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METFORAL TBL OBD 500MG N120

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-29
METFORAL-drug/medicine -tablets aproximate price on "METFORAL TBL OBD 500MG N120 " in Riga city, Latvia is:
  • 8.47€  9.16$  7.24£  978Rub  97.6SEK  37PLN  33.71₪ 


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  METFORAL TBL OBD 500MG N120     Recheck

ATC codeA10BA02 

Active substances: Metforminum

 


Vendor, principal: Berlin-Chemie Ag
METFORAL TBL OBD 500MG N120 is compensated medicine in Latvia. 

 Prescription drug (℞) 

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 .

METFORMIN-RATIOPHARM 500MG N120

Package leaflet: information for the user

Metformin-ratiopharm 500 mg film-coated tablets Metformin-ratiopharm 850 mg film-coated tablets

Metformin hydrochloride

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

1. What Metformin-ratiopharm is and what it is used for

Metformin-ratiopharm is an oral antidiabetic medicine (blood sugar lowering medicine).
Indications.
Used for treating non-insulin-dependent (type 2) diabetes, especially recommended for overweight patients if dieting and physical exercise have not been enough to control metabolism.
Metformin is a biguanide derivative with an antihyperglycaemic effect that lowers both basal and postprandial glucose content in the blood. It does not stimulate the secretion of insulin and therefore does not cause hypoglycaemia.
The effect of metformin is believed to rely on three mechanisms:
1)   A decrease in the production of glucose in the liver due to the inhibition of gluconeogenesis and glycogenolysis.
2)   An increase in the insulin sensitivity of muscle tissues and therefore an increase in peripheral utilisation and absorption of glucose.
3)   A reduction in the rate of intestinal absorption of glucose.
Adults
Your doctor may prescribe you Metformin-ratiopharm as a monotherapy or in combination with other oral antidiabetic medicines or insulin.
Children and adolescents
Your doctor may prescribe Metformin-ratiopharm to children aged 10 or older and adolescents as a monotherapy or in combination with insulin.
In humans, independent of its effect on blood sugar levels, metformin has a beneficial effect on lipid metabolism, which was demonstrated in medium-term and long-term controlled studies of administering the medicine. Metformin lowers the levels of total cholesterol, LDL cholesterol and triglycerides.

What you need to know before you take Metformin-ratiopharm

2.

Do not take Metformin-ratiopharm

-   If you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6);
-   If your kidney function has decreased significantly.
-   If you have uncontrolled diabetes that is accompanied with severe hyperglycaemia (high blood sugar levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see section below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood, which may lead to diabetic precoma. Symptoms include abdominal pain, fast and deep breathing, sleepiness or unusual fruity odour of the breath.
-   If you have an acute condition that may lead to the impairment of liver function, such as
■   dehydration (deficit of body water) due to prolonged vomiting or severe diarrhoea;
■   severe infections;
■   shock.
-   If you get an intravascular injection of contrast media containing iodine, before or during the examination and up to 48 hours following it.
-   If you have acute or chronic diseases that may cause hypoxia in tissues, such as:
■   heart or respiratory failure;
■   recent heart attack;
■   shock.
-   If you have liver failure or acute alcohol poisoning.
-   In the case of alcoholism.

Warnings and precautions

Risk of lactic acidosis
Metformin-ratiopharm may cause a very rare, but severe complication called lactic acidosis, particularly if your kidneys are not working properly. Factors that increase the risk of lactic acidosis include uncontrolled diabetes, severe infections, prolonged fasting or alcohol use, dehydration (see further information below), liver problems and any medical conditions in which there is decreased blood supply to some body part (e.g. severe heart disease).
If any of the above applies to you, ask your doctor for more information.
Stop taking Metformin-ratiopharm for a while if you have a condition that may cause dehydration (significant loss of body fluids), such as vomiting, diarrhoea, fever, exposure to heat or reduced consumption of liquids. For more information, talk to your doctor.

Stop taking Metformin-ratiopharm and contact your doctor or the emergency department of the nearest hospital if you have any of the symptoms of lactic acidosis, as this may lead to coma.

