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DIOFLAV 1000
1000 mg film-coated tablets
Micronised flavonoids (diosmin and hesperidin)
Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you
• Keep this leaflet. You may need to read it again. .
• If you have any further questions, ask your pharmacist.
• If you have any undesirable effects, including possible undesirable effects not listed in this leaflet, talk to your doctor, pharmacist or nurse. See Section 4.
• If you do not feel better or get worse after 7 days, speak to a doctor.
1. What Dioflav 1000 is and what it is used for
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 2. What you need to know before taking Dioflav 1000
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 3. How to take Dioflav 1000
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 4. Possible undesirable effects
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 5. How to store Dioflav 1000
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 6. Contents of the pack and other information
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1. What Dioflav 1000 is and what it is used for

Dioflav 1000 is a venotropic and vascular protector. It is used for:
• Treatment of symptoms and signs of venous insufficiency (heavy legs, pain, tiredness, oedema).
• Symptomatic treatment of haemorrhoid attacks.

2. What you need to know before taking Dioflav 1000

Do not take Dioflav 1000:
• If you are allergic (hypersensitive) to the active substance or any of the other ingredients of this medicine (listed in Section 6).

WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Dioflav 1000.

OTHER MEDICINES AND DIOFLAV 1000
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Dioflav 1000 with food and drink
Not relevant.

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
As a precautionary measure, it is preferable to avoid the use of Dioflav 1000 during pregnancy.

Breastfeeding
Breastfeeding is not recommended during treatment, due to insufficient data on the excretion of the product into breast milk.

DRIVING AND USING MACHINES
Dioflav 1000 does not appear to interfere with the ability to drive or use machines. If you experience dizziness, do not drive or use machines.

3. HOW TO TAKE DIOFLAV 1000

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Talk to your doctor, pharmacist or nurse if you have any questions.

Dosage
The recommended dose is 1 film-coated tablet per day.
Haemorrhoidal attack
For the first 4 days: 1 tablet 3 times daily.
In the next 3 days: 1 tablet 2 times daily; then return to maintenance dose: 1 tablet per day.

If you take more Dioflav 1000 than you should
If you take more Dioflav 1000 than you should, contact your doctor or pharmacist immediately.
Experience of overdoses with Dioflav 1000 is limited, but reported symptoms include diarrhoea, nausea, abdominal pain, pruritus and rash.

If you forget to take Dioflav 1000
Take your next dose at the usual time. Do not take a double dose to make up for a missed dose.
If your symptoms do not improve after one week, see your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. POSSIBLE UNDESIRABLE EFFECTS

Like all medicines, this medicine can cause undesirable effects, although not everybody has them.
In order of decreasing frequency, undesirable effects may include:

Nervous system disorders:
• Rare: dizziness, headache, malaise.

Gastrointestinal disorders:
• Frequent: diarrhoea, dyspepsia, nausea, vomiting.
• Infrequent: colitis.
• Frequency unknown: abdominal pain.

Skin and subcutaneous tissue disorders:
• Rare: rash, pruritus, urticaria.
• Not known: isolated swelling of the face, lips, eyelids.
• Exceptionally Quincke’s disease.

Reporting undesirable effects
If you have any undesirable effects, including possible undesirable effects not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report undesirable effects directly to INFARMED, I.P. using the contact information indicated below. By reporting undesirable effects, you can help provide more information on the safety of this medicine.

Website: http://www.infarmed.pt/web/infarmed/submissaoram (preferably)
or at the following addresses:
Direção de Gestão do Risco de Medicamentos
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Phone: +351 21 798 73 73
Medicines Helpline: 800222444 (free)
E-mail: farmacovigilancia@infarmed.pt

5. How to store Dioflav 1000
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the outer packaging. The expiry date is the last day of the month indicated.
This medicinal product does not require any special storage conditions.
Do not dispose of any medicine in the drains or in household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

The composition of Dioflav 1000
Its active substances are micronised flavonoids (diosmin and hesperidin). Each 1,000 mg film-coated tablet contains:
• 90% diosmin, i.e. 900 mg per film-coated tablet.
• 10% flavonoids expressed as hesperidin, i.e. 100 mg per film-coated tablet.
The other components are:
Core: Gelatin, microcrystalline cellulose (type 102), maize starch, talc and magnesium stearate.
Coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, yellow iron oxide (E 172), red iron oxide (E 172), maltodextrin, guar galactomannan, hypromellose, medium-chain triglycerides and talc.

What Dioflav 1000 looks like and contents of the pack
Oval, brownish-orange film-coated tablet with rounded edges and a groove on each side. The groove is there to make it easier to split and swallow and not to divide into equal doses.
Dioflav 1000 is sold in packs of 10, 30 and 60 film-coated tablets in PVC/Alu blister strips.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Towa Pharmaceutical, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal

Manufacturer
ExtractumPharma Co. Ltd.
IV körzet 6
6413 Kunfehértó
Hungary

Detailed and up-to-date information on this medicine is available by scanning the 2D code included with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/dioflav1000.

This leaflet was last revised in February 2023.