Qaialdo

Package leaflet: Information for the patient

Qaialdo 10 mg/mL oral suspension

spironolactone
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Qaialdo is and what it is used for
2. What you need to know before taking Qaialdo
3. How to take Qaialdo
4. Possible side effects
5. How to store Qaialdo
6. Contents of the pack and other information

1. What Qaialdo is and what it is used for

Qaialdo contains the active substance spironolactone, which belongs to a group of medicines called "diuretics". Spironolactone works by blocking the effects of aldosterone, a hormone that helps regulate fluid balance in the body. Spironolactone promotes the elimination of excess salts and water and helps prevent potassium levels from dropping too low. This action reduces oedema. Spironolactone is indicated for the treatment of various conditions in neonates, children and adults.
Qaialdo is used to treat refractory oedema (persistent swelling due to fluid accumulation that has not responded to other treatments) associated with:

• congestive heart failure (when the heart does not pump blood effectively, leading to fluid buildup around the heart, causing shortness of breath, fatigue and swelling of the ankles);
• hepatic cirrhosis (a type of liver disease) with ascites (fluid accumulation in the abdomen) and oedema (swelling);
• malignant ascites (a condition in which tumour-containing fluid accumulates in the abdomen);
• nephrotic syndrome (a kidney disorder causing excessive loss of protein from the kidneys into the urine);
• essential hypertension (high blood pressure with no known cause).

Qaialdo is also used for the diagnosis and treatment of primary hyperaldosteronism (a condition in which the body produces excessive amounts of a hormone called aldosterone, leading to fluid retention). Children should only be treated under the supervision of a paediatric specialist.

2. What you need to know before taking Qaialdo

Do not take Qaialdo

• if you are allergic to spironolactone or to any of the other ingredients of this medicine (listed in section 6);
• if you have Addison’s disease (a disorder in which the adrenal glands do not produce certain hormones in sufficient amounts);
• if you have hyperkalaemia (high levels of potassium in the blood);
• if you have anuria (a condition in which a patient produces no urine or is unable to urinate);
• if you have sudden kidney failure;
• if you have severe kidney disease;
• if you are taking eplerenone (another medicine used to treat hyperaldosteronism);
• if you are taking potassium-sparing diuretics (medicines that can increase urine production without loss of potassium) or any potassium supplements.

Children with moderate or severe kidney disease must not take Qaialdo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Qaialdo:

• if you suffer from kidney disease. This is particularly important for children with hypertension;
• if you suffer from liver disease;
• if you are an elderly patient and/or have an obstruction in the parts of the body that collect and eliminate urine, or suffer from a condition that may cause electrolyte imbalances (salts such as sodium, potassium, calcium, chloride, and bicarbonate in the blood and other body fluids);
• if you have severe heart failure and are being treated with Qaialdo, your doctor will monitor your blood potassium levels due to the risk of hyperkalaemia, which can be fatal. Recommended monitoring of potassium and creatinine is 1 week after starting therapy or increasing the dose of spironolactone, then once a month for the first 3 months, every 3 months for one year, and subsequently every 6 months;
• if your kidney function decreases or you develop kidney failure, you may experience a significant increase in blood potassium levels. This can affect heart function and, in extreme cases, may be fatal.

Your doctor or nurse will regularly perform blood tests to monitor fluid and electrolyte levels (potassium and sodium).
Treatment with Qaialdo may increase potassium and blood urea nitrogen levels (a marker of liver and kidney problems) and reduce sodium levels, especially in elderly patients and/or those with heart, kidney, or liver problems. High potassium levels (hyperkalaemia) can be fatal in extreme cases.
Concomitant administration of Qaialdo with certain medicines, for example trimethoprim/sulfamethoxazole (co-trimoxazole), potassium supplements, and potassium-rich foods may cause severe hyperkalaemia.
Symptoms of severe hyperkalaemia may include muscle cramps, irregular heartbeat, diarrhoea, nausea, dizziness, or headache.
Spironolactone may cause gynaecomastia (enlarged breasts), breast pain, and menstrual irregularities (irregular periods).
Frequent blood tests are recommended, especially in elderly patients and those with impaired kidney function.
Other medicines and Qaialdo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking abiraterone for the treatment of prostate cancer. Use with abiraterone is not recommended.
Inform your doctor if you are taking mitotane for the treatment of malignant adrenal gland tumours. This medicine must not be used concomitantly with mitotane.
Concomitant use of carbenoxolone or lithium salts should be avoided.
Your doctor may decide to adjust the dose of Qaialdo if you are taking any of the following medicines:

