Fluss

Package leaflet: Information for the patient

Fluss 40 mg + 25 mg tablets

furosemide + triamterene
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Fluss is and what it is used for

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

• Furosemide is a diuretic, a medicine that works by increasing the amount of urine excreted by the kidneys.
• Triamterene is a potassium-sparing diuretic; it works by preventing the loss of potassium from the blood, thereby reducing the risk of potassium deficiency in the blood caused by the use of furosemide.

Fluss is indicated in adults for the following conditions:

• Fluid accumulation in the body ( edema ) due to heart and blood vessel disease (cardiocirculatory insufficiency), including cases resistant to treatment with medicines acting on the heart (cardiotonics)
• Fluid accumulation in the abdomen ( ascites ) due to liver disease (hepatic cirrhosis) or heart disease (congestive heart failure)
• All conditions involving water and salt retention ( hydro-saline retention ), especially when associated with a disease causing increased production of aldosterone, a hormone secreted by a gland in our body called the adrenal gland (hyperaldosteronism)
• High blood pressure ( hypertension ) as adjunctive therapy.

2. What you should 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 have high levels of potassium in the blood (hyperkalemia)
• if you have progressive deterioration of kidney function
• if you have reduced urine production (anuria)
• if you have reduced levels of electrolytes (salts normally dissolved in blood and body fluids)
• if you have severe liver disease (hepatic cirrhosis) causing numbness and weakness (pre-comatose state).

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

• you suffer from electrolyte imbalance (salts normally dissolved in blood and body fluids)
• you have high blood sugar levels (diabetes); your doctor will perform periodic checks of glucose in urine (glycosuria), blood sugar (glycemia), and electrolyte balance
• you have severe heart disease (heart failure); your doctor will regularly monitor your electrolyte balance
• you have reduced kidney function, even mild; your doctor will regularly monitor your electroly游戏副本

3. How to take Fluss

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Fluss tablets orally with half a glass of water, preferably one hour before eating, as concomitant food intake may reduce the absorption of the medicine.

The recommended dose in adults varies depending on the individual patient's condition:

• in cases of mild fluid retention: 1 tablet daily or on alternate days
• in patients with fluid accumulation in the abdomen (ascites) or marked fluid accumulation in the body (edema): 1–2 tablets daily or on alternate days
• in the treatment of severe fluid retention (for example, in chronic circulatory failure and cardiac asthma): 2–4 tablets twice a week
• in supportive treatment of high blood pressure (hypertension): 1 tablet daily or on alternate days

Patients with severe liver disease (hepatic insufficiency):
If you suffer from severe liver disease, your doctor will advise starting Fluss treatment at the lowest dose and will closely monitor your electrolyte concentrations (salts normally dissolved in blood and body fluids).

Use in children and adolescents
This medicine is not recommended for use in children and adolescents.

If you take more Fluss than you should
If you take an excessive dose of Fluss, contact your doctor immediately or go to the nearest hospital, where appropriate treatment will be provided.
Symptoms of overdose may include:

• increased urine output
• excretion of sodium in urine (natriuresis)
• reduction in circulating blood volume (hypovolemia)
• low blood pressure

In case of overdose, your doctor will assess the most appropriate therapy.

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

If you stop taking Fluss
If you have any questions about using 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
• decrease in blood sodium (hyponatremia)
• decrease in blood acids (hypochloremic metabolic alkalosis)
• reduction in blood pressure
• decrease in blood potassium (hypokalemia)
• decrease in blood calcium (hypocalcemia)
• decrease in blood magnesium (hypomagnesemia)
• nausea, vomiting
• diarrhea
• increase in blood potassium (hyperkalemia)

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

• impaired glucose tolerance (due to hypokalemia)
• high levels of uric acid in the blood (hyperuricemia)
• inflammatory joint disease (gout)
• reduction in HDL cholesterol
• increase in LDL cholesterol
• increase in triglycerides
• fatigue
• headache (cephalalgia)
• dizziness
• tingling sensations (paresthesia)
• agitation
• visual disturbances
• changes in heart rhythm (cardiac arrhythmias)
• reduction in circulating blood volume (hypovolemia)
• dry mouth
• intestinal motility disorders
• muscle cramps
• reduced volume of excreted urine
• urinary incontinence
• urinary obstruction (in patients with prostatic hypertrophy)
• skin rash
• increased creatinine in the blood
• transient reduced kidney function (renal impairment)

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

• reduction in certain blood cells due to bone marrow failure (bone marrow depression)
• disease due to insufficient production of blood cells (aplastic anemia)
• blood disorder (agranulocytosis)
• reduction in the number of platelets in the blood (thrombocytopenia)
• disease due to destruction of certain blood cells, red blood cells (hemolytic anemia)
• sensation of ringing in the ears (tinnitus)
• irreversible hearing loss (especially after prolonged high-dose use of furosemide)
• inflammation of blood vessels (vasculitis)
• inflammatory kidney disease (interstitial nephritis)
• inflammation of the pancreas (pancreatitis)
• difficulty in bile flow from the liver to the intestine (cholestasis)
• appearance of red or white wheals of various sizes (urticaria)
• purpura
• appearance of target-like bright red lesions (erythema multiforme)
• skin irritation with loss of the upper skin layer (exfoliative dermatitis)
• photosensitivity reactions (reactions to light exposure)
• kidney stones (nephrocalcinosis)
• reduced kidney function (interstitial nephritis)
• urinary tract stones (urinary calculi)
• reduced kidney ability to perform its functions (acute renal failure)
• fever
• reduction in hemoglobin levels in the blood due to decreased red blood cell formation (megaloblastic anemia)
• reduction in the number of all blood cells (pancytopenia)
• chronic formation of blisters on skin exposed to sunlight (pseudoporphyria)
• allergic reaction called serum sickness, characterized by skin rashes, joint pain, fever, swollen lymph nodes, and decreased blood pressure

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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 stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fluss contains

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

Description of the appearance of Fluss and contents of the pack
Pack containing 20 tablets in PVC/aluminum blisters
Marketing Authorization Holder
ACARPIA FARMACEUTICI S.r.l.
Viale L. Majno, 18
20129 Milano (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)