TORAZIDEX 10mg x 30 tabl
Patient information leaflet
Torazidex 5 mg tablets
Torazidex 5 mg tablets
Torazidex 10 mg tablets
Torazidex 10 mg tablets
torasemide ( torasemide )
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 personally. 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, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What this leaflet contains
- What Torazidex is and what it is used for
- What you need to know before you take Torazidex
- How to take Torazidex
- Possible side effects
- How to store Torazidex
- Package contents and additional information
1. What Torazidex is and what it is used for
Torazidex 5 mg is used to treat:
- high blood pressure
- swelling caused by increased fluid in the body (edema)
Torazidex 10 mg is used to treat:
- swelling caused by increased fluid in the body (edema)
Torasemide is a diuretic, which means it is a medication that increases urine output.
2. What you need to know before you take Torazidex
Do not take Torazidex if you are/have
- allergic to:
− torasemide or any of the other ingredients of this medicine (listed in section 6)
− similar medicines called “sulfonylureas”, used to treat high blood sugar, containing active substances whose names usually end in “-mid”
- kidney failure with insufficient urine production
- severe liver disease with loss of consciousness
- low blood pressure
- decreased blood volume
- you breastfeed
- decreased levels of potassium or sodium in the blood
- severe urination disorders , for example caused by an enlarged prostate gland
- gout
- irregular heartbeat
- taking medications such as cefixime, cefuroxime, cefaclor, cephalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin, or tobramycin
- decreased kidney function , due to medications that cause kidney damage
Warnings and precautions
Talk to your doctor before taking Torazidex if any of the following apply to you:
- abnormalities in the amount of acids and bases in the blood
- pathological changes in blood count
- taking lithium, a medication to treat depression
- diabetes
If you take torasemide for a long time, your doctor will regularly monitor your blood counts, especially if you are also taking other medications, if you have diabetes or arrhythmia.
Children and adolescents
Torazidex is not recommended for children and adolescents under 18 years of age.
Other drugs and Torazidex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines may affect or be affected by Torazidex:
- medicines to treat high blood pressure, especially medicines with an active ingredient whose name ends in “-pril”
- medications that improve the pumping function of the heart, such as digitoxin, digoxin, or methyldigoxin
- diabetes treatment medications
- probenecid , a medicine to treat gout
- medicines to treat inflammation and pain, such as acetylsalicylic acid or indomethacin
- sulfasalazine, mesalazine or olsalazine, medicines to treat inflammatory bowel diseases
- medicines to treat infections, such as cefixime, cefuroxime, cefaclor, cephalexin, cefadroxil, cefpodoxime proxetil, kanamycin, neomycin, gentamicin, amikacin or tobramycin
- containing platinum, such as cisplatin (a medicine to treat cancer)
- lithium , a drug to treat depression
- theophylline, a medicine to treat asthma
- some medicines used for muscle relaxation, the names of whose active ingredients end in “-curonium” or “-curium”
- all medications for treating constipation
- cortisone-containing medications , such as hydrocortisone, prednisone, or prednisolone
- cholestyramine , a medicine to lower blood lipid levels
- adrenaline or noradrenaline , medicines to increase blood pressure
- warfarin , a medicine to treat blood clots
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
- Pregnancy
During pregnancy, take Torazidex only if your doctor says it is absolutely necessary . In this case , the lowest possible dose should be used.
- Breastfeeding
Torazidex should not be used in women who are breastfeeding as it may harm the baby.
Driving and using machines
When taking Torazidex, dizziness or drowsiness may occur, especially at the beginning of treatment, when increasing the dose, when switching to the drug, when starting to take an additional drug or when using alcohol simultaneously. If your attention is impaired, do not drive or operate machinery.
Torazidex contains lactose
This medicine contains lactose, which is a type of sugar. 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 Torazidex
Always take Torazidex exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Torazidex 5 mg tablets
Treatment of high blood pressure
- ½ tablet once daily
If necessary, your doctor may increase the dose to 1 tablet once a day, at the earliest two months after starting treatment.
Treatment of swelling caused by increased fluid in the body (edema)
- 1 tablet once daily
If necessary, your doctor may gradually increase the dose to 4 tablets once a day.
Dividing the tablet:
The tablet can be divided into two equal doses.
Place the tablet on a hard, flat surface with the score line facing up. Press the middle of the tablet with your finger and it will split into two equal halves.
Torazidex 10 mg tablets
Treatment of swelling caused by increased fluid in the body (edema)
- ½ tablet once daily
If necessary, your doctor may gradually increase the dose to 2 tablets once a day.
Dividing the tablet:
The tablet can be divided into two equal doses.
Place the tablet on a hard, flat surface with the score line facing up. Press with your finger on the left and right sides of the single score line and the tablet will split into two equal halves.
Use in children and adolescents
There is insufficient experience with the use of torasemide in children and adolescents. For this reason, this medicine is not recommended for children and adolescents under 18 years of age.
Mildly impaired liver function
Your doctor will treat you with caution as the level of torasemide in your blood may increase.
Method of administration
Take the tablets every morning, regardless of meals, unchewed, with 100 ml of water, which is equal to half a glass.
Duration of treatment
It will be assessed by your supervising doctor. Torazidex can be administered for a long time for several years or until the excess fluid in the tissues disappears.
If you take more Torazidex than you should
Contact your doctor immediately.
Overdose may cause excessive water excretion (urine), drowsiness, confusion, weakness, dizziness, hypotension, circulatory collapse, and indigestion.
Always take all remaining tablets with you, as well as the box, as this will allow easier identification of the tablets.
If you forget to take Torazidex
Take the missed dose as soon as possible the same day or take the next dose at the normal time the next day. Do not take a double dose to make up for a missed dose.
If you stop taking Torazidex
Do not stop taking torasemide without your doctor's permission, as this may seriously harm you and reduce the therapeutic effect.
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.
Side effects may occur with the following frequencies:
Common : may affect up to 1 in 10 people
- disturbances in the amount of body water and mineral salts, especially when there is a limited salt intake
- increased concentration of alkaline substances in the body
- muscle cramps
- increased concentrations of uric acid, sugar and fats in the blood
- decreased levels of potassium and sodium in the blood
- decreased blood volume
- stomach and/or intestinal disorders such as loss of appetite, stomach pain, nausea (feeling sick), vomiting, diarrhoea, constipation
- increase in levels of certain liver enzymes, such as gamma-glutamyltransferase
- headache
- dizziness
- fatigue
- weakness
Uncommon: may affect up to 1 in 100 people
- increase in urea and creatinine concentrations in the blood
- dry mouth
- tingling or numbness in the hands and feet
- difficulty urinating (e.g. due to prostate hyperplasia)
Very rare: may affect up to 1 in 10,000 patients
- narrowing or constriction of blood vessels caused by thickening of the blood
- lower than normal blood pressure
- circulatory disorders, especially when standing up
- irregular heartbeat
- chest pain, a condition that often presents with severe chest pain
- heart attack
- seizures
- inflammation of the pancreas
- allergic reactions with itching and rash
- increased skin sensitivity to light
- severe skin reactions
- decrease in the number of red and white blood cells and platelets
- visual disturbances
- ringing or tinnitus in the ears
- hearing loss
Not known: frequency cannot be estimated from the available data
- insufficient blood flow to the brain
- confusion
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system to the Bulgarian Medicines Agency, 8 Damyan Gruev Str., 1303 Sofia, tel.: +35928903417, website: www.bda.bg. By reporting side effects, you can help to obtain more information on the safety of this medicine.
5. How to store Torazidex
Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.
Store below 25 °C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What Torazidex contains
- The active substance is torasemide.
Each tablet contains 5 mg.
Each tablet contains 10 mg torasemide.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate, corn starch, silica, colloidal anhydrous.
What Torazidex looks like and contents of the pack
5 mg tablets:
The Torazidex tablet is round, white to off-white with a score line.
10 mg tablets:
The Torazidex tablet is round, white to off-white with a dividing line in the form of a cross.
Types of packaging:
10, 14, 20, 28, 30, 50, 56, 100, 400 (20 x 20) tablets
Not all types of packaging can be released for sale.
Marketing Authorisation Holder
Sandoz dd
Verovškova 57, 1000 Ljubljana
Slovenia
Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
Lek SA
50C Domaniewska str., 02-672 Warsawa
Poland
Lek SA
ul. Podlipie 16, 95-010 Strykow
Poland
This medicinal product is authorised for use in the Member States of the EEA under the following names:
Belgium Torasemide Sandoz 5 mg tabletten
Torasemide Sandoz 10 mg tablets
Bulgaria Torazidex 5 mg tablets
Torazidex 10 mg tablets
Germany Torasemid Sandoz 5 mg tabletten
Torasemid Sandoz 10 mg tablets
Sweden Torahexal 5 mg tablet
Torahexal 10 mg tablet
Estonia Torasemide Hexal 10 mg
Italy Torasemide Hexal 10 mg compresse
Lithuania Toridium 10 mg tablets
Latvia Torasemide Hexal 10 mg tablets
Date the leaflet was last revised
MM/YYYY
