RONAME 4 mg TABLETS

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 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 your acid levels rise in your body 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 applies to you. If you are not sure, 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 change in your treatment.
• You have severe liver or kidney problems.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Roname.

It may occur that hemoglobin levels decrease and red blood cells break down (hemolytic anemia) in patients who lack an enzyme called glucose-6-phosphate dehydrogenase.

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

Important information about hypoglycemia (low blood sugar levels)

If you are taking Roname, you may have hypoglycemia (low blood sugar levels). Please see below for more information about hypoglycemia, its signs, and treatment.

The following factors can increase the risk of you suffering from hypoglycemia:

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

Signs of hypoglycemia include:

• Feeling of empty stomach, headache, nausea, vomiting, drowsiness, sleepiness, 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 of helplessness.
• The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden chest pain that may radiate to neighboring areas (angina pectoris and cardiac arrhythmias).

If your blood sugar levels continue to drop, you may experience considerable confusion (delirium), have convulsions, lose self-control, have shallow breathing, and a slower heart rate, and you may become unconscious. The clinical picture of a severe drop in blood sugar is similar to 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, sugary tea.

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

Blood tests

Your blood and urine sugar levels should be regularly checked. Your doctor may ask for blood tests to check your blood cell count and to see how your liver is working.

Children and adolescents

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

Other medicines and Roname

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may want to change your dose of Roname if you are taking other medicines that 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 levels):

• Other medicines for treating diabetes mellitus (such as insulin or metformin).
• Medicines for treating pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone; and aspirin derivatives).
• Medicines for treating urinary tract infections (such as some long-acting sulfonamides).
• Medicines for treating fungal and bacterial infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin).
• Medicines for thinning the blood (coumarin derivatives such as warfarin).
• Medicines for increasing muscle mass (anabolic agents).
• 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 to control abnormal heart rhythm (disopyramide)
• Medicines for treating cancer (cyclophosphamide, trofosfamide, and ifosfamide).
• Medicines for treating gout (allopurinol, sulfinpyrazone, and probenecid).
• Medicines used for weight loss (fenfluramine)
• Medicines for improving circulation when administered in high doses by intravenous infusion (pentoxifylline).
• Medicines for treating nasal allergies such as hay fever (tritoqualine).
• Medicines called sympatholytics for treating 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 levels):

• 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 nasal congestion, cough, and colds, or used for weight reduction, 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 (barbiturics).
• Medicines for treating convulsions (phenytoin).
• Medicines for increasing eye pressure (acetazolamide).
• Medicines for treating high blood pressure or low blood sugar levels (diazoxide).
• Medicines for treating severe low blood sugar levels (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 hide 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 blood clotting (coumarin 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

Consuming alcohol may increase or decrease the hypoglycemic effect of glimepiride in an unpredictable way.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Pregnancy

Roname should not be taken during pregnancy.

Breastfeeding

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

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar levels are low (hypoglycemia) or high (hyperglycemia) or if you have vision problems due to these conditions. Keep in mind that this puts 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 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 some sugars, consult them before taking this medicine.

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

3. How to take Roname 4 mg Tablets

Follow exactly the instructions for administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Taking this medicine:

• Take this medicine by mouth, just before or with the first meal of the day (usually breakfast). If you do not have breakfast, you should take the product as your doctor has told you. It is important not to skip any meals when 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 and urine sugar tests and will be determined by your doctor. Do not take more tablets than your doctor has told you.

• The initial dose is one 1 mg Roname tablet per day.
• If necessary, your doctor will indicate a gradual increase in dose after 1-2 weeks of treatment.
• The maximum recommended dose is 6 mg of Roname per day.
• You may start with a combination treatment of glimepiride plus metformin or glimepiride plus insulin. In these cases, your doctor will indicate the appropriate doses of glimepiride, metformin, and insulin for you individually.
• If your weight changes or if you change your lifestyle, or if you are under stress, you may need to change the doses of Roname, so you should inform your doctor.
• If you think the effect 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 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 more intense monitoring will be necessary.

If you take more Roname than you should

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

As hypoglycemia can last for a while, it is very important that the patient is carefully monitored until there is no more danger. It may be necessary to take safety measures, such as hospitalization. Show the package or remaining tablets to the doctor so they can see 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 forget to take Roname

Do not take a double dose to make up for forgotten doses.

If you stop taking Roname

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

If you have any further questions on 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 all people suffer from 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: 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, often with skin rash) that can trigger severe reactions with difficulty breathing, low blood pressure, and sometimes ending in shock.
• Abnormal liver function, including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis), or liver failure.
• Skin allergy (hypersensitivity) such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe.
• Severe hypoglycemia, including loss of consciousness, seizures, or coma.

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

Rare Adverse 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 can cause pale skin tone and produce weakness or difficulty breathing).

Generally, these alterations disappear when treatment with Roname is discontinued.

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

Very Rare Adverse Effects:

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

Frequency Not Known:

• Skin allergy (hypersensitivity) such as itching, skin rash, hives, and hypersensitivity to light. Some mild allergic reactions can become severe, causing problems with swallowing or breathing, 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 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 bruising under the skin.

Reporting of Adverse Effects

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

5. Storage of Roname 4 mg Tablets

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Keep in the original packaging to protect it from moisture.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofRoname 4 mg Tablets

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

Appearance of the Product and Package Contents

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

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

Marketing Authorization Holder and Manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the Last Revision of this Prospectus: October 2018

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