ZTALMY 50 mg /Ml Оральная Суспензия

Содержание инструкции

1. ZTALMY 50 mg/mL oral suspension
   1. What is ZTALMY and what is it used for
   2. What you or your child need to know before taking ZTALMY
2. ZTALMY if you have doubts about these effects or if you are taking central nervous system depressants
   1. How to take ZTALMY
   2. Possible side effects
   3. How to store ZTALMY
   4. Package Contents and Other Information

ZTALMY 50 mg/mL oral suspension

ganaxolone
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced by you or the patient while taking this medicine. See the end of
section 4 for information on how to report adverse effects.

Read this leaflet carefully before you or your child takes this medicine,
as it contains important information.

• 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 only for you. Do not give it to other people, even if their symptoms are the same as yours or your child's, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What ZTALMY is and what it is used for
• 2. What you or your child needs to know before you take ZTALMY
• 3. How to take ZTALMY
• 4. Possible side effects
• 5. How to store ZTALMY
• 6. Contents of the pack and other information

1. What is ZTALMY and what is it used for

ZTALMY contains the active substance ganaxolone, a neuroactive steroid that works by binding to
specific receptors and preventing epileptic seizures from originating in the brain.
ZTALMY is used, in patients aged between 2 and 17 years, for the treatment of a rare disease
characterized by epileptic seizures called “cyclin-dependent kinase-like 5 deficiency disorder
(CDKL5)” (CDD). If ZTALMY helps to treat seizures, it can continue to be used when you or your
child reach 18 years of age.
ZTALMY is used in association with other antiepileptic drugs.
This medicine reduces the number of epileptic seizures that you or your child may have each
day.

2. What you or your child need to know before taking ZTALMY

Do not take ZTALMYif you are allergic to ganaxolone or any of the other ingredients of this
medicine (listed in section 6).

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

• you or your child experience drowsinessZTALMY can cause drowsiness, or a feeling of excessive calm and relaxation (i.e. a feeling of sedation). Talk to your doctor or pharmacist before taking

ZTALMY if you have doubts about these effects or if you are taking central nervous system depressants

such as other medicines for the treatment of seizures like opioids, antidepressants or alcohol, because these may increase drowsiness and the sedative effects of ZTALMY.

• You or your child have had thoughts about harming yourself or committing suicideIf you notice unusual changes in mood or behavior, or if you have thoughts about harming yourself or committing suicide, contact your doctor immediately. If you are caring for a child with CDD, you should pay attention to any unusual changes in their mood or behavior or any talk that might indicate thoughts of self-harm or suicide. If you notice any of these behaviors, contact your doctor immediately.
• You or your child have a history of alcohol or substance abuse dependenceZTALMY may be misused or used for inappropriate purposes. Talk to your doctor or pharmacist before taking ZTALMY if you have a history of alcohol or substance abuse dependence.
• You or your child have severe liver problemsYour doctor will closely monitor you or your child during treatment and may reduce the dose of ZTALMY.

Children and adolescents
ZTALMY should not be given to children under 2 years of age, as there is no information on use in children under this age group.

Other medicines and ZTALMY
Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicine. Taking ZTALMY with some other medicines can cause unwanted effects, change the action of other medicines or the action of ZTALMY.
Do not start or stop taking other medicines without first consulting your doctor or pharmacist.
Tell your doctor if you or your child is taking any of the following medicines, as the dose of ZTALMY may need to be adjusted:

• medicines containing valproate, used to treat epilepsy, may require a lower dose of ZTALMY;
• medicines that can reduce the action of ZTALMY may require a higher dose of ZTALMY;
• other antiepileptic or anticonvulsant medicines, such as carbamazepine, phenytoin, phenobarbital and primidone;
• antibiotics, such as rifampicin;
• St. John's wort (Hypericum perforatum), a herbal remedy used for mild depression.

The interaction between this medicine and oral contraceptives has not been studied. Talk to your doctor if you are taking oral contraceptives.

ZTALMY with alcohol
Alcohol should not be consumed as it may increase drowsiness and the sedative effects of ZTALMY.

Pregnancy
If you are pregnant or suspect you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
ZTALMY is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.

Breast-feeding
Do not use ZTALMY while breast-feeding, unless your doctor decides that the benefits of taking ZTALMY outweigh the potential risks.

Driving and operating machinery
ZTALMY may make you feel sleepy/drowsy. If you experience these symptoms, do not drive vehicles, ride a bicycle or operate machinery until you feel alert.

ZTALMY contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per mL, i.e. it is essentially “sodium-free”.

ZTALMY contains sodium benzoate and benzoic acid
Each mL of this medicine contains 0.92 mg sodium benzoate and 0.00068 mg of benzoic acid. In newborns up to 4 weeks of age, sodium benzoate and benzoic acid can increase jaundice (yellowing of the skin and eyes).

