Pizona Combi 15 mg / 850 mg. 28 tablets

1. What is Pisona Kombi and what it is used for

Pizona Combi contains pioglitazone and metformin. It is a medicine for the treatment of diabetes and is used in adults with type 2 (non-insulin dependent) diabetes when metformin therapy alone is insufficient. Type 2 diabetes usually develops in older people, especially as a result of being overweight and when the body either does not produce enough insulin (a hormone that controls blood sugar levels) or cannot effectively use the insulin produced. Your doctor will check that Pizona Combi is working 3 to 6 months after you start taking it.

Pisona Kombi helps to control your blood sugar level when you suffer from type 2 diabetes by helping the body to make better use of the insulin it produces.

2. What you need to know before you take Pison Combi

Do not take Pisona Combi

if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6);

if you suffer from heart failure;

if you have recently had a heart attack, have severe circulatory problems including shock or difficulty breathing;

if you have liver disease;

if you drink a lot of alcohol (every day or only occasionally);

if you have uncontrolled diabetes, for example with severe hyperglycaemia (high blood sugar), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see 'Risk of lactic acidosis' below) or ketoacidosis. Ketoacidosis is a condition in which substances , called "ketone bodies," build up in the blood and this can lead to a diabetic coma.Symptoms include stomach pain, fast and deep breathing, sleepiness, or an unusual fruity smell on your breath.

if you have or have had bladder cancer;

if you have blood in your urine that has not been tested by your doctor;

if your kidney function is severely reduced;

if you have a severe infection or are dehydrated;

if you are about to have a certain type of X-ray examination with the injection of a contrast substance, talk to your doctor, as you must stop taking Pizona Kombi for a certain time before and after the examination;

if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Pizona Combi (see also section 4):

if you have heart problems. Some patients with long-standing type 2 diabetes and heart disease or stroke who are treated with pioglitazone and insulin at the same time develop heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain, or localized swelling (oedema),

if you retain water (fluid retention) or have heart failure, especially if you are over 75 years of age. You should also tell your doctor if you are taking anti-inflammatory drugs, which can also cause fluid retention and edema.

if you suffer from a type of diabetic eye disease called macular edema (swelling at the back of the eye), talk to your doctor if you notice a change in your vision.

if you have ovarian cysts (polycystic ovary syndrome). There is an increased chance of getting pregnant because you may ovulate again when you are taking Pizona Combi. If this applies to you, use appropriate contraception to avoid an unplanned pregnancy.

if you have liver problems. Before you start taking Pizona Combi, you will have blood tests to check your liver function. This check can be periodically repeated. Tell your doctor as soon as possible if you experience signs that suggest a liver problem (such as unexplained nausea, vomiting, stomach pain, fatigue, loss of appetite and/or dark urine), as your liver function should to be checked.

It is also possible for you to have a decrease in the number of blood cells (anaemia).

Risk of lactic acidosis

Pisona Kombi can cause a very rare but very serious side effect called lactic acidosis, especially if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, severe infections, prolonged fasting or alcohol intake, dehydration (see more information below), liver problems, and any condition where part of the body has a reduced supply of oxygen ( such as acute severe heart disease). If any of the above applies to you, talk to your doctor for further guidance.

Stop taking Pizona Combi for a short time if you have an illness that can lead to dehydration (significant loss of body fluids) such as prolonged vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Pizona Combi and contact a doctor or the nearest hospital immediately if you have any of the symptoms of l

Hypoglycemia

If you take Pizona Combi with other diabetes medicines, there is a chance that your blood sugar will be below normal levels (hypoglycaemia). If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart rate, visual disturbances or difficulty concentrating, you should take some sugar to bring your blood sugar level back up. Ask your doctor or pharmacist for more information if you are not sure how to recognize this condition. It is recommended to carry with you lump sugar, sweets, biscuits or fruit juice with sugar.

Bone fractures

A higher number of bone fractures was observed in patients, especially women, taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and adolescents

Use in children and adolescents under 18 years of age is not recommended.

