Antinervinum

Leaflet attached to the packaging: patient information

Antinervinum

Valerianae tinctura + Crataegi tinctura + Lupuli strobili tinctura
Syrup, (1032 mg + 903 mg + 645 mg) /5 ml

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or according to
the doctor's or pharmacist's instructions.

• This leaflet should be kept, so that it can be read again if necessary.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.
• If there is no improvement or the patient feels worse after 14 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Antinervinum and what is it used for
• 2. Important information before taking Antinervinum
• 3. How to take Antinervinum
• 4. Possible side effects
• 5. How to store Antinervinum
• 6. Package contents and other information

1. What is Antinervinum and what is it used for

Antinervinum is a herbal medicinal product, intended for traditional use, whose effectiveness in the indicated indications is based solely on a long period of use and experience.
Antinervinum is traditionally used in states of increased nervous tension, periodic difficulties in falling asleep.

2. Important information before taking Antinervinum

When not to take Antinervinum:

• if the patient is allergic to the active substances or to any of the excipients listed in point 6,
• if the patient has poor tolerance to valerian.

Warnings and precautions

Before taking Antinervinum, the patient should discuss it with their doctor, pharmacist, or nurse.
Antinervinum contains ethanol and sorbitol.
Antinervinum contains 28 - 34% ethanol by volume, which is up to 1.3 g per 5 ml dose, equivalent to 34 ml of beer or 14 ml of wine per dose. It may be harmful to individuals with alcohol dependence. This should be taken into account in pregnant or breastfeeding women and groups at increased risk, such as individuals with liver disease or epilepsy.
A single dose of Antinervinum (5 ml) contains 1.1 g of sorbitol. Patients who have previously been diagnosed with intolerance to certain sugars should consult their doctor.

Children and adolescents

Due to the ethanol content and lack of data on safety, it is not recommended to use the medicine in children under 12 years of age. Details on the use of Antinervinum in children and adolescents can be found in point 3.

Antinervinum and other medicines

Interactions with other medicines are not known. It is not recommended to take Antinervinum simultaneously with other medicines with a sedative effect.
The patient should inform their doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines planned to be taken.

Taking Antinervinum with food, drink, and alcohol

Interactions with food or alcohol are unknown.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The effect of the medicine on fertility has not been established.

Driving and operating machinery

Antinervinum contains alcohol, see the "Warnings and precautions" section, which impairs the ability to drive vehicles, operate moving machinery, and affects psychomotor performance (swimming, working at heights, and other activities). Therefore, it is not recommended to perform these activities for up to two hours after taking the medicine.

3. How to take Antinervinum

Antinervinum should always be taken exactly as described in the patient leaflet or according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose for adults and adolescents over 12 years: 3 times a day, 5 ml (1 teaspoon).
In case of difficulty falling asleep, 5 - 10 ml (1 - 2 teaspoons) 1 hour before bedtime.
Children under 12 years: not recommended.
Not to be used in children under 6 years. The use of Antinervinum in children aged 6-12 years may be decided by a doctor.

Taking a higher dose of Antinervinum than recommended

No symptoms of overdose have been reported to date. Valerian root in an amount equivalent to 250 g of the product caused mild symptoms (fatigue, cramps in the abdominal cavity, chest pressure, feeling of emptiness in the head, hand tremors, and pupil dilation), which subsided within 24 hours. If symptoms worsen, symptomatic treatment should be applied.
Due to the sorbitol content, the preparation may cause loose stools. Sorbitol in a dose above 10 g may have a mild laxative effect.

Missing a dose of Antinervinum

A double dose should not be taken to make up for a missed dose.
In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Antinervinum can cause side effects. Rarely, cases of poor tolerance to valerian preparations may occur, characterized by a feeling of discomfort and belching. The sorbitol content may cause loose stools.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl

5. How to store Antinervinum

The medicine should be stored at a temperature not exceeding 25°C, out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label and carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Antinervinum contains

The active substances of the medicine are:

• Valerianae tinctura (1:4 - 4.5). Extraction solvent: ethanol 70% (V/V) - 20.0 g/100 g,
• Crataegi tinctura (1:3.25 - 3.75). Extraction solvent: ethanol 60% (V/V) - 17.5 g/100 g,
• Lupuli strobili tinctura (1:5). Extraction solvent: ethanol 70% (V/V) - 12.5 g/100 g. Other ingredients are sorbitol 70% and purified water. Antinervinum contains ethanol: 28.0 - 34.0% V/V.

What Antinervinum looks like and what the package contains

Brown, transparent liquid with a characteristic valerian smell; may become cloudy during storage.
The immediate packaging of Antinervinum is 200 ml and 300 ml brown glass bottles containing 200 g or 300 g of the medicine, respectively. The 200 ml bottles are closed with white HDPE caps, 22 mm in diameter, with a conical seal. The 300 ml bottles are closed with white HDPE caps, 28 mm in diameter, with a guarantee ring and conical seal. The outer packaging (carton) contains an informational leaflet and a measuring cup for the medicine with a capacity of 12.5 ml, with a scale of 1.0; 2.5; 5.0; 7.5; 10.0 ml, made of polypropylene with CE 1434 marking. Not all package sizes may be available.

Responsible entity and manufacturer

Responsible entity:
Farmaceutyczne Produkty Bonifraterskie Sp. z o. o.
ul. Krakowska 50/4
31-066 Kraków
Tel.: (+48) 12 357 65 98,
Email: pharmaceutical@bonifratrzy.pl
Manufacturer:
PHYTOPHARM Klęka SA
Klęka 1, 63-040 Nowe Miasto nad Wartą, Poland
Tel.: + 48 61 28 68 700
Fax: + 48 61 28 68 709

Date of the last update of the leaflet: