SLOWMET 500 мг Таблетки с пролонгированным высвобождением

Содержание инструкции

1. SLOWMET 500 mg, 750 mg and 1000 mg prolonged-release tablets
   1. What you need to know before taking SLOWMET
   2. How to take SLOWMET
   3. Possible side effects
   4. How to store SLOWMET
   5. Contents of the pack and other information

SLOWMET 500 mg, 750 mg and 1000 mg prolonged-release tablets

Metformin

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it could 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:
What SLOWMET is and what it is used for

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

SLOWMET contains the active ingredient metformin, belonging to a group of medicines called
oral antidiabetic drugs, which regulate blood glucose levels when these are excessively high.
SLOWMET prolonged-release tablets is indicated for the treatment of type 2 diabetes, a disease
characterized by high blood glucose levels and loss of insulin activity, which normally
should reduce them. In particular, this medicine is useful for people who cannot take
immediate-release metformin, due to severe stomach and intestinal problems (gastrointestinal) and for
people in whom these problems reduce the effectiveness of the medicine.
This medicine can be used alone (monotherapy) or in combination with other medicines, including
insulin, for the treatment of diabetes.

2. What you need to know before taking SLOWMET

Do not take SLOWMET
if you are allergic to metformin or any of the other ingredients of this medicine (listed
in section 6);
if you have severely reduced kidney function;
if you have uncontrolled diabetes associated with, for example, severe hyperglycemia (high blood glucose
levels), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see below "Risk of
lactic acidosis") or ketoacidosis. Ketoacidosis is a condition in which substances called "ketone
bodies" accumulate in the blood and can lead to diabetic precoma. Symptoms include
stomach pain, rapid and deep breathing, drowsiness and breath with an unusually
fruity odor;

• if you are dehydrated;
• if you have a severe infection;
• if you suffer from a severe problem with blood circulation (shock);
• if you have a decrease in heart or lung function (unstable heart failure or respiratory failure);
• if you have recently had a heart attack;
• if you have severe liver problems (hepatic insufficiency), if you are a heavy drinker of alcohol (acute alcohol intoxication, alcoholism) (See section “SLOWMET with alcohol”);
• if you are going to undergo specific tests and they need to administer substances containing iodine into a vein (intravascular administration of iodine-containing contrast agents) (See sections “Warnings and precautions” and “Other medicines and SLOWMET”);
• if you are breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking SLOWMET.
Before and during therapy with SLOWMET, your doctor must periodically check your kidney function
(serum creatinine levels). In particular, if your kidney function is normal, it is recommended to perform
these checks at least once a year, if instead you have kidney problems (serum creatinine levels at the upper
limit of normal) or are elderly, at least 2-4 times a year (See section “Elderly”).

Risk of Lactic Acidosis
SLOWMET can cause a very rare but very serious side effect called lactic acidosis, in
particular if your kidneys do not function properly. The risk of developing lactic acidosis is higher in the presence
of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below
for more information), liver problems and any other medical condition characterized by a
reduced oxygen supply to a part of the body (such as in the case of severe heart disease).

Contact your doctor immediately for further instructions if:

• you know you have an inherited genetic disease that affects the mitochondria (the components that produce energy inside cells), such as MELAS syndrome ( Mitochondrial Encephalopathy,myopathy, Lactic Acidosis and Stroke-like episodes, mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, MaternalInherited Diabetes and Deafness);
• you experience any of these symptoms after starting to take metformin: seizures, decreased cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and hearing loss.

If you have any of the medical conditions described above, consult your doctor for further instructions.
Take this medicine with caution and inform your doctor:

• if you are taking other medicines for the treatment of diabetes (See section “Other medicines and SLOWMET”);
• if you suffer from a blood disease (megaloblastic anemia), as SLOWMET causes a reduction in the absorption of Vitamin B12 and its levels in the blood (See section “Possible side effects”). Periodic monitoring of Vitamin B12 may be necessary.

