InfoCons Consumer Protection informs you – Potactasol – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using this medicine because it contains important information for you .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse .
• If you ge t any side effects , talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4 .

ℹ️ 1. What Potactasol is and what it is used for

Potactasol contains the active substance topotecan which helps to kill tumour cells.

Potactasol is used to treat:

• ovarian cancer or small cell lung cancer that has come back after chemotherapy
• advanced cervical cancer if surgery or radio therapy is not possible. In this case Potactasol treatment is combined with medicines containing cisplatin.

⚠️ 2. What you need to know before you use Potactasol

Do not use Potactasol

• if you are allergic to topotecan or a ny of the other ingredients of this medicine (listed in section 6);
• if you are breast -feeding.;
• if your blood cell counts are too low. Your doctor will tell you whether this is the case, based on the results of your last blood test.

Tell you doctor if you think any of these could apply to you.

Warnings and precautions

Talk to your doctor before using Potactasol :

• if you have any kidney problems. Your dose of Potactasol may need to be adjusted. Potactasol is not recommended in case of severe kidney impairment;
• if you have liver problems. Potactasol is not recommended in case of severe liver impairment;
• if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.

Potactasol may cause a decrease in the number of blood clotting cells (platelets). This can lead to severe bleeding from relatively small injuries such as a small cut. Rarely, it can lead to more sever e bleeding (haemorrhage). Talk to your doctor for advice on how t o minimize the risk of bleeding.

The incidence of side effects is more frequent in patients who are in poor general health. The doctor will evaluate your general health during the treatment and you should tell him/her in case you have fever, infection or are in some ways feeling unwell.

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

Other medicines and Potactasol

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

Pregnancy and breast -feeding Potactasol should not be used in pregnant women, unless clearly necessary. If you are or think you might be pregnant, tell your doctor immediately.

You should use effective contraceptive measures while being treated with Potactasol and for 6 months following completion of treatment. Ask your doctor for advice.

Men are recommended to use effective contraceptive measures and to not father a child while receiving Potactasol and for 3 months following completion of treatment. Patients who are concerned about their ferti lity should ask their doctor for counselling on fertility and family planning options prior to starting treatment.

You must not breast -feed while on treatment with Potactasol .

Driving and using machines

Potactasol can make you feel tired or weak. If you experience this, do not drive or use machines.

Potactasol contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium -free’.

💊 3. How to use Potactasol

Your dose of Potactasol will depend on:

• the disease being treated,
• your body surface area (m 2),
• the results of blood tests carried out before and during treatment,
• how well you tolerate treatment.

Adults Ovarian cancer and s mall cell lung cancer The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days. This treatment cycle will normally be repeated every three weeks.

Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days. This treatment cycle will normally be repeated every three weeks.

For cervical cancer, it will be used together with another anticancer medicines containing cisplatin.

For more information about cisplatin, pleas e refer to the corresponding package leaflet.

Patients with impaired kidney function Your doctor might need to reduce your dose based on your kidney function.

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

How Potactasol is given A doctor or nurse will give you the reconstituted and diluted Potactasol solution as an infusion (drip), usually into your arm, over about 30 minutes.

29 If you are given too much Potactasol As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.

In the unlikely event of an overdose, your doctor will monitor you for side effects. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.

❗ 4. Possible side effects

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

Serious side effects

You must tell your doctor immediately if you experience any of the following serious side effects.

They may require hospitalisation and could even be life- threatening.

• Infections (very common ; may affect more than 1 in 10 people ), with signs such as:
• fever
• serious decline of your general condition
• local symptoms, such as sore throat or burning sensation when urinating
• severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Potactasol may reduce your ability to fight infections.
• Lung inflamma tion (rare ; may affect up to 1 in 1,000 people ), with signs such as:
• difficulty breathing
• cough
• fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions ”. This condition can be fatal.
• Severe allergic (anaphylactic) reactions ( rare; may affect up to 1 in 1,000 people ), with signs such as:
• swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash.

Other side effects with Potactasol include

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

• Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia). In some cases you may need a blood transfusion.
• Decrese in number of circulating white blood cells (leucotyes) in the blood. Abnormal low number of neutrophil granulocytes (a type of white blood cell) in the blood, with or without fever.
• Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
• Weight loss and loss of appetite (anorexia); tiredness; weakness.
• Feeling sick (nausea), vomiting; diarrhoea; 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 (hypersensitivity) reactions (including rash).
• Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells. Symptoms may include yellow skin (jaundice).
• Decrease in the number of all blood cells (pancytopenia) .
• Feeling unwell.

30 – Serious blood infection , which can be fatal .

• Itching (pruritus).

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

• Swelling caused by fluid build- up (angioedema) e.g. around the eyes and lips as well as hands, feet and throat. If severe it may cause breathing difficulties.
• Itchy rash (or hives).

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

• Mild pain and inflammation a t the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage .

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

• Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
• Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).

If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Potactasol .

Reporting of side effects

If you get any side effects, talk to your doctor 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.

🌡️ 5. How to store Potactasol

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

Keep the vial in the outer carton in order to protect from light.

Storage after reconstitution and dilution Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.

The physico- chemical stability of the medicinal product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25 oC ± 2oC and then diluted.

From a microbiological point of view, the product should be used immediately. If not used immediately, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validat ed aseptic conditions.

Any unused product or waste material should be disposed of in accordance with local requirements 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 topotecan (as hydrochloride). After reconstitution 1 ml concentrate contains 1 mg topotecan.
• The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide (see section 2) .

What Potactasol looks like and contents of the pack

Potactasol is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip -off caps. Vials may or may not be sheathed in a protective sleeve. 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 any information about this medicine, 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 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 Norge Teva Norway AS Tlf: +47 66775590 32 Ελλάδα TEVA HELLAS A.E.

Τηλ: +30 211 8805000 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 2 57267911 Italia Teva Italia S.r.l.

Tel: +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 Κύπρος TEVA HELLAS A.E.

Ελλάδα Τηλ: +30 211 8805000 Sverige Teva Sweden AB Tel: +46 42121100 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67323666 United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . ———————————- —————————————————————————————-

🩺 Information intended for healthcare professionals only

Potactasol INSTRUCTIONS ON USE Reconstitution and dilution prior to administration Before infusion, Potactasol powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows:

• Potactasol 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill)
• Potactasol 4 mg with 4 ml wa ter for injections Reconstitution will result in a concentrate containing 1 mg topotecan per ml.

This concentrate (1 mg/ml) must be diluted prior to administration.

The volume of reconstituted concentrate corresponding to the calculated individual dose should be further diluted with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose, to give a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:

Volume for 25 microgram/m l solution Volume for 50 microgram/ml solution 1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml Add 19 ml to give 20 ml 4 ml of 1 mg/ml topotecan solution Add 156 ml to give 160 ml Add 76 ml to give 80 ml Storage after reconstitution and dilution Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C in normal light conditions , and for 24 hours at 2° C to 8°C when protected from light.

Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions .The concentrates tested were reconstituted and stored at 25 ± 2°C for 12 hours 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, in -use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2° C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Handling and disposal The normal procedures for proper handling and disposal of anti -tumour medicinal products should be adopted: − Staff should be trained to reconstitute and dilute the the medicinal product. − Pregnant staff should be excluded from working with this medicinal product. − Staff handling this medicinal product during reconstitution and dilution should wear protective clothing including mask, goggles and gloves . − Accidental contact with the skin or eyes should be treated immediately with copious amounts of water. − All ite ms for administration or cleaning, including gloves, should be placed in high -risk, waste disposal bags for high -temperature incineration.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Potactasol (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/10/660).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.