Package leaflet: information for the patient

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

Metformin
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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:
What SLOWMET is and what it is used for

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

SLOWMET contains the active substance metformin, which belongs to a group of medicines called oral antidiabetics that regulate blood glucose levels when they are excessively high.
SLOWMET prolonged-release tablets are indicated for the treatment of type 2 diabetes, a condition characterized by high blood glucose levels and reduced insulin activity, which normally helps lower them. In particular, this medicine is useful for people who cannot take immediate-release metformin due to severe stomach and intestinal (gastrointestinal) problems, and for those in whom such problems reduce the effectiveness of the medicine.
This medicine may 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 to 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, for example, with 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 may lead to diabetic precoma. Symptoms include
abdominal 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 serious circulatory problem (shock);
if you have reduced heart or lung function (unstable heart failure or respiratory failure);
if you have recently had a heart attack;
if you have serious liver problems (hepatic failure), or if you are a heavy drinker of alcohol (acute alcohol intoxication, alcoholism) (See section “SLOWMET and alcohol”);
if you are due to undergo specific tests and need to be given intravenously certain iodine-containing substances (intravascular administration of iodinated 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 treatment with SLOWMET, your doctor should periodically check your kidney function
(serum creatinine levels). In particular, if your kidney function is normal, these checks are recommended at least once a year; if, however, you have kidney problems (serum creatinine levels at the upper limit of normal) or are elderly, checks should be performed at least 2–4 times a year (See section “Elderly patients”).
Risk of lactic acidosis
SLOWMET may cause a very rare but very serious side effect called lactic acidosis, particularly if the kidneys are not functioning 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 further information), liver problems, or any other medical condition characterized by reduced oxygen supply to part of the body (such as in severe heart disease).
Contact your doctor immediately for further instructions if:

you know you have a hereditary genetic disease affecting mitochondria (the components producing energy within 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, Maternal Inherited Diabetes and Deafness);
you experience any of the following symptoms after starting metformin: seizures, decreased cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g., pain or numbness), headache, 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 disorder (megaloblastic anemia), since SLOWMET causes reduced absorption of Vitamin B12 and lower blood levels of it (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 be alarmed.
During treatment with this medicine, continue to:

consume 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 laboratory tests as required for diabetes.

Temporarily stop taking SLOWMET if you develop a medical condition
that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhea,
fever, heat exposure, or if you are drinking less fluid 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, as lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

vomiting
stomach ache (abdominal pain)
muscle cramps
a general feeling of malaise associated with severe fatigue
difficulty breathing
reduced body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are undergoing major surgery, you must stop taking SLOWMET during the procedure and for a certain period afterwards. Your doctor will decide when to stop and when to restart treatment with SLOWMET.
During treatment with SLOWMET, your doctor will monitor your kidney function at least once
a year, or more frequently if you are elderly and/or if kidney function worsens.
Children
Since data on the use of SLOWMET in children are not available, this medicine should not
be used in children.
Elderly patients
In elderly individuals, reduced kidney function is more common and often occurs without obvious symptoms (asymptomatic). For this reason, during treatment with this medicine, your doctor must carefully monitor kidney function.
Other medicines and SLOWMET
If you are due to receive an injection of an iodinated contrast agent into the bloodstream, for
example for an X-ray examination, you must stop taking SLOWMET before or during the injection. Your doctor
will decide when to stop and when to restart treatment with SLOWMET.
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
You may need to have more frequent blood glucose and kidney function tests, 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 to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib)
certain medicines for treating high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
glucocorticoids (systemic and local), used to treat inflammation and allergies,
beta-blockers used for heart problems and to lower blood pressure, and beta-2 blockers for the treatment of asthma. In such cases, your doctor must perform frequent checks and, if necessary, adjust the dose of SLOWMET, since these medicines increase blood glucose levels (intrinsic hyperglycemic activity). Insulin, sulfonylureas, or meglitinides, used to treat diabetes, because when taken together with SLOWMET, they may cause excessive reduction of blood sugar levels (hypoglycemia). Therefore, if necessary, your doctor must adjust the dose of SLOWMET.

