500 mg, 850 mg and 1000 mg film-coated tablets
Metformin hydrochloride

What Metformin Orifarm is and what it is used for

Metformin Orifarm contains the active substance metformin hydrochloride. Metformin hydrochloride belongs to a group of medicines called biguanides and is used in patients with non-insulin-dependent (type II) diabetes in adults and children from 10 years of age.

Insulin is a hormone produced in the pancreas that helps the body absorb glucose (sugar) from the blood. The body uses glucose to produce energy or stores it for future needs.

If you have diabetes, the pancreas does not produce enough insulin or the body cannot use the insulin that is produced well enough. This leads to high glucose levels in the blood. Metformin helps to lower blood glucose levels to a level that is as close to normal as possible.

If you are an adult and overweight, taking metformin for a long time can also help reduce the risk of complications associated with diabetes. Metformin is associated with either stable body weight or a slight weight loss.

Metformin Orifarm is a medicine used to treat type 2 diabetes mellitus in adults, especially in obese people, where diet and exercise alone do not provide sufficient control over blood sugar.

Adults 

Your doctor may prescribe Metformin Orifarm as the only treatment or in combination with other medicines to treat diabetes (medicines taken by mouth or insulin ).

Children and young people 

Children 10 years of age or older and adolescents can take Metformin Orifarm as their only treatment or with insulin.

Metformin hydrochloride contained in Metformin Orifarm may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or another healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Metformin Orifarm

Do not take Metformin Orifarm

  • if you are allergic to metformin hydrochloride or any of the other ingredients of this medicine (listed in section 6). 
  • if you have uncontrolled diabetes , such as severe hyperglycaemia (high blood sugar), 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, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness or that your breath has a different, fruity odor.
  • if you have severe renal impairment.
  • if you have impaired kidney function due to e.g.
    • if the body has lost too much water (dehydration), e.g. due to prolonged or severe diarrhea, or if you have vomited several times in a row. Dehydration can lead to kidney problems which can cause lactic acidosis (see “Warning and Caution” below)
  • if you have a severe infection , e.g. an infection that affects the lungs, trachea or kidneys. Severe infection can lead to kidney problems which can cause lactic acidosis (see “Warning and Precautions” below).
  • if you have acute or chronic diseases that can cause serious circulatory problems in your tissues (tissue hypoxia) such as
    • heart failure or difficulty breathing 
    • recent myocardial infarction ( myocardial infarction ) 
    • collapse or trauma ( shock ) 
  • if you have liver problems, drink a lot of alcohol or suffer from alcoholism

You need to consult a doctor about

  • you need to have an examination, such as an X-ray or a computed tomography scan , which means that you are receiving contrast media containing iodine injected into your blood
  • you will undergo major surgery

You must stop taking metformin for a certain period before and after the examination or operation. Your doctor will decide if you need any other treatment during this time. You must follow your doctor’s instructions carefully.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before taking Metformin Orifarm.

Risk of lactic acidosis

Metformin Orifarm can cause the very rare, but very serious side effect of lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

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

Stop taking Metformin Orifarm for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Metformin Orifarm and contact your doctor or nearest hospital immediately if you experience any of the symptoms of lactic acidosis as the condition may lead to coma.

The symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate .

Lactic acidosis is an acute medical condition that must be treated in a hospital.

If you are going to have a major operation, you must stop taking Metformin Orifarm during the operation and for some time after it. Your doctor will decide when you need to stop taking Metformin Orifarm and when you should start taking it again.

Metformin itself does not cause hypoglycemia (too low blood sugar), but if you take metformin with other antidiabetic medicines that can cause hypoglycaemia (eg sulphonylureas, insulin, meglitinides) there is a risk of hypoglycaemia. If you get symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, it usually helps to eat or drink something that contains sugar.

