Lodiab XR Prolonged release tablets contain the active ingredient metformin hydrochloride which belong to a group of medicines called biguanides, used in the treatment of Type 2 (non-insulin dependent) diabetes mellitus.

Lodiab XR is used together with diet and exercise to lower the risk of developing Type 2 diabetes in overweight adults, when diet and exercise alone for 3 to 6 months have not been enough to control blood glucose (sugar). You are at high risk of developing Type 2 diabetes if you have additional conditions like high blood pressure, age above 40 years, and an abnormal amount of lipids (fat) in the blood or a history of diabetes during pregnancy. The medicine is particularly effective if you are aged below 45 years, are very overweight, have high blood glucose levels after a meal or developed diabetes during pregnancy.

Lodiab XR is used for the treatment of Type 2 diabetes when diet and exercise changes alone have not been enough to control blood glucose (sugar).

Insulin is a hormone that enables body tissue to take glucose from the blood and to use it for energy or for storage for future use. People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a buildup of glucose in the blood which can cause a number of serious long-term problems so it is important that you continue to take your medicine, even though you may not have any obvious symptoms. Lodiab XR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Lodiab XR is associated with either a stable body weight or modest weight loss.

Lodiab XR Prolonged Release Tablets are specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin.

Do not take Lodiab XR if:

• You are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching or shortness of breath.

• You have liver problems

• You have severely reduced kidney function

• You have uncontrolled diabetes, with, for example, severe hyperglycemia (high blood glucose), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see ‘Risk of lactic acidosis’ below) or ketoacidosis. Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual, fruity smell.

• You have lost too much water from your body (dehydration). Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions’).

• You have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions’).

• You have been treated for acute heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Warnings and precautions’).

• You are a heavy drinker of alcohol.

• You are under 18 years of age.

Warnings and precautions

Risk of lactic acidosis

Lodiab XR may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration, liver problems and any medical conditions in which a 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 instructions.

Stop taking Lodiab XR for a short time if you have a condition that may be associated with dehydration

(Significant loss of body fluids) such as severe vomiting, diarrhea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Lodiab XR and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:

• Vomiting

• Stomach ache (abdominal pain)

• Muscle cramps

• General feeling of not being well with severe tiredness

• Difficulty in breathing

• Reduced body temperature and heartbeat

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

If you need to have major surgery you must stop taking Lodiab XR during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Lodiab XR.

During treatment with Lodiab XR, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.

If you are older than 75 years, treatment with Lodiab XR should not be started to lower the risk of developing type 2 diabetes.

You may see some remains of the tablets in your stools. Do not worry - this is normal for this type of tablet.

You should continue to follow any dietary advice that your doctor has given you and you should make sure that you eat carbohydrates regularly throughout the day.

Do not stop taking this medicine without speaking to your doctor. 

Other medicines and Lodiab XR

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Lodiab XR before or at the time of injection. Your doctor will decide when you must stop and when to restart your treatment with Lodiab XR.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including those obtained without a prescription. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Lodiab XR. It is especially important to mention the following:

• Medicines which increase urine production (diuretics such as furosemide).

• Medicines used to treat pain and inflammation (NSAID 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)

• Steroids such as prednisolone, mometasone, beclometasone.

• Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics.

• Medicines that may change the amount of Lodiab XR in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Lodiab XR with alcohol:

Avoid excessive alcohol intake while taking Lodiab XR since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions’).

Pregnancy and breast-feeding

Do not take Lodiab XR if you are pregnant or breast feeding.

If you are pregnant or breast-feeding, think you may be a pregnant or are planning to have a baby ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Lodiab XR taken on its own does not cause ‘hypos’ (symptoms of low blood sugar or hypoglycemia, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery. However, you should be aware, that Lodiab XR taken with other antidiabetic medicines can cause hypos, so in this case you should take extra care when driving or operating machinery. 

Information about ingredient of Lodiab XR

This medicine contains less than 1mmol sodium (23mg) per dosage unit, that is to say it is essentially ‘sodium free’.

· Your doctor may prescribe Lodiab XR tablet for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.

· Always take Lodiab XR exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

· Swallow the tablets whole with a glass of water, do not chew.

· Recommended dose usually starts with 500 milligrams daily. After you have been taking Lodiab XR for about 2 weeks, your doctor may measure your blood sugar and adjust the dose according to it. The maximum daily dose is 2000 milligrams of Lodiab XR.

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

· Normally, you should take the tablets once a day, with your evening meal. In some cases, your doctor may recommend that you take the tablets twice a day. Always take the tablets with food.

If you take more Lodiab XR than you should

If you take extra dose by mistake do not worry, but if you have unusual symptoms, contact your doctor. If the overdose is large, lactic acidosis is more likely. Symptoms of lactic acidosis are non-specific, such as vomiting, bellyache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heartbeat.

If you experience some of these symptoms, you should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking Lodiab XR immediately and contact a doctor or the nearest hospital straightaway.

If you forget to take Lodiab XR

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

· 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 Lodiab XR and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

· Abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice (may affect up to 1 user in 10,000). If you develop yellowing of the eyes and/or skin contact your doctor immediately.

Other possible side effects

Very common (affects more than 1 person in 10):

• Diarrhea, nausea, vomiting, stomach ache or loss of appetite. If you get these, do not stop taking the tablets as these symptoms will normally go away in about 2 weeks. It helps if you take the tablets with or immediately after a meal.

Common (affects less than 1 person in 10, but more than 1 person in 100):

• Taste disturbance

Very rare (affects less than 1 person in 10,000):

• Decreased vitamin B12 level.

• Skin rashes including redness, itching and hives.

Reporting of side effects

If any of the side effects gets serious, or if you notice any possible side effects not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly (see section 6). By reporting side effects you can help provide more information on the safety of this medicine.

To report any side effect(s):

• Saudi Arabia:

• The National Pharmacovigilance Centre (NPC):

- SFDA Call Center: 19999

- E-mail: npc.drug@sfda.gov.sa

- Website: https://ade.sfda.gov.sa

• Other GCC States:

- Please contact the relevant competent authority.

• Keep Lodiab XR tablets out of the sight and reach of children.

• Do not use them after the expiry date that is printed on the pack after “EXP:”. The expiry date refers to the last day of that month.

• Do not store above 30 °C.

• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.