Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - nityr

Document Subject

Generated Narrative: MedicinalProductDefinition mpaf7ada14ad8929ea357c14ec95ee08dd

identifier: http://ema.europa.eu/identifier/EU/1/18/1290/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

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productName: Nityr 10 mg tablets

type: Full name

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part: nan

type: Invented name part

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part: nan

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-af7ada14ad8929ea357c14ec95ee08dd

identifier: http://ema.europa.eu/identifier/EU/1/18/1290/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - nityr

Attesters

What is in this leaflet

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

Nityr contains the active substance nitisinone.

Nityr is used to treat:

• A rare disease called hereditary tyrosinemia type 1 in adults, adolescents and children.
• A rare disease called alkaptonuria (AKU) in adults.

In these diseases your body is unable to completely break down the amino acid tyrosine (amino acids are building blocks of our proteins), forming harmful substances. These substances are accumulated in your body. Nityr blocks the breakdown of tyrosine and the harmful substances are not formed.

For the treatment of hereditary tyrosinemia type 1, you must follow a special diet while you are taking this medicine, because tyrosine will remain in your body. This special diet is based on low tyrosine and phenylalanine (another amino acid) content.

For the treatment of AKU, your doctor may advise you to follow a special diet.

Do not take Nityr

• if you are allergic to nitisinone or any of the other ingredients of this medicine (listed in section 6).

Do not breast-feed while taking this medicine, see section Pregnancy and breast-feeding .

Warnings and precautions
Talk to your doctor or pharmacist before taking Nityr.

• Your eyes will be checked by an ophthalmologist before and regularly during nitisinone treatment. If you get red eyes or any other signs of effects on the eyes, contact your doctor immediately for an eye examination. Eye problems could be a sign of inadequate dietary control (see section 4).
  During the treatment, blood samples will be drawn in order for your doctor to check whether the treatment is adequate and to make sure that there are no possible side effects causing blood disorders.

If you receive Nityr for treatment of hereditary tyrosinemia type 1, your liver will be checked at regular intervals because the disease affects the liver.

Follow-up by your doctor should be performed every 6 months. If you experience any side effects, shorter intervals are recommended.

Other medicines and Nityr
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Nityr may interfere with the effect of other medicines, such as:

• Medicines for epilepsy (such as phenytoin)
• Medicines against blood clotting (such as warfarin)

Nityr with food
Nityr can be taken with or without food throughout your course of treatment.

Pregnancy and breast-feeding The safety of this medicine has not been studied in pregnant and breast-feeding women.
Please contact your doctor if you plan to become pregnant. If you become pregnant you should contact your doctor immediately.
Do not breast-feed while taking this medicine, see section Do not take Nityr .

Driving and using machines This medicine has minor influence on the ability to drive and use machines. However, if you experience side effects affecting your vision you should not drive or use machines until your vision is back to normal (see section 4 Possible side effects ).

Nityr contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For hereditary tyrosinemia type 1, treatment with this medicine should be started and supervised by a doctor experienced in the treatment of the disease .

For hereditary tyrosinemia type 1, the recommended total daily dose is 1 mg/kg body weight administered orally. Your doctor will adjust the dose individually.
It is recommended to administer the dose once daily. However, due to the limited data in patients with body weight < 20 kg, it is recommended to divide the total daily dose into two daily administrations in this patient population.

For AKU, the recommended dose is 10 mg once daily.

Patients who have problems swallowing Nityr tablets whole, are recommended to take alternative nitisinone formulations.

If you take more Nityr than you should
If you have taken more of this medicine than you should, contact your doctor or pharmacist as soon as possible.

If you forget to take Nityr Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, contact your doctor or pharmacist.

If you stop taking Nityr
If you have the impression that the medicine is not working properly, talk to your doctor. Do not change the dose or stop the treatment without talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any side effects relating to the eyes, talk to your doctor immediately to have an eye examination. Treatment with nitisinone leads to higher levels of tyrosine in the blood which can cause eye related symptoms. In patients with hereditary tyrosinemia type 1, commonly reported eye related side effects (may affect more than 1 in 100 people) caused by higher tyrosine levels are inflammation in the eye (conjunctivitis), opacity and inflammation in the cornea (keratitis), sensitivity to light (photophobia) and eye pain. Inflammation of the eyelid (blepharitis) is an uncommon side effect (may affect up to 1 in 100 people).

In AKU patients, eye irritation (keratopathy) and eye pain are very commonly reported side effects (may affect more than 1 in 10 people).

Other side effects reported in patients with hereditary tyrosinemia type 1 are listed below: Other common side effects

• Reduced number of platelets (thrombocytopenia) and white blood cells (leukopenia), shortage of certain white blood cells (granulocytopenia).

Other uncommon side effects

• increased number of white blood cells (leucocytosis),
• itching (pruritus), skin inflammation (exfoliative dermatitis), rash.

Other side effects reported in patients with AKU are listed below: Other common side effects

• bronchitis
• pneumonia
• itching (pruritus), rash

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

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 carton and bottle label after EXP.
The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.
Store in the original bottle in order to protect from light.
Once the bottle is opened, the medicine can be stored for a period of 2 months, after which it must be discarded.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Nityr contains

• The active substance is nitisinone. Each tablet contains 10 mg nitisinone.
• The other ingredients are glycerol dibehenate and lactose monohydrate (see section 2 under Nityr contains lactose ).

What Nityr looks like and contents of the pack
Nityr are white to beige, round, flat tablets, which may display light yellow to brown speckles, marked with L on one side and 10 on the other side.
Nityr is available in a bottle containing 60 tablets.

Marketing Authorisation Holder
Cycle Pharmaceuticals (Europe) Limited 70 Sir John Rogerson s Quay
Dublin 2, D02 RIreland

Manufacturer Millmount Healthcare Limited Block-7, City North Business Campus Stamullen, Co. Meath,
K32 YD60, Ireland

Sciensus International B.V. Bijsterhuizen 36604 LV Wijchen Netherlands

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency website:
http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.