The symptoms of lactic acidosis are:
-   Vomiting.
-   Abdominal pain.
-   Muscle cramps.
-   Generally feeling unwell    and    very tired.
-   Breathing difficulties.
-   Decreased body temperature    and heart rate.
Lactic acidosis is a severe medical condition that needs to be treated at the hospital.
If you are about to have major surgery, you must stop taking Metformin-ratiopharm for some time before and after the procedure. Your doctor will determine when you must stop and when you can continue taking Metformin-ratiopharm.
During treatment, your doctor will test your kidney function at least once a year or more frequently if you are elderly and/or your kidney function is decreasing.
Kidney function
As metformin is excreted by the kidneys, the levels of serum creatinine need to be checked before and periodically after you begin treatment:
-   At least once a year in patients with normal kidney function.
-   At least 2...4 times a year in patients with serum creatinine levels on the higher end of the normal range and also in elderly patients.
In elderly patients, a decrease in kidney function occurs often and without symptoms. Particular care must be taken in situations where there is a risk of developing kidney function disorders (e.g. before treatment with high blood pressure medicines, diuretics or nonsteroidal anti-inflammatory drugs).
Administering contrast media containing iodine
If you need to have an injection of contrast media containing iodine into your bloodstream, for example, for an X-ray or scan, you must stop taking Metformin-ratiopharm before and for the duration of the injection. Your doctor will determine when you must stop and when you can continue taking Metformin-ratiopharm.
Surgical operations
You must stop taking metformin hydrochloride 48 hours before selective surgical operations performed under general anaesthesia. Treatment may be continued no sooner than 48 hours after the operation or after the continuation of oral feeding and only in the case of normal kidney function.
Children and adolescents
Before starting treatment with Metformin-ratiopharm in children and adolescents, the diagnosis of type 2 diabetes must be confirmed by a doctor.
One-year controlled clinical trials showed no effect of metformin hydrochloride on growth or adolescence, but long-term studies have not been conducted.
Only a few children from age group 10...12 were included in the clinical trials, which is why special care should be taken when using Metformin-ratiopharm to treat children in that age range.
Further precautions
All patients must continue their diet and make sure that their intake of carbohydrates is spread throughout the whole day. Overweight patients must continue their low-calorie diet.
To keep diabetes under control, routine laboratory tests are necessary.
Metformin on its own does not cause hypoglycaemia. However, caution should be exercised when combining it with insulin or sulphonylureas, as these combinations may cause hypoglycaemia. The symptoms include sudden sweating, trembling, palpitations, restlessness and uncontrollable appetite. As the hypoglycaemia progresses, the patient may lose consciousness.

Other medicines and Metformin-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Inadvisable combinations
Alcohol
In the event of alcohol poisoning, the risk of lactic acidosis is increased, especially in the following cases:
-   Fasting or undernourishment
-   Hepatic impairment
Avoid drinking alcohol and taking medicines containing alcohol.
Contrast media containing iodine
If you need to have an injection of contrast media containing iodine into your bloodstream, for example, for an X-ray or scan, you must stop taking Metformin-ratiopharm before and for the duration of the injection. Your doctor will determine when you must stop and when you can continue taking Metformin-ratiopharm.
Combinations that require special consideration
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It may be necessary to perform more frequent blood sugar and kidney function tests or adjust the dose of Metformin-ratiopharm. It is especially important to tell your doctor about the following medicines:
-   Medicines that increase urine excretion (diuretics).
-   Pain and anti-inflammatory medicines (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib).
-   Certain high blood pressure medicines (ACE inhibitors and angiotensin II receptor antagonists).
-   Glucocorticoids (for systemic and topical use).
-   ß2-sympathomimetic medicines (certain medicines used to treat bronchial asthma).
Cimetidine (medicine used to lower excessive production of gastric acid) may increase the risk of lactic acidosis.
ACE inhibitors (high blood pressure medicines) may lower blood sugar levels. During treatment with ACE inhibitors, as well as when stopping treatment with the latter, it may be necessary to immediately adjust the dose of Metformin-ratiopharm.

Metformin-ratiopharm with alcohol

Avoid excessive consumption of alcohol while taking Metformin-ratiopharm, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy, breast-feeding and fertility

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
Patients with diabetes who are pregnant or planning to have a baby should not use this medicine.
In such cases, blood sugar levels should be kept in the normal range with insulin therapy. If this applies to you, tell you your doctor, who will then switch you to insulin therapy.
Uncontrolled diabetes during pregnancy (gestational or permanent) increases the risk of deformities and perinatal death.
Breast-feeding
Metformin is excreted into human breast milk. No side effects have been reported in breast-fed newborns/infants. This medicine should not be taken while breast-feeding without permission from your doctor.

Driving and using machines

Monotherapy with Metformin-ratiopharm does not cause hypoglycaemia or affect the ability to drive or use machines.
In the case of combined therapy with other antidiabetic medicines (sulphonylurea, insulin, repaglinides) there is a risk of hypoglycaemia, therefore the ability to drive or use machines may be affected.