During treatment with Metformin Orifarm, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

Other medicines and Metformin Orifarm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you need to get an injection in the blood with contrast media that contain iodine, for example in connection with an X-ray or computed tomography, you must stop taking Metformin Orifarm before or at the time of injection. Your doctor will decide when you need to stop taking Metformin Orifarm and when you should start taking it again.

You may need to have more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Metformin Orifarm. You must mention the following:

  • corticosteroids (used to treat a variety of conditions, such as severe dermatitis or asthma )
  • drugs that increase urine production ( diuretics )
  • drugs used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
  • certain medicines for high blood pressure ( ACE inhibitors and angiotensin II receptor antagonists)
  • special medicines for bronchial asthma (beta-2 agonists , eg salbutamol )
  • medicines that can change the amount of metformin in your blood, especially if you have impaired kidney function (eg verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
  • other drugs used to treat diabetes .

Metformin Orifarm with alcohol

Avoid high alcohol intake while taking Metformin Orifarm as alcohol may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Women with diabetes who are pregnant or planning to become pregnant should not be treated with Metformin Orifarm. Instead, insulin should be used to keep blood sugar levels as low as possible. Tell your doctor if you are pregnant or planning to become pregnant so that he or she can change your treatment to insulin therapy.

Do not take this medicine if you are breastfeeding or if you are planning to breastfeed your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Metformin alone ( monotherapy ) does not cause hypoglycemia (hypoglycemia). This means that it does not affect your ability to drive or use machines.

Taking Metformin Orifarm with other antidiabetic medicines ( eg sulfonylureas, insulin, or meglitinides) can cause low blood sugar levels with symptoms such as increased sweating, fainting, dizziness, and weakness, which in turn affects your ability to drive and use machines safely. Symptoms of hypoglycemia include weakness, dizziness, sweating, rapid heartbeat, visual disturbances, or difficulty concentrating. Do not drive or use machines if you experience such symptoms.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Metformin Orifarm

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Metformin Orifarm cannot replace the beneficial effects of a healthy lifestyle. Continue to follow any dietary advice your doctor has given you and exercise regularly.

The dosage of Metformin Orifarm should be determined by your doctor according to your blood sugar levels.

If your doctor has not prescribed anything else, the recommended dose is:

For adults 

Adults usually start with 500 mg or 850 mg metformin hydrochloride 2-3 times a day. The maximum daily dose is 3,000 mg divided into 3 doses.

For children aged 10 or over and young people

The usual starting dose is 500 mg or 850 mg metformin hydrochloride once a day.

Dose one can be increased to a maximum daily dose of 2,000 mg divided into 2 or 3 doses. Treatment of children aged 10-12 years is only recommended according to your doctor’s instructions, as experience in this age group is limited.

If you have impaired kidney function

Your doctor may prescribe a lower dose.

If you are older

Your dose can be adjusted if you are older.

If you are also taking insulin

Your doctor will tell you how to start treatment with metformin.

Check

  • Your doctor will adjust your dose of metformin to your blood sugar levels. You need to talk to your doctor regularly. This is especially important for children and adolescents or if you are older.
  • Your doctor will also examine your kidney function at least once a year. You may need more frequent check-ups if you are older or if your kidneys are not working properly.

How to take Metformin Orifarm

Take the tablets with or after a meal. This way you avoid side effects that affect digestion.

The tablets must not be crushed or chewed. Swallow each tablet with a glass of water.

  • If you take one dose a day, take it in the morning (breakfast).
  • If you take two doses a day, take one dose in the morning (breakfast) and one in the evening (dinner).
  • If you take three dose your day, take one dose in the morning (breakfast), one at noon (lunch) and evening (dinner).

850 mg: The notch is only for you to split the tablet if you have difficulty swallowing it whole.

1,000 mg: The tablet can be divided into two equal doses.

If after a while you think that the effect of Metformin Orifarm is too strong or too weak, talk to your doctor or pharmacist.

