10 mg/ml oral drops, solution
furosemide
1. What Impugan is and what it is used for
Furosemide acts directly on the kidneys, primarily by passing more sodium into the urine. A consequence of this is that more water is excreted and the number of urine increases. Impugan is a very fast-acting diuretic. The effect is often noticeable as early as 30 minutes after taking a dose. The diuretic effect depends on the size of the dose, and is maximal after 1-2 hours and subsides within about 4 hours.
The impugan also has a usually weak blood pressure-lowering effect that lasts longer than the diuretic effect.
The impugan is used for fluid retention ( edema ) due to impaired function of eg heart, lungs, kidneys or liver and high blood pressure.
2. What you need to know before using Impugan
Do not use Impugan
- if you are allergic to furosemide or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to substances similar to furosemide , such as certain medicines for diabetes or medicines for infection .
- if you have symptoms such as weakness, difficulty breathing and dizziness. This may be a sign of too little fluid in the body (dehydration).
- if you have severe liver or kidney damage.
Warnings and cautions
Talk to your doctor or pharmacist before taking Impugan:
- If you are older, if you are taking other medicines that can lower your blood pressure , or if you have any other illness that carries a risk of lowering your blood pressure .
You mustn’t make major changes to your eating habits and intake of salts, especially table salt (eg through fasting), without consulting a doctor.
Furosemide should be used with caution in infants due to the risk of kidney stones.
Other medicines and Impugan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant treatment with gentamicin ( antibiotic ) and other similar antibiotics ( aminoglycosides ) should be avoided.
The treatment effect may be affected if Impugan is taken at the same time as certain other medicines. These include cardiac medications ( digitalis glycosides, sotalol, or ACE inhibitors ), analgesics (non-steroidal anti-inflammatory drugs), lithium (used in manic-depressive illness), or other antihypertensive agents. The treating physician, therefore, needs to be aware of such concomitant medication.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is a risk that the fetus is affected. Therefore, always consult a doctor before using Impugan during pregnancy.
Breast-feeding
A breastfed baby may be affected. Do not use Impugan during lactation except on certain prescriptions from the doctor. Breastfeeding mothers should be aware that the amount of milk may decrease.
Driving and using machines
No known effect on the ability to drive or perform precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Impugan contains alcohol and sodium
The impugan contains alcohol
Impugan oral drops contain 9.8% ethanol (alcohol). At a normal dose for adults, 2-4 ml of Impugan oral drops, the ethanol content is 200-400 mg, which corresponds to up to 1 cl of beer or up to 0.4 cl of wine.
The impugan contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 24 ml, ie essentially ‘sodium-free.
3. How to use Impugan
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
The recommended dose for adults with edema or high blood pressure: 20-80 mg per day.
The recommended dose for children: 1-3 mg/kg body weight per day.
The drops can be mixed in lukewarm tea and cold milk, but acidic drinks such as juice and juice should be avoided.
If you use more Impugan than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Dizziness and fainting can be signs of overdose as well as troublesome side effects. See below.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Impugan and tell your doctor immediately if you get any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people)
- The impugan can affect the white blood cells so that the defense against infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat / pharynx / mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ) . It is important that you then inform about your medication.
- Intense skin rash including hives , severe itching , blisters, skin loosening and swelling of the skin and inflammation of the mucous membranes, or blisters and loosening of the top layer of the skin ( Stevens-Johnson syndrome , toxic epidermal necrolysis )
Has been reported (occurs in an unknown number of users)
- Red, scaly, widespread rash with nodules under the skin, blisters mainly in the folds of the skin, on the torso and arms together with fever, in connection with the start of treatment ( acute generalized exanthematous pustulosis , AGEP).
- Widespread rash, fever and enlarged lymph nodes (DRESS).
Other side effects that may occur:
Very common (may affect more than 1 user in 10)
- Kidney stones in infants
Common (may affect up to 1 in 10 people)
- Decreased potassium content in the blood, which can manifest itself in the form of muscle weakness.
- Reduced levels in the blood of e.g. sodium, magnesium , chlorine and calcium .
- Elevated uric acid content in the blood.
- Decreased blood volume due to reduced amount of fluid in the tissues . This is especially true for treatment with high doses and for long-term treatment.
Uncommon (may affect up to 1 in 100 people)
- Nausea and vomiting.
- Low blood pressure .
- Severe decrease in the number of blood cells , which can cause weakness, bruising and increased susceptibility to infection ( aplastic anemia ).
- Dehydration.
- Deafness (sometimes persistent).
Rare (may affect up to 1 in 1,000 people)
- Reduction of platelets , which may increase the risk of bleeding and bruising.
- Severe decrease in the number of white blood cells , which increases the susceptibility to infection.
- Inflammation of the blood vessels, often with skin rashes or red to purple discolorations of the skin.
- Liver effects that cause changes in blood tests.
- Rash, itching , red to purple skin discoloration.
- Red, scaly patches on the skin, hair loss or loosening of nails (called exfoliative dermatitis ).
- Circular, irregular red spots on the skin of the hands and arms (erythema multiforme).
- Skin reactions to sunlight.
- Increased blood sugar levels.
- Ringing in the ears, and hearing loss may occur during treatment with high doses .
Has been reported (occurs in an unknown number of users)
- Inflammation of the pancreas which can cause severe pain in the abdomen and back.
- Deterioration of renal impairment and inflammation .
- Liver effects.
- dizziness, fainting and unconsciousness (caused by low blood pressure )
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store the Impugan
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Used before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified 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. Contents of the packaging and other information
Content declaration
- The active substance is furosemide . 1 ml (milliliter) of Impugan contains 10 mg of furosemide .
- The other ingredients are saccharin sodium (sweetener), sodium hydroxide, ethanol (alcohol content 9.8%) and water.
What the medicine looks like and contents of the pack
Impugan appearance:
The oral drops are a colorless or slightly yellowish solution.
Pack sizes:
Bottle (30 ml) with graduated dose pipette
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma Troyan AD
1 Krayrechna Str
BG-5600 Troyan
Bulgaria