Diosminum Aflofarm

Package Leaflet: Information for the Patient

Diosminum Aflofarm, 500 mg, Tablets

Diosminum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

Table of Contents of the Leaflet

• 1. What is Diosminum Aflofarm and what is it used for
• 2. Important information before taking Diosminum Aflofarm
• 3. How to take Diosminum Aflofarm
• 4. Possible side effects
• 5. How to store Diosminum Aflofarm
• 6. Contents of the pack and other information

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

Diosminum Aflofarm increases venous tone and has a protective effect on blood vessels. It increases lymphatic drainage by enhancing the peristalsis (motility) of lymphatic vessels and lymph flow. The medicine acts on microcirculation, reducing the permeability of small blood vessels, perivascular inflammation, and stasis in microcirculation. It also reduces the fragility of small blood vessels.

Indications for Use

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

• feeling of heavy legs;
• leg pain;
• night cramps. Symptomatic treatment in case of exacerbation of symptoms associated with hemorrhoids.

If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

2. Important Information Before Taking Diosminum Aflofarm

When Not to Take Diosminum Aflofarm

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

Warnings and Precautions

If symptoms associated with hemorrhoids persist or worsen despite treatment, a doctor should be consulted. Treatment of symptoms associated with hemorrhoids should be short-term.

Diosminum Aflofarm and Other Medicines

The doctor should be informed 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

The medicine should be taken during meals.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only if necessary, and only on the advice of a doctor. If the patient becomes pregnant during treatment, she should consult a doctor, as only the doctor can decide whether to continue treatment.
Breastfeeding
Due to the lack of data on the passage into breast milk, the use of the medicine during breastfeeding is not recommended.

Driving and Using Machines

The medicine has no effect on driving or operating 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, which means it is considered "sodium-free".

3. How to Take Diosminum Aflofarm

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
The medicine is administered orally.

Recommended Dose

1 tablet twice a day (morning and evening), during meals.
In case of exacerbation of symptoms associated with hemorrhoids, 6 tablets per day for 4 days, and then 4 tablets per day for the next 3 days, during meals.
A higher dose of the medicine than recommended should not be taken.

Taking a Higher Dose of Diosminum Aflofarm Than Recommended

No cases of overdose have been reported.
Taking a higher dose of the medicine than recommended may cause gastrointestinal disorders, vomiting, and nausea.
In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.

Missing a Dose of Diosminum Aflofarm

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted. There is no data on the effects of stopping treatment.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare(occurring in 1 to 10 people out of 10,000):

• diarrhea;
• indigestion;
• nausea;
• vomiting;
• dizziness;
• headache;
• malaise;
• rash (itchy, red bumps on the skin);
• itching;
• hives (light red, itchy blisters on the skin).

The observed side effects do not require the medicine to be discontinued.

Reporting Side Effects

If any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to Store Diosminum Aflofarm

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month.
Lot – means batch number.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack 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 in the form of tablets.
The pack contains 20, 30, or 60 tablets.

Marketing Authorization Holder and Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
phone: (42) 22-53-100

Date of Last Revision of the Leaflet: