Trigrim 10 mg. 30 tablets

1. What Trigrim is and what it is used for
Trigrim contains a medicine called torasemide. It belongs to a group of medicines called diuretics or 'water tablets'*.

Trigrim 5 mg tablets are used to treat high blood pressure (hypertension).

Trigrim 5 mg and 10 mg tablets are used to treat and prevent swelling caused by excess fluid in the body (oedema) and effusions due to heart failure.

The tablets work by causing more water to be excreted (urine).

Trigrim is indicated for use in adults.

2. What you need to know before you take Trigrim
Do not take Trigrim if:

you are allergic to torasemide or any of the other ingredients of this medicine (listed in section 6);

you are being treated for diabetes (high blood sugar). These medicines are called 'sulfonylureas' and include chlorpropamide, glibenclamide, glipizide and tolbutamide; have kidney problems with no urine (anuria);
have severe liver problems (hepatic coma or hepatic precoma);
have low blood pressure (hypotension);
have reduced blood volume (hypovolemia);
have low levels of sodium or potassium in the blood (detected by a blood test);
have difficulty urinating, including prostate enlargement;
are breast-feeding. See section “Pregnancy and breast-feeding”.
Do not take Trigrim if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Trigrim.

Warnings and precautions
Talk to your doctor or pharmacist before taking Trigrim.

Talk to your doctor or pharmacist before taking Trigrim if:

you have gout (uric acid crystals in the joints);
you have severe heart rhythm disturbances (cardiac arrhythmia);
you have severe changes in the body's acid-base balance;
you are taking antibiotics called "aminoglycosides" or "cephalosporins" (used to treat infections) or lithium (used to treat mental problems);
you have changes in your blood count (thrombocytopenia or anemia in patients without kidney failure);
you have impaired kidney function caused by taking medicines.
Your doctor may check your kidney function, blood pressure, glucose, uric acid, creatinine, lipids and the amount of electrolytes (e.g. potassium) at regular intervals. See also "Do not take Trigrim".

Trigrim may cause a false positive doping test.

Children and adolescents
Trigrim is not recommended for children and adolescents under 18 years of age.

Other medicines and Trigrim
Talk to your doctor if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change the dose of the medicines you are taking or take other measures. In some cases, you may need to stop taking a medicine. This applies especially to the medicines listed below if taken at the same time as Trigrim:

It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:

Other medicines to treat high blood pressure.

ACE inhibitors (to treat heart disease).

Medications such as digoxin or digitoxin (to treat heart disease).

Medications to treat diabetes. Probenecid (to treat gout).

Non-steroidal anti-inflammatory drugs (NSAIDs). These include indomethacin and ibuprofen.

Aminoglycoside antibiotics (kanamycin, gentamicin, tobramycin) or cephalosporins, to treat infections.

High doses of salicylates, such as aspirin.

Theophylline (to treat asthma).

Laxatives.
Adrenaline (epinephrine) or noradrenaline (norepinephrine). Used to treat low blood pressure.
Cholestyramine or other "ion exchange resins" (for high blood cholesterol levels).
Steroid medicines such as hydrocortisone, prednisolone and dexamethasone.
Muscle relaxants (muscle relaxants).
Cisplatin (for cancer).
Lithium (for mental health problems).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.

Do not take Trigrim if you are pregnant, think you may be pregnant or are breast-feeding, as it is not known how Trigrim will affect your baby.

Driving and using machines
You may feel dizzy when taking Trigrim. If this happens, do not drive or use machines.

Trigrim contains lactose (a type of sugar)

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

3. How to take Trigrim

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

Essential hypertension

The recommended dose is 2.5 mg torasemide daily (half a 5 mg tablet). The blood pressure lowering effect begins during the first week of treatment and reaches its maximum with
ice for about 12 weeks.
If blood pressure is not normalised after 12 weeks of treatment with half a 5 mg tablet daily, the dose may be increased to one 5 mg tablet of Trigrim daily. The dose should not be increased further to 1 tablet of Trigrim 5 mg daily, as this will not lead to a greater reduction in blood pressure.

Water retention (oedema) and/or effusion due to heart failure
The recommended dose is 5 mg of torasemide daily. This is usually the maintenance dose. Your doctor may increase the dose to 10 mg daily if necessary. Depending on the severity of the disease, the dose may be increased to 20 mg of torasemide.

If you take more Trigrim than you should
If you accidentally take too many tablets, contact a doctor immediately or go to the nearest emergency department. Your blood pressure may drop and your pulse may increase.
Low heart rate, dizziness, decreased kidney function including kidney failure, severe prolonged low blood pressure including shock and death have also been reported.

If you forget to take Trigrim
If you forget to take a dose, take it as soon as you remember and continue taking it as before. If you have missed a dose for the day, take your usual dose the next day.

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

If you stop taking Trigrim
It is important to take Trigrim every day until your doctor tells you otherwise. If you think the effect of Trigrim is too strong or too weak, talk to your doctor or pharmacist.

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.

If you experience any of the following symptoms, seek medical attention immediately:

swelling of the face, tongue or throat
difficulty swallowing
hives or difficulty breathing
These side effects are very rare (may affect less than 1 in 10,000 people) but are extremely serious and patients should stop taking the medicine and see a doctor immediately.
Other side effects that may occur are:
Common (may affect up to 1 in 10 people):
metabolic alkalosis;
muscle cramps (especially at the start of treatment);
increased levels of certain substances in the blood, including sugar, uric acid and fats (lipids);
potassium deficiency (hypokalaemia) in combination with a diet low in potassium, vomiting, diarrhoea, use of high doses of laxatives and in patients with chronic liver function disorders;
fluid and electrolyte imbalance (e.g. hypovolaemia, hyponatraemia);
gastrointestinal disturbances (e.g. loss of appetite, stomach pain, nausea, vomiting, diarrhoea, constipation) especially at the start of treatment;
increased levels of certain liver enzymes (gamma-glutamyltransferase) in the blood;
headache, dizziness, tiredness, weakness (especially at the start of treatment).
Uncommon (may affect up to 1 in 100 people):
increased blood creatinine and urea levels;
urinary retention, dilatation of the bladder;
dry mouth;
abnormal skin sensations such as tingling, prickling, burning (paraesthesia).
Very rare (may affect up to 1 in 10,000 people):
thrombocytopenia, leukopenia, anaemia;
allergic skin reactions (pruritus, exanthema), sensitivity to light;
thromboembolic complications, confusional states;
low blood pressure (hypotension);
cerebral ischaemia;
arrhythmias, acute myocardial infarction, myocardial ischaemia, angina pectoris, syncope;
inflammation of the pancreas causing abdominal pain (pancreatitis);
visual disturbances;
tinnitus, hearing loss.
Your doctor may do blood tests from time to time to make sure that Trigrim is working safely.

If any of these side effects become serious or bothersome, or if you notice any effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects
If you get any side effects, tell your doctor or pharmacist
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Trigrim
Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. 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 need. These measures will help protect the environment.

6. Contents of the pack and other information
What Trigrim contains
The active substance is torasemide.
Each tablet contains 5 mg or 10 mg torasemide.

Excipients: lactose monohydrate, corn starch, anhydrous colloidal silicon dioxide, magnesium stearate.
What Trigrim looks like and contents of the pack
Trigrim 5 mg are white or almost white, round, flat tablets, with a score line, with a diameter of 7.0 mm ± 1 mm.

Trigrim 10 mg are white or almost white, round, flat tablets, with a score line, with a diameter of 9.0 mm ± 1 mm.

Trigrim are available in a cardboard box containing 30 tablets in PVC/Al blisters.

 

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