Package Insert: Information for the User

Roname 2 mg Tablets

glimepiride

Read this entire package insert carefully before taking this medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information.

Roname is a medication that lowers blood sugar levels, active via oral administration. This medication belongs to a group of medications that lower blood sugar levels called sulfonylureas. Roname increases the amount of insulin released by your pancreas. Insulin lowers your blood sugar levels.

What is Roname 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 able to control your blood sugar levels.

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 components of this medicine (listed in section 6).
• If you have diabetes mellitus type 1.
• If you have diabetic ketoacidosis (a complication of diabetes when your body's acid levels rise and you may have some of the following symptoms: fatigue, dizziness, 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 circumstances affect 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 your medicine if:

• You are recovering from any illness, operation, infection with fever, or other forms of stress. Inform your doctor as it may be necessary to make some changes to your treatment.
• You have severe liver or kidney dysfunction.

If you are unsure whether anything mentioned above affects you, consult your doctor or pharmacist before taking Roname.

It may occur that your hemoglobin levels drop and you develop a red blood cell rupture (hemolytic anemia) in patients who lack an enzyme called glucose-6-phosphatase.

The available information on the use of Roname in people under 18 years 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 have hypoglycemia (low blood sugar). Please see below for more information about hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of you suffering hypoglycemia:

• Malnutrition, irregular meal times, omission or delay of meals, or fasting periods.
• Changes in your diet.
• Taking more Roname than you need.
• Having severe liver disease.
• Having any other hormonal disease (such as thyroid gland problems, pituitary gland problems, or adrenal cortex problems).
• Drinking alcohol (especially if you skip a meal).
• Taking certain medications (see "Taking Roname with other medicines").
• Increasing your physical exercise and not eating enough or taking foods with fewer carbohydrates than normal.

The symptoms of hypoglycemia include:

• Feeling of empty stomach, headache, nausea, vomiting, lethargy, sleepiness, sleep disturbances, restlessness, irritability, difficulty concentrating, reduced alertness and reaction time, depression, confusion, speech and vision disturbances, tremors, slurred speech, partial paralysis, sensory disturbances, dizziness, feeling of abandonment.
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heart rate, high blood pressure, palpitations, sudden chest pain that may radiate to adjacent areas (angina pectoris and cardiac arrhythmias).

If your blood sugar levels continue to drop, you may experience significant confusion (delirium), seizures, loss of control, shallow breathing, and a slower heart rate, and you may become unconscious. The clinical picture of a severe drop in blood sugar resembles a stroke.

Treatment of hypoglycemia:

In most cases, the symptoms of low blood sugar disappear quickly when you take something sweet, such as sugar cubes, sweet juices, or sweet tea.

Therefore, you should always carry something sweet (such as sugar cubes) with you. Remember that artificial sweeteners are not effective. Please consult your doctor or go to the hospital if, after taking sugar, you do not recover or if the symptoms recur.

Blood tests

Your blood sugar levels and urine levels should be regularly monitored. Your doctor may ask you to have blood tests to check the number of blood cells and see how your liver is functioning.

Children and adolescents

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

Other medicines and Roname

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Your doctor may wish to change your Roname dose if you are taking other medicines, which may increase or decrease the effect of Roname on your 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 treating pain and inflammation (phenylbutazone, azapropazone, oxifenbutazone; and aspirin derivatives).
• Medicines for treating urinary tract infections (such as some sulfonamides with prolonged action).
• Medicines for treating fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medicines for diluting the blood (cumarin derivatives such as warfarin).
• Medicines for increasing muscle mass (anabolic steroids).
• Medicines used in hormone replacement therapy in men.
• Medicines for treating depression (fluoxetine, MAO inhibitors).
• Medicines for lowering high cholesterol levels (fibrates).
• Medicines for lowering high blood pressure (ACE inhibitors).
• Medicines called antiarrhythmics used for controlling abnormal heart rhythm (disopyramide).
• Medicines for treating cancer (cyclophosphamide, trophosphamide, and ifosfamide).
• Medicines for treating gout (allopurinol, sulfinpyrazone, and probenecid).
• Medicines used for weight loss (fenfluramine).
• Medicines for increasing circulation when administered at high doses in intravenous infusion (pentoxifylline).
• Medicines for treating allergic rhinitis such as hay fever (tritoqualine).
• Medicines called sympatholytics for treating high blood pressure, heart failure, or prostatic 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 for increasing urine production such as certain antihypertensives (diuretics and thiazide diuretics).
• Medicines used to stimulate the thyroid gland (such as levothyroxine).
• Medicines for treating allergies and inflammation (glucocorticoids).
• Medicines for treating severe mental disorders (chlorpromazine and other phenothiazine derivatives).
• Medicines for increasing heart rate, for treating asthma or congestion, cough, and colds, or used in life-threatening emergencies (adrenaline and sympathomimetics).
• Medicines for lowering high cholesterol levels (nicotinic acid).
• Medicines for treating constipation when used for a prolonged period (laxatives).
• Medicines for treating nervousness and sleep problems (barbiturates).
• Medicines for treating seizures (phenytoin).
• Medicines for increasing 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 treating stomach ulcers (called H2 antagonists).
• Medicines for treating high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may even mask the signs of hypoglycemia, so special care is needed when taking these medicines.

