Biseltoc (Pentoxiverine Citrate)

What Is Biseltoc and What Is It Used For?

Biseltoc is a prescription cough suppressant containing pentoxiverine citrate, indicated for the treatment of symptoms of dry cough (non-productive cough) in adults and children over 6 years of age. It works by reducing overstimulation of the cough centre in the brain and normalizing the cough reflex.

Biseltoc belongs to a class of medicines known as antitussives, or cough suppressants. The active substance, pentoxiverine citrate, acts centrally on the cough reflex centre located in the medulla oblongata of the brain. Unlike opioid-based cough suppressants such as codeine, pentoxiverine does not bind to opioid receptors and therefore carries no risk of opioid-related dependence. It reduces the overstimulation of the cough centre that causes repeated, uncontrolled coughing episodes, thereby normalizing the cough reflex without completely abolishing it.

The medicine is specifically designed for dry, non-productive cough – the type of cough that does not bring up mucus or phlegm. Dry cough is commonly caused by viral upper respiratory tract infections, post-nasal drip, irritation from environmental factors, or as a residual symptom after acute bronchitis. It is important to distinguish between dry cough and productive cough (which produces mucus), as suppressing a productive cough can be counterproductive and potentially harmful, since the body needs to clear mucus from the airways.

In addition to its central antitussive activity, pentoxiverine has mild local anaesthetic properties and weak bronchospasmolytic effects, meaning it can provide some relief from throat irritation and help relax the smooth muscles of the airways. These additional properties make it particularly useful for managing the irritating, tickling sensation that often accompanies dry cough.

Biseltoc is available as an oral solution at a concentration of 2.13 mg/ml (equivalent to 1.35 mg pentoxiverine per ml). The solution has a pear flavour, making it more palatable for both adults and children. It is supplied in amber glass bottles of 95 ml or 190 ml with a child-resistant closure and a graduated measuring cup with markings at 5 ml, 7.5 ml, and 15 ml.

Approved uses in different countries

Biseltoc and its equivalent formulations are approved for use across the European Economic Area (EEA) under various brand names. In Finland and Sweden, it is marketed as Biseltoc. In Belgium and Luxembourg, it is sold as Pentoxyverine Sanofi. In Italy, the product is known as Bisolsec, while in Spain it is marketed as Bisolvon Calmatos. In Austria, the equivalent product is called Mucomat Hustenstiller. Regardless of the brand name, all formulations contain the same active substance – pentoxiverine citrate at 2.13 mg/ml – and share the same indications, dosing recommendations, and safety profile.

The marketing authorisation holder is Opella Healthcare France SAS (part of the Sanofi group), with manufacturing carried out by NextPharma SAS in Limay, France. Local distribution in the Nordic countries is managed by STADA Nordic ApS based in Denmark.

What Should You Know Before Taking Biseltoc?

Before taking Biseltoc, you should be aware of several important contraindications and precautions. This medicine must not be used in children under 6 years, during pregnancy or breastfeeding, or in patients with respiratory difficulties or central nervous system (CNS) depression. Always inform your doctor or pharmacist about your medical history and other medicines you are taking.

Contraindications

Biseltoc must not be used in the following situations. If any of these apply to you, do not take this medicine and consult your doctor for an alternative treatment:

• Allergy to pentoxiverine or any of the other ingredients in the medicine (listed in the composition section below)
• Respiratory difficulties – if you have any condition that causes difficulty breathing, including severe asthma, chronic obstructive pulmonary disease (COPD) with respiratory failure, or any form of respiratory depression
• CNS depression – if you have symptoms of reduced central nervous system activity such as excessive drowsiness, muscle weakness, reduced consciousness, or decreased sensitivity to touch
• Pregnancy and breastfeeding – due to the potential for harmful effects on the baby, including respiratory difficulties, seizures, and CNS depression
• Children under 6 years of age – safety and efficacy have not been established in this age group, and the risk of serious adverse effects, including seizures and respiratory depression, is higher in young children

