Leaflet: information for the user

Doxium Strong 500 mg hard capsules

Dobesilate calcium

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

2. What you need to know before starting to take Doxium Strong

3. How to take Doxium Strong

4. Possible side effects

5. Storage of Doxium Strong

6. Contents of the pack and additional information

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

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

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

Do not take Doxium Fuerte

• if you are allergic to the active ingredient or any of the other components of this medication.

Warnings and Precautions

Consult your doctor before starting to take Doxium Fuerte:

• If you have kidney insufficiency, as you may require dose adjustment, especially if you have severe kidney insufficiency requiring dialysis.
• If you present any symptoms or signs of infection such as fever, mucosal inflammation at the level of the palate, tonsils, tongue. In these cases, it is recommended to suspend treatment. Your doctor may recommend performing a blood analytical control.
• If you have liver insufficiency, as you may require dose adjustment.
• If you are to undergo laboratory tests (e.g., blood analysis), as dobesilate of calcium could interfere with the results (e.g., creatinine). Laboratory tests should be performed before daily medication.

Be especially careful withDoxium Fuerte

Like other medications, Doxium Fuerte may trigger severe hypersensitivity reactions (allergic reactions). In case of suffering any such reaction, treatment should be discontinued.

Dobesilate of calcium may cause interference with the enzymatic value of creatinine (kidney function measurement) resulting in lower values than expected. If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Use of Doxium Fuerte with othermedications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

No interactions with other medications 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not administer during pregnancy. In case of pregnancy or suspicion of it, you should suspend treatment and inform your doctor as soon as possible.

Breastfeeding

Do not administer during the breastfeeding period.

Driving and operating machinery

At the recommended doses, this medication has not been described to affect the ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor.Remember to take your medication.

Your doctor will inform you of the treatment duration.

The capsules should be swallowed with water or another 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 estimate that the action of Doxium Strong is too strong or too weak, inform your doctor or pharmacist.

If you take more Doxium Strong than you should

If you have taken more Doxium Strong 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 Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Doxium Strong

If you forgot to take the medication, 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 compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been described frequently:

Gastrointestinal Disorders

Abdominal pain, nausea, diarrhea, and vomiting

Nervous System Disorders

Headache (headache)

Musculoskeletal and Connective Tissue Disorders

Arthralgia (joint pain), myalgia (muscle pain)

Investigations

Increased alanine aminotransferase (increase in a liver enzyme)

The following adverse effects have been described infrequently:

General Disorders

Fever, chills, asthenia, fatigue

Immune System Disorders

Hypersensitivity reactions such as rash (skin reaction), allergic dermatitis, pruritus (itching), urticaria (hives with itching), facial edema (swelling in the face)

The following adverse effect has been described very rarely:

Immune System Disorders

Anaphylactic reaction (allergic reaction that can be generalized and severe)

The following adverse effects have been described with unknown frequency:

Blood and Lymphatic System Disorders

Agranulocytosis (severe decrease in white blood cells in the blood that may be accompanied by infections), leucopenia (decrease in the total count of white blood cells in the blood that may be accompanied by infections), neutropenia (decrease in white blood cells in the blood that may be accompanied by infections).

These reactions are generally reversible spontaneously after discontinuing treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: https//www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

• Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Doxium Fuerte Composition

- The active ingredient is calcium dobesilate monohydrate. Each hard capsule contains 500 mg of calcium dobesilate monohydrate.

- The other components are powdered cellulose, magnesium stearate, and silicon dioxide. The capsules contain indigotin, erythrosine, titanium dioxide, water, and gelatin. The ink contains titanium dioxide, povidone, and Shellac.

Product appearance and packaging contents

Doxium Fuerte is presented in packaging with 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

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/