Troxerutin Cinfalab 1 g granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Troxerutin cinfalab 1 g granules for oral solution

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine as described 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

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

1. What is Troxerutina cinfalab and what is it used for

The active substance of Troxerutina cinfalab is troxerutin, which belongs to the group of drugs known as vasoprotectives, which protect the blood vessels (systemic vasoprotectives).

It is indicated in adults for the relief of symptoms of mild venous insufficiency in the legs, such as:

• pain, heaviness, and tightness
• tingling and itching in legs with varicose veins
• swollen legs.

2. What you need to know before starting to take Troxerutina cinfalab

Do not take Troxerutina cinfalab

• If you are allergic to troxerutin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Troxerutina cinfalab if:

• you have edema in the lower limbs due to heart, kidney, or liver disease
• in children under 18 years of age.

Children and adolescents

The use of Troxerutina cinfalab is not recommended in children.

Taking Troxerutina cinfalab with other medicines

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

Taking Troxerutina cinfalab with food and drinks

Taking this medicine with food or drinks does not affect its efficacy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

According to generally accepted safety recommendations, Troxerutina cinfalab should not be used during the first 3 months of pregnancy.

Driving and using machines

You may experience fatigue and dizziness while using Troxerutina cinfalab, although this is rare. If this occurs, do not drive or operate machinery.

Troxerutina cinfalab contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; therefore, it is essentially “sodium-free”.

3. How to take Troxerutina cinfalab

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

Adults:

The recommended dose is 1 sachet per day.

Symptom relief usually occurs within the first 2 weeks of treatment. If you do not experience relief after 2 weeks or if symptoms worsen, you should consult your doctor.

Under medical advice, treatment may continue with the same daily dose (1 sachet) for up to 2–3 months.

Use in children and adolescents

This medicine is intended for adults. Children should not take it unless considered necessary by their doctor.

How to take

Dissolve the contents of the sachet in a glass of water and drink immediately.

If you take more Troxerutina cinfalab than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Troxerutina cinfalab

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 can cause adverse effects, although not everyone will experience them.

If you experience any of the following symptoms, which may be signs of an allergic/anaphylactoid reaction, stop treatment and consult a doctor immediately:

• difficulty breathing or swallowing;
• swelling of the face, lips, tongue, or throat;
• severe skin itching, with red rash, hives, or lumps.

Rare adverse effects: may affect up to 1 in 1,000 patients.

Gastrointestinal disorder, flatulence, diarrhoea, 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 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 can also report them directly through 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 Troxerutina cinfalab

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

Do not use this medicine after the expiry date which is 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 conditions.

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

6. Contents of the pack and other information

Composition of Troxerutina cinfalab

• The active substance is troxerutin. Each sachet contains 1000 mg of troxerutin.
• The other components are: mannitol (E-421), sodium saccharin (E-954), and orange flavour (flavouring preparations, flavouring substances, natural flavouring substances, corn maltodextrin, gum arabic (E-414), ascorbic acid (E-300), and butylated hydroxyanisole (BHA) (E-320)).

Appearance of the medicine and contents of the pack

Troxerutina cinfalab 1 g granules for oral solution are single-dose sachets made of a printed metal composite composed of coated paper / extruded polyethylene / aluminium / heat-seal resin, containing a fine yellow powder with an orange aroma.

Troxerutina cinfalab is available in packs containing 14 or 30 sachets.

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: February 2021.

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/