Natussic

Package leaflet: Information for the patient

Natussic, 7.5 mg/5 ml, syrup
Butamirati citras
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.
• If there is no improvement after 5 to 7 days, or if the patient feels worse, consult a doctor.

Table of contents

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

1. What Natussic is and what it is used for

The active substance in Natussic is butamirate citrate.
Natussic is an antitussive medicine intended for symptomatic treatment of cough of various origins.
If there is no improvement after 5 to 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using the medicine Natussic

When not to use Natussic:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If cough persists for more than 7 days, consult a doctor.
Due to the cough reflex suppression caused by citric acid butamirate, concomitant use of expectorant medicines should be avoided (see section "Natussic and other medicines").
Children
Natussic syrup should not be used in children under 3 years of age.
Natussic and other medicines
Inform your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
Concomitant use of expectorant medicines should be avoided, as this may lead to accumulation of respiratory secretions, increasing the risk of bronchospasm and respiratory tract infection.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Natussic may cause drowsiness. Therefore, caution should be exercised when driving or operating machinery.
Natussic contains 2500 mg of sorbitol in 5 ml of syrup
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body does not break down fructose—has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child. The caloric value of sorbitol is 2.6 kcal/g.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Natussic contains 5 mg of benzoic acid in 5 ml of syrup
Natussic contains 96% ethanol
The medicine contains a small amount of ethanol (alcohol), less than 100 mg per dose.

3. How to use Natussic

This medicine should always be taken exactly as described in the patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use Natussic for longer than 5 to 7 days without consulting a doctor.
Natussic syrup is for oral use.
A measuring spoon is provided with the medicine package to measure the correct dose of syrup.
The measuring spoon used for administering the syrup should be washed and dried after each use.
The usual dosage is as follows:
children aged 3 to 6 years: 5 ml of syrup three times daily,
children aged 6 to 12 years: 10 ml of syrup three times daily,
adolescents over 12 years of age: 15 ml of syrup three times daily,
adults: 15 ml of syrup four times daily.
Natussic syrup should not be used in children under 3 years of age.
Use of a higher than recommended dose of Natussic
If a higher than recommended dose of Natussic is taken, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhoea, dizziness and low blood pressure.
If a higher than recommended dose is taken, seek immediate medical advice.
Missed dose of Natussic
Do not take a double dose to make up for a forgotten dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Rare adverse effects (occurring in 1 to 10 per 10,000 people):
drowsiness,
nausea,
diarrhea,
urticaria.
If any of these symptoms occur, treatment with the medicine should be discontinued and medical advice should be sought.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet,
inform a doctor or pharmacist. Adverse effects can be reported directly to the
Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
tel. + 48 22 49 21 301, fax: + 48 22 49 21 309,
e-mail: [email protected].
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to collect further information on the safety of using the medicine.

5. How to store Natussic medicine

Store in a tightly closed original container, at a temperature below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Shelf life after first opening the bottle: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Natussic contains

• The active substance is butamirate citrate. 5 ml of syrup contains 7.5 mg of butamirate citrate (1 ml of syrup contains 1.5 mg of butamirate citrate).
• The other ingredients (excipients) are: non-crystallizing liquid sorbitol, glycerol, sodium saccharin (E 954), vanillin, benzoic acid (E 210), sodium hydroxide, ethanol 96% (v/v), purified water.

What Natussic looks like and contents of the pack
Natussic syrup is a colourless, clear syrup with a characteristic taste and vanilla-like odour.
Brown glass bottle type III with HDPE cap and PE foam seal, with tamper-evident ring, with a PP measuring spoon, in a cardboard box.
Pack sizes:
1 bottle of 100 ml
1 bottle of 200 ml
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Product Information
tel. 22 742 00 22
e-mail: [email protected]