40 mg tablets
furosemide
1. What Furosemide Hexal is and what it is used for
Furosemide Hexal is used to treat:
- swelling caused by fluid accumulation in tissue is, in patients with
- heart disease
- liver disease
- kidney disease.
This also includes a kidney disease with extensive protein loss, elevated fat levels, and swelling due to fluid retention. If you have this specific kidney disease, it should be treated in the first place.
- swelling of the lungs due to fluid retention
- high blood pressure
Furosemide Hexal is a diuretic, ie. a drug that increases urinary excretion.
Furosemide contained in Furosemide Hexal may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Furosemide Hexal
Do not take Furosemide Hexal if you
- is allergic to
- furosemide
- medicines with a chemical structure similar to furosemide, so-called sulfonamides, which are used against bacterial infections, diabetes, increased pressure in the eyes, or increase urine
- or any of the other ingredients of this medicine (listed in section 6).
- have a renal failure with insufficient urine production, which does not respond to treatment with furosemide.
- have a serious liver disease that affects brain function.
- has greatly reduced potassium or sodium levels in the blood.
- has decreased blood volume or is dehydrated.
If either of these conditions occurs during treatment, your doctor may stop treatment with Furosemide Hexal and treat them.
- Ammar.
Warnings and cautions
Talk to your doctor or pharmacist before taking Furosemide Hexal if any of the following apply to you:
- Low blood pressure
- Diabetes. Undetected diabetes may become apparent. Regular blood sugar checks are recommended.
- Gout. Regular checks of uric acid levels are recommended.
- Problems with urine flow e.g. due to prostate enlargement, or decreased urine output. Your doctor will closely monitor your urine output.
- The decreased protein level in the blood. Your doctor will prescribe dose one of Furosemide Hexal carefully.
- Renal impairment also applies to patients with liver disease, called a hepatorenal syndrome. Your doctor may need to change the dose of Furosemide Hexal.
- Exposure to high blood pressure (if, for example, you have a disease of the blood vessels in the brain or heart disease).
- Premature babies. Your doctor will check your kidney function. This is because kidney stones can form. Specialist care is required during the first weeks of life for premature babies with certain breathing difficulties.
- If you are elderly, if you are taking other medicines that can lower your blood pressure or if you have other medical conditions that carry a risk of lowering your blood pressure.
- Risk of low mineral content or abnormal changes in the body’s acid-base balance, which can occur if you have lost a lot of water due to vomiting, diarrhea, or heavy sweating, have other diseases (liver or heart disease), or use other medicines (See section “Other medicines and Furosemide Hexal ”).In general, your doctor will regularly check your blood for minerals, uric acid, glucose, and creatinine, and especially for high-risk patients and long-term treatment. Disorders in the number of minerals and the acid-base balance must be corrected. Your doctor may temporarily stop treatment with Furosemide Hexal.
- Long-term treatment with Furosemide Hexal. Potassium-rich diets are recommended, e.g. potatoes, bananas, tomatoes, spinach, and dried fruit. Sometimes your doctor may recommend that you also take potassium-containing medicines, or replace Furosemide Hexal with a suitable alternative.
- An inflammatory disease that causes joint pain, rash, and fever (systemic lupus erythematosus). The disease may worsen or break out.
- Use of other medicines. See section 2 “Other medicines and Furosemide Hexal”.
Other medicines and Furosemide Hexal
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 Furosemide Hexal:
- Medicines for inflammation and pain, e.g. acetylsalicylic acid and indomethacin.
- Drugs to strengthen the heart’s pumping ability, e.g. digitoxin, digoxin, and methyldigoxin.
- Drugs that can cause a certain type of abnormal heartbeat, so-called QT prolongation, e.g.
- terfenadine, a medicament against allergy s
- some medicines for an irregular heartbeat.
- Medicines for infection, e.g.
- drugs with an active substance whose name begins with “cef”
- kanamycin, gentamycin, tobramycin
- polymyxin.
- Other medicines that can damage your hearing.
- Medicines for high blood pressure, e.g.
- other drugs that increase urine output
- drugs with an active substance whose name ends with “pril”. Your doctor may need to reduce your dose or stop treatment with Furosemide Hexal temporarily.
- drugs with an active substance whose name ends with “sartan”.
- other medicines that lower blood pressure et.
- Lithium, a drug for depression and mental illness. Your doctor will monitor your blood lithium levels carefully.
- Risperidone, a medicine for mental illness. Your doctor will make a very careful assessment of the risks and benefits of concomitant treatment with Furosemide Hexal. This is especially true for elderly patients with dementia.
- Chloral hydrate, a drug for sleep disorders. Avoid using Furosemide Hexal if you are taking chloral hydrate.
