Aflavic Max

Package Leaflet: Information for the User

AFLAVIC MAX, 1000 mg, tablets

Diosmin

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 the package leaflet or as directed by
your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after a few days, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is AFLAVIC MAX and what is it used for

The active substance of the medicine is micronized diosmin, which improves the tone of the venous vessel walls, normalizes their permeability, and has a protective effect on the vessels.

Indications for use of the medicine

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

• feeling of heaviness in the legs;
• leg pain;
• night cramps. Symptomatic treatment in case of exacerbation of symptoms associated with anal hemorrhoids (hemorrhoids).

2. Important information before taking AFLAVIC MAX

When not to take AFLAVIC MAX:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking AFLAVIC MAX, you should discuss it with your doctor or pharmacist.
In case of exacerbation of symptoms associated with anal hemorrhoids, you should remember that therapy with AFLAVIC MAX is only symptomatic and should be short-term. If the symptoms do not subside, you should undergo an examination by a proctologist who will choose the appropriate treatment method.
Taking this medicine for symptomatic treatment in case of exacerbation of symptoms associated with anal hemorrhoids does not exclude the administration of other rectal medicines.
In case of any doubts, you should contact your doctor.

AFLAVIC MAX and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. Interactions with other medicines are not known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Studies conducted on animals have not shown any teratogenic effects. There have been no reports of harmful effects of diosmin in humans. Nevertheless, there is not enough data to completely rule out the risk, so the medicine can only be taken during pregnancy if absolutely necessary.
Breastfeeding
It is not known whether the medicine passes into breast milk, so breastfeeding should be avoided during treatment.

Driving and using machines

No studies have been conducted on the effect of AFLAVIC MAX on the ability to drive and use machines.

AFLAVIC MAX contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered sodium-free.

3. How to take AFLAVIC MAX

This medicine should always be taken exactly as described in the package leaflet or as directed by
your doctor or pharmacist. In case of doubts, you should ask your doctor or pharmacist.
The medicine is taken orally.

Recommended dose

1 tablet per day, during a meal.
Exacerbation of symptoms associated with anal hemorrhoids: 3 tablets per day for 4 days, then 2 tablets per day for the next 3 days, during meals.
Do not take more than the recommended dose of the medicine.
The dividing line on the tablet is only intended to facilitate breaking the tablet to make it easier to swallow, not to divide it into equal doses.

Taking more than the recommended dose of AFLAVIC MAX

Overdose symptoms are not known.
In case of overdose, you should contact your doctor.

Missing a dose of AFLAVIC MAX

You should not take a double dose to make up for a missed dose.

Stopping treatment with AFLAVIC MAX

In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, AFLAVIC MAX can cause side effects, although not everybody gets them.
The following side effects may occur:
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).

Observed side effects do not require discontinuation of the medicine.
Reporting side effects
If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist, or nurse. 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: 22 49-21-301
Fax: 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 AFLAVIC MAX

There are no special recommendations for storing the medicine at a certain temperature.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
“EXP”. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist 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 AFLAVIC MAX contains

• The active substance of the medicine is micronized diosmin.
• The other ingredients are: sodium croscarmellose, polyvinyl alcohol (8-88), talc, magnesium stearate, anhydrous colloidal silica.

What AFLAVIC MAX looks like and contents of the pack

The tablets are beige, oblong with a dividing line on one side, and have a biconvex shape with acceptable color variations.
The dividing line on the tablet is intended to facilitate breaking the tablet to make it easier to swallow.
The pack contains 10, 30, or 60 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Phone: (24) 357 44 44
Fax: (24) 357 45 45

Date of last revision of the leaflet: