VENOLEN

Package leaflet: Information for the user

Venolen 2% cream

Troxerutin
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.
• Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms.

Contents of this leaflet:

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

1. What Venolen is and what it is used for

The active substance in Venolen is troxerutin, which belongs to a class of medicines known as capillary-protecting agents (bioflavonoids), used to protect blood capillaries.
This medicine is indicated for the treatment of symptoms due to venous insufficiency (such as leg swelling, night cramps, sensation of leg heaviness) and for conditions involving capillary fragility.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you should know before using Venolen

Do not use Venolen

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6). If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine (see "Pregnancy and breastfeeding").

Warnings and precautions
It is advisable to discontinue treatment with this medicine during the menstrual period.
Consult your doctor or pharmacist before using Venolen 2% cream.

Other medicines and Venolen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No other medicines are known to interact with or alter the effect of Venolen 2% cream.

Venolen with food and drink
There are no known foods or beverages that affect the action of Venolen.

Pregnancy and breastfeeding
The safety of this medicine during pregnancy has not been established; therefore, it is advisable not to use this medicine during pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
Venolen 2% cream does not affect your ability to drive or operate machinery.

Venolen 2% cream contains methyl and propyl p-hydroxybenzoates,
which may cause allergic reactions (including delayed reactions). If such reactions occur, consult your doctor or pharmacist. This medicine contains 4000 mg of propylene glycol per 40 g tube of cream.

3. How to use Venolen

Use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–3 applications per day.
If you use more Venolen than you should
Signs or symptoms of overdose with this medicine have not been reported.
If you have any doubts about the use of Venolen 2% cream, ask your doctor or pharmacist for advice.
If you forget to use Venolen
Do not use a double dose to make up for the missed dose; continue with the next application as usual.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.
Rare (may affect up to 1 in 1,000 patients):
mild gastrointestinal disturbances and facial vasodilation (which may manifest as swelling and/or redness of the face).
The use, especially if prolonged, of topical medicines applied to the skin may lead to sensitization phenomena. In such cases, treatment must be discontinued and medical advice sought to establish appropriate therapy.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Venolen

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
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 Venolen contains

• The active substance is Troxerutin.
• The other ingredients are: ascorbic acid, polyglycolized fatty acid ester, propylene glycol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of Venolen and contents of the pack
Venolen is a cream for topical use, supplied in a tube.
The pack contains one 40 g tube of cream.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PHARMA LINE S.r.l. – Via Bertani, 2 – 20154 Milan, Italy
Manufacturer
Rafarm S.A. - Korinthou Str. 12, N. Psihico, Athens – Greece

Patient Information Leaflet: Information for the user

Venolen 300 mg hard capsules

Troxerutin
Equivalent medicine
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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Venolen is and what it is used for

The active substance in Venolen is troxerutin, which belongs to a class of medicines known as capillary-protecting agents (bioflavonoids), used to protect the blood capillaries.
This medicine is indicated for the treatment of symptoms attributable to venous insufficiency (such as swelling of the legs, nocturnal cramps, sensation of leg heaviness) and for conditions of capillary fragility.
Consult your doctor if you do not notice any improvement or if your symptoms worsen.

2. What you need to know before taking Venolen

Do not take Venolen

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine (see "Pregnancy and breastfeeding").

Warnings and precautions
It is advisable to discontinue treatment with this medicine during the menstrual period.
Talk to your doctor or pharmacist before taking Venolen 300 mg hard capsules.
Other medicines and Venolen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No other medicines are known to interact with Venolen 300 mg hard capsules.
Venolen with food and drink
There are no known foods or beverages that affect the action of Venolen.
Pregnancy and breastfeeding
The safety of this medicine during pregnancy has not been established; therefore, it is advisable not to take this medicine during pregnancy.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Venolen does not impair your ability to drive or operate machinery.

3. How to take Venolen

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose at the beginning of treatment (loading dose) is 2 capsules daily,
followed by a maintenance period (maintenance dose, lasting 2 to 4 weeks or longer) with a
recommended dose of one capsule daily.
Venolen 300 mg hard capsules should be taken before or during meals.
If you take more Venolen than you should
Signs or symptoms of overdose with this medicine have not been reported.
If you have any doubts about how to use Venolen 300 mg hard capsules, ask your doctor or
pharmacist for advice.
If you forget to take Venolen
Do not take a double dose to make up for the missed dose; instead, continue taking the medicine as usual.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Rare (may affect up to 1 in 1,000 patients):
mild gastrointestinal disturbances and facial vasodilation (which may manifest as swelling and/or redness of the face).

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 via the national reporting system at the following website:
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 Venolen

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
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.
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 Venolen contains

• The active substance is Troxerutin.
• The other components are: ascorbic acid. Capsule constituents: gelatin, titanium dioxide.

Description of the appearance of Venolen and contents of the pack
Venolen is presented as hard capsules.
Pack contents: 20 capsules of 300 mg.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
PHARMA LINE S.r.l. - Via Canova, 12 – 20145 Milan, Italy
Manufacturer
One Pharma Industrial Pharmaceutical Company S.A., 60 km N.N.R. Athinon-Lamias, Sximatari
Voiotias - Greece