SOLOSA 2 mg Coated Tablet

Содержание инструкции

1. SOLOSA 2 mg, 3 mg and 4 mg tablets
   1. What is Solosa and what is it for
   2. What you need to know before taking Solosa
   3. How to take Solosa
   4. Possible side effects
   5. How to store Solosa
   6. Contents of the pack and other information

SOLOSA 2 mg, 3 mg and 4 mg tablets

glimepiride

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Solosa is and what it is used for
• 2. What you need to know before you take Solosa
• 3. How to take Solosa
• 4. Possible side effects
• 5. How to store Solosa
• 6. Contents of the pack and other information

1. What is Solosa and what is it for

Solosa is an orally active medicine that lowers blood sugar levels. This medicine
belongs to a group of drugs that lower blood sugar levels called sulfonylureas.
Solosa works by increasing the amount of insulin released by the pancreas. Insulin then lowers blood sugar levels.

What is Solosa for:

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

2. What you need to know before taking Solosa

Do not take Solosa and tell 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 urination and muscle soreness)
• You are in a diabetic coma
• You suffer from a severe kidney disease
• You suffer from a severe liver disease

Do not take this medicine if any of these conditions apply to you. If you have doubts, 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 injuries, surgery, an infection with fever, or from other forms of stress, inform your doctor because it may be necessary to temporarily modify the treatment
• you suffer from a severe liver or kidney disease

If you are not sure if any of these conditions apply to you, consult your doctor or pharmacist before taking Solosa.
In patients who do not have the glucose-6-phosphate dehydrogenase enzyme, a decrease in hemoglobin levels and the breakdown of red blood cells (hemolytic anemia) may occur.
The information available on the use of Solosa in people under 18 years of age is limited.
Therefore, use in these patients is not recommended.

Important information about hypoglycemia (low blood sugar)
When you take Solosa, you may experience hypoglycemia (low blood sugar levels). Read below for
more information about hypoglycemia, its symptoms and its treatment.

The following factors can increase the risk of having hypoglycemia:

• You are not eating enough, you eat at irregular times, you have skipped or delayed meals, or you are on a fasting period
• You have changed your diet
• You have taken more Solosa than necessary
• You have decreased kidney function
• You suffer from a severe liver disease
• You suffer from particular disorders induced by hormones (disorders of the thyroid, pituitary or adrenal cortex)
• You drink alcoholic beverages (especially if you skip a meal)
• You are taking certain other medicines (see below 'Other medicines and Solosa').
• If you are doing more exercise and do not eat enough or eat foods that contain less carbohydrates than usual

Warning signs of hypoglycemia include:

• Hunger, headache, nausea, vomiting, slowness, drowsiness, sleep disturbances, restlessness, aggressiveness, difficulty concentrating, reduced state of alertness, reduced ability to react, depression, confusion and speech and vision disorders, difficulty speaking, tremor, partial paralysis, sensory disturbances, dizziness, weakness.
• You may also experience the following symptoms: sweating, clammy 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 decrease, you may experience significant confusion (delirium), develop
convulsions, loss of self-control, breathing may become weak and the heartbeat may slow down and
you may lose consciousness. The clinical picture of very low blood sugar levels can resemble
that of a stroke.

Treatment of hypoglycemia:
In many cases, the symptoms of low blood sugar levels disappear very quickly if you consume
sugars, such as sugar cubes, sugar-sweetened beverages or sugared tea.
Therefore, always carry some 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 you or if the symptoms occur again.

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

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

Other medicines and Solosa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The doctor may change your dose of Solosa if you take other medicines that can decrease or
increase the effects of Solosa on blood sugar levels.
The following medicines can increase the blood sugar lowering effects of
Solosa. This can 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 some 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 mass (anabolics)
• Medicines used for hormone 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 antiarrhythmic agents used to control irregular heartbeats (disopyramide)
• Medicines used to treat gout (allopurinol, probenecid, sulfinpyrazone)
• Medicines used to treat cancer (cyclophosphamide, ifosfamide, trofosfamide)
• Medicines used to reduce weight (fenfluramine)
• Medicines used to increase circulation when given intravenously in high doses (pentoxifylline)
• Medicines used to treat allergies in the nose, such as hay fever (tritoqualine)
• Medicines called sympatholytics used to treat high blood pressure, heart failure or symptoms of the prostate

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

• Medicines that contain female sex hormones (estrogens, progestins)
• Medicines used to help produce urine (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 the heartbeat, to treat asthma or nasal congestion, cough and cold, used to reduce weight, or used in life-threatening emergencies (adrenaline and sympathomimetics)
• Medicines used to treat high cholesterol (nicotinic acid)
• Medicines used to treat constipation if used for a long time (laxatives)
• Medicines used to treat seizures (phenytoin)
• Medicines used to treat nervousness and sleep disorders (barbiturates)
• Medicines used to treat increased pressure in the eye (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 can increase or decrease the blood sugar lowering effects of
Solosa:

• Medicines used to treat stomach ulcers (so-called anti-H2)
• Medicines used to treat high blood pressure or heart failure such as beta-blockers, clonidine, guanitidine and reserpine. These can also mask the symptoms of hypoglycemia, so particular attention is required when taking these medicines.

Solosa can 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 reduce cholesterol, has an effect on the absorption of Solosa. To
avoid this effect, it is recommended to take Solosa at least 4 hours before colesevelam.

Solosa with food, drinks and alcohol
Drinking alcoholic beverages can increase or decrease the blood sugar lowering effects of
Solosa in an unpredictable way.

Pregnancy and breastfeeding
Pregnancy
Solosa should not be taken during pregnancy. Tell your doctor if you are planning a pregnancy or if you are already
pregnant or think you may be pregnant.

