Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - litfulo

Document Subject

Generated Narrative: MedicinalProductDefinition mp601fc65b81b2fd37245e8ad7fc0f0dd7

identifier: http://ema.europa.eu/identifier/EU/1/23/1755/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Litfulo 50 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-601fc65b81b2fd37245e8ad7fc0f0dd7

identifier: http://ema.europa.eu/identifier/EU/1/23/1755/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - litfulo

Attesters

What is in this leaflet

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

Litfulo contains the active substance ritlecitinib. It is used to treat severe alopecia areata in adults and adolescents 12 years of age and older. Alopecia areata is a disease where the body s own immune system attacks hair follicles, causing inflammation that leads to hair loss on the scalp, face and/or other parts of the body.

Litfulo works by reducing the activity of enzymes called JAK3 and TEC kinases, which are involved in inflammation at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.

Do not take Litfulo

• if you are allergic to ritlecitinib or any of the other ingredients of this medicine (listed in section 6).
• if you have a serious infection ongoing, including tuberculosis.
• if you have severe liver problems.
• if you are pregnant or breast-feeding (see the pregnancy, contraception, breast-feeding and fertility section).

Warnings and precautions
Talk to your doctor or pharmacist before and during treatment with Litfulo if you:

• have an infection (possible signs may be fever, sweating, chills, muscle aches, cough, shortness of breath, blood in your phlegm, weight loss, diarrhoea, stomach pain, burning when you urinate, urinating more often than usual, feeling very tired). Litfulo can reduce your body s ability to fight infections and so worsen an existing infection or make it more likely for you to get a new infection.
• if you have diabetes or are older than 65 years of age, you may have an increased risk of getting infections.
• have, or have had, tuberculosis or have been in close contact with someone with tuberculosis, or if you reside or travel in regions where tuberculosis is very common. Your doctor will test you for tuberculosis before starting Litfulo and may retest you during treatment.
• have ever had a herpes infection (such as chickenpox or shingles), because Litfulo may allow it to come back. Tell your doctor if you get a painful skin rash with blisters as this can be a sign of shingles.
• have ever had hepatitis B or hepatitis C. Your doctor will test you for hepatitis before starting Litfulo and may retest you during treatment.
• have cancer or have had any cancer it is not clear if Litfulo increases the risk of cancer, and your doctor will discuss with you if treatment with this medicine is appropriate and whether check-ups including regular skin checks will be necessary during treatment.
• have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism). Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins.
• have had blood clots in an artery in the eye (retinal occlusion) or heart (heart attack). Tell your doctor if you experience acute changes to your eyesight (blurry vision, partial or complete loss of vision), chest pain, shortness of breath as these changes may be a sign of blood clots in the arteries.
• have recently had or plan to have a vaccination (immunisation) this is because certain vaccines (live vaccines) are not recommended while using Litfulo. Check with your doctor to see if your vaccinations are up to date and if you require additional vaccinations, including vaccination for shingles, before treatment with Litfulo.
• have unexplained symptoms caused by a problem with the nervous system while taking Litfulo. Your doctor will discuss with you if treatment should be discontinued.

Additional monitoring tests

Your doctor will carry out blood tests to check if you have low white blood cell count or low platelet count before and approximately 4 weeks after starting Litfulo treatment and may adjust your treatment if necessary.

Children
This medicine is not approved for use in children below the age of 12 years because the safety and benefits of Litfulo are not established in this age group.

Other medicines and Litfulo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist before taking Litfulo if you are taking some of the medicines to treat:

• anxiety or sleep disorders (such as midazolam),
• heart rhythm problems (such as quinidine),
• gout (such as colchicine),
• rejection in organ transplantation (such as cyclosporine, everolimus, tacrolimus and sirolimus),
• migraine (such as dihydroergotamine and ergotamine),
• schizophrenia and chronic psychosis (such as pimozide),
• asthma (such as theophylline),
• muscle spasms (such as tizanidine),
• idiopathic pulmonary fibrosis (such as pirfenidone).

Litfulo may increase the amount of these medicines in your blood.

If any of the above apply to you or if you are not sure, talk to your doctor or pharmacist before taking Litfulo.

