Skip to Content

UK Edition. Click here for US version.

NOCTEAZE SR 1000MG PROLONGED-RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

Nocteaze SR 500mg, 750mg, 1000mg
Prolonged-release Tablets
Metformin hydrochloride

Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor, or
pharmacist.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
•  If you get any side effects, talk to your doctor,or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1 What Nocteaze SR is and what it is used for
2 What you need to know before you take
Nocteaze SR
3 How to take Nocteaze SR
4 Possible side effects
5 How to store Nocteaze SR
6 Contents of the pack and other information
1 What Nocteaze SR is and what it is used for
Nocteaze SR contains the active ingredient metformin
hydrochloride and belongs to a group of medicines called
biguanides, used in the treatment of diabetes.
Nocteaze SR is used for the treatment of Type 2 (non-insulin
dependent) diabetes mellitus in adults when diet and exercise
changes alone have not been enough to control blood glucose
(sugar). Insulin is a hormone that enables body tissues to take
glucose from the blood and to use it for energy or for storage
for future use. People with Type 2 diabetes do not make
enough insulin in their pancreas or their body does not respond
properly to the insulin it does make. This causes a build-up
of glucose in the blood which can cause a number of serious
long-term problems so it is important that you continue to take
your medicine, even though you may not have any obvious
symptoms. Nocteaze SR makes the body more sensitive to
insulin and helps return to normal the way your body uses
glucose.
Nocteaze SR is associated with either a stable body weight or
modest weight loss.
Nocteaze SR is specially made to release the drug slowly in your
body and therefore are different to many other types of tablet
containing metformin.

2 What you need to know before you take

Nocteaze SR

Do not take Nocteaze SR:

• If you are allergic to metformin or to any of the other
ingredients of this medicine (listed in section 6).
• If you have ketosis (this is a symptom of uncontrolled diabetes
in which substances called ‘ketone bodies’ accumulate in the
blood – you may notice that your breath has an unusual, fruity
odour).
• If you have long-term kidney or liver problems.
• If you have had serious complications with your diabetes or
other serious conditions which resulted in rapid weight loss,
nausea, vomiting or dehydration.
• If you have a severe infection or have recently suffered a
severe injury.
• If you have been treated for heart problems or have recently
had a heart attack or have severe circulatory problems or
breathing difficulties.
• If you are a heavy drinker of alcohol.

Warnings and precautions
After you have started taking your medicine:

If you have diabetes you should have your blood or urine tested
for sugar regularly. You should return to your doctor at least once
a year to check the function of your kidneys (more often if you
are elderly or if you have kidney problems).
If you start to lose weight unexpectedly or suffer severe
nausea or vomiting, uncontrolled rapid breathing,
abdominal pains, feeling cold or muscle cramps, stop taking
the medicine and tell your doctor straight away. This can be
a sign of a rare, but serious, complication with your diabetes
called ‘lactic acidosis’ which means there is too much acid in
the blood (see also under ‘4. Possible side effects’).
You may see some remains of the tablets in your stools. Do not
worry as this is normal for this type of tablet.
If you need to have an X-ray examination involving the
injection of a dye, tell the doctor that you take Nocteaze SR
as you may need to stop taking it for a few days after the
examination.
Tell your doctor if you are going to have an operation under
general anaesthetic, as you may need to stop taking Nocteaze
SR for a couple of days before and after the procedure.
You should continue to follow any dietary advice that your
doctor has given you and you should make sure that you eat
carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to your
doctor.

Children and adolescents

Children and adolescents should not use this medicine. It is
not known if this medicine is safe and effective when used in
children and adolescents under 18 years of age.

Other medicines and Nocteaze SR

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
If you are taking any of the following medicines, your blood
sugar levels may need to be checked more often and your dose
adjusted:
• Steroids such as prednisolone, mometasone, beclometasone.
• Diuretics (water tablets) such as furosemide.
• Sympathomimetic medicines including epinephrine and
dopamine used to treat heart attacks and low blood pressure.
Epinephrine is also included in some dental anaesthetics.
You should avoid drinking alcohol and using alcohol-containing
medicines as this will increase the risk of lactic acidosis (see
under ‘4. Possible side effects’).

Nocteaze SR with food, drink and alcohol

You should take Nocteaze SR with or immediately after food e.g.
with your evening meal.
You should avoid drinking alcohol.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.
It is not recommended to take this medicine if you are breastfeeding or if you are planning to breast-feed your baby.

Driving and using machines

Nocteaze SR taken on its own does not cause ‘hypoglycemia’
(symptoms of low blood sugar, such as faintness, confusion and
increased sweating) and therefore should not affect your ability
to drive or use machinery.
You should be aware, however, that Nocteaze SR taken with
other antidiabetic medicines can cause low blood sugar, so in
this case you should take extra care when driving or operating
machinery.

continued over page

AAAG8564

Metformin (Nocteaze SR) 500mg, 750mg & 100mg PIL - UK
item no: AAAG8564

dimensions: 100 x 600

print proof no: 5

pharmacode:

origination date: 14.05.14

min pt size: 8

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 22.05.14

Technical Approval

revised by: S.Anson

date sent: 14.05.14 + 21.05.14

supplier: Generic Partners

technically app. date: 21.05.14

Non Printing Colours
1.
2.
3.

