Package leaflet: Information for the patient

ALVENEX 450 mg tablets, 450 mg powder for oral suspension

Diosmin
Please read all of this leaflet carefully before 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 instructed.

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. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What ALVENEX is and what it is used for

ALVENEX 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.
ALVENEX is indicated:

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

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

2. What you need to know before taking ALVENEX

Do not take ALVENEX

if you are allergic to diosmin or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or breastfeeding (see the section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ALVENEX.
There are no specific precautions regarding the use of ALVENEX.

Other medicines and ALVENEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between ALVENEX and other medicines are known.
Interaction studies have not been conducted.

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 and breastfeeding.

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

ALVENEX 450 mg oral suspension powder contains fructose
ALVENEX contains a type of sugar called fructose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take ALVENEX

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.
The recommended dose is 1 tablet or 1 sachet of ALVENEX twice daily, at regular intervals, unless otherwise directed by your doctor.
Tablets: Swallow the tablet with a small amount of water.
Oral suspension powder: Dissolve the contents of 1 sachet in a small amount of water (about half a glass) and shake well.
If you take more ALVENEX than you should
In case of accidental overdose of ALVENEX, inform your doctor immediately or go to the nearest hospital.
No cases of overdose have been reported.
If you forget to take ALVENEX
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of ALVENEX, 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 side effects may occur:

Common (may affect up to 1 in 10 people)

Diarrhoea
Dyspepsia
Nausea
Vomiting

Uncommon (may affect up to 1 in 100 people)

Colitis

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

Dizziness
Headache
Malaise
Rash
Itching
Urticaria

Not known (frequency cannot be estimated from the available data)

Abdominal pain
Facial swelling, swelling of the lips, swelling of the eyelids, Quincke's oedema
Thrombocytopenia

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 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 ALVENEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container 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 no longer required. This will help protect the environment.

6. Package contents and other information

What ALVENEX 450 mg tablets contains
The active substance is diosmin. One tablet contains 450 mg of diosmin.
The other components are: polyethylene glycol 4000, magnesium stearate (E572), talc, anhydrous colloidal silica.

What ALVENEX 450 mg oral suspension powder contains
The active substance is diosmin. One sachet contains 450 mg of diosmin.
The other components are: fructose, polyethylene glycol 4000, maize starch, magnesium stearate (E572),
orange sweet essence.

Description of the appearance of ALVENEX and contents of the pack
Tablets: carton containing two blisters of 10 tablets each.
Oral suspension powder: carton containing 20 sachets.

Marketing Authorization Holder
Dymalife Pharmaceutical Srl – Via Bagnulo, 95 – 80063 Piano di Sorrento (NA).

Manufacturer
Lachifarma Srl - S.S.16 Zona Industriale - 73010 Zollino (LE) – Italy