Solosa: detailed information

Package leaflet: Information for the user

SOLOSA 2 mg, 3 mg and 4 mg tablets

glimepiride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

What Solosa is and what it is used for
What you need to know before taking Solosa
How to take Solosa
Possible side effects
How to store Solosa
Contents of the pack and other information

1. What Solosa is and what it is used for

Solosa is an oral antidiabetic medicinal product that lowers blood sugar levels. This medicine
belongs to a group of medicines that lower blood sugar levels known as sulphonylureas.
Solosa works by increasing the amount of insulin released by the pancreas. Insulin then lowers
blood sugar levels.
What Solosa is used for:

Solosa is used to treat a type of diabetes (type 2 diabetes mellitus) when diet, exercise, and weight reduction alone are not sufficient to control blood sugar levels.

2. What you should know before taking Solosa

Do not take Solosa and inform your doctor if:

You are allergic to glimepiride or other sulfonylureas (medicines used to lower 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)
You have type 1 diabetes mellitus
You have diabetic ketoacidosis (a complication of diabetes in which acid levels in the body are increased and you may experience some of the following signs: fatigue, nausea, frequent need to urinate, and muscle aches)
You are in diabetic coma
You have severe kidney disease
You have severe liver disease

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Solosa if:

You are recovering from injury, surgery, infection with fever, or other forms of stress; inform your doctor, as your treatment may need to be temporarily adjusted
You have severe liver or kidney disease

If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Solosa.

In patients lacking the enzyme glucose-6-phosphate dehydrogenase, a decrease in hemoglobin levels and breakdown of red blood cells (hemolytic anemia) may occur.

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

Important information about hypoglycemia (low blood sugar levels)

When taking Solosa, you may experience hypoglycemia (low blood sugar levels). Read below for further information on hypoglycemia, its symptoms, and treatment.

The following factors may increase the risk of hypoglycemia:

Not eating enough, irregular meal times, skipped or delayed meals, or fasting
You have changed your diet
You have taken more Solosa than prescribed
You have reduced kidney function
You have severe liver disease
You have certain hormone-related disorders (thyroid, pituitary, or adrenal cortex disorders)
You consume alcoholic beverages (especially if skipping a meal)
You are taking certain other medicines (see below 'Other medicines and Solosa')
You are engaging in increased physical activity without eating enough or consuming foods with fewer carbohydrates than usual

Warning symptoms of hypoglycemia include:

Hunger pangs, headache, nausea, vomiting, sluggishness, drowsiness, sleep disturbances, restlessness, aggression, difficulty concentrating, reduced alertness, reduced reaction ability, depression, confusion, speech and vision disturbances, difficulty speaking, tremor, partial paralysis, sensory disturbances, dizziness, weakness.
The following symptoms may also occur: sweating, moist skin, anxiety, rapid heartbeat, high blood pressure, palpitations, sudden chest pain that may spread to nearby areas (angina pectoris and cardiac arrhythmias).

If blood sugar levels continue to drop, you may experience severe confusion (delirium), seizures, loss of self-control, breathing may become weak, heart rate may slow down, and you may lose consciousness. The clinical picture of very low blood sugar levels may resemble that of a stroke.

Treatment of hypoglycemia:

In many cases, symptoms of low blood sugar disappear very quickly after consuming sugar, such as sugar cubes, sugary drinks, or sweetened tea. Therefore, always carry sugar with you (e.g., sugar cubes). Remember that artificial sweeteners are not effective. Contact your doctor or go to a hospital if you notice that taking sugar does not help or if symptoms recur.

Laboratory tests

You should regularly monitor your blood or urine sugar levels. Your doctor may also prescribe blood tests to monitor blood cell counts and liver function.

Children and adolescents

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

Other medicines and Solosa

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

Your doctor may adjust your dose of Solosa if you are taking other medicines that can decrease or increase the blood sugar-lowering effects of Solosa.

