Package leaflet: Information for the user

Flebostasin R 50 mg modified-release hard capsules

Triterpenic glycosides
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.

Keep this leaflet. You may need to read it again.
If you want more information or advice, consult your pharmacist.
If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 4 weeks.

Contents of this leaflet:

What Flebostasin R is and what it is used for
What you need to know before taking Flebostasin R
How to take Flebostasin R
Possible side effects
How to store Flebostasin R
Contents of the pack and other information

1. What Flebostasin R is and what it is used for

Flebostasin R is an oral medicine containing triterpenic glycosides, substances that protect blood vessels by improving blood circulation (vasoprotective agents).
Flebostasin R is used in adults to treat symptoms related to venous insufficiency (difficulty in blood returning to the heart) and capillary fragility.
Consult your doctor if you do not feel better or if you feel worse after 4 weeks.

2. What you need to know before taking Flebostasin R

Do not take Flebostasin R

if you are allergic to triterpenic glycosides or to any of the other ingredients of this medicine (listed in section 6)
if you are pregnant or breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Flebostasin R.
You should consult a doctor before taking Flebostasin R if you have or have had in the past any of the following conditions:

skin inflammation
thrombophlebitis (inflammation of superficial veins, which may manifest, for example, as swelling in the legs, ankles or feet, redness of the skin, pain in the affected area)
varicose veins (varices)
skin hardening
ulcers (skin lesions due to reduced blood flow in certain body areas)
rapid swelling of both legs
kidney disease leading to the kidney’s inability to perform its normal functions (renal insufficiency)
heart disease leading to the heart’s inability to supply an adequate amount of blood to meet the body’s normal needs (heart failure).

Children and adolescents
Use in children and adolescents is not recommended, as safety and efficacy have not been established.
Other medicines and Flebostasin R
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are currently known.
Flebostasin R with food and drink
Take Flebostasin R before meals, especially if you experience stomach or intestinal disturbances. See section 3, "How to take Flebostasin R".
Pregnancy and breastfeeding
Do not take Flebostasin R if you are pregnant or breastfeeding.
Driving and using machines
Flebostasin R does not affect the ability to drive or operate machinery.

3. How to take Flebostasin R

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 capsule twice daily.
Caution: Do not exceed the recommended doses without medical advice.
Use in children and adolescents
Use in children and adolescents is not recommended, as safety and efficacy have not been established.
How to take
Take Flebostasin R in the morning and evening before meals; this is especially important if you experience stomach or intestinal disturbances.
Swallow the capsule with plenty of water or other liquid.
Duration of treatment
It may take 4 weeks of treatment before the beneficial effects of the medicine become apparent.
Do not use the medicine for longer than 4 weeks without first consulting your doctor.
If during treatment you notice persistence or worsening of symptoms, consult your doctor.
If you take more Flebostasin R than you should
No cases of accidental overdose of Flebostasin R have been reported.
However, if you accidentally ingest or take an excessive dose of Flebostasin R, contact your doctor immediately or go to the nearest hospital.
If you forget to take Flebostasin R
If you miss a dose, continue treatment as indicated in this package leaflet.
Do not take a double dose to make up for the missed dose.
If you stop treatment with Flebostasin R
If you have any questions about the use of 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.
You may experience the following side effects:

allergic reactions
itching
nausea
stomach and intestinal disorders. If you experience stomach or intestinal disturbances, it is recommended to take the medicine during meals.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flebostasin R

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep the blisters in the outer packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Flebostasin R contains

The active substance is: dried horse chestnut seed extract 300 mg (each capsule contains 300 mg of dried horse chestnut seed extract, equivalent to 50 mg of triterpene glycosides)
The other components are: dextrin, vinylpyrrolidone-vinyl acetate copolymer 60:40, triethyl citrate, ammonium methacrylate copolymer type A, ammonium methacrylate copolymer type B, talc, gelatin, purified water, titanium dioxide E 171, iron oxide red E 172, iron oxide yellow E 172, iron oxide black E 172, quinoline yellow E 104, indigotine E 132.

Description of the appearance of Flebostasin R and package contents
Flebostasin R is available as hard capsules, packaged in blisters in a carton containing 30 capsules.
Marketing Authorization Holder
SCHARPER S.p.A.
Viale Ortles, 12 – 20139 Milan
Manufacturer
Temmler Werke GmbH - WEIHENSTEPHANER STRASSE 28 - Munich (Germany)
Swiss Caps GmbH Grassingerstrasse 9 – 83043 - Germany