Breastfeeding
Solosa can pass into breast milk. Solosa should 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 increased (hyperglycemia), or if you develop vision problems
as a result of these conditions. Keep in mind that you may pose a risk to yourself and
others (for example, driving a car or using machinery). Ask your doctor for
advice on whether it is appropriate for you to drive if:

• you have frequent hypoglycemic attacks,
• you have few or no warning symptoms of hypoglycemia.

Solosa contains lactose.If your doctor has diagnosed you with intolerance to some 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.

Taking this medicine

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

How much medicine to take
The dose of Solosa depends on your needs, condition and the results of your blood and urine sugar tests and
is established by your doctor. Do not take more tablets than those prescribed by your doctor.
Usually the initial dose of Solosa is 1 mg once a day.
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.
A combination therapy of glimepiride + metformin or glimepiride + insulin may be started. In this
case, your doctor will establish the correct dose of glimepiride, metformin or specific insulin for you.
If your weight changes, or you modify your lifestyle, or you are in a stressful situation, a change in the doses of Solosa may be necessary,
so inform your doctor.
If you feel that the effects of the medicine are too weak or too strong, do not change the dose yourself, but
ask your doctor.

If you take more Solosa than you should
If you have taken too much Solosa or have taken an extra dose, there is a risk of hypoglycemia (for
the symptoms of hypoglycemia see Paragraph 2) and therefore you should immediately take a sufficient amount of
sugar (e.g. a small sugar cube, sugary drinks or sweetened tea) and
immediately inform your doctor. If you are treating hypoglycemia due to accidental ingestion in children, the
amount of sugar administered must be carefully monitored to avoid producing a
dangerous hyperglycemia. Food or
drinks should not be given to people in a state of unconsciousness.
Since the state of hypoglycemia can last for some time, it is very important that the patient is
carefully monitored until the danger has passed. Hospitalization may be necessary, even
as a precautionary measure. Show the doctor the box or the remaining tablets, so that the doctor
can see what has been taken.
Severe cases of hypoglycemia with loss of consciousness and severe neurological insufficiency are cases of
medical emergency requiring immediate medical treatment and hospitalization. Ensure
that there is always an informed person who can call the doctor in case of emergency.

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

If you stop taking Solosa
If you stop or discontinue treatment, you should know that you will not achieve the desired effect of lowering blood sugar levels and that the disease will worsen. Continue to take Solosa 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Tell your doctor immediately if any of the following symptoms occur:

• Allergic reactions (including inflammation of blood vessels, often with skin rash) which can become a serious reaction with difficulty breathing, low blood pressure and sometimes progressing to shock.
• Abnormal liver function including yellowing of the skin and eyes (jaundice), problems with bile flow (cholestasis), liver inflammation (hepatitis) or liver failure.
• Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to the sun. Some mild allergic reactions can become serious reactions.
• Severe hypoglycemia with loss of consciousness, convulsions or coma.

Some patients have experienced the following adverse events while taking Solosa:

Rare side effects(may affect 1 to 10 patients in 10,000)

• Lower than normal blood sugar levels (hypoglycemia) (See section 2)
• Decrease in the number of blood cells:
• Platelets (which increases the risk of bleeding or bruising)
• White blood cells (which increases the risk of infections)
• Red blood cells (which can make the skin pale and cause weakness and shortness of breath) These problems generally improve when stopping Solosa
• Weight gain
• Hair loss
• Change in sense of taste

Very rare side effects(may affect less than 1 patient in 10,000)

• Allergic reactions (including inflammation of blood vessels, often with skin rash) which can become a serious reaction with difficulty breathing, low blood pressure and sometimes progressing to shock. If any of these symptoms occur, tell your doctor immediately
• Abnormal liver function including yellowing of the skin and eyes (jaundice), impaired bile flow (cholestasis), liver inflammation (hepatitis) or liver failure. If any of these symptoms occur, tell your doctor immediately
• Nausea or vomiting, diarrhea, feeling full or bloated, and abdominal pain
• Decrease in sodium levels in the blood (seen with blood tests)

Side effects of unknown frequency (frequency cannot be estimated based on available data):

• Allergy (hypersensitivity) of the skin such as itching, rash, hives and increased sensitivity to the sun. Some mild allergic reactions can become serious reactions with problems swallowing or breathing, swelling of the lips, throat or tongue. Therefore, if any of these adverse events occur, tell your doctor immediately
• Allergic reactions may occur with sulfonylureas, sulfonamides or related drugs
• Vision problems may occur at the start of treatment with Solosa. This is due to changes in blood sugar levels, and should improve soon
• Increased liver enzymes
• Severe unusual bleeding or bruising under the skin

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse .
You can also report side effects directly through 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 that is stated on the package and on the blister after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Store in the original package to protect the medicine from moisture.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in 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 ingredient is glimepiride. Each tablet contains 2 mg, 3 mg or 4 mg of glimepiride, depending on the dosage indicated on the blister and the carton.
• The other ingredients are lactose monohydrate, sodium carboxymethylcellulose (type A), magnesium stearate, microcrystalline cellulose, povidone 25000.
• In addition, the tablets contain colorants:
• 2 mg tablets contain yellow iron oxide (E172) and indigo carmine aluminium lake (E132)
• 3 mg tablets contain yellow iron oxide (E172)
• 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:
2 mg tablets are green in colour
3 mg tablets are pale yellow in colour
4 mg tablets are blue in colour
They are available in blister packs of 14, 20, 28, 30, 50, 60, 90, 112, 120 and 280 tablets.
Not all pack sizes and strengths 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