Pregnancy, contraception, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Contraception in women

If you are a woman of childbearing potential, you should use an effective method of contraception during treatment with Litfulo, and for at least one month after your last treatment dose. Your doctor can advise you on suitable methods of contraception.

Pregnancy

Do not use Litfulo if you are pregnant, think you may be pregnant or are planning to have a baby. This medicine can harm the developing baby. Tell your doctor right away if you become pregnant or think you might have become pregnant during treatment.

Breast-feeding

Do not use Litfulo while breast-feeding as it is not known if this medicine passes into breast milk or if breast-fed babies are affected. You and your doctor should decide if you will breast-feed or use this medicine.

Fertility

It is unknown if Litfulo reduces fertility in women or men of childbearing potential.

Driving and using machines Litfulo has no or limited effect on the ability to drive or use machines.

Litfulo 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.

The recommended dose is 50 mg once a day taken by mouth.

You should swallow your capsule whole with water. Do not open, crush or chew the capsule before swallowing as it may change how much medicine gets into your body.

You can take the capsule either with or without food.

If you take more Litfulo than you should If you take more Litfulo than you should, contact your doctor. You may get some of the side effects described in section 4. If you forget to take Litfulo

• If you miss a dose, take it as soon as you remember, unless your next dose is due in less than 8 hours.
• If there is less than 8 hours before your next dose, just skip the missed dose and take your next dose as usual when it is due.
• Do not take a double dose to make up for a forgotten capsule.

If you stop taking Litfulo You should not stop taking Litfulo without discussing this with your doctor.

If you need to stop taking Litfulo for a short time (not more than 6 weeks), the risk of losing your scalp hair is low.

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

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

Serious side effects

Talk to your doctor and get medical help straight away if you get any signs of:

• Shingles (herpes zoster), a painful skin rash with blisters with or without fever
• Hives (urticaria), an itching skin rash

Other side effects

Common (may affect up to 1 in 10 people)

• Infections of nose, throat or the windpipe
• Diarrhoea
• Dizziness
• Acne
• Rash (other than hives and shingles)
• Inflammation (swelling) of the hair follicles which may be itchy or painful (folliculitis)
• Increase in an enzyme called creatine phosphokinase, shown by blood test (blood creatine phosphokinase increased)

Uncommon (may affect up to 1 in 100 people)

• Low platelet count shown by blood test (platelet count decreased)
• Low white blood cell count shown by blood test (lymphocyte count decreased)
• Increase of liver enzymes in the blood (ALT and AST increased)

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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, bottle, or blister 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 package in order to protect from light.

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 Litfulo contains

• The active substance is ritlecitinib. Each hard capsule contains ritlecitinib tosylate equivalent to 50 mg ritlecitinib.

• The other ingredients are:
  Hard capsule content: cellulose microcrystalline, lactose monohydrate, crospovidone ), glycerol dibehenate (see section 2 Litfulo contains lactose monohydrate ). Hard capsule shell: hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133). Printing ink: shellac, propylene glycol, ammonia solution concentrated, black iron oxide (E172), potassium hydroxide.

What Litfulo looks like and contents of the pack Litfulo 50 mg opaque hard capsules have a yellow body and blue cap approximately 16 mm long and 6 mm wide of which the body is printed with RCB 50 and the cap is printed with Pfizer in black.

The 50 mg hard capsules are provided in high-density polyethylene (HDPE) bottles with polypropylene closure containing 28 hard capsules or in OPA/Al/PVC/Al blisters containing 30 or 90 hard capsules. The bottle contains a silica gel desiccant used to keep the capsules dry. Do not swallow the silica gel desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG
Boulevard de la Plaine 1050 Bruxelles
Belgium

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Betriebsst tte Freiburg
Mooswaldallee 1
79090 Freiburg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4
,
Te .: +359 2 970 4Magyarorsz g Pfizer Kft. Tel.: + 36 1 488 37 esk republika Pfizer, spol. s r.o. Tel: +420 283 004 Malta Vivian Corporation Ltd. Tel: +356 21344Danmark Pfizer ApS Tlf: +45 44 20 11 Nederland Pfizer bv Tel: +31 (0)800 63 34 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0

Pfizer A.E.
: +30 210 6785Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L. Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf. S mi: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520
Pfizer . . (Cyprus Branch) : +357 22817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel: + 371 670 35 This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: