InfoCons Consumer Protection informs you – Bopediat – Package Leaflet

Before anything else

Read all of this leaflet carefully before you or your child start s taking this medicine because it contains important information for you or your child.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your or your child’s doctor, pharmacist or nurse.
• This medicine has been prescribed for you or your child 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 or your child get s any side effects, talk to your or their doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Bopediat is and what it is used for

Bopediat contains the active substance furosemide. Furosemide belongs to a group of medicines called diuretics, which increase the amount of urine passed by the kidneys, helping to remove excess fluids from the body. Diuretics are also known as water tablets.

Bopediat is used in children from birth to less than 18 years of age for the treatment of:

• oedema (fluid retention) caused by heart , kidney or liver diseases, and
• hypertension (high blood pressure) associated with chronic (long -term) kidney disease .

The active substance in Bopediat, furosemide, blocks the reabsorption of sodium and chloride from a part of the kidneys known as the loop of Henle. This leads to increased production of urine, which helps remove excess fluid from the body and lowers blood pressure by reducing the volume of fluid in blood vessels.

⚠️ 2. What you need to know before you or your child tak es Bopediat

Do not take Bopediat if you or your child

are allergic to furosemide or any of the other ingredients of this medicine (listed in section 6).

• have absence of urine production (anuria) or acute renal failure with anuria not responding to this medicine .
• have significant problems passing urine because of a blockage in the flow of urine (urinary tract obstruction).
• have a low volume of blood or other fluids circulating in your body (hypovolaemia) .
• are dehydrated.
• have very low blood potassium levels (severe hypokalaemia) (see section 4, “Possible side effects”).
• have very low blood sodium levels (severe hyponatraemia ) 24 • have inflammation of the liver (hepatitis ) that severely affects liver function and are either on haemodialysis ( a procedure for removing waste products from the blood used in patients with kidney disease ) or have severe kidney failure .
• have brain dysfunction caused by liver problems (hepatic encephalopathy).

Warnings and precautions

Talk to your or your child’s doctor, pharmacist, or nurse before you or your child take Bopediat if you or your child:

• have pre-diabetes or diabetes (condition in which the body cannot adequately control blood sugar levels). Blood sugar levels should be checked regular ly.
• have gout (too much uric acid in the blood). Treatment with Bopediat may make gout attacks more frequent.
• have problems with your liver as there is a risk of developing hepatic encephalopathy, a condition which can cause confusion, sleepiness, or unusual behavio ur. Contact your doctor immediately if you notice any of these symptoms .
• have an urinary tract obstruction.
• have abnormal blood levels of sodium (salt), potassium or creatinine (a measure of kidney function).
• have low blood pressure.
• become dehydrated whil st taking Bopediat .
• have systemic lupus erythematosus (a condition in which the body’s defence system attacks normal tissue causing symptoms such as swollen joints, tiredness and rashes) . Treatment with Bopediat might make this worse .
• are taking other medical treatments which may cause a drop in blood pressure or have other medical problems involving a risk of a decrease in blood pressure.
• are pregnant.
• seek medical help immediately if you get a severe rash, blisters, peeling skin, mouth or eye sores, swelling of the face or tongue, fever, or feel very unwell (severe cutaneous adverse reaction, SCARs).
• have h epatorenal syndrome (a serious condition where kidney function worsens due to severe liver disease).
• have low levels of protein in the blood ( hypoproteinaemia ).
• are a premature baby with gallstones (cholelithiasis ).
• are an infant with secondary hyperparathyroidism (overactive parathyroid glands due to another condition) or bone disease.

During treatment, your or your child ’s doctor will organise medical check -ups and blood tests to monitor how your or your child’s treatment is going. Treatment may need to be stopped for a short time, or the dose reduced, if you become dehydrated, lose too much fluid, or your body’s chemical balance is disturbed (e.g. low potassium or sodium levels) .

Exposure to the sun or UV rays: tell your doctor if you or your child’s skin reacts strongly (such as reddens, burns, or blisters more easily than usual) after exposure to the sun or UV rays (photosensitivity), because your treatment may have to be stopped.

