Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Starlix 180mg film coated tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Nateglinide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Starlix is The active substance of Starlix, nateglinide, belongs to a group of medicines called oral antidiabetics. Starlix is used to treat adult patients with type 2 diabetes. It helps to control the level of sugar in the blood. Your doctor will prescribe Starlix together with metformin, if inadequately controlled despite a maximally tolerated dose of metformin. How Starlix works Insulin is a substance produced in the body by the pancreas. It helps to decrease blood sugar levels, especially after meals. If you have type 2 diabetes, your body may not start producing insulin quickly enough after meals. Starlix works by stimulating the pancreas to produce insulin more quickly, which helps to keep blood sugar levels under control after meals. Starlix tablets start to act within a very short time after they are swallowed and are eliminated from the body rapidly. 2.
What you need to know before you take it
e Starlix
Follow all instructions given to you by your doctor, pharmacist or nurse carefully, even if they are different from what is in this leaflet. Do not take Starlix if you are allergic to nateglinide or any of the other ingredients of this medicine (listed in section 6). if you have type 1 diabetes (i.e. your body does not produce any insulin).
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if you are experiencing any symptoms of severe hyperglycaemia (very high blood sugar and/or diabetic ketoacidosis). These symptoms include excessive thirst, frequent urination, weakness, fatigue, nausea, shortness of breath or confusion. if you know that you have a severe liver problem. if you are pregnant or planning to become pregnant. if you are breast-feeding. If any of these apply to you, do not take Starlix and talk to your doctor. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Starlix. Diabetic patients may develop symptoms associated with low blood sugar (also called hypoglycaemia). Oral antidiabetics, including Starlix, may also produce symptoms of hypoglycaemia.
If you have low blood sugar you may experience sweating, tremors (feeling shaky), anxiety, difficulty concentrating, confusion, weakness or fainting or have other signs listed in section 4, "Possible side effects". If this happens to you, eat or drink something containing sugar, and talk to your doctor. Some people are more likely to get symptoms of low blood sugar than others. Take care: if you are over 65 years of age. if you are undernourished. if you have another medical condition that may cause low blood sugar (e.g. an under-active pituitary or adrenal gland). If any of these apply to you, monitor your blood sugar levels more carefully. Watch carefully for signs of low blood sugar, especially: if you have exercised more strenuously than usual. if you have drunk alcohol. Talk to your doctor before taking Starlix if you know that you have a liver problem. if you have a severe kidney problem. if you have problems with drug metabolism. if you are due to have an operation. if you have recently suffered a fever, an accident or an infection. Your treatment may need to be adjusted. Children and adolescents Starlix is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied. Elderly Starlix can be used by people over 65 years of age. Such patients should take special care to avoid low blood sugar. Other medicines and Starlix Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The amount of Starlix that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.
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It is especially important that you tell your doctor, pharmacist or nurse if you are taking: Non-steroidal anti-inflammatory agents (used, for example, to treat muscle and joint pain). Salicylates such as aspirin (used as painkillers). Monoamine oxidase inhibitors (used to treat depression). Beta blockers or ACE inhibitors (angiotensin-converting enzyme inhibitors) (used, for example, to treat high blood pressure and certain heart conditions). Diuretics (used to treat high blood pressure). Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders). Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil (used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout). Sympathomimetics (used, for example, to treat asthma). Anabolic hormones (e.g. methandrostenolone). St. John's Wort, also known as Hypericum perforatum (a herbal medicine). Somatropin (a growth hormone). Somatostatin analogues such as lanreotide and octreotide (used to treat acromegaly). Rifampin (used, for example, to treat tuberculosis). Phenytoin (used, for example, to treat seizures). Your doctor may adjust the dose of these medicines. Starlix with food, drink and alcohol Take Starlix before meals (see section 3, "How to take Starlix"); its effect may be delayed if it is taken during or after meals. Alcohol may disturb the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Starlix. Pregnancy, breast-feeding and fertility Do not take Starlix if you are pregnant or planning to become pregnant. See your doctor as soon as possible if you become pregnant during treatment. Do not breast-feed during treatment with Starlix. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine. Driving and using machines Your ability to concentrate or react may be reduced if you have low blood sugar (hypoglycaemia). Bear this in mind if you drive a car or operate machines as you might put yourself or others at risk. You should ask for doctor advice on driving if you have frequent episodes of hypoglycaemia or if you are not aware of the first signs of hypoglycaemia. Starlix contains lactose Starlix tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3.
