Venosmine

Patient Information Leaflet: Information for the User

VENOSMINE 4% cream
Diosmin
Please read this leaflet carefully before using this 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 instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What VENOSMINE is and what it is used for

VENOSMINE contains the active substance diosmin, which belongs to a group of medicines called bioflavonoids. These act by strengthening the walls of blood vessels and improving venous blood circulation.
VENOSMINE is indicated:

• for the treatment of a condition characterized by impaired return of blood to the heart (venous insufficiency);
• to strengthen fragile capillaries.

Contact your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before using VENOSMINE

Do not use VENOSMINE

• if you are allergic to diosmin 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 VENOSMINE.
Do not apply the cream if there are skin irritations present with liquid discharge (wet eczema).
The use, especially if prolonged, of this medicine, as with other topical medicines, may lead to sensitization.
If this occurs, stop treatment and consult your doctor, who will advise appropriate therapy.

Other medicines and VENOSMINE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between VENOSMINE and other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of this medicine is not recommended during pregnancy.

Driving and operating machinery
This medicine does not impair the ability to drive or operate machinery.

VENOSMINE contains lanolin and parahydroxybenzoates
VENOSMINE contains lanolin, which may cause local skin reactions (e.g. contact dermatitis). This medicine also contains parahydroxybenzoates (methyl p-hydroxybenzoate, propyl p-hydroxybenzoate) which may cause allergic reactions (including delayed reactions).

3. How to take VENOSMINE

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply the cream 2 or 3 times daily to the affected area.
If you suffer from swelling due to fluid accumulation around the ankles (malleolar edema) or from slowed blood circulation in the superficial veins (superficial venous stasis), you may enhance cream absorption through the skin by gently massaging the area with upward motions.
If you use more VENOSMINE than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
No cases of overdose have been reported.
Adverse events that could occur in case of overdose include gastrointestinal events (such as diarrhea, nausea, abdominal pain) and skin reactions (such as itching, rash).
If you have any questions about using VENOSMINE, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
The following adverse effects may occur:
Rare: (may affect up to 1 in 1,000 people)

• stomach pain (gastralgia), nausea, diarrhoea;
• dizziness.

The following adverse effects or reactions have been reported and are classified according to the following frequency: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100); rare (>1/10,000, <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).

• Gastrointestinal disorders: Rare: gastralgia, nausea, diarrhoea.
• Nervous system disorders: Rare: dizziness.

The following adverse effects have been observed for the active substance:

• Nervous system disorders: Rare: headache, malaise.
• Gastrointestinal disorders: Common: dyspepsia, vomiting.
• Uncommon: colitis.
• Not known: abdominal pain.
• Skin and subcutaneous tissue disorders: Rare: rash, pruritus, urticaria.
• Not known: facial, lip or eyelid swelling; angioedema (Quincke's oedema).
• Blood and lymphatic system disorders: Not known: thrombocytopenia.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store VENOSMINE

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.
Keep the container tightly closed.
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 VENOSMINE contains
The active substance is diosmin. 100 g of cream contain 4 g of diosmin.
The other components are: semisynthetic glycerides (softisan 100), anionic emulsifying wax (lanette SX),
anhydrous lanolin, polysorbate 80, dimethylpolysiloxane 100, dimethylpolysiloxane 500, methyl p-hydroxybenzoate,
propyl p-hydroxybenzoate, lemon fragrance, purified water.
Description of the appearance of VENOSMINE and contents of the pack
Carton containing a tube of 40 g of cream.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati, 40 – 20121 Milan - Italy
Manufacturer
INDUSTRIA FARMACEUTICA NOVA ARGENTIA S.r.l.
Via Pascoli, 1
20064 – Gorgonzola (MI) – Italy.