When taking this medicine, you or your child should limit exposure to sunlight and UV rays, avoid sunbeds, wear protective clothing when outdoors, and use a high sun protection factor (SPF) sunscreen. If a skin reaction occurs, contact your doctor.

If you are not sure if any of the above apply to you or your child , talk to your doctor , pharmacist or nurse before taking Bopediat.

Newborns and premature infants Use of Bopediat in newborns and premature infants should be carefully monitored by a doctor, pharmacist or nurse.

25 In premature infants, this medicine may increase the risk of a heart condition called patent ductus arteriosus (a blood vessel near the heart that stays open when it should have closed after birth ). Your doctor will carefully consider the benefits and risks before giving this medicine and monitor your baby during treatment.

If this medicine is used in newborns and premature infants , long-term use of this medicine at high doses may require ultrasound scans of the kidneys.

Other medicines and Bopediat

Tell your doctor or pharmacist if you or your child is taking, ha s recently taken, or might take any other medicines.

Tell your doctor if you or your child is taking:

• Medicines that can lower the levels of potassium in the blood, such as water tablets (diuretics), corticosteroids, tetracosactide, amphotericin B, and certain laxatives;
• Medicines that can lower the levels of sodium in your blood, such as diuretics, desmopressin, certain antidepressants, carbamazepine and oxcarbazepine;
• Medicines that may affect your hearing (such as vancomycin, teicoplanin, aminoglycosides, platinum compounds and loop diuretics) ;
• Blood pressure -lowering medicines, including digitalis medicinal products , diuretics, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and alpha -blockers;
• Medicines containing ciclosporin used as an immunosuppressant;
• Medicines containing phenytoin used to treat epilepsy;
• Diabetes medicines such as metformin ;
• Medicines used to treat behaviour or mental health conditions (such as risperidone) ;
• Medicine used to treat mood disorders such as bipolar disorder (lithium) ;
• Medicines that may cause a type of heart rhythm disorder called torsades de pointes . These include: o Some antidepressants (such as citalopram, escitalopram), o Some medicines used to treat mood and behaviour disorders (such as phenothiazines [chlorpromazine, cyamemazine, fluphenazine, levomepromazine, pipotiazine, mequitazine], benzamides [amisulpride, sulpiride, sultopride, tiapride], butyrophenones [droperidol, haloperidol, pipamperone], pimozide, sertindole, flupentixol, zuclopenthixol), o Some antibiotics from the macrolide group (such as spiramycin (into a vein) erythromycin into a vein ) or the fluoroquinolone group (such as moxifloxacin, levofloxacin), o Some medicines used to treat cancer and its side effects (such as toremifene, arsenic compounds, and dolasetron into a vein ), o Some medicines used to treat malaria (such as halofantrine, lumefantrine), o Some medicines used to treat infections caused by fungi or parasites (such as pentamidine), o Some medicines used to treat constipation (such as cisapride, prucalopride), o some medicines used to treat heart rhythm disorders (such as quinidine, hydroquinidine disopyramide, dofetilide, amiodarone, sotalol, ibutilide, dronedarone), o Bepridil (a medicine used to treat angina pectoris (chest pain )), o Vincamine into a vein (a medicine used to treat minor neurological disorders related to age), o Methadone (a medicine used to treat drug addiction) (see section ” Warnings and precautions”) .
• Medicines that may cause nephrotoxicity and/or kidney injury when taken with furosemide , e.g.: o Medicines containing aminoglycosides (a type of antibiotic drugs); o ACE inhibitors or angiotensin II receptor blockers (for high blood pressure); o Non-steroidal anti -inflammatory drugs and acetylsalicylic acid (aspirin) ; o Medicines containing iodinated contrast agents for diagnostic purposes ;

26 o Medicines containing platinum compounds, used to treat some types of cancer .

