Roname 4 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Roname 4 mg tablets

glimepiride

Read the entire leaflet carefully before starting to take this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Roname 4 mg tablets are and what they are used for.
2. What you need to know before taking Roname 4 mg tablets.
3. How to take Roname 4 mg tablets.
4. Possible side effects.
5. How to store Roname 4 mg tablets.

Pack contents and other information.

1. What Roname 4 mg tablets are and what they are used for

Roname is a medication that lowers blood sugar levels and is active when taken orally. This medicine belongs to a group of blood sugar-lowering medications called sulfonylureas. Roname increases the amount of insulin released by your pancreas. Insulin reduces your blood sugar levels.

What Roname is used for

Roname is used to treat a type of diabetes (type 2 diabetes mellitus) when diet, physical exercise, and weight reduction have not been sufficient to control your blood sugar levels.

2. What you need to know before taking Roname 4 mg tablets

Do not take Roname

• If you are allergic to glimepiride or other sulfonylureas (medicines used to lower your blood sugar levels such as glibenclamide) or sulfonamides (medicines for bacterial infections such as sulfamethoxazole), or to any of the other ingredients of this medicine (listed in section 6).
• If you have type 1 diabetes mellitus.
• If you have diabetic ketoacidosis (a complication of diabetes when acid levels in your body rise and you may have one or more of the following symptoms: fatigue, dizziness (nausea), frequent urination, and muscle stiffness).
• If you are in a diabetic coma.
• If you have severe kidney disease.
• If you have severe liver disease.

Do not take this medicine if any of the above conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Roname.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine if:

• You are recovering from an illness, surgery, infection with fever, or other forms of stress. Inform your doctor, as your treatment may need to be adjusted.
• You have severe liver or kidney impairment.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Roname.

A decrease in hemoglobin levels and rupture of red blood cells (hemolytic anemia) may occur in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

Available information on the use of Roname in individuals under 18 years of age is limited. Therefore, its use is not recommended in these patients.

Important information about hypoglycemia (low blood sugar)

If you are taking Roname, you may experience hypoglycemia (low blood sugar). See below for more information about hypoglycemia, its signs, and treatment.

The following factors may increase your risk of hypoglycemia:

• Malnutrition, irregular meal times, skipping or delaying meals, or periods of fasting.
• Changes in your diet.
• If you take more Roname than you need.
• If you have severe liver disease.
• If you have other hormonal disorders (such as thyroid, pituitary, or adrenal cortex gland problems).
• If you consume alcohol (especially if you skip a meal).
• If you take certain medicines (see “Taking Roname with other medicines”).
• If you increase your physical exercise and do not eat enough or consume fewer carbohydrates than usual.

Signs of hypoglycemia include:

• Feeling hungry, headache, nausea, vomiting, lethargy, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, feeling helpless.
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden chest pain that may radiate to nearby areas (angina and cardiac arrhythmias).

If your blood sugar continues to drop, you may experience severe confusion (delirium), seizures, loss of self-control, shallow breathing, slower heart rate, and may become unconscious. The clinical picture of severe hypoglycemia resembles that of a stroke.

Treatment of hypoglycemia:

In most cases, symptoms of low blood sugar disappear quickly after consuming sugar, such as sugar lumps, sweet fruit juices, or sugared tea.

Therefore, you should always carry a source of sugar with you (e.g., sugar lumps). Remember that artificial sweeteners are not effective. Please consult your doctor or go to hospital if symptoms do not improve after taking sugar or if symptoms recur.

Blood tests

Your blood and urine sugar levels should be monitored regularly. Your doctor may request blood tests to monitor blood cell counts and assess liver function.

Children and adolescents

The use of Roname is not recommended in children under 18 years of age.

Other medicines and Roname

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust your dose of Roname if you are taking other medicines that may increase or decrease its effect on blood sugar levels.

