VENORUTON 2% Żel

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1. Venoruton 500 mg effervescent tablets, 1000 mg effervescent tablets
   1. What is Venoruton and what is it used for
   2. What you need to know before taking Venoruton
   3. How to take Venoruton
   4. Possible side effects
   5. How to store Venoruton
   6. Contents of the pack and other information
2. Venoruton 1000 mg powder for oral solution, 500 mg film-coated tablets, 2% gel
   1. What is Venoruton and what is it used for
   2. What you need to know before using Venoruton
   3. How to use Venoruton
   4. Possible side effects
   5. How to store Venoruton
   6. Contents of the pack and other information

Venoruton 500 mg effervescent tablets, 1000 mg effervescent tablets

oxerutine

Read this leaflet carefully before takingthis 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.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if you feel worse.

Contents of this leaflet:

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

1. What is Venoruton and what is it used for

Venoruton is a medicine that contains the active ingredient oxerutin, a substance obtained from the flowers and leaves of Sophora Japonica, which belongs to the flavonoid family. Oxerutin has an antioxidant action and protects blood vessels.
Venoruton is indicated in the treatment of:

• venous insufficiency (a condition affecting the venous system, especially that of the lower limbs, which can manifest, for example, with swelling, feeling of heaviness, pain or cramps in the legs and feet).
• capillary fragility (easy rupture of capillaries that become visible on the skin and can cause spots and bruises).

Consult your doctor if you do not feel better or if you feel worse, if the disorder recurs repeatedly
or if you notice any recent change in its characteristics.

2. What you need to know before taking Venoruton

Do not take Venoruton

• if you are allergic to the active ingredient 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 Venoruton.
Do not take Venoruton if you suffer from leg swelling caused by heart, kidney
and liver diseases.

Children and adolescents
Venoruton should not be used in children and adolescents.

Other medicines and Venoruton
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
To date, no specific interactions of oxerutin with other medicines have been reported, although
interaction with other medicines cannot be completely ruled out.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Venoruton is not recommended during pregnancy as the safety of
this medicine in pregnancy has not been established.
Breastfeeding
Oxerutin passes into breast milk in negligible amounts and therefore it is believed that at the
recommended doses there are no effects on newborns/infants.

Driving and operating machinery
Venoruton does not alter or negligibly alters the ability to drive vehicles and operate machinery.
In rare cases, fatigue and dizziness have been reported.
If these symptoms occur, do not drive and do not operate machinery.

Venoruton 500 mg and 1000 mg effervescent tablets contains potassium and sodium
This medicine contains 10.15 mmol (or 396 mg) of potassium per tablet. This should be taken into
consideration in patients with reduced kidney function or in patients following a low
potassium diet.
This medicine contains 82 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 4.1% of the maximum recommended daily intake with the diet of an adult.

3. How to take Venoruton

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is

• Venoruton 1000 mg effervescent tablets: 1 tablet per day.
• Venoruton 500 mg effervescent tablets: 2 tablets per day.

Dissolve the tablet carefully in a glass of water to be drunk before or during meals.
Use only for short periods of treatment.
Do not exceed the recommended doses.
If symptoms do not improve or should reappear, consult your doctor or pharmacist
before continuing or resuming treatment.
Consult your doctor or pharmacist if you do not feel better or if you feel worse, if the disorder
occurs repeatedly or if you notice any recent change in its characteristics.

If you take more Venoruton than you should
No signs or symptoms of Venoruton overdose have ever been reported.
In case of accidental ingestion of an excessive dose of Venoruton, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Venoruton
Do not take a double dose to make up for a missed dose.

If you stop taking Venoruton
If you have any doubts 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.

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

• stomach or intestinal disorders;
• gas in the stomach (flatulence);
• diarrhoea;
• abdominal pain;
• indigestion (dyspepsia);
• skin rash;
• itching;
• urticaria.

