Package leaflet: Information for the user

PARACODINA SYRUP

Dihydrocodeine + benzoic acid
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PARACODINA Syrup is and what it is used for
What you need to know before taking PARACODINA Syrup
How to take PARACODINA Syrup
Possible side effects
How to store PARACODINA Syrup
Contents of the pack and other information

1. What PARACODINA Syrup is and what it is used for

PARACODINA Syrup belongs to the class of antitussive medicines.
It is used to treat dry cough.

2. What you need to know before taking PARACODINA Syrup

Do not take PARACODINA Syrup:

if you are allergic to dihydrocodeine, benzoic acid, or any of the other ingredients of this medicine (listed in section 6),
if you have severe hepatic insufficiency (severe liver dysfunction),
if you have respiratory insufficiency,
if you suffer from chronic constipation,
if you are taking, or have taken within the last two weeks, an antidepressant belonging to the group of monoamine oxidase inhibitors (MAOIs), or another medicine belonging to the group of narcotic analgesics,
if you are breastfeeding.

Do not administer PARACODINA Syrup to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking PARACODINA Syrup.
Strictly follow the recommended doses, as PARACODINA Syrup may cause dependence.

Elderly patients: exercise caution when using this medicine, especially at high doses and/or for prolonged periods, as opium alkaloids may worsen symptoms of pre-existing conditions (cerebral disorders, difficulty in urination, etc.).
Patients on a low-calorie diet: please note that one teaspoon of PARACODINA Syrup contains 1 gram of glucose.

Other medicines and PARACODINA Syrup
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of PARACODINA Syrup on the central nervous system are enhanced by concomitant use of other medicines such as:

sedatives
tranquillisers
antihistamines.
Concomitant use of PARACODINA Syrup and sedative medicines such as benzodiazepines or related derivatives increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are available. However, if your doctor prescribes PARACODINA Syrup together with another sedative medicine, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and strictly follow the dosing instructions provided by your doctor. It may be helpful to inform family members and friends to watch for the signs and symptoms listed above. Contact your doctor if these symptoms occur. Your doctor will closely monitor you if you are taking PARACODINA Syrup together with any of the listed medicines to prevent unexpected and undesirable effects due to interaction.

PARACODINA Syrup with food and alcohol

During treatment, do not consume alcohol.
Do not take this syrup on an empty stomach.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

This medicine crosses the placenta, so it is possible that your baby may experience neonatal respiratory depression. During pregnancy and early infancy, use this product only if strictly necessary and under direct medical supervision.
Do not use PARACODINA Syrup during breastfeeding (see "Do not take PARACODINA Syrup").

Driving and using machines
Since drowsiness may commonly occur during treatment, exercise caution before driving or operating machinery or performing tasks requiring full alertness.
PARACODINA Syrup contains sucrose:
This medicine contains 2.5 g of sucrose per dose (1 teaspoon). This should be taken into account in patients with diabetes mellitus.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take PARACODINA Syrup

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The usual dose is (unless otherwise prescribed by the doctor):
Adults: 1–2 teaspoons several times a day
Adolescents: ½–1 teaspoon several times a day
Children (over 2 years of age): ¼–½ teaspoon several times a day
One teaspoon corresponds to 5 mL (equivalent to 12 mg of dihydrocodeine bitartrate and 12 mg of benzoic acid).
In elderly patients, the dosage must be carefully determined by the doctor, who will assess whether a reduction of the above doses is necessary.
PARACODINA Syrup should be taken after meals, either alone or, if needed, diluted in water or other liquids.
If you take more PARACODINA Syrup than you should
If you accidentally swallow or take too much PARACODINA, contact your doctor immediately or go to the nearest hospital.
The most important symptoms of opioid intoxication reported are: deep coma, reduced respiratory rate, low blood pressure, miosis (pupil constriction), decreased urine output, drop in body temperature, and pulmonary edema.
In cases of overdose (such as accidental ingestion of excessive doses) or in hypersensitive individuals, more severe signs of depression of the nervous system and of respiratory and cardiovascular functions may occur.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Following the instructions contained in this leaflet reduces the risk of side effects.
At usual doses, the most frequent effects are:

sedation and/or drowsiness,
gastrointestinal disturbances such as nausea, vomiting and constipation.

Occasionally reported have been:

headache,
dizziness,
weakness (asthenia),
agitation, especially in elderly people.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via
reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PARACODINA Syrup

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers
to the product kept in its original, unopened packaging and stored correctly.
OPENING THE BOTTLE:
To open:

Place the bottle on a flat surface
Press down on the bottle cap and unscrew it To close:
Screw the cap tightly closed

Schematic drawing showing how to unscrew a bottle and then place and press on the top to

Store at room temperature not exceeding 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What PARACODINA Syrup contains
The active substances are: 200 mg of dihydrocodeine bitartrate and 200 mg of benzoic acid per 100 g of syrup.
The other components are: purified water, althea extract, grindelia extract, glycerin, sucrose.

Description of the appearance of PARACODINA Syrup and package contents
Syrup – 100 g bottle

Marketing Authorization Holder
Teofarma S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

Manufacturer:
Teofarma S.r.l. - Viale Certosa, 8/A - 27100 Pavia

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): www.agenziafarmaco.gov.it