NOTICE
ANSM - Updated on: 02/11/2020
IN THIS ANNEX, THE TERMS "MARKETING AUTHORIZATION" ARE TO BE UNDERSTOOD AS "REGISTRATION OF A TRADITIONAL HERBAL MEDICINE" AND THE TERM "AUTHORIZATION" MEANS "REGISTRATION"
Name of the medicinal product
PHYTOTUX, syrup
Tolu balsam
Ipeca (root tincture)
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You should always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel worse after 7 days.
What is in this leaflet?
1. What is PHYTOTUX syrup and what is it used for?
2. What information should you know before taking PHYTOTUX syrup?
3. How should you take PHYTOTUX syrup?
4. What are the possible side effects?
5. How should PHYTOTUX syrup be stored?
6. Package contents and other information.
1. WHAT IS PHYTOTUX syrup AND WHAT IS IT USED FOR?
A traditional herbal medicine used for mild acute bronchial conditions.
Its use is limited to the indications specified, based solely on long-standing use.
PHYTOTUX syrup is indicated for adults, adolescents, and children 6 years of age and older.
2. WHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING PHYTOTUX SYRUP?
Never take PHYTOTUX syrup:
· if you are allergic to the active ingredients or any of the other ingredients in this medicine listed in Section 6, particularly to thyme or the Lamiaceae family, or to benzoic acid.
· Due to the presence of demetine, this medicine is contraindicated in patients with heart disease, skeletal muscle disorders, or kidney, liver, or gastrointestinal damage.
Warnings and Precautions
Consult your doctor or pharmacist before taking PHYTOTUX syrup.
This medication contains 3.08 g of sorbitol per dose (5 mL) and 9.24 g per dose (15 mL).
Sorbitol is a source of fructose. If your doctor has told you that you or your child has an intolerance to certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder characterized by the inability to break down fructose, talk to your doctor before you or your child takes or receives this medication.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
This medication contains 2.25% by volume of ethanol (alcohol), i.e., up to 89 mg per dose (5 mL), which is equivalent to 3 mL of beer, 1 mL of wine per dose, and up to 266 mg per dose (15 mL), which is equivalent to 7 mL of beer or 3 mL of wine per dose. Dangerous if used by people with alcoholism. Caution is advised in pregnant or breastfeeding women, children, and high-risk groups such as those with liver failure or epilepsy.
In cases of thick, purulent sputum, fever, or chronic bronchial and lung disease, the treatment plan should be reevaluated.
Children
This medication should not be administered to children under 6 years of age.
Other Medications and PHYTOTUX, Syrup
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
PHYTOTUX, syrup with food and beverages
Not applicable.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Due to insufficient data, this medication is not recommended for pregnant or breastfeeding women.
Driving and operating machinery
Not applicable.
PHYTOTUX syrup contains ethanol and sorbitol.
3. HOW TO TAKE PHYTOTUX, syrup?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you have any doubts.
Dosage
Adults and adolescents over 15 years of age: a dose of 15 mL, 1 to 4 times a day.
Children weighing 30 to 50 kg (approximately 10 to 15 years old): a 5 mL dose, 3 to 4 times a day.
Children weighing 20 to 30 kg (approximately 6 to 10 years old): a dose of 5 mL, 2 to 3 times a day.
Children under 6 years of age: This medication is contraindicated in children under 6 years of age.
Route of administration
Oral use.
Measure the exact dose using the measuring cup.
Duration of treatment
7 days.
If symptoms persist beyond 7 days of use, consult a doctor or pharmacist.
If you have taken more PHYTOTUX syrup than you should have
Consult your doctor or pharmacist.
If you forget to take PHYTOTUX syrup
Do not take a double dose to make up for the dose you missed.
If you stop taking PHYTOTUX syrup
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everyone gets them.
There are no known side effects to date. If you experience any side effects, consult a doctor.
Reporting side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr
By reporting side effects, you help provide more information on the safety of the medication.
5. HOW SHOULD PHYTOTUX SYRUP BE STORED?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiration date printed on the label and outer packaging. The expiration date refers to the last day of that month.
No special storage precautions.
The medicine should be used within 1 month of first opening.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medication down the drain or with household trash . Ask your pharmacist to dispose of medications you no longer use. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What PHYTOTUX Syrup Contains
· The active ingredients are:
Tolu balsam (Myroxylon balsamum L. Harms var. balsamum)........................................ 1.14 mg
Ipecac (Cephaelis ipecacuanha) (root tincture)..................................................... 0.0996 mL
Solvent: 65% ethanol (v/v)
Drug-to-solvent ratio: 1:10
Per 5 mL of syrup.
· The other ingredients are:
Sorbitol (70% solution), ethanol, purified water, orange blossom-flavored water, poppy fluid extract, wild thyme fluid extract, potassium sorbate, hydroxyethylcellulose, citric acid monohydrate.
What is PHYTOTUX, syrup, and contents of the outer packaging
This medication comes in syrup form. 250 mL bottle with measuring cup.
Marketing Authorization Holder
LABORATOIRES LEHNING
3 RUE DU PETIT MARAIS
57640 SAINTE-BARBE
FRANCE
Marketing Authorization Holder
LEHNING LABORATORIES
3 Petit Marais Street
57640 SAINTE-BARBE
FRANCE
Manufacturer
LEHNING LABORATORIES
3 Petit Marais Street
57640 SAINTE-BARBE
FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The date this package insert was last revised is:
[to be completed later by the marketing authorization holder]
Other
Detailed information on this drug is available on the ANSM website (France).