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

• Medicines that inhibit coagulation (cumarin derivatives such as warfarin).

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

Taking Roname with food, drinks, and alcohol

The consumption of alcohol may increase or decrease the hypoglycemic effect of glimepiride in an unpredictable manner.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine.

In these circumstances, consult your doctor, who will probably prescribe the use of insulin.

Pregnancy

Roname should not be taken during pregnancy.

Lactation

Roname may pass into breast milk. Roname should not be used during lactation.

Driving and operating 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. Please note that this puts you and others at risk (for example, when driving or operating machinery). Please consult your doctor if you can drive if:

• You have frequent episodes of hypoglycemia,
• You have few or no warning signs of hypoglycemia.

Roname contains Lactose

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Administration of this medication:

• Take this medication orally, just before or with the first meal of the day (usually breakfast). If you do not take breakfast, take the product as your doctor has told you. It is essential 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 needs, condition, and results of your blood sugar and urine analysis, and will be established by your doctor. Do not take more tablets than your doctor has told you.

• The initial dose is one 1 mg tablet of Roname per day.
• If necessary, your doctor will indicate a gradual increase in the dose after 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of Roname per day.
• You may start with a combined treatment of glimepiride and metformin or glimepiride and insulin. In these cases, your doctor will indicate the individualized doses of glimepiride, metformin, and insulin for you.
• If your weight changes or you change your lifestyle, or you are under stress, you may need to change the doses of Roname, so inform your doctor.
• If you estimate that the action of glimepiride is too strong or too weak, do not change the dose yourself and 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 the elderly.

Since biological functions may be decreased, your doctor will adjust the dose with caution and close monitoring will be necessary.

If you take more Roname than you should:

If you have taken too much Roname, or an extra dose, there is a risk of hypoglycemia (see section 2 for hypoglycemia symptoms), and therefore, you must consume immediately sufficient sugar (e.g., sugar cubes, sweet juices, sweet tea), and inform your doctor immediately. When treating hypoglycemia due to accidental ingestion in children, the amount of sugar to be administered must be carefully controlled to avoid the possibility of producing a dangerous hyperglycemia. People in a coma should not take food or drinks.

Since hypoglycemia can last for a while, it is very important that the patient be closely monitored until there is no longer a risk. It may be necessary to hospitalize the patient as a safety measure. Show the packaging or remaining tablets to your doctor so that they can know what you have taken.

Severe cases of hypoglycemia accompanied by loss of consciousness and severe neurological failure are medical emergencies that require immediate medical treatment and hospitalization. You should ensure that there is always someone informed who can call a doctor in case of an emergency.

If you forgot to take Roname:

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Roname:

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The assessment of side 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.

Unknown frequency: the frequency cannot be estimated from the available data.

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

• Allergic reactions (including inflammation of blood vessels, frequently with skin rash) that may trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading to shock.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), inflammation of the liver (hepatitis), or liver insufficiency.
• Skin allergy (hypersensitivity) such as itching, skin rash, urticaria, and light sensitivity. Some mild allergic reactions may become severe.
• Severe hypoglycemia, including loss of consciousness, seizures, or coma.

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

Rare side effects:

• Low blood sugar levels (hypoglycemia) (see section 2).
• Reduction in the number of blood cells:

• Platelets (which increases the risk of bleeding or bruising).
• White blood cells (which makes infections more frequent).
• Red blood cells (which may cause pale skin tone and difficulty breathing).

These changes usually disappear when treatment with Roname is discontinued.

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

Very rare side effects:

• Allergic reactions (including inflammation of blood vessels, frequently with skin rash) that may trigger severe reactions with difficulty breathing, low blood pressure, and sometimes leading 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 insufficiency. If you experience any of these symptoms,inform your doctor immediately.
• Nausea, vomiting, diarrhea, feeling of fullness, swelling, or stomach pain.
• Decreased sodium levels in the blood (visible in blood tests).

Unknown frequency:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 300C.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition ofRoname 2 mg tablets

• The active ingredient is glimepiride. Each tablet contains 2 mg of glimepiride.
• The other components are: Lactose monohydrate, carboxymethyl starch sodium (type A) (from potato), magnesium stearate, microcrystalline cellulose, povidone 25000, yellow iron oxide (E172) and aluminium lake indigo carmine (E132).

Appearance of the product and contents of the packaging

Roname 2 mg aregreen, oval-shaped, scored tablets on both faces.

Roname 2 mgtablets are available in packs of 30 and 120 tablets.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Last review date of this leaflet: October 2018

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es