PARACODINA 10.25 mg/ml Krople doustne, roztwór
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Treść ulotki
- PARACODINA 10.25 mg/mL oral drops, solution
- What is PARACODINA 10.25 mg/mL oral drops, solution and what it is used for
- What you need to know before you take PARACODINA 10.25 mg/mL oral drops, solution
- How to take PARACODINA 10.25 mg/mL oral drops, solution
- Possible side effects
- How to store PARACODINA 10.25 mg/mL oral drops, solution
- Contents of the pack and other information
PARACODINA 10.25 mg/mL oral drops, solution
dihydrocodeine
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is PARACODINA 10.25 mg/mL oral drops, solution 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 you take 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 any of the other ingredients of this medicine (listed in section 6),
- if you suffer from hepatic insufficiency (severe liver dysfunction),
- if you suffer from respiratory insufficiency,
- if you suffer from chronic constipation,
- if you are taking other medicines belonging to the group of narcotic analgesics,
- if you have received antidepressant treatment based on monoamine oxidase inhibitors in 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, withdrawal symptoms such as irritability, agitation, insomnia, anxiety and palpitations (perception of the heartbeat) may occur when treatment is stopped.
- talk to your doctor if you are elderly and are taking PARACODINA at high doses and/or for a long period of time, as the medicine may worsen the symptoms of other diseases (e.g. brain disorders, difficulty urinating).
Other medicines and PARACODINA 10.25 mg/mL oral drops, solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take this medicine together with other medicines belonging to the group of narcotic
analgesics.
Do not take this medicine if you have received antidepressant treatment based on monoamine oxidase
inhibitors in the last 2 weeks.
You must be particularly careful if you take PARACODINA together with other medicines that act
on the central nervous system, in particular other antidepressant medicines such as sedatives, tranquillizers,
antihistamines and alcohol. The concomitant use of PARACODINA and sedative drugs such as benzodiazepines or
derivatives increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and may
be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes PARACODINA together with another sedative drug, the dose and
duration of concomitant treatment must be limited by your doctor.
Tell your doctor about all the sedative drugs you are using and strictly follow the instructions on
dosage provided by your doctor. It may be helpful to inform relatives and friends to be aware of the signs and
symptoms mentioned above. Contact your doctor if these symptoms occur.
The doctor will monitor you closely if you are taking other medicines, to avoid unexpected and undesirable effects due to the interaction.
PARACODINA 10.25 mg/mL oral drops, solution and alcohol
Do not drink alcohol while taking this medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
- this medicine passes through the placenta, so it is possible that the baby may have breathing problems at birth. The doctor will prescribe PARACODINA only if absolutely necessary.
- this medicine is excreted in breast milk. It should not be taken while breastfeeding (see “Do not take PARACODINA”).
Driving and using machines
Because drowsiness is not uncommon during treatment, be particularly careful
before driving vehicles or using machinery.
PARACODINA 10.25 mg/mL oral drops, solution contains methylparahydroxybenzoate.
It may cause allergic reactions (even delayed ones).
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 each maximum dosage unit for
adults (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 following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Dosage
The recommended dose is:
Adults and adolescents (over 12 years of age): 25-45 drops, 3 or 4 times a day (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): 12-22 drops, 3 or 4 times a day (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 established by the doctor who will evaluate a possible decrease in
dosage.
Method of administration
PARACODINA drops should be taken on a full stomach with a little water or on a sugar lump.
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 loss of
consciousness), decreased respiratory rate, sudden drop in blood pressure, miosis (constriction of the pupil), decreased diuresis (urine production),
sudden reduction in body temperature, pulmonary edema (fluid accumulation in the
lungs).
In case of ingestion/taking an excessive dose of PARACODINA, immediately inform your
doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody 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):
- severe skin reactions (Stevens-Johnson syndrome)
- inflammatory reaction with rapid swelling of the tissues under the skin and mucous membranes (angioedema). The following side effects have been reported with unknown frequency (frequency cannot be estimated based on 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 effects, including those not listed in this leaflet, please inform
your doctor or pharmacist.
You can also report side effects directly through the national reporting system at 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 which is stated on the packaging. The expiry date refers to the last day of that month and the product in intact packaging,
correctly stored.
Store at a temperature below 25 °C.
OPENING THE BOTTLE:
To open it:
- place the bottle on a flat surface
- press on the bottle cap and unscrew it To close it:
- close the cap tightly
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What PARACODINA 10.25 mg/mL oral drops, solution contains
The active ingredient is:
dihydrocodeine rhodinate ……. 10.25 mg
per 1 mL (31 drops) of solution.
1 drop of solution contains 0.33 mg of dihydrocodeine rhodinate.
The other ingredients are: citric acid, purified water, ethyl alcohol 95%, honey aroma, caramel
(E150), cocoa essence, thyme essence, glycerin, methyl parahydroxybenzoate, sodium saccharin,
sucrose.
Description of the appearance of PARACODINA 10.25 mg/mL oral drops, solution and contents of the
pack
14.63 ml dropper bottle
Marketing Authorisation 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
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- Postać farmaceutycznaOral drops, solution, 10.25 MG/ML
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- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki PARAKODINAPostać farmaceutyczna: Syrup, 100 MLSubstancja czynna: combinationsProducent: KENVUE ITALIA S.P.A.Bez receptyPostać farmaceutyczna: Oral drops, solution, 15 MG/MLSubstancja czynna: dextromethorphanWymaga receptyPostać farmaceutyczna: Syrup, 3 mg/mlSubstancja czynna: dextromethorphanProducent: MONTEFARMACO OTC S.P.A.Bez recepty
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PARAKODINA jest produkowany przez TEOFARMA S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
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