During treatment with this medicine, you may find parts of the tablet in your stools. If this
happens, do not worry.

During therapy with this medicine continue to:

• eat foods such as bread and pasta (carbohydrates) throughout the day;
• follow the diet prescribed by your doctor, if you are overweight (low-calorie diet);
• undergo the laboratory tests, provided for in case of diabetes.

Stop taking SLOWMET for a short period of time if you have a medical condition
that may be associated with dehydration(significant loss of body fluids) such as severe vomiting, diarrhea,
fever, exposure to heat or if you drink less fluids than usual. Contact your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking SLOWMET and contact
your doctor or the nearest hospital immediately,because lactic acidosis can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a generalized feeling of discomfort associated with severe fatigue
• difficulty breathing
• reduced body temperature and slower heartbeat

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are going to have major surgery, you should stop taking SLOWMET
during the surgery and for a certain period of time afterwards. Your doctor will decide when you should
stop and when you should resume treatment with SLOWMET.
During treatment with SLOWMET, your doctor will check your kidney function at least once
a year or more frequently if you are elderly and/or if kidney function worsens.

Children
As there is no data available on the use of SLOWMET in children, this medicine should not
be used in children.

Elderly
In elderly people, reduced kidney function is more common and often does not manifest with
evident symptoms (asymptomatic). For this reason, during treatment with this medicine, the doctor must
carefully monitor kidney function.

Other medicines and SLOWMET
If you are going to have an iodine-containing contrast agent injected into your bloodstream, for example to
perform an X-ray, you must stop taking SLOWMET before or during the injection. Your doctor
will decide when you should stop and when you should resume treatment with SLOWMET.
Tell your doctor if you are taking, have recently taken or may take any other medicine.
You may need to have your blood sugar and kidney function tested more frequently, or your
doctor may decide to adjust the dose of SLOWMET. It is particularly important to mention
the following:

• medicines that increase urine production (diuretics)
• medicines used for the treatment of pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
• some medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
• glucocorticoids (systemic and local), used for the treatment of inflammation and allergies,
• beta-blockers used for heart problems and to lower blood pressure beta 2 blockers for the treatment of asthma. In this case, the doctor must subject you to frequent checks and, if necessary, modify the dose of SLOWMET, as these medicines increase blood glucose levels (intrinsic hyperglycemic activity) insulin, sulfonylureas or meglitinides, for the treatment of diabetes, because, if taken together with SLOWMET, they can cause an excessive reduction in blood sugar levels (hypoglycemia). For this reason, if necessary, the doctor must correct the dose of SLOWMET.

SLOWMET with alcohol
Avoid excessive alcohol consumption during treatment with SLOWMET as this may increase
the risk of lactic acidosis (see section "Warnings and precautions").
Avoid consuming beverages and medicines containing alcohol as the risk of some side effects
(lactic acidosis) is greater, especially if you are fasting, malnourished or have severe liver problems (hepatic insufficiency).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor
for advice before taking this medicine.
Talk to your doctor if changes to your treatment or monitoring of your blood glucose levels are necessary.
Do not take SLOWMET if you are breastfeeding

Driving and using machines
SLOWMET does not impair the ability to drive or operate machinery. However, avoid driving if you are
taking SLOWMET together with other medicines used to treat diabetes (e.g. sulfonylureas, insulin
or meglitinides).