If you take more Metformin Orifarm than you should

An overdose of Metformin Orifarm does not lead to hypoglycemia but increases the risk of hyperacidity (increased oxygen content) in the blood, caused by lactic acidosis. The symptoms of early hyperacidity are similar to the side effects that metformin causes on the gastrointestinal tract: malaise, vomiting, diarrhea, and stomach pain. In severe cases, you can also get muscle pain, muscle cramps, rapid, uncontrollable breathing as well as lowering consciousness and coma. This can develop in a few hours and requires immediate medical attention.

If you forget to take Metformin Orifarm

If you forget to take Metformin Orifarm, take the next dose at the time you would normally take it. Try to keep prescribing one in the future. Do not take a double dose to make up for a forgotten dose.

If you stop taking Metformin Orifarm

If you stop taking Metformin Orifarm, you should be aware of the risk of getting uncontrolled blood sugar levels and the long-term effects of diabetes mellitus, such as damage to the eyes, kidneys, and blood vessels.

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

Possible side effects

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


Metformin Orifam can cause very rare (may affect up to 1 user in 10,000) but very serious side effects such as lactic acidosis (see section “Warnings and precautions”). If this happens to you, you must stop taking Metformin Orifarm and contact your doctor or nearest hospital immediately as lactic acidosis may lead to coma.


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

  • Digestive problems, e.g. nausea, vomiting, diarrhea, stomach pain or loss of appetite. These side effects usually occur at the beginning of treatment with Metformin Orifarm. It helps if you distribute the doses throughout the day and if you take the tablets with or immediately after a meal. If symptoms persist, stop taking Metformin Orifarm and talk to your doctor.


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

  • Taste change.


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

  • Lactic acid . This is a very rare but serious complication, which can occur especially if the kidneys are not functioning properly.Symptoms of lactic acidosis are nonspecific (see section “Warnings and precautions”).
  • Deviations in liver function tests or hepatitis (this may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking Metformin Orifarm and contact your doctor.
  • Skin reactions such as redness of the skin ( erythema ), itching or hives .
  • Low levels of vitamin B12 in the blood. In the long run, this can lead to anemia , pain in the mouth or tongue or any numbness or tingling in the hands and feet.

Children and young people

Limited information shows that the type and severity of side effects are similar for children and adolescents as for adults.

How to store Metformin Orifarm

Keep this medicine out of the sight and reach of children. If a child is being treated with Metformin Orifarm, parents and caregivers should monitor the use of this medicine.

Do not use this medicine after the expiry date which is stated on the blister pack, plastic jar, or carton after EXP. The expiration date is the last day of the specified month.

Storage instructions

No special storage instructions.

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.

Contents of the pack and other information

Content declaration

The active substance is metformin hydrochloride.

  • Each film-coated tablet contains 500 mg, 850 mg or 1000 mg of metformin hydrochloride, corresponding to 390 mg, 663 mg and 780 mg of metformin , respectively .

Other ingredients are:

  • Sodium starch glycolate (type A), povidone K-30, corn starch, colloidal anhydrous silica, magnesium stearate, hypromellose 15cP, talc, titanium dioxide (E 171), macrogol 6000, propylene glycol.

What the medicine looks like and contents of the pack

500 mg: White to off-white, biconvex, film-coated tablets that are smooth on both sides.

850 mg: White to off-white, capsule-shaped, biconvex, film-coated tablets, scored on one side and even on the other.

1,000 mg: White to off-white, oval, biconvex, film-coated tablets with a deep notch on one side and a notch on the other.

Blister pack: 100×1, 9, 10, 20, 21, 30, 40, 50, 56, 60, 84, 90, 100, 120, 180, 200, 300, 500, 600 or 1000 tablets.

Plastic bottles: 10, 20, 21, 30, 40, 50, 56, 60, 90, 100, 120, 180, 200, 300, 400, 500, 600 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm 

info@orifarm.com

This medicinal product is authorized under the European Economic Area under the names

Denmark, Norway, and Sweden: Metformin Orifarm

Muhammad Nadeem

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