• Medicines that may cause hypotension when taken with furosemid e, e.g.: o Alpha -blockers (for high blood pressure); o Medicines containing baclofen (a medicine used to treat involuntary muscle contractions); o Medicines containing nitrate derivatives and related compounds for chest pain (angina pectoris); o Imipramine antidepressants and neuroleptics (for mental diseases); o Medicines containing amifostine (medicines used to treat cancer) .

Your doctor may have to change your or your child’s dose and/or take other precautions if you or your child is taking the following medicine:

• Aliskiren, used to treat high blood pressure.

Pregnancy, breast-feeding and fertility

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.

There are no or limited amount of data from the use of furosemide in pregnant women. Studies in animals have shown reproductive toxicity.

Bopediat is not recommended during pregnancy and in women of childbearing potential not using contraception.

Furosemide/metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely. Breast -feeding should be discontinued during treatment with Bopediat.

Driving and using machines

Bopediat has no or negligible influence on the ability to drive and use machines.

Bopediat contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium –

free’. Bopediat contains sulphites

May rarely cause severe hypersensitivity reactions and bronchospasm.

💊 3. How to take Bopediat

Always take this medicine exactly as your or your child’s doctor or pharmacist has told you. Check with the doctor or pharmacist if you are not sure.

The number of tablets you or you r child need to take will depend on your or your child’s body weigh t and as well as the reason for and severity of the illness being treated .

The recommended daily dose is 1 to 2 mg/kg of body weight, given as a single dose or as two divided doses.

Bopediat should be taken by mouth.

The tablet can be taken with or without food.

This medicine comes as an orodispersible tablet, which means it dissolves in the mouth. Place the tablet on the tongue or in the buccal cavity (the space inside the mouth between the cheeks and teeth) and allow it to disperse. A small drink of water may be taken after the tablet has fully disintegrated.

27 Alternatively, for ne wborns , the tablet may be placed in the cheek pouch instead of on the tongue, but this may increase how long the tablet takes to dissolve .

Alternatively, Bopediat can be dispersed in tap water . Once dispersed , it can be also given via a dosing syringe. The amount of water required is 1 mL for every 2 tablets or part thereof (e.g. 1 mL for 2 tablets, 2 mL for 2.5 tablets, 3 tablets or 4 tablets). Boiled and cooled water should be used in children under 6 months of age. After administering Bopediat, draw into the syringe the same volume of water used to prepare the dose and administer it to the patient. This ensures the entire dose is delivered .

Bopediat orodispersible tablets have been designed with a functional score line (dividing mark) .

In order to accurately give half a tablet , hold the tablet firmly and break it down the central score line.

The tablet will divide into two equal halves.

Some patients may need to be given Bopediat through a feeding tube (nasogastric tube, tube sizes ranging from 4 Fr to 10 Fr) that goes directly into the stomach . Bopediat disperses in tap water and once dispersed it can be given through a feeding tube according to the instructions below . Boiled and cooled water should be used in children under 6 months of age .

1. Place the number of required B opediat orodispersible tablets into a syringe (5, 10 or 20 mL syringe depending on number of tablets to be given).

2. Draw the required amount of water into the syringe: 1 mL for every 2 tablets or part thereof (e.g.

1 mL for 2 tablets, 2 mL for 2.5 tablets, 3 tablets or 4 tablets).

3. Make sure the end of the syringe is closed securely with a cap or held closed with a finger.

4. To disperse the tablets, turn the syringe upside down in a 180 ° movement by turning the wrist for at least 30 seconds (approximately 40 movements). Visually check if the tablets have been completely dissolved and if not, extend the number of movements/time as needed to obtain a complete dispersion.

5. Remove air from the syringe and apply the dose to the feeding tube. After giving the dose , flush the tube with water :

• 3 mL for very small tubes (4 Fr)
• 5 mL for all other tube sizes (5 -10 Fr) If you or your child takes more Bopediat than they should Do not give more medicine than your or your child’s doctor tells you to. If you or your child has swallowed more tablets than the doctor has prescribed, tell your doctor immediately or contact your nearest h ospital casualty/ accident and e mergency department even if there are no signs of discomfort.