The following medicines may increase the blood sugar-lowering effects of Solosa. This may lead to a risk of hypoglycemia (low blood sugar levels):

Other medicines used to treat diabetes mellitus (such as insulin or metformin)
Medicines used to treat pain and inflammation (phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like drugs)
Medicines used to treat urinary tract infections (such as certain long-acting sulfonamides)
Medicines used to treat bacterial and fungal infections (tetracyclines, chloramphenicol, fluconazole, miconazole, quinolones, clarithromycin)
Medicines used to inhibit blood clotting (coumarin derivatives such as warfarin)
Medicines used to enhance muscle strength (anabolic agents)
Medicines used for hormonal replacement therapy in men
Medicines used to treat depression (fluoxetine, MAO inhibitors)
Medicines used to lower high cholesterol levels (fibrates)
Medicines used to lower high blood pressure (ACE inhibitors)
Medicines called antiarrhythmics used to control abnormal heartbeats (disopyramide)
Medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone)
Medicines used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide)
Medicines used for weight reduction (fenfluramine)
Medicines used to improve circulation when given as high-dose intravenous infusions (pentoxifylline)
Medicines used to treat nasal allergies, such as hay fever (tritoqualine)
Medicines known as sympatholytics used to treat high blood pressure, heart failure, or prostate symptoms

The following medicines may decrease the blood sugar-lowering effects of Solosa. This may lead to a risk of hyperglycemia (high blood sugar levels):

Medicines containing female sex hormones (estrogens, progestins)
Medicines used to promote urine production (thiazide diuretics)
Medicines used to stimulate the thyroid (such as levothyroxine)
Medicines used to treat allergies and inflammation (glucocorticoids)
Medicines used to treat severe mental disorders (chlorpromazine and other phenothiazine derivatives)
Medicines used to increase heart rate, treat asthma or nasal congestion, cough and cold, used for weight reduction, or used in life-threatening emergencies (adrenaline and sympathomimetics)
Medicines used to treat high cholesterol (nicotinic acid)
Medicines used to treat constipation if used long-term (laxatives)
Medicines used to treat seizures (phenytoin)
Medicines used to treat nervousness and sleep disorders (barbiturates)
Medicines used to treat increased eye pressure (acetazolamide)
Medicines used to treat high blood pressure or low blood sugar (diazoxide)
Medicines used to treat infections and tuberculosis (rifampicin)
Medicines used to treat very low blood sugar levels (glucagon)

The following medicines may either increase or decrease the blood sugar-lowering effects of Solosa:

Medicines used to treat stomach ulcers (H2 blockers)
Medicines used to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanethidine, and reserpine. These may also mask the symptoms of hypoglycemia; therefore, particular caution is required when taking these medicines.

Solosa may increase or decrease the effects of the following medicines:

Medicines used to inhibit blood clotting (coumarin derivatives such as warfarin)

Colesevelam, a medicine used to lower cholesterol, affects the absorption of Solosa. To avoid this interaction, you are advised to take Solosa at least 4 hours before colesevelam.

Solosa with food, drinks, and alcohol

Drinking alcoholic beverages may unpredictably increase or decrease the blood sugar-lowering effects of Solosa.

Pregnancy and breastfeeding

Pregnancy

Solosa must not be taken during pregnancy. Inform your doctor if you are planning a pregnancy, are already pregnant, or think you might be pregnant.

Breastfeeding

Solosa may pass into breast milk. Solosa must not be taken if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

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 develop vision problems due to these conditions. Be aware that you may put yourself and others at risk (e.g., when driving a car or operating machinery). Consult your doctor for advice on whether it is appropriate for you to drive if:

You have frequent hypoglycemic episodes,
You have few or no warning symptoms of hypoglycemia.

Solosa contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Solosa contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take Solosa

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
How to take this medicine

Take this medicine by mouth, immediately before or during your first main meal of the day (usually breakfast). If you do not eat breakfast, take the medicine at the time prescribed by your doctor. It is important not to skip any meals while taking Solosa.
Swallow the tablets with at least half a glass of water. Do not crush or chew the tablets.
Each tablet may be divided into two equal doses.

How much medicine to take
The dose of Solosa depends on your individual needs, condition, and results of blood and urine sugar tests, and will be determined by your doctor. Do not take more tablets than prescribed by your doctor.
The usual starting dose of Solosa is 1 mg once daily.
If necessary, your doctor may increase the dose every 1–2 weeks of treatment.
The maximum recommended dose of Solosa is 6 mg per day.
Combination therapy with glimepiride + metformin or glimepiride + insulin may be initiated. In such cases, your doctor will determine the appropriate dose of glimepiride, metformin, or insulin for you.
If your weight changes, or if you alter your lifestyle, or are under stress, your Solosa dose may need adjustment—inform your doctor.
If you think the effect of the medicine is too weak or too strong, do not change the dose on your own—consult your doctor.

