Package leaflet: Information for the patient

Procto-Hemolan control 1000 mg, tablets
Diosmin
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 information leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that it can be consulted again if necessary.
If advice or further information is needed, please contact a pharmacist.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement or if the patient feels worse after 7 days, consult a doctor.

Contents of the leaflet

What Procto-Hemolan control is and what it is used for
Important information before taking Procto-Hemolan control
How to take Procto-Hemolan control
Possible side effects
How to store Procto-Hemolan control
Contents of the pack and other information

1. What Procto-Hemolan control is and what it is used for
Procto-Hemolan control increases venous vessel tone and has a protective effect on blood vessels.
It enhances lymphatic drainage by increasing peristalsis (motility) of lymphatic vessels and lymph flow.
The drug acts on microcirculation, reducing permeability of small blood vessels, perivascular inflammatory conditions, and stasis in the microcirculation. It also reduces susceptibility of small blood vessels to rupture.
Indications
Symptomatic treatment of exacerbations of symptoms associated with haemorrhoidal disease (haemorrhoids).
If there is no improvement or if the patient feels worse after 7 days, consult a doctor.

2. Important information before taking Procto-Hemolan control

When not to take Procto-Hemolan control

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 associated with haemorrhoidal disease persist or worsen despite treatment, consult a doctor. Treatment of symptoms related to haemorrhoidal disease should be short-term.
Procto-Hemolan control and other medicines
Inform the doctor about all medicines currently or 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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The medicine may be used during pregnancy only if clearly necessary and only under medical supervision. If a patient becomes pregnant during treatment, she should consult a doctor, as only a doctor can decide whether treatment should be continued.
Breastfeeding
Due to lack of data on passage into breast milk, use of the medicine during breastfeeding is not recommended.
Driving and operating machinery
Procto-Hemolan control has no influence on the ability to drive or operate machinery.

3. How to take Procto-Hemolan control

This medicine should always be taken as described in the patient information leaflet or according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
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, taken with meals.
Do not exceed the recommended dose.
The break line on the tablet is intended only to facilitate tablet division for easier swallowing and does not indicate division into equal doses.
Taking more than the recommended dose of Procto-Hemolan control
No cases of poisoning due to overdose have been reported.
Taking more than the recommended dose may cause gastrointestinal disturbances, vomiting, and nausea.
If more than the recommended dose has been taken, seek immediate advice from your doctor or pharmacist.
Missed dose of Procto-Hemolan control
Do not take a double dose to make up for a missed dose.
If in doubt about the use of this medicine, consult your doctor or pharmacist. There is no data available on the consequences of discontinuing treatment.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The following adverse effects may occur
Rare (occur in 1 to 10 people in 10,000):

diarrhoea;
indigestion;
nausea;
vomiting;
dizziness;
headache;
malaise;
rash (itchy, red bumps on the skin);
itching;
urticaria (pinkish, itchy blisters on the skin).
The adverse effects observed do not necessitate discontinuation of the medicine.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
e-mail: [email protected]
Reporting adverse effects allows additional information on the safety of the medicine to be collected.

5. How to store Procto-Hemolan control

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 outer carton. The expiry date refers to the last day of the specified month.
Details on the blister:
Lot – batch number
EXP – expiry date
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Procto-Hemolan control contains

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

What Procto-Hemolan control looks like and contents of the pack
Procto-Hemolan control is a scored tablet.
The pack contains 10, 20 or 30 tablets.
Marketing Authorisation 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