0.5 mg, 1 mg and 2 mg tablets
Repaglinide
What Repaglinide Stada is and what it is used for
Repaglinide Stada contains repaglinide and is an oral tablet for the treatment of diabetes. Repaglinide Stada helps your pancreas to produce more insulin and lower your blood sugar ( glucose ).
Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of sugar in your blood or where your body does not normally respond to the insulin it produces (formerly called non-insulin-dependent diabetes or age-related diabetes).
Repaglinide Stada is used to control type 2 diabetes as a supplement to diet and exercise. Treatment is usually started if diet, exercise, and weight loss alone are not enough to control (or lower) your blood sugar. Repaglinide Stada can also be given with metformin, another diabetes medicine.
What you need to know before you use Repaglinide Stada
Do not use Repaglinide Stada
- if you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6)
- if you have type 1 diabetes (insulin-dependent diabetes mellitus )
- if the acid level in the body is elevated ( diabetic ketoacidosis )
- if you have severe liver disease
- if you are taking gemfibrozil (for the treatment of high blood fats).
If any of the above apply to you, tell your doctor and do not take Repaglinide Stada.
Warnings and cautions
Talk to your doctor or pharmacist before taking Repaglinide Stada. Special if:
- you have liver problems. Repaglinide Stada is not recommended for patients with moderate liver disease. Repaglinide Stada should not be taken if you have severe liver disease (see Do not take Repaglinide Stada )
- you have kidney problems. Repaglinide Stada should then be used with caution
- you are going to have major surgery or have recently had a serious illness or infection. In such cases, diabetes control may be insufficient
- if you are under 18 or over 75 years of age. Repaglinide Stada can then not be recommended, as studies in these age groups are lacking.
If you get an insulin sensation
You get insulin sensation (hypoglycemia) if your blood sugar gets too low. It could happen:
- if you take more Repaglinide Stada than you should
- if you exercise more than usual
- if you are taking other medicines or have kidney or liver problems (see the second section under 2. What you need to know before taking Repaglinide Stada ).
The warning signs of low blood sugar can come on suddenly and manifest themselves as: cold sweat; cold and pale skin; headache; palpitation; nausea; strong hunger; temporary vision changes; drowsiness; unusual fatigue and weakness; nervousness or tremors; feelings of anxiety; confusion; concentration difficulties.
If your blood sugar is low or you get an insulin sensation: eat glucose tablets or a snack or a drink that contains a lot of sugar and then rest.
When the symptoms of hypoglycemia have disappeared or your blood sugar level has stabilized, you can continue treatment with Repaglinide Stada.
Tell people around you that you have diabetes and that if you become unconscious due to low blood sugar, they should put you on your side and get medical attention immediately. They must not give you anything to eat or drink. Then there is a risk that you will suffocate.
- If severe insulin sensitivity is not treated, it can cause brain damage (temporary or permanent) and even death.
- If you get an insulin sensation and lose consciousness, or if you get a lot of insulin sensations, talk to your doctor. Dosage of Repaglinide Stada, diet, or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may become too high (this is called hyperglycemia). It can have the following causes:
- You have taken too little dose of Repaglinide Stada
- You have an infection or fever
- You have eaten more than usual
- You have exercised less than usual.
The warning signals appear gradually. They manifest as: increased urine output; thirst; dry skin and dry mouth. Talk to your doctor. Dosage of Repaglinide Stada, diet, or exercise may need to be adjusted.
Other medicines and Repaglinide Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can take Repaglinide Stada with metformin, another diabetes medicine if your doctor tells you to. If you are taking gemfibrozil (for the treatment of high blood fats), you should not take Repaglinide Stada.
