POTACTASOL 1 mg Powder For Intravenous Infusion Solution

Зміст інструкції

1. Potactasol 1 mg powder for concentrate for infusion solution
   1. What is Potactasol and what is it used for
   2. What you need to know before using Potactasol
   3. How to use Potactasol
   4. Possible side effects
   5. How to store Potactasol
   6. Contents of the pack and other information

Potactasol 1 mg powder for concentrate for infusion solution

Potactasol 4 mg powder for concentrate for infusion solution
Topotecan

Read this leaflet carefully before you start this medicine because 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 nurse.
• If you get any side effects, see section 4, and speak with your doctor or pharmacist.

Contents of this leaflet

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

1. What is Potactasol and what is it used for

Potactasol contains the active substance topotecan which helps to kill cancer cells.
Potactasol is used to treat:

• ovarian cancer or small cell lung cancer that has relapsed after chemotherapy
• advanced cervical cancer when surgical or radiation treatment is not possible. In this case, treatment with Potactasol is combined with other drugs containing cisplatin.

2. What you need to know before using Potactasol

Do not use Potactasol

• if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6);
• if you are breastfeeding;
• if the number of red blood cells is too low. Your doctor will advise you if this is the case, based on the results of your latest blood tests. Tell your doctorif any of these situations apply to you.

Warnings and precautions
Talk to your doctor before using Potactasol:

• if you have kidney problems. It may be necessary to vary the dose of Potactasol. The use of Potactasol is not recommended in case of severe impairment of kidney function;
• if you have liver problems. The use of Potactasol is not recommended in case of severe impairment of liver function;
• if you suffer from lung inflammation with signs such as cough, fever and difficulty breathing, see also section 4 “Possible side effects”.

Potactasol may cause a reduction in the number of cells responsible for blood clotting
(platelets). This can lead to serious bleeding following relatively minor injuries
such as small cuts. Rarely it can lead to more serious bleeding
(haemorrhages). Talk to your doctor for advice on how to minimize the risk of
bleeding.
The incidence of side effects is more frequent in patients who are not in good
general health. The doctor will assess your general health condition during
treatment; inform your doctor of any fever, infections or any
discomfort.

Use in children and adolescents
Experience in children and adolescents is limited and therefore treatment is
not recommended.

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

Pregnancy and breastfeeding
Potactasol should not be used during pregnancy unless absolutely necessary.
Tell your doctor immediately if you are pregnant or suspect you may be pregnant.
Effective contraceptive methods should be used to avoid becoming pregnant or
fathering a child during treatment with Potactasol. Ask your doctor for advice.
Patients who are concerned about their fertility should ask their doctor for advice on
fertility and family planning options before starting treatment.
Do not breastfeed during treatment with Potactasol.

Driving and using machines
Potactasol may cause a feeling of tiredness or weakness. If you feel tired or weak
do not drive vehicles or use machinery.

Potactasol contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, it is therefore
essentially “sodium-free”.

3. How to use Potactasol

The dose of Potactasol that will be administered to you will be calculated by the doctor based on:

• the disease to be treated,
• your body surface area (m²),
• the results of blood tests performed before and during treatment,
• how well you tolerate the treatment.

Adults

Ovarian cancer and small cell lung cancer
The usual dose is 1.5 mg per m²of body surface area once daily for 5 days.
This treatment cycle is usually repeated every three weeks.

Cervical cancer
The usual dose is 0.75 mg per m²of body surface area once daily for 3 days.
This treatment cycle is usually repeated every three weeks.
In the treatment of cervical cancer ,topotecan is combined with other drugs
information.

Patients with reduced kidney function
The doctor may need to reduce the dose based on kidney function.

How Potactasol is prepared
Potactasol is supplied as a powder for concentrate for solution for infusion. The powder
must be dissolved and the resulting concentrate must be further diluted before
administration.

How Potactasol is administered
A doctor or nurse will administer the reconstituted and diluted solution of Potactasol to you with
a drip infusion into a vein, usually in the arm, for approximately
30 minutes.

If you are given too much Potactasol
Since this medicine is administered by a doctor or nurse, it is unlikely that
you will be given too much Potactasol. In the unlikely event of an overdose, the doctor
will monitor you for side effects. Inform the doctor or nurse if you have any doubts
about the amount of medicine you are being given.

4. Possible side effects

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

Serious side effects
If any of the following serious side effects occur, seek immediatemedical attention.
Hospitalization may be necessary and life could even be at risk.

• Infections(very common; may affect more than 1 in 10 people), with signs such as:
• Fever
• Severe worsening of general condition
• Local symptoms, such as sore throat or a burning sensation when urinating
• Severe stomach pain, fever and possibly diarrhea (rarely with blood) may be signs of intestinal inflammation (neutropenic colitis) Potactasol may reduce the ability to fight infections.
• Inflammation of the lungs(rare; may affect up to 1 in 1,000) with signs such as:
• Difficulty breathing
• Cough
• Fever. You are at greater risk of developing this serious condition (interstitial lung disease) if you already have lung disease, if you have previously received radiation treatment, or if you have previously taken medicines that have caused lung damage; see also section 2 “Warnings and precautions”. This condition can be fatal.
• Severe allergic reactions (anaphylactic)(rare: may affect up to 1 in
• 1,000), with signs such as:
• Swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash.

Other side effects associated with the use of Potactasol are:
Very common side effects (may affect more than 1 in 10 people)

• General feeling of weakness and fatigue, which may be symptoms of a reduction in the number of red blood cells (anemia). In some cases you may need a blood transfusion.
• Reduction in the number of white blood cells circulating in the blood (leukocytes). Abnormal reduction in the number of neutrophils (a type of white blood cells) in the blood, with or without fever.
• Unusual bruising and bleeding, sometimes severe, caused by a decrease in the number of cells responsible for blood clotting (platelets).
• Weight loss and loss of appetite (anorexia); fatigue; weakness.
• Feeling unwell (nausea), vomiting; diarrhea; stomach pain; constipation.
• Inflammation of the lining of the mouth and digestive tract.
• Fever.
• - Hair loss.

