Patient Information Leaflet

Dinesper 500 mg film-coated tablets

Micronized flavonoids consisting of 90% diosmin and 10% flavonoids (expressed as
hesperidin)
Please read 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 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 6 weeks of treatment for chronic venous disease or after 7 days of treatment for acute haemorrhoidal attack.

Contents of this leaflet

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

1. What Dinesper is and what it is used for

Dinesper contains active substances that affect venous activity and protect the veins; they increase
venous tone and capillary resistance.
Dinesper is indicated in adults for:

the treatment of signs and symptoms of chronic venous disease of the lower limbs, such as pain, sensation of heaviness, nocturnal cramps, and swelling.
the treatment of symptoms associated with acute hemorrhoidal attack, such as pain, bleeding, and swelling in the anal region.

If you are taking this medicine to treat symptoms of chronic venous disease and
also have a leg ulcer, other skin changes, or hemorrhoids, always consult your doctor
for appropriate treatment.

2. What you need to know before taking Dinesper

Do not take Dinesper

if you are allergic to diosmin and to other flavonoids expressed as hesperidin, 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 this medicine:
Chronic venous disease
If your condition worsens during treatment, with symptoms such as inflammation of the skin or veins, hardening of the subcutaneous tissue, severe pain, skin ulcers, or atypical symptoms such as sudden swelling of one or both legs, speak to your doctor immediately.
Dinesper does not help reduce swelling of the lower limbs if this is caused by heart, kidney or liver diseases.
If you are using compression therapy for chronic venous disease, you must continue compression therapy during treatment with Dinesper.
Treatment with Dinesper is more effective when combined with a healthy lifestyle. It is recommended to avoid exposure to sunlight, follow a healthy diet, engage in regular physical activity, and avoid sitting or standing for long periods.
Acute haemorrhoidal attack
If you have an acute haemorrhoid attack, you may take Dinesper only for a limited period of time. If symptoms worsen or persist after 7 days, consult your doctor.
If your condition worsens during treatment, for example if you notice increased rectal bleeding, blood in the stool, or have doubts about bleeding from haemorrhoids, consult your doctor.
Treatment with Dinesper does not replace specific treatment for other anal disorders.
Other medicines and Dinesper
No interactions between this medicine and other medicines have been reported so far. However, you must inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Special populations
Dosage-related studies have not been conducted in patients with renal and/or hepatic impairment or in elderly patients.
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 any medicine.
The safety of Dinesper during pregnancy has not been established. Therefore, its use is not recommended during this period.
It is not known whether Dinesper passes into human breast milk. Your doctor must decide whether to discontinue breastfeeding or to discontinue/abstain from treatment with Dinesper.
Driving and operating machinery
Dinesper has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.
Dinesper contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Dinesper

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose for adults is:

Chronic venous disease

The recommended daily dose is 2 tablets, which may be taken as a single dose or in two separate doses.
You should take the medicine for at least 4–5 weeks before an improvement can be expected.
If symptoms worsen or do not improve after 6 weeks of treatment, consult your doctor.
If symptoms improve, treatment may be continued for up to 2 months. Upon advice of your doctor, treatment may be further prolonged.

Acute hemorrhoidal attack

The recommended daily dose during the first 4 days of treatment is 6 tablets, administered as 3 tablets twice daily or 2 tablets three times daily. For the following 3 days, the dose is 2 tablets twice daily (4 tablets per day). If symptoms worsen or persist after 7 days of treatment, consult your doctor.

Method of administration
Dinesper should be taken during meals.
Swallow the tablet with liquid.

If you take more Dinesper than you should
If you have taken more tablets than prescribed, speak to your doctor or pharmacist.

If you forget to take Dinesper
Do not take a double dose to make up for the missed dose.
If you have any questions 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.
Reported side effects include:
Common (may affect up to 1 in 10 people):
Diarrhoea, indigestion, nausea (feeling unwell), vomiting.
Uncommon (may affect up to 1 in 100 people):
Colitis (inflammation of the colon).
Rare (may affect up to 1 in 1,000 people):
Dizziness, feeling of restlessness, headache, malaise (feeling unwell), vertigo (spinning sensation).
Skin rash, itching, urticaria.
Not known (frequency cannot be estimated from the available data):
Abdominal pain.
Oedema (swelling of the face, lips and eyelids), angioedema (rapid swelling of tissues, such as the face, lips, tongue or throat, which may cause breathing difficulties).

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 available at the following website: 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 Dinesper

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Dinesper tablets contain

Each tablet contains 500 mg of micronized flavonoids, consisting of 450 mg of diosmin and 50 mg of flavonoids (expressed as hesperidin).
The other ingredients are:

Tablet core: gelatin, sodium starch glycolate (type A), microcrystalline cellulose,
talc, magnesium stearate (E470b)
Tablet coating: sodium lauryl sulfate, Opadry orange: hypromellose 2910/6 (E 464),
glycerol (E 422), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), and macrogol 6000.

Description of the appearance of Dinesper and contents of the pack
Oblong, pink-orange coated tablets with a score line on one side only, 17 mm long and 7.5 mm wide.
The score line is intended to facilitate swallowing and is not intended for dividing the tablet into equal doses.
The tablets are packaged in aluminum/PVC blisters, with the blisters contained in a cardboard carton.
Pack sizes: 30, 60 and 120 film-coated tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
Kern Pharma S. L.
Poligono Industrial Colon II, Calle Venus 72
Terrassa, Barcelona 08228
Spain
Mylan Hungary Kft.
Mylan Utca 1
2900 Komarom
Hungary