How to take it
Starlix
Always take this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The recommended starting dose of Starlix is 60 mg three times daily, taken before each of the three main meals. Your doctor may check the amount of Starlix that you are taking on a regular basis and may adjust the dose according to your needs. The maximum recommended dose is 180 mg three times
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daily, taken before each of the three main meals. Take Starlix before meals. Its effect may be delayed if it is taken during or after meals. Take Starlix before the three main meals, usually: 1 dose before breakfast 1 dose before lunch 1 dose before dinner It is best to take it right before a main meal but you can take it up to 30 minutes before. Do not take it if you are not going to eat a main meal. If you miss a meal, skip that dose of Starlix and wait until your next meal. Swallow the tablets whole with a glass of water. Even though you are taking medicines for your diabetes, it is important to keep following the diet and/or exercise programme your doctor has recommended for you. If you take more Starlix than you should If you have accidentally taken too many tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately. Medical attention may be necessary. If you experience symptoms of low blood sugar (listed in section 4, "Possible side effects"), eat or drink something containing sugar. If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help – or make sure that someone else does this for you. If you have to go to a doctor or hospital, take the pack and this leaflet with you. If you forget to take Starlix If you forget to take a tablet, simply take the next one before your next meal. Do not take a double dose to make up for a forgotten dose. If you stop taking Starlix Continue to take this medicine as long as your doctor prescribes it so that it can continue to control your blood sugar. Do not stop taking Starlix unless your doctor tells you to. If you have any further questions on the use of this medicine, talk to your doctor, pharmacist or nurse. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects caused by Starlix are usually mild to moderate. Common (may affect up to 1 in 10 people): These are symptoms of low blood sugar (hypoglycaemia), which are usually mild. These include: sweating dizziness shaking weakness hunger feeling your heart beating fast tiredness feeling sick (nausea)
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These symptoms can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking. If you do get symptoms of low blood sugar, eat or drink something containing sugar. Other side effects may include: Common (may affect up to 1 in 10 people): abdominal pain, indigestion, diarrhoea, nausea Uncommon (may affect up to 1 in 100 people): vomiting Rare (may affect up to 1 in 1,000 people): mild abnormalities in liver function tests, allergic (hypersensitivity) reactions such as rash and itching Very rare (may affect up to 1 in 10,000 people): skin rash with blisters affecting the lips, eyes and/or mouth, sometimes with headache, fever and/or diarrhoea Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 5.
How to store it
Starlix
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 after EXP. The expiry date refers to the last day of that month. Store in the original package. Do not store above 30°C. Do not use any Starlix pack that is damaged or shows signs of tampering. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Starlix contains The active substance is nateglinide. Each tablet contains 60, 120 or 180 mg nateglinide. The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone; croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous. The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172). What Starlix looks like and contents of the pack Starlix 60 mg film-coated tablets are pink, round tablets with "STARLIX" marked on one side and "60" on the other. Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with "STARLIX" marked on one side and "120" on the other. Starlix 180 mg film-coated tablets are red, ovaloid tablets with "STARLIX" marked on one side and "180" on the other. Each blister pack contains 12, 24, 30, 60, 84, 120 or 360 tablets. Not all pack sizes or tablet strengths may be available in your country.
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Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland Manufacturer Novartis Farma S.p.A. Via Provinciale Schito, 131 I-80058 Torre Annunziata – Napoli Italy For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370 This leaflet was last revised in 05/2018 Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
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Frequently asked questions about Starlix 180mg film coated tablets
How do I take Starlix 180mg film coated tablets?
Starlix 180mg film coated tablets comes as tablet containing 180mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Starlix 180mg film coated tablets?
The active substance in Starlix 180mg film coated tablets is nateglinide.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Starlix 180mg film coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Starlix 180mg film coated tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: nateglinide
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
4.2. Posology and method of administration
Posology
Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner).The dosage of nateglinide should be determined by the physician according to the patient's requirements.The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA1c. This may be increased to 120 mg three times daily.Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements. Since the primary therapeutic effect of Starlix is to reduce mealtime glucose, (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1–2 hour post-meal glucose.The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.Special populations ElderlyThe clinical experience in patients over 75 years of age is limited. Paediatric population
There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended. Patients with hepatic impairment
No dose adjustment is necessary for patients with mild to moderate hepatic impairment. As patients with severe liver disease were not studied, nateglinide is contraindicated in this group. Patients with renal impairment
No dose adjustment is necessary in patients with mild to moderate renal impairment. Although there is a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15–50 ml/min) was comparable between renal subjects requiring haemodialysis and healthy subjects. Although safety was not compromised in this population dose adjustment may be required in view of low Cmax. Others
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful titration is required to avoid hypoglycaemic reactions.