3 How to take Nocteaze SR
Your doctor may prescribe Nocteaze SR for you to take on its
own, or in combination with other oral antidiabetic medicines
or insulin.
Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Dosage
Usually you will start treatment with 500mg Nocteaze SR daily.
After you have been taking Nocteaze SR for about 2 weeks, your
doctor may measure your blood sugar and adjust the dose. The
maximum daily dose is 2000mg of Nocteaze SR.

How to take the tablets

Normally, you should take the tablets once a day, with your
evening meal.
In some cases, your doctor may recommend that you take the
tablets twice a day. Always take the tablets with food.
Swallow the tablets whole with a glass of water, do not chew,
split or crush the tablets.

Use in children and adolescents

Children and adolescents below 18 years should not use this
medicine.

Use in elderly

The dose will be determined after tests have been carried out on
your kidney function.

If you take more Nocteaze SR than you should

If you take extra tablets by mistake you need not worry, but
if you have unusual symptoms, contact your doctor. These
symptoms may include weakness, confusion, fast breathing and
new onset of nausea, vomiting or stomach pain. If the overdose
is large, lactic acidosis is more likely and this is a medical
emergency requiring treatment in hospital (see also under ‘4.
Possible side effects’).

If you forget to take Nocteaze SR

Take it as soon as you remember with some food. Do not take a
double dose to make up for a forgotten dose.

If you stop taking Nocteaze SR

You should not stop taking this medicine without talking to your
doctor first. If you stop taking Nocteaze SR, your blood sugar
may rise again.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
If you notice any of the following side effects, stop taking
Nocteaze SR and see your doctor immediately:
Very rare (may affect up to 1 in 10,000 people):
• unexpected weight loss, very severe nausea or vomiting, very
fast breathing which you cannot stop, stomach pains or feeling
cold.
These can be signs of serious problems with your diabetes
and may mean you have a very rare side effect called “lactic
acidosis” (too much acid in the blood). If this happens, see a
doctor as you will need treatment straight away.
Frequency not known (frequency cannot be estimated from
the available data)
• Abnormal liver function tests and hepatitis (inflammation of
the liver) which may result in jaundice. If you develop yellowing
of the eyes and/or skin contact your doctor immediately.
Other possible side effects are listed by frequency as follows:
Very common (may affect more than 1 in 10 people):
• Diarrhoea, nausea, vomiting, stomach ache or loss of appetite.
If you get these, do not stop taking the tablets as these
symptoms will normally go away in about 2 weeks.
Common (may affect up to 1 in 10 people):
• Taste disturbance
Very rare (may affect up to 1 in 10,000 people):
• Decreased vitamin B12 levels which may result in anaemia
• Skin rashes including redness, itching and hives.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side affects you can help provide more information
on the safety of this medicine.

5 How to store Nocteaze SR
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 after “EXP”. The expiry date refers to the last day of
that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines
you no longer use. These measures will help protect the
environment.

6 Contents of the pack and other information
What Nocteaze SR contains

• The active substance is metformin (as hydrochloride). Each
prolonged-release tablet contains 500mg, 750mg or 1000mg of
metformin hydrochloride corresponding to 390mg, 585mg and
780mg metformin base, respectively.
• The other ingredients are magnesium stearate, colloidal
anhydrous silica, povidone K30 and hypromellose.

What Nocteaze SR looks like and contents of the pack

Nocteaze SR 500mg prolonged-release tablets are white to offwhite, capsule shaped uncoated tablets, 16.50 mm in length,
8.20 mm in width and 6.70 mm in thickness, debossed with
‘XR500’ on one side and plain on other side.
Nocteaze SR 750mg prolonged-release tablets are white to offwhite, capsule shaped, uncoated tablets, 19.60 mm in length,
9.30 mm in width and 7.40 mm in thickness, debossed with ‘XR
750’ on one side and plain on other side.
Nocteaze SR 1000mg prolonged-release tablets are white to
off-white, capsule shaped, uncoated tablets, 21.10 mm in length,
10.10 mm in width and 8.90 mm in thickness, debossed with ‘XR
1000’ on one side and plain on other side.
Nocteaze SR is available in blister packs containing 28 or 56
tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Medicofarma S.A.
ul. Kozienicka 97
26-600 Radom
Poland
This leaflet was last revised in May 2014.

AAAG8564

Metformin (Nocteaze SR) 500mg, 750mg & 100mg PIL - UK
item no: AAAG8564

dimensions: 100 x 600

print proof no: 5

pharmacode:

origination date: 14.05.14

min pt size: 8

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 22.05.14

Technical Approval

revised by: S.Anson

date sent: 14.05.14 + 21.05.14

supplier: Generic Partners

technically app. date: 21.05.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide