KIGABEQ 100 mg Soluble Tablet

Зміст інструкції

1. Kigabeq 100 mg soluble tablets
2. Kigabeq 500 mg soluble tablets
   1. What is Kigabeq and what is it used for
   2. What you need to know before your child takes Kigabeq
   3. How to administer Kigabeq
   4. Possible side effects
   5. How to store Kigabeq
   6. Contents of the pack and other information

Kigabeq 100 mg soluble tablets

For children from 1 month of life to less than 7 years

Kigabeq 500 mg soluble tablets

For children from 1 month of life to less than 7 years
vigabatrin

Read this leaflet carefully before giving the medicine to the child because
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 for your child. Do not give it to other people, even if they have the same symptoms as your child, as it could be dangerous.
• If the child experiences any side effects, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Kigabeq and what is it used for

Kigabeq contains vigabatrin and is used for the treatment of infants and children from 1 month of age to less than 7 years. It is used for the treatment of infantile spasms (West syndrome) or, in combination with other antiepileptic drugs, for the treatment of partial epilepsy not adequately controlled by conventional therapy.

2. What you need to know before your child takes Kigabeq

Do not give Kigabeq:

• if the child is allergic to vigabatrin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your child’s doctor before giving Kigabeq if the child:

• suffers from or has previously suffered from depression or any other psychiatric condition
• has had kidney problems because they may develop symptoms such as sedation or confusion
• has had eye problems.

During treatment with vigabatrin, loss of visual field (loss of vision to the sides of the child's visual field) may occur. You should discuss this possibility with the doctor before the child starts treatment and the doctor will explain how to identify this undesirable effect. This loss of visual field can be severe and permanent and must therefore be diagnosed early to prevent progression. Worsening of visual field loss may continue after treatment is stopped. It is important to immediately report to the doctor if any of these changes in the child's vision occur. The doctor will check the child's visual field before starting treatment with vigabatrin and will continue checks at regular intervals during treatment.
If the child presents symptoms such as drowsiness, a decrease in consciousness and movements (stupor) or confusion, report it to the doctor who may reduce the dose or stop the treatment with Kigabeq.
A small number of people treated with antiepileptic drugs such as vigabatrin have developed thoughts of self-harm or suicide. Pay attention to symptoms suggestive of these thoughts: sleep disturbances, loss of appetite or weight, isolation, loss of interest in favorite activities.
If, at any time, the child exhibits these symptoms, contact the child’s doctor immediately.
Movement disorders have occurred in infants treated for infantile spasms (West syndrome). If you notice unusual movement in the child, report it to the doctor who may modify the treatment.
Tell your child’s doctor if you have undergone or are about to undergo laboratory tests because this medicine can lead to abnormal results.
You should talk to your child’s doctor if their condition does not improve within one month of starting taking vigabatrin.

Children
Do not give this medicine to children under 1 month of age or over 7 years of age.

Other medicines and Kigabeq
Tell your doctor if the child is taking, has recently taken or might take any other medicine.
Kigabeq should not be used in combination with other medicines that may have adverse effects on the eyes.

Pregnancy and breastfeeding
This medicine is not intended for use by women of childbearing potential or who are breastfeeding.

Driving and operating machinery
The child should not ride a bicycle, climb or engage in dangerous activities if they experience symptoms of dizziness or lightheadedness with Kigabeq. Visual disturbances have occurred in some patients treated with this medicine that may affect the ability to ride a bicycle, climb or participate in dangerous activities.

Kigabeq contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to administer Kigabeq

Administer this medicine to the child exactly as directed by the doctor. If you have any doubts, consult the doctor or pharmacist.

Dose
Do not change the dose on your own. The doctor develops the dose individually for your child, taking into account their body weight.
Kigabeq is available in 100 mg or 500 mg tablets that can be administered together to make up the correct dose for the child. Always check the label and the size of the tablet to be sure to administer the correct dose.
In infantile spasms (West syndrome) the recommended initial dose is 50 milligrams per kilogram of body weight per day. In refractory partial epilepsy (focal onset seizures), the recommended initial dose is 40 milligrams per kilogram per day. The doctor will adjust the dose during treatment, if necessary. If the child has kidney problems, the doctor may prescribe a lower dose.
The following table shows the number of Kigabeq tablets to administer to the child according to the dose prescribed by the doctor.

