FLUSS 40 mg/25 mg Коированная Таблетка

Содержание инструкции

1. Fluss 40 mg + 25 mg tablets
   1. What is Fluss and what is it for
   2. What you need to know before taking Fluss
   3. How to take Fluss
   4. Possible side effects
   5. How to store Fluss
   6. Contents of the pack and other information

Fluss 40 mg + 25 mg tablets

furosemide + triamterene

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Fluss is and what it is used for
• 2. What you need to know before you take Fluss
• 3. How to take Fluss
• 4. Possible side effects
• 5. How to store Fluss
• 6. Contents of the pack and other information

1. What is Fluss and what is it for

Fluss is a combination of two active ingredients, furosemide and triamterene:

• furosemideis a diuretic, a medicine that works by increasing the amount of urine eliminated by the kidneys
• triamtereneis a potassium-sparing diuretic, it works by preventing the elimination of potassium from the blood and thus reducing the risk of potassium deficiency in the blood induced by the use of furosemide.

Fluss is indicated in adultsin cases of:

• fluid accumulation in the body (edema) due to heart and blood vessel disease (cardiocirculatory insufficiency), even if resistant to treatment with medicines that act on the heart (cardiac kinetic agents)
• fluid accumulation in the abdomen (ascites) due to liver disease (hepatic cirrhosis) or heart disease (congestive heart failure)
• all conditions of water and salt retention (fluid-salt retention), especially if accompanied by a disease that causes an increase in the production of aldosterone, a hormone secreted by a gland in our body called the adrenal gland (hyperaldosteronism)
• high blood pressure (hypertension) as supportive therapy.

2. What you need to know before taking Fluss

Do not take Fluss

• if you are allergic to furosemide, triamterene or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from high levels of potassium in the blood (hyperkalaemia)
• if you suffer from progressive deterioration of kidney function
• if you suffer from reduced urine production (anuria)
• if you suffer from reduction of electrolytes (salts normally dissolved in the blood and body fluids)
• if you suffer from a severe liver disease (hepatic cirrhosis) that causes numbness and weakness (precomatose state).

Warnings and precautions
Talk to your doctor before taking Fluss.
In particular, talk to your doctor if:

• you suffer from electrolyte imbalance (salts normally dissolved in the blood and body fluids)
• you suffer from high blood sugar levels (diabetes), your doctor will perform periodic checks of glycosuria (sugar in the urine), glycaemia (sugar in the blood) and electrolyte balance
• you suffer from a severe heart condition (heart failure), your doctor will regularly check your electrolyte balance
• you suffer from reduced kidney function, even mild, your doctor will regularly check your electrolyte balance
• you suffer from reduced liver function or alcoholic cirrhosis (liver disease caused by alcohol abuse) as you may experience a decrease in potassium and magnesium in the blood, so your doctor may ask you to undergo appropriate tests
• you suffer from fluid buildup in the lungs (pulmonary edema) following a heart attack, in these cases the doctor will monitor you to avoid low blood pressure and reduced blood flow to the body
• you suffer from severe liver diseases (such as hepatic coma)
• you suffer from folic acid deficiency (vitamin B9) (e.g. you suffer from a liver disease called hepatic cirrhosis) as you may develop megaloblastic anaemia (disease due to difficulty in the formation of blood cells). The doctor will perform the necessary checks and, if deemed necessary, may administer vitamin B9
• you suffer from obstruction of urine flow (such as in prostatic hypertrophy) forced diuresis can cause urinary retention. In these cases your doctor will ask you to check the amount of urine produced
• you smoke tobacco (as it contains nicotine) as this may reduce the effect of the medicine (see section “Other medicines and Fluss”).

Triamterene may cause a bluish discoloration of the urine.

Elderly patients:
If you are elderly, your doctor will ask you to undergo regular tests to assess the
electrolyte balance (salts normally dissolved in the blood and body fluids) and
creatinine.
No dose adjustment is necessary unless you suffer from reduced kidney or
liver function (renal or hepatic insufficiency).

For athletes:
The use of the drug without therapeutic necessity constitutes doping and may still
result in a positive doping test.

Weight loss:
During treatment with this medicine, make sure you do not lose more than 1 kg per day to avoid
dehydration; especially pay attention if you suffer from reduced liver function (hepatic insufficiency) and fluid buildup in the abdomen (ascites).

Children and adolescents
It is not indicated for use in children and adolescents as safety and efficacy have not been
established in this patient group.

Other medicines and Fluss
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor if you are taking:

• medicines to lower blood pressure(such as ACE inhibitors, angiotensin receptor antagonists, beta-blockers, calcium antagonists, diuretics, nitrates) as they may lower blood pressure excessively
• diuretics(medicines that act by increasing the amount of urine produced by the kidneys) as they may worsen sodium deficiency in the blood
• potassium-sparing diuretics(such as amiloride and spironolactone) which may lead to an excessive increase in potassium in the blood
• loop diureticsand thiazide diureticswhich may worsen potassium deficiency in the blood
• carbamazepine(medicine used in the treatment of epilepsy) and diureticsas they may worsen sodium deficiency in the blood
• aminoglutethimide(medicine used in the treatment of Cushing's syndrome and breast cancer) as it may worsen sodium deficiency in the blood
• trimethoprim(an antibiotic) as it may worsen sodium deficiency in the blood
• corticosteroids(anti-inflammatory medicines) which may worsen potassium deficiency in the blood
• glycyrrhizin(contained in liquorice), as it may worsen potassium deficiency in the blood (see section “Fluss with food and beverages”)
• potassium salts, may cause high levels of potassium in the blood
• medicines used to lower blood pressure and treat heart failure(such as ACE inhibitors and angiotensin receptor antagonists) as they may cause high levels of potassium in the blood. The doctor may tell you to reduce the dose for these latter
• cyclosporineor tacrolimus(medicines used after organ transplantation) as they may cause high levels of potassium in the blood
• drospirenone(oral contraceptive), may cause high levels of potassium in the blood
• dipiridamole(medicine that inhibits platelet aggregation) as it may lower blood pressure excessively
• tizanidine(medicine used in the treatment of spasticity) as it may lower blood pressure excessively
• alprostadil(medicine used in the treatment of erectile dysfunction) as it may lower blood pressure excessively
• NSAIDs(non-steroidal anti-inflammatory drugs) this combination is not recommended, as these may reduce the hypotensive and diuretic effect and/or increase the risk of decreased kidney function
• amphotericin Bas this may worsen potassium deficiency in the blood or increase kidney toxicity
• probenecid(medicine to reduce uric acid in the blood), may lower blood pressure excessively and sodium elimination
• phenytoin(antiepileptic medicine) which may lower blood pressure excessively and sodium elimination
• cholestyramine(medicine to lower cholesterol) as this prevents the absorption of Fluss; therefore the doctor will advise you to take cholestyramine preferably 4-6 hours after the administration of Fluss
• aminoglycosides and cephalosporins(antibiotic medicines) as they may cause damage to the kidneys and inner ear
• cisplatin(anticancer medicine), may cause damage to the inner ear
• warfarin(anticoagulant medicine) as the association with Fluss may reduce the anticoagulant effect
• clofibrate(medicine that reduces cholesterol levels in the blood)
• hypoglycemic drugs, (to lower blood sugar levels) as their effectiveness may be reduced by the use of Fluss and therefore a dose adjustment may be necessary in case of concomitant use
• lithium(mood stabilizer), phenobarbital(anticonvulsant medicine) and amantadine(medicine used in Parkinson's disease) as Fluss may reduce the elimination of these medicines leading to toxic concentrations of these drugs
• muscle relaxants(medicines used to reduce muscle spasms) if potassium levels in the blood are reduced, their effect may be reduced
• digoxinand medicines that prolong the QT interval(such as amiodarone, sotalol, quinidine, chlorpromazine, terfenadine, erythromycin) as they may be affected by the electrolyte changes induced by FLUSS (e.g. hypokalaemia) and cause arrhythmias (irregular heartbeat)
• nicotine(contained in tobacco) as it may reduce the effect of Fluss

Fluss with food and beverages
As concomitant intake of food may reduce the absorption of Furosemide, it is recommended to
take this medicine on an empty stomach (see section 3 “How to take Fluss”).
Avoid consuming liquorice as it may worsen potassium deficiency in the blood.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine.

Pregnancy:
Do not take this medicine during pregnancy unless in case of absolute necessity, and under the
direct control of the doctor.

Breastfeeding:
Do not take this medicine if you are breastfeeding, if the use of the combination is considered
essential, it is advisable to stop breastfeeding.

Driving and operating machinery
Fluss can occasionally cause low blood pressure (hypotension), especially at the beginning
of therapy. This may manifest as dizziness or fainting. If this happens, it is advisable not to
drive vehicles or operate other machinery.

Fluss contains lactose
Fluss contains lactose (milk sugar). If your doctor has diagnosed you with lactose
intolerance, consult him before taking this medicine.

