Diosmin EG
Italy
Table of Contents
Package leaflet: Information for the patient
DIOSMINA EG 450 mg film-coated tablets
Read this leaflet carefully before taking this medicine because it contains important information for you.
Take 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 you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
- Contact your doctor if you do not notice any improvement or if your symptoms worsen after 7 days.
Contents of this leaflet:
- What DIOSMINA EG is and what it is used for
- What you need to know before taking DIOSMINA EG
- How to take DIOSMINA EG
- Possible side effects
- How to store DIOSMINA EG
- Contents of the pack and other information
1. What DIOSMINA EG is and what it is used for
DIOSMINA EG is a medicine containing micronized diosmin, used to protect veins and capillaries.
DIOSMINA EG is indicated for the treatment of:
- venous insufficiency of the lower limbs (which may manifest, for example, as swelling, heaviness, pain or cramps in the legs and feet) and haemorrhoids (veins in the anal region);
- capillary fragility (easy rupture of capillaries, which become visible on the skin and may cause spots and bruising);
- acute haemorrhoidal attack (sudden onset of bleeding due to rupture of haemorrhoids, pain and itching in the anal region).
Consult your doctor if you do not feel better or if you feel worse after one week of treatment.
2. What you need to know before taking DIOSMINA EG
Do not take DIOSMINA EG
- if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).
Children and adolescents
There are no data available to support the use of this medicine in children and adolescents.
Warnings and precautions
If sudden swelling, skin discoloration, severe pain, or ulcers develop in one or both legs, contact your doctor immediately.
The treatment is likely to provide greater benefit when combined with a healthy lifestyle:
- avoid sun exposure and prolonged standing
- maintain a healthy body weight
- wear compression stockings, if recommended by your doctor
If you are taking this medicine to treat haemorrhoids and symptoms do not improve within 7 days of treatment, a specialist visit (with a proctologist) is recommended.
Other medicines and DIOSMINA EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Pregnancy and breastfeeding
The safety of this medicine during pregnancy has not been established; therefore, do not take this medicine during pregnancy.
Breastfeeding
There are no data available regarding the passage of this medicine into breast milk; therefore, do not take this medicine during breastfeeding.
Driving and using machines
There are no data available to assess the effect of this medicine on the ability to drive vehicles or operate machinery.
DIOSMINA EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
DIOSMINA EG contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
3. How to take DIOSMINA EG
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.
Venous insufficiency (including haemorrhoids) and capillary fragility
The recommended daily dose is 2 tablets, taken either as a single dose or divided into two separate doses,
during meals. You may continue treatment for up to 8 weeks. The treatment should be reassessed if symptoms
persist or worsen, or if continued treatment beyond 8 weeks is required.
Do not exceed the maximum daily dose.
Acute haemorrhoidal attack
The recommended dose is 3 tablets twice daily (6 tablets per day), taken with the two main meals, for the
first 4 days of treatment; during the following 3 days, the daily dose is 2 tablets twice daily (4 tablets per day).
Do not exceed the maximum daily dose.
If you are taking DIOSMINA EG to treat symptoms of chronic venous disease, speak with your doctor or
pharmacist if you do not feel better or if you feel worse. If continued treatment with DIOSMINA EG is needed,
the duration of treatment will be determined by your doctor.
If you are taking DIOSMINA EG to treat symptoms of haemorrhoidal disease, consult your doctor or
pharmacist if you do not feel better or if you feel worse after 7 days.
If you take more DIOSMINA EG than you should
In case of accidental overdose of DIOSMINA EG, inform your doctor or go to the nearest hospital.
If you forget to take DIOSMINA EG
Do not take a double dose to make up for the forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects that may occur with the frequencies described below include:
Common (occur in 1 to 10 out of 100 patients):
Diarrhoea, indigestion (dyspepsia), nausea, vomiting.
Uncommon (occur in 1 to 10 out of 1,000 patients):
Colitis.
Rare (occur in 1 to 10 out of 10,000 patients):
Skin redness (rash), itching, urticaria, dizziness, headache, malaise.
Not known (frequency cannot be estimated from the available data):
Abdominal pain, swelling of the face, lips, eyelids (oedema), rapid swelling of the face, lips, mouth, tongue or throat which may lead to difficulty in breathing (angioedema), abnormally low platelet count (thrombocytopenia).
Following the instructions in the leaflet reduces the risk of side effects.
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 DIOSMINA EG
This medicine does not require any special storage temperature.
Keep this medicine in its original packaging to protect it from light.
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.
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 DIOSMINA EG contains
The active substance is micronized diosmin 450 mg.
The other components are:
Tablet core: gelatin, sodium starch glycolate, microcrystalline cellulose (E460), talc, magnesium stearate.
Film coating: Opadry OY-L28900 white (containing lactose monohydrate, hypromellose (E464), titanium dioxide (E171) and polyethylene glycol 4000), yellow iron oxide (E172), red iron oxide (E172).
Description of the appearance of DIOSMINA EG and package contents
Salmon-coloured, biconvex, elongated film-coated tablets, marked "D500" on one side.
DIOSMINA EG is available in PVC-PVDC/aluminum blister packs containing 30, 60 and 120 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.P.A.,
VIA PAVIA, 6,
20136 MILAN
Manufacturer
Stada Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel – Germany
Laboratorios Cinfa S.A., Ctra. Olaz-Chipi 10 Pol. Ind. Areta 31620 Huarte Navarra – Spain