Package leaflet: Information for the patient

ADPROCTIN
500 mg, hard capsules
Calcii dobesilas monohydricus
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 side effects, 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, consult your doctor.

Contents of the leaflet

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

1. What Adproctin is and what it is used for

Adproctin is a medicine in the form of hard capsules. It contains the active substance calcium dobesilate monohydrate, which acts on capillary vessel walls. It reduces their excessive permeability and fragility and increases their resistance, thereby preventing fluid leakage through vessel walls.
Additionally, it accelerates collagen synthesis, which is an important component of arterial walls.
Adproctin reduces blood viscosity, increases erythrocyte flexibility, and also exerts anti-aggregatory effects. This improves peripheral venous circulation, reduces venous stasis, and inhibits the development of thrombotic changes associated with varicose veins.
Adproctin also reduces permeability and fragility of lymphatic vessels and improves lymphatic drainage, thus reducing edema.

Indications
Symptomatic treatment of hemorrhoidal disease (hemorrhoids).
Adproctin is indicated for use in adults.

2. Important information before using Adproctin

When not to use Adproctin

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
in children and adolescents.

Warnings and precautions
Do not use for longer than 4 weeks without consulting a doctor.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.
The medicine should be used with caution in patients with impaired liver function or in those with active peptic ulcer disease of the stomach and/or duodenum, or chronic gastritis.
Periodic monitoring of gastric and duodenal function is recommended. If symptoms worsen, discontinue the medicine and consult a doctor.
Immediately stop using the medicine and contact a doctor if symptoms such as fever, sore throat or larynx, pain during swallowing, nasal mucositis, oral mucositis, or inflammation of the genital and anal areas occur, as these may be signs of a serious condition – agranulocytosis.
Consult a doctor even if the above warnings relate to conditions that occurred in the past.

Use of Adproctin in patients with renal impairment
Use with caution in patients with impaired kidney function. In patients with severe renal insufficiency, especially those undergoing dialysis, reduced doses of the medicine should be used.

Children and adolescents
The effect of the medicine has not been studied in children and adolescents. Adproctin should not be used in children and adolescents.

Adproctin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
There are no data available on interactions between Adproctin and other medicines.
Adproctin may affect laboratory test results of serum creatinine levels. Therefore, inform the doctor about all laboratory tests performed in the patient, especially those assessing kidney function.
If blood samples or other specimens need to be collected during treatment with Adproctin, to minimize the potential impact of the medicine on test results, samples should be taken before the first daily dose of the medicine.

Adproctin with food and drink
The medicine is taken orally during main meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Adproctin may be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adproctin is contraindicated during the first trimester of pregnancy.

Breastfeeding
The medicine passes into breast milk in very small amounts. There is no data on its effect on the breastfed infant; therefore, women should discontinue breastfeeding before starting treatment with Adproctin.

Driving and operating machinery
Adproctin has no influence on the ability to drive or operate machinery.

3. How to use Adproctin

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
Unless otherwise prescribed by a doctor, the usual dose for adults is 1 to 2 capsules per day (corresponding to a daily dose of 500 mg to 1000 mg).
The duration of treatment depends on the severity of symptoms and the course of the disease. Do not use for longer than 4 weeks without consulting a doctor.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.
Patients with renal function impairment
The efficacy and safety of calcium dobesilate have not been evaluated in patients with impaired renal function. Caution should be exercised when using Adproctin in patients with renal function disorders. In cases of severe renal failure requiring dialysis, the dose should be reduced.
Patients with hepatic function impairment
The efficacy and safety of calcium dobesilate have not been evaluated in patients with impaired liver function. Caution should be exercised when using Adproctin in patients with liver function disorders.
Method of administration
The medicine should be taken orally during main meals.
Use of a higher than recommended dose of Adproctin
If more than the recommended dose has been taken, consult a doctor or pharmacist.
Missed dose of Adproctin
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare (in less than 1 in 1,000 people but more than 1 in 10,000 people):

abdominal pain,
nausea,
diarrhoea,
vomiting,
skin reactions,
joint pain,
headache and dizziness,
fever.

Very rare (in less than 1 in 10,000 people):

bone marrow suppression with agranulocytosis (an acute condition which may present as high fever, oral infections or inflammatory conditions in the anal or genital area). In such cases, the use of the medicine must be discontinued and a doctor should be consulted immediately.

Cases of local (rash) and generalized (urticaria) allergic reactions have been reported.
Most adverse reactions resolve after discontinuation of Adproctin or after dose reduction.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Phone: +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 provide more information on the safety of the medicine.

5. How to store Adproctin

Store below 30°C. Keep in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 packaging and other information

What Adproctin contains

The active substance is calcium dobesilate monohydrate. Each hard capsule contains 500 mg of calcium dobesilate monohydrate.
The other ingredients are: microcrystalline cellulose, magnesium stearate, titanium dioxide (E 171), indigo carmine (E 132), gelatin.

What Adproctin looks like and contents of the pack
Adproctin is available as hard capsules.
The capsule is cylindrical-oval, two-piece. The inner part (body) – white, the outer part (cap) – blue. The capsule contents – white or almost white powder.
Available pack sizes:
30 hard capsules,
60 hard capsules.
PVC/PVDC/Aluminium blisters in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy „GALENA”
ul. Krucza 62
53-411 Wrocław
Poland