0.5 mg, 1 mg and 2 mg repaglinide tablets respectively
What Repaglinide Teva is and what it is used for
Repaglinide Teva contains repaglinide and is an oral tablet for the treatment of diabetes.
Repaglinide Teva 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 respond normally to the insulin it produces.
Repaglinide Teva is used to control type 2 diabetes in adults 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 Teva can also be given with metformin, another diabetes medicine.
Repaglinide Teva lowers blood sugar, which helps prevent complications of your diabetes.
What you need to know before you use Repaglinide Teva
Do not use Repaglinide Teva
- 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
- if the acid level in the blood is elevated (diabetic ketoacidosis)
- if you have severe liver disease
- if you are taking gemfibrozil (for the treatment of high blood fats).
Warnings and cautions
Talk to your doctor before taking Repaglinide Teva:
- if you have liver problems. Repaglinide Teva is not recommended for patients with moderate liver disease. Repaglinide Teva should not be taken if you have severe liver disease (see Do not use Repaglinide Teva).
- if you have kidney problems. Repaglinide Teva should then be used with caution.
- if 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 Teva can then not be recommended, as studies in these age groups are lacking.
Talk to your doctor if any of the above apply to you. You may not be treated with Repaglinide Teva, but your doctor will advise you.
Children and young people
Do not take this medicine if you are under 18 years of age.
If you get a feeling of insulin (low blood sugar)
You get a feeling of insulin (hypoglycemia) if your blood sugar gets too low. It could happen:
- if you take more Repaglinide Teva than you should
- if you exercise more than usual
- if you are taking other medicines or have kidney or liver problems (see other sections under 2. What you need to know before taking Repaglinide Teva).
The warning signs of low blood sugar can come on suddenly and manifest themselves as cold sweats; 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 Teva.
Tell people around you that you have diabetes and that if you become unconscious, they should put you on the sidelines 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. The dose of Repaglinide Teva, diet, or exercise may need to be adjusted.
If your blood sugar gets too high
Your blood sugar may get too high ( hyperglycemia ). It can have the following causes:
- You have taken too little dose of Repaglinide Teva
- You have an infection or fever
- You have eaten more than usual
- You have exercised less than usual.
The warning signs of high blood sugar gradually appear. They manifest as: increased urine output; thirst; dry skin and dry mouth. Talk to your doctor. The dose of Repaglinide Teva, diet, or exercise may need to be adjusted.
Other medicines and Repaglinide Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You can take Repaglinide Teva 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 Teva.
Your body may react differently to Repaglinide Teva 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 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).
Tell your doctor if you have recently taken or are planning to take any of these or any other medicines without a prescription.
Repaglinide Teva with alcohol
Alcohol may alter Repaglinide Teva’s ability to lower blood sugar. Pay attention to signs of insulin sensation.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
You should not take Repaglinide Teva if you are pregnant or planning to become pregnant.
You should not take Repaglinide Teva 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
How to take Repaglinide Teva
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
Your doctor will decide on your dose.
- The usual 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 Teva than your doctor has prescribed.
If you take more Repaglinide Teva 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 forget to take Repaglinide Teva
If you miss a dose, take the next dose as usual – do not take a double dose.
If you stop taking Repaglinide Teva
Keep in mind that you will not get the desired effect if you stop taking Repaglinide Teva. 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.
Low blood sugar (hypoglycemia)
The most common side effect is low blood sugar, which may affect up to 1 in 10 people (see If you get an insulin sensation in section 2). Reactions to low blood sugar are generally mild/moderate but may temporarily develop into hypoglycaemic unconsciousness or coma. If this happens, seek medical attention immediately.
Allergy
Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty breathing, palpitations, dizziness, and sweating may be signs of an anaphylactic reaction. Contact a doctor immediately.
Other side effects ar
Common (may affect up to 1 in 10 people)
- Abdominal pain
- Diarrhea.
Rare (may affect up to 1 in 1,000 people)
- Acute coronary heart disease (does not need to be related to the drug).