Warnings and Precautions

Talk to your doctor or pharmacist before taking Biseltoc if you have any of the following conditions. In some cases, your doctor may decide that an alternative treatment is more appropriate, or may want to monitor you more closely during treatment:

• Impaired liver function – Biseltoc is not recommended for use in patients with liver disease. Do not take this medicine unless your doctor has confirmed it is safe for you to use
• Impaired kidney function – if you have reduced kidney function, your doctor may need to adjust your dose or monitor you more carefully
• Chronic cough – if your cough is long-standing (for example, due to asthma, reduced lung capacity, or smoking) or if it produces a large amount of mucus, Biseltoc may not be appropriate
• Glaucoma (increased pressure in the eye) – pentoxiverine may have anticholinergic-like effects that could worsen this condition
• Enlarged prostate (benign prostatic hyperplasia) or difficulty emptying the bladder – the medicine may worsen urinary retention
• Bowel obstruction or peptic ulcer – use with caution in patients with gastrointestinal conditions
• High blood pressure or irregular heart rhythm – pentoxiverine should be used with caution in patients with cardiovascular conditions
• Myasthenia gravis – a neuromuscular disorder that causes muscle weakness; pentoxiverine may exacerbate symptoms

Children with a known predisposition to seizures (convulsions) should be monitored closely throughout the treatment period. The risk of seizures is a rare but serious potential side effect, particularly in younger patients.

Pregnancy and Breastfeeding

Biseltoc must not be taken during pregnancy or while breastfeeding. Pentoxiverine may cause potentially harmful effects on the infant, including respiratory difficulties, seizures, and symptoms of central nervous system depression. If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine. Your doctor can recommend alternative treatments for dry cough that have an established safety profile in pregnancy.

It is not known whether pentoxiverine passes into breast milk. Given the potential risks to the nursing infant, breastfeeding mothers should not use Biseltoc. If treatment is necessary, your doctor may advise you to temporarily discontinue breastfeeding or to use a different medicine.

Driving and operating machinery

Biseltoc may sometimes cause tiredness and drowsiness, even when taken at the recommended dose. If you experience these effects, you should not drive or operate heavy machinery until the symptoms resolve. You are personally responsible for assessing whether you are fit to perform activities that require alertness. The concurrent use of alcohol or other CNS depressants can intensify any drowsiness caused by Biseltoc, further impairing your ability to drive safely.

How Does Biseltoc Interact with Other Drugs?

Biseltoc can increase the effects of substances that depress the central nervous system, including sleeping pills, sedative medications, antihistamines, and alcohol. Always inform your doctor or pharmacist about all medicines you are taking, including over-the-counter and herbal products.

Drug interactions occur when one medicine affects the way another medicine works, either increasing or decreasing its effectiveness, or increasing the risk of side effects. While pentoxiverine has a relatively limited interaction profile compared to opioid-based antitussives, there are several important interactions to be aware of.

The most clinically significant interaction involves other substances that depress the central nervous system (CNS). Pentoxiverine can potentiate (strengthen) the effects of these agents, leading to increased drowsiness, sedation, reduced alertness, and in severe cases, respiratory depression. Patients taking any CNS depressant should discuss the use of Biseltoc with their doctor before starting treatment.

Food and alcohol interactions

Biseltoc can be taken with or without food. However, alcohol consumption should be avoided during the treatment period. Alcohol is a CNS depressant, and its effects are enhanced by pentoxiverine, which can result in excessive drowsiness, impaired judgement, slowed reaction times, and reduced coordination. Even moderate amounts of alcohol can significantly increase the sedative effects of this medicine.

Herbal and supplement interactions

Certain herbal remedies and dietary supplements may interact with Biseltoc. In particular, herbal preparations with sedative properties – such as valerian root, passionflower, kava, and chamomile – may increase the risk of excessive drowsiness when combined with pentoxiverine. St John’s wort (Hypericum perforatum), a commonly used herbal antidepressant, may affect the metabolism of various medicines, and its concomitant use with Biseltoc should be discussed with a healthcare professional.

