Leaflet: information for the user

Variliv Diosmina500 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 for 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.
• Ifyou 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 must consult a doctor if your condition worsens or does not improve after 2 weeks.

1. What isVariliv Diosminaand what it is used for

2. What you need to know before starting to takeVariliv Diosmina

3. How to takeVariliv Diosmina

4. Possible side effects

5. Storage ofVariliv Diosmina

6. Contents of the pack and additional information

Diosmina is a venotonic medication: it increases the tone of the veins and the resistance of 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.

Do not take Variliv Diosmina :

If you are allergic to diosmina, other flavonoids, or any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Variliv Diosmina.

Do not use for an extended period without medical supervision.

Children and adolescents

Variliv Diosmina is not indicated for children and adolescents (under 18 years).

Taking Variliv Diosmina with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. There are no known interactions with food or other medications; however, never take another medication on your own initiative without your doctor's recommendation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

No adverse effects have been reported in humans. However, caution should be exercised when using diosmina 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 have been described on the ability to drive and operate machinery with Variliv Diosmina.

Variliv Diosmina contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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 moreVariliv Diosmina than 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 takeVariliv Diosmina

It is essential to take this medication every day. However, if you forgot to take one or more doses of Variliv Diosmina, 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.

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

These adverse effects include:

• Frequent (less than 1 in 10 but more than 1 in 100): gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
• Less Frequent (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, discomfort) and skin reactions (skin rash, pruritus, urticaria).
• Unknown frequency: 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).

These adverse effects have been reported without the need to interrupt treatment.

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 Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es/By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store 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.

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

Composition ofVariliv Diosmina

The active ingredient is diosmina (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, biconvex, oblong, salmon-colored, and marked with the code “D500”.

Each package contains 30 and 60 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra)-Spain

Last review date of this leaflet: June 2018

The detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)www.aemps.gob.es/