HistaVerin 2 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Histaverin 2 mg/ml syrup

codeine phosphate sesquihydrate

Read all of this leaflet carefully before you start using 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Histaverin is and what it is used for
2. What you need to know before taking Histaverin
3. How to take Histaverin
4. Possible side effects
5. How to store Histaverin
6. Contents of the pack and other information

1. What Histaverin is and what it is used for

This medicine is presented in the form of syrup containing codeine as the active substance. Codeine belongs to a group of medicines called antitussives, which act by relieving cough.

This medicine is indicated for the symptomatic treatment of dry or non-productive cough (not accompanied by mucus and/or phlegm) in adults and adolescents over 12 years of age.

2. What you need to know before taking Histaverin

Do not take Histaverin:

• If you are allergic to codeine or any of the other ingredients of this medicine (listed in section 6).
• If you are under 12 years of age.
• If you have chronic obstructive pulmonary disease (COPD), acute asthma attacks, or respiratory depression of any degree.
• If you know that you metabolize codeine very rapidly.
• If you have diarrhea associated with pseudomembranous colitis (inflammation of the colon) caused by antibiotic medications (such as cephalosporins, lincomycins, or penicillins), or diarrhea caused by poisoning until the toxic substance has been eliminated from the gastrointestinal tract.
• If you have paralytic ileus (paralysis of intestinal movement) or are at risk of developing it.
• If you are breastfeeding (see section Pregnancy and breastfeeding).

Warnings and precautions

Take special care with Histaverin:

• If you have heart, liver, or kidney problems.
• If you have prostatic hypertrophy (enlarged prostate) or urethral stenosis (abnormal narrowing of the urethra).
• If you have adrenal insufficiency (Addison's disease).
• If you have hypothyroidism (reduced thyroid function).
• If you have multiple sclerosis (a progressive nervous system disorder).
• If you have chronic ulcerative colitis (inflammation of the large intestine).
• If you have gallbladder disorders.
• If you have conditions associated with reduced respiratory capacity.
• If you are elderly, as this medicine may reduce respiratory activity and increase the risk of urinary retention, prostate obstruction or enlargement, age-related decline in kidney function, and adverse effects.
• If you have a head injury (severe blow to the head) or increased intracranial pressure (elevated pressure inside the skull), as codeine may increase respiratory depression (slow or shallow breathing). Additionally, codeine may mask the clinical progression in patients with head trauma.
• If you have an acute abdominal condition, as codeine may interfere with diagnosis or clinical monitoring.
• If you have chronic constipation, as codeine may worsen it.
• If you take codeine repeatedly, physical dependence (addiction) and tolerance (reduced effect due to becoming accustomed to the medicine) may develop. Treatment should be discontinued gradually after prolonged use.

Codeine is converted into morphine in the liver by an enzyme. Morphine is the substance responsible for codeine's effects. Some people have a genetic variation of this enzyme that affects them differently. In some individuals, little or no morphine is produced, resulting in no cough relief. Others produce very high levels of morphine and are at greater risk of serious adverse reactions. If you experience any of the following adverse effects, stop taking this medicine immediately and seek medical help: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, malaise or feeling unwell, constipation, loss of appetite.

Adolescents over 12 years of age

The use of codeine is not recommended in adolescents with respiratory problems for the treatment of cough.

Taking Histaverin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

In particular, if you are using any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

• Narcotic analgesics (painkillers), antipsychotics (medicines that regulate brain imbalances), anxiolytics (medicines that reduce anxiety), neuromuscular blockers (medicines that reduce muscle function).
• Other opioid medicines (opium-derived) such as buprenorphine and naltrexone.
• Neuromuscular blockers (medicines that reduce muscle function).
• Monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression or Parkinson’s disease) or tricyclic antidepressants.
• Hydroxyzine (a medicine used to treat allergies).
• Certain phenothiazines (medicines used to treat nervous, mental, and emotional disorders, also used to control severe nausea and vomiting).
• Antiperistaltic antidiarrheals (medicines that reduce intestinal movement).
• Anticholinergics (medicines that reduce the effects of acetylcholine).

Taking Histaverin with food and drink

Consuming alcoholic beverages may increase the risk of reduced brain activity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

The use of Histaverin is not recommended during the first three months of pregnancy.

Codeine crosses the placental barrier between mother and child. Taking this medicine during pregnancy may be harmful to the embryo or fetus and must be monitored by your doctor, who will decide whether you can take this medicine.

Breastfeeding:

Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk.

