Paracodina 2.4 mg/ml syrup
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Paracodina 2.4 mg/ml syrup
Dihydrocodeine bitartrate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What Paracodina is and what it is used for
- What you need to know before taking Paracodina
- How to take Paracodina
- Possible side effects
- How to store Paracodina
- Contents of the pack and other information
1. What Paracodina is and what it is used for
Paracodina is available as a syrup containing dihydrocodeine bitartrate as the active substance. Dihydrocodeine belongs to a group of medicines called antitussives, which are used to treat cough.
This medicine is indicated for the symptomatic treatment of dry cough (not accompanied by mucus).
2. What you need to know before taking Paracodina
Do not take Paracodina
- If you are allergic to dihydrocodeine and its salts or to any of the other components of this medicine (listed in section 6).
- If you have respiratory problems such as Chronic Obstructive Pulmonary Disease (COPD), respiratory depression (slow or insufficient breathing), or acute asthma attacks.
- If you are in a coma (a severe state of unconsciousness).
- If you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”).
- During breastfeeding (see section “Pregnancy and breastfeeding”).
- In children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Paracodina.
Its use is not recommended:
- If you suffer from diseases associated with respiratory problems,
- If you have disorders of consciousness or increased intracranial pressure (elevated pressure inside the head), or a history of epileptic seizures, as respiratory depression (slow or insufficient breathing) may worsen,
- If you are in the first four months of pregnancy (see section “Pregnancy and breastfeeding”),
- If you have chronic constipation or are at risk of, or suffer from, paralytic ileus (paralysis of intestinal movement),
- If you have diarrhea associated with pseudomembranous colitis (inflammation of the colon) caused by antibiotics, or diarrhea due to poisoning until the toxic substance has been eliminated from the gastrointestinal tract,
- If you have opioid dependence.
Use with caution:
- In elderly patients, as they may be more sensitive to the effects of this medicine,
- If you have liver or kidney problems,
- If you suffer from prostate hypertrophy (enlarged prostate) or urethral stenosis (abnormal narrowing of the urethra),
- If you have biliary tract disorders,
- If you suffer from diarrhea associated with chronic ulcerative colitis (inflammation and ulceration of the colon and rectum).
Do not take this medicine if you know you are a rapid metabolizer of codeine or dihydrocodeine, as this may increase the risk of adverse effects.
Long-term administration of Paracodina is not recommended, as it may lead to physical and psychological dependence (addiction) and tolerance. If cough persists for more than three days, consult your doctor again.
Children
Since this medicine is contraindicated in bronchial asthma, it should be noted that chronic cough in children may be a symptom of bronchial asthma.
Use of Paracodina with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
The following medicines may interact and therefore should not be taken together with Paracodina without first consulting your doctor:
- Medicines used to treat depression called MAO inhibitors (monoamine oxidase inhibitors), or if you have taken these types of medicines within the last two weeks.
- Central Nervous System (CNS) depressants (medicines that act on the brain and cause drowsiness), such as sleeping medications, antihistamines (used to treat allergies), medicines used to treat anxiety, medicines used to treat certain mental disorders, certain analgesics, or general anesthetics.
- Tricyclic antidepressants.
- Cimetidine and other drugs that affect hepatic metabolism.
Taking Paracodina with food, drinks, and alcohol
Do not consume alcoholic beverages during treatment. Taking dihydrocodeine together with CNS depressants such as alcohol may reduce coordination, prolong reaction time, and impair recent memory.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Paracodina if you are in the third trimester of pregnancy. Use close to delivery and at high doses may cause slow or insufficient breathing in the newborn.
Use of this medicine is not recommended during the first and second trimesters of pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
This medicine passes into breast milk. Therefore, you should not take Paracodina during breastfeeding. If its use is essential, breastfeeding must be discontinued.
Driving and using machines
Ask your doctor whether you can drive or operate machinery while being treated with Paracodina. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment and/or when taking it together with other medicines.