If you take more Solosa than you should
If you have taken too much Solosa or taken an extra dose, there is a risk of hypoglycaemia (for symptoms of hypoglycaemia, see Section 2). You should immediately take an adequate amount of sugar (e.g. a small bar of sugar cubes, sugary drinks, or sweetened tea) and inform your doctor immediately. When treating hypoglycaemia due to accidental ingestion in children, the amount of sugar administered must be carefully monitored to avoid dangerous hyperglycaemia. Do not give food or drinks to unconscious individuals.
Since hypoglycaemia may last for some time, it is very important that the patient is closely monitored until the danger has passed. Hospitalisation may be necessary, even as a precautionary measure. Show your doctor the medicine pack or any remaining tablets so that the doctor can see what has been taken.
Severe cases of hypoglycaemia with loss of consciousness and serious neurological impairment are medical emergencies requiring immediate medical treatment and hospitalisation. Ensure that an informed person is always available who can call the doctor in an emergency.

If you forget to take Solosa
Do not take a double dose to make up for a forgotten dose.

If you stop taking Solosa
If you interrupt or stop treatment, be aware that you will not achieve the desired blood sugar-lowering effect and your condition may worsen. Continue taking Solosa for as long as your doctor instructs you to do so.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Immediately contact your doctor if you experience any of the following symptoms:

Allergic reactions (including inflammation of blood vessels, often with skin rash), which may become severe with difficulty breathing, low blood pressure and sometimes progress 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 failure.
Skin allergy (hypersensitivity) such as itching, rash, hives and increased sensitivity to sunlight. Some mild allergic reactions may become severe.
Severe hypoglycaemia with loss of consciousness, seizures or coma.

The following adverse events have been reported in some patients taking Solosa:
Rare side effects (may occur in 1 to 10 out of 10,000 patients)

Blood sugar levels lower than normal (hypoglycaemia) (See section 2)
Decrease in blood cell counts:
Platelets (increasing the risk of bleeding or bruising)
White blood cells (increasing the risk of infections)
Red blood cells (which may cause paleness, weakness and shortness of breath). These problems generally improve when stopping Solosa.
Weight gain
Hair loss
Change in taste sensation

Very rare side effects (may occur in fewer than 1 out of 10,000 patients)

Allergic reactions (including inflammation of blood vessels, often with skin rash), which may become severe with difficulty breathing, low blood pressure and sometimes progress to shock. If any of these symptoms occur, contact your doctor immediately
Abnormal liver function including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), inflammation of the liver (hepatitis) or liver failure. If any of these symptoms occur, contact your doctor immediately
Nausea or vomiting, diarrhoea, feeling of fullness or bloating, and abdominal pain
Decreased sodium levels in the blood (detected by blood tests)

Side effects of unknown frequency (frequency cannot be estimated from the available data):

Skin allergy (hypersensitivity) such as itching, rash, hives and increased sensitivity to sunlight. Some mild allergic reactions may become severe with difficulty swallowing or breathing, swelling of the lips, throat or tongue. Therefore, if any of these adverse events occur, contact your doctor immediately
Allergic reactions may occur with sulphonamides, sulphonylureas or related drugs
At the beginning of treatment with Solosa, vision problems may occur. These are due to changes in blood sugar levels and should improve quickly
Increased liver enzymes
Severe, unusual bleeding or bruising under the skin

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Solosa

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
expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original packaging to protect the medicine from moisture.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Solosa contains

The active substance is glimepiride. Each tablet contains 2 mg, 3 mg or 4 mg of glimepiride, according to the dosage indicated on the blister and the box.
The other ingredients are monohydrate lactose, sodium carboxymethylstarch (type A), magnesium stearate, microcrystalline cellulose, povidone 25000.
Additionally, the tablets contain colouring agents:
The 2 mg tablets contain yellow iron oxide (E172) and indigo carmine aluminium lake (E132)
The 3 mg tablets contain yellow iron oxide (E172)
The 4 mg tablets contain indigo carmine aluminium lake (E132)

Description of the appearance of Solosa and contents of the pack
All Solosa tablets are oblong and scored on both sides. Each tablet can be divided into two equal doses. They are of different colours:
The 2 mg tablets are green
The 3 mg tablets are pale yellow
The 4 mg tablets are blue
Available in blister packs containing 14, 20, 28, 30, 50, 60, 90, 112, 120 and 280 tablets.
Not all pack sizes and dosages may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Laboratori Guidotti S.p.A. – Via Livornese, 897 – PISA – La Vettola
Manufacturer:
A. Menarini Manufacturing Logistics and Services s.r.l., Via Campo di Pile, 67100 L’Aquila, Italy