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

• severe allergic reactions even after the first intake (anaphylactoid reactions);
• allergic reactions (hypersensitivity reactions);
• dizziness;
• headache;
• hot flushes;
• fatigue.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 Venoruton

Keep this medicine out of the sight and reach of children.
Store at a temperature below 30°C.
Keep the container tightly closed to protect the medicine from light and moisture.
Do not use this medicine after the expiry date which is stated on the packaging after Scad.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Venoruton contains

• The active ingredient is oxerutin. Each effervescent tablet contains 500 mg or 1000 mg of oxerutin.
• The other ingredients are: citric acid, potassium carbonate, potassium bicarbonate, sodium bicarbonate,macrogols, potassium acesulfame, povidone, orange flavour (supported on maltodextrin), magnesium stearate.

Description of the appearance of Venoruton and contents of the pack
Venoruton is available in the form of effervescent tablets of 500 mg or 1000 mg, packaged in a tube
with a desiccant cap.
The pack contains:

• 20 effervescent tablets of 500 mg.
• 30 effervescent tablets of 1000 mg (n. 2 tubes of 15 tablets each).

Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A. Via Pavia 6 – 20136 Milano

Manufacturer
Novartis Consumer Health GmbH OTC, Zielstattstrasse 40, Munchen, Germany.

Venoruton 1000 mg powder for oral solution, 500 mg film-coated tablets, 2% gel

oxerutin

Read this leaflet carefully before usingthis medicine because it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

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

1. What is Venoruton and what is it used for

Venoruton is a medicine that contains the active ingredient oxerutin, a substance obtained from the flowers and leaves of Sophora Japonica, which belongs to the flavonoid family. Oxerutin has an antioxidant effect and protects blood vessels.
Venoruton is indicated in the treatment:

• of venous insufficiency (a condition affecting the venous system, especially that of the lower limbs and the veins of the anal region (haemorrhoids), which can manifest, for example, with swelling, a feeling of heaviness, pain or cramps in the legs and feet).
• of capillary fragility (easy rupture of capillaries that become visible on the skin and can cause spots and bruises). If you do not feel better or if you feel worse, if the disorder recurs or if you notice any recent change in its characteristics, consult your doctor.

2. What you need to know before using Venoruton

Do not use Venoruton
If you are allergic to the active ingredient or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Venoruton.
Do not take Venoruton if you suffer from leg swelling caused by heart, kidney
and liver diseases.
If skin irritation or allergic reactions occur with the use of Venoruton gel, especially
with prolonged use, discontinue treatment with Venoruton gel and consult your doctor who will give you
adequate treatment.

Children and adolescents
Venoruton should not be used in children and adolescents.

Other medicines and Venoruton
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
To date, no specific interactions of oxerutin with other medicines have been reported, although
interaction with other medicines cannot be completely ruled out.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Venoruton is not recommended during pregnancy as the safety of
this medicine in pregnancy has not been established.
Breastfeeding
Oxerutin passes into breast milk in negligible amounts and therefore it is believed that at the recommended doses there are no effects on infants/babies.

Driving and using machines
Venoruton does not or negligibly alters the ability to drive vehicles and use machines.
In rare cases, fatigue and dizziness have been reported.
If these symptoms occur, do not drive and do not use machines.
Venoruton gel does not alter the ability to drive vehicles and use machines.

Venoruton 1000 mg powder contains sodium saccharin
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Venoruton 500 mg film-coated tablets contains the azo dye Yellow
sunset lacquer aluminium (E110)
This medicine contains yellow sunset lacquer aluminium (E110) which may cause
allergic reactions.

Venoruton gel contains benzalkonium chloride
This medicine contains 0.391 mg of benzalkonium chloride per dose equivalent to 0.05 mg/g. Benzalkonium chloride may irritate the skin. If you are breastfeeding, do not apply this medicine to the breast
because the baby could ingest it with its milk.

