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BETALOC AMP 1MG/ML 5ML N5

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-28
BETALOC-drug/medicine -ampoules aproximate price on "BETALOC AMP 1MG/ML 5ML N5" in Riga city, Latvia is:
  • 17.90€  19.36$  15.35£  2067Rub  206SEK  77PLN  70.85₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -ampoules  BETALOC AMP 1MG/ML 5ML N5     Recheck

Reģ. Nr.: I001493

ATC codeC07AB02 

Active substances: Metoprololi Tartras

 


Vendor, principal: Astra Ab

 Prescription drug (℞) 

* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates.Only the distribution of over-the-counter remedies through the website is permitted in Latvia in accordance with national laws and regulations.
 .

BETALOC ZOK 50MG N30

Package leaflet: information for the user

Betaloc ZOK 25, extended-release tablets for delivering 23.75 mg of the active substance Betaloc ZOK 50, extended-release tablets for delivering 47.5 mg of the active substance Betaloc ZOK 100, extended-release tablets for delivering 95 mg of the active substance
Metoprolol succinate

Read all of this leaflet carefully before you start using 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 symptoms 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.

What is in this leaflet

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

1.   What Betaloc ZOK is and what it is used for

Metoprolol succinate is a selective beta-1-adrenergic receptor blocker. Metoprolol succinate reduces the effect of stress hormones on the beta-1-adrenergic receptors in the heart, kidneys and brain.
Betaloc ZOK is used:
-   To treat high blood pressure (to reduce blood pressure, to reduce the risk of developing cardiovascular disease and mortality, including sudden death) and reduce the risk of complications (e.g. stroke, myocardial infarction, sudden death) resulting from high blood pressure
-   To treat myocardial infarction and prevent further infarctions (maintenance therapy after myocardial infarction).
-   For heart and chest pain caused by stress or physical exercise on patients with ischemia or coronary heart disease (stenocardia).
-   For improving survival rates in the case of chronic heart failure, for decreasing the need for hospitalisation and alleviating cardiac symptoms (symptomatic mild or severe chronic heart failure with other treatments for heart failure: to improve survival rate, to reduce the need for hospitalisation, to improve left ventricle function, to treat heart failure and improve quality of life);
-   In patients with arrhythmia, especially in the case of tachycardia (arrhythmia, especially supraventricular tachycardia).
-   To prevent migraines (migraine prophylaxis).

2.   What you need to know before you use Betaloc ZOK Do not take Betaloc ZOK:

-   If you are allergic (hypersensitive) to metoprolol succinate or any of the other ingredients of Betaloc ZOK (listed in section 6).
-   If you have ever had symptoms caused by low blood sugar (hypoglycemia).
-   If you have ever had unusual reactions to other medicines.
Also inform your doctor of any other health problems, especially if they are related to the heart, circulatory system, lungs, liver or kidneys. Make sure to mention allergic reactions to insect bites, foods or other substances.

Warnings and precautions

-   Talk to your doctor immediately if your heart rate becomes too slow during treatment with Betaloc ZOK. Your doctor may lower your dose or taper you off the medicine.
-   Tell your doctor or dentist about using Betaloc ZOK if you are planning to undergo dental procedures or operations under general anaesthesia.
-   Treatment with Betaloc ZOK should not be stopped suddenly. If stopping treatment is necessary, it should be done gradually, over a period of at least two weeks if possible. The dosage should be tapered off to half a tablet of Betaloc ZOK 25 once a day, which should be taken at least 4 days before stopping treatment.
Tell your doctor about previous allergic, unpleasant or unusual reactions to Betaloc ZOK or other medicines.

Other medicines and Betaloc ZOK

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines.
Medicines that may alter the therapeutic effect of metoprolol succinate are other medicines which affect the cardiovascular system (e.g. digitalis/digoxin, calcium channel blockers, medicines for arrhythmia, sympathetic ganglion blockers, hydralazine), monoamine oxidase (MAO) inhibitors, inhalational anaesthetics, some antibiotics (e.g. rifampicin), peptic ulcer medicines (e.g. cimetidine), nonsteroidal anti-inflammatory drugs (e.g. indomethacin, celecoxib), certain antidepressants and antipsychotics, antihistamines, other beta-adrenergic receptor blockers (e.g. eye drops that contain beta-adrenergic receptor blockers) and other substances (e.g. alcohol, some hormones).
If you are using both clonidine and Betaloc ZOK and you need to stop clonidine treatment, then taking Betaloc ZOK should be stopped a few days before stopping clonidine treatment. See section "Warnings and precautions” on stopping treatment with Betaloc ZOK.
It may be necessary to modify the dosage of Betaloc ZOK if you are also using oral medicines for diabetes.

