METOPROLOL-EGIS 25MG TABL. N60 N30

ATC code: C07AB02 

Active substances: Metoprololi Succinas

Vendor, principal: Egis. 
METOPROLOL-EGIS 25MG TABL. N60 N30 is compensated medicine in Latvia. 

 Prescription drug (℞) 

METOPROLOL POLPHARMA 25MG N28

Package leaflet: Information for the user

Metoprolol Polpharma 25, 23,75 mg prolonged-release tablets Metoprolol Polpharma 50, 47,5 mg prolonged-release tablets Metoprolol Polpharma 100, 95 mg prolonged-release tablets Metoprolol Polpharma 200, 190 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.

-   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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.   What Metoprolol Polpharma is and what it is used for
2.   What you need to know before you take Metoprolol Polpharma
3.   How to take Metoprolol Polpharma
4.   Possible side effects
5.   How to store Metoprolol Polpharma
6.   Contents of the pack and other information

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

Metoprolol succinate belongs to a group of medicines called beta-blockers.
It is used to treat:
•   high blood pressure
•   a tight pain in the chest caused by insufficient oxygen to the heart (angina pectoris)
•   irregular heart rhythm (arrhythmia)
•   stable heart failure with symptoms (such as shortness of breath or swollen ankles), when taken together with other medicines for heart failure
•   palpitations (feeling your heart beat) due to non-organic (functional) heart disorders.
It is used to prevent:
•   further heart attacks or damage to the heart after a heart attack
•   migraine
Children and adolescents from 6-18 years:
•   for treating high blood pressure (hypertension).

2.   What you need to know before you take Metoprolol Polpharma Do not take Metoprolol Polpharma and tell your doctor if you:

•   are allergic (hypersensitive) to metoprolol, other beta-blockers or any of the other ingredients of this medicine (listed in section 6)
•   have heart conduction problems (2^nd or 3^rd degree atrioventricular block) or heart rhythm problems (sick sinus syndrome)
•   have untreated heart failure, are receiving treatment to increase heart contractions or are in shock caused by heart problems
•   suffer from severe blood circulation problems (severe peripheral arterial disease)
•   have a slow heart rate (less than 50 beats/min)
•   have low blood pressure
•   suffer from increased acidity of the blood (metabolic acidosis)
•   have severe asthma or COPD (chronic obstructive pulmonary disease).
•   have untreated phaeochromocytoma (high blood pressure due to a rare tumour in one of you adrenal glands)
•   have heart failure and your blood pressure keeps falling below 100 mmHg.
Are taking any of the following medicines: (See also “Taking other medicines)
•   Monoamine Oxidase Inhibitors (MAOIs) ( for depression)
•   verapamil and dilitazam. (to lower your blood pressure)
•   an antiarrhythmic such as disopyramide

Warnings and precautions

Take special care with Metoprolol Polpharma and tell your doctor if you:
•   have asthma
•   have Prinzmetal's angina (tight chest pain usually occurring during the night)
•   have diabetes mellitus (low blood sugar levels may be hidden by this medicine)
•   have phaeochromocytoma (high blood pressure due to a rare tumour in one of your adrenal glands)
•   are having treatment to reduce allergic reactions. Metoprolol Polpharma may increase your hypersensitivity to the substances you are allergic to and increase the severity of allergic reactions
•   have an overactive thyroid, (symptoms such as increased heart rate, sweating, tremor, anxiety, increased appetite or weight loss may be hidden by this medicine)
•   have or have suffered from psoriasis (severe skin rashes)
•   suffer from blood circulation problems which may cause your fingers and toes to tingle or turn pale or blue
•   suffer from a heart conduction disorder (heart block)
•   have heart failure and one of the following:
-   unstable heart failure (NYHA IV)
-   had a heart attack or angina attack in the last 28 days
-   reduced kidney or liver function
-   are under 40 years old or over 80 years old
-   diseases of the heart valves
-   enlarged heart muscle
-   had heart surgery in the last 4 months.
If you are going to have an anaesthetic please tell your doctor or dentist that you are taking metoprolol tablets.