How to administer the medicine
Ask your child's doctor to show you how to administer the medicine. If you have any doubts, consult the doctor or pharmacist.
Kigabeq is for oral administration and can be taken before or after meals. The tablet can be divided into two equal parts.
Use only water to prepare the solution.

• Pour one or two teaspoons (approximately 5-10 ml) of water into a glass or cup.
• Add to the water the correct dose of Kigabeq tablets (whole or halved).
• Wait until the tablet has completely dissolved. This takes less than a minute, but dissolving can be accelerated by gently stirring the mixture by hand.
• The mixture will be whitish and cloudy. This is normal and the cloudiness is due to the fact that the tablet contains some excipients that do not dissolve completely.
• Give the mixture to the child immediately directly from the glass or cup.
• If the child is unable to drink from the glass or cup, an oral syringe can be used to gently squirt the mixture into the child's mouth, being careful not to cause choking: sit directly in front of and below the child so that the child's head is tilted forward and administer the mixture against the cheek.
• Rinse the glass or cup with one or two teaspoons (approximately 5-10 ml) of water and have the child drink it to be sure they take all the medicine.
• If the child is unable to swallow, the mixture can be administered via a gastric tube, using a suitable syringe. The tube should be rinsed with 10 ml of water

If the child takes too much Kigabeq
If the child accidentally takes an excessive number of Kigabeq tablets, report it immediately to the doctor or go to the nearest hospital or poison control center. Possible signs of overdose include dizziness or decreased level of consciousness.

If you forget to administer Kigabeq to the child
If you forget to administer a dose to the child, administer the dose as soon as you remember. If it is almost time for the next dose, give only one dose. Do not administer a double dose to make up for the missed tablet.

If you stop administering Kigabeq to the child
Treatment should not be discontinued without consulting the doctor. If the doctor decides to discontinue treatment, they will tell you to gradually reduce the dose. Do not stop treatment suddenly as this may cause the return of seizures in the child.
If you have any doubts 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 everyone will experience them.
Some patients may have more seizures (fits) while taking Kigabeq. In this case, contact your child's doctor immediately.

Serious side effects
Consult your doctor immediately if your child experiences the following:
Very common side effects (may affect more than 1 in 10 people)

• Changes in visual field - Approximately 33 out of 100 patients treated with vigabatrin may have changes in their visual field (restricted visual field). Visual field defects can range from mild to severe. They are usually diagnosed after months or years of treatment with vigabatrin. Changes in the visual field can be permanent, so it is important to diagnose them early to prevent progression. If your child experiences visual disturbances, contact your doctor immediately or go to hospital.

Other side effects include:
Very common side effects (may affect more than 1 in 10 people)

• excitement or restlessness
• pronounced fatigue and drowsiness
• joint pain

Common side effects (may affect up to 1 in 10 people)

• headache
• weight gain
• tremor (shaking)
• swelling (edema)
• dizziness
• sensation of numbness or tingling (pins and needles)
• decreased concentration and memory
• psychological problems, including aggression, nervousness, irritability, depression, abnormal thinking and unfounded suspicion (paranoia) and insomnia. These side effects usually resolve with a reduction in the dose of vigabatrin or with gradual discontinuation of the medicine. However, do not reduce the dose without first consulting your child's doctor. Contact your doctor if your child experiences these psychological effects
• nausea (feeling sick), vomiting and abdominal pain
• blurred vision, diplopia (double vision) and uncontrolled eye movement, which can cause dizziness
• speech disorders
• decreased number of red blood cells (anemia)
• hair loss (alopecia)

Uncommon side effects (may affect up to 1 in 100 people)

• lack of coordination or clumsiness
• more serious psychological problems such as euphoria or overexcitement, causing unusual behavior, and a feeling of detachment from reality
• skin rash

Rare side effects (may affect up to 1 in 1,000 people)

• severe allergic reaction, causing swelling of the face or throat. If your child experiences these symptoms, seek medical attention immediately.
• blisters or hives
• marked sedation (drowsiness), stupor and confusion (encephalopathy). These side effects usually resolve with a reduction in the dose or with gradual discontinuation of the medicine. However, do not reduce the dose without first consulting your child's doctor. Contact your doctor if your child experiences these effects
• attempted suicide
• other eye problems, such as retinal disorder causing, for example, poor night vision and difficulty adjusting between bright and dimly lit areas, sudden or unexplained loss of vision, sensitivity to light

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

• other eye problems, such as eye pain (optic neuritis) and vision loss, including color vision (optic atrophy)
• hallucinations (perceiving, seeing or hearing things that are not there)
• liver problems

