FULVESTRANT 250 mg Solution

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet attached to the packaging: patient information
3. Fulvestrant Cipla, 250 mg, solution for injection in a pre-filled syringe
   1. You should read the contents of this leaflet carefully before using the medicine, as it contains important information for you.
   2. Table of contents of the leaflet
4. What is Fulvestrant Cipla and what is it used for
5. Important information before taking Fulvestrant Cipla
   1. When NOT to take Fulvestrant Cipla
   2. Warnings and precautions
   3. Children and adolescents
   4. Fulvestrant Cipla and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
6. How to take Fulvestrant Cipla
7. Possible side effects
   1. Serious side effects
   2. In case of the following side effects, you should immediately and urgently contact your doctor:
   3. If you experience any of the following side effects, you should inform your doctor, pharmacist, or nurse:
   4. All other side effects:
   5. Reporting side effects
8. How to store Fulvestrant Cipla
9. Contents of the pack and other information
   1. What Fulvestrant Cipla contains
   2. What Fulvestrant Cipla looks like and contents of the pack
   3. Marketing authorization holder
   4. Cipla Europe NV
   5. Manufacturer
   6. Laboratorios Farmalán, S.A.
   7. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. Member State
   9. Marketing authorization holder
   10. Medicine name
   11. Date of last revision of the leaflet: .
   12. Information intended for healthcare professionals only:

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Fulvestrant Cipla, 250 mg, solution for injection in a pre-filled syringe

fulvestrant

You should read the contents of this leaflet carefully before using the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Fulvestrant Cipla and what is it used for
• 2. Important information before taking Fulvestrant Cipla
• 3. How to take Fulvestrant Cipla
• 4. Possible side effects
• 5. How to store Fulvestrant Cipla
• 6. Contents of the pack and other information

1. What is Fulvestrant Cipla and what is it used for

Fulvestrant Cipla contains the active substance fulvestrant, which belongs to a group of medicines called estrogen receptor antagonists. Estrogens, female sex hormones, can sometimes influence the development of breast cancer.
Fulvestrant Cipla is used:

• as a single medicine, in the treatment of postmenopausal women with a certain type of breast cancer called hormone receptor-positive breast cancer, which is locally advanced or has spread to other parts of the body (metastasized) or
• in combination with palbociclib in the treatment of women with a certain type of breast cancer called hormone receptor-positive breast cancer, without overexpression of human epidermal growth factor receptor 2, which is locally advanced or has spread to other parts of the body (metastasized). Women who have not yet reached menopause will also receive a medicine called a luteinizing hormone-releasing hormone (LHRH) agonist.

When Fulvestrant Cipla is given in combination with palbociclib, it is also important to read the patient information leaflet for palbociclib. If you have any questions about palbociclib, you should consult your doctor.

2. Important information before taking Fulvestrant Cipla

When NOT to take Fulvestrant Cipla

• if you are allergic to fulvestrant or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding
• if you have severe liver function disorders

Warnings and precautions

You should inform your doctor, pharmacist, or nurse before treatment with Fulvestrant Cipla if you have ever had any of the following health problems:

• if you have ever had kidney or liver disease
• if you have had a reduced number of platelets (which allow blood to clot) or bleeding disorders
• if you have ever had a blood clotting disorder
• if you have ever had problems with decreased bone mineral density (osteoporosis)
• alcohol dependence

Children and adolescents

Fulvestrant Cipla is not recommended for use in children and adolescents under 18 years of age.

Fulvestrant Cipla and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
In particular, you should inform your doctor if you are taking anticoagulant medicines (medicines that prevent blood clots).

Pregnancy and breastfeeding

Fulvestrant Cipla should not be given to pregnant women. Women who may become pregnant should use effective contraception during treatment with Fulvestrant Cipla and for 2 years after the last dose.
During treatment with Fulvestrant Cipla, you should not breastfeed.