Take the medicine in its original packag e with you to enable the doctor to identify your medic ine easily.

Possible signs of taking too much of this medicine include :

• Passing a lot of urine or feeling very thirst y
• Fast heartbeat
• Feeling weak, faint or lightheaded
• Drowsiness, confusion or unusual sleepiness 28 • Muscle weakness or floppy limbs
• Very low blood pressure
• Sudden kidney failure
• Blood clots .

If you or your child forgets to take Bopediat If you or your child forgets to take Bopediat, skip the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you or your child stops taking Bopediat Do not stop taking or giving Bopediat unless your or your child’s doctor tells you to.

If you have any further questions on the use of this medicine, ask your or your child’s doctor, pharmacist or nurse.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Bopediat a nd seek medical attention immediately if you notice any of the following symptoms:

• Reddish non- elevated, target-like or circular patches on the skin of the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu -like symptoms. These may be signs of conditions named Stevens -Johnson syndrome (frequency not known) or toxic epidermal necrolysis (frequency not known) .
• Widespread rash, high body temperature and enlarged lymph nodes. These may be signs of a life-threatening condition called DRESS (drug reaction with eosinophilia and systemic symptoms) . The frequ ency of this side effect is not known.
• A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the start of treatment and may be signs of a condition called acute generalised exanthematous pustulosis (frequency not known) .
• Sudden severe allergic reaction with breathing difficulty, swelling to the ton gue/lips , light- headedness, fast heartbeat, sweating and loss of consciousness (anaphylactic reactions) . The frequency of this side effect is rare.

Other possible side effects

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

• Decrease in the total amount of fluid in the body (hypovolaemia) . Signs of hypovol aemia include feeling dizzy or lightheaded , feeling very thirsty , reduced urine output and cool clammy skin.
• A marked drop in blood pressure when moving from a sitting to a standing position (orthostatic hypotension) , which may be accompanied by dizziness and/or faintness.
• Increase in creatinine in the blood which can be a sign of worsening kidney problems (blood creatinine increased) .
• Increase in fats (triglycerides) in the blood (blood triglycerides increased).
• Changes in the amount of salt s and water in your body (electrolyte imbalance) .
• Loss of too much water from your body (dehydration).

Common (may affect up to 1 in 10 people)

• Brain probl ems e.g. confusion, drowsiness , caused by liver problems (hepatic encephalopathy) .
• High levels of uric acid in the blood (blood uric acid increased) , which may lead to physical symptoms such as painful inflammation in the joints (gout) .

29 • Increase in cholesterol in the blood (blood cholesterol increased) .

• Low blood potassium levels (hypokalaemia) .
• Low blood sodium levels (hyponatraemia) .
• Production of excessive amount s of urine (polyuria) .
• A condition where the blood becomes more concentrated due to loss of fluid (haemoconcentration) .

Uncommon (may affect up to 1 in 100 people)

• Skin reactions which may be allergic or non-allergic (skin reaction).
• Itchy rash which is raised or bumpy (urticaria).
• An autoimmune disorder that causes blisters in the skin and moist body surfaces (pemphigoid) .
• An allergic reaction that causes widespread, blistering sores on the skin (g eneralised bullous fixed drug eruption) .
• Itching (prurit us).
• Sunburn-like reactions following exposure to the sun or UV radiation (photosensitivity) .
• A skin reaction that causes red spots or patches on the skin, that may look like a target or “bulls- eye” with a dark red centre surrounded by paler red rings (erythema multiforme) .
• Little reddish -purple patches on the skin (purpura) .
• Feeling sick (n ausea).
• Impairment of hearing (auditory disorder) .
• Deafness (which may be irreversible).
• Impaired ability to control blood sugars (carbohydrate tolerance decreased) .
• An increase in blood sugars (blood glucose increased).
• Low levels of blood platelets, components that help the blood to clot (thrombocytopenia) .

