Siofor 1000 mg. 90 tablets

1. What Siofor 1000 mg is and what it is used for

What is Siofor 1000 mg

Siofor 1000 mg contains metformin, a diabetes medicine that belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that helps your body absorb glucose (sugar) from the blood. Your body uses glucose as an energy source or stores it for future needs. If you have diabetes, your pancreas does not produce enough insulin or the body is not able to use the insulin that is secreted in an optimal way.

This leads to high blood glucose levels. Siofor 1000 mg helps to reduce blood sugar as close to normal levels as possible.

If you are an overweight adult, long-term use of Siofor 1000 mg will also help reduce the risk of diabetes-related complications. Siofor 1000 mg is associated with stabilization or a moderate reduction in body weight.

What is Siofor 1000 mg used for

Siofor 1000 mg is used to treat patients with type 2 diabetes (so-called non-insulin dependent diabetes) when diet and exercise alone are not enough to control blood sugar levels. In particular, it is used in overweight patients.

Elderly patients can take Siofor 1000 mg alone or in combination with other medicines for the treatment of diabetes (medicines taken by mouth or insulin).

Children aged 10 years, older and adolescents can take Siofor 1000 mg alone or in combination with insulin.

2. What you should know before taking Snofor 1000 mg

Do not take Siofor 1000 mg:

if you are allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6);

if you have severely reduced kidney function;

if you have liver problems;

• 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 condition in which substances called "ketone bodies" build up in the blood and this can lead to a diabetic coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or an unusual fruity smell on your breath;

with a large loss of fluids (dehydration), both due to prolonged or severe diarrhea and after continuous vomiting. Dehydration can lead to kidney problems, which can put you at risk of lactic acidosis (see “Warnings and precautions” below);

if you have a severe infection, such as a lung, bronchial or kidney infection. Severe infections can lead to kidney problems, which can put you at risk of lactic acidosis (see below “Warnings and precautions);

if you are being treated for acute heart failure or if you have recently had a heart attack, if you have severe circulation problems (such as shock) or difficulty breathing. This can lead to an insufficient supply of oxygen to the tissues, which can put you at risk of lactic acidosis (see below “Warnings and precautions”);

if you drink a lot of alcohol.

If any of the conditions listed above apply to you, consult your doctor before starting to take this medicine.

Warnings and precautions

Talk to your doctor before taking Siofor 1000 mg.

Be sure to consult your doctor:

if you are about to have an X-ray examination or a scan requiring intravascular administration of iodine-containing contrast agents;

if you are about to have major surgery.

You must stop taking Siofor 1000 mg during and for some time after the procedure.

Your doctor will decide when to stop and when to resume treatment with Siofor 1000 mg. It is important to strictly follow your doctor's instructions.

Risk of lactic acidosis

Siofor 1000 mg can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems and any condition where part of the body has a reduced supply of oxygen ( such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further guidance.

Stop taking Siofor 1000 mg for a short period of time if you have an illness that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal . Talk to your doctor for further instructions.

Stop taking Siofor 1000 mg 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

ohm.

Symptoms of lactic acidosis include:

vomiting

stomach pain (abdominal pain)

muscle spasms

a general feeling of malaise, accompanied by severe fatigue

difficulty breathing

decreased body temperature and pulse

Lactic acidosis is a medical emergency and must be treated in a hospital.

During treatment with Siofor 1000 mg, your doctor will check your kidney function at least once a year, or more often if you are elderly and/or if you have impaired kidney function.

If taken alone, Siofor 1000 mg does not cause hypoglycemia (very low blood sugar levels). However, if you take Siofor 1000 mg with other diabetes medications that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If symptoms of hypoglycemia such as weakness, dizziness, increased sweating, fast heart rate, visual disturbances or difficulty concentrating occur, taking food or liquid containing sugar usually helps.

Other drugs and Siofor 1000 mg

If you are to be injected with a contrast agent containing iodine into the bloodstream, for example in the context of an X-ray or scan, you should stop taking Siofor 1000 mg before or during the injection. Your doctor will decide when you should stop and when you should resume treatment with Siofor 1000 mg (see above "You must consult your doctor").

Inform your doctor if you are taking/using, have recently taken/used or may be taking/using other medicines and Siofor 1000 mg at the same time. It may be necessary to check blood glucose and kidney function more often, or your doctor may adjust the dose of Siofor 1000 mg. It is extremely important to mention the following:

drugs that increase urine output (diuretics);

medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib);

certain medicines for the treatment of high blood pressure (ACE-inhibitors and angiotensin II receptor antagonists);

beta-2 agonists such as salbutamol or terbutaline (used to treat asthma

corticosteroids (used to treat many conditions such as severe skin inflammation or asthma);

other medicines to treat diabetes;

other medicines that can change the amount of Siofor 1000 mg in the blood, especially if you have reduced kidney function (eg verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use other medicines.

Siofor 1000 mg with alcohol

Avoid excessive alcohol consumption while taking Siofor 1000 mg, as this may increase the risk of lactic acidosis (see Warnings and Precautions), especially if you have liver problems or are malnourished. This also applies to medicines that contain alcohol.

Pregnancy, lactation and fertility

During pregnancy, diabetes is treated with insulin. Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant, as she/he may change your treatment.

