Procto-hemolan control

Package Leaflet: Information for the Patient

Procto-Hemolan control 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 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 any possible side effects not listed in the 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 Procto-Hemolan control and what is it used for
• 2. Important information before taking Procto-Hemolan control
• 3. How to take Procto-Hemolan control
• 4. Possible side effects
• 5. How to store Procto-Hemolan control
• 6. Contents of the pack and other information

1. What is Procto-Hemolan control and what is it used for

Procto-Hemolan control 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

Symptomatic treatment in case of exacerbation of symptoms associated with anal varices (hemorrhoids).
If there is no improvement or the patient feels worse after 7 days, a doctor should be consulted.

2. Important information before taking Procto-Hemolan control

When not to take Procto-Hemolan control

• 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 anal varices persist or worsen despite treatment with the medicine,
a doctor should be consulted. Treatment of symptoms associated with anal varices should be short-term.

Procto-Hemolan control 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.

Procto-Hemolan control 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 a doctor's prescription. If the patient becomes pregnant during treatment, she should consult a doctor, as only a 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 using machines.

3. How to take Procto-Hemolan control

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

Recommended dose

3 tablets per day for 4 days, followed by 2 tablets per day for the next 3 days, during meals.
A higher dose of the medicine than recommended should not be taken.
The dividing line on the tablet only facilitates breaking it, to make it easier to swallow, and not to divide it into equal doses.

Taking a higher dose of Procto-Hemolan control than recommended

No cases of poisoning with the medicine due to 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 Procto-Hemolan control

A double dose should not be taken to make up for a missed dose.
In case of 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.

The following side effects may occur

Rarely(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 discontinuation of the medicine.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed.
Side effects can be reported directly to the Department for 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
e-mail: ndl@urpl.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Procto-Hemolan control

The medicine should be stored out of sight and reach of children.
It should be stored at a temperature below 25°C.
The medicine should not be used after the expiration date stated on the blister pack and carton. The expiration date refers to the last day of the specified month.
Markings on the blister pack
Lot – batch number
EXP – expiration date
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Procto-Hemolan control contains

• The active substance of the medicine is diosmin.
• One tablet contains 1000 mg of diosmin.
• The other ingredients are: polyvinyl alcohol, sodium croscarmellose, talc, anhydrous colloidal silica, magnesium stearate.

What Procto-Hemolan control looks like and what the pack contains

Procto-Hemolan control is in the form of tablets with a dividing line.
The pack contains 10, 20, or 30 tablets.

Marketing authorization holder

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

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of last revision of the leaflet:22.06.2020