Riomet

Riomet (metformin hydrochloride oral solution) is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride, USP (N,N­dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:

Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5•HCl and a molecular weight of 165.62. Metformin hydrochloride, USP 2.0 g is soluble in 20 mL of water. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. It is freely soluble in water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride.

Riomet (Cherry Flavor) contains 500 mg of metformin hydrochloride, USP per 5 mL and the following inactive ingredients: Artificial cherry flavor, hydrochloric acid, potassium bicarbonate, purified water, saccharin calcium, and xylitol.

Riomet (Strawberry Flavor) contains 500 mg of metformin hydrochloride, USP per 5 mL and the following inactive ingredients: Hydrochloric acid, N&A strawberry flavor (propylene glycol and glycerin), potassium bicarbonate, purified water, sucralose, and xylitol.

• Diabetes (Type 1 and Type 2)
• Oral Diabetes Prescription Medications

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Riomet is excreted in human breastmilk or if it will harm your nursing baby.

WARNING: LACTIC ACIDOSIS

• Lactic acidosis is a rare but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.
• The onset is often subtle accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap, and elevated blood lactate.
• If acidosis is suspected Riomet should be discontinued and the patient hospitalized immediately.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take metformin with a meal, unless your doctor tells you otherwise. Some forms of metformin are taken only once daily with the evening meal. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Metformin is only part of a complete treatment program that may also include diet, exercise, weight control, and special medical care. Follow your doctor's instructions very closely.

Your doctor may have you take extra vitamin B12 while you are taking metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature away from moisture, heat, and light.

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of metformin may cause lactic acidosis, which may be fatal.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as:

• muscle pain or weakness;

• numb or cold feeling in your arms and legs;

• trouble breathing;

• feeling dizzy, light-headed, tired, or very weak;

• stomach pain, nausea with vomiting; or

• slow or uneven heart rate.

Common side effects may include:

• nausea, vomiting, upset stomach; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Using metformin alone, with a type of oral antidiabetic medicine called a sulfonylurea, or with insulin, will help to lower blood sugar when it is too high and help restore the way you use food to make energy.

Many people can control type 2 diabetes with diet and exercise. Following a specially planned diet and exercise will always be important when you have diabetes, even when you are taking medicines. To work properly, the amount of metformin you take must be balanced against the amount and type of food you eat and the amount of exercise you do. If you change your diet or exercise, you will want to test your blood sugar to find out if it is too low. Your doctor will teach you what to do if this happens.

Metformin does not help patients does not help patients who have insulin-dependent or type 1 diabetes because they cannot produce insulin from their pancreas gland. Their blood glucose is best controlled by insulin injections.

This medicine is available only with your doctor's prescription.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Riomet (metformin hydrochloride oral solution) is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride, USP (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:

Metformin hydrochloride, USP is a white crystalline powder with a molecular formula of C4H11N5•HCl and a molecular weight of 165.62. Metformin hydrochloride, USP 2.0 g is soluble in 20 mL of water. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. It is freely soluble in water; slightly soluble in alcohol; practically insoluble in acetone and in methylene chloride.

Riomet (Cherry Flavor) contains 500 mg of metformin hydrochloride, USP per 5 mL and the following inactive ingredients: Artificial cherry flavor, hydrochloric acid, potassium bicarbonate, purified water, saccharin calcium, and xylitol.

Riomet (Strawberry Flavor) contains 500 mg of metformin hydrochloride, USP per 5 mL and the following inactive ingredients: Hydrochloric acid, N&A strawberry flavor (propylene glycol and glycerin), potassium bicarbonate, purified water, sucralose, and xylitol.

Riomet (metformin hydrochloride oral solution) 500 mg/5 mL is a clear, colorless liquid with characteristic cherry or clear, colorless to light yellow liquid with characteristic strawberry flavor filled in 4 oz./16 oz. HDPE bottles with induction sealed child-resistant cap.

Cherry Flavor

NDC 10631-206-01 Bottles of 4 fl. oz. (118 mL)

NDC 10631-206-02 Bottles of 16 fl. oz. (473 mL)

Strawberry Flavor

STORAGE

Store at controlled room temperature 15° - 30° C (59° - 86° F) [See USP].

You may report side effects to FDA at 1-800-FDA-1088.

Riomet is a registered trademark of Sun Pharmaceutical Industries Limited.

Manufactured for:

Ranbaxy Laboratories Inc.

Jacksonville, FL 32257 USA