QAIALDO 10 mg /Ml Оральная Суспензия

Содержание инструкции

1. Qaialdo 10 mg/mL oral suspension
   1. What is Qaialdo and what is it 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. Package Contents and Other Information

Qaialdo 10 mg/mL oral suspension

spironolattone

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 you take 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 is Qaialdo and what is it used for

Qaialdo contains the active ingredient spironolactone, which belongs to a group of medicines
called “diuretics”. Spironolactone works by blocking the effects of aldosterone, a hormone that
helps to control the fluid balance in the body. Spironolactone leads to the elimination of excess salts and
water and prevents potassium levels from decreasing excessively. This action reduces
edema. Spironolactone is indicated for the treatment of various conditions in newborns, children and adults.
Qaialdo is used for the treatment of refractory edema (persistent swelling due to fluid accumulation, which has not responded to other treatments) associated with:

• congestive heart failure (when the heart does not pump blood as it should and a build-up of fluid around the heart occurs, 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 edema (swelling);
• malignant ascites (a condition in which cancer cells containing fluid accumulate in the abdomen);
• nephrotic syndrome (a kidney disorder that causes excessive leakage of proteins from the kidneys into the urine);
• essential hypertension (high blood pressure without a known cause).

Qaialdo is also used for the diagnosis and treatment of primary hyperaldosteronism (a
condition in which the body produces an excessive amount of a hormone called aldosterone, which
causes fluid retention). Children should only be treated under the guidance of a
pediatric specialist.

2. What you need to know before taking Qaialdo

Do not take Qaialdo

• if you are allergic to spironolactone or 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 enough hormones);
• if you have hyperkalemia (high levels of potassium in the blood);
• if you have anuria (a condition in which a patient does not produce urine or is unable to urinate);
• if you have acute renal failure;
• if you have severe kidney disease;
• if you are taking eplerenone (another medicine used for the treatment of hyperaldosteronism);
• if you are taking potassium-sparing diuretics (medicines that can increase urine production without loss of potassium) or any potassium supplement.

Children with moderate or severe kidney disease should not take Qaialdo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Qaialdo:

• if you suffer from a kidney disease. This is particularly important for children with high blood pressure;
• if you suffer from a 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 can cause electrolyte disorders (salts such as sodium, potassium, calcium, chloride and bicarbonate in the blood and other fluids in the body);
• if you have severe heart failure and are being treated with Qaialdo, the doctor will monitor the levels of potassium in the blood due to the risk of hyperkalemia, which can be fatal. The recommended potassium and creatinine monitoring is 1 week after the start of therapy or the increase of the spironolactone dose, then once a month for the first 3 months, then every three months for a year and subsequently every 6 months;
• if kidney function decreases or if you develop renal failure, you may experience a strong increase in potassium levels in the blood. This can affect the functioning of the heart and, in extreme cases, can be fatal.

The doctor or nurse will regularly perform blood tests to check the levels of fluids
and electrolytes (potassium and sodium).
Treatment with Qaialdo may increase the levels of potassium and blood urea nitrogen (a marker
of liver and kidney problems) and reduce the levels of sodium, especially in the elderly and/or patients with
problems with the heart, kidneys and liver. High potassium levels (hyperkalemia) can be fatal in extreme
cases.
The concomitant administration of Qaialdo with certain medicines, for example
trimethoprim/sulfamethoxazole (co-trimoxazole), potassium supplements and potassium-rich foods
may cause severe hyperkalemia.
The symptoms of severe hyperkalemia may include muscle cramps, irregular heartbeat,
diarrhea, nausea, dizziness or headache.
Spironolactone may induce gynecomastia (enlarged breasts), breast pain and menstrual irregularities
(irregular periods).
Frequent blood tests are recommended, especially in the elderly and in patients 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 medicine.
Tell your doctor if you are taking abiraterone for the treatment of prostate cancer. Use with
abiraterone is not recommended.
Tell your doctor if you are taking mitotane for the treatment of malignant tumors of the adrenal
glands. This medicine should not be used in conjunction with mitotane.
The concomitant use of carbenoxolone or lithium salts should be avoided.
Your doctor may decide to change 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 potassium levels in the blood);
• antipyrine used to lower fever;
• cholestyramine, ammonium chloride (risk of increased potassium levels in the blood and acidosis);
• non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid, indomethacin, ibuprofen or mefenamic acid (risk of increased potassium levels in the blood);
• potassium supplements (risk of increased potassium levels in the blood);
• norepinephrine;
• regional or general anesthesia;
• heparin, low molecular weight heparin, medicines that prevent blood clots (risk of increased potassium levels in the blood);
• medicines known to cause hyperkalemia (risk of increased potassium levels in the blood);
• trimethoprim and trimethoprim-sulfamethoxazole (risk of increased potassium levels in the blood);
• medicines for high blood pressure, including other diuretics; digoxin or other cardiac glycosides used in the treatment of heart failure. A dose adjustment of these medicines may be necessary.

