Roumetza 500

Dosage and method of administration
Swallow the tablet whole and without chewing, with food or at the end of a meal. If you forget to take the medicine, you should take the next dose at the usual time and avoid doubling the next dose.

Warnings and precautions:
Consult your doctor before taking this medicine in the following cases:

• If an X-ray test with contrast agent injection is required, metformin should be discontinued before or at the time of the test and the drug should be discontinued for 48 hours after ensuring normal kidney function.

• Risk of lactic acidosis

Metformin tablets may cause a rare but very serious side effect, especially in patients with kidney failure, called lactic acidosis. Symptoms of lactic acidosis include vomiting, abdominal pain with muscle cramps, a general feeling of unwellness with fatigue, and difficulty breathing. If these symptoms occur, stop taking metformin immediately and seek medical attention immediately.

• Hypoglycemia

Metformin tablets alone do not cause hypoglycemia (severe low blood glucose). However, there is a risk of hypoglycemia if you take metformin tablets with other medicines (such as sulfonylureas, insulin, meglitinides) to treat diabetes. If you have symptoms of hypoglycemia such as weakness, dizziness, increased sweating, fast heartbeat, visual disturbances, or difficulty concentrating, eating or drinking sugary foods usually helps to improve your symptoms. If these symptoms occur, avoid driving or using machines.

• Vitamin B12 deficiency is a known side effect of metformin. Symptoms of B12 deficiency include a specific type of anemia, jaundice, pain and inflammation, tongue, nerve disorders, neuropathy, memory disorders, paresthesia in the hands and feet, movement disorders, vision disorders, and mood changes. In order to reduce the risks of vitamin B12 deficiency, it is recommended that patients have their serum vitamin B12 levels monitored regularly and that they take dietary supplements or vitamin B12 supplements during treatment with metformin.

Drug interactions:
Consult your doctor if you are taking any of the following medications:

• Medicines that increase urine production (diuretics), beta-2 agonists such as salbutamol or terbutaline
• Corticosteroids
• Medicines that may change the amount of metformin in your blood, especially if you have poor kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, crizotinib, olaparib)
• Medications used to treat pain and inflammation (NSAIDs) and COX-2 inhibitors such as ibuprofen and celecoxib)
• Certain medications to treat high blood pressure (ACE inhibitors and angiotensin receptor antagonists)
• If you need to have an injection of iodine-containing contrast material, for example for an X-ray scan, you should stop taking metformin tablets before or at the time of the injection, as directed by your doctor.

Contraindications

• If you are allergic to metformin hydrochloride or any of the excipients
• Having long-term liver or kidney problems
• Having a serious infection or injury
• Having acute heart failure with a history of heart attack, severe circulatory problems (such as shock), or breathing problems

Pregnancy and breastfeeding:
This medicine is not recommended during pregnancy and breastfeeding.

Recommended amount

Adults
The dosage and method of administration of the drug is determined by the doctor, but the usual dosage of this drug is as follows:
Usually, treatment begins with 500 mg of metformin once or twice a day, and the therapeutic dose can be increased weekly according to the doctor’s opinion. The maintenance dose is 500 mg 2-3 times a day. The maximum daily dose is 2550 mg, which is taken in divided doses.
Kidney function should be carefully monitored every 3 to 6 months.

Overdose
In cases of overdose, the patient should immediately inform their doctor. Taking large amounts of metformin may cause lactic acidosis in the patient. Lactic acidosis is a medical emergency that must be treated in a hospital.

Side effects

Along with its beneficial effects, every medicine may cause some unwanted effects. Although not all of these effects are seen in every person, consult your doctor if you experience the following side effects.
Very common side effects
are digestive problems such as nausea, vomiting, diarrhea, abdominal pain and loss of appetite. These side effects often occur at the beginning of treatment with metformin tablets.

Common side effects

Taste disturbance

Rare complications

Lactic acidosis,
liver function test abnormalities with hepatitis, which will resolve with discontinuation of the drug.

Skin reactions such as skin redness (erythema), itching, or an itchy rash (urticaria)

Decreased vitamin B12 levels

How to store
the medicine: Keep it out of the sight and reach of children.

Avoid taking expired medications.

Store the medicine at a temperature below 30°C, away from light and moisture.