Label: information for the patient

Read 80 mg soft capsules

For adults

Lavender oil (Lavandula angustifolia Mill., essential oil)

Read this label carefully before starting to take this medication, as it contains important information for you.

• Follow exactly the administration instructions for this medication contained in this label or those indicated by your doctor or pharmacist.
• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 1 month of treatment.

Revisea is a traditional plant-based medication for the treatment of transient symptoms of anxiety in adults, based exclusively on its traditional use.

Additional information for use:

Anxiety may cause one or several temporary symptoms, such as uncontrollable worry, restlessness, tension, or sleep alteration.

Do not take Revisea

If you are allergic to lavender oil or any of the other components of this medication (listed in section 6), or if you have liver function impairment.

Warnings and precautions

If you suffer from excessive anxiety and/or difficult-to-control 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 be suffering from a mental illness that requires medical supervision.

If you feel that the symptoms persist without change after a month of treatment or worsen, consult your doctor.

The use of lavender oil is not recommended in patients with severe renal impairment requiring dialysis due to a lack of clinical data.

There is limited data 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 is no data available on the use of this medication in this age group.

Other medications and Revisea

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

No interactions between lavender oil and other medications have been reported. According to available data, no interactions with other medications are expected.

Available experimental data do not provide any evidence of interactions with other active principles affecting the CNS. As a precaution, lavender oil should not be taken with other anxiolytic, sedative, or alcohol medications due to a lack of clinical data on possible interactions.

Pregnancy and breastfeeding

Pregnancy

Experimental research does not indicate any harmful effect of lavender oil on pregnant women. As there is no clinical data available on the use of lavender oil during pregnancy, this medication is not recommended during pregnancy.

Breastfeeding

The components of the active principle or their metabolites are unknown to be excreted in breast milk. Consequently, breastfeeding mothers should not take lavender oil.

Driving and operating machines

According to the results of a clinical study designed to evaluate the influence of lavender oil on the ability to drive in a small number of healthy individuals, the influence of lavender oil on the ability to drive and operate machines is negligible or null. However, patients who feel affected, for example by fatigue, should not drive or operate machines. There is no data available for patients over 58 years of age.

Revisea contains sorbitol

This medication contains approximately 8.4 mg of sorbitol in each soft capsule.

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.

The recommended dose is:

Adults: Take one soft capsule per day, approximately at the same time.

Do not take lavender oil for more than 3 months. If symptoms persist without change after 1 month of treatment or if symptoms worsen, you must consult your doctor.

Soft capsules must be taken without chewing, with a sufficient amount of liquid (preferably a glass of water).

Lavender oil should not be taken in a lying position.

Children and Adolescents

Lavender oil should 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Revisea

Do not take a double dose to compensate for the missed doses; continue treatment as indicated by your doctor or as described in this leaflet.

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

The following list of adverse effects includes all reactions that occurred during treatment with lavender oil, including those that occurred with higher doses or during prolonged treatment.

Of unknown frequency (cannot be estimated from available data):

Severe hypersensitivity reactions (allergic reactions) with swelling, circulatory problems, and/or respiratory problems have been reported. In such cases, call a doctor immediately.

If you experience a hypersensitivity reaction (allergic reaction), stop taking this medication.

Frequent (1 to 10 out of 100 people treated):

• Belching.

Of unknown frequency (cannot be estimated from available data):

• Other gastrointestinal discomforts;
• Dermatological allergic reactions.

Reporting 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 prospectus. You can also report them directly through theSpanish 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.

Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD”.

No special storage conditions are required.

Do not dispose of medications through drains or trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Revisea

Each soft capsule contains:

Active ingredient: 80 mg of essential oil ofLavandula angustifolia Mill, in the form of Lavender essential oil.

The other components (excipients) are:

Content of the capsule: Refined rapeseed oil.

Capsule coating: Gelatin, liquid sorbitol (non-crystallizable) (E-420), 85% glycerol, and purified water. Colorants: Carmine acid (E-120); Patent Blue V (E-131).

Appearance of the product and content of the packaging

Purple-colored round capsules containing a clear and yellowish oily solution.

They are presented in packaging containing 30 soft capsules conditioned in PVC/PVDC-Aluminum blisters.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa – Barcelona
Spain

Responsible for manufacturing

Laboratorio Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet: February 2024

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