3. How to take Fluss

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Take the Fluss tablets orally with ½ glass of water, preferably one hour before
taking food as concomitant intake may reduce the absorption of the
medicine.
The recommended dosein adultsvaries according to the conditions of individual patients:

• in cases of mildfluid retention: 1 tablet per day or on alternate days
• in subjects with fluid accumulation in the abdomen (ascites) or significant fluid accumulation in the body (edema): 1-2 tablets per day or on alternate days
• in the treatment of severe fluid retention(such as in chronic circulatory failure and cardiac asthma): 2-4 tablets twice a week
• in supportive treatment of high blood pressure (hypertension): 1 tablet per day, or on alternate days

Patients with severe liver disease (hepatic insufficiency):
If you suffer from a severe liver disease, your doctor will advise you to start treatment with Fluss at the
lowest dosage and will carefully monitor the concentrations of electrolytes (salts normally
dissolved in the blood and body fluids).

Use in children and adolescents
The use of this medicine in children and adolescents is not indicated.

If you take more Fluss than you should
If you take an excessive dose of Fluss, seek immediate medical attention or go to the
nearest hospital, where they will provide you with appropriate care.
Symptoms of overdose may include:

• increased amount of urine eliminated
• elimination of sodium with urine (natriuresis)
• decreased blood volume (hypovolemia)
• reduction of blood pressure.

In case of taking an excessive dose of the medicine, the doctor will assess the most appropriate therapy.

If you forget to takeFluss
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Fluss
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Fluss you may experience the following side effects, listed by
frequency:

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

• dehydration
• decreased sodium in the blood (hyponatremia)
• decreased acids in the blood (hypochloremic metabolic alkalosis)
• reduction of blood pressure
• decreased potassium in the blood (hypokalaemia)
• decreased calcium in the blood (hypocalcaemia)
• decreased magnesium in the blood (hypomagnesaemia)
• nausea, vomiting
• diarrhoea
• increased potassium in the blood (hyperkalaemia)

Common (may affect up to 1 in 100 people):

• glucose intolerance (due to hypokalaemia)
• elevated uric acid in the blood (hyperuricaemia)
• inflammatory joint disease (gout)
• reduction of HDL cholesterol
• increased LDL cholesterol
• increased triglycerides
• fatigue
• headache
• dizziness
• tingling (paraesthesia)
• agitation
• vision changes
• irregular heartbeat (cardiac arrhythmias)
• decreased circulating blood volume (hypovolaemia)
• dry mouth
• intestinal motility disorders
• muscle cramps
• reduced urine output
• urinary incontinence
• urinary obstruction (in patients with prostatic hypertrophy)
• skin rash
• increased creatinine in the blood
• transient reduced kidney function (renal insufficiency)

Rare (may affect up to 1 in 1,000 people):

• reduction of a certain number of blood cells due to bone marrow failure (myelodepression)
• disease due to insufficient production of blood cells (aplastic anaemia)
• blood disease (agranulocytosis)
• decreased number of platelets in the blood (thrombocytopenia)
• disease due to the destruction of some blood cells, red blood cells (hemolytic anaemia)
• ringing in the ears (tinnitus)
• irreversible hearing loss (especially after prolonged use at high doses of furosemide)
• inflammation of blood vessels (vasculitis)
• inflammatory kidney disease (interstitial nephritis)
• inflammation of the pancreas (pancreatitis)
• difficulty of bile flow from the liver to the intestine (cholestasis)
• appearance of red or white wheals of various sizes (urticaria)
• purpura
• appearance of target-shaped lesions, bright red in colour (erythema multiforme)
• irritation with loss of the upper layer of the skin (exfoliative dermatitis)
• reactions to exposure to light (photosensitivity reactions)
• kidney stones (nephrocalcinosis)
• reduced kidney function (interstitial nephritis)
• urinary tract stones (urolithiasis)
• reduced ability of the kidney to perform its functions (acute renal failure)
• fever
• reduced amount of hemoglobin in the blood due to reduced formation of red blood cells (megaloblastic anaemia)
• reduced number of all cells present in the blood (pancytopenia)
• chronic blistering of the skin exposed to sunlight (pseudoporphyria)
• allergic reaction called serum sickness, which manifests with rashes, pain

in the joints, fever, swollen lymph nodes and decreased blood
pressure

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Fluss

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fluss contains

• The active ingredients are: furosemide 40 mg and triamterene 25 mg per tablet
• The other ingredients are: corn starch, lactose, magnesium stearate, talc.

Description of the appearance of Fluss and contents of the pack
Box containing 20 tablets in PVC/aluminium blisters

Marketing Authorisation Holder
ACARPIA FARMACEUTICI S.r.l.
Viale L. Majno, 18
20129 Milan (Italy)

Manufacturer
Vamfarma
Via John Fitzgerald Kennedy, 5
26833 Comazzo (LO)
Doppel Farmaceutici S.r.l.
Via Volturno, 48
20089 Quinto De' Stampi - Rozzano (MI)