Dioflav 500 mg comprimidos recubiertos con pelicula
Introduction
Leaflet: information for the user
Dioflav500 mg film-coated tablets
diosmina
Read this leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if you get worse or do not improve after 2 weeks.
1. What is Dioflav and what it is used for
2. What you need to know before starting to take Dioflav
3. How to take Dioflav
4. Possible side effects
5. Storage of Dioflav
6. Contents of the pack and additional information
1. What is Dioflav and what is it used for
Dioflavis a venotonic medication: it increases the tone of the veins and the resistance of the capillaries (small blood vessels).
It is indicated, in adults, for the relief of symptoms related to mild lower limb venous insufficiency, such as pain, heaviness, tightness, tingling, and itching in legs with varicose veins or swollen legs.
Consult a doctor if symptoms worsen or do not improve after 2 weeks of treatment.
2. What you need to know before starting to take Dioflav
Do not takeDioflav
If you are allergic to diosmin, to other flavonoids or to any of the other components ofthis medication (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Dioflav.
Do not use for an extended period without medical supervision..
Children and adolescents
Dioflav is not indicated for children and adolescents (under 18 years).
Other medications and Dioflav
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.
No interactions with food or other medications are known, in any case never take another medication on your own initiative without your doctor's recommendation.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.
Pregnancy
No adverse effects have been reported in humans. Extreme caution should be exercised when using diosmin during pregnancy, weighing the potential benefits of this medication during the same.
Breastfeeding
No information is available on whether the medication passes into breast milk; it is not recommended to use during breastfeeding.
Driving and operating machinery
No effects on the ability to drive and operate machinery have been described with Dioflav.
Dioflav contains lactose and sodium
If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.
This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.
3. How to Take Dioflav
Adults
The recommended dose is 2 tablets per day, divided into two doses, one tablet at midday, and another at night, with meals.
If symptoms do not improve or worsen in the first 2 weeks of treatment, you must consult your doctor.
At the doctor's discretion, treatment can be continued with the same daily dose (2 tablets per day) for 2-3 months.
If you take more Dioflavthan you should:
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to takeDioflav:
It is essential to take this medication every day. However, if you forgot to take one or more doses of Dioflav, take another as soon as you remember and then continue with the prescribed treatment.
Do not take a double dose to compensate for the missed doses.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medications, this medication may produce adverse effects, although not all people may experience them.
These adverse effects include:
- Frequent (may affect up to 1 in 10 people): Gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
- Less Frequent (may affect up to 1 in 100 people): Colitis.
- Rare (may affect up to 1 in 1000 people): Nervous system disorders (dizziness, headache, discomfort) and skin reactions (skin rash, pruritus, urticaria).
- Unknown Frequency (cannot be estimated from available data): Abdominal pain, isolated edema of the face, lips, and eyelids (swelling). Exceptionally, angioedema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat that may cause difficulty breathing).
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
5. Dioflav Preservation
Keep out of sight and reach of children.
Preserve in the original packaging to protect it from light.
Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.
Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Dioflav :
The active principle is diosmin (500 mg per tablet).
The other components are:
- Tablet core: microcrystalline cellulose (E-460), gelatin, sodium carboxymethyl starch, talc, and magnesium stearate.
- Tablet coating: lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000, yellow iron oxide (E-172), and red iron oxide (E-172).
Appearance of the product and contents of the packaging:
Coated tablets with a film, biconvex, oblong, salmon-colored, and marked with “D500” on one side.
Each package contains 30 or 60 tablets.
Only some package sizes may be commercially available.
Holder of the marketing authorization
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Responsible for manufacturing:
Laboratorios Cinfa, S.A.
Olaz-Chipi, 10 - Industrial Park Areta
31620 Huarte-Pamplona (Navarra)-Spain
This leaflet has been approved in December 2023
The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) www.aemps.gob.es/
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