If you are about to undergo surgery with the use of anesthetic, inform the responsible doctor that
you are taking Qaialdo.

Qaialdo with food and drink
The use of Qaialdo with a diet high in potassium salt and potassium-containing salt substitutes
may result in an increase in potassium levels in the blood. See section 2. “Do not
take Qaialdo”.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Qaialdo should not be used during breastfeeding. Discuss the use of Qaialdo with your doctor,
who will advise you to consider an alternative method to feed the baby while
taking this medicine.

Driving and using machines
Be careful if you drive vehicles or use machines. Drowsiness and dizziness have been associated with spironolactone treatment,
which may negatively affect the ability to drive vehicles or
use machines 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 in 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 him before taking
this medicine.
As Qaialdo 10 mg/mL contains 400 mg of sucrose per mL, this must be taken into account in terms of
daily intake. This data should be considered in people affected by diabetes mellitus.
Qaialdo may be harmful to teeth.

3. How to take Qaialdo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Dose
Your doctor will recommend the dose and frequency. The dose must be taken with food.
Use in adults
Your doctor will decide the most appropriate dose for your situation. Treatment starts at the lowest
dose and can be increased, if necessary, to a maximum of 400 mg of spironolactone per day.
If you have any doubts about how much medicine to take, ask your doctor or pharmacist.
Use in the elderly
Your doctor will start with a low initial dose and gradually increase the dose as needed to
achieve the desired effect.
Use in children
If you are giving Qaialdo to a child, the dose given will depend on the child's age and weight.

• The dose for a newborn is between 1 and 2 mg/kg per day, divided into one or two doses.
• The dose in 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), can be used in cases of resistant ascites or primary hyperaldosteronism.

Route and method of administration
Oral use.
This medicine must be taken with meals.
Always use the syringes provided to take the medicine.
The smallest syringe is used to draw up doses less than or equal to 10 mg. The syringe can contain at
most 1 mL. The syringe has lines indicating an increment of 0.1 mL and is marked at
0.5 and 1.0 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 can hold up to 5 mL. This syringe has lines indicating an
increment of 0.1 mL and is marked at intervals of 1 mL. This syringe should be used to
measure doses greater than 10 mg.
It is important to use the correct dosing syringe for administering the medicine. Your doctor or
pharmacist will tell you which syringe to use based on the prescribed dose.
When you take the medicine or give it to a child or another person, wash your hands before and
after.
To use the medicine, follow the instructions below:

Figure 1Figure 2Figure 3Figure 4Figure 5

• 1. Shake the bottle thoroughlybefore use (to ensure the medicine is well mixed) (figure 1).
• 2. Remove the cap from the bottle (figure 2), place the adapter inserting it firmly into the opening of the bottle and leave it in this position for subsequent doses (figure 3).
• 3. Insert the tip of the dosing syringe into the hole in the adapter (figure 4). To administerthe correct dose, your doctor or pharmacist will advise you on the correct syringe to use,the 1 mL or the 5 mL one.
• 4. Turn the bottle upside down (figure 5).
• 5. Pull back the plunger of the syringe to transfer the medicine from the bottle into the syringe. Pull the plunger up to the mark corresponding to the prescribed dose (figure 5). If you are unsure about the amount of medicine to draw up into the syringe, always ask your doctor or nurse for advice.
• 6. Put the bottle back in an upright position and gently remove the syringe from the adapter, holding it by the body rather than the plunger.
• 7. Gently place the tip of the syringe in your mouth and inside your cheek.
• 8. Push the plunger slowly and gently to gradually dispense the medicine inside your cheek and swallow it. DO NOT push the plunger forcefully or spray the medicine into the back of your throat, as it may go down the wrong way.
• 9. Remove the syringe from your mouth.

• 10. Swallow the dose of oral suspension and drink some water, making sure no medicine remains in your mouth.
• 11. Put the cap back on the bottle leaving the adapter in place. Make sure the cap is tightly closed.
• 12. Wash the syringe with warm water and rinse well. Hold the syringe under water and pull the plunger up and down several times to ensure the inside of the syringe is clean. Allow the syringe to dry completely in the air before using it again to administer a dose. Do not dry it manually. Store the syringe in a clean place together with the medicine.

Repeat the above operations for each dose, according to the instructions of your doctor or
pharmacist.

