NAUTAMINE Tablet

FOR ADLUTS AND CHILDREN OVER THE AGE OF 2 YEARS ONLY.

Adults and children over the age of 12 years:

The tablets should be swallowed with a glass of water.

1 to 1,5 tablets to be taken half an hour prior to departure. Repeat if required after 6 hours, without exceeding 6 tablets per day.

Children from 6 to 12 years old:

The tablets should be swallowed with a glass of water.

1 tablet to be taken half an hour prior to departure. Repeat required after 6 hours, without exceeding 4 tablets per day.

Children from 2 to 6 years old:

Crush quarter or half tablet per dose to be taken half an hour prior to departure. Repeat if required after 6 hours, without exceeding 4 crushed half-tablets per day.

Method and route of administration:

Oral route

MUST NOT BE USED in the following cases:

- children under the age of 2 due to the dosage form,

- some forms of glaucoma (increased pressure inside the eye),

- difficulty passing urine caused by a prostate or other problem,

- known allergy to antihistamines.

SHOULD NOT GENERALLY BE USED, unless otherwise indicated by your doctor, if you are breast-feeding or being treated with enoxacin.

LIKE ANY ACTIVE PRODUCT THIS MEDICINE MAY IN CERTAIN PERSONS GIVE RISE TO VARYING DEGRESS OF UNPLEASANT EFFECTS:

Some undesirable effects require you to IMMEDIATELY STOP TAKING THE TREATMENT AND CONTACT A DOCTOR.

- Allergic reactions:

- skin rash (erythema, eczema, purpura, urticarial);

- Quincke’s oedema (urticarial (hives) with sudden swelling of the face and neck that may cause breathing difficulties);

- anaphylactic shock:

- Marked reduction in white blood cells, that may be manifested by the onset of recurrence of a fever, accompanied or otherwise by signs of infection;

- Abnormal reduction in blood platelets, that may be reflected by nosebleeds or bleeding gums.

Other undesirable effects may occur, such as :

- Drowsiness, impaired alertness,

- Memory or concentration problems, dizziness (more common in the elderly),

- Poor motor coordination, tremor,

- Confusion, hallucinations,

- Dry mouth, disturbed vision, urinary retention, constipation, palpitations, fall in blood pressure.

More rarely, signs of excitation (agitation, nervousness, insomnia) may occur.

PLEASE TELL YOUR DOCTOR OR PHARMACIST ABOUT ANY UNWANTED AND UNPEASANT EFFEC NOT MENTIOONED IN THIS LEAFLET.

IN ORDER TO PREVENT POSSIBLE INTERCTIONS BETWEEN SEVERAL MEDICINES, YOU MUST SYSTEMATICALLY INFORM YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING ANY OTHER MEDICINES.

This medicine contains an antihistamine: diphenhydramine.

Other medicines also contain these substances. Do no combine them, in order to ensure that you do not exceed the maximum recommended dose .

Pregnancy:

It is possible to take this medicine while you are pregnant, as long as it is only taken for a short time (a few days) at the recommended doses.

At the end pregnancy, the excessive use of this medicine may have harmful effects on your newborn baby. Consequently, you should always consult your doctor before using it.

Breast-feeding:

This medicine crosses into the breast milk. It is therefore not advised in breast-feeding women.

As a general rule, you should always ask a doctor or pharmacist for advice before taking any medication during pregnancy or breast-feeding.

In the event of long-term liver or kidney disease, CONSULT YOUR DOCTOR so that he can adjust the dosage.

This medicine should only be taken under MEDICAL ADVICE in the elderly:

- predisposed to constipation, dizziness or drowsiness,

- with prostate problems;

CONTACT YOUR DOCTOR before taking this antihistamine.

This medicine can cause marked drowsiness, which is accentuated by alcohol:

do not drink alcohol or take medicines containing alcohol throughout the duration of treatment.

ANTI-MOTION SICKNESS DRUG

prevent and treat travel sickness