This medicine is not recommended if you are breast-feeding.

Driving and using machines

If taken alone, Siofor 1000 mg does not cause hypoglycaemia (very low blood sugar levels), which means it will not affect your ability to drive or use machines.

However, special care is required if you take Siofor 1000 mg together with other drugs for the treatment of diabetes that can cause hypoglycemia (such as sulfonylurea products, insulin, meglitinides). Symptoms of hypoglycemia include weakness, dizziness, increased sweating, rapid heart rate, visual disturbances, or difficulty concentrating. Do not drive or operate machinery if you experience these symptoms.

3. How to take Siofor 1000 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Siofor 1000 mg cannot replace the benefits of a healthy lifestyle. Continue to follow the diet recommended by your doctor and exercise regularly.

Recommended dose

Adult patients usually start treatment with half a tablet of Siofor 1000 mg (equivalent to 500 mg of metformin hydrochloride) 2 to 3 times a day or 850 mg of metformin hydrochloride 2 to 3 times a day (this dose cannot be achieved with Siofor 1000 mg).

The maximum daily dose is 1 film-coated tablet Siofor 1000 mg 3 times a day.

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

Use in children and adolescents

Children 10 years of age and older and adolescents usually start with half a tablet of Siofor 1000 mg once daily (equivalent to 500 mg of metformin hydrochloride) or 850 mg of metformin hydrochloride once daily (this dose cannot be achieved with Siofor 1000 mg).

The maximum daily dose is 1 film-coated tablet Siofor 1000 mg twice a day. Treatment of children from 10 to 12 years of age is recommended only after specialized consultation with a doctor, as experience in this age group is limited.

If you also take insulin. Your doctor will advise you on how to start the administration of Siofor 1000 mg.

Tracking

Your doctor will monitor your blood sugar levels regularly and adjust the dose of Siofor 1000 mg according to your blood sugar level. Consult your doctor regularly. This is especially important in children and adolescents or if you are elderly.

Your doctor will check your kidney function at least once a year. More frequent examinations may be necessary if you are elderly or your kidneys are not functioning normally.

How can you split a Siofor 1000 mg tablet

The tablet can be divided into two equal doses.

Thanks to the shape of the tablet, Siofor 1000 mg allows easy and accurate separation of the film-coated tablet. The film-coated tablet can be split with both hands or if you place the tablet with the deeper bevel on the underside on a hard, flat surface and press with your thumb on top

How to take Siofor 1000 mg

Take the tablets during or after a meal. In this way, you will avoid adverse drug reactions affecting digestion. Do not crush or chew the tablets. Swallow the tablet with a glass of water.

If you take one dose daily, take it in the morning (with breakfast).

If your dose is divided into two doses, take them in the morning (with breakfast) and in the evening (with dinner).

If your dose is divided into three doses, take them in the morning (for breakfast), in the afternoon (for lunch) and in the evening (for dinner).

If after some time it seems to you that the effect of Siofor 1000 mg is too strong or too weak, consult your doctor or pharmacist.

If you have taken more than the required dose of Siofor 1000 mg

If you have taken a larger dose of Siofor 1000 mg than you should, you may experience signs of lactic acidosis. Symptoms of lactic acidosis are vomiting, abdominal pain with muscle spasms, general malaise with feeling very tired and difficulty breathing. In this case, you may need immediate hospital treatment, as lactic acidosis can lead to coma. Contact a doctor or the nearest hospital immediately.

If you forgot to take Siofor 1000 mg

Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

Siofor 1000 mg 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 must stop taking Siofor 1000 mg and contact a doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

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

eating disorders

assimilation such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite. These side effects usually occur when starting treatment with Siofor 1000 mg. In this case, it will help if you distribute the intake of doses during the day and take the tablets during or immediately after a meal. If symptoms persist, stop taking Siofor 1000 mg and inform your doctor.

Common side effects (may affect up to 1 in 10 people)

changes in taste.

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

skin reactions such as reddening of the skin (erythema), itching or an itchy rash (urticaria);

low levels of vitamin B12 in the blood;

abnormal liver function tests or hepatitis (inflammation of the liver;

this can cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or eyes). If this happens to you, stop taking this medicine and contact a doctor.

Children and adolescents

Limited data in children and adolescents indicate that adverse drug reactions are similar in type and severity to those reported in adults.

5. How to store Siofor 1000 mg

Keep out of the reach of children!

If Siofor 1000 mg is administered to a child, parents and relatives should monitor how the drug is administered.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date corresponds to the last day of the specified 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 1000 mg contains

The active substance is: metformin hydrochloride (metformin hydrochloride). One film-coated tablet contains 1000 mg metformin hydrochloride (equivalent to 780 mg metformin).

The other ingredients are: hypromellose, povidone K 25, magnesium stearate (Ph. Eur) [vegetable], macrogol 6000, titanium dioxide (E 171).

What Siofor 1000 mg looks like and contents of the pack

White, oblong, biconvex, film-coated tablets with a bevel (snap-tab) on one side and a score on the other side.

The tablet may be divided into two equal doses (see section 3 for instructions on splitting).

Siofor 1000 mg is available in packs of 30, 60, 90 or 120 film-coated tablets.

Not all packages can be put on sale.