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

• movement disorders and abnormalities on brain magnetic resonance imaging scans in infants treated for infantile spasms
• swelling of the protective layer of nerve cells in part of the brain, as observed on Magnetic Resonance Imaging, especially in infants
• decreased vision

Reporting of side effects
If your child experiences any side effects, including those not listed in this
leaflet, please tell your doctor or pharmacist. 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 Kigabeq

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 and the bottle. The expiry
date refers to the last day of that month. This medicine must be used within
100 days of first opening.
This medicine does not require any special storage conditions.
The solution must be administered immediately after preparation.
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. Contents of the pack and other information

What Kigabeq contains

• The active ingredient is vigabatrin.
• One soluble tablet of Kigabeq 100 mg contains 100 mg of vigabatrin
• One soluble tablet of Kigabeq 500 mg contains 500 mg of vigabatrin
• The other ingredients are: crospovidone type B, mannitol, sodium stearyl fumarate.

Description of the appearance of Kigabeq and contents of the pack
Kigabeq is presented as oval, white, scored soluble tablets.
Tablet size 100 mg: 9.4 mm x 5.3 mm
Tablet size 500 mg: 16.0 mm x 9.0 mm
The solution in water is whitish and cloudy.
Packs:
Kigabeq 100 mg is supplied in packs of 100 tablets.
Kigabeq 500 mg is supplied in packs of 50 tablets.

Marketing Authorisation Holder
ORPHELIA Pharma SAS
85 boulevard Saint-Michel
75005 Paris
France

Manufacturer
FARMEA
10 rue Bouché-Thomas ZAC d’Orgemont
49000 Angers
France
Centre Spécialités Pharmaceutiques
76-78 avenue du Midi
63800 Cournon d’Auvergne
France
Biocodex
1 avenue Blaise Pascal
60000 Beauvais
France
For further information on this medicinal product, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Lietuva
ENTAFARMA
Klonėnų vs. 1,
LT-19156 Širvintai dist. munic.
Tel. +370 382 33001
e-mail: [email protected]

България
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Luxembourg/Luxemburg
ORPHELIA Pharma SAS
Tél/Tel: + 33 1 42 77 08 18

Česká republika
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18

Magyarország
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Danmark
Biocodex Oy
Metsänneidonkuja 8
FI-02130 Espoo
Tel: +358 9 329 59100
e-mail: [email protected]

Malta
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18

Deutschland
Desitin Arzneimittel GmbH
Weg beim Jäger 214
D-22335 Hamburg
Tel.: +49 (0) 40 591 01 0
E-Mail: [email protected]

Nederland
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Eesti
ENTAFARMA
Klonėnų vs. 1,
LT-19156 Širvintai dist. munic.
Tel. +370 382 33001
e-mail: [email protected]

Norge
Biocodex AS
C/O regus Lysaker
Lysaker Torg 5, 3 etg
NO-1366 Lysaker
Tel: +47 66 90 55 66
e-mail: [email protected]

Ελλάδα
Biocodex
7 avenue Gallieni
F-94250 Gentilly

Österreich
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

España
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Polska
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

France
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Portugal
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Hrvatska
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18

Ireland
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18

România
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18

Slovenija
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18

Ísland
ORPHELIA Pharma SAS
Sími: + 33 1 42 77 08 18

Slovenská republika
ORPHELIA Pharma SAS
Tel: + 33 1 42 77 08 18

Suomi/Finland
Biocodex Oy
Metsänneidonkuja 8
FI-02130 Espoo
Tel: +358 9 329 59100
e-mail: [email protected]

Κύπρος
ORPHELIA Pharma SAS
Τηλ: + 33 1 42 77 08 18

Italia
Biocodex
7 avenue Gallieni
F-94250 Gentilly
Tel: + 33 (0)1 41 24 30 00
e-mail: [email protected]

Sverige
Biocodex AB
Knarrnäsgatan 7
SE-164 40 Kista
Tel: +46 8 615 2760
e-mail: [email protected]

Latvija
ENTAFARMA
Klonėnų vs. 1,
LT-19156 Širvintai dist. munic.
Tel. +370 382 33001
e-mail: [email protected]

United Kingdom(Northern Ireland)
VERITON PHARMA LTD
Tel: + 44 (0) 1932 690 325
Fax: +44 (0) 1932 341 091
Web: www.veritonpharma.com

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