3. How to take Metformin-ratiopharm

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
If not determined otherwise, the following dosage regimen applies.
Monotherapy and combined therapy with other oral antidiabetic medicines
-   The treatment should be started gradually. In general, the starting dose is 1 or 2 film-coated tablets a day, taken with food or after a meal. After 10...15 days, the dose should be adjusted according to current blood sugar levels. Increasing the dose gradually may help reduce gastrointestinal side effects. The maximum recommended dose is 3 g of metformin a day.
-   In the case of replacing some other oral antidiabetic medicines with metformin, the previous treatment must first be stopped and then treatment with metformin should be started according to the dosage regimen stated above.
Combining with insulin
Metformin may be combined with insulin to achieve better control over blood sugar levels. Metformin is administered according to the standard regimen (1 film-coated tablet 2...3 times a day), insulin is administered according to measured blood sugar levels.
Elderly patients
In elderly patients, the starting and maintenance dose of metformin tablets must be smaller due to the higher risk of decreased kidney function. Every dose adjustment must be preceded by a careful evaluation of kidney function.
Administration instructions for children aged 10 or older and adolescents
Monotherapy and combined therapy with insulin:
The standard starting dose is one Metformin-ratiopharm film-coated tablet a day (equivalent to 500 mg or 850 mg of metformin hydrochloride). The maximum recommended dose is 2 g of metformin hydrochloride a day.
Method of administration
The film-coated tablets must be swallowed whole without chewing with a sufficient amount (e.g. one glass) of water during or after a meal. If you have to take 2 film-coated tablets a day, you should take them as separate doses, e.g. 1 film-coated tablet after breakfast and 1 after dinner.
If you feel that the effect of Metformin-ratiopharm is too strong or too weak, talk your doctor or pharmacist.
If your kidney function has deteriorated, your doctor may decrease the dose.

If you take more Metformin-ratiopharm than you should

If you think you have overdosed, contact your doctor or emergency medical staff immediately and they will take further action!
Metformin-ratiopharm does not cause hypoglycaemia, but it may cause lactic acidosis. Early symptoms of lactic acidosis may resemble the gastrointestinal side effects of metformin: nausea, vomiting, diarrhoea and abdominal pain. The progression to a complete clinical picture involving muscle pain and cramps, dyspnoea and clouded consciousness may take only a few hours and requires immediate hospitalisation. Haemodialysis is the most efficient method to remove lactate and metformin from the body.

If you forget to take Metformin-ratiopharm

Do not take a double dose to make up for a forgotten dose, but continue treatment as prescribed.

If you stop taking Metformin-ratiopharm

If you stop using the medicine without orders from the doctor, you must take into account that high and uncontrolled blood sugar levels may over time lead to late complications of diabetes, such as damage to the eyes, kidneys or blood vessels.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Incidence of side effects:
Very common (> 1/10)
Common (> 1/100 to < 1/10)
Uncommon (> 1/1,000 to < 1/100)
Rare (> 1/10,000 to < 1/1,000)
Very rare (> 1/10,000, including isolated cases)
The following very rare side effects are severe and you must immediately contact your doctor if they occur.
-   Metformin-ratiopharm may cause a very rare but severe side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Metformin-ratiopharm and contact your doctor or go to the emergency department of the nearest hospital, as lactic acidosis may lead to coma.
-   Abnormal results for liver function tests or hepatitis (inflammation of the liver which may cause tiredness, loss of appetite, weight loss, and which may or may not be accompanied with a yellow discoloration of the skin and the whites of the eyes).
Other side effects
Gastrointestinal abnormalities
Very common: nausea, vomiting, diarrhoea, abdominal pain and loss of appetite.
These side effects occur most often at the beginning of the treatment and will usually subside on their own. To avoid gastrointestinal complaints, it is recommended to take metformin with or after a meal in 2 or 3 single doses. Increasing the dose gradually may also help alleviate gastrointestinal side effects. Common: changes in the sense of taste.
Nervous system disorders Common: impaired sense of taste.
Uncommon: headache, dizziness, tiredness.
Metabolic and nutritional disorders
Very rare: Decreased absorption and serum levels of vitamin B12 in the case of prolonged treatment with metformin. This aetiology should be considered if the patient has a certain type of anaemia (megaloblastic anaemia).
Skin and subcutaneous tissue disorders
Very rare: skin reactions such as erythema (redness of the skin), itching, urticaria.

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 Metformin-ratiopharm

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature. 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 you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Metformin-ratiopharm contains

-   The active substance is metformin hydrochloride.
One film-coated tablet contains 500 mg of metformin hydrochloride, which is equivalent to 389.62 mg of metformin.
One film-coated tablet contains 850 mg of metformin hydrochloride, which is equivalent to 662.36 mg of metformin.
-   The other ingredients are povidone K30, povidone K90, colloidal anhydrous silicon, magnesium stearate, purified water, hypromellose, titanium dioxide, macrogol 400, isopropyl alcohol.

What Metformin-ratiopharm looks like and contents of the pack

500 mg: white to off-white oblong film-coated tablet with “93” embossed on one side and “48” embossed on the other side. Dimensions: 14.7 x 8.1 mm, thickness 5.9-6.9 mm.
850 mg: white to off-white oblong film-coated tablet with “93” embossed on one side and “49” on the other side. Dimensions: 17.6 x 8.8 mm, thickness 8.0-9.0 mm.
The transparent PVC/PVDC aluminium blister pack contains 120 film-coated tablets. The OPA/PVC/PVDC aluminium blister pack contains 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany

Manufacturers

Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Germany
Teva Pharmaceutical Works Private Limited Company H-4042, Debrecen Pallagi ut 13 Hungary
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonia UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Phone: +372 6610 801

This leaflet was last revised in March 2017






  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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