Driving and using machines

It has not been found that Fulvestrant Cipla affects the ability to drive or use machines. If you feel tired after taking Fulvestrant Cipla, you should not drive or use machines.
Fulvestrant Cipla contains 500 mg of alcohol (ethanol) per injection, which is equivalent to 100 mg/ml (10% w/v). This amount of alcohol in each injection of this medicine is equivalent to 13 ml of beer or 5 ml of wine.
This amount of alcohol is unlikely to have an effect on adults and adolescents. It may cause some effect in younger children, such as drowsiness.
The alcohol in this medicine may alter the effects of other medicines. If you are taking other medicines, you should consult your doctor or pharmacist.
If you are pregnant or breastfeeding, you should consult your doctor or pharmacist before taking this medicine.
If you are dependent on alcohol, you should consult your doctor or pharmacist before taking this medicine.
Fulvestrant Cipla contains 500 mg of benzyl alcohol per injection, which is equivalent to 100 mg/ml.
Benzyl alcohol may cause allergic reactions.
Fulvestrant Cipla contains 750 mg of benzyl benzoate per injection, which is equivalent to 150 mg/ml.

3. How to take Fulvestrant Cipla

Your doctor or nurse will slowly inject Fulvestrant Cipla intramuscularly, with each injection given in a different buttock.
The recommended dose is 500 mg of fulvestrant (two 250 mg/5 ml injections), given once a month, and an additional dose of 500 mg given 2 weeks after the first dose.
If you have any further doubts about the use of this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Serious side effects

In case of the following side effects, you should immediately and urgently contact your doctor:

• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat, which may be symptoms of anaphylactic reactions
• thromboembolic disease (increased risk of venous thrombosis)*
• hepatitis
• liver failure

If you experience any of the following side effects, you should inform your doctor, pharmacist, or nurse:

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

• injection site reactions, such as pain and/or inflammation
• changes in liver enzyme activity (in blood tests)*
• nausea
• feeling weak, fatigue*
• joint and muscle pain
• hot flashes
• skin rash
• allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat

All other side effects:

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

• headache
• vomiting, diarrhea, or loss of appetite*
• urinary tract infections
• back pain*
• increased bilirubin levels (a pigment produced by the liver)
• thromboembolic disease (increased risk of venous thrombosis)*
• decreased platelet count (thrombocytopenia)
• vaginal bleeding
• lower back pain radiating to one leg (sciatica)
• sudden weakness, numbness, tingling, or loss of mobility in one leg, especially on one side of the body, sudden difficulty walking or maintaining balance (peripheral neuropathy)

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

• thick, white vaginal discharge and vaginal candidiasis (infection)
• bruising and bleeding at the injection site
• increased activity of gamma-glutamyltransferase, a liver enzyme measured in blood tests
• hepatitis (inflammation of the liver)
• liver failure
• numbness, tingling, and pain
• anaphylactic reactions

* Includes side effects for which the impact of Fulvestrant Cipla cannot be assessed due to the underlying disease.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Fulvestrant Cipla

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label on the syringe after the abbreviation: EXP. The expiry date refers to the last day of the month stated.
Store and transport at a refrigerated temperature (2°C – 8°C).
You should limit the storage of the product at a temperature other than 2°C – 8°C. You should avoid storing at a temperature above 30°C and not exceed a period of 28 days with an average storage temperature below 25°C (but above the range 2°C – 8°C). If the temperature range is exceeded, you should immediately apply the recommended storage conditions (store and transport in a refrigerator at 2°C – 8°C). Exceeding the proper storage temperature may have a cumulative effect on the quality of the product, and the 28-day period cannot be exceeded during the product's shelf life. Exposure to a temperature below 2°C does not damage the product if it is not stored at a temperature below

• 20°C.

Store the pre-filled syringe in its original packaging to protect it from light.
Medical personnel are responsible for the proper storage, use, and disposal of the packaging after the used Fulvestrant Cipla medicine.
This medicine may pose a risk to aquatic environments. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Fulvestrant Cipla contains

• The active substance is fulvestrant. One pre-filled syringe (5 ml) contains 250 mg of fulvestrant.
• The other ingredients are: ethanol (96 percent), benzyl alcohol (E1519), benzyl benzoate, and purified castor oil.

