Paracodina

PARACODINA 10.25 mg/mL oral drops, solution
dihydrocodeine
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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PARACODINA 10.25 mg/mL oral drops, solution is and what it is used for
2. What you need to know before taking PARACODINA 10.25 mg/mL oral drops, solution
3. How to take PARACODINA 10.25 mg/mL oral drops, solution
4. Possible side effects
5. How to store PARACODINA 10.25 mg/mL oral drops, solution
6. Contents of the pack and other information

1. What PARACODINA 10.25 mg/mL oral drops, solution is and what it is used for

This medicine contains dihydrocodeine.
It is a cough suppressant for dry cough.

2. What you need to know before taking PARACODINA 10.25 mg/mL oral drops, solution

Do not take PARACODINA 10.25 mg/mL oral drops, solution:

• if you are allergic to dihydrocodeine or to any of the other ingredients of this medicine (listed in section 6),
• if you have hepatic insufficiency (severe liver dysfunction),
• if you have respiratory insufficiency,
• if you suffer from chronic constipation,
• if you are taking other medicines belonging to the group of narcotic analgesics,
• if you have taken an antidepressant treatment based on monoamine oxidase inhibitors within the last 2 weeks,
• if you are breastfeeding. Do not use PARACODINA 10.25 mg/mL oral drops, solution in children under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking PARACODINA 10.25 mg/mL oral drops, solution.

• PARACODINA may cause symptoms of dependence after prolonged use. In case of dependence, when treatment is discontinued, withdrawal symptoms such as irritability, agitation, insomnia, anxiety, and palpitations (awareness of heartbeat) may occur.
• consult your doctor if you are elderly and taking PARACODINA at high doses and/or for a long period of time, as the medicine may worsen symptoms of other diseases (e.g. brain disorders, difficulty in urinating).

Other medicines and PARACODINA 10.25 mg/mL oral drops, solution
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine together with other medicines belonging to the group of narcotic analgesics.
Do not take this medicine if you have taken an antidepressant treatment based on monoamine oxidase inhibitors within the last 2 weeks.
You must exercise particular caution if you take PARACODINA together with other medicines acting on the central nervous system, especially other antidepressants such as sedatives, tranquillisers, antihistamines, and alcohol. The concomitant use of PARACODINA and sedative medicines such as benzodiazepines or 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 possible.
However, if your doctor prescribes PARACODINA 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 using and strictly follow the dosing instructions provided by your doctor. It may be helpful to inform family members and friends to watch for the above-mentioned signs and symptoms. Contact your doctor if these symptoms occur.
Your doctor will closely monitor you if you are taking other medicines, to avoid unexpected and undesirable effects due to interactions.

PARACODINA 10.25 mg/mL oral drops, solution and alcohol
Do not drink alcohol when taking this medicine.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

• this medicine crosses the placenta, so it is possible that the newborn may experience breathing problems. Your doctor will prescribe PARACODINA only if clearly needed.
• this medicine is excreted in breast milk. It must not be taken while breastfeeding (see "Do not take PARACODINA").

Driving and using machines
Since drowsiness is not uncommon during treatment, take particular care before driving or using machinery.

PARACODINA 10.25 mg/mL oral drops, solution contains methyl parahydroxybenzoate.
It may cause allergic reactions (including delayed reactions).

PARACODINA 10.25 mg/mL oral drops, solution contains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

PARACODINA 10.25 mg/mL oral drops, solution contains ethanol.
This medicine contains 253 mg of alcohol (ethanol) per maximum adult dosage unit (45 drops). The amount in a dose (45 drops) of this medicine is equivalent to less than 5 ml of beer or 2 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to take PARACODINA 10.25 mg/mL oral drops, solution

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage
The recommended dose is:
Adults and adolescents (over 12 years of age): 25–45 drops, 3 or 4 times daily (every 6–8 hours), if necessary.
Do not exceed the maximum daily dose corresponding to approximately 50 mg of dihydrocodeine.
Children and adolescents (from 6 to 12 years of age): 12–22 drops, 3 or 4 times daily (every 6–8 hours), if necessary.
Do not exceed the maximum daily dose corresponding to approximately 25 mg of dihydrocodeine.
PARACODINA is contraindicated in children under 6 years of age.
Elderly: the dose will be carefully determined by the doctor, who may consider reducing the dosage.

Method of administration
PARACODINA drops should be taken with a full stomach, with a small amount of water or on a sugar cube.

Duration of treatment
Do not exceed 7 days of treatment.

If you take more PARACODINA 10.25 mg/mL oral drops, solution than you should
The most important symptoms of opioid intoxication reported are: deep coma (state of unconsciousness), decreased respiratory rate, sudden drop in blood pressure, miosis (pupil constriction), reduced urine output (urine production), sudden drop in body temperature, and pulmonary edema (fluid accumulation in the lungs).
In case of ingestion/overdose of PARACODINA, contact your doctor immediately or go to the nearest hospital.

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 everyone gets them.
The following side effects have been reported with uncommon frequency (may affect up to 1 in 100 people):

• itching
• skin rash

The following side effects have been reported with rare frequency (may affect up to 1 in 1,000 people):

• severe skin reactions (Stevens-Johnson syndrome)
• inflammatory reaction with rapid swelling of the tissues beneath the skin and mucous membranes (angioedema, Quincke's edema)

The following side effects have been reported with unknown frequency (frequency cannot be estimated from the available data):

• sedation
• drowsiness
• nausea
• vomiting
• constipation
• headache
• dizziness
• asthenia (weakness)
• agitation, especially in elderly people

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PARACODINA 10.25 mg/mL oral drops, solution

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 last day of that month and applies to the product in its original, unopened packaging stored correctly.
Store below 25 °C.

OPENING THE BOTTLE:
To open:

• place the bottle on a flat surface
• press down on the cap and unscrew it

To close:

• screw the cap tightly back on

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What PARACODINA 10.25 mg/mL oral drops, solution contains
The active substance is:
dihydrocodeine thiocyanate ……. 10.25 mg
per 1 mL (31 drops) of solution.
1 drop of solution contains 0.33 mg of dihydrocodeine thiocyanate.
The other components are: citric acid, purified water, 95% ethyl alcohol, honey flavour, caramel (E150), cocoa essence, thyme essence, glycerine, methyl p-hydroxybenzoate, sodium saccharin, sucrose.

Description of the appearance of PARACODINA 10.25 mg/mL oral drops, solution and contents of the pack
Dropper bottle of 14.63 ml

Marketing Authorization Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Fax 0382.525845
e-mail: [email protected]

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