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

• Fever (pyrexia) .
• An excess of eosinophils, a type of white blood cell (eosinophilia) .
• Low levels of neutrophils, a type of white blood cell that fights infection (neutropenia) .
• Sensation like numbness, tingling, pins and needles (paraesthesia) .
• Vomiting .
• Diarrhoea.
• A kidney disorder in which there is inflammation within the kidneys that affects their ability to filter blood and make urine (tubulointerstitial nephr itis).
• Ringing or buzzing in the ears (t innitus ).
• Infla mmation of the blood vessels (vasculitis) .
• Sudden swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, severe itching or rash (anaphyla ctic reaction).

Very rare (may affect up to 1 in 10 000 people)

• Sudden inflammation of the pancreas causing severe pain the belly and back (pancreatitis acute).
• Liver damage due to the build-up of bile, a fluid made in the liver that helps to breakdown fats (cholestatic liver injury) .
• Increase in levels of liver enzymes as seen in blood tests (transaminases increased) .
• Very low level of a type of white blood cell called granulocytes which are important to fight infection (agranulocytosis) .
• A condition where the bone marrow stops making blood cells (bone marrow failure).

Not known (frequency cannot be estimated from the available data)

• Formation of blood clots in the blood vessels (thrombosis) .
• Di fficulty releasing urine from the bladder (urinary retention ).
• Kidney stones (nephrolithiasis) .
• Build -up of calcium in the kidneys (nephrocalcinosis) .

30 • Increase in urea in the blood (blood urea increased) .

• Decrease in the amount of potassium in the blood associated with a decrease in chloride in the blood and an acid-base imbalance, together with an increase in aldosterone secretion (pseudo- Bartter syndrome).
• A change in the acid -base balance in the blood (metabolic alkalosis) .
• An inflammatory, connective tissue disease that can affect the joints and many organs, including the skin, heart, lungs, kidneys, and nervous system (systemic lupus erythematosus) .
• Dizziness.
• Fainting (syncope).
• Loss of consciousness.
• Headache.
• Breakdown of muscles often leading to kidney damage (rhabdomyolysis ).
• A non-cancerous, raised skin lesion that may itch or change colour (lichenoid keratosis) .
• A widespread rash with small pus-filled bumps, often with fever ( Acute generalised exanthematous pustulosis (AGEP)).
• A severe rash with blistering of the skin, mouth, eyes or genitals (Stevens-Johnson syndrome (SJS)).
• A rash with fever, swollen glands and possible effects on internal organs such as the liver, kidneys or lungs ( Drug reaction with eosinophilia and systemic symptoms (DRESS) ).
• Peeling of large areas of skin (Toxic epidermal necrolysis (TEN) ).

Reporting of side effects

If you or your child gets any side effects, talk to your or your child’s doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects, you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Bopediat

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 carton and b lister after ‘EXP ’.

The expiry date refers to the last day of that month.

Do not store above 25 °C.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Bopediat contains

• The active substance is furosemide.

Bopediat 5 mg orodispersible tablets contain 5 mg of furosemide.

• The other excipient s are: mannitol (E 421), maize starch, croscarmellose sodium (E 468), povidone (E 1201), strawberry flavour (contains gum arabic (E 414), sodium, furaneol , sulphites (E 220) , acetic acid (E 260)) (see section 2 ‘Bopediat contains sulphites’) , sodium stearyl fumarate (see section 2 ‘ Bopediat contains sodium ’), iron oxide red (E 172).

What Bopediat looks like and contents of the pack

31 Bopediat 5 mg orodispersible tablet s are pale red, round, flat with bevelled edge with ‘F’ debossed on one side and a score line on the other side with a diameter of 5.7 mm. The tablet can be divided into equal doses.

Bopediat 5 mg orodispersible tablets are available in PVC/PVDC/aluminium blister s containing 28 tablets each.

Each carton contains 28, 56, 84 or 112 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Proveca Pharma Limited 2 Dublin Landings North Wall Quay Dublin 1 Ireland

Manufacturer

Haupt Pharma Münster GmbH Schleebrüggenkamp 15 48159 Münster Germany

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Bopediat (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2027).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.