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

• Allergic reactions (hypersensitivity, including rash). Unusually high levels of bilirubin. Bilirubin is a “waste product” produced by the liver during the breakdown of red blood cells. Symptoms may include yellowing of the skin (jaundice).
• Decrease in the number of all blood cells (pancytopenia)
• Feeling unwell.
• Severe blood infection, which can be fatal.
• Itching.

Rare side effects (may affect up to 1 in 1,000)

• Swelling due to fluid retention (angioedema), for example around the eyes and lips and at the level of hands, feet and throat. If these symptoms occur severely, they can cause difficulty breathing.
• Itchy skin rash (or hives).

Very rare side effects (may affect up to 1 in 10,000)

• Mild pain and inflammation at the injection site following accidental administration of the medicine into the surrounding tissues (extravasation), for example due to leakage of the medicine.

Not known (frequency cannot be estimated from the available data)

• Severe stomach pain, nausea, blood in vomit, dark or bloody stools (possible symptoms of gastrointestinal perforation).
• Sores in the mouth, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhea, bloody stools (possible signs and symptoms of inflammation of the lining of the mouth, stomach and/or intestines [mucosal inflammation]).

If you are being treated for cervical cancer, you may experience side effects due to
the other medicine (cisplatin) that is being administered with Potactasol.

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

5. How to store Potactasol

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is reported on the vial and on the package
after EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer packaging to protect the medicine from light.
Storage after reconstitution and dilution
The chemical and physical stability of the concentrate has been demonstrated for 24 hours at a temperature of
25 ± 2°C, in normal light conditions and for 24 hours at a temperature from 2°C to 8°C if protected
from light.
The chemical and physical stability of the solution of the concentrated medicine obtained after dilution
in infusion solution (0.9 % sodium chloride and 5 % glucose) has been demonstrated for
4 hours at room temperature in normal light conditions on samples reconstituted and stored
respectively for 12 hours and 24 hours at 25 ± 2°C and then diluted.
From a microbiological point of view, the product must be used immediately. If not used
immediately, the storage times in use and the storage conditions before use
are the responsibility of the user and generally do not exceed 24 hours from 2 °C to 8°C,
unless the reconstitution/dilution has been carried out under validated and controlled aseptic conditions.
The unused medicine and waste derived from such medicine must be disposed of in accordance with
current local regulations for cytotoxic material.

6. Contents of the pack and other information

What Potactasol contains

• The active substance is topotecan. Each vial contains 1 mg or 4 mg of topotecan (as hydrochloride). After reconstitution 1 ml of concentrate contains 1 mg of topotecan.
• The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide (see paragraph 2).

Description of the appearance of Potactasol and contents of the pack
Potactasol is supplied in colorless type I glass vials with a grey rubber stopper
bromobutyl and aluminum seals with snap-on plastic closures. The vials may be
wrapped or not wrapped in a protective coating.
The vials contain either 1 mg or 4 mg of topotecan.
Each pack contains one vial.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
S.C. Sindan-Pharma S.R.L.
11 Ion Mihalache Blvd
Bucharest
Romania
For further information on this medicinal product, please contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
ratiopharm GmbH
Tel: +49 73140202

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/.
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The following information is intended exclusively for healthcare professionals:

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

Potactasol
PACKAGE LEAFLET
Reconstitution and dilution before administration
Before infusion, Potactasol powder for concentrate for solution for infusion must be
reconstituted with an adequate amount of water for injections, as follows:

• Potactasol 1 mg with 1.1 ml of water for injections (as it contains an overfill of 10 %)
• Potactasol 4 mg with 4 ml of water for injections

Reconstitution will result in a concentrate containing 1 mg of topotecan per ml.
This concentrate (1 mg/ml) must be diluted before administration.
To obtain a final concentration in the infusion solution between
25 and 50 micrograms/ml, the volume of reconstituted concentrate corresponding to the dose
calculated individually must be further diluted with either sodium chloride 9 mg/ml (0.9 %
) or glucose 5 % w/v, for example:

Stability after reconstitution and dilution
The chemical and physical stability of the concentrate has been demonstrated for 24 hours at a temperature of
25 ± 2°C under normal light conditions, and for 24 hours at a temperature of 2°C to 8°C when
protected from light.
The chemical and physical stability of the solution obtained after dilution of the concentrate in a
sodium chloride 9 mg/ml (0.9 %) injection solution or in 50 mg/ml glucose solution for
infusion has been demonstrated for 4 hours at 25 ± 2°C, under normal light conditions. The
concentrated samples were reconstituted and stored at 25 ± 2°C for 12 and 24 hours
respectively after reconstitution, and then diluted.
From a microbiological point of view, the product should be used immediately. If not
used immediately, the storage times and conditions prior to use are the responsibility of the user and
do not normally exceed 24 hours at 2 °C to 8°C, unless the reconstitution/dilution has been
carried out in validated and controlled aseptic conditions.

Handling and disposal
Usual procedures should be adopted for the correct handling and disposal of antineoplastic medicinal
products:

• Personnel should be instructed on how to dilute the medicinal product.
• Pregnant personnel should be excluded from activities related to the use of this medicinal product.
• Personnel using the medicinal product during reconstitution and dilution should wear protective clothing, including mask, goggles and gloves.
• In case of accidental contact with skin or eyes, treat immediately with large amounts of water.
• All instruments and materials used for administration and cleaning, including gloves, should be placed in high-risk waste bags for incineration at high temperature.