4.3. Contraindications
Starlix is contraindicated in patients with:• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1• Type 1 diabetes (C-peptide negative)• Diabetic ketoacidosis, with or without coma• Pregnancy and breast-feeding (see section 4.6)• Severe hepatic impairment
4.4. Special warnings and precautions for use
General
Nateglinide should not be used in monotherapy.Like other insulin secretagogues, nateglinide is capable of producing hypoglycaemia.Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those treated with oral antidiabetic agents (see section 4.8). Elderly, malnourished patients and those with adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose-lowering effect of these treatments. The risk of hypoglycaemia in type 2 diabetic patients may be increased by strenuous physical exercise, or ingestion of alcohol.Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose baseline HbA1c was close to the therapeutic target (HbA1c <7.5%).Combination with metformin is associated with an increased risk of hypoglycaemia compared to monotherapy.Hypoglycaemia may be difficult to recognise in subjects receiving beta blockers.When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur. At such times, it may be necessary to discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis.Starlix contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine. Special populations
Nateglinide should be used with caution in patients with moderate hepatic impairment.No clinical studies have been conducted in patients with severe hepatic impairment or children and adolescents. Treatment is therefore not recommended in these patient groups.
4.5. Interaction with other medicinal products and other forms of interaction
A number of medicinal products influence glucose metabolism and possible interactions should therefore be taken into account by the physician:The following agents may enhance the hypoglycaemic effect of nateglinide: angiotensin-converting enzyme inhibitors (ACEI), non-steroidal anti-inflammatory agents, salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents and anabolic hormones (e.g. methandrostenolone).The following agents may reduce the hypoglycaemic effect of nateglinide: diuretics, corticosteroids, beta2 agonists, somatropin, somatostatin analogues (e.g. lanreotide, octreotide), rifampin, phenytoin and St John's wort.When these medicinal products - that enhance or reduce the hypoglycaemic effect of nateglinide - are administered to or withdrawn from patients receiving nateglinide, the patient should be observed closely for changes in glycaemic control.Data available from both in vitro and in vivo experiments indicate that nateglinide is predominantly metabolised by CYP2C9 with involvement of CYP3A4 to a smaller extent.In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC (~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination half-life. A more prolonged effect and possibly a risk of hypoglycaemia cannot be excluded in patients when nateglinide is co-administered with CYP2C9 inhibitors.Particular caution is recommended when nateglinide is co-administered with other more potent inhibitors of CYP2C9 (e.g. fluconazole, gemfibrozil or sulfinpyrazone), or in patients known to be poor metabolisers for CYP2C9.Interaction studies with a 3A4 inhibitor have not been carried out in vivo.In vivo, nateglinide has no clinically relevant effect on the pharmacokinetics of medicinal products metabolised by CYP2C9 and CYP3A4. The pharmacokinetics of warfarin (a substrate for CYP3A4 and CYP2C9), diclofenac (a substrate for CYP2C9), and digoxin were unaffected by coadministration with nateglinide. Conversely, these medicinal products had no effect on the pharmacokinetics of nateglinide. Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are CYP2C9 or CYP3A4 substrates upon coadministration with Starlix. Similarly, there was no clinically significant pharmacokinetic interaction of Starlix with other oral antidiabetic agents such as metformin or glibenclamide.Nateglinide has shown a low potential for protein displacement in in vitro studies.
4.6. Fertility, pregnancy and lactation
Pregnancy
Studies in animals have shown developmental toxicity (see section 5.3). There is no experience in pregnant women, therefore the safety of Starlix in pregnant women cannot be assessed. Starlix, like other oral antidiabetic agents, must not be used in pregnancy. Breast-feeding
Nateglinide is excreted in the milk following a peroral dose to lactating rats. Although it is not known whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants may exist and therefore nateglinide should not be used in lactating women.
4.7. Effects on ability to drive and use machines
The effect of Starlix on the ability to drive or operate machinery has not been studied.Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.
4.8. Undesirable effects
Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse reactions have been seen. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Hypoglycaemia
As with other antidiabetic agents, symptoms suggestive of hypoglycaemia have been observed after administration of nateglinide. These symptoms included sweating, trembling, dizziness, increased appetite, palpitations, nausea, fatigue, and weakness. These were generally mild in nature and easily handled by intake of carbohydrates when necessary. In completed clinical trials, symptoms of hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone, and 4.1% with placebo. Immune system disorders
Rare: Hypersensitivity reactions such as rash, itching and urticaria. Metabolism and nutrition disorders
Common: Symptoms suggestive of hypoglycaemia. Gastrointestinal disorders
Common: Abdominal pain, diarrhoea, dyspepsia, nausea.Uncommon: Vomiting. Hepatobiliary disorders
Rare: Elevations in liver enzymes. Other events
Other adverse events observed in clinical studies were of a similar incidence in Starlix-treated and placebo-treated patients.Post-marketing data revealed very rare cases of erythema multiforme. Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
In a clinical study in patients, Starlix was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated. There is no experience of an overdose of Starlix in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect, with the development of hypoglycaemic symptoms. Hypoglycaemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe hypoglycaemic reactions with coma, seizure or other neurological symptoms should be treated with intravenous glucose. As nateglinide is highly protein-bound, dialysis is not an efficient means of removing it from the blood.
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Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.