Revisea 80 mg soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Revisea 80 mg soft capsules
For adults
Lavender oil (Lavandula angustifolia Mill., essential oil)
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Follow exactly the instructions for use of this medicine as described in this leaflet or as 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 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 1 month of treatment.
Contents of the leaflet
- What Revisea is and what it is used for
- What you need to know before taking Revisea
- How to take Revisea
- Possible side effects
- How to store Revisea
- Contents of the pack and other information
1. What Revisea is and what it is used for
Revisea is a traditional herbal medicinal product used for the treatment of transient anxiety symptoms in adults, based solely on its traditional use.
Additional information on use:
Anxiety may cause one or more temporary symptoms, such as difficulty controlling worry, restlessness, tension, or sleep disturbance.
2. What you need to know before starting to take Revisea
Do not take Revisea
If you are allergic to lavender oil or to any of the other components of this medicine (listed in section 6), or if you have impaired liver function.
Warnings and precautions
If you suffer from excessive anxiety and/or uncontrollable worries and/or three or more anxiety-related symptoms (e.g., restlessness, fatigue, difficulty concentrating, irritability, muscle tension, sleep disturbances) for a prolonged period, you should consult a doctor, as you may have a mental disorder requiring medical supervision.
If you feel that your symptoms remain unchanged after one month of treatment or if they worsen, consult your doctor.
The use of lavender oil is not recommended in patients with severe renal impairment requiring dialysis due to lack of clinical data.
Limited data are available on the use of lavender oil in patients over 65 years of age.
Children and adolescents
The use of lavender oil is not recommended in children and adolescents under 18 years of age, as there are no data available on the use of this medicine in this age group.
Other medicines and Revisea
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
There have been no reported cases of interaction between lavender oil and other medicines. According to available data, no interactions with other medicinal products are expected.
Available experimental data do not indicate any interactions with other active substances acting on the CNS. As a precautionary measure, lavender oil should not be taken concomitantly with other anxiolytic, sedative drugs, or alcohol due to lack of clinical data on potential interactions.
Pregnancy and breastfeeding
Pregnancy
Experimental studies do not provide any indication suggesting a harmful effect of lavender oil in pregnant women. However, since there are no clinical data on the use of lavender oil during pregnancy, this medicine is not recommended during pregnancy.
Breastfeeding
It is unknown whether the active substance components or their metabolites are excreted in breast milk. Therefore, breastfeeding mothers should not take lavender oil.
Driving and use of machines
According to results from a clinical study designed to evaluate the influence of lavender oil on driving ability in a small number of healthy individuals, the influence of lavender oil on the ability to drive and use machines is none or negligible. Nevertheless, patients who experience effects such as fatigue should not drive or operate machinery. Data are not available for patients over 58 years of age.
Revisea contains sorbitol
This medicine contains approximately 8.4 mg of sorbitol in each soft capsule.
3. How to take Revisea
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.
The recommended dose is:
Adults: Take one soft capsule daily, at approximately the same time each day.
Do not take lavender oil for longer than 3 months. If symptoms persist unchanged after 1 month of treatment, or if symptoms worsen, you should consult your doctor.
The soft capsules must be taken without chewing, with a sufficient amount of liquid (preferably a glass of water).
Lavender oil must not be taken while lying down.
Children and adolescents
Lavender oil must not be administered to individuals under 18 years of age.
If you take more Revisea than you should
No cases of overdose have been reported.
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 medication and the amount ingested.
If you forget to take Revisea
Do not take a double dose to make up for missed doses; continue treatment as directed by your doctor or as described in this leaflet.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following list of adverse effects includes all reactions reported during treatment with lavender oil, including those occurring at higher doses or during prolonged treatment.
Unknown frequency (cannot be estimated from available data):
Severe hypersensitivity reactions (allergic reactions) have been reported, with swelling, circulatory problems and/or respiratory problems. In such cases, contact a doctor immediately.
If you experience a hypersensitivity reaction (allergic reaction), stop taking this medicine.
Frequent (1 to 10 in every 100 treated people):
- burping.
Unknown frequency (cannot be estimated from available data):
- other gastrointestinal discomforts;
- skin allergic reactions.
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 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 Revisea
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after “EXP”.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your usual pharmacy. 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 Revisea
Each soft capsule contains:
Active substance: 80 mg of essential oil of Lavandula angustifolia Mill, in the form of Lavender essential oil.
The other components (excipients) are:
Capsule contents: Refined rapeseed oil.
Capsule shell: Gelatin, liquid (non-crystallizable) sorbitol (E-420), 85% glycerol, and purified water. Colourants: Carminic acid (E-120); Patent Blue V (E-131).
Appearance of the product and contents of the container
Round purple soft capsules containing a clear yellowish oily solution.
Packaged in containers containing 30 soft capsules in PVC/PVDC-Aluminum blisters.
Marketing Authorization Holder
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa – Barcelona, Spain
Manufacturer
Laboratorio Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain
Date of the most recent revision of this leaflet: February 2024
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.