SLOWMET and alcohol
Avoid excessive alcohol consumption during treatment with SLOWMET, as this may increase the
risk of lactic acidosis (see section "Warnings and precautions").
Avoid drinking beverages and taking medicines containing alcohol, as the risk of certain side effects (lactic acidosis) is higher, especially if you are fasting, malnourished, or have serious liver problems (hepatic failure).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor
before taking this medicine.
Talk to your doctor if changes to your treatment or monitoring of blood glucose levels are needed.
Do not take SLOWMET if you are breastfeeding.
Driving and using machines
SLOWMET does not affect the ability to drive or use 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 contain less than 1 mmol (23 mg)
of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take SLOWMET

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
If you are already taking a medicine to control diabetes and wish to switch to SLOWMET, discuss this with your
doctor, who will assess your condition and advise you accordingly.
Take the tablets with a glass of water, during the evening meal.
At the beginning of treatment, the recommended dose is 1 SLOWMET 500 mg tablet once daily.
After 10–15 days, depending on your blood glucose levels, your doctor may gradually adjust the dose
to avoid stomach and intestinal problems. The maximum recommended dose is 4 SLOWMET 500 mg tablets
per day (corresponding to a maximum daily dose of 2000 mg).
If you think the dose you are taking is insufficient, discuss this with your doctor.
SLOWMET may be taken together with insulin for better control of blood sugar levels. The recommended dose
of SLOWMET is 1 tablet of 500 mg once daily. The insulin dose, however, must be determined by your doctor
based on your blood glucose levels (glycaemia).
If you have reduced kidney function, your doctor may prescribe a lower dose.

Use in the elderly
In elderly patients, your doctor may recommend 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
Taking an excessive dose of this medicine may lead to increased acidity of the blood (lactic acidosis).
In case of ingestion/overdose of this medicine, seek immediate medical attention at 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 for your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking SLOWMET
Consult your doctor before stopping treatment with this medicine, as interruption or discontinuation of treatment may lead to excessive blood sugar levels, and damage to the eyes, kidneys, and circulation.

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 everyone 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 occur more frequently at the beginning of treatment and, in many cases, resolve spontaneously.
Common (may affect more than 1 in 100 people)

altered taste (tasting flavours differently).

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

SLOWMET may cause a very rare but serious side effect called lactic acidosis (see section "Warnings and precautions"). If this occurs, you must stop taking SLOWMET and contact your doctor or go immediately to the nearest hospital, because lactic acidosis can lead to coma.
skin irritations (erythema, urticaria), itching;
reduced absorption of Vitamin B12 and decreased blood levels of Vitamin B12 (see section “Warnings and precautions”).
changes in liver function tests or inflammation of the liver (hepatitis), which resolve upon discontinuation of SLOWMET.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. 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 SLOWMET

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SLOWMET 500 mg prolonged-release tablets contain

The active substance is metformin hydrochloride. One tablet contains 500 mg of metformin hydrochloride (equivalent to 390 mg of metformin base).
The other components are: sodium carmellose, hypromellose 100,000cP, hypromellose 5cP, microcrystalline cellulose, magnesium stearate, purified water.

What SLOWMET 750 mg prolonged-release tablets contain

The active substance is metformin hydrochloride. One tablet contains 750 mg of metformin hydrochloride (equivalent to 585 mg of metformin base).
The other components are: sodium carmellose, hypromellose 100,000cP, magnesium stearate, purified water.

What SLOWMET 1000 mg prolonged-release tablets contain

The active substance is metformin hydrochloride. One tablet contains 1000 mg of metformin hydrochloride (equivalent to 780 mg of metformin base).
The other components are: sodium carmellose, hypromellose 100,000cP, magnesium stearate, purified water.

Description of the appearance of SLOWMET and contents of the pack
500 mg prolonged-release tablets: box containing 30 or 60 tablets in PVC/PVDC-aluminum blisters.
750 mg prolonged-release tablets: box containing 30 or 60 tablets in PVC/PVDC-aluminum blisters.
1000 mg prolonged-release tablets: box containing 30 or 60 tablets in PVC/PVDC-aluminum blisters.
Marketing Authorization 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)