ZTALMY contains benzyl alcohol
Each mL of this medicine contains 0.00023 mg of benzyl alcohol. Benzyl alcohol can cause allergic reactions. In young children, benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (wheezing respiratory syndrome). Do not administer to newborns up to 4 weeks of age unless otherwise recommended by your doctor. In young children (under 3 years of age), do not use for more than one week, unless otherwise recommended by your doctor or pharmacist. The risk is higher in young children due to accumulation. If you are pregnant or breast-feeding, or if you have liver or kidney disease, ask your doctor or pharmacist for advice. This is because large amounts of benzyl alcohol can accumulate in the body and cause adverse effects (called metabolic acidosis).

ZTALMY contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine contains 1.02 mg of methyl parahydroxybenzoate and 0.2 mg of propyl parahydroxybenzoate per mL, which may cause allergic reactions (including delayed reactions).

3. How to take ZTALMY

ZTALMY is administered under the supervision of a doctor experienced in the treatment
of epilepsy. Take this medicine following the doctor's instructions exactly at all times. If you have
any doubts, consult your doctor or pharmacist.
This is an oral suspension (a liquid to be swallowed). Your doctor or pharmacist will tell you the
amount (in mL) of oral suspension to take each day and how many times a day to take it.

The doctor will calculate the dose based on your body weight.You may start by taking a low
dose that the doctor will gradually increase over time.
If you have severe liver impairment, the doctor will start treatment with a lower dose and
follow a different titration schedule.
Patient with weight less than or equal to28 kg
For you or your child, the dose will be gradually increased over 4 weeks to receive
the recommended maximum daily dose of 63 mg/kg/day, administered in three separate doses every
8 hours.
Patient with weight greater than28 kg
For you or your child, the dose will be gradually increased over 4 weeks to receive
the recommended maximum daily dose of 1,800 mg/day, administered in three separate doses every
8 hours.
It is recommended to take 3 equal doses throughout the day. However, as ZTALMY may
cause drowsiness, the doctor may decide to administer a lower dose during the day and
a higher dose in the evening, to avoid drowsiness during the day.
Contact your doctor if you have any doubts about the dose or if you think it may need to
be modified.
How to take ZTALMY

• Take the medicine during or immediately after meals
• If possible, try to take it with similar types of food (e.g., with similar fat content), so as to achieve the same effect each time
• Do not mix ZTALMY with foods or beverages
• To ensure an accurate dose, use the reusable oral administration syringes provided in each package.

Instructions for use
Each package containing 1 bottle contains:

a 1 bottle of oral suspension closed with a child-resistant cap n a i l a t
I 2 reusable oral administration syringes of 12 mL and 2 reusable oral administration syringes of 3 mL a i z n e g A

1 bottle adapter

c o

ZTALMY is also available in a package with 5 bottles of oral suspension, 5 reusable oral administration syringes of 12 mL and 5 bottle adapters. The package containing
5 bottles of ZTALMY does not include a 3 mL reusable oral administration syringe.

• If you have any doubts about how to prepare or take the prescribed dose of ZTALMY, contact your doctor, pharmacist or nurse.
• In the 1-bottle package, reusable oral administration syringes of 12 mL and 3 mL are provided. If the dose is less than or equal to 3 mL, use the smaller 3 mL syringes to take the medicine. If the dose is greater than 3 mL, use the larger 12 mL syringes to take the dose.
• For oral administration, always use the correct reusable syringe provided with ZTALMY to ensure you measure the right amount of ZTALMY. Do not use kitchen spoons. For administration, do not mix ZTALMY with foods or beverages.
• Each 3 mL oral administration syringe can be used for 16 consecutive days. After 16 days, the used syringe should be discarded and the spare syringe in the box should be used.
• Use ZTALMY within 30 days of first opening the bottle. There is a space on the bottle label to write down the date to discard the bottle after opening, so you do not forget it.
• After 30 days, discard any unused ZTALMY and start a new bottle.

Preparing the bottle

l 1. Hold the bottle in your hand and shake it a well for 1 minute. t Always shake the bottle well for 1 minute, then let it rest I for 1 minute so that any foam that forms a during shaking can settle before measuring and i administering each dose of z ZTALMY. This helps to measure the correct amount of medicine. n NB: this operation must be e provided for each dose of the medicine.

i

2. Remove the child-resistant cap on the bottle by pushing it down and rotating it to the left (counterclockwise).	a c o
3. Puncture and remove the induction seal from the bottle. NB: this operation is only provided for the first use of the bottle.	F a r m
4. Hold the bottle tightly with one hand, pushing the adapter firmly into the neck of the bottle with the other hand and making sure it is fully inserted. If the adapter is not fully inserted, it may detach and cause suffocation. NB: once inserted, do not remove the pressure adapter from the bottle.	a n a d e l

Preparing the dose

t 5. Insert the tip of the appropriate reusable oral administration syringe into the bottle adapter and, once the syringe is in position, turn the bottle upside down. It is important to use the correct reusable oral administration syringe to measure the dose: if the dose is equal to or less than 3 mL (150 mg), use the smaller 3 mL syringe if the dose is greater than 3 mL (150 mg), use the larger 12 mL syringe.

