with a high concentration of acid agents in the body (acidosis)

• vasospastic angina due to spasms of the coronary arteries (Prinzmetal’s angina)

• severe kidney impairment

• intermittent claudication; the condition of patients with intermittent claudication may worsen when blood pressure becomes lower with Metoprolol ratiopharm medication

• before undergoing surgery inform the doctor that you have this medication.

Other medicines and Metoprolol ratiopharm

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

Certain concomitant medications can change the effect of Metoprolol ratiopharm therapy or respectively Metoprolol ratiopharm can change the effect of these concomitant medications. Therefore it is particularly important to tell the doctor of the use of the following medications:

• propafenone, amiodarone, quinidine, verapamil, diltiazem, clonidine, disopyramide and hydralazine, digitalis/digoxin (medicines for treatment of cardiovascular diseases)

• barbituric acid derivatives (antiepileptic medicines)

• anti-inflammatory medicines (for example indometacin and celecoxib)

• adrenaline (medicine used for treatment of acute shock and severe allergic reactions)

• phenylpropanolamine (medicine against the swelling of nasal mucosa)

• diphenhydramine (antiallergic medicine)

• terbinafine (medicine for treatment of fungal infections in the skin)

• rifampicin (medicine for treatment of tuberculosis)

• other beta blocking agents (for example eye drops)

• MAO inhibitors (antidepressants and medicines for treatment of Parkinson’s disease)

• inhalation anaesthetics (agents used in anaesthesia)

• oral antidiabetics

• cimetidine (antacid)

• antidepressants (paroxetine, fluoxetine and sertraline).

Metoprolol ratiopharm with food and drink

Metoprolol ratiopharm can be taken with or without food.

Pregnancy and 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.

Pregnancy

Metoprolol may only be used in pregnancy (particularly in the last 3 months) after the responsible doctor has precisely evaluated the benefits and risks. Metoprolol passes into the placenta and reduces perfusion of the placenta; this can damage the unborn child. Metoprolol should be discontinued 48-72 hours before the calculated time of birth. If this is not possible, the new born baby must be carefully monitored for 48-72 hours after the birth.

Breast feeding

Metoprolol passes into breast milk. Undesirable effects are not to be expected after therapeutic dosages. Breast fed babies should nevertheless be observed for possible drug effects.

Driving and using machines

Metoprolol ratiopharm may in rare cases cause dizziness and tiredness and affect the ability to concentrate. So before you drive a vehicle, use machinery, or carry out other activities that require concentration, make sure you know how you react to the effects of Metoprolol ratiopharm.

Metoprolol ratiopharm containssucrose

Metoprolol ratiopharm contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Metoprolol ratiopharm

Always take this medicine exactly as your doctor has told you.Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults:

Children and adolescents:

High blood pressure:

For children aged 6 years and older, the dose depends on the child’s weight. The doctor will work out the correct dose for your child.

The usual start dose is 0.5 mg/kg once a day. The dose will be adjusted to the nearest tablet strength. Your doctor may increase the dose to 2.0 mg/kg once a day depending on blood pressure response. Doses above 200 mg once daily have not been studied in children and adolescents.

Metoprolol ratiopharm prolonged-releasetablets are not recommended for children under 6 years.

Method of administration

Metoprolol ratiopharm prolonged-release tablets can be divided but not crushed or chewed and should be swallowed with a sufficient amount of liquid (at least half a glass).

Metoprolol ratiopharm prolonged-release tablets provide a steady effect over the entire 24‑hour period, and should therefore be taken once daily.

The tablet can be divided into equal doses.

If you take more Metoprolol ratiopharm than you should

If you have taken a too high dose of a medicine, always contact a doctor, hospital or the Poison Information Centre for risk evaluation and to receive guidance.

Depending on the extent of the overdose, this can lead to excessive reduction in blood pressure and a decrease in heart rate. As a consequence of the failure of heart function, this can even lead to cardiac arrest, heart muscle weakness and shock. Other symptoms include problems in breathing, constriction of the muscles in the respiratory tract, vomiting, disturbances of consciousness and even occasionally generalised seizures.

If you forget to take Metoprolol ratiopharm

If you forgot to take Metoprolol ratiopharm, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with your normal dosage schedule. You should check with your doctor or pharmacist if you are not sure.

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

If you stop taking Metoprolol ratiopharm

Do not stop taking Metoprolol ratiopharm without first discussing it with your doctor because certain symptoms (for example palpitation and angina pectoris) can worsen if the use of the medicine is discontinued abruptly.