Betaloc ZOK with food and drink

Drinking alcohol during treatment with metoprolol succinate may increase the levels of metoprolol succinate in the blood and increase its effect.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine. Tell your doctor if you are pregnant, planning to have a baby or breast-feeding. Do not use Betaloc ZOK during pregnancy or breast-feeding unless your doctor deems it vitally important.
ß-blockers, including metoprolol, may cause fetal damage and premature birth. Betaloc ZOK may cause side effects, such as reduced heart rate of the fetus or new-born child.
Betaloc ZOK is excreted into human milk to a limited degree. If the breast-feeding mother is taking metoprolol succinate in normal doses, the risk of negative side effects to the infant appears to be low.

Driving and using machines

As metoprolol succinate may cause dizziness and fatigue, you should be aware of the medicine’s effects on you before driving or using machines.

3. How to take Betaloc ZOK

Always use Betaloc ZOK exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Betaloc ZOK extended-release tablets or halved tablets must not be chewed or crushed. They have to be swallowed with liquid. The score line on Betaloc ZOK 50 and Betaloc ZOK 100 tablets is meant for halving the tablet to ease swallowing. Betaloc ZOK 50 and Betaloc ZOK 100 tablets cannot be halved into equal doses. Only the Betaloc ZOK 25 tablet can be halved into equal doses.
It is recommended to take Betaloc ZOK once a day with or without food. Ask your doctor how and when to take this medicine.
Hypertension
Adults: In the case of mild or moderate hypertension, one Betaloc ZOK 50 tablet is taken once a day. In patients, whose condition does not respond to treatment with one Betaloc ZOK 50 tablet, the doctor may increase the dose to 95...190 mg (one or two tablets of Betaloc ZOK 100) once a day or combine Betaloc ZOK with other blood pressure lowering medicines.
It has been reported that prolonged treatment with metoprolol at doses 95...190 mg (one or two tablets of Betaloc ZOK 100) per day reduces the risk of possible complications caused by high blood pressure (stroke, myocardial infarction, sudden death).
Children: Betaloc ZOK is not recommended for the treatment of children under 6 years of age. For children aged 6 years and older, the dosage depends on the body mass of the child. The doctor will determine the right dosage for the child.
Myocardial infarction (maintenance therapy)
The usual dosage for prolonged treatment is 190 mg (two tablets of Betaloc ZOK 100) once a day. It has been reported that prolonged treatment with metoprolol at a dose of 190 mg (two tablets of Betaloc ZOK 100) per day reduces the risk of mortality and recurrent myocardial infarction.
Stenocardia
The recommended dosage is 95...190 mg (one to two tablets of Betaloc ZOK 100) once a day. Your doctor may prescribe you other medicines for treating stenocardia at the same time.
Heart failure
The dosage should be adapted individually, the recommended starting dose is either half or one whole tablet of Betaloc ZOK 25 once a day for the first 1...2 weeks of treatment. After that, it is recommended to double the dose every two weeks until reaching the maximum dose of 190 mg (two tablets of Betaloc ZOK 100) once a day or until reaching the highest tolerated dosage.
Arrhythmia
The recommended dose is 95...190 mg (one to two tablets of Betaloc ZOK 100) once a day. Functional arrhythmias with palpitations
The recommended dose is 95 mg (one tablet of Betaloc ZOK 100) once a day. If necessary, your doctor can increase the dose to 190 mg (two tablets of Betaloc ZOK 100) per day.
Migraine prophylaxis
The recommended dosage is 95...190 mg (one to two tablets of Betaloc ZOK 100) once a day.
If you feel that the effect of Betaloc ZOK tablets is too strong or too weak, talk to your doctor or pharmacist.

