nogen Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diuresal Injection 10mg/ml

Furosemide

Read all of this leaflet carefully before you start

taking this medicine because it contains

important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor, pharmacist or nurse.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

*    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Diuresal Injection is and what it is used for

2.    What you need to know before you are given Diuresal Injection

3.    How Diuresal Injection is given to you

4.    Possible side effects

5.    How to store Diuresal Injection

6.    Contents of the pack and other information

1. WHAT DIURESAL INJECTION IS AND WHAT IT IS USED FOR

Diuresal belongs to a group of medicines called diuretics. Diuretics make you pass more water (urine).

Excess fluid can build up in certain conditions which affect the heart, lungs, kidneys or liver. It can also be used for mild to moderate high blood pressure as well as a condition in pregnancy called toxaemia where there is high blood pressure and protein in the urine.

Diuresal Injection is used to remove that fluid by making you pass more water. lt may also be used when your kidneys are not functioning properly and not producing normal amounts of urine.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DIURESAL INJECTION

You should not be given Diuresal Injection if

you:

*    Are hypersensitive (allergic) to furosemide, other sulphonamide related drugs or any of the other ingredients of Diuresal Injection (see section 6)

*    Have severe kidney failure

*    Have very low levels of potassium, sodium or other electrolytes in your blood (your doctor will be able to advise you)

*    Are not producing any urine

*    Have porphyria (an inherited condition causing skin blisters, abdominal pain and brain or nervous system disorders)

*    You have an altered level of consciousness and coma as a result of liver disease

*    Have Addisons disease (inadequate functioning of the adrenal gland)

*    Have severe dehydration (causing continuous dry mouth and thirst) or are ill from having lost a lot of body fluids

*    Have digitalis poisoning (feeling or being sick, high levels of potassium in the blood, slow, fast or irregular heart beats)

*    Are breastfeeding (see 'Pregnancy and breastfeeding section).

Warnings and precautions:

Make sure you doctor is aware of these situations,

before you are given this medicine if you:* Are elderly, if you are on other medications which cause the blood pressure to drop and if you have other medical conditions that are risks for the drop of blood pressure.

*    Have low blood volume (hypovolaemia)

*    Have low blood pressure (hypotension)

*    Have liver or kidney problems

*    Have diabetes. If you are taking insulin, your doctor may need to adjust your insulin dosage

*    Have had gout (severe joint pain)

*    Metabolic acidosis (too much acid in the body)

*    Prostate trouble or difficulty passing urine

*    Are an elderly patient with dementia and also taking risperidone

*    Are administering to a premature infant as there could be possible formation of kidney

stones

*    Are prone to low levels of sodium, potassium or other electrolytes in the blood and therefore regular blood tests will be carried out by your doctor to check this.

Your doctor may monitor you and take blood for testing while you are on this treatment.

Other medicines and Diuresal Injection:

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

In particular tell your doctor if you are taking any of the following:

*    Drugs to lower blood pressure, such as ACE inhibitors e.g ramipril, enalapril. Your doctor may need to change the dose or ask you to stop taking them

*    Medicines for high blood pressure or heart problems such as calcium channel blockers, beta blockers, clonidine, moxonidine, amiodarone

*    Non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin for pain

*    Digoxin used to treat heart failure

*    Alprostadil, moxisylyte used to treat erectile dysfunction (impotence)

*    Antidepressants tricyclics, monoamino oxidase inhibitors (MAOIs), reboxetine or phenothiozines, and anxiolytics eg barbiturates

*    Antifungals such as amphotericin if used for a long time

*    Medicines used as general anaesthetics and medicines for relaxing your muscles during surgery such as baclofen, tizanidine, tubocurarine

*    Carbamazepine to control epilepsy

*    Corticosteroids used to treat allergic reactions

*    Laxatives used over a long period of time e.g bisacodyl or senna

*    Other diuretics such as acetazolamide

*    Carbenoxolone, sucralfate to treat ulcers

*    Drugs for asthma such as theophylline, salbutamol, terbutaline

*    Antibiotics that affect your kidneys or ears (e.g gentamicin, neomycin) or high doses of cephalosporins

*    Lithium used for mental illnesses

*    Medicine to control diabetes such as insulin or glucocorticoid tablets

*    Liquorice often used in cough medicines if taken in large amounts

*    Risperidone used to treat schizophrenia

*    Phenytoin used for epilepsy

*    Cisplatin used for some cancers

*    Aminoglutethimide used for breast cancer

*    Ciclosporin used to stop rejection of organs after a transplant

*    Methotrexate used for cancers of the skin, joint or bowel

*    Probenecid used for treatment of gout

*    Medicines for Parkinsonism e.g levodopa

*    Medicines for kidney cancer e.g aldesleukin.

Pregnancy and breastfeeding:

Do not have Diuresal Injection if you are pregnant. Talk to your doctor before having this medicine if you are pregnant, might become pregnant or think you might be pregnant.

Do not breastfeed if you are being given Diuresal Injection. This is because small amounts may pass into the mother's milk. Talk to your doctor before having this medicine if you are breast feeding or planning to breastfeed.

Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breastfeeding.

Driving and using machines:

Diuresal may cause some patients to be less alert which can interfere with the ability to drive or operate machines.

Diuresal Injection contains sodium:

This medicinal product contains less than 1mmol sodium (23mg) per dose i.e. essentially 'sodium free'.