What Is the Correct Dosage of Biseltoc?

The recommended dosage of Biseltoc depends on age and body weight. Adults and adolescents over 15 years (weighing more than 60 kg) take 15 ml 3 to 4 times daily. Children aged 6–15 years are dosed according to their weight: 5 ml, 7.5 ml, or 15 ml, 3 to 4 times daily. Always use the included measuring cup for accurate dosing.

Always take Biseltoc exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure about the correct dose, consult your doctor or pharmacist. The dosage is based on age and body weight as detailed in the table below.

Adults

The standard adult dose is 15 ml of Biseltoc oral solution taken 3 to 4 times daily. Each 15 ml dose delivers approximately 31.95 mg of pentoxiverine citrate (equivalent to approximately 20.25 mg of pentoxiverine base). Use the graduated measuring cup provided with the medicine to measure each dose accurately. The doses should be evenly spaced throughout the day.

If your dry cough is also causing a sore throat, it is recommended to gargle with the solution briefly before swallowing each dose. This allows the mild local anaesthetic properties of pentoxiverine to provide additional relief to the irritated throat tissue. If the cough is particularly troublesome at night and disrupts sleep, the last dose of the day should be taken just before bedtime.

Children (6–15 years)

The dosage for children is determined by body weight rather than age alone, to ensure safe and effective dosing. Children weighing between 20 and 26 kg should take 5 ml three to four times daily. Those weighing between 27 and 45 kg should take 7.5 ml three to four times daily. Older children weighing between 46 and 60 kg take the adult dose of 15 ml three to four times daily. Biseltoc must not be given to children under 6 years of age.

Biseltoc is not recommended for children whose cough produces significant amounts of mucus, as suppressing the cough reflex in these cases may lead to mucus accumulation in the airways. Children with a known risk of seizures should be carefully monitored during the entire treatment period.

Elderly patients

No specific dose adjustment is generally required for elderly patients. However, older adults may be more sensitive to the sedative effects of pentoxiverine and to the potential anticholinergic-like effects of the medicine. Elderly patients with impaired liver or kidney function should consult their doctor before using Biseltoc. The lowest effective dose should be used, and patients should be monitored for signs of excessive sedation, urinary retention, or constipation.

Missed Dose

If you forget to take a dose of Biseltoc, simply skip the missed dose and take your next dose at the usual time. Do not take a double dose to compensate for the one you missed. Taking more than the recommended amount increases the risk of side effects without providing additional therapeutic benefit.

Overdose

If you or someone else has taken too much Biseltoc, or if a child has accidentally ingested the medicine, contact your local emergency services or poison control centre immediately for assessment and advice. Symptoms of overdose may include severe drowsiness, respiratory depression, seizures (particularly in children), and loss of consciousness. Prompt medical attention is essential, as respiratory depression can be life-threatening if left untreated.

What Are the Side Effects of Biseltoc?

Like all medicines, Biseltoc can cause side effects, although not everyone experiences them. The most common side effects are gastrointestinal symptoms such as upper abdominal pain, diarrhoea, dry mouth, nausea, and vomiting. Uncommon effects include drowsiness and fatigue. Very rare but serious side effects include seizures, respiratory depression, and anaphylactic shock.

Side effects are classified according to how frequently they occur. Understanding these frequency categories helps you assess the likelihood of experiencing any particular side effect. The categories used are based on international conventions: very common (more than 1 in 10 people), common (up to 1 in 10), uncommon (up to 1 in 100), rare (up to 1 in 1,000), very rare (up to 1 in 10,000), and not known (cannot be estimated from available data).

Most side effects of Biseltoc are mild to moderate and resolve on their own without the need for medical intervention. However, some side effects can be serious and require immediate medical attention. It is important to be aware of both common and rare side effects so that you can recognise them early and seek appropriate help if needed.