• potassium-sparing diuretics and aldosterone blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists (risk of increased blood potassium levels);
• antipyrine used to reduce fever;
• cholestyramine, ammonium chloride (risk of increased blood potassium levels and acidosis);
• non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid, indomethacin, ibuprofen, or mefenamic acid (risk of increased blood potassium levels);
• potassium supplements (risk of increased blood potassium levels);
• noradrenaline;
• regional or general anaesthesia;
• heparin, low molecular weight heparin, medicines that prevent blood clot formation (risk of increased blood potassium levels);
• medicines known to cause hyperkalaemia (risk of increased blood potassium levels);
• trimethoprim and trimethoprim-sulfamethoxazole (risk of increased blood potassium levels);
• medicines for high blood pressure, including other diuretics; digoxin or other cardiac glycosides used in the treatment of heart failure. Dose adjustments of these medicines may be necessary.

If you are about to undergo surgery involving anaesthesia, inform the responsible doctor that you are taking Qaialdo.
Qaialdo with food and drinks
Taking Qaialdo with a diet high in potassium salts or potassium-containing salt substitutes may lead to increased blood potassium levels. See section 2. “Do not take Qaialdo”.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Qaialdo must not be used during breastfeeding. Discuss the use of Qaialdo with your doctor, who will advise you to consider an alternative method of feeding your baby while taking this medicine.
Driving and using machines
Be cautious if driving or operating machinery. Treatment with spironolactone has been associated with drowsiness and dizziness, which may negatively affect your ability to drive or operate machinery safely.
Qaialdo contains sodium benzoate (E211)
This medicine contains 0.75 mg of sodium benzoate per mL. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
Qaialdo contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose within the recommended dosage range, i.e., essentially “sodium-free”.
Qaialdo contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Since Qaialdo 10 mg/mL contains 400 mg of sucrose per mL, this should be taken into account regarding daily intake. This information is particularly relevant for people with diabetes mellitus.
Qaialdo may be harmful to teeth.

3. How to take Qaialdo

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
Your doctor will recommend the dose and frequency. The dose should be taken with food.
Use in adults
Your doctor will decide the most appropriate dose for your condition. Treatment starts at the lowest dose
and may be increased, if necessary, up to a maximum of 400 mg of spironolactone per day.
If you have any doubts about how much medicine to take, consult your doctor or pharmacist.
Use in elderly patients
Your doctor will start with a low initial dose and gradually increase it as needed to achieve the desired
effect.
Use in children
If you are administering Qaialdo to a child, the dose administered will depend on the child's age and
weight.

• The dose for a newborn ranges from 1 to 2 mg/kg per day, divided into one or two doses.
• The dose for a child aged between 1 month and 18 years is 1–3 mg/kg per day in one or two divided doses (without exceeding 200 mg per day).
• Higher doses, up to a maximum of 7 mg/kg per day in newborns and 9 mg/kg per day in older children (without exceeding 400 mg per day), may be used in cases of refractory ascites or primary hyperaldosteronism.