Alcohol may increase drowsiness; therefore, alcoholic beverages should not be consumed during treatment.
Use in athletes
Athletes are advised that this medicine contains a component that may result in a positive doping test.
Paracodina contains sucrose
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 2.4 g of sucrose per 5 ml dose.
It may cause dental caries.
3. How to take Paracodina
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the dose of this medicine you should take and the duration of treatment. It is important to use the smallest dose that controls your symptoms. This medicine should not be taken for more than 3 days. If your cough has not improved after three days, you should consult your doctor again.
The administration of this medicine depends on the presence of symptoms; therefore, the dose may be reduced as symptoms begin to subside.
The recommended dose is:
Adults and adolescents over 12 years of age: 5 to 10 ml of syrup (1 to 2 teaspoonfuls of 5 ml) up to three times a day.
Do not exceed the maximum daily dose of 72 mg of dihydrocodeine (30 ml of syrup per day).
Children aged 6–12 years: 1 to 2 ml of syrup up to three times a day.
Do not exceed the maximum daily dose of 15 mg of dihydrocodeine, corresponding to 6.25 ml of this syrup.
Children aged 2–5 years: 1 ml of syrup up to three times a day.
Do not exceed the maximum daily dose of 7.5 mg of dihydrocodeine, corresponding to 3.125 ml of this syrup.
Children under 2 years of age must not take this medicine; it is contraindicated.
Important note: For safety reasons, and in order to ensure accurate dosing in children under 12 years of age, the use of an oral dosing syringe is recommended.
Consult your pharmacist to determine the most appropriate device for administering the dose prescribed by your doctor.
If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you take more Paracodina than you should
Taking very high doses may cause initial excitement, anxiety, insomnia, and subsequently, in some cases, drowsiness, loss of reflexes progressing to stupor or coma, headache, pupil constriction, changes in blood pressure, arrhythmias (irregular heartbeats), dry mouth, allergic reactions, cold and clammy skin, decreased or increased heart rate, seizures, gastrointestinal disturbances, nausea, vomiting, and respiratory depression (slow or inadequate breathing). In severe poisoning, apnea (pauses in breathing or shallow breathing) may occur, followed by circulatory collapse (loss of basal vascular tone, insufficient blood return to the heart), cardiac arrest, and death.
If you have taken more Paracodina than you should, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20. If severe poisoning has occurred, the doctor will take the necessary measures.
If you forget to take Paracodina
Do not take a double dose to make up for forgotten doses.
If you stop taking Paracodina
Treatment should be discontinued gradually after prolonged use, as physical dependence and tolerance may develop with repeated administration of this medicine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The assessment of the frequency of adverse reactions is based on the following criteria: Very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people).
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The following adverse effects have been observed, whose frequency cannot be estimated: stomach discomfort, constipation, vomiting, nausea, fatigue, drowsiness, dizziness, inability to urinate, breathing difficulties (dyspnea), respiratory depression.
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Rare adverse effects: headache, itching, urticaria.
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Very rare adverse effects: euphoria, allergic skin reaction known as Quincke's edema, pupillary constriction, loss of vision, circulatory problems, angina pectoris.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Paracodina
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and containers should be returned to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Paracodina
- The active substance is dihydrocodeine bitartrate. Each 5 ml of syrup (one teaspoonful) contains approximately 12 mg of dihydrocodeine bitartrate.
- The other components are: glycerol (E-422), sucrose, benzoic acid (E-210), cherry flavour, and purified water.
Appearance of the product and contents of the pack
Paracodina is presented as a slightly yellowish syrup. Each container holds 125 ml of syrup.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TEOFARMA S.r.l. Via F.lli Cervi, 8 Valle Salimbene (Pavia).
Manufacturer:
Teofarma S.r.l. Viale Certosa, 8/A Pavia, Italy.
Date of the most recent revision of this package leaflet: July 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.es/).