What Fulvestrant Cipla looks like and contents of the pack

Fulvestrant Cipla is a clear, colorless to yellowish, viscous solution in a pre-filled syringe containing 5 ml of solution for injection. To administer the recommended monthly dose of 500 mg, the contents of two pre-filled syringes should be injected.
Fulvestrant Cipla is available in four types of packaging: packaging containing 1 pre-filled syringe, packaging containing 2 pre-filled syringes, packaging containing 4 pre-filled syringes, and packaging containing 6 pre-filled syringes. The packaging also includes one, two, four, or six needles with a safety system (BD Safety Glide) for administering the medicine.
Not all pack sizes may be marketed.

Marketing authorization holder

Cipla Europe NV

De Keyserlei 58-60, Box-19
2018 Antwerp
Belgium

Manufacturer

Laboratorios Farmalán, S.A.

Calle La Vallina s/n, Edificio 2
Polígono Industrial Navatejera
24193, Villaquilambre, León
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Member State

Marketing authorization holder

Medicine name

Netherlands
Fulvestrant Leon Farma 250 mg solution for injection in a pre-filled syringe
France
Fulvestrant Farmalan 250 mg solution injectable en seringue pré-remplie
Austria
Fulvestrant AptaPharma 250 mg Injektionslösung in einer Fertigspritze
Slovenia
Fulvestrant AptaPharma 250 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Croatia
Fulvestrant AptaPharma 250 mg otopina za injekciju u napunjenoj štrcaljki
Hungary
Fulvestrant AptaPharma 250 mg oldatos injekció előretöltött fecskendőben
Germany
Fulvestrant Cipla 250 mg Injektionslösung in einer Fertigspritze
Czech Republic
Fulvestrant Cipla
Poland
Fulvestrant Cipla
Romania
Fulvestrant Cipla 250 mg soluție injectabilă în seringă preumplută

Date of last revision of the leaflet: <{month YYYY}>.

Information intended for healthcare professionals only:

Fulvestrant Cipla 500 mg (2 × 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes (see section 3).
Administration instructions
Note – the needle with a safety system (BD SafetyGlide Safety Hypodermic Needle) should not be placed in an autoclave before use. When handling the medicine and disposing of the leftovers, you should avoid hand contact with the needle.
Applicable to both syringes:

• Remove the glass syringe from the container and check if it is not damaged.
• Open the outer packaging of the needle with a safety system (SafetyGlide).
• Before administering parenteral solutions, you should visually inspect them for the presence of particulate matter and changes in color.
• Hold the syringe vertically in the striped part (C). With your other hand, grasp the cap (A) and carefully twist the rigid plastic cap counterclockwise (see Figure 1).

Figure 1

• Remove the rigid plastic cap (A) in a vertical position upwards. To maintain sterility, do not touch the tip of the syringe (B) (see Figure 2).

Figure 2

• Attach the needle with a safety system to the Luer-Lock tip and tighten to secure it (see Figure 3).
• Check if the needle is connected to the Luer-Lock tip before moving to a vertical position.
• When tightening the needle, you should proceed so as not to damage its sharp end.
• Bring the needle with the cap close to the injection site.
• Remove the cap from the needle.
• Remove any excess air from the syringe.

Figure 3

• The medicine should be administered intramuscularly, slowly (1-2 minutes/injection), into the buttock muscle (on the buttock). For the convenience of the person administering, the needle bevel is on the same surface as the lever of the needle safety system (see Figure 4).

Figure 4
Immediately after administering the medicine, you should activate the needle safety system by pushing its lever forward (see Figure 5).
WARNING: Proceed so as to ensure your safety and the safety of others. Listen for the click and visually confirm that the needle tip is fully covered.

Figure 5
Disposal of leftovers
The pre-filled syringes are intended onlyfor single use.
This medicine may pose a risk to aquatic environments. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.