If you take more Qaialdo than you should
If you accidentally take more Qaialdo than you should, seek immediate medical attention or go to the
nearest hospital emergency room.
Symptoms of an overdose are drowsiness, dizziness, dehydration and possibly
confusion. Do not drive.
You may also feel sick or vomit, suffer from diarrhea and develop skin rashes that look like
flat red patches on the skin, with small bumps on top.
Changes in sodium and potassium levels in the blood may make you feel weak and cause
tingling, prickling or numbness of the skin and/or muscle spasms, but it is unlikely that these
symptoms are associated with a serious 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 the
dose, take it as soon as you remember, unless it is less than 8 hours until the next
dose.

If you stop taking Qaialdo
It is important to continue taking Qaialdo until your doctor tells you to stop treatment,
even if you start to feel better.
If you stop taking Qaialdo too soon, your condition may worsen.
If you have any doubts about using this medicine, ask 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, the symptoms may be serious.

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

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

• Hyperkalemia (high levels of potassium in the blood)

Common:may affect up to 1 in 10 people

• Confusion
• Dizziness
• Nausea
• Itching
• Rash
• Muscle spasms or leg cramps
• Sudden kidney failure
• Gynecomastia (enlargement of the breasts in men)
• Breast pain (in men)
• General feeling of unwellness

Uncommon: may affect up to 1 in 100 people

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

Not known:frequency cannot be estimated based on available data

• Leukopenia (low levels of white blood cells)
• Agranulocytosis (very low levels of a type of white blood cells called granulocytes, important for fighting infections)
• Anemia (low levels of red blood cells, which can cause fatigue and paleness)
• Thrombocytopenia (low levels of platelets in the blood, which can cause bleeding and bruising)
• Eosinophilia (an excess of eosinophils, a type of white blood cells)
• Purpura (purple spots similar to bruises)
• Changes in libido in men and women
• Impotence in men
• Stomach and intestinal problems
• Pemphigoid (skin disorder that presents with fluid-filled blisters)
• Rash with eosinophilia and systemic symptoms (a serious reaction affecting the skin, blood and internal organs).
• Stevens-Johnson syndrome (potentially life-threatening reaction with flu-like symptoms and painful rash affecting skin, mouth, eyes and genitals)
• Toxic epidermal necrolysis (potentially life-threatening reaction with flu-like effects and blister formation on skin, eyes, mouth and genitals)
• Alopecia (hair loss)
• Hirsutism (excessive body hair growth)
• Headache
• Sleepiness
• Ataxia (inability to coordinate muscle movements)
• Fever

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed 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 pack after “Exp.” The expiry
date refers to the last day of that month.
After first opening the bottle, store at a temperature below 25 °C and dispose of any unused medicine
after 12 weeks.
Keep the bottle tightly closed.
Do not dispose of any medicine in drains or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help to protect the environment.

6. Package Contents and Other Information

What Qaialdo contains

• The active ingredient 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, masking flavour, 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 Qaialdo and package contents
Qaialdo is a viscous, white or off-white oral suspension.
It is supplied in 150 mL glass bottles, with a child-resistant closure cap.
Each pack contains one bottle, an adapter and two dosing syringes (one syringe graduated up to
1 mL and one syringe graduated up to 5 mL).
The doctor or pharmacist will advise which syringe to use based on the prescribed dose.

Marketing Authorisation Holder
Nova Laboratories Ireland Limited
3rd Floor Ulysses House
Foley Street, Dublin 1
D01 W2T2
Ireland

Manufacturer
Pronav Clinical Ltd.
Unit 5
Dublin Road Business Park
Carraroe, Sligo
F91 D439
Ireland
More detailed information on this medicine is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .

APPENDIX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATION OF THE TERMS
OF MARKETING AUTHORISATIONS
Scientific conclusions
In light of the assessment by the Pharmacovigilance and Risk Assessment Committee
( Pharmacovigilance and Risk Assessment Committee, PRAC) of the Periodic Safety Update Reports
( Periodic Safety Update Report, PSUR) for spironolactone, the PRAC’s scientific conclusions
are as follows:
In light of the data available in the literature, and the information reported in the EU Summary of Product Characteristics of mitotane, the
PRAC considers that a causal relationship between spironolactone and reduced levels of mitotane in plasma in
patients with adrenocortical carcinoma treated with mitotane is at least a reasonable possibility. The
PRAC concluded that the product information for medicines containing spironolactone should be
modified accordingly.
Having examined the PRAC’s recommendation, the Committee for Human Medicinal Products
( Committee for Human Medicinal Products, CHMP) agrees with the related overall conclusions and
with the justification for the recommendation.

Justification for variation of the terms of marketing authorisations
Based on the scientific conclusions on spironolactone, the CHMP considers that the benefit/risk
balance of the medicines containing spironolactone remains unchanged, subject to the proposed changes
to the product information.
The CHMP recommends the variation of the terms of the marketing authorisations.