Patient Information Leaflet

Paracodina 2,4 mg/ml syrup

Dihydrocodeine bitartrate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Paracodina is and what it is used for

2. What you need to know before you start taking Paracodina

3. How to take Paracodina

4. Possible side effects

5. Storage of Paracodina

6. Contents of the pack and additional information

Paracodina is presented in the form of a syrup containing dihydrocodeine bitartrate as the active ingredient. Dihydrocodeine belongs to a group of medications called antitussives that are used to treat cough.

This medication is indicated for the symptomatic treatment of dry cough (not accompanied by mucus).

Do not take Paracodina

• If you are allergic to dihydrocodeine and its salts or to any of the other components of this medication (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 loss of consciousness).
• If you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”).
• During the breastfeeding period (see section “Pregnancy and breastfeeding”).
• In children under 2 years old.

Warning and precautions

Consult your doctor or pharmacist before starting to take Paracodina.

Do not recommend its use:

• If you have diseases that involve respiratory problems,
• If you have consciousness problems or elevated intracranial pressure (high pressure inside the head) or have a history of seizures, as it may increase respiratory depression (slow or insufficient breathing),
• If you are in the first four months of pregnancy (see section “Pregnancy and breastfeeding”),
• If you have chronic constipation or have a risk or have paralytic ileus (intestinal movement paralysis),
• If you have pseudomembranous colitis (colon inflammation) caused by antibiotics or in diarrhea caused by poisoning until the toxic material has been eliminated from the gastrointestinal tract,
• If you have opioid dependence.

Should be administered with caution:

• In elderly people, as it may be more sensitive to the effects of this medication,
• If you have liver or kidney problems,
• If you have prostate hypertrophy (prostate enlargement), urethral stenosis (abnormal urethral narrowing),
• If you have gallbladder diseases,
• If you have chronic ulcerative colitis (colon and rectum inflammation and ulceration) associated diarrhea.

Do not take this medication if you know that you metabolize codeine or dihydrocodeine very quickly, as there may be a risk of more side effects.

Do not recommend prolonged administration of Paracodina as it may produce physical and psychological dependence (addiction) and tolerance. If the cough persists for more than three days, consult your doctor again.

Children

Since this medication is contraindicated in asthma bronchial, it should be taken into account that chronic cough in children could be a symptom of asthma bronchial.

Use of Paracodina with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

The following medications may interfere and should not be taken with Paracodina without consulting your doctor:

• Medications used to treat depression called MAOIs (monoamine oxidase inhibitors) or if you have taken this type of medication in the last two weeks.
• Central Nervous System Depressants (medications that act on the brain and produce drowsiness), such as medications that help you fall asleep, antihistamines (used to treat allergies), medications used to treat anxiety, medications used to treat certain mental disorders, certain analgesics or general anesthetics.
• Tricyclic antidepressants.
• Cimetidine and other medications that affect liver metabolism.

Paracodina intake with food, drinks and alcohol

Do not take alcoholic beverages during treatment. The administration of dihydrocodeine with Central Nervous System Depressants such as alcohol may cause a reduction in coordination, as well as prolongation of reaction time and deterioration of recent memory.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take Paracodina if you are in the third trimester of pregnancy. The use close to delivery and at high doses may cause slow or insufficient breathing in the newborn.

Do not recommend the use of this medication during the first and second trimesters of pregnancy, unless your doctor considers it strictly necessary.

Breastfeeding

This medication passes into breast milk. Therefore, do not take Paracodina during breastfeeding. If it is necessary, breastfeeding should be interrupted.

Driving and using machines

Ask your doctor if you can drive or use machines during Paracodina treatment. It is essential to observe how this medication affects you before driving or using machines. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Be especially careful at the beginning of treatment and/or when administering it with other medications.

Alcohol may potentiate drowsiness, so do not take alcoholic beverages during treatment.

Use in athletes

Inform athletes that this medication contains a component that may produce a positive result in doping control tests.

Paracodina contains saccharose

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Patients with diabetes mellitus should note that this medication contains 2.4 g of saccharose per dose of 5 ml.

It may cause tooth decay.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the dose you should take of this medication and the duration of treatment. It is essential to use the smallest dose that controls symptoms. This medication should not be taken for more than 3 days. If there is no relief from cough after three days, you should consult your doctor again.

The administration of the medication is subject to the appearance of symptoms, so the dose can be reduced as these symptoms disappear.

The recommended dose is:

Adults and adolescents over 12 years:5 to 10 ml of syrup (1 to 2 teaspoons 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 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, which corresponds to 6.25 ml of this syrup.

Children 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, which corresponds to 3.125 ml of this syrup.

Children under 2 years cannot take this medication, it is contraindicated.

Important note: For safety reasons, to administer the correct dose in children under 12 years, it is recommended to use a dosing syringe.

Consult your pharmacist about which device is most suitable for administering the dose indicated by your doctor.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Paracodina than you should

The ingestion of very high doses can produce initial excitement, anxiety, insomnia, and subsequently, in certain cases, drowsiness, lack of reflexes that progresses to stupor or coma, headache, pupil constriction, blood pressure alterations, arrhythmias (irregular heartbeats), dry mouth, allergic reactions, cold and sticky skin, decrease or increase in heart rate, convulsions, gastrointestinal disturbances, nausea, vomiting, and respiratory depression (slow or insufficient breathing). In severe poisoning, apnea (pauses in breathing or shallow breathing), circulatory collapse (loss of basal tone of the vessel walls, insufficient return of blood to the heart), cardiac arrest, and death may appear.

If you have taken more Paracodina than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 91 562 04 20. If a severe poisoning has occurred, the doctor will take the necessary measures.

If you forgot to take Paracodina

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Paracodina

The administration should be suspended gradually after prolonged use, as physical dependence and tolerance may appear with repeated administration of this drug.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The assessment of the frequency of adverse reactions is based on the following criteria: Very frequent (may affect more than 1 in 10 patients), frequent (may affect up to 1 in 10 patients), infrequent (may affect up to 1 in 100 patients), rare (may affect up to 1 in 1,000 patients), very rare (may affect up to 1 in 10,000 patients).

• The following adverse effects have been observed, but their frequency could not be established: stomach discomfort, constipation, vomiting, nausea, fatigue, drowsiness, dizziness, inability to urinate, breathing difficulties (dyspnea), respiratory depression.

• Rare adverse effects: headache, itching, urticaria.

• Very rare adverse effects: euphoria, skin allergic reaction known as Quincke's edema, pupil constriction, vision loss, circulation problems, angina pectoris.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracodina

• The active principle is dihydrocodeine bitartrate. Each 5 ml of syrup (one teaspoon) contains approximately 12 mg of dihydrocodeine bitartrate.
• The other components are: glycerol (E-422), sucrose, benzoic acid (E-210), cherry aroma, and purified water.

Appearance of the product and content of the container

Paracodina is presented in the form of a weakly yellowish syrup. Each container contains 125 ml of syrup.

Holder of the marketing authorization and manufacturer

Holder of the marketing authorization:

TEOFARMA S.r.l. Via F.lli Cervi, 8 Valle Salimbene (Pavia).

Manufacturer:

Teofarma S.r.l. Viale Certosa, 8/A Pavia, Italy.

Last review date of this leaflet: July 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.es/).