3. HOW DIURESAL INJECTION IS GIVEN TO YOU

Diuresal Injection will always be given to you by a doctor or nurse. It may be given by injecting the solution into a muscle or by injecting it slowly into a vein.

The usual dose:

This is given by intravenous infusion or intramuscular injection.

Adults:

Intravenous injections must be given slowly, lnitially a dose of 2ml to 4ml (20mg to 40mg) is given intramuscularly or intravenously.

Elderly:

The dose may be reduced in this age group. Children:

Doses for children are in the range of 0.5mg to 1.5mg per kg body weight.

If you think you have been given more Diuresal Injection than you should have

As the injection will be administered by a doctor, it is unlikely that you will be given more than is necessary. However, if you think you have been given too much, tell your doctor immediately.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Diuresal Injection can cause side effects, although not everyone gets them.

If you experience any of the following reactions you should report them to your doctor immediately.

*    Allergic reactions. The signs may include inflammation of the kidney (nephritis) swollen ankles, skin rashes, being more sensitive to the sun than usual, high temperature (fever) or inflammation of the blood vessels causing pain in the joints and red and purple discoloration of the skin

*    Severe allergic reactions. The signs may include shock such as difficulty in breathing, cold clammy skin, pale skin colour and racing heart beats

*    Severe stomach or back pain. These could be signs of pancreatitis

*    Increased thirst, headache, muscle weakness, confusion or irregular heartbeats. These could be signs of dehydration or changes in your normal body chemicals. Severe hydration can lead to blood clots

*    You notice yellowing of your skin or eyes and your urine becomes darker in colour. These could be signs of a liver problem, in patients who already have liver problems, a more serious liver problem known as liver encephalopathy may occur. Symptoms include forgetfulness, irritability, fits and coma

*    Blistering or peeling of the skin around the lips, eyes mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson syndrome. In a more severe form of the condition called Toxic Epidermal Necrolysis, layers of the skin may peel off to leave large areas of raw exposed skin all over the body

*    A rash with pustule formation, this could be a condition called acute genralised exanthematous pusutulosis (AGEP)

*    A fever and wide spread skin rash. This may be the symptoms of a condition called DRESS syndrome (Drug rash with eosinophilia and systemic symptoms).

Tell your doctor if you notice any of the following side effects:

*    Pass more water (urine) than you usually do People with bladder and prostate problems may notice pain when passing urine. This is due to retention of urine

*    If you have diabetes you may be less able to control the levels of glucose in your blood

*    Elevated uric acid levels (hyperuricaemia) which may lead to gout causing a swollen painful joint or joints

*    Pain at the site of injection (in the muscles)

*    Allergic reactions such as skin rashes, increase in skin reactions due to light, inflammation of the blood vessels, fever, shock and/or experience kidney problems. If any of these reactions occur, the treatment should be withdrawn.

Deposits of calcium salts in the kidneys or heart defects such as cardiac rhythm disorders and patent ductus arteriosus have been reported in premature babies following treatment with Furosemide.

*    Acute generalised exanthematous pustulosis (AGEP) (acute febrile drug eruption)

*    Dizziness, fainting and loss of consciousness (caused by symptomatic hypotension).

Blood tests:

*    During treatment with Diuresal Injection the blood levels of some fats (cholesterol and triglycerides) may rise

*    Diuresal Injection may lead to transitory increase in blood creatinine and urea levels

*    Diuresal Injection may increase the levels of liver enzymes.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE DIURESAL INJECTION

Do not use this medicine after the expiry date printed on the ampoule or carton.

Do not store above 25°C.

Do not refrigerate or freeze.

Keep the container in the outer carton in order to protect from light.

If only part used, discard the remaining solution.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

Keep out of the sight and reach of children

6. FURTHER INFORMATION

What Diuresal Injection contains:

Diuresal Injection contains the active ingredient furosemide. Each 1ml of solution contains 10mg of furosemide.

Other ingredients are: sodium-chloride, sodium hydroxide and water.

Uncommon (affects less than 1 in 100 people)

*    Deafness (sometimes irreversible).

Rare (affects less than 1 in 1,000 people)

*    Bruising more easily, getting infections, feeling weak or tired more than usual

*    Diuresal Injection can affect the number of blood cells, causing serious blood problems. This could lead to withdrawal of treatment

*    Tingling or feeling numb on the skin

*    Problems hearing or ringing in the ears (tinnitus). This especially affects people who already have problem with their kidneys.

What Diuresal Injection looks like and contents of the pack

Diuresal Injection is a clear, colourless or almost colourless sterile solution.

Diuresal is available in:

2ml amber glass ampoules in packs of 10 or 25 5ml amber glass ampoules in packs of 5.

Marketing Authorisation Holder:

Ennogen Pharma Limited,

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford,DA1 5BS, UK

Very rare (affect less than 1 in 10,000 people)

*    Muscle cramps, spasm of the hands and feet (due to very low calcium levels in the blood).

Not known: frequency cannot be estimated

from the data available:

*    Loss of concentration, slower reactions, feeling sleepy or weak. This could be due to low blood pressure

*    Problems with your eyesight

*    Feeling sick (nausea) or a general feeling of being unwell, diarrhoea and being sick (vomiting), constipation or dry mouth

Manufacturer:

Rorer Healthcare Limited

Brampton Road, Hampden Park, Eastbourne

East Sussex, BN22 9Ag

This leaflet was last revised in December 2015.