LITFULO 50 mg Twarde Kapsułki

Treść ulotki

1. Litfulo 50 mg hard capsules
   1. What is Litfulo and what is it used for
   2. What you need to know before taking Litfulo
   3. How to take Litfulo
   4. Possible side effects
   5. How to store Litfulo
   6. Package Contents and Other Information

Litfulo 50 mg hard capsules

ritlecitinib

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 during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.

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

report important safety information that you need to be aware of. Keep this patient card
with you.

Contents of 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

1. What is Litfulo and what is it used for

Litfulo contains the active substance ritlecitinib. It is used to treat severe alopecia areata in adults and
adolescents aged 12 years and older. Alopecia areata is a disease in which your
immune system attacks the hair follicles, causing inflammation that leads to hair loss and facial/body
hair loss.
Litfulo works by reducing the activity of enzymes called JAK3 and TEC kinases involved
in hair follicle inflammation. This reduces inflammation, promoting hair and hair regrowth in patients with alopecia areata.

2. What you need to know before taking Litfulo

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 ongoing infection, including tuberculosis;
• if you have severe liver problems;
• if you are pregnant or breastfeeding (see section “Pregnancy, contraception, breastfeeding and fertility”).

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

• you have an infection (possible signs may include fever, sweating, chills, muscle aches, cough, shortness of breath, blood in your sputum, weight loss, diarrhea, stomach pain, burning during urination, more frequent urination than usual, acute feeling of fatigue). Litfulo may reduce the body's ability to fight infections and therefore worsen an existing infection or increase the likelihood of contracting a new one;
• you have diabetes or are over 65 years of age, you may have a higher risk of contracting infections.
• you have, or have had, tuberculosis or have been in close contact with someone with tuberculosis or if you live in or travel to geographical areas where tuberculosis is very common. Your doctor will test you for tuberculosis before starting treatment with Litfulo and may repeat the test during treatment;
• you have already had a herpes infection (such as chickenpox or shingles), as Litfulo may cause it to recur. Tell your doctor if you develop a painful rash with blisters as it may be a sign of shingles;
• you have already had hepatitis B or hepatitis C; your doctor will test you for hepatitis before starting treatment with Litfulo and may repeat the test during treatment.
• you have cancer or have had it in the past; it is unclear whether Litfulo increases the risk of cancer and your doctor will assess with you whether treatment with this medicine is appropriate and whether you will need to undergo examinations during such treatment, including periodic skin checks;
• you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism). Tell your doctor if you experience pain and swelling in your leg, chest pain or shortness of breath as these may be signs of blood clots in the veins;
• you have had blood clots in an artery in your eye (retinal occlusion) or heart (heart attack). Tell your doctor if you experience sudden changes in vision (blurred vision, partial or total loss of vision), chest pain or shortness of breath, as these changes may be a sign of blood clots in the arteries.
• you have recently received or plan to receive a vaccination (immunization), because some vaccines (live vaccines) are not recommended during the use of Litfulo. Before starting treatment with Litfulo, check with your doctor if your vaccinations are up to date and if any others are needed, including the one against shingles.
• you have unexplained symptoms caused by a problem with the nervous system while taking Litfulo. The doctor will assess with you whether the treatment should be stopped or not.

Further monitoring tests
Your doctor will perform blood tests to check if you have a low white blood cell count or a low
platelet count before and about 4 weeks after starting treatment with Litfulo and, if
necessary, may modify it.

Children
This medicine is not approved for use in children under 12 years of age because the safety
and benefits of Litfulo have not been 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 medicine.
In particular, tell your doctor or pharmacist before taking Litfulo if you are taking some
medicines for the treatment of:

• 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 cause an increase in these medicines in the blood.
If any of the above conditions apply to you or if you have doubts, talk to your doctor or
pharmacist before taking Litfulo.

Pregnancy, contraception, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Contraception in women
If you are a woman of childbearing potential, you must use effective contraceptive measures during treatment with
Litfulo and for at least one month after the last dose of treatment. Your doctor can advise you on appropriate
contraceptive methods.
Pregnancy
Do not use Litfulo if you are pregnant or suspect you are pregnant. This
medicine may harm the developing baby. Tell your doctor immediately if you become
pregnant or think you may be pregnant during treatment.
Breastfeeding
Do not use Litfulo if you are breastfeeding as it is not known whether this medicine is excreted in breast
milk or has effects on infants. You and your doctor must decide whether to breastfeed or
use this medicine.
Fertility
It is not known whether Litfulo reduces fertility in women or men of childbearing potential.

Driving and using machines
Litfulo does not alter or negligibly alters the ability to drive vehicles or use machines.

Litfulo contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking
this medicine.

3. How to take Litfulo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 50 mg once a day to be taken orally.
You must swallow the capsule whole with water. Do not open, crush or chew the capsule before
swallowing as this could change the amount of medicine absorbed by the body.
You can take the capsule independently of meals.

If you take more Litfulo than you should
If you take more Litfulo than you should, contact your doctor as you may experience some of the
undesirable effects described in section 4.

If you forget to take Litfulo

• If you forget a dose, take it as soon as you remember, unless the time remaining until the next dose is less than 8 hours
• If less than 8 hours remain until the next dose, you can skip the forgotten dose and take the next dose as usual when scheduled.
• Do not take a double dose to make up for a missed capsule.

If you stop taking Litfulo
You should not stop taking Litfulo without talking to your doctor.
If it is necessary to stop taking Litfulo for a short period (not longer than
6 weeks), the risk of hair loss is low.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects
Seek immediate medical attention if you experience signs of:

• herpes zoster, a painful rash with blisters accompanied or not by fever
• urticaria, an itchy rash

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

• Infections of the nose, throat or trachea
• Diarrhoea
• Dizziness
• Acne
• Skin rash (different from urticaria and Herpes Zoster)
• Inflammation (swelling) of the hair follicles which may be itchy or painful (folliculitis)
• Increase of an enzyme called creatine phosphokinase, evident from blood tests (increased blood creatine phosphokinase)

Uncommon(may affect up to 1 in 100):

• Low platelet count evident from blood tests (decreased platelet count)
• Low white blood cell count evident from blood tests (decreased lymphocyte count)
• Increased liver enzymes in the blood (increased ALT and AST)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Litfulo

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, bottle or
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular temperature conditions for storage.
Store in the original package to protect the medicine from light.
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 Litfulo contains

• The active ingredient is ritlecitinib. Each hard capsule contains ritlecitinib tosylate equivalent to 50 mg of ritlecitinib.
• The other ingredients are: Hard capsule contents: microcrystalline cellulose, anhydrous lactose, crospovidone, dibeenate glycerol (see section 2 “Litfulo contains anhydrous lactose”). Hard capsule shell: hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), brilliant blue FCF (E133). Printing ink: shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide.

Description of the appearance of Litfulo and package contents
The opaque hard capsules of Litfulo 50 mg have a yellow body and a blue cap, are approximately 16 mm long and 6 mm wide, with “RCB 50” printed on the body and “Pfizer” printed on the cap in black.
The 50 mg hard capsules are supplied in high-density polyethylene (HDPE) bottles with a 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 to keep the capsules dry. Do not ingest the silica gel desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
For further information on this medicinal product, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон България
Teл.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: + 36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

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