Doxium Fuerte 500 mg hard capsules
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Doxium Fuerte 500 mg hard capsules
Calcium dobesilate
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
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Package leaflet contents
- What Doxium Fuerte is and what it is used for
- What you need to know before taking Doxium Fuerte
- How to take Doxium Fuerte
- Possible side effects
- Storage of Doxium Fuerte
- Contents of the pack and other information
1. What Doxium Fuerte is and what it is used for
Doxium Fuerte is presented in the form of hard capsules. Each package contains 60 hard capsules of 500 mg each.
Doxium Fuerte is a medicine containing a substance called calcium dobesilate, which regulates the functions of the blood capillary and also acts on blood components. Its direct biological activity involves the release of a vasodilator substance (nitric oxide), which helps improve microcirculatory alterations.
Doxium Fuerte is indicated for ocular alterations caused by diabetes, such as non-proliferative diabetic retinopathy.
2. What you need to know before starting Doxium Fuerte
Do not take Doxium Fuerte
- if you are allergic to the active substance or to any of the other components of this medicine.
Warnings and precautions
Consult your doctor before starting to take Doxium Fuerte:
- If you have renal insufficiency, as dose adjustment may be required, especially if you have severe renal insufficiency requiring dialysis.
- If you experience any symptoms or signs of infection such as fever, mucosal inflammation affecting the palate, tonsils, or tongue. In such cases, discontinuation of treatment is advised. Your doctor may recommend regular blood monitoring.
- If you have hepatic insufficiency, as dose adjustment may be required.
- If you are scheduled for laboratory tests (e.g., blood tests), since calcium dobesilate may interfere with test results (e.g., creatinine). Laboratory tests should be performed before the daily dose of the drug is taken.
Take special care with Doxium Fuerte
Like other medicines, Doxium Fuerte may trigger serious hypersensitivity (or allergic) reactions. If you experience any such reaction, treatment must be discontinued.
Calcium dobesilate may interfere with enzymatic creatinine measurements (used to assess kidney function), resulting in lower values than expected. If you are undergoing any diagnostic tests (including blood and urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.
Use of Doxium Fuerte with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions with other medicines have been reported.
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 become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
This medicine must not be administered during pregnancy. If pregnancy occurs or is suspected, treatment must be discontinued immediately and your doctor must be informed.
Breastfeeding
This medicine must not be administered during breastfeeding.
Driving and using machines
At the recommended doses, this medicine has not been reported to affect the ability to drive or operate machinery.
3. How to take Doxium Fuerte
Follow exactly the instructions given by your doctor for taking this medicine. Remember to take your medication.
Your doctor will tell you how long to continue the treatment.
The capsules should be swallowed with water or another liquid, and it is advisable to take them after meals.
The recommended dose is 3-4 capsules per day (1500-2000 mg), divided into two doses.
If you think that 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, contact your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medicine and the amount ingested.
If you forget to take Doxium Fuerte
If you forget to take your medicine, take the missed dose as soon as you remember on the same day. If you miss a day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported frequently:
Gastrointestinal disorders
Abdominal pain, nausea, diarrhoea and vomiting
Nervous system disorders
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 reported uncommonly:
General disorders
Fever, chills, asthenia, fatigue
Immune system disorders
Hypersensitivity reactions such as rash (skin reaction), allergic dermatitis, pruritus (itching), urticaria (itchy, raised skin lesions), facial oedema (swelling of the face)
The following adverse effect has been reported very rarely:
Immune system disorders
Anaphylactic reaction (allergic reaction that may be generalized and severe)
Some cases with unknown frequency have been reported:
Blood disorders
Agranulocytosis (severe decrease in white blood cells in blood, which may be associated with infections), leucopenia (decrease in total white blood cell count in blood, which may be associated with infections), neutropenia (decrease in white blood cells in blood, which may be associated with infections).
These reactions are generally reversible spontaneously after discontinuation of treatment.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Doxium Fuerte
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Keep this medicine out of the sight and reach of children.
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Store below 25°C, in the original packaging.
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Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. 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 components are powdered cellulose, magnesium stearate, and silicon dioxide. The capsules contain indigotine, erythrosine, titanium dioxide, water, and gelatin. The printing ink contains titanium dioxide, povidone, and shellac.
Appearance of the product and contents of the pack
Doxium Fuerte is available in packs containing 60 hard capsules.
The capsules are opaque, with a dark blue cap 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 up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/