Driving and using machines

Histaverin may cause drowsiness, affecting mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

Histaverin contains tartrazine, ethanol, methyl parahydroxybenzoate, and sucrose

This medicine may cause allergic reactions because it contains the colouring agent tartrazine (E-102). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 8.08% ethanol (alcohol), equivalent to 653 mg per 10 ml dose, which corresponds to 16.2 ml of beer or 6.7 ml of wine. This medicine is harmful for people with alcoholism.

The alcohol content should be considered in pregnant or breastfeeding women, children, and high-risk populations such as patients with liver disease or epilepsy.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 6 grams of sucrose per 10 ml dose.

Warning for athletes

This medicine contains codeine, which may result in a positive doping test.

Tolerance, dependence, and addiction

This medicine contains codeine, which is an opioid. It may cause dependence and/or addiction.

Repeated use of opioids may lead to reduced effectiveness of the medicine (becoming accustomed to it, known as tolerance). Repeated use of Histaverin may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of loss of control over the amount or frequency of medicine use.

The risk of dependence or addiction varies from person to person. Your risk may be higher if:

• You or any member of your family have abused alcohol or are dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while taking Histaverin, it could be a sign of dependence or addiction:

• You need to take the medicine for longer than recommended by your doctor.
• You need to take a higher dose than recommended.
• You may feel the need to keep taking the medicine even if it does not help relieve your cough.
• You are using the medicine for reasons other than prescribed, e.g., "to stay calm" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop or control your use of the medicine.
• You feel unwell when you stop taking the medicine, and feel better once you take it again ("withdrawal effects").

If you experience any of these symptoms, consult your doctor to determine the best course of treatment, when it is appropriate to stop the medicine, and how to do so safely.

3. How to take Histaverin

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Histaverin should be taken orally. The lowest effective dose for symptom control should be used. Treatment should last for the shortest possible duration.

The administration of the medicine depends on the occurrence of symptoms, and the dose may be reduced as symptoms subside.

Histaverin should be used for the shortest time necessary to relieve symptoms. Do not administer for more than 3 days without consulting your doctor again.

The recommended dose for different age groups is as follows:

Adults and adolescents over 12 years of age

10 – 20 mg of codeine, equivalent to 5 – 10 ml (1–2 teaspoonfuls) of syrup, up to 4 times daily. The interval between doses should be at least 6 hours.

Elderly patients

Lower doses or longer dosing intervals may be required compared to the adult population. See section Warnings and Precautions.

Use in children and adolescents

Must not be taken by children under 12 years of age.

The use of codeine is not recommended in adolescents aged 12 to 18 years who have impaired respiratory function (see section Warnings and Precautions).

If you take more Histaverin than you should

In general, symptomatic treatment will be provided, including restoration of respiratory function, and intravenous administration of appropriate doses of naloxone as an antidote.

In cases of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Histaverin

Do not take a double dose to make up for missed doses.

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 can cause adverse effects, although not everyone experiences them.

The following adverse effects may occur with an unknown frequency, i.e. the frequency cannot be estimated from the available data.

Nervous system disorders

• Dizziness and somnolence.
• Seizures.

Gastrointestinal disorders

• Constipation, nausea, and vomiting.

Skin and subcutaneous tissue disorders

• Pruritus (itching).

Immune system disorders

• Skin rashes in allergic patients.

Psychiatric disorders

• Confusion, euforia, and dysphoria (general state of discomfort).

Respiratory, thoracic and mediastinal disorders

• Respiratory depression (reduced breathing).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Histaverin

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Histaverin

• The active substance is codeine. Each ml of syrup contains 2 mg of codeine phosphate sesquihydrate (as codeine phosphate hemihydrate).
• The other components are sodium citrate (E-331), menthol, sucrose, methyl p-hydroxybenzoate (E-218), citric acid monohydrate, peppermint (containing tartrazine E-102), peppermint flavour, ethyl alcohol (ethanol), and water.

Appearance of the product and contents of the pack

The syrup is presented in a topaz-coloured PET container containing 250 ml or 100 ml of syrup, equipped with a white child-resistant closure.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Estedi, S.L.

Montseny, 41

08012 Barcelona (Spain)

Manufacturer

Laboratorio Estedi, S.L.

Leopoldo Alas, 7

08012 Barcelona (Spain)

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Laboratorio Aldo-Unión, S.L.

C/ Baronesa de Maldá, 73

08950 Esplugues de Llobregat

(Barcelona) Spain

Date of the most recent review of this leaflet: December 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)