Patient leaflet - Nityr 10 mg tablets
1. WHAT NITYR IS AND WHA
T IT IS USED FOR
Nityr contains the active subst Nityr is used to treat:
ance nitisinone.
A rare disease called hered adults, adolescents and chi
itary tyrosinemia type 1 in ldren.
A rare disease called alkapt
onuria (AKU) in adults
In these diseases your body down the amino acid tyrosine of our proteins), forming substances are accumulated breakdown of tyrosine and t
is unable to completely break (amino acids are building blocks harmful substances. These in your body. Nityr blocks the he harmful substances are not
formed.
For the treatment of heredita follow a special diet while because tyrosine will remain i based on low tyrosine and phe content.
ry tyrosinemia type 1, you must you are taking this medicine, n your body. This special diet is nylalanine (another amino acid)
For the treatment of AKU, your a special diet.
doctor may advise you to follow
2. WHAT YOU NEED TO KNO
W BEFORE YOU TAKE NITYR
Do not take Nityr
if you are allergic to nitisin ingredients of this medicin
one or any of the other e (listed in section 6).
Do not breast-feed while tak “Pregnancy and breast-feeding
ing this medicine, see section ”.
Warnings and precautions
Talk to your doctor or pharma
cist before taking Nityr.
| Paper | TBC | ||
Cycle Pharma Previous Code
an ophthalmologist before ne treatment.
her signs of effects on the eyes, ately for an eye examination. n of inadequate dietary control
During the treatment, blood s for your doctor to check whet and to make sure that there causing blood disorders.
amples will be drawn in order her the treatment is adequate are no possible side effects
If you receive Nityr for treatm type 1, your liver will be check the disease affects the liver.
ent of hereditary tyrosinemia ed at regular intervals because
Follow-up by your doctor sh months. If you experience any are recommended.
ould be performed every 6 side effects, shorter intervals
Other medicines and Nityr
Tell your doctor or pharmacist i
f you are taking, have recently taken or might take any other m Nityr may interfere with the eff
edicines.
ect of other medicines, such as: as phenytoin)
- Medicines for epilepsy (such
Medicines against blood clo
tting (such as warfarin)
Nityr with food
Nityr can be taken with or w course of treatment.
ithout food throughout your
Pregnancy and breast-feeding
The safety of this medicine has and breast-feeding women. If you are pregnant or breas pregnant or are planning to ha pharmacist for advice before ta Do not breast-feed while taking not take Nityr”.
not been studied in pregnant t-feeding, think you may be ve a baby, ask your doctor or king this medicine.
this medicine, see section “Do
Driving and using machines
This medicine has minor influe use machines. However, if affecting your vision you shou until your vision is back to norm effects”).
nce on the ability to drive and you experience side effects ld not drive or use machines al (see section 4 “Possible side
Nityr contains lactose
If you have been told by yo intolerance to some sugars, con this medicine.
ur doctor that you have an tact your doctor before taking
3. HOW TO TAKE NITYR
Always take this medicine exact Check with your doctor or phar
ly as your doctor has told you. macist if you are not sure.
For hereditary tyrosinemia t medicine should be started experienced in the treatment o
ype 1, treatment with this and supervised by a doctor f the disease.
For hereditary tyrosinemia typ daily dose is 1 mg/kg body we doctor will adjust the dose indi It is recommended to admi However, due to the limited dat <20 kg, it is recommended to d two daily administrations in thi
e 1, the recommended total ight administered orally. Your vidually.
nister the dose once daily. a in patients with body weight ivide the total daily dose into s patient population.
For AKU, the recommended do
se is 10 mg once daily.
owcard or search for MHRA or Apple App Store.
http://www.mhra.gov.uk/yell
Yellow Card in the Google Play
Patients who have problems s are recommended to take alte
wallowing Nityr tablets whole, rnative nitisinone formulations.
By reporting side effects y information on the safety of th
ou can help provide more is medicine.
