Leaflet: information for the user

Venoruton oxerutinas 1 g powder for oral solution

Oxerutinas

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 Venoruton oxerutinas and what it is used for

2. What you need to know before starting to take Venoruton oxerutinas

3. How to take Venoruton oxerutinas

4. Possible side effects

5. Storage of Venoruton oxerutinas

6. Contents of the pack and additional information

The active ingredient of Venoruton oxerutinas is oxerutinas, which belongs to the group of Vasoprotectores medications, which protect blood vessels (systemic vasoprotectors).

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.

Do not take Venoruton oxerutinas:

- if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Venoruton oxerutinas if:

- you have swelling in your lower limbs due to a heart, kidney, or liver disease

- you are under 18 years old.

Children and adolescents

Do not recommend the use of Venoruton oxerutinas in children.

Taking Venoruton oxerutinas with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Venoruton oxerutinas with food, drinks, and alcohol

The taking of this medication with food or drinks does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

According to general safety recommendations, do not use Venoruton oxerutinas during the first 3 months of pregnancy.

Driving and operating machinery

You may experience fatigue and dizziness when taking Venoruton oxerutinas, although this is rare. If this happens, do not drive or operate machinery.

Venoruton oxerutinas contains saccharose

This medication contains saccharose. If your doctor has told you 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, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

Adults:

The recommended dose is 1 tablet per day.

Relief of symptoms usually occurs within the first 2 weeks of treatment.

If you do not feel relief after 2 weeks or symptoms worsen, you must consult your doctor.

On doctor's orders, treatment can be continued with the same daily dose (1 tablet) for 2-3 months.

Use in children and adolescents

This medication is for adults.

How to take

To open, please separate the packets by the perforated area. Open each packet individually by tearing the packet from the indicated point by the arrow; if you cannot open the packet with your hand, you can use scissors.

Dissolve the contents of the packet in 1 glass of water and drink afterwards.

If you take more Venoruton oxerutinas than you should

In case of accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Venoruton oxerutinas

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.

If you interrupt treatment with Venoruton oxerutinas

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

If any of these symptoms are experienced,which may be signs of an allergic/anaphylactic reaction,discontinue treatment and consult a doctor immediately:

- difficulty breathing or swallowing;

- swelling of the face, lips, tongue, or throat;

- severe itching of the skin, with red rash, hives, or bumps.

Rare Adverse Effects: may affect up to 1 in 1,000 patients

Gastrointestinal disorder,flatulence, diarrhea, abdominal pain, stomach discomfort, dyspepsia, rash, itching, or urticaria.

Very Rare Adverse Effects:may affect up to 1 in 10,000 patients

Allergic reactions

Dizziness, headache, fatigue, skin redness.

Reporting Adverse Effects

If any type of adverse effect is experienced, consult a doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. Adverse effects can also be reported directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. Website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture. Store below 30°C.

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

Composition of Venoruton

- The active ingredient is oxerutinas.

Cada sobre contains 1 g of oxerutinas

- The other components (excipients) are manitol (E-421), sacarina sódica, aroma of orange (contains sacarosa and maltodextrina).

Appearance of the product and contents of the packaging

Yellowish pale powder.

Venoruton powder for oral solution is presented in packaging of 14, 28 or 30 sachets of PET/Polietilene/Aluminio 12 µm/Surlyn.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Responsible for manufacturing

SmithKline Beecham, S.A.

Ctra. de Ajalvir, Km. 2,500

Alcalá de Henares, 28806

Madrid- Spain

O

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Last review date of this leaflet: December 2019

Other sources of information

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Sanitary Products (AEMPS) http://www.aemps.gob.es/