Other medicines and Pisona Kombi

If you are to have an injection of an iodinated contrast agent into your bloodstream, for example in the context of an X-ray or scan, you should stop taking Pizona Kombi before the injection. Your doctor will decide when you should stop and when you should resume treatment with Pizona Combi.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your blood glucose and kidney function may need to be checked more often, or your doctor may adjust the dose of Pizona Combi. It is extremely important to tell your doctor or pharmacist if you are taking any of the medicines listed:

gemfibrozil (used to lower cholesterol);

rifampicin (to treat tuberculosis and other infections);

cimetidine (used to reduce stomach acid);

glucocorticoids (used to treat inflammation);

beta-2-agonists (used to treat asthma);

drugs that increase urine output (diuretics);

medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors such as ibuprofen and celecoxib);

certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).

Pisona Combi with alcohol

Avoid alcohol or medicines containing alcohol while taking Pizona Combi, as alcohol may increase the risk of lactic acidosis (see section "Warnings and precautions").

Pregnancy, lactation and fertility

you should tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant. Pisona Combi is not recommended during pregnancy. If you wish to become pregnant, your doctor will advise you to stop taking this medicine,

do not use Pisona Combi if you are breast-feeding or if you plan to breast-feed (see above after "Do not take Pisona Combi").

Driving and using machines

This medicinal product does not affect the ability to drive or use machines, but be careful if you experience changes in vision.

3. How to take Pizona Kombi

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose is one tablet taken twice a day. If necessary, your doctor may tell you to take a different dose. If you have reduced kidney function, your doctor may prescribe a lower dose, which you may need to take as separate tablets of pioglitazone and metformin.

You should swallow the tablets with a glass of water. You can take the tablets during or immediately after a meal to reduce the likelihood of stomach irritation.

If you follow a special diet for diabetes, you should continue it while taking Pizona Combi. You should monitor your weight regularly. If it increases, tell your doctor.

Your doctor will ask you to have periodic blood tests during your treatment with Pizona Combi. This is necessary to check if your liver is working normally. At least once a year (and in elderly people or with kidney problems more often) your doctor will check that your kidney function is not impaired.

If you have taken more than the required dose of Pizona Combi

If you accidentally take too many tablets or someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar may drop below normal levels and you may raise it by taking sugar. It is recommended that you carry lumps of sugar, sweets, biscuits or sugar-sweetened fruit juice with you. If you have taken more than the required dose of Pizona Kombi, you may get lactic acidosis (see above under "Warnings and precautions").

If you have missed taking Pisona Kombi

Take Pisona Combi daily as prescribed. If you forget to take a dose, skip the missed dose and continue with the next one as per your usual schedule. Do not take a double dose to make up for a missed tablet.

If you have stopped taking Pisona Kombi

Pisona Kombi should be taken every day

Very common (may affect more than 1 in 10 people)

tummy ache;

nausea;

vomiting;

diarrhea;

loss of appetite.

Common (may affect up to 1 in 10 people)

localized swelling (edema);

increased weight;

headache;

respiratory infection;

impaired vision;

joint pain;

impotence;

blood in the urine;

decrease in the number of blood cells (anaemia);

stiffness;

taste disturbances.

Infrequent

inflammation of the sinuses (sinusitis);

gases;

insomnia (insomnia).

Very rare

decrease in the amount of vitamin B12 in the blood;

redness of the skin;

itchy skin;

raised itchy rash (urticaria).

Not known (frequency cannot be estimated from the available data)

inflammation of the liver (hepatitis);

the liver does not function properly (changes in liver enzymes).

5. How to store the Piso Combi

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiration date corresponds to the last day of the specified month.

This medicine does not require special storage conditions. Store in the original package in order to protect from light.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What the Pisona Kombi contains

The active substances are pioglitazone and metformin hydrochloride. Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.

The other ingredients are: microcrystalline cellulose, povidone (KZO), croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide.

What does Pisona Kombi look like and what is in the package

White, oblong, biconvex, film-coated tablets debossed with '15/850' on one side and plain on the other.

Available in aluminium/aluminium blisters, in packs containing 28, 56. Not all pack types may be marketed.