Other medicines and Metoprolol Polpharma

Do not take Metoprolol Polpharma if you are already taking:
•   Monoamine Oxidase Inhibitors (MAOIs) for depression (can increase the effect on lowering blood pressure)
•   other blood pressure lowering medicines such as verapamil and diltiazem (can cause slow heart beat or an increased drop in blood pressure)
•   antiarrhythmics such as disopyramide (may increase the risk of irregular or slow heart beat and reduce heart function).
Before taking Metoprolol Polpharma, tell your doctor if you are taking or have taken recently any of the following medicines or are taking any non prescribed medicines:
•   The following medicines can increase the effect on lowering blood pressure:
-   cimetidine (for ulcers)
-   hydralazine and clonidine (blood pressure lowering medicines)
-   terbinafine (for fungal infection)
-   paroxetine, fluoxetine, and sertraline (for depression)
-   hydroxychloroquine (for malaria)
-   chlorpromazine, triflupromazine, chlorprothixene (antipsychotic medications)
-   amiodarone, chinidine, and propafenone (for irregular heart rhythm)
-   diphenhydramine (antihistamine)
-   celecoxib (for pain).
•   The following medicines can reduce the effect on lowering blood pressure:
-   indometacin (for pain)
-   rifampicin (antibiotics).
•   Other medicines that may affect or can be affected by metoprolol:
-   other beta-blockers, e.g. eye drops.
-   adrenaline (epinephrine), noradrenaline (norepinephrine) or other sympathomimetics
-   medicines used to treat diabetes, the symptoms of low blood sugar may be hidden
-   lidocaine
-   reserpine, alpha-methyldopa, guanfacine, cardiac glycosides.

Metoprolol Polpharma with alcohol

Alcohol may increase the blood pressure lowering effect of Metoprolol Polpharma tablets.

Pregnancy and breastfeeding

Metoprolol Polpharma are not recommended during pregnancy or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Metoprolol Polpharma may make you feel tired and dizzy. Make sure you are not affected before you drive or operate machinery, particularly after changing to another medicine or if taken with alcohol.

3. How to take Metoprolol Polpharma

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Take once daily with a glass of water in the morning. Swallow the tablet whole or divided. Do not chew or crush before swallowing.

Usual doses:

•   High blood pressure:
47.5 mg metoprolol succinate once daily. The dose may be increased to 95-190 mg once daily if necessary.

•   Tight chest pain (Angina pectoris):

95-190 mg metoprolol succinate once daily.

•   Irregular heart beats (arrhythmia):

95-190 mg metoprolol succinate once daily.

•   Preventive therapy following a heart attack.

190 mg metoprolol succinate once daily.

•   Palpitations due to heart disease:

95 mg metoprolol succinate once daily. The dose may be increased to 190 mg once daily if necessary.

•   Prevention of migraine:

95-190 mg metoprolol succinate once daily.

•   Patients with stable heart failure:

Always follow your doctor’s advice.

Patients with impaired liver function:

If you have severely impaired liver function your doctor may adjust the dose. Always follow your doctor’s advice.

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 0.48 mg/kg once a day but not exceeding 47.5 mg. The dose will be adjusted to the nearest tablet strength. Your doctor may increase the dose to 1.9 mg/kg depending on blood pressure response. Doses above 190 mg once daily have not been studied in children and adolescents.
Metoprolol Polpharma tablets are not recommended for children under 6 years.

If you take more Metoprolol Polpharma 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, irregular heart rhythm, cardiac arrest, shortness of breath, deep unconsciousness, nausea, vomiting and blue colouring of the skin.