The following medicines may increase the hypoglycemic effect of Roname. This may lead to a risk of hypoglycemia (low blood sugar):

• Other medicines for treating diabetes mellitus (such as insulin or metformin).
• Medicines for pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone; and aspirin derivatives).
• Medicines for urinary tract infections (such as certain long-acting sulfonamides).
• Medicines for fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medicines to thin the blood (coumarin derivatives such as warfarin).
• Medicines to increase muscle mass (anabolic agents).
• Medicines used in male hormone replacement therapy.
• Medicines for treating depression (fluoxetine, MAO inhibitors).
• Medicines to lower high cholesterol levels (fibrates).
• Medicines to lower high blood pressure (ACE inhibitors).
• Medicines called antiarrhythmics used to control abnormal heart rhythms (disopyramide).
• Medicines for treating cancer (cyclophosphamide, trofosfamide, and ifosfamide).
• Medicines for treating gout (allopurinol, sulfinpyrazone, and probenecid).
• Medicines used for weight loss (fenfluramine).
• Medicines to improve circulation when given at high doses by intravenous infusion (pentoxifylline).
• Medicines for nasal allergies such as hay fever (tritoqualine).
• Medicines called sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms.

The following medicines may decrease the hypoglycemic effect of Roname. This may lead to a risk of hyperglycemia (high blood sugar):

• Medicines containing female sex hormones (estrogens and progestogens).
• Medicines that increase urine production such as certain antihypertensives (saluretics and thiazide diuretics).
• Medicines used to stimulate the thyroid gland (such as levothyroxine).
• Medicines for allergies and inflammation (glucocorticoids).
• Medicines for treating severe mental illnesses (chlorpromazine and other phenothiazine derivatives).
• Medicines to increase heart rate, treat asthma or nasal congestion, cough and colds, or used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics).
• Medicines for lowering cholesterol (nicotinic acid).
• Medicines for constipation when used long-term (laxatives).
• Medicines for nervousness and sleep problems (barbiturates).
• Medicines for seizures (phenytoin).
• Medicines to increase eye pressure (acetazolamide).
• Medicines for treating high blood pressure or low blood sugar (diazoxide).
• Medicines for treating severe low blood sugar (glucagon).
• Medicines for treating infections, tuberculosis (rifampicin).

The following medicines may increase or decrease the hypoglycemic effect of Roname:

• Medicines for stomach ulcers (called H2 antagonists).
• Medicines for high heart pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the signs of hypoglycemia, so special caution is required when taking these medicines.

Roname may also increase or decrease the effects of the following medicines:

• Medicines that inhibit blood clotting (coumarin derivatives such as warfarine).

Colesevelam, a medicine used to lower cholesterol, affects the absorption of Roname. To avoid this interaction, it is recommended to take Roname at least 4 hours before colesevelam.

Taking Roname with food, drinks, and alcohol

Alcohol intake may unpredictably increase or decrease the hypoglycemic action of glimepiride.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

In these circumstances, consult your doctor, who will likely prescribe insulin instead.

Pregnancy

Roname must not be taken during pregnancy.

Breastfeeding

Roname may pass into breast milk. Roname must not be used during breastfeeding.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar levels drop (hypoglycemia) or rise (hyperglycemia), or if you experience vision problems due to these conditions. Be aware that this may put you and others at risk (e.g., when driving or operating machinery). Please consult your doctor if you can drive if:

• you have frequent episodes of hypoglycemia,
• you have absent or few warning signs of hypoglycemia.

Roname contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

3. How to take Roname 4 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

How to take this medicine:

• Take this medicine orally, just before or with the first meal of the day (usually breakfast). If you do not eat breakfast, you should take the product as directed by your doctor. It is important not to skip any meals while taking Roname.
• Swallow the tablet with at least half a glass of water. Do not break or chew the tablets.

How much to take:

The dose of Roname depends on your individual needs, condition, and results of your blood and urine sugar tests, and will be determined by your doctor. Do not take more tablets than your doctor has prescribed.

• The starting dose is one 1 mg Roname tablet per day.
• If necessary, your doctor may gradually increase your dose after 1–2 weeks of treatment.
• The maximum recommended dose is 6 mg of Roname per day.
• You may start combination therapy with glimepiride plus metformin or glimepiride plus insulin. In such cases, your doctor will determine the appropriate individual doses of glimepiride, metformina, and insulin for you.
• If your weight changes, if you change your lifestyle, or if you are under stress, you may need to adjust your Roname dose; therefore, inform your doctor.
• If you feel that the effect of glimepiride is too strong or too weak, do not change the dose yourself; inform your doctor or pharmacist.

Use in children

Glimepiride has not been studied in children.

