Package leaflet: Information for the patient

Diosminum Aflofarm, 500 mg, tablets
Diosminum
Please read all of this leaflet carefully before taking this medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Leaflet contents

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

1. What Diosminum Aflofarm is and what it is used for

Diosminum Aflofarm increases venous vessel tone and exerts a protective effect on blood vessels. It enhances lymphatic drainage by stimulating peristalsis (motility) of lymphatic vessels and lymph flow. The drug acts on the microcirculation by reducing permeability of small blood vessels, perivascular inflammatory conditions, and stasis in the microcirculation. It also reduces the susceptibility of small blood vessels to rupture.

Indications
Chronic venous insufficiency of the lower limbs (varicose veins):

sensation of leg heaviness;
leg pain;
nocturnal cramps.

Symptomatic treatment of flare-ups of haemorrhoidal disease (haemorrhoids).

If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

2. Important information before taking Diosminum Aflofarm

When not to take Diosminum Aflofarm

if the patient is allergic to diosmin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If symptoms related to haemorrhoids persist or worsen despite treatment,
the patient should consult a doctor. Treatment of haemorrhoid-related symptoms should be
short-term.
Diosminum Aflofarm and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
No interactions with other medicines have been reported.
Diosminum Aflofarm with food and drink
Take the medicine during meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult a doctor or pharmacist before using this medicine.
Pregnancy
This medicine may be used during pregnancy only if clearly necessary and only under medical prescription. If the patient becomes pregnant while being treated, she should seek medical advice, as only a doctor can decide whether treatment should be continued.
Breastfeeding
Due to lack of data on passage into breast milk, use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
Diosminum Aflofarm has no influence on the ability to drive or operate machinery.
Diosminum Aflofarm contains sodium
The medicine contains 0.429 mg of sodium per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Diosminum Aflofarm

This medicine should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
Recommended dose
1 tablet twice daily (in the morning and evening), during meals.
In case of exacerbation of haemorrhoidal symptoms, take 6 tablets daily for 4 days, followed by 4 tablets daily for the next 3 days, taken during meals.
Do not take more than the recommended dose of the medicine.
Taking more than the recommended dose of Diosminum Aflofarm
There have been no reported cases of poisoning due to overdose of this medicine.
Taking more than the recommended dose may cause gastrointestinal disturbances, vomiting and nausea.
If you have taken more than the recommended dose, seek immediate advice from your doctor or pharmacist.
Missed dose of Diosminum Aflofarm
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist. There is no data available on the consequences of discontinuing treatment.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Rarely (occurs in 1 to 10 people per 10,000):

diarrhoea;
indigestion;
nausea;
vomiting;
dizziness;
headache;
malaise;
rash (itchy, red skin bumps);
itching;
urticaria (pinkish, itchy wheals on the skin).

Observed adverse reactions do not necessitate discontinuation of the medicine.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, patients should inform their doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diosminum Aflofarm

Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
LOT – means batch number.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Diosminum Aflofarm contains

The active substance is diosmin.

One tablet contains 500 mg of diosmin.

The other ingredients are: microcrystalline cellulose, mannitol, polyvinyl alcohol, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate.

What Diosminum Aflofarm looks like and contents of the pack
Diosminum Aflofarm is a tablet.
The pack contains 20, 30 or 60 tablets.
Marketing Authorisation Holder and Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100