Very rare (may affect up to 1 in 10,000 people)
- Vomiting
- Constipation
- Visual disturbances
- Severe liver problems, and abnormal liver function such as an increase in liver enzymes in your blood.
Unknown frequency
- Hypersensitivity (such as rash, itchy skin, redness of the skin, swelling of the skin)
- Nausea
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
How to store Repaglinide Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer carton and blister. The expiration date is the last day of the specified month.
Sensitive to light. Store in the original package.
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.
- The other ingredients are:
microcrystalline cellulose (E460), meglumine, poloxamer 188, povidone K 30, anhydrous calcium hydrogen phosphate, anhydrous colloidal silica, potassium polarizing, corn starch, magnesium stearate, indigo carmine aluminum (E132) (only yellow oxide) (1 mg tablets only), red iron oxide (E172) (2 mg tablets only)
What the medicine looks like and the contents of the pack
Repaglinide Teva 0.5 mg tablet is a light blue or blue, capsule-shaped tablet debossed with “93” on one side and “210” on the other side.
Repaglinide Teva 1 mg tablet is a yellow or light yellow, capsule-shaped tablet debossed with “93” on one side and “211” on the other side.
Repaglinide Teva 2 mg tablet is a speckled peach-colored, capsule-shaped tablet debossed with “93” on one side and “212” on the other.
The tablets are available in pack sizes of 30, 90, 120, 270, and 360 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Teva BV
Swensen 5
2031 GA Haarlem
Netherlands
Manufacturer
Teva Pharmaceutical Works Private Limited Company
Pallagi from 13
Debrecen H-4042
Hungary
TEVA Pharmaceutical Works Private Limited Company
H-2100 Gödöllő
Táncsics Mihály út 82
Ungern
TEVA UK Ltd
Brampton Road
Hampden Park
Eastbourne, East Sussex
BN22 9AG, UK
Pharmachemie BV
Swensen 5
2031 GA Haarlem
The Netherlands
GALIEN LPS
98 rue Bellocier
89100 Sens
France
Merckle GmbH
Ludwig-Merckle-Straße 3,
89143 Blaubeuren-Weiler
Germany
TEVA PHARMA SLU
C / C, No. 4, Polígono Industrial Malpica,
50016 Zaragoza
Spain
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel / Tel: +32 3 820 73 73 | LithuaniaUAB “Sicor Biotech”Tel: +370 5 266 0203 |
| BulgariaTeva Pharmaceuticals Bulgaria ЕООДTel: +359 2 489 95 82 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AGTel: +32 3 820 73 73 |
| Czech RepublicTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: +36 1 288 64 00 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals Ireland, L-IrelandTel: +353 51 321740 |
| GermanyTeva GmbHTel: +49 731 402 08 | The NetherlandsTeva Nederland BVTel: +31 800 0228 400 |
| EestiTeva Eesti esindus UAB Sicor Biotech Eesti subsidiaryTel: +372 6610801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 210 72 79 099 | Austriaratiopharm Arzneimittel Vertriebs-GmbHTel: +43 1 97 007 |
| SpainTeva Pharma, SLUTel: +34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| FranceTeva HealthTel: +33 1 55 91 7800 | PortugalTeva Pharma – Pharmaceutical Products LdaTel: +351 21 476 75 50 |
| CroatiaPliva Hrvatska dooTel: +385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +40 21 230 65 24 |
| IrelandTeva Pharmaceuticals IrelandTel: +353 51 321740 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| Icelandratiopharm Oy, FinlandPhone: +358 20 180 5900 | Slovak RepublicTEVA Pharmaceuticals Slovakia sroTel: +421 2 5726 7911 |
| ItalyTeva Italia SrlTel: +39 02 89 17 98 1 | Finland / Finlandratiopharm OyPuh / Tel: +358 20 180 5900 |
| .ΠροςTeva Αλλάς Α.Ε., .λλάδα:Ηλ: +30 210 72 79 099 | SwedenTeva Sweden ABTel: +46 42 12 11 00 |
| LatviaUAB “Sicor Biotech” subsidiary LatvijāTel: +371 67 784 980 | United KingdomTeva UK LimitedTel: +44 1977 628500 |