If you forget to take Metoprolol Polpharma

If you forget to take a dose, take it as soon as you remember, then go on as before.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Metoprolol Polpharma

Do not suddenly stop taking Metoprolol Polpharma 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment and contact your doctor at once if you have symptoms of an allergic reaction such as itchy skin rash, flushing, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

effects or notice any other effects not listed: from lying position), which very rarely may

Tell your doctor if you notice any of the following side Very common (more than 1 in 10 patients):

•   marked fall in blood pressure (also on standing up cause fainting
•   tiredness.
Common (less than 1 in 10 but more than 1 in 100 patients):
•   slow heartbeat
•   difficulty in maintaining balance (very rarely with fainting)
•   cold hands and feet palpitations
•   dizziness, headache
•   feeling sick, diarrhoea, constipation, abdominal pain
•   shortness of breath with strenuous physical activity.
Uncommon (less than 1 in 100 but more than 1 in 1,000 patients):
•   temporary worsening of symptoms of heart failure
•   fluid retention (swelling)
•   chest pain
•   pins and needles
•   muscle cramps
•   vomiting (being sick)
•   weight gain
•   depression
•   reduced concentration
•   difficulty in sleeping (insomnia)
•   drowsiness
•   nightmares
•   shortness of breath
•   skin rash
•   increased sweating.
Rare (less than 1 in 1,000 but more than 1 in 10,000 patients):
•   worsening of diabetes
•   nervousness, anxiety
•   visual disturbances
•   dry or irritated eyes
•   conjunctivitis (a kind of eye infection)
•   impotence (inability to obtain an erection)
•   Peyronie’s syndrome (bending of penis on erection)
•   irregular heart beat
•   heart conduction disturbances
•   dry mouth
•   runny nose
•   hair loss
•   changes in liver function tests.
Very rare (less than 1 in 10,000 users):
•   changes in blood cells counts (thrombocytopenia, leukopenia)
•   forgetfulness
•   confusion
•   hallucinations
•   mood changes
•   ringing in the ears
•   hearing problems
•   taste changes
•   inflammation of the liver (hepatitis)
•   sensitivity to light
•   worsening or new psoriasis (a type of skin disease)
•   muscle weakness
•   joint pain
•   tissue death in patients with severe blood circulation problems.
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 www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metoprolol Polpharma

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not take the tablets after the expiry date which is stated on the carton. The expiry date is also stated on the back of the strip after ‘Exp’. The expiry date refers to the last day of the 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 Polpharma contains

•   The active substance (the ingredient that makes the tablets work) is metoprolol succinate. Each tablet contains:
-   23.75 mg metoprolol succinate equivalent to 25 mg metoprolol tatrate
-   47.5 mg metoprolol succinate equivalent to 50 mg metoprolol tatrate
-   95 mg metoprolol succinate equivalent to 100 mg metoprolol tatrate
-   190 mg metoprolol succinate equivalent to 200 mg metoprolol tatrate
•   The other ingredients are:
Tablet core: cellulose, microcrystalline; methylcellulose; maize starch: glycerol; ethylcellulose and magnesium stearate.
Tablet coating: cellulose, microcrystalline; hypromellose; stearic acid and titanium dioxide (E171).

What Metoprolol Polpharma looks like and contents of the pack

Metoprolol Polpharma 23.75 mg, 47.5 mg, 95 mg and 190 mg tablets are white, oval. biconvex film-coated tablets scored on both sides.
10, 14, 20, 28, 30, 50, 56, 60, 98, 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Pharmaceutical Works POLPHARMA SA 19 Pelplinska Str.
83-200 Starogard Gdanski Poland
Manufacturer
Pharmaceutical Works POLPHARMA SA 19 Pelplinska Str.
83-200 Starogard Gdanski Poland
or
Farmaprojects, S.A. Santa Eulalia 240-242,
08902 L’Hospitalet de LLobregat- Barcelona Spain
or
Pharmaceutical Works POLPHARMA SA Production Department in Nowa D^ba 1 Szypowskiego Str.
39-460 Nowa D^ba Poland
or
Sofarimex Industria Qmmica e Farmaceutica, S.A. Av. das Industrias- Alto do Colaride 2735-213 Cacem Portugal
(only 25 mg, 50 mg and 100 mg tablet manufacturer)
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Pharmaceutical Company "POLPHARMA" SA Representative office in Baltic countries E. Ožeškienes 18 A,
Kaunas, LT-44254 Lithuania
Phone: + 370 37 325131

This leaflet was last revised in March 2018.