Doxium (dobesilate calcium) 60 Tablets

DOXIUM 500 mg capsules are taken orally.

Excipients

Contains yellow iron oxide, titanium dioxide and indigotine.

2. What is DOXIUM and what is it used for?

DOXIUM is presented in blister packages containing 30 or 60 capsules. Each capsule contains calcium dobesilate as an active ingredient.

It is used in circulatory disorders of small vessels (especially in disorders of the eye vessels due to diabetes), vascular circulation disorders in the legs, cramping and sloth and also in hemorrhoidal disorders.

3. How to use DOXIUM?

Instructions for proper use and frequency of dosing / administration

should always be taken as indicated by your doctor. DOXIUM is used only in adults.

In general, once or twice a day, 1 or 2 capsules should be taken with some water.

The highest daily dose is 4 capsules.

The dose and duration of treatment are determined by the physician's recommendation according to the disease to be treated.

Your doctor will tell you how often and how many capsules DOXIUM will use. According to your response to treatment, your doctor may recommend a higher or lower dose.

Do not exceed the recommended dose.

Application method and method

DOXIUM is for oral use only.

The capsule is swallowed with some water during the meal before it is opened or chewed.

Use in

children In children (and adolescents under 18 years of age), there is currently no data available to recommend a dosage regimen for routine use.

Use in the

elderly Elderly (65 years and older) practice is exactly the same as in adults.

Specific Use

Kidney / Liver Failure: In Conditions Patients with severe renal failure entering dialysis, the dose should be reduced.

Your doctor will tell you how long your treatment will take with DOXIUM. Do not discontinue treatment early, because stopping DOXIUM treatment may make your illness worse.

If you have an impression that the effect of DOXIUM is too strong or weak, talk to your doctor or pharmacist.

If you use more DOXIUMuse

than you should use, talk to a doctor or pharmacist if you have used more than you should DOXIUM.

If you have forgotten to use DOXIUM, do not use

a double dose to compensate for the missed doses.

If you forget to take your medicine, take this dose as soon as you realize you forgot it and take the next dose at the usual time.

Effects when treatment with DOXIUM is discontinued

None.

4. What are the possible side effects?

As with all medicines, DOXIUM may have side effects in people who are sensitive to the substances contained in its contents.

If you have any of the following, stop using DOXIUM and IMMEDIATELY tell your doctor or contact the emergency department of the hospital nearest you:Ulc on the

•throat, intestines and other mucosal membranes, as well as on the skin due to reduced white blood cells.

These are all very serious side effects.

If you have one of these, you have a serious allergy to DOXIUM. You may need urgent medical attention or hospitalization.

All of these very serious side effects are very rare.

If you notice any of the following, report it immediately to your doctor or contact your nearest hospital emergency department:

• Skin rash, fever, joint pain

These are all serious side effects. Emergency medical intervention may be required. Serious side effects are very rare.

If you notice any of the following, tell your doctor:

• Nausea

• Diarrhea

• Vomiting

These are mild side effects of DOXIUM.

If these symptoms do not occur spontaneously or are severe / distressing, contact your doctor.

2. Things to consider before using

DOXIUM DO NOT USE DOXIUM

if you are allergic to calcium dobesilate or DOXIUM components.

USE DOXIUM CAREFULLY in the following cases

:

- If you enter dialysis, use DOXIUM only under serious medical supervision

- If there is fever, infection in the oral cavity (tonsillitis), sore throat, inflammation in the genital area or symptoms related to it, stop taking DOXIUM immediately and inform your doctor. Your doctor will perform your blood count and, if necessary, other tests.

- DOXIUM is only used in adults.

. Please consult your doctor if these warnings are valid for you even at any time in the past. A Using

DOXIUM with food and drink with food and beverages

There is no interaction.

Pregnancy

Consult your doctor or pharmacist before using the medicine. DOXIUM should not be used during pregnancy unless necessary.

If you notice that you are pregnant at the time of your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Calcium dobesilate passes into breast milk in low amounts. Therefore, one of the treatment or breastfeeding should be discontinued.

Driving and using machines of the

tools and use of machines

Important information about some aids in thedoxıum content

warning is not required due to the use of any road or dose for any of the excipients contained in the Content.

Concomitant use with other medicines

doxium is no evidence of any drug interactions.

5. Storage of

DOXIUM Keep DOXIUM out of the reach of children and in its packaging. Store at room temperature below 30 ° C.

Use in accordance with expiration dates.

Do not use DOXIUM after the expiration date.

4.1. Therapeutic indications

• Microangiopathy (especially in diabetic retinopathy)

• It is indicated for pain, cramping and lazy venous failure.

4.2. Posology and method of administration

: The

dose and duration of treatment are determined by the physician's recommendation according to the disease to be treated.

Application frequency and duration:

Only used in adults.

The daily dose is between 500 and 2000 mg. In general, once or twice a day, 1 or 2 capsules should be taken with some water.

Application: For

oral use only.

The capsules should be taken with food before opening.

Additional information on special populations:

Renal / hepatic impairment: Dose should be reduced in patients with severe renal failure.

Pediatric population: In children there is currently no data available to recommend a dosage regimen for routine use.

4.3. Contraindications

4.4. Special warnings and precautions for use In

patients with severe renal failure entering dialysis, the dose should be reduced.

4.5. Interactions with other medical products and other forms of interaction

4.6. Pregnancy and

lactation

Pregnancy category

Cd.

Women with child-bearing potential / contraception (Contraception)

DOXIUM is not available for use in pregnant women.

Animal studies are insufficient in terms of effects on pregnancy / and / or / embryonic / fetal development / and-or / birth / and / or postnatal development (see section 5.3). The potential risk for humans is unknown.

DOXIUM should not be used during pregnancy unless necessary.

Pregnancy should not be used if

calcium dobesilate is not known to pass the placental barrier, it should be used if it believes that the benefit of the drug to the pregnant woman will justify the potential risk on fetus.

Lactation

Calcium dobesilate passes into breast milk in low amounts. Therefore, one of the treatment or breastfeeding should be discontinued.

Reproductive ability / Fertility

4.7. Effects on ability to drive and use machines

4.8. Undesirable effects

DOXIUM is very well tolerated, even during long-term treatments.

Frequencies are defined as follows: very common (> 1/10); common (> 1/100 to <1/10); non-widespread (> 1 / 1,000 to <1/100); infrequently (> 1 / 10,000 to <1 / 1,000); very rare (<1 / 10,000), unknown (unpredictable).

Diseases of the blood and lymph system

Very rare: isolated cases of agranulocytosis have been reported when used with elderly patients and other drugs

Gastrointestinal disorders

Sparse: Nausea, diarrhea, vomiting

Skin and subcutaneous tissue disorders

Rare: Skin rash, pruritus

Musculoskeletal disorders, connective tissue and bone diseases

Infrequent: Joint pain

General disorders and diseases related to the site of application

Uncommon: Fever, chills, shivering

These side effects are usually eliminated by discontinuation of treatment.

In gastrointestinal disorders, the dose should be reduced or treatment should be temporarily discontinued.

Treatment with skin rashes, fever, joint pain or changes in blood formula

4.9. Overdosage and treatment

No cases of overdose have been reported to date.