Variliv diosmina forte 1.000 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Variliv Diosmina Forte 1,000 mg film-coated tablets

Diosmin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for taking this medicine contained in this leaflet or those provided 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

1. What Variliv Diosmina Forte is and what it is used for
2. What you need to know before taking Variliv Diosmina Forte
3. How to take Variliv Diosmina Forte
4. Possible adverse effects
5. How to store Variliv Diosmina Forte
6. Contents of the pack and other information

1. What Variliv Diosmina Forte is and what it is used for

Variliv Diosmina Forte 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 of the lower limbs, such as pain, sensation of 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 Diosmina Forte

Do not take Variliv Diosmina Forte

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 Diosmina Forte.

Do not use for prolonged periods without medical supervision.

Children and adolescents

Variliv Diosmina Forte is not indicated for use in children and adolescents (under 18 years of age).

Other medicines and Variliv Diosmina Forte

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 must 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

As a precautionary measure, it is preferable to avoid using Variliv Diosmina Forte during pregnancy.

Breastfeeding

Breastfeeding is not recommended during treatment due to the lack of data on the excretion of the medicine in breast milk.

Driving and using machines

No effects on the ability to drive or operate machinery have been reported with Variliv Diosmina Forte.

Variliv Diosmina Forte contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Variliv Diosmina Forte contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".

3. How to take Variliv Diosmina Forte

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults

The recommended dose is 1 tablet per day, preferably in the morning. The tablets should be taken with water to facilitate swallowing.

The tablet may be divided into equal doses.

Symptom relief usually occurs within the first 2 weeks of treatment.

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 with the same daily dose (1 tablet daily) for up to 2–3 months.

If you take more Variliv Diosmina Forte 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.

Experience with overdose of Variliv Diosmina Forte is limited, but reported symptoms include diarrhea, nausea, abdominal pain, pruritus, and skin rash.

If you forget to take Variliv Diosmina Forte

It is important to take this medicine every day. However, if you forget to take one or more doses, take it as soon as you remember and then continue with your regular treatment.

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

These adverse effects include:

• Common (may affect up to 1 in 10 people): gastrointestinal disorders (diarrhea, indigestion, nausea, and vomiting).
• Uncommon (may affect up to 1 in 100 people): colitis.
• Rare (may affect up to 1 in 1,000 people): nervous system disorders (dizziness, headache, and malaise) and skin reactions (rash, pruritus, and urticaria).
• Frequency not known (cannot be estimated from the available data): abdominal pain, isolated swelling of the face, lips, and eyelids. Very rarely, angioedema (Quincke's edema) (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat, which may cause breathing difficulties).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/ By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Variliv Diosmina Forte

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Variliv Diosmina Forte

• The active substance is diosmin (1,000 mg per tablet).

• The other components are:

Tablet core: microcrystalline cellulose (E-460), gelatin, sodium carboxymethyl starch (type A) (from potato), talc, and magnesium stearate.

Tablet coating: lactose monohydrate, hypromellose, titanium dioxide (E-171), macrogol 4000, yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the medicine and contents of the container

Film-coated tablets, biconvex, oblong, scored, salmon-colored, marked with the code "D1000" on one side.

The tablets are packaged in unit-dose blisters made of PVC-PVDC/Aluminum. Each package contains 30 tablets.

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 review of this leaflet: January 2022

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/86537/P_86537.html

QR code to: https://cima.aemps.es/cima/dochtml/p/86537/P_86537.html