Use in the elderly

No specific studies have been conducted in elderly patients.

Since biological functions may be reduced, your doctor will adjust your dose cautiously and closer monitoring may be required.

If you take more Roname than you should

If you accidentally take too much Roname or an extra dose, there is a risk of hypoglycemia (for symptoms of hypoglycemia, see section 2). You should immediately consume sufficient sugar (for example, sugar lumps, sweet fruit juice, sugared tea) and inform your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar administered must be carefully controlled to avoid causing dangerous hyperglycemia. Unconscious individuals must not be given food or drink.

Since hypoglycemia may last for some time, it is very important that the patient is carefully monitored until there is no further danger. As a precaution, hospital admission may be necessary. Show the packaging or remaining tablets to the doctor so they can determine what you have taken.

Severe cases of hypoglycemia associated with loss of consciousness and serious neurological impairment are medical emergencies requiring immediate medical treatment and hospitalization. You should ensure that there is always someone informed who can call a doctor in case of emergency.

If you forget to take Roname

Do not take a double dose to make up for a missed dose.

If you stop taking Roname

If you interrupt or stop treatment, keep in mind that the desired effect of lowering blood sugar will not be achieved, or your condition may worsen again. Continue taking Roname until your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The assessment of adverse effects is based on the following frequencies:

Rare: may affect up to 1 in 1,000 people.
Very rare: may affect up to 1 in 10,000 people.
Frequency not known: frequency cannot be estimated from the available data.

Contact your doctor immediately if you experience any of the following symptoms:

• Allergic reactions (including inflammation of blood vessels, often with skin rash), which may lead to severe reactions with breathing difficulties, drop in blood pressure, and sometimes resulting in shock.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver failure.
• Skin allergy (hypersensitivity), such as itching, skin rash, hives, and light sensitivity. Some mild allergic reactions may progress to severe reactions.
• Severe hypoglycaemia, including loss of consciousness, seizures, or coma.

Some patients have experienced the following adverse effects while taking Roname:

Rare adverse effects:

• Blood sugar levels lower than normal (hypoglycaemia) (see section 2).

• Reduction in blood cell counts:

• Platelets (which increases the risk of bleeding or bruising).

• White blood cells (which makes infections more likely).

• Red blood cells (which may cause paleness of the skin and lead to weakness or difficulty breathing).

In general, these abnormalities resolve when treatment with Roname is discontinued.

• Weight gain.
• Hair loss.
• Change in taste sensation.

Very rare adverse effects:

• Allergic reactions (including inflammation of blood vessels, often with skin rash), which may trigger severe reactions with breathing difficulties, drop in blood pressure, and sometimes lead to shock. If you experience any of these symptoms, inform your doctor immediately.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver, or liver failure. If you experience any of these symptoms, inform your doctor immediately.
• Nausea, vomiting, diarrhoea, feeling of heaviness, bloating, or stomach pain.
• Decreased sodium levels in blood (detectable in blood tests).

Frequency not known:

• Skin allergy (hypersensitivity), such as itching, skin rash, hives, and light sensitivity. Some mild allergic reactions may progress to severe reactions with difficulty swallowing or breathing, or swelling of the lips, throat, or tongue. Therefore, if you experience any of these adverse effects, inform your doctor immediately.
• Allergic reactions to sulfonylureas, sulfonamides, or related medicines.
• You may experience vision disturbances when starting treatment with Roname. This is due to changes in blood sugar levels and should improve quickly.
• Increased liver enzymes.
• Unusual severe bleeding or bruising under the skin.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Roname 4 mg tablets

Keep this medicine out of the sight and reach of children.

Do not store above 30 °C.

Store in the original packaging to protect from moisture.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Roname 4 mg tablets

• The active substance is glimepiride. Each tablet contains 4 mg of glimepiride.
• The other components are: monohydrate lactose, sodium carboxymethyl starch (type A) (from potato), magnesium stearate, microcrystalline cellulose, povidone 25000 and indigo carmine aluminium lake (E132).

Appearance of the product and contents of the pack

Roname 4 mg are light blue, oblong tablets, scored on both sides.

Roname 4 mg tablets are available in packs of 30 and 120 tablets.

Marketing Authorization Holder and Manufacturer

LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain

Date of the most recent revision of this leaflet: October 2018

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es