6. Slowly pull back the plunger of the syringe, so that the volume (number of mL) of oral suspension needed is drawn into the syringe. Align the end of the plunger with the volume marking required, as shown in the figure on the side. If there is an air bubble in the syringe, push the liquid back into the bottle while keeping the bottle upside down and repeat operation 6 until the bubble disappears.

F a r m a c o

7. Put the bottle upright and carefully remove the oral administration syringe from the adapter. l a t I

i a n a d e l

Taking or administering ZTALMY

z n 8. Place the tip of the oral administration syringe inside the cheek and gently push the plunger to allow the medicine to flow out. Do not push the plunger forcefully, or direct the medicine towards the back of the mouth or throat.

9. Screw the child-resistant cap tightly back onto the bottle, rotating the cap to the right (clockwise). You do not need to remove the bottle adapter; the cap fits over it.	m a c o
10. Wash the oral administration syringe immediately after use. Remove the plunger from the syringe cylinder and rinse both parts with tap water at room temperature. Caution: do not use bleach or other harsh cleaning solutions. Do not wash the oral administration syringe in the dishwasher.	d e l F a r
11. Eliminate water from both parts of the syringe and let them dry in the air separately until next use. Make sure that both parts are completely dry before l inserting the plunger into a the syringe cylinder for subsequent use. If both parts are not t completely dry before the next dose, use the syringe provided in the package. If you are using the 12 mL syringe that accompanies each bottle, do not discard the reusable oral administration syringes until the bottle is empty. If you use the 3 mL syringe, discard it after 16 days.	i a n a
e 12. Repeat operations 1-3 and 6-12 for each subsequent dose.

If you take more ZTALMY than you should
If, accidentally, you take more ZTALMY than you should, inform your doctor or
pharmacist immediately or contact the emergency room of the nearest hospital and bring the medicine with you. You may
experience drowsiness after taking an excessive amount of medicine.

If you forget to take ZTALMY
If you forget to take a dose, you can take the missed dose up to 4 hours before the next
scheduled dose. If less than 4 hours remain until the next dose, it is recommended to skip the missed dose
and continue with the next scheduled dose.

If you stop taking ZTALMY
Do not reduce the dose or stop taking ZTALMY without first consulting your doctor.
Suddenly stopping this treatment may increase seizures. Your doctor will explain how to gradually stop taking ZTALMY.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine. Tell your doctorif you
experience any of the following side effects:

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

• feeling sleepy;
• fever.

Common(may affect up to 1 in 10 people):

• feeling calm or overly relaxed;
• feeling excessively tired during the day or sleeping longer than usual at night;
• lack of energy;
• drooling;
• production of more saliva than usual.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system detailed in Appendix V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store ZTALMY

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 package and on the
vial label after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Dispose of any unused
medicine 30 days after first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What ZTALMY contains

• The active ingredient is ganaxolone. Each mL of oral suspension contains 50 mg of ganaxolone.
• The other ingredients are: hypromellose (E464), polyvinyl alcohol (E1203), sodium lauryl sulfate (E487), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium benzoate (E211), anhydrous citric acid (E330), disodium citrate dihydrate (E311), artificial cherry flavour [including propylene glycol (E1520) and benzyl alcohol (E1519)], sucralose (E955), simethicone emulsion [simethicone, polysorbate 65, methylcellulose, polyethylene glycol monostearate, glyceryl monostearate, xanthan gum, benzoic acid (E210), sorbic acid and purified water], purified water (see also paragraphs 2 "ZTALMY contains sodium", "ZTALMY contains sodium benzoate and benzoic acid", "ZTALMY contains benzyl alcohol" and "ZTALMY contains methyl parahydroxybenzoate and propyl parahydroxybenzoate").

Description of the appearance of ZTALMY and package contents
ZTALMY is an oral suspension ranging in colour from white to whitish. It is supplied in a plastic
bottle fitted with a child-resistant plastic cap. Each bottle contains 110 mL of
oral suspension.
ZTALMY is supplied in packs of:

• one bottle of oral suspension, two 12 mL oral dispensing syringes and two 3 mL oral dispensing syringes, and a bottle adapter; or
• five bottles of oral suspension, five 12 mL oral dispensing syringes and five bottle adapters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Immedica Pharma AB
113 63 Stockholm
Sweden

Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website, http://www.ema.europa.eu .