Route and method of administration
For oral use.
This medicine should be taken with meals.
Always use the syringes provided to take the medicine.
The smaller syringe (1 mL) is used to draw up doses less than or equal to 10 mg. It has clear
markings every 0.1 mL. Each 0.1 mL contains 1 mg of spironolactone. A full syringe contains
10 mg of spironolactone. Use this syringe only if the total dose you need to take is less than or
equal to 10 mg.
The larger syringe (5 mL) is used to draw up doses greater than 10 mg. It has lines indicating
increments of 0.2 mL and is marked at intervals of 1 mL and 2.5 mL. Each 1 mL contains 10 mg of
spironolactone. A full syringe contains 50 mg of spironolactone.
For doses greater than 10 mg (1 mL) that need to be measured in increments of 0.1 mL (e.g., 1.5 mL),
both syringes must be used:

1. Use the larger 5 mL syringe to measure up to the nearest 0.2 mL line (e.g., 1.4 mL).
2. Then use the smaller 1 mL syringe to measure the remaining amount (e.g., 0.1 mL).
3. Take each dose one after the other.

It is important to use the correct dosing syringe for administering the medicine. Your doctor or
pharmacist will advise you which syringe to use based on the prescribed dose.

When taking the medicine or administering it to a child or another person, wash your hands before and after.
Follow the instructions below for using the medicine:

Figure 1 Figure 2 Figure 3 Figure 4 Figure 5

1. Shake the bottle well before use (to ensure the medicine is properly mixed) (Figure 1).
2. Remove the bottle cap (Figure 2), insert the adapter firmly into the bottle opening, and leave it in place for subsequent doses (Figure 3).
3. Insert the tip of the oral syringe into the adapter’s opening (Figure 4). To administer the correct dose, your doctor or pharmacist will advise you which syringe to use—the 1 mL or the 5 mL syringe.
4. Invert the bottle (Figure 5).
5. Pull back the plunger of the syringe to draw the medicine from the bottle into the syringe. Pull the plunger until the mark corresponding to the prescribed dose is reached (Figure 5). If you are unsure about the amount of medicine to draw into the syringe, always consult your doctor or nurse.
6. Return the bottle to an upright position and gently remove the syringe from the adapter, holding it by the barrel rather than the plunger.
7. Gently place the tip of the syringe into the mouth, inside the cheek.
8. Slowly and gently push the plunger to gradually release the medicine into the cheek area, then swallow. Do not push the plunger forcefully or spray the medicine to the back of the mouth or throat, as it may cause choking.
9. Remove the syringe from the mouth.
10. Swallow the oral suspension and drink some water, ensuring no medicine remains in the mouth.
11. Replace the bottle cap, leaving the adapter in place. Make sure the cap is securely closed.
12. Wash the syringe with warm water and rinse thoroughly. Hold the syringe under running water and pull the plunger up and down several times to ensure the inside is clean. Allow the syringe to air-dry completely before using it again for the next dose. Do not dry it manually. Store the syringe in a clean place together with the medicine.

Repeat the above steps for each dose, according to your doctor’s or pharmacist’s instructions.
If you take more Qaialdo than you should
If you accidentally take more Qaialdo than you should, contact your doctor or the nearest hospital emergency department immediately.
Symptoms of an overdose may include drowsiness, dizziness, dehydration, and possibly confusion. Do not drive.
You may also feel nauseous or vomit, have diarrhoea, or develop skin rashes appearing as flat red patches with small overlapping bumps.
Changes in blood sodium and potassium levels may cause weakness, tingling, prickling, or numbness of the skin and/or muscle spasms, although these symptoms are unlikely to be associated with a severe overdose.
If you forget to take Qaialdo
Do not take a double dose to make up for a missed dose. If you forget to take a dose, take it as soon as you remember, unless there are less than 8 hours remaining before the next scheduled dose.
If you stop taking Qaialdo
It is important to continue taking Qaialdo for as long as your doctor instructs you to continue, even if you start to feel better.
If you stop treatment with Qaialdo too early, your condition may worsen.
If you have any questions about the use of 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.
If you experience any of the following symptoms after taking the medicine, inform your doctor immediately. Although very rare, these symptoms may be serious.

• Itching and blistering of the skin, around the lips and elsewhere on the body, red or purplish rash that spreads and forms blisters (Stevens-Johnson syndrome)
• Detachment of the upper layer of the skin from the lower layers all over the body (toxic epidermal necrolysis)
• Skin rash, fever and swelling (which may be symptoms of a more serious condition, drug reaction with eosinophilia and systemic symptoms)
• Yellowing of the skin and eyes (spironolactone may impair liver function)
• Irregular heartbeat that may be fatal, feeling of tiredness, paralysis (loss of muscle function) or breathing difficulties, which may be symptoms of increased potassium levels in the blood. Your doctor will regularly perform blood tests to monitor your potassium and other electrolyte levels. If necessary, your doctor may discontinue treatment.

List of other side effects of Qaialdo by frequency:
Very common: may affect more than 1 in 10 people

• Hyperkalaemia (high potassium levels in the blood)

Common: may affect up to 1 in 10 people

• Confusion
• Dizziness
• Nausea
• Itching
• Rash
• Muscle or leg cramps
• Sudden kidney failure
• Gynaecomastia (breast enlargement in men)
• Breast pain (in men)
• Feeling of general malaise

Uncommon: may affect up to 1 in 100 people

• Breast changes, such as breast lumps (in men)
• Electrolyte disturbances in the body, such as high calcium levels in the blood
• Abnormal liver function
• Urticaria (itchy skin rash)
• Menstrual problems in women
• Breast pain (in women)

Not known: frequency cannot be estimated from the available data

• Leucopenia (low white blood cell count)
• Agranulocytosis (very low levels of a type of white blood cells called granulocytes, important for fighting infections)
• Anaemia (low red blood cell count, which may cause fatigue and paleness)
• Thrombocytopenia (low platelet count in the blood, which may cause bleeding and bruising)
• Eosinophilia (excess of eosinophils, a type of white blood cell)
• Purpura (purple spots resembling bruises)
• Changes in libido in men and women
• Impotence in men
• Stomach and intestinal problems
• Bullous pemphigoid (a skin disorder presenting with fluid-filled blisters)
• Drug reaction with eosinophilia and systemic symptoms (a severe reaction affecting the skin, blood and internal organs)
• Stevens-Johnson syndrome (a potentially life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals)
• Toxic epidermal necrolysis (a potentially life-threatening reaction with flu-like symptoms and blistering of the skin, eyes, mouth and genitals)
• Alopecia (hair loss)
• Hypertrichosis (excessive growth of body hair)
• Headache
• Drowsiness
• Ataxia (inability to coordinate muscle movements)
• Fever

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Qaialdo

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 packaging after "Exp." The expiry
date refers to the last day of that month.
After first opening the bottle, store below 25 °C and discard any unused medicine after 12 weeks.
Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Qaialdo contains

• The active substance is spironolactone. Each mL of suspension contains 10 mg of spironolactone.
• The other ingredients are sodium benzoate (E 211), sucrose, sodium citrate (E 331), citric acid monohydrate (E 330), liquid strawberry flavour, flavour-masking agent, polysorbate 80 (E 433), simeticone 30% emulsion, xanthan gum (E 415), and purified water.

See section 2 “Qaialdo contains sodium benzoate”, “Qaialdo contains sodium”, and “Qaialdo contains sucrose”.

Description of the appearance of Qaialdo and contents of the pack
Qaialdo is a white or almost white, viscous oral suspension.
It is supplied in 150 mL glass bottles with a child-resistant cap.
Each package contains one bottle, one adapter, and two dosing syringes (one syringe graduated up to 1 mL and one syringe graduated up to 5 mL).
Your doctor or pharmacist will advise you which syringe to use depending on the prescribed dose.

Marketing Authorisation Holder
Lipomed GmbH
Hegenheimer Strasse 2
79576 Weil am Rhein
Germany

Manufacturer
Pronav Clinical Ltd.
Unit 5
Dublin Road Business Park
Carraroe, Sligo
F91 D439
Ireland

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.