Your body may react differently to Repaglinide Stada if you are taking other medicines, especially these:
- MAO inhibitors (used to treat depression)
- Beta-receptor blockers (used to treat high blood pressure or heart disease)
- ACE inhibitors (used to treat heart disease)
- Salicylates (included with some painkillers)
- Octreotide (used to treat cancer)
- Non-steroidal anti-inflammatory drugs ( NSAIDs ) (painkillers)
- Steroids (anabolic steroids and corticosteroids – used in anemia or treatment of inflammation )
- Oral contraceptives ( birth control pills )
- Thiazides ( diuretics or diuretics)
- Danazol (used to treat breast cysts and endometrial tissue outside the uterus, called endometriosis )
- Thyroid drugs (used to treat low levels of thyroid hormones)
- Adrenergic agents (used to treat asthma )
- Clarithromycin, trimethoprim, rifampicin ( antibiotics )
- Itraconazole, ketoconazole (antifungal)
- Gemfibrozil (used to treat high blood fats)
- Ciclosporin (used to inhibit the immune system)
- Deferasirox (used to remove excess iron from the body)
- Clopidogrel (prevents the formation of blood clots)
- Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy )
- St. John’s wort (herbal medicine).
Repaglinide Stada with food, drink, and alcohol
Take Repaglinide Stada before main meals. Alcohol may alter the ability of Repaglinide Stada to lower blood sugar. Pay attention to signs of insulin sensation.
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.
You should not take Repaglinide Stada if you are pregnant or planning to become pregnant. You should contact your doctor as soon as possible if you become pregnant or plan to become pregnant during treatment.
You should not take Repaglinide Stada if you are breastfeeding.
Driving and using machines
Your ability to drive or use machines may be affected if your blood sugar is too high or too low. Remember that you can put yourself and others at risk. Talk to your doctor if you can drive if you:
- often have insulin sensations
- receive few or no warning signs of low blood sugar.
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.
Repaglinide Stada contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. next to “sodium-free”.
How to use Repaglinide Stada
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide on your dose.
- The recommended starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
- Your doctor may increase the dose to one up to 4 mg immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.
Do not take more Repaglinide Stada than your doctor has prescribed.
If you use more Repaglinid Stada than you should
If you take too many tablets, your blood sugar may become too low and lead to insulin sensation. See If you get an insulin sensation for more information on what this is and how it is treated.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Repaglinide Stada
If you miss a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop using Repaglinide Stada
Keep in mind that you will not get the desired effect if you stop taking Repaglinide Stada. Your diabetes may worsen. If your treatment needs to be changed, always consult your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people)
- hypoglycemia (see If you get an insulin sensation section 2 ). The risk of getting hypoglycemia may increase if you take other medicines
- abdominal pain
- or diarrhea.
Rare (may affect up to 1 in 1,000 people)
- acute coronary heart disease (need not be associated with the drug).
Very rare (may affect up to 1 in 10,000 people)
- allergies (such as swelling, difficulty breathing, palpitations, dizziness, and sweating, which may be signs of anaphylactic reaction ). Contact a doctor immediately
- after vomiting
- constipation
- visual disturbances
- severe liver problems, abnormal liver function, and an increase in liver enzymes in your blood.
No known frequency (occurs in an unknown number of users)
- Hypoglycaemic coma or unconsciousness (very severe hypoglycaemic events – see If you experience insulin ). Contact a doctor immediately
- Hypersensitivity (such as rash, itchy skin, redness of the skin, swelling of the skin)
- Nausea.
How to store Repaglinide Stada
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
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 repaglinide.
1 tablet contains 0.5 mg, 1 mg or 2 mg repaglinide.
Other ingredients are:
Microcrystalline cellulose, poloxamer 188, croscarmellose sodium, magnesium stearate.
What the medicine looks like and the contents of the pack
Repaglinide Stada 0.5 mg
White, round, 3.4 mm thick, and biconvex tablets.
Repaglinide Stada 1 mg
White, round, 3.4 mm thick, and biconvex tablets marked “1”.
Repaglinide Stada 2 mg
White, round, 4.2 mm thick, and biconvex tablets marked “2”.
The tablets are available in the following pack sizes containing 15, 30, 90, 120, 180, or 270 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Stada Arzneimittel GmbH, Muthgasse 36, 1190 Vienna, Austria
Centrafarm Services BV, Nieuwe Donk 9, 4879 AC Etten Leur, The Netherlands
Eurogenerics NV, Heizel Esplanade B22, B-1020 Brussels, Belgium
LAMP SAN PROSPERO SPA, Via della Pace, 25 / A, 41030 San Prospero (Modena), Italy
PharmaCoDane ApS., Marielundvej 46, DK-2730 Herlev, Denmark
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark