Variliv diosmin 500 mg film-coated tablets
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Variliv Diosmina is and what it is used for
- 2. What you need to know before starting to take Variliv Diosmin
- 3. How to take Variliv Diosmina
- 4. Possible adverse effects
- **Reporting of adverse reactions**
- 5. Storage of Variliv Diosmin
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Variliv Diosmina 500 mg film-coated tablets
Diosmin
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 2 weeks.
Contents of the leaflet
- What Variliv Diosmina is and what it is used for
- What you need to know before taking Variliv Diosmina
- How to take Variliv Diosmina
- Possible adverse effects
- How to store Variliv Diosmina
- Contents of the pack and other information
1. What Variliv Diosmina is and what it is used for
Diosmina is a venotonic medication: it increases venous tone and capillary resistance (small blood vessels).
It is indicated in adults for the relief of symptoms related to mild venous insufficiency in the lower limbs, such as pain, heaviness, tightness, tingling, and itching in varicose legs or swollen legs.
You should consult a doctor if your condition worsens or does not improve after 2 weeks of treatment.
2. What you need to know before starting to take Variliv Diosmin
Do not take Variliv Diosmin:
If you are allergic to diosmin, to other flavonoids, or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Variliv Diosmin.
Do not use for prolonged periods without medical supervision.
Children and adolescents
Variliv Diosmin is not indicated for use in children and adolescents (under 18 years of age).
Taking Variliv Diosmin 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 food or other medicines are known. However, you should never take another medicine on your own initiative without first consulting your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
There is no evidence of harmful effects in humans. However, caution should be exercised when using diosmin during pregnancy, with careful assessment of the potential benefit of this medicine.
Breastfeeding
It is not known whether the medicine passes into breast milk; therefore, its use during breastfeeding is not recommended.
Driving and use of machines
No effects on the ability to drive or operate machinery have been reported with Variliv Diosmin.
Variliv Diosmin contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Variliv Diosmina
Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults:
The recommended dose is 2 tablets daily, divided into two doses: one tablet at midday and one tablet in the evening, taken with meals.
If symptoms do not improve or worsen within the first 2 weeks of treatment, you should consult your doctor.
Under medical advice, treatment may continue at the same daily dose (2 tablets daily) for up to 2–3 months.
If you take more Variliv Diosmina than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Variliv Diosmina
It is important to take this medicine every day. However, if you forget to take one or more doses of Variliv Diosmina, take the missed dose as soon as you remember, and then continue with your prescribed treatment.
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 produce adverse effects, although not everyone experiences them.
These adverse effects include:
- Common (less than 1 in 10 but more than 1 in 100): gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
- Uncommon (less than 1 in 100 but more than 1 in 1,000): colitis.
- Rare (less than 1 in 1,000 but more than 1 in 10,000): nervous system disorders (dizziness, headache, malaise) and skin reactions (rash, pruritus, urticaria).
- Frequency not known: abdominal pain, isolated swelling of the face, lips and eyelids. Very rarely, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue or throat, which may cause difficulty breathing).
These adverse effects have been reported without the need to discontinue treatment.
Reporting of adverse reactions
If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/ By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Variliv Diosmin
Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect it from light.
Do not use this medicine after the expiry date stated on the container, following “EXP”. 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Variliv Diosmin
The active substance is diosmin (500 mg per tablet).
The other components are:
Tablet core: microcrystalline cellulose (E-460), gelatin, sodium carboxymethyl starch from potato, 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 medicine and contents of the pack
Film-coated tablets, biconvex, oblong, salmon-colored, marked with the code "D500".
Each pack contains 30 or 60 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent revision of this leaflet: June 2018
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es/