SLOWMET contains sodium
SLOWMET 500 mg, 750 mg and 1000 mg prolonged-release tablets contains less than 1 mmol (23 mg)
of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take SLOWMET

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
If you are already taking a medicine to control diabetes and want to switch to SLOWMET, talk to your
doctor who will evaluate your situation and tell you how to do it.
Take the tablets with a sip of water, with the evening meal.
At the beginning of treatment, the recommended dose is 1 SLOWMET 500 mg tablet, once a day.
After 10-15 days, based on blood glucose levels, your doctor may decide to gradually modify
the dose, to avoid problems at the level of the stomach and intestines. The maximum recommended dose is 4
SLOWMET 500 mg tablets per day (which corresponds to a maximum daily dose of 2000
mg).
If you think the dose you are taking is insufficient, talk to your doctor.
SLOWMET can be taken in association with insulin for better control of blood sugar
levels. The recommended dose of SLOWMET is 1 tablet of 500 mg, once a day. The dose of
insulin, however, must be established by the doctor based on blood glucose levels (glycemia).
If you have reduced kidney function, your doctor may prescribe a lower dose.

Use in the elderly
In elderly patients, the doctor may advise a lower dosage, due to reduced kidney function.
Periodic monitoring of kidney function is necessary (See section “Elderly”).

If you take more SLOWMET than you should
Following the intake of an excessive dose of this medicine, an increase in blood acidity
(lactic acidosis) may occur.
In case of ingestion/intake of an excessive amount of this medicine, immediately
go to the nearest hospital.

If you forget to take SLOWMET
If you forget to take a dose, take it as soon as you remember, unless it is almost time to take
the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking SLOWMET
Consult your doctor before stopping treatment with this medicine as stopping or
suspending treatment may cause an excessive increase in blood sugar, damage to
the eyes, kidneys and circulation.
If you have any doubts about 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.
The following side effects may occur:

Very common(may affect more than 1 in 10 people)
nausea, vomiting, diarrhoea, abdominal pain, loss of appetite. These side effects are
more frequent at the beginning of therapy and, in many cases, resolve spontaneously.

Common(may affect more than 1 in 100 people)

• taste alterations (feeling tastes in an altered way).

Very rare(may affect up to 1 in 10,000 people)

• SLOWMET can cause a very rare but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this occurs, you must stop takingSLOWMET and immediately contact your doctor or the nearest hospital, because lactic acidosis can lead to coma.
• skin irritations (erythema, urticaria), itching;
• reduction of Vitamin B12 absorption and its levels in the blood (See section “Warnings and precautions”).
• alteration of liver function tests or liver inflammation (hepatitis) which resolves upon stopping the use of SLOWMET.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 SLOWMET

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
No special storage conditions are required for this medicine.
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 SLOWMET 500 mg prolonged-release tablets contain

• The active ingredient is metformin hydrochloride. One tablet contains 500 mg of metformin hydrochloride (corresponding to 390 mg of metformin base).
• The other ingredients are: sodium carboxymethylcellulose, hypromellose 100,000cP, hypromellose 5cP, microcrystalline cellulose, magnesium stearate, purified water.

What SLOWMET 750 mg prolonged-release tablets contain

• The active ingredient is metformin hydrochloride. One tablet contains 750 mg of metformin hydrochloride (corresponding to 585 mg of metformin base).
• The other ingredients are: sodium carboxymethylcellulose, hypromellose 100,000cP, magnesium stearate, purified water.

What SLOWMET 1000 mg prolonged-release tablets contain

• The active ingredient is metformin hydrochloride. One tablet contains 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin base).
• The other ingredients are: sodium carboxymethylcellulose, hypromellose 100,000cP, magnesium stearate, purified water.

Description of the appearance of SLOWMET and contents of the pack
Prolonged-release tablets 500 mg: pack of 30, 60 tablets in PVC/PVDC Aluminium blisters.
Prolonged-release tablets 750 mg: pack of 30, 60 tablets in PVC/PVDC Aluminium blisters.
Prolonged-release tablets 1000 mg: pack of 30, 60 tablets in PVC/PVDC Aluminium blisters.

Marketing Authorisation Holder
I.B.N. SAVIO S.r.l. - Via del Mare, 36 – 00071 Pomezia (RM) – Italy

Manufacturers
Savio Industrial S.r.l., Via Emilia, 21 – Pavia
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - Anagni (FR)