Patient leaflet - Xywin 60 mg prolonged-release tablets

1. What Xywin 60 mg Prolonged-release Tablets is and what it is used for

Xywin 60 mg Prolonged-release Tablets is a medicine that reduces blood sugar levels. Xywin 60 mg Prolonged-release Tablets contains gliclazide, an oral anti-diabetic medicine belonging to the sulphonylurea group.

Xywin is used in a certain form of diabetes (type 2 diabetes mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate eﬀect on keeping blood sugar at the correct level.

2. What you need to know before you take Xywin 60 mg Prolonged-release Tablets

Do not take Xywin 60 mg Prolonged-release Tablets:

if you are allergic to gliclazide or any of the
other ingredients of this medicine (listed in section 6), or to other medicines of the same group (sulfonylureas), or to other related medicines (hypoglycaemic sulfonamides),
if you have insulin-dependent diabetes
(type 1),
if you have ketone bodies and sugar in
your urine (this may mean you have diabetic keto-acidosis), a diabetic pre-coma or coma,
if you have severe kidney or liver disease, · if you are taking medicines to treat fungal
infections (miconazole) (see section “Other medicines and Xywin”),
if you are breastfeeding (see Section
“Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor before taking Xywin 60 mg Prolonged-release Tablets

You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and where necessary, reduce weight.

During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the ﬁrst few weeks of treatment the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (hypoglycaemia) may occur: · if you take meals irregularly or skip meals

altogether,

if you are fasting,
if you are malnourished,
if you change your diet,
if you increase your physical activity and
carbohydrate intake does not match this increase,
if you drink alcohol, especially in
combination with skipped meals, · if you take other medicines or natural
remedies at the same time,
if you take too high doses of gliclazide, · if you suﬀer from particular hormone
induced disorders (functional disorders of the thyroid gland, of the pituitary gland or adrenal cortex),
if your kidney function or liver function is
severely decreased.

If you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness, and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heart beat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suﬀer from considerable confusion (delirium), develop convulsions, lose self control, your breathing may be shallow and your heart beat slowed down, you may become unconscious.

In most cases the symptoms of low blood sugar vanish very quickly when you consume some form of sugar, for instance glucose

tablets, sugar cubes, sweet juice, sweetened tea. You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artiﬁcial sweeteners are not eﬀective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta blockers).

If you are in stress-situations (accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar

(hyperglycaemia) may occur when gliclazide has not yet suﬃciently reduced the blood sugar, when you have not complied with the treatment plan prescribed by your doctor, if you take St John's Wort (Hypericum perforatum) preparations (see section "Other medicines and Xywin 60 mg Prolonged-release Tablets"), or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

If these symptoms occur, you must contact your doctor or pharmacist.

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when gliclazide is prescribed at the same time than medicines belonging to a class of antibiotics called ﬂuoroquinolones, especially in elderly patients. In this case, your doctor will remind you the importance of monitoring your blood glucose.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deﬁciency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.

Cases of acute porphyria have been described with some other sulfonylurea drugs, in patients who have porphyria (inherited genetic disorders with accumulation in the body of porphyrins or porphyrin precursors).

Children and adolescents

Xywin 60 mg Prolonged-release Tablets is not recommended for use in children due to a lack of data.

Other medicines and Xywin 60 mg Prolonged-release Tablets

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

The blood sugar lowering eﬀect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken:

other medicines used to treat high blood sugar (oral anti-diabetics, GLP-1 receptor inhibitors or insulin),
antibiotics (sulfonamides clarithromycin), · medicines to treat high blood pressure or heart failure (beta blockers, ACE-inhibitors such as captopril, or enalapril),
medicines to treat fungal infections
(miconazole, ﬂuconazole),
medicines to treat ulcers in the stomach or duodenum (H receptor antagonists),
2
medicines to treat depression
(monoamine oxidase inhibitors), · painkiller or antirheumatics
(phenylbutazone, ibuprofen),
medicines containing alcohol.

The blood glucose lowering eﬀect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

medicines to treat disorders of the central nervous system (chlorpromazine), · medicines reducing inﬂammation
(corticosteroids),
medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline),
medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol),
St John's Wort – Hypericum perforatum – preparations.

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called ﬂuoroquinolones is taken at the same time than Xywin 60 mg Prolonged-release Tablets especially in elderly patients.

Xywin 60 mg Prolonged-release Tablets may increase the eﬀects of medicines which reduce blood clotting (e.g. warfarin). Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staﬀ you are taking Xywin 60mg Prolonged-release Tablets.

Xywin 60 mg Prolonged-release Tablets with food, drink and alcohol

Xywin 60 mg Prolonged-release Tablets can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.

Pregnancy and breastfeeding

Xywin 60 mg Prolonged-release Tablets is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Xywin 60 mg Prolonged-release Tablets while you are breastfeeding.

Driving and using machines

Your ability to concentrate or react may be impaired if your blood sugar is too low 140 mm

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(hypoglycaemia), or too high

(hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:

have frequent episodes of low blood sugar
(hypoglycaemia)
have few or no warning signals of low
blood sugar (hypoglycaemia).

Xywin 60 mg Prolonged-release Tablets contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Xywin 60 mg Prolonged-release Tablets

Dose

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose:

The dose is determined by the doctor,
depending on your blood and possibly urine sugar levels.
Change in external factors (weight
reduction, change in life style, stress) or improvements in the blood sugar control may require changed gliclazide doses. · The recommended daily dose is one tablet
of Xywin 30 mg Prolonged-release Tablets to two tablets of Xywin 60 mg Prolonged-release Tablets (maximum 120mg) in a single intake at breakfast time. This depends on the response to treatment. Xywin 60 mg Prolonged-release Tablets is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your tablet(s) whole and do not chew them.

You must always eat a meal after taking your tablet(s).

If a combination therapy of Xywin 60 mg
Prolonged-release Tablets with metformin, an alpha glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4inhibitor, a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you.
If you notice that your blood sugar levels
are high although you are taking this medicine as prescribed, you should contact your doctor or pharmacist.

If you take more Xywin 60 mg Prolonged-release Tablets than you should

If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia) described in section 2. The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, for instance a child has taken the product unintentionally. Unconscious patients must not be given food or drink.

It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take Xywin 60 mg Prolonged-release Tablets

It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Xywin 60 mg Prolonged-release Tablets, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If your doctor switches you from gliclazide 80mg tablets or from other anti-diabetics to Xywin 60 mg Prolonged-release Tablets

Your doctor will decide your initial dose and monitor you more closely for a short time.

If you stop taking Xywin 60 mg Prolonged-release Tablets

As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side eﬀects

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

The most commonly observed side eﬀect is low blood sugar (hypoglycaemia). For symptoms and signs see

Section “Warnings and precautions” in section 2"What you need to know before you take Xywin 60mg Prolonged-release Tablets".

If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek medical attention

immediate .

Blood disorders

Decrease in the number of cells in the blood has been reported (for instance platelets, red and white blood cells)

This may cause:

paleness,
prolonged bleeding,
bruising,
sore throat
fever

These symptoms usually vanish when the treatment is discontinued.

Liver disorders

There have been isolated reports of abnormal liver function, which can cause yellow skin and eyes. If you get this, see your doctor

immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin disorders

Skin reactions have been reported such as · rash,

redness,
itching,
hives
blisters
angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing diﬃculty). Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking Xywin 60mg Prolonged-release Tablets , seek urgent advice from a doctor and tell him that you are taking this medicine. · exceptionally, signs of severe hypersensitivity reactions (DRESS) have been reported: initially as ﬂu-like symptoms and a rash on the face then an extended rash with a high temperature.

Digestive disorders

Stomach pain or discomfort,
feeling or being sick,
indigestion,
diarrhoea
constipation

These eﬀects are reduced when Xywin 60 mg Prolonged-release Tablets is taken with a meal as recommended, See Section 3 “How to take Xywin 60 mg Prolonged-release Tablets”.

Eye disorders

Your vision may be aﬀected for a short time especially at the start of treatment. This eﬀect is due to changes in blood sugar levels. As for other sulfonylureas, the following adverse events have been observed · cases of severe changes in the number of blood cells and allergic inﬂammation of the wall of blood vessels,

reduction in blood sodium
(hyponatraemia),
symptoms of liver impairment (e.g.
jaundice) which in most cases disappeared after withdrawal of the sulfonylureas, but may lead to life threatening liver failure in isolated cases.

Reporting of side eﬀects

If you get any side eﬀects, talk to your doctor or pharmacist or nurse. This includes any possible side eﬀects not listed in this leaﬂet. You can also report side eﬀects directly via the Yellow Card Scheme at

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eﬀects you can help provide more information on the safety of this medicine.

5. How to store Xywin 60 mg Prolonged-release Tablets

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 tablet carton and the blister strip after 'EXP'. The expiry date refers to the last day of that month.

This medicine 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 Xywin 60 mg Prolonged-release Tablets contains

The active substance is gliclazide. Each tablet contains 60 mg gliclazide in a prolonged-release formulation. The other ingredients are: lactose monohydrate, maize starch, Hypromellose 2208, 4000 MPA.S,

Hypromellose 2208,100 MPA.S, magnesium stearate.

What Xywin 60 mg Prolonged-release Tablets looks like and contents of the pack Xywin 60 mg Prolonged-release Tablets White to oﬀ white oval shaped tablet, debossed with 'C55' on one side and plain on the other side.

Xywin 60 mg Prolonged-release Tablets are packaged in an aluminium/aluminium blister pack and these blisters are further packed in outer carton to give packs of 10, 14, 20, 30, 28, 50, 60, 56, 100 and 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ipca Laboratories UK Ltd

Unit 97-98, Silverbriar, Sunderland Enterprise Park East,

Sunderland, SR5 2TQ

United Kingdom

This leaﬂet was last revised in 06/2025

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