If you take more Nityr than yo
u should
If you have taken more of th contact your doctor or pharma
is medicine than you should, cist as soon as possible.
If you forget to take Nityr
Do not take a double dose to you forget to take a dose, cont
make up for a forgotten dose. If act your doctor or pharmacist.
If you stop taking Nityr
If you have the impression th properly, talk to your doctor. D the treatment without talking
at the medicine is not working
o not change the dose or stop to your doctor.
If you have any further questio ask your doctor, pharmacist or
ns on the use of this medicine, nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this med although not everybody gets t
icine can cause side effects, hem.
If you notice any side effects r doctor immediately to have a with nitisinone leads to higher which can cause eye related hereditary tyrosinemia type related side effects (may affec caused by higher tyrosine leve (conjunctivitis), opacity and (keratitis), sensitivity to light Inflammation of the eyelid (ble effect (may affect up to 1 in 10
elating to the eyes, talk to your n eye examination. Treatment levels of tyrosine in the blood symptoms. In patients with 1, commonly reported eye t more than 1 in 100 people) ls are inflammation in the eye inflammation in the cornea (photophobia) and eye pain. pharitis) is an uncommon side 0 people).
In AKU patients, eye irritation very commonly reported side in 10 people).
(keratopathy) and eye pain are effects (may affect more than 1
Other side effects reported tyrosinemia type 1 are listed b
in patients with hereditary elow:
Other common side effects
Reduced number of platele white blood cells (leukopen blood cells (granulocytopen
ts (thrombocytopenia) and ia), shortage of certain white ia).
Other uncommon side effects
increased number of white
blood cells (leucocytosis), mmation (exfoliative
- itching (pruritus), skin infla dermatitis), rash.
Other side effects reported in below:
patients with AKU are listed
5. HOW TO STORE NITYR Keep this medicine out of the s
ight and reach of children.
Do not use this medicine after on the carton and bottle labe refers to the last day of that m
the expiry date which is stated l after “EXP”. The expiry date onth.
Do not store above 30°C.
Store in the original bottle in o Once the bottle is opened, the period of 2 months, after whic
rder to protect from light. medicine can be stored for a h it must be discarded.
Do not throw away any m household waste. Ask your ph
edicines via wastewater or armacist how to throw away medicines you no longer us protect the environment.
e. These measures will help
6. CONTENTS OF THE PACK A
ND OTHER INFORMATION
What Nityr contains
The active substance is nitis
inone.
Each tablet contains 10 mg
nitisinone.
The other ingredients are gl monohydrate (see sectio lactose’).
ycerol dibehenate and lactose n 2 under ‘Nityr contains
What Nityr looks like and cont
ents of the pack
Nityr are white to beige, round light yellow to brown speckles and “10” on the other side. Nityr is available in a bottle con
, flat tablets which may display marked with “L” on one side taining 60 tablets.
Marketing Authorisation Hold
er
Cycle Pharmaceuticals Ltd
The Broers Building, 21 JJ Thomson Avenue, Cambridge, CB3 0FA
United Kingdom
Manufacturer
Central Pharma Contract Packa Caxton Rd,
ging Ltd
Bedford, MK41 0XZ
United Kingdom
This leaflet was last revised on
24 June 2024
Other common side effects
- bronchitis
- pneumonia
itching (pruritus), rash
Patented: see
www.cyclepharma.com/produ
ct-patent-information
Reporting of side effects
If you get any side effects, talk nurse. This includes any possib leaflet. You can also repo the Yellow Card Scheme Websi
to your doctor, pharmacist or le side effects not listed in this rt side effects directly via te:
AW000333
Printable Colours: 1
| UK | AW000333 | ||
| Date | |||
| Description | Nityr Tablets 10 mg | ||
| AW000317 | |||
CMO Code
Flat Size
Folded Size
Tech. Drawing
Notes
N/A
N/A
10 pt N/A pt