- Sucralfate, a medicine for ulcers in the stomach and intestines. There must be at least 2 hours between the intake of Furosemide Hexal and sucralfate.
- Medicines for diabetes.
- Medicines to raise blood pressure and increase heart rate in certain shock conditions, e.g. adrenaline and noradrenaline.
- Theophylline, a drug for asthma and other respiratory problems.
- Some muscle relaxants with active substances whose names end in “curonium” or “curium”.
- Cisplatin, an anti-cancer drug. Your doctor will prescribe the lowest possible dose of Furosemide Hexal and a positive fluid balance is recommended.
- Phenytoin, a drug for epilepsy and certain pain conditions.
- Carbamazepine, a medicine for epilepsy, certain pain conditions, and stages of elation/depression.
- Aminoglutethimide, a drug for breast cancer and Cushing’s syndrome, manifests as a round, moon-shaped face.
- Corticosteroid s, drugs for inflammation or to prevent rejection of transplanted organs, such as cortisone.
- Carbenoxolone, a drug for ulcers and inflammation of the esophagus.
- Medicines for constipation.
- Probenecid, a medicine for gout.
- Methotrexate, a medicine for severe joint inflammation, cancer, and psoriasis.
- Ciclosporin, a drug to prevent graft rejection and to treat severe skin diseases and severe eye and joint inflammation.
- Contrast agents, drugs used in X-rays of internal organs or blood vessels.
Furosemide Hexal with food
Avoid eating large amounts of licorice while taking Furosemide Hexal.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- PregnancyOnly takes Furosemide Hexal during pregnancy if your doctor thinks it is necessary. If Furosemide Hexal is used during pregnancy, your doctor will closely monitor it
- mineral holder
- the percentage of blood cells in the blood
- the growth of your unborn child.
- Breast-feeding you should not take Furosemide Hexal if you are breast-feeding.
Driving and using machines
Furosemide Hexal may cause side effects that may impair the ability to drive and use machines, especially at the beginning of treatment and when increasing the dose. If you feel that your attention span is impaired, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Furosemide Hexal contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Furosemide Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to take Furosemide Hexal
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Take the tablets at least half an hour before a meal, with a glass of water.
The tablet can be divided into two equal doses.
Your doctor will adjust the dose just for you until an effective dose is reached.
The recommended dose for adults and the elderly are:
Swelling due to fluid accumulation in tissue are
- Starting dose:
- ½ to 1 tablet for patients with heart or liver disease
- 1 tablet for patients with kidney disease.
If the treatment does not give satisfactory results, your doctor may recommend that you take up to 2 tablets after 6 hours. After a further 6 hours, an extra dose of 4 tablets can be taken if the result is still not satisfactory. Patients with renal impairment may need a higher dose.
- Maintenance dose: 1 to 2 tablets daily.
High blood pressure
- Usual dose: 1 tablet once daily. In severe cases, your doctor may increase the dose by one to 1 tablet daily. Your doctor will prescribe additional medicines to lower your blood pressure if the treatment results are not satisfactory.
Use for children under 18 years
- Starting dose: calculated by the doctor and based on the child’s body weight. When at least 6-8 hours have passed, the doctor may increase the dose if the treatment with the previous dose has not given the desired result.
- Max dose: 1 tablet daily.
Hepatic impairment
Your doctor may adjust your dose if your liver function is moderately or severely impaired. See also section 2, “Do not take Furosemide Hexal”, the third item on the list.
Impaired renal function
Your doctor may need to adjust dose one.
Duration of treatment
Determined by the attending physician.
If you take more Furosemide Hexal then you should
Contact a doctor or pharmacist immediately for appropriate treatment.
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to take Furosemide Hexal
Take the missed dose on the same day as soon as you remember, or take the next dose, as usual, the next day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Furosemide Hexal
Do not stop taking Furosemide Hexal without your doctor’s permission. It can seriously injure you and reduce the effect of the treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately or see the nearest emergency department if you get any of the following serious side effects:
- Severe allergic reaction. Signs may include hives, swelling of the face, lips, tongue,e or throat, difficulty breathing, cold sweaty skin, pale skin,n and rapid heartbeat (rare: may affect up to 1 in 1,000 people).
- Severe abdominal pain or back pain. It can be a sign of pancreatitis (very rare: may affect up to 1 in 10,000 people).
- Increased tendency to get bruises (less common: may occur in up to 1 in 100 users), more infection than usual, sudden high fever, very sore throat and mouth sores (rare: may occur in up to 1 in 1,000 users), an unusual feeling of weakness or tiredness, pale skin, shortness of breath, dark urine (very rare: may affect up to 1 in 10,000 users). This may be a sign of a low number of different types of blood cells.