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

4. Possible side effects

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

Common (less than 1 in 10 but more than 1 in 100 patients):

Tiredness, headache, dizziness, cold hands and feet, low pulse rate, palpitation, stomach ache, nausea, vomiting, diarrhoea, constipation.

Uncommon (less than 1 in 100 patients but more than 1 in 1,000 patients):

Chest pain, weight gain, sleep disturbances, tingling in the skin, shortness of breath, worsening of symptoms in the airways, transient impairment of heart failure.Blood pressure can decrease severely during a myocardial infarction.

Rare (less than 1 in 1,000 patients but more than 1 in 10,000 patients):

Increased sweating, hair loss, changes in taste, transient impairment in sexual function, nightmares, lowered spirits, memory disturbances, confusion, nervousness, anxiety, hallucinations, occurrence of hypersensitivity reactions in the skin such as redness or rash and worsening of psoriasis, hypersensitivity to sunlight, decrease in platelet count (thrombocytopenia), slowing of heart function, arrhythmias, oedema, fainting, liver effects, visual disturbances, ringing in the ears (tinnitus).

Very rare (less than 1 in 10,000 users):

Following reactions have been reported:

Joint ache, inflamed liver, muscle cramps, dry mouth, dry and irritated eyes, allergic rhinitis (runny and stuffy nose), impairment of concentration, local tissue death (gangrene) in patients with severe circulatory disturbances.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes anypossibleside effects not listed in this leaflet. You can also report side effects directly (see detail below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Metoprolol ratiopharm

Keep this medicine out of sight and the reach of children.

Do not use this medicine after the expiry date which is stated on the package after EXP.The expiry date refers to the last day of that month.

Do not store above 25^oC.

Do not throw away any medicines via wastewater. 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 ratiopharm contains

• The active substance is metoprolol succinate.
  Each tablet contains 23.75 mg, 47.5 mg, 95 mg or 190 mg metoprolol succinate equivalent to 25 mg, 50 mg, 100 mg or 200 mg of metoprolol tartrate.

• The other ingredients are

Tablet core:

Sugar spheres (containing sucrose and maize starch), macrogol, ethyl acrylate-methyl methacrylate copolymer, povidone, microcrystalline cellulose, magnesium stearate, silica (colloidal anhydrous).

Tablet coating:

Hypromellose, talc, macrogol, titanium dioxide (E 171).

What Metoprolol ratiopharm looks like and contents of the pack

Metoprolol ratiopharm 25 mg prolonged-release tablets

White, oblong, biconvex tablet with a break line on both sides (dimension: approx. 9.2 x 4.2 mm).

Metoprolol ratiopharm 50 mg prolonged-release tablets

White, oblong, biconvex tablet with a break line on both sides (dimension: approx. 12.2 x 5.7 mm).

Metoprolol ratiopharm 100 mg prolonged-release tablets

White, oblong, biconvex tablet with a break line on both sides (dimension: approx. 15.2 x 7.2 mm).

Metoprolol ratiopharm 200 mg prolonged-release tablets

White, oblong, biconvex tablet with a break line on both sides (dimension: approx. 19.2 x 9.2 mm).

Blisters:

Metoprolol ratiopharm 25 mg prolonged-release tablets are available in packs with 14, 28, 30, 50x1, 50, 56, 60, 90, 98, 100 prolonged-release tablets.

Metoprolol ratiopharm 50 mg prolonged-release tablets are available in packs with 28, 30, 50x1, 50, 56, 60, 90, 98, 100 prolonged-release tablets

Metoprolol ratiopharm 100 mg prolonged-release tablets are available in packs with 28, 30, 50x1, 50, 56, 60, 90, 98, 100 prolonged-release tablets

Metoprolol ratiopharm 200 mg prolonged-release tablets are available in packs with 28, 30, 50, 56, 60, 90, 98, 100 prolonged-release tablets

Bottles:

Metoprolol ratiopharm prolonged-release tablets are available in bottles with 30, 60, 100, 250 and 500 prolonged-release tablets.

(Not all pack sizes may be marketed.)

Marketing Authorisation Holder

ratiopharm GmbH,

Graf-Arco-Strasse 3,

D-89079 Ulm, Germany

Manufacturer

Merckle GmbH,

Ludwig-Merckle-Strasse 3,

D-89143 Blaubeuren, Germany

Etnovia Oy,

Teollisuustie 16-18,

60100 Seinäjoki, Finland

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark: Metoprololsuccinat Teva

Finland, Norway, Slovakia: Metoprolol ratiopharm

Sweden: Metoprolol ratiopharm

Netherlands: Metoprololsuccinaat ratiopharm retard

Poland (only 23,75, 47,5, 95 mg): Metoprololum 123ratio

This leaflet was last approved in 23 September 2014