If you use more Betaloc ZOK than you should

If you have taken more Betaloc ZOK than recommended, see your doctor or pharmacist immediately.
The following signs of toxicity may appear at excessive doses: slow or irregular heart rate, breathing difficulties, swelling of the legs, palpitations, dizziness, fainting, chest pain, cold skin, weak pulse, confusion, anxiety, cardiac arrest, tightness in the chest, partial or complete loss of consciousness (or coma), nausea, vomiting, blue discoloration of the skin.
When also drinking alcohol or taking other blood pressure lowering medicines, quinidine or hypnotics (barbiturates) when having overdosed with Betaloc ZOK, the overdose symptoms may be exacerbated.
The first symptoms of overdose appear within 20 minutes to 2 hours of taking the medicine.
If you get some of the symptoms listed above, you must talk to your doctor immediately or turn to an emergency medicine department.

If you forget to take Betaloc ZOK

If you have forgotten to take a dose of Betaloc ZOK and less than 12 hours have passed, take the forgotten dose immediately. If 12 or more hours have passed since the forgotten dose, take only half of the forgotten dose. Take the next dose at the right time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported on patients treated with metoprolol succinate, although the connection to using the medicine has not been entirely confirmed in all cases. If you experience some of the symptoms listed below and the symptoms persist, talk to your doctor.
Common side effects include fatigue, dizziness, headache, slow heart rate, vertigo caused by a change in body position (very rarely may lead to fainting), cold feet and hands, nausea, abdominal pain, diarrhoea, constipation, shortness of breath during physical exercise, heart palpitations.
Uncommon side effects include feelings of burning, tingling or numbness, muscle cramps, temporary exacerbation of heart disease symptoms (breathing difficulties, weakness or swelling of lower limbs), significant drop in blood pressure during myocardial infarction (cardiogenic shock), minor changes in ECG that do not affect heart function, swelling, chest pain, depression, difficulty concentrating, drowsiness, difficulty falling asleep, nightmares, skin rash, vomiting, increased perspiration, weight gain.
Rare side effects include heart blocks (changes in ECG), arrhythmia, nervousness, anxiety, changes in liver function, hair loss, allergic rhinitis, visual impairment, dry eyes and/or irritation, dry mouth, watery eyes and/or redness of the eyes caused by allergic reaction, impotency or sexual dysfunction.
Very rare side effects include disturbances in the blood supply to limbs in patients with severe circulatory problems, joint pain, memory loss / memory impairment, confusion, hallucinations, skin reactions caused by photosensitivity (or sensitivity of the skin to light), exacerbation of psoriasis, murmur in the ears, changes in the sense of taste, decrease in the amount of thrombocytes in the blood, hepatitis.

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.
Do not stop taking Betaloc ZOK without talking to your doctor first.

5. How to store Betaloc ZOK

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30 °C.
Do not use this medicine after the expiry date which is stated on the carton after “Use by:”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines that you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Betaloc ZOK contains:

-   The active substance is metoprolol succinate.
-   The excipients are ethyl cellulose, hypromellose, microcrystalline cellulose, paraffin, macrogol, silicon dioxide, sodium stearyl fumarate and titanium dioxide.

What Betaloc ZOK looks like and contents of the pack

BETALOC ZOK 25, extended-release tablets for delivering 23.75 mg of the active substance. 1 tablet contains 23.75 mg of metoprolol succinate, which is equivalent to 25 mg of metoprolol tartrate and 20 mg of metoprolol.
BETALOC ZOK 50, extended-release tablets for delivering 47.5 mg of the active substance.
1 tablet contains 47.5 mg of metoprolol succinate, which is equivalent to 50 mg of metoprolol tartrate and 39 mg of metoprolol.
BETALOC ZOK 100, extended-release tablets for delivering 95 mg of the active substance.
1 tablet contains 95 mg of metoprolol succinate, which is equivalent to 100 mg of metoprolol tartrate and 78 mg of metoprolol.
30 or 100 tablets per plastic bottle with a polypropylene cap (HDPE), or 14, 28, 30 or 98 tablets in an aluminium (PVC) blister pack.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
AstraZeneca AB S-151 85 Södertälje Sweden
Manufacturer:
AstraZeneca AB Gärtunavägen S-151 85 Södertälje Sweden
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
AstraZeneca Eesti OÜ Järvevana tee 9 11314 Tallinn Phone: +372 6549 600

This leaflet was last revised in October 2014






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia




[*1]

DDD. Information source: WHO Collaborating Centre for Drug Statistics Methodology. Norwegian Institute of Public Health


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