Lasea 80 mg soft capsules

Lasea is a herbal medicinal product.

How is it used?

What is Lasea and what is it used for?

Lasea is a herbal medicinal product.

Lasea is used to treat temporary anxious mood.

Additional information on use:
Anxious mood may cause one or more temporary symptoms, such as for example, difficult-to-control worry, restlessness, tension or sleep disturbance.

Lasea is used in adults.

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What should you be aware of before taking it?

What should you be aware of before taking Lasea?

Lasea must not be taken

- if you are allergic to lavender oil or any of the other ingredients of this medicine listed in section 6, or if you have liver dysfunction.

Warnings and Precautions

If you suffer from excessive anxiety and/or worry that you find difficult to control and/or if you suffer from three or more symptoms associated with anxiety (such as restlessness, tiredness, difficulty concentrating, irritability, muscle tension, sleep disturbance) for a prolonged period of time, you must consult a doctor. You may be suffering from a
psychological condition that requires medical attention.

Talk to your doctor if you have the impression that the symptoms persist unchanged after 1 month of treatment or if the symptoms worsen.

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

Limited data are available on the use of Lasea in patients over 65 years of age.

Children and adolescents

Lasea is not recommended in children and adolescents under 18 years of age as there are no data on the use of this medicinal product in this age group.

Taking Lasea with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines.

There are no reports of interactions of Lasea with other medicines. Based on available data, interactions with other medicinal products are not expected.

The available experimental data provide no evidence of interactions with other substances active in the central nervous system. As a precaution, Lasea should not be taken with other medicinal products for the treatment of anxiety disorders, tranquillisers or alcohol
as there are no clinical data on possible interactions.

Pregnancy and lactation

Pregnancy

Experimental studies have not shown any evidence of harmful effects of Lasea in pregnant women. As no clinical data are available on the use of Lasea during pregnancy, this product is not recommended during pregnancy.

Lactation

It is not known whether the active substance or its metabolites pass into breast milk. Lasea should therefore not be taken by breast-feeding mothers.

Driving and ability to operate machinery

The influence of Lasea on driving ability was investigated in a clinical study in a relatively small number of healthy subjects. According to the results, Lasea has no or negligible influence on the ability to drive and operate machinery. Nevertheless, patients who feel impaired - for example due to fatigue - must not drive a vehicle or operate machinery. Data on patients over 58 years of age are not available.

Lasea contains sorbitol

This medicinal product contains approximately 12 mg of sorbitol per soft capsule.

How should the medicine be taken?

How should Lasea be taken?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults:

Take one soft capsule once a day at about the same time.

Lasea should not be taken for more than 3 months.

Talk to your doctor if symptoms persist unchanged after 1 month of treatment or if symptoms get worse.

The soft capsules should be taken unchewed with plenty of liquid, preferably a glass of water.

Do not take Lasea while lying down.

Children and adolescents

Lasea is not to be taken by anyone under 18 years of age.

If you have taken a larger amount of Lasea than you should

No cases of overdose have been reported.

If you forget to take Lasea

Do not take twice the amount if you have forgotten to take it before. Continue taking the medicine as directed by your doctor or as described in this leaflet.

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What are the possible side effects?

How should Lasea be stored?

Keep this medicine out of the reach of children.

You must not use this medicinal product after the expiry date which is stated on the carton and on the container (blister) after Use by:". The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

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Special notes on contents

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Contents of the pack and further information

What Lasea contains

1 soft capsule contains:

Active ingredient: 80 mg lavender oil (Lavandula angustifolia Mill., aetheroleum).

The other ingredients are:

Capsule contents: Rapeseed oil, refined. Capsule shell: succinylated gelatin, glycerol 85%,, sorbitol 70%, liquid (non-crystallising), carminic acid, aluminium salt (E 120), patent blue V, aluminium salt
(E 131), titanium dioxide (E 171).

What Lasea looks like and contents of the pack

Ovoid, bluish-purple, opaque soft capsules.

Lasea is available in packs of 14, 28, 42, 56 and 84 soft capsules.

Not all pack sizes may be marketed.

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