Fleboside
Italy
Table of Contents
Package leaflet: Information for the patient
FLEBOSIDE 300 mg + 3 mg coated tablets
Troxerutin + carbazochrome
Please read this leaflet carefully before taking 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 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 you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What FLEBOSIDE is and what it is used for
- What you need to know before taking FLEBOSIDE
- How to take FLEBOSIDE
- Possible side effects
- How to store FLEBOSIDE
- Contents of the pack and other information
1. What FLEBOSIDE is and what it is used for
FLEBOSIDE contains two active substances, troxerutin and carbazochrome. Troxerutin is a naturally derived substance (bioflavonoid) that has a protective effect on blood vessels (capillary-protective action). Carbazochrome reduces bleeding time (haemorrhage) by constricting small blood vessels (local vasoconstrictor action). The combination of these two active substances results in the arrest of bleeding (haemostasis) and protection of blood vessels (vasoprotection).
This medicinal product is indicated for the treatment of:
- symptoms due to blood circulation problems (venous insufficiency);
- fragility of small blood vessels (capillaries).
2. What you need to know before taking FLEBOSIDE
Do not take FLEBOSIDE
- if you are allergic to troxerutin, to carbazochrome, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking FLEBOSIDE.
Other medicines and FLEBOSIDE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between FLEBOSIDE and other medicines are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of FLEBOSIDE during pregnancy and breastfeeding is not recommended, as harmful effects on the fetus and breastfed infant cannot be ruled out.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
FLEBOSIDE contains sucrose and the colouring agent sunset yellow FCF (E110)
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains the colouring agent sunset yellow FCF, which may cause allergic reactions.
3. How to take FLEBOSIDE
Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–4 tablets daily, taken by mouth (orally).
Your doctor will determine the appropriate dose for you, according to your needs.
If you take more FLEBOSIDE than you should
Cases of overdose are not known.
In the event of accidental ingestion/overdose of FLEBOSIDE, inform your doctor immediately or go to the nearest hospital.
If you forget to take FLEBOSIDE
Do not take a double dose to make up for a missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):
- Stomach disorders (gastric intolerance), including nausea.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store FLEBOSIDE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via 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 FLEBOSIDE contains
- The active substances are troxerutin and carbazochrome. Each coated tablet contains 300 mg of troxerutin and 3 mg of carbazochrome.
- The other components are: acacia gum, maize starch, talc, titanium dioxide (E171), polyvinylpyrrolidone, colloidal silicon dioxide, magnesium stearate, calcium carbonate, kaolin, orange yellow S (E110), indigotine (E132), sucrose.
Description of the appearance of FLEBOSIDE and package contents
Box containing 30 coated tablets in PVC/aluminum blisters
Marketing Authorization Holder
ACARPIA FARMACEUTICI S.r.l.
Viale L. Majno 18, 20129 Milano (Italy)
Manufacturers
KLEVA S.A. – Parnithos Avenue 189, Acharnai Attiki, 13675 – Greece
Complete manufacturing, control and release
CIT S.r.l.
Via Primo Villa, 17
20875 Burago Molgora (MB)
Secondary packaging and release
Package leaflet: information for the user
FLEBOSIDE 150 mg/3 ml + 1.5 mg/3 ml injectable solution
Troxerutin + carbazochrome
Please read this leaflet carefully before using 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, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What FLEBOSIDE is and what it is used for
- What you need to know before using FLEBOSIDE
- How to use FLEBOSIDE
- Possible side effects
- How to store FLEBOSIDE
- Package contents and other information
1. What FLEBOSIDE is and what it is used for
FLEBOSIDE contains two active substances, troxerutin and carbazochrome. Troxerutin is a
naturally-derived substance (bioflavonoid) that has a protective effect on blood vessels (capillary-protective
action). Carbazochrome reduces bleeding time (haemorrhage) by constricting small blood vessels (local
vasoconstrictor action). The combination of these two active ingredients results in the arrest of bleeding
(haemostasis) and protection of blood vessels (vasoprotection).
This medicinal product is indicated for the treatment of:
- symptoms due to blood circulation problems (venous insufficiency);
- fragility of small blood vessels (capillaries).
2. What you need to know before using FLEBOSIDE
Do not use FLEBOSIDE
- if you are allergic to troxerutin, carbazochrome, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using FLEBOSIDE.
This medicine is not authorized for administration via subcutaneous injections (mesotherapy).
Other medicines and FLEBOSIDE
Tell your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No interactions between FLEBOSIDE and other medicines are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
The use of FLEBOSIDE during pregnancy and breastfeeding is not recommended, as harmful effects on the fetus or breastfed infant cannot be ruled out.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.
FLEBOSIDE contains sodium
This medicine contains 28.3 mg (or 1.23 mmol) of sodium per maximum dose (3 vials). This corresponds to 1.4% of the maximum recommended daily dietary intake of sodium for an adult. This should be taken into consideration in patients with impaired renal function or those on a low-sodium diet.
3. How to use FLEBOSIDE
Use this medicine exactly as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-3 vials daily by intramuscular injection.
Do not mix the medicine with solutions containing ascorbic acid.
If you use more FLEBOSIDE than you should
Cases of overdose are not known.
In case of accidental ingestion/absorption of an excessive dose of FLEBOSIDE, inform your doctor immediately or go to the nearest hospital.
If you forget to use FLEBOSIDE
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions may occur:
Frequency not known (frequency cannot be estimated from the available data):
- Skin irritation (local and generalized erythema), in case of improper subcutaneous administration (mesotherapy: intradermal or subcutaneous route).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store FLEBOSIDE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via 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 FLEBOSIDE contains
- The active substances are troxerutin and carbazochrome. Each vial (3 ml) contains 150 mg of troxerutin and 1.5 mg of carbazochrome.
- The other components are: sodium chloride, water for injections.
Description of the appearance of FLEBOSIDE and package contents
Box containing 10 glass vials of 3 ml.
Marketing Authorization Holder
ACARPIA FARMACEUTICI S.r.l.
Viale L. Majno 18, 20129 Milano (Italy)
Manufacturers
KLEVA S.A. – Parnithos Avenue 189, Acharnai Attiki, 13675 – Greece
Complete manufacturing, control and release
CIT S.r.l.
Via Primo Villa, 17
20875 Burago Molgora (MB)
Secondary packaging and release