- Increased thirst, headache, dizziness or dizziness, fainting, confusion, muscle or joint pain or feeling weak, cramps or spasms, indigestion, or irregular heartbeat. This can be a sign of dehydration or disturbances in the body’s normal amount of minerals (very common: may occur in more than 1 in 10 users).
- Yellowish skin or yellowish eyes and dark brown urine. This may be a sign of liver problems (very rare: may affect up to 1 in 10,000 people). For patients who already have liver problems, a more serious liver problem that affects brain function can occur (it is called liver encephalopathy). Symptoms include forgetfulness, seizures, mood swings, and coma (common: may affect up to 1 in 10 people).
- Extensive skin rash, blistering or flaking skin around lips, eyes, mouth, nose, genitals, or other parts of the body, flu-like symptoms, and fever. This may be a sign of a severe skin reaction (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [DRESS], or acute generalized exanthematous pustulosis [AGEP]) (occurs in an unknown number of users ).
- Unexplained muscle aches, soreness, or weakness. This may be a sign of severe muscle breakdown (occurs in an unknown number of users).
- Lack of urination (low urine output), nausea, fatigue, pain in the side (flank pain), swollen legs, or blood in the urine. This may be a sign of kidney problems (occurs in an unknown number of users).
Other side effects may occur with the following frequencies:
Very common (may affect more than 1 user in 10):
- decreased blood volume
- increased concentration of triglycerides (a fatty substance) in the blood
- lower blood pressure than normal
- circulation problems, especially when getting up. These circulatory problems can also mean circulatory collapse.
- increased creatinine levels in the blood
Common (may affect up to 1 in 10 people):
- increased concentration of blood cells is due to fluid loss
- decreased levels of potassium, sodium, and chloride in the blood
- increased level of uric acid in the blood, gout
- increased concentration of cholesterol (a fatty substance) in the blood
- increased urine output
Uncommon (may affect up to 1 in 100 people):
- higher blood sugar level
- hearing problems, usually transient and especially in patients with impaired renal function or low protein content in the blood
- deafness (sometimes irreversible )
- nausea
- itching
- hives, skin rash
- allergic reactions in the skin and mucous membranes
- dermatitis
- severe inflammation of the skin and mucous membranes, with signs such as blistering and fever (bullous erythema multiforme, bullous pemphigoid, exfoliative dermatitis )
- red or purple spots on the skin
- increased photosensitivity
Rare (may affect up to 1 in 1,000 people):
- emotional disorders such as ant crawling, tingling, burning sensation, or numbness
- inflammation of the blood vessels
- vomiting, diarrhea
- ringing or wheezing in the ears
- nephritis affects the fluid surrounding the kidney ducts
- fever
- increased number of a certain type of white blood cell called eosinophilic granulocyte s
Very rare (may affect up to 1 in 10,000 people):
- increase of some liver enzymes called transaminase s
Has been reported (occurs in an unknown number of users):
- lower calcium or magnesium levels in the blood
- too high pH (alkaline), saline loss, and low blood pressure due to kidney disease (pseudo-Bartter syndrome), associated with misuse and/or long-term use of this medicine
- a blood clot that can clog a blood vessel
- dizziness, fainting, and unconsciousness (caused by low blood pressure ), headache
- increased sodium or chloride content in the urine
- increased level of urea in the blood
- urination problems may develop into acute urinary retention (inability to empty the bladder)
- storage of calcium salts in the vessels and tissues of the kidneys and/or urinary stones in the kidneys of premature babies
- the increased risk that the blood vessel connecting the pulmonary artery and aortic arch will not close if this medicine is given to premature babies during the first weeks of life
- exacerbation or outbreak of an inflammatory disease that causes joint pain, rash, and fever (systemic lupus erythematosus).
5. How to store Furosemide Hexal
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, carton, and jar after EXP. or EXP. The expiration date is the last day of the specified month.
Blister
Store the blister in the outer carton. Sensitive to light.
Can
No special storage instructions.
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. Each tablet contains 40 mg of furosemide.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate, corn starch, and sodium starch glycolate.
What the medicine looks like and the contents of the pack
Furosemide Hexal tablets are round, white, slightly curved, and with a scoreline on one side.
The tablets are packed in polypropylene/aluminum blisters in a carton, or packed in a can of HDPE.
Blisters: 10, 12, 14, 20, 28, 30, 50, 56, 60, 84, 100 or 250 tablets.
Jar: 100 or 250 tablets
Not all pack sizes or pack types may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto von Guericke Allee 1, 39179 Barleben, Germany