3. How to use Venoruton

Use this medicine following exactly as stated in this leaflet or as instructed
by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is

• Venoruton 1000 mg powder: 2 to 3 sachets per day, depending on the severity of the symptom, also in venous insufficiency of the hemorrhoidal plexus (hemorrhoids). Dissolve the contents of each sachet of powder well in a little water and drink it before or during meals.
• Venoruton 500 mg coated tablets: 2 - 3 tablets per day, also in venous insufficiency of the hemorrhoidal plexus (hemorrhoids). Use the tablets by swallowing them whole, with a little water, without chewing, before or during meals.
• Venoruton gel: apply an adequate amount of gel to both the affected area and the surrounding areas, 2 times a day (morning and evening). Gently massage the treated area to allow the medicine to penetrate until complete absorption, i.e. until you no longer feel that the skin is wet to the touch.

Use only for short periods of treatment.
Do not exceed the recommended doses.
If symptoms do not improve or should reappear, consult your doctor or pharmacist
before continuing or resuming treatment.
Consult your doctor or pharmacist if you do not feel better or if you feel worse, if the disorder
occurs repeatedly or if you notice any recent change in its characteristics.

If you take more Venoruton than you should
No signs or symptoms of Venoruton overdose have ever been reported.
In case of accidental ingestion of an excessive dose of Venoruton, immediately notify your
doctor or go to the nearest hospital.

If you forget to take Venoruton
Do not take a double dose to make up for a missed dose.

If you stop taking Venoruton
If you have any doubts 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.
For 1000 mg powder for oral solution and Venoruton 500 mg film-coated tablets:

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

• stomach or intestinal disorders;
• wind (flatulence);
• diarrhoea;
• abdominal pain;
• indigestion (dyspepsia);
• skin rash;
• itching;
• urticaria.

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

• severe allergic reactions even after the first dose (anaphylactoid reactions);
• allergic reactions (hypersensitivity reactions);
• dizziness;
• headache;
• hot flushes;
• fatigue.

For Venoruton 2% gel:

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

• allergic reactions with the appearance of skin changes, which disappear when treatment is stopped.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 Venoruton

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 packaging after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Venoruton contains

• The active ingredient is oxerutin.
• Venoruton 1000 mg powder for oral solution: one sachet contains 1000 mg of oxerutin.
• Venoruton 500 mg film-coated tablets: one tablet contains 500 mg of oxerutin.
• Venoruton gel: 100 g of gel contain 2 g of oxerutin.
• The other ingredients are:
• Powder for oral solution: mannitol, sodium saccharin, citric acid monohydrate.
• Film-coated tablets: 30 percent polyacrylate dispersion, talc, magnesium stearate, macrogols, copovidone, sunset yellow lacca aluminium (E 110),titanium dioxide.
• Gel: carbomers, sodium hydroxide, disodium edetate, benzalkonium chloride, purified water.

Description of the appearance of Venoruton and contents of the pack

• 1000 mg powder for oral solution: pale yellow powder, odorless packaged in single-dose sachets. The pack contains 30 sachets.
• 500 mg film-coated tablets for oral use: oblong orange tablets packaged in blisters. The pack contains 20, 30 or 60 tablets.
• 2% gel: homogeneous, clear to slightly opalescent, transparent, golden yellow colored gel, virtually odorless, packaged in a tube. The pack contains 40 g or 100 g of gel. Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A. Via Pavia 6 – 20136 Milano

Manufacturer

• Venoruton 1000 mg powder for oral solution SMITHKLINE BEECHAM, S.A., Ctra. De Ajalvir, Alcalà de Hanares, Madrid (Spain)
• Venoruton 500 mg film-coated tablets Novartis Farma S.p.A., Via Provinciale Schito n. 131, Torre Annunziata (NA) or at Recipharm Uppsala AB, Björkgatan 30, Uppsala, 751 82 Uppsala, Sweden
• Venoruton 2% gel

Novartis Farma S.p.A., Via Provinciale Schito n. 131, Torre Annunziata (NA)
or at
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Barthstraße 4, 80339, Munich
(Germany)