Repaglinide Krka - Repaglinide uses, dose and side effects

Repaglinide Krka contains repaglinide and is an oral tablet for the treatment of diabetes. Repaglinide Krka 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 Krka 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 Krka can also be given with metformin, another diabetes medicine.

Repaglinide Krka lowers blood sugar, which helps prevent complications of your diabetes.

What you need to know before using Repaglinide Krka

Do not use Repaglinide Krka

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 your blood is elevated (diabetic ketoacidosis).
if you have severe liver disease.
if you have gemfibrozil (a medicine used to reduce blood fats).

Warnings and cautions

Talk to your doctor before taking Repaglinide Krka:

if you have liver problems. Repaglinide Krka is not recommended for patients with moderate liver disease. Repaglinide Krka should not be taken if you have severe liver disease (see Do not take Repaglinide Krka).
if you have kidney problems. Repaglinide Krka should 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 Krka 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. Then you may not be treated with Repaglinide Krka, 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 an insulin sensation (low blood sugar)

You get insulin sensation ( hypoglycaemia ) if your blood sugar gets too low. It could happen:

if you take more Repaglinide Krka 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 Krka).

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 hypoglycaemia have disappeared or your blood sugar level has stabilized, you can continue treatment with Repaglinide Krka.

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. Dose a Repaglinide Krka, 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 hyperglycaemia ). It can have the following causes:

if you take too little Repaglinide Krka
whether you have an infection or fever
if you have eaten more than usual
if 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. Dose a Repaglinide Krka, diet or exercise may need to be adjusted.

Other medicines and Repaglinide Krka

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

You can take Repaglinide Krka with metformin, another diabetes medicine if your doctor tells you to.

If you are taking gemfibrozil (used to treat high blood fats), do not take Repaglinide Krka.

Your body may react differently to Repaglinide Krka 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 (angiotensin converters) (are used to treat certain heart conditions).
Salicylates (included in some painkillers).
Octreotide (used to treat cancer).
Non-steroidal anti-inflammatory drugs ( NSAIDs ) (painkillers).
Steroids (anabolic steroids and corticosteroids – used in anaemia 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, and 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 Krka with food, drink and alcohol

Alcohol may alter Repaglinide Krka’s ability 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 for advice before using this medicine.

You should not take Repaglinide Krka if you are pregnant or planning to become pregnant.

You should not take Repaglinide Krka 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:

have insulin sensations
receive few or no warning signs of low blood sugar

Repaglinide Krka contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.

How to use Repaglinide Krka

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.

Your doctor will determine 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 Krka than your doctor has prescribed.

If you use more Repaglinide Krka 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 (low blood sugar) for more information on what this is and how it is treated.

If you forget to use Repaglinide Krka

If you miss a dose, take the next dose as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop using Repaglinide Krka

Keep in mind that you will not get the desired effect if you stop taking Repaglinide Krka. Your diabetes may worsen. If any change is needed, you must contact your doctor.

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 ( hypoglycaemia )

The most common side effect is low blood sugar, which may affect up to 1 in 10 people (see ” If you get a feeling of insulin (low blood sugar) ” in section 2). Reactions to low blood sugar are generally mild/moderate but can sometimes develop into hypoglycaemic unconsciousness or coma. If this happens, seek medical attention immediately.

Allergy

Allergies are very rare (may affect up to 1 in 10,000 people). 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
Diarrhoea

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.

No known frequency (can not be calculated from the available data)

Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin; if these symptoms occur, contact your doctor as soon as possible)
Nausea.

How to store Repaglinide Krka

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 carton and blister after EXP. The expiration date is the last day of the specified month.

Store in the original package.

Sensitive to light.

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. Each tablet contains 0.5 mg, 1 mg, 2 mg repaglinide.
The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate, croscarmellose sodium, povidone K25, glycerol, magnesium stearate, and meglumine, poloxamer, yellow iron oxide (E172) only in 1 mg tablets and red iron oxide (E172) only in 2 mg tablets. See section 2 “Repaglinide Krka contains sodium”.

What the medicine looks like and the contents of the pack

The 0.5 mg tablets are white, round and biconvex with bevelled edges.

The 1 mg tablets are light brownish yellow, round and biconvex with bevelled edges with possibly darker dots.

The 2 mg tablets are pink, marbled, round and biconvex with bevelled edges with possibly darker dots.

Packs of 30, 60, 90, 120, 270 or 360 tablets in blisters are available.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer