Package leaflet: Information for the user Theroflan

0.5 mg tablets Theroflan 1.0 mg tablets Theroflan 2.0 mg tablets

Repaglinide

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 Theroflan is and what it is used for

2.    What you need to know before you take Theroflan

3.    How to take Theroflan

4.    Possible side effects

5.    How to store Theroflan

6.    Contents of the pack and other information

1.    What Theroflan is and what it is used for

Theroflan is an oral antidiabetic medicine containing repaglinide which helps your pancreas produce more insulin and thereby lower your blood sugar (glucose).

Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces.

Theroflan is used to control type 2 diabetes in adults as an add-on to diet and exercise: treatment is usually started if diet, exercise and weight reduction alone have not been able to control (or lower) your blood sugar. Theroflan can also be given with metformin, another medicine for diabetes.

Theroflan has been shown to lower the blood sugar, which helps to prevent complications from your diabetes.

2.    What you need to know before you take Theroflan

Do not take Theroflan

•    If you are allergic to repaglinide or any of the other ingredients of this medicine (listed in section 6).

•    If you have type 1 diabetes

•    If the acid level in your blood is raised (diabetic ketoacidosis)

•    If you have a severe liver disease

•    If you take gemfibrozil (a medicine used to lower increased fat levels in the blood).

Warnings and precautions

Talk to your doctor before taking Theroflan:

•    If you have liver problems. Theroflan is not recommended in patients with moderate liver disease. Theroflan should not be taken if you have a severe liver disease (see Do not take [Repaglinide]).

•    If you have kidney problems. Theroflan should be taken with caution.

•    If you are about to have major surgery or you have recently suffered a severe illness or infection. At such times diabetic control may be lost.

•    If you are under 18 or over 75 years of age. Theroflan is not recommended. It has not been studied in these age groups.

Talk to your doctor if any of the above applies to you. Theroflan may not be suitable for you. Your doctor will advise you.

Children and adolescents

Do not take this medicine if you are under 18

years of age.

If you get a hypo (low blood sugar)

You may get a hypo (short for hypoglycaemia) if your blood sugar gets too low. This may happen:

•    If you take too much Theroflan

•    If you exercise more than usual

•    If you take other medicines or suffer from liver or kidney problems (see other sections of 2. What you need to know before you take Theroflan).

The warning signs of a hypo may come on suddenly and can include: cold sweat; cool pale skin; headache; rapid heart beat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.

If your blood sugar is low or you feel a hypo coming on: eat glucose tablets or a high sugar snack or drink, then rest.

When symptoms of hypoglycaemia have disappeared or when blood sugar levels are stabilised continue Theroflan treatment.

Tell people you have diabetes and that if you pass out (become unconscious) due to a hypo, they must turn you on your side and get medical help straight away. They must not give you any food or drink. It could choke you.

•    If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death.

•    If you have a hypo that makes you pass out, or a lot of hypos, talk to your doctor. The amount of Theroflan, food or exercise may need to be adjusted.

If your blood sugar gets too high

Your blood sugar may get too high (hyperglycaemia). This may happen:

•    If you take too little Theroflan

•    If you have an infection or a fever

•    If you eat more than usual

•    If you exercise less than usual.

The warning signs of too high blood sugar

appear gradually. They include: increased urination; feeling thirsty; dry skin and dry mouth. Talk to your doctor. The amount of Theroflan, food or exercise may need to be adjusted.

Other medicines and Theroflan

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

You can take Theroflan with metformin, another medicine for diabetes, if your doctor prescribes it.

If you take gemfibrozil (used to lower increased fat levels in the blood) you should not take Theroflan.

Your body's response to Theroflan may change if you take other medicines, especially these:

•    Monoamine oxidase inhibitors (MAOI) (used to treat depression)

•    Beta blockers (used to treat high blood pressure or heart conditions)

•    ACEinhibitors (used to treat heart conditions)

•    Salicylates (e.g. aspirin)

•    Octreotide (used to treat cancer)

•    Nonsteroidal anti-inflammatory drugs (NSAID) (a type of painkillers)

•    Steroids (anabolic steroids and corticosteroids -used for anemia or to treat inflammation)

•    Oral contraceptives (birth control pills)

•    Thiazides (diuretics or ''water pills")

•    Danazol (used to treat breast cysts and endometriosis)

•    Thyroid products (used to treat low levels of thyroid hormones)

•    Sympathomimetics (used to treat asthma)

•    Clarithromycin, trimethoprim, rifampicin (antibiotic medicines)

•    Itraconazole, ketokonazole (antifungal medicines)

•    Gemfibrozil (used to treat high blood fats)

•    Ciclosporin (used to suppress the immune system)

•    Deferasirox (used to reduce chronic iron overload)

•    Clopidogrel (prevents blood clots)

•    Phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)

•    St. John's wort (herbal medicine).

Theroflan with alcohol

Alcohol can change the ability of Theroflan to reduce the blood sugar. Watch for signs of a hypo.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take Theroflan if you are pregnant or you are planning to become pregnant.

You should not take Theroflan if you are breastfeeding.

Driving and using machines

Your ability to drive or use a machine may be affected if your blood sugar is low or high. Bear in mind that you could endanger yourself or others. Please ask your doctor whether you can drive a car if you:

•    Have frequent hypos

•    Have few or no warning signs of hypos.

3. How to take Theroflan

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will work out your dose.

•    The normal starting dose is 0.5 mg before each main meal. Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.

•    The dose may be adjusted by your doctor by up to 4 mg to be taken immediately before or up to 30 minutes before each main meal. The maximum recommended daily dose is 16 mg.

Do not take more Theroflan than your doctor has recommended.

If you take more Theroflan than you should

If you take too many tablets, your blood sugar may become too low, leading to a hypo. Please see If you get a hypo on what a hypo is and how to treat it.

If you forget to take Theroflan

If you miss a dose, take the next dose as usual -do not double the dose.

If you stop taking Theroflan

Be aware that the desired effect is not achieved if you stop taking Theroflan. Your diabetes may get worse. If any change of your treatment is necessary contact your doctor first.

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.

Hypoglycaemia

The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see If you get a hypo in section 2). Hypoglycaemic reactions are generally mild/moderate but may occasionally develop into hypoglycaemic unconsciousness or coma. If this happens, medical assistance is needed immediately.

Allergy

Allergy is very rare (may affect up to 1 in 10,000 patients). Symptoms such as swelling, difficulty in breathing, rapid heartbeat, feeling dizzy and sweating could be signs of anaphylactic reaction. Contact a doctor immediately.

Other side effects

Common (may affect up to 1 in 10 patients)

•    Stomach pain

•    Diarrhoea

Rare (may affect up to 1 in 1000 patients)

•    Acute coronary syndrome (but it may not be due to the medicine )

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

•    Vomiting

•    Constipation

•    Visual disturbances

•    Severe liver problems, abnormal liver function such as increased liver enzymes in your blood.

Frequency not known

•    Hypersensitivity (such as rash, itchy skin, reddening of the skin, swelling of the skin)

•    Feeling sick (nausea).

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 the Yellow Card Scheme (www. mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Theroflan

Keep this medicine out of the sight and reach of children.

This product does not need any special storage conditions

Do not use this medicine after the expiry date which is stated on the carton and the blister foil after EXP. The expiry date refers to the last date of that month.

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 Theroflan contains

The active substance is repaglinide.

The other ingredients are:

Microcrystalline cellulose (E460), calcium hydrogen phosphate anhydrous, maize starch, amberlite (polacrilin potassium), poloxamer 407, meglumine, glycerol, Povidone and silica, colloidal anhydrous , magnesium stearate, iron oxide yellow (E172) only in the 1.0 mg tablets and iron oxide red (E172) only in the 2.0 mg tablets.

What Theroflan looks like and contents of the pack

Theroflan tablets are round and biconvex.

0.5 mg tablets are white, 1.0 mg tablets are yellow, mottled and 2.0 mg tablets are pink, mottled.

Theroflan are available in blister packs of 30, 90 and 120 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder

Pharmathen S.A., Dervenakion 6, 15351 Pallini,

Attiki, Greece

tel.: +30 210 666 4300

fax: +30 210 666 6749

e-mail: info@pharmathen.com

Manufacturer

Pharmathen S.A., Dervenakion 6, 15351 Pallini,

Attiki, Greece

tel.: +30 210 666 4300

fax: +30 210 666 6749

e-mail: info@pharmathen.com

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom Theroflan 0.5 mg, 1 mg, 2 mg Cyprus Theroflan 0.5 mg, 1 mg, 2 mg Greece Theroflan 0.5 mg, 1 mg, 2 mg Italy Theroflan0.5 mg, 1 mg, 2 mg

This leaflet was last revised in March 2016

Pharmathen International S.A

Industrial Park Sapes Rodopi Perfecture, Block 5,

Rodopi 69300, Greece

tel: +30 25320 31376

fax: +30 25320 31471

e-mail: info@pharmathen.com