Metolazon Abcur

Document: Metolazon Abcur tablet ENG PL change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metolazon Abcur 5 mg tablets

Metolazone

Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Metolazon Abcur is and what it is used for

2. Before you take Metolazon Abcur

3. How to take Metolazon Abcur

4. Possible side effects

How to store Metolazon Abcur

6. Further information

WHAT METOLAZON ABCUR IS AND WHAT IT IS USED FOR

Metolazon Abcur is a diuretic drug containing the active substance metolazone. It is used in the treatment of oedema (liquid accumulations in the tissues) of kidney diseases resistant to other therapy.

BEFORE YOU TAKE Metolazon Abcur

Do not take Metolazon Abcur

- if you are allergic (hypersensitive) to metolazone or any of the other ingredients of Metolazon Abcur.

- if you ever have had an allergic reaction to diuretics belonging to a group called sulphonamides or thiazides.

- if you are no longer able to urinate

- in case of coma or comatose conditions which is caused by liver cirrhosis

- if you have a serious disorder of the electrolyte balance in your blood

Take special care with Metolazon Abcur

- if you suffer from any additional disease, especially kidney disease, diabetes and rheumatism. Inform your doctor about your disease.

- if you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems. Then you should see your doctor immediately. Metolazon Abcur may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

- if you will undergo surgery. Then your dose of Metolazon Abcur must be carefully adjusted. Inform your doctor about the surgery.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. You should inform your physician about all additional drugs you may have been using (herbal medicine included). This is especially important, if you are using the following medications:

- Lithium (used for treatment of a particular kind of depression)

- Digoxin (used for treatment of heart insufficiency)

- NSAIDs (used for treatment of pain, fever and inflammation)

- Ciclosporin (a drug that affects the immune system)

- Diuretics (other than Metalozon Abcur; used for treatment of kidney diseases, high blood pressure, heart failure and liver cirrhosis)

- ACE inhibitors (used for treatment of high blood pressure and heart failure)

- Warfarin (used to prevent blood clotting)

- Insulin or oral antidiabetics

- Corticosteroids

- ACTH (a pituitary hormone)

- Sotalol (used for treatment of heart diseases and hypertension)

- Barbiturates (used for treatment of insomnia, anxiety and epilepsia)

- Angiotension-II-antagonists (used for treatment of high blood pressure, heart failure and kidney damage due to diabetes)

Taking Metolazon Abcur with food and drink

If you take Metolazon Abcur in combination with alcohol, your blood pressure may decrease and result in dizziness, debility and fatigue.

You should take the tablet with the same meal each day, eg breakfast.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should not use Metolazon Abcur during pregnancy and the lactation period.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, treatment with Metolazon Abcur may cause adverse reactions affecting the ability to drive a vehicle or to operate machines, such as tiredness and dizziness. If you feel tired or drowsy, you should not drive or use machines.

Important information about some of the ingredients of Metolazon Abcur

Metolazon Abcur contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

HOW TO TAKE Metolazon Abcur

Always take Metolazon Abcur exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Initially the dosage should be 2.5 mg per day. The tablets have a break notch on one side and can be divided into equal halves. Your physician may adjust the dosage according to your individual reaction on the drug and increase the dosage if necessary.

You should take the tablet with the same meal each day, eg breakfast.

You should not change the prescribed dosage on your own initiative. If you believe, you are not getting the adequate dosage, please contact your physician or pharmacist.

If you take more Metolazon Abcur than you should

Contact a doctor or hospital for risk assessment and advice if you have taken too large a dose of the medicine, or if for example, a child has ingested the medicine by mistake.

An overdose of Metolazon Abcur might lead to thirst, nausea, vomiting, disorientation, drowsiness, muscle cramps and low blood pressure. In severe cases an overdose may result in irregular heart rate.

If you forget to take Metolazon Abcur

Do not take a double dose to make up for a forgotten tablet.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Metolazon Abcur can cause side effects, although not everybody gets them.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist.

The following side effects may occur in connection with the use of Metolazon Abcur:

Common (occurring in more than 1 out of 100 patients)

- Nausea, vomiting, congestion and diarrhoea

- Muscle cramps

- Headache, dizziness and tiredness

- Low levels of potassium, sodium and chloride in the blood

- High levels of uric acid, urea and creatinin and sugar in the blood

- Glucose in the urine.

Uncommon (occurring in less than 1 out of 100 patients)

- Reduced number of white blood cells

- Skin rash

- Inflammation in the blood vessels

- Gout

Rare (occuring in less than 1 out of 1000 patients)

- Reduced number of red blood cells

- Reduced number of white blood cells (agranulocytosis)

- Reduced number of platelets in the blood

- High levels of calcium in the blood

- Low levels of magnesium in the blood

- Hepatitis and intrahepatic cholestasis

- Renal failure

- A severe skin reaction, starting with a painful red area, developing into large blisters then peeling of layers of skin (toxic epidermal necrolysis)

Metolazon Abcur may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems, you should see your doctor immediately.

HOW TO STORE Metolazon Abcur

This medicinal product does not require any special storage condition.

Keep out of the reach and sight of children.

Do not use Metolazon Abcur after the expiry date which is stated on the carton after “EXP.” The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Metolazon Abcur contains

The active substance is metolazone 5 mg.

The other ingredients are croscarmellose sodium, microcrystalline cellulose, lactose monohydrate and sodium stearyl fumarate.

What Metolazon Abcur looks like and contents of the pack

Metolazon Abcur tablets are round and white with bevelled edge on both sides and a break notch on one side. The tablets and can be divided into equal halves.

Metolazon Abcur is supplied in blister packs with 20, 28, 30, 50, 56, 60, 98 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Abcur AB

Box 1452

251 14 Helsingborg

Sweden

Manufacturer

Formula GmbH

Goerzallee 305 b, DE-14167 Berlin

Germany

Viminco A/S

Lodshusvej 11, 4230 Skælskør

Denmark

This leaflet was last approved in

2011-03-28