Neospasmina at night

Patient Information Leaflet

NEOSPASMINA NOC, 3.15 ml/15 ml, oral solution
Extractum fluidum compositum ex: Crataegi fructu, Valerianae radice, Lupuli flore, Passiflorae herba
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What Neospasmina Noc is and what it is used for
2. What you need to know before taking Neospasmina Noc
3. How to take Neospasmina Noc
4. Possible side effects
5. How to store Neospasmina Noc
6. Contents of the pack and other information

1. What Neospasmina Noc is and what it is used for

Traditional herbal medicinal product used based on long-standing use without appreciable risk.
Neospasmina Noc is a traditional herbal medicinal product containing a liquid extract composed of Crataegus fruit, Valerian root, Hop strobile, and Passionflower herb.
The medicine has mild sedative properties and helps facilitate sleep.

Indications:
Traditional herbal medicinal product used as an adjunct in the treatment of:

• Nervous disorders such as mild tension and feelings of anxiety;
• Difficulty in falling asleep.

2. Important information before using Neospasmina Noc

When not to use Neospasmina Noc

• if the patient is allergic to hawthorn, valerian root, hops, passionflower, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Neospasmina Noc, discuss this with your doctor or pharmacist.
Do not use in patients with brain damage or psychiatric disorders.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended due to lack of data.
In children aged 6 to 12 years and adolescents, the medicine should be used under medical supervision. Due to the ethanol content of the medicine, it should not be used in children under 6 years of age.
Neospasmina Noc and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use with synthetic sedatives is not recommended.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Due to the ethanol content of the medicine, it should not be used during pregnancy and breastfeeding.
There are no data on the effect of this product on fertility.
Driving and operating machinery
This medicine may impair the ability to drive or operate machinery. Patients taking this medicine should not drive or operate machinery.
The medicine contains up to 10% (V/V) ethanol. A single dose contains 1200 mg of alcohol in each 15 ml of syrup.
Neospasmina Noc contains sucrose, ethanol, sodium benzoate (E 211), and sodium
The medicine contains 10 g of sucrose in 15 ml of syrup (13 g of sucrose in 20 ml of syrup; 40 g of sucrose in 60 ml of syrup). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine. This should be considered in patients with diabetes.
This medicine may harm the teeth.
This medicine contains 1200 mg of alcohol (ethanol) in each 15 ml of syrup (1600 mg of alcohol (ethanol) in each 20 ml of syrup; 4800 mg of alcohol (ethanol) in each 60 ml of syrup). The amount of alcohol in this medicine is equivalent to 30 ml of beer or 12 ml of wine per 15 ml of syrup (40 ml of beer or 16 ml of wine per 20 ml of syrup; 120 ml of beer or 48 ml of wine per 60 ml of syrup).
The alcohol in this medicine may have harmful effects on children. Symptoms may include drowsiness and changes in behavior. It may also affect their ability to concentrate and physical activity.
If the patient has epilepsy or liver problems, he or she should consult a doctor or pharmacist before using this medicine.
The alcohol in this medicine may alter the effect of other medicines. If the patient is taking other medicines, he or she should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, he or she should consult a doctor or pharmacist before using this medicine.
The medicine contains 37.5 mg of sodium benzoate (E 211) in 15 ml of syrup (50.4 mg of sodium benzoate in 20 ml of syrup; 151 mg of sodium benzoate in 60 ml of syrup).
The medicine contains less than 1 mmol (23 mg) of sodium per 15 ml and 20 ml of syrup, meaning the medicine is considered "sodium-free".

3. How to use Neospasmina Noc

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Neospasmina Noc is intended for symptomatic treatment.
Oral use.
Adults:

• as an adjunct in the treatment of nervous disorders such as mild tension states and feelings of anxiety: single dose of 15 ml (equivalent to 18.9 g) of syrup, taken 2 to 3 times daily;
• as an adjunct in the treatment of sleep onset difficulties: single dose of 20 ml (equivalent to 25.2 g) of syrup, taken half an hour to one hour before bedtime.

Maximum dose: 4 single doses (60 ml).
If symptoms persist during treatment for more than 14 days, consult a doctor or other qualified healthcare professional.
Use of a higher than recommended dose of Neospasmina Noc
Valerian root in doses exceeding 20 g (equivalent to 261.3 ml of syrup) may cause mild symptoms (fatigue, abdominal cramps, dizziness, chest tightness, hand tremor, and pupil dilation), which usually resolve within 24 hours.
In the event of such symptoms, supportive treatment should be applied.
Missed dose of Neospasmina Noc
Do not use a double dose to make up for a missed dose.
Stopping Neospasmina Noc
Neospasmina Noc is intended for use when symptoms occur.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody experiences them.
Gastrointestinal disorders (e.g. nausea, abdominal cramps) may occur during the use of products containing valerian root. Frequency unknown.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Neospasmina Noc

Store in a tightly closed container at a temperature not exceeding 25°C.
Opalescence with possible formation of plant-derived sediments may occur.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Neospasmina Noc contains

• The active substance is a liquid extract composed of hawthorn fruit, valerian root, hops strobiles, and passionflower herb. 100 g of syrup contains: 17 g of liquid extract composed (1:1) of Crataegus monogyna Jacq. (Lindm.); Crataegus laevigata (Poir.) D.C., fructus (hawthorn fruit) / Valeriana officinalis L., radix (valerian root) / Humulus lupulus L., flos (hops strobile) / Passiflora incarnata L., herba (passionflower herb) (36/36/18/10). Extraction solvent: ethanol 50% (V/V).
• Other ingredients: sucrose, sodium benzoate (E 211), orange essence, purified water. The medicine contains up to 10% (V/V) ethanol.

What Neospasmina Noc looks like and contents of the pack
A 30 ml amber glass bottle with a polyethylene cap, with a measuring cup, in a cardboard box.
1 bottle of 119 ml
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
„Herbapol-Lublin” S.A.
ul. Diamentowa 25, 20-471 Lublin