DOXIUM FUERTE 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Doxium Fuerte 500 mg Hard Capsules

Calcium Dobesilate

Contents of the Package Leaflet

1. What is Doxium Fuerte and what is it used for
2. What you need to know before you take Doxium Fuerte
3. How to take Doxium Fuerte
4. Possible side effects
5. Storage of Doxium Fuerte
6. Contents of the pack and other information

1. What is Doxium Fuerte and what is it used for

Doxium Fuerte is presented in the form of hard capsules. Each pack contains 60 hard capsules of 500 mg each.

Doxium Fuerte is a medicine that contains a substance called calcium dobesilate, which regulates the functions of the blood capillaries and also acts on the components of the blood. Its direct biological activity involves the release of a vasodilator substance (nitric oxide) that helps to improve microcirculatory disorders.

Doxium Fuerte is indicated for eye disorders caused by diabetes, such as non-proliferative diabetic retinopathy.

2. What you need to know before you take Doxium Fuerte

Do not take Doxium Fuerte

• if you are allergic to the active substance or to any of the other ingredients of this medicine.

Warnings and precautions

Consult your doctor before taking Doxium Fuerte:

• If you have kidney failure, as you may need a dose adjustment, especially if you have severe kidney failure that requires dialysis.
• If you have any symptoms or signs of infection, such as fever, inflammation of the mucous membranes at the level of the palate, tonsils, tongue. In these cases, it is recommended to suspend treatment. Your doctor may recommend that you have a blood test.
• If you have liver failure, as you may need a dose adjustment.
• If you are going to have laboratory tests (e.g., blood tests), as calcium dobesilate may interfere with the results (e.g., creatinine). Laboratory tests should be performed before the daily intake of the drug.

Be careful with Doxium Fuerte

Like other medicines, Doxium Fuerte can cause severe hypersensitivity reactions (or allergic reactions). If you experience any such reaction, treatment should be discontinued.

Calcium dobesilate may cause interference with the enzymatic value of creatinine (a measure of kidney function), resulting in lower values than expected. If you are going to have any diagnostic tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Using Doxium Fuerte with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

No interactions with other medicines have been described.

Taking Doxium Fuerte with food and drinks

It is recommended to take Doxium Fuerte after meals.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Doxium Fuerte during pregnancy. If you become pregnant or think you may be pregnant, stop taking the medicine and inform your doctor as soon as possible.

Breastfeeding

Do not take Doxium Fuerte during breastfeeding.

Driving and using machines

At the recommended doses, this medicine has not been shown to affect the ability to drive or use machines.

3. How to take Doxium Fuerte

Follow exactly the administration instructions of this medicine as indicated by your doctor. Remember to take your medicine.

Your doctor will indicate the duration of the treatment.

The capsules should be swallowed with water or some other liquid and it is recommended to administer them after meals.

The recommended dose is 3-4 capsules per day (1500-2000 mg), divided into two doses.

If you think the effect of Doxium Fuerte is too strong or too weak, tell your doctor or pharmacist.

If you take more Doxium Fuerte than you should

If you have taken more Doxium Fuerte than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Doxium Fuerte

If you forget to take the medicine, you should take the dose as soon as you remember on the same day. If you do not take your capsule one day, take your normal dose the next day. Do not take a double dose to make up for the forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported frequently:

Gastrointestinal disorders

Abdominal pain, nausea, diarrhea, and vomiting

Nervous system disorders

Headache

Musculoskeletal and connective tissue disorders

Arthralgia, myalgia

Investigations

Increased alanine aminotransferase (increase in a liver enzyme)

The following side effects have been reported infrequently:

General disorders

Fever, chills, asthenia, fatigue

Immune system disorders

Hypersensitivity reactions such as rash, allergic dermatitis, pruritus, urticaria, facial edema

The following side effect has been reported very rarely:

Immune system disorders

Anaphylactic reaction

The following side effects have been reported with an unknown frequency:

Blood disorders

Agranulocytosis, leucopenia, neutropenia

These reactions are generally reversible after discontinuing treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxium Fuerte

• Keep this medicine out of the sight and reach of children.

• Store below 25°C, in the original package.

• Do not use this medicine after the expiry date which is stated on the package. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Doxium Fuerte

• The active substance is calcium dobesilate monohydrate. Each hard capsule contains 500 mg of calcium dobesilate monohydrate.
• The other ingredients are powdered cellulose, magnesium stearate, and silicon dioxide. The capsules contain indigotine, erythrosine, titanium dioxide, water, and gelatin. The ink contains titanium dioxide, povidone, and shellac.

Appearance of the product and contents of the pack

Doxium Fuerte is presented in packs of 60 hard capsules.

The capsules are opaque with a dark blue head and a light blue body, with the name printed on both.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer:

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

This leaflet was approved in: June 2017

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/