Siofor 500 mg. 60 tablets

1. What Siofor SR is and what it is used for

Siofor SR contains the active substance metformin hydrochloride, which belongs to a group of medicines called biguanides used to treat diabetes.

Siofor SR is used to treat type 2 (non-insulin dependent) diabetes mellitus when diet or exercise alone is not enough to control blood glucose (sugar). Insulin is a hormone that helps body tissues take in glucose from the blood and use it for energy or store it for later use. People with type 2 diabetes do not produce enough insulin in their pancreas, or their body does not respond properly to the insulin it does produce. This causes glucose to build up in the blood, which can cause a number of serious long-term problems, so it's important to keep taking your medicine even though you may not have obvious symptoms. Siofor SR increases the body's sensitivity to insulin and helps return to the normal way the body uses glucose.

Siofor SR is associated with either stable body weight or mild weight loss.

Siofor SR is specially designed to gradually release the drug in the body and is therefore different from many other types of tablets that contain metformin.

2. What you need to know before you take Siofor SR

DO NOT take Siofor SR

if you are allergic to metformin or any of the other ingredients of Siofor SR (listed in section 6). An allergic reaction can cause a rash, itching or shortness of breath;

if you have liver problems;

if you have severely reduced kidney function;

if you have uncontrolled diabetes, for example with severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see 'Risk of lactic acidosis' below) or ketoacidosis. Ketoacidosis is a disease in which substances , called "ketone bodies", accumulate in the blood and this can lead to diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or unusual or fruity breath;

if you have lost too much water from your body (dehydration). Dehydration can lead to kidney problems, which can put you at risk of lactic acidosis (see "Warnings and precautions");

if you have a severe infection, such as an infection that affects your lungs, bronchial system or kidneys. Severe infections can lead to kidney problems, which can put you at risk of lactic acidosis (see Warnings and Precautions);

if you are being treated for acute heart disease, have recently had a heart attack, or have severe circulation problems or breathing difficulties. This may lead to a lack of oxygen delivery to the tissues, which may put you at risk of lactic acidosis (see "Warnings and precautions");

if you drink large amounts of alcohol;

if you are under 18 years of age.

Warnings and precautions

Talk to your doctor before taking Siofor® SR.

Risk of lactic acidosis

Siofor SR can cause a very rare but very serious side effect called lactic acidosis, especially if the kidneys are not functioning properly. Also, the risk of developing lactic acidosis is increased in uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see additional information below), liver problems, and any disease in which part of the body has a reduced flow of oxygen (e.g. acute severe heart disease).

If any of the above applies to you, talk to your doctor for further instructions.

Stop taking Siofor SR for a short time if you have an illness that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea, high fever, exposure to heat, or if you drink less fluids than usual. Talk to your doctor for further instructions.

Stop taking Siofor SR and contact a doctor or the nearest hospital immediately if you have any of the symptoms of lactic acidosis, as this condition can lead to coma.

Symptoms of lactic acidosis include:

vomiting;

stomach pain (abdominal pain);

muscle cramps;

general feeling of malaise with a strong feeling of exhaustion;

difficulty breathing;

decreased body temperature and heart rate.

Lactic acidosis is an emergency and must be treated in a hospital. If you need major surgery, you MUST STOP taking Siofor SR during and for some time after the procedure. Your doctor will decide when to stop and when to restart your treatment with Siofor® SR.

During treatment with Siofor SR, your doctor will check your kidney function at least once a year, or more often if you are elderly and/or if you have reduced kidney function.

You may notice remnants of the tablets in your stool. Don't worry - this is normal for this type of ta

3. How to take Siofor SR

Your doctor may prescribe Siofor SR alone or in combination with other oral antidiabetic agents or with insulin. Always take Siofor SR exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist.

Recommended dose

You will usually start treatment with 500 milligrams of Siofor SR daily. After you have been taking Siofor SR for about 2 weeks, your doctor may measure your blood sugar level and adjust the dose.

The maximum daily dose is 2000 milligrams of Siofor SR.

If you have reduced kidney function, your doctor may prescribe a lower dose.

You should usually take the tablets once a day with the evening meal.

In some cases, the doctor may recommend taking tablets twice a day. Always take the tablets with food.

Take the tablets whole with a glass of water - do not chew them.

If you have taken more than the required dose of Siofor SR

If you take more tablets by mistake, do not worry, but if you have unusual symptoms, contact your doctor. If the overdose is large, lactic acidosis is very likely to occur. The symptoms of lactic acidosis are non-specific, for example vomiting, stomach pain (abdominal pain) with muscle cramps, feeling generally unwell with a strong feeling of exhaustion and difficulty breathing. Additional symptoms are low body temperature and palpitations. If you have any of these symptoms, you should immediately stop taking Siofor SR and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

If you miss taking Siofor SR

Take it with food as soon as you remember. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Siofor SR can cause side effects, although not everybody gets them.

The following side effects may occur:

Siofor SR can cause a very rare (may affect up to 1 user in 10,000) but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens, you should stop taking Siofor SR and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

Siofor SR may cause abnormalities in liver function tests and hepatitis (inflammation of the liver), which may cause jaundice (may affect up to 1 user in 10,000). If your eyes and/or skin turn yellow, contact your doctor immediately.

Other possible side effects are listed by frequency as follows:

Very common (may affect more than 1 in 10 people):

diarrhoea, nausea, vomiting, stomach pain or loss of appetite. If you get them, do not stop taking the tablets as these symptoms will usually go away in about 2 weeks. In this case, it will help if you take the tablets during or immediately after a meal.

Common (may affect up to 1 in 10 people):

taste changes.

Very rare (may affect up to 1 in 10,000 people):

decreased levels of vitamin B12;

5. How to store Siofor SR

Keep out of the reach of children.

Do not use Siofor SR after the expiry date, which is stated on the blister pack and carton after "EXP:". The expiry date corresponds to the last day of the indicated month.

This medicinal product does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use.

These measures will help protect the environment.

6. Contents of the package and additional information

What Siofor SR contains

The active substance is metformin hydrochloride.

Each Siofor SR 500 mg extended-release tablet contains 500 mg of metformin hydrochloride (corresponding to 390 mg of metformin).

Each Siofor SR 750 mg extended-release tablet contains 750 mg metformin hydrochloride (corresponding to 585 mg metformin).

Each Siofor SR 1000 mg extended-release tablet contains 1000 mg metformin hydrochloride (corresponding to 780 mg metformin).

The other ingredients are magnesium stearate, carmellose sodium, silicon dioxide and hypromellose. What Siofor® SR looks like and what the package contains

Siofor SR 500 mg extended-release tablets are white to off-white oblong engraved with "SR 500" on one side and plain on the other side. The tablet dimensions are 16.50 mm in length, 8.20 mm in width and 6.10 in thickness mm.

Siofor SR 750 mg extended-release tablets are white to off-white oblong engraved with "SR 750" on one side and plain on the other side. The tablet dimensions are 19.60 mm long, 9.30 mm wide and 6.90 mm thick. mm.

Siofor SR 1000 mg prolonged-release tablets are white to off-white, oval tablets engraved with "SR 1000" on one side