Gastrointestinal side effects

The most frequently reported side effects of Biseltoc involve the gastrointestinal system. Upper abdominal pain, nausea, and vomiting are the most common complaints, reported by up to 1 in 10 users. These symptoms are usually mild and tend to improve as your body adjusts to the medicine. Taking Biseltoc with food may help reduce gastrointestinal discomfort. Diarrhoea may also occur, partly due to the sorbitol content of the oral solution, which can have a mild laxative effect in some individuals.

Neurological side effects

Drowsiness and fatigue are uncommon side effects that affect up to 1 in 100 users. These effects are related to the central action of pentoxiverine on the brain and are more likely to occur at higher doses or when the medicine is taken together with other CNS depressants. Very rarely, more serious neurological effects have been reported, including seizures (particularly in young children) and, in cases where the frequency is not known, restlessness, hallucinations, and confusion. If you experience any of these symptoms, stop taking Biseltoc and contact your doctor immediately.

Respiratory side effects

As a centrally acting cough suppressant, pentoxiverine has the potential to affect the respiratory centre in the brain. Very rarely, serious respiratory side effects have been reported, including respiratory depression, laboured breathing, and respiratory arrest. These effects are most likely to occur in overdose situations or in very young children, which is why the medicine is contraindicated in children under 6 years. Patients with pre-existing respiratory conditions should use Biseltoc only under close medical supervision.

Reporting side effects

Reporting suspected side effects after a medicine has been approved is important, as it enables continuous monitoring of the medicine’s benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national medicines regulatory authority. In the United Kingdom, reports can be made to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card scheme. In the European Union, reports should be made to the relevant national competent authority.

How Should You Store Biseltoc?

Store Biseltoc out of the sight and reach of children. No special storage conditions are required. After first opening, use within 6 months. Do not use the medicine after the expiry date printed on the label and carton.

Proper storage of medicines is essential to ensure they remain effective and safe to use throughout their shelf life. Biseltoc does not require any special storage conditions – it can be stored at normal room temperature. There is no need to refrigerate the solution.

Once you have opened the bottle for the first time, the oral solution should be used within 6 months. After this period, any remaining solution should be discarded, even if the bottle is not empty. Write the date of opening on the bottle label as a reminder. Do not use Biseltoc after the expiry date printed on the label and carton (abbreviated as “EXP”). The expiry date refers to the last day of the stated month.

Always keep the bottle tightly closed with the child-resistant cap when not in use. This prevents accidental ingestion by children and protects the solution from contamination. Do not dispose of medicines via the drain or with household waste. Return unused or expired medicines to your local pharmacy for safe disposal. This helps protect the environment.

What Does Biseltoc Contain?

Each millilitre of Biseltoc oral solution contains 2.13 mg of pentoxiverine citrate (equivalent to 1.35 mg of pentoxiverine). The solution also contains excipients including sorbitol, glycerol, propylene glycol, benzoic acid, benzyl alcohol, saccharin sodium, and pear and ginger flavourings.

Active ingredient

The active substance in Biseltoc is pentoxiverine citrate. Each 1 ml of oral solution contains 2.13 mg of pentoxiverine citrate, which is equivalent to 1.35 mg of the free base pentoxiverine. Pentoxiverine (also known as carbetapentane in some markets) is a centrally acting antitussive agent that has been used clinically since the mid-20th century for the management of non-productive cough.

Excipients (inactive ingredients)

The following excipients are present in Biseltoc oral solution:

• Benzoic acid – preservative (0.75 mg/ml)
• Liquid sorbitol (non-crystallising) (E420) – sweetener and vehicle (300 mg/ml)
• Glycerol – humectant and viscosity agent
• Propylene glycol – co-solvent (100 mg/ml)
• Citric acid monohydrate – pH adjuster
• Sodium citrate dihydrate – buffer
• Saccharin sodium – artificial sweetener
• Pear flavouring – for palatability
• Ginger flavouring (contains flavouring substances, benzyl alcohol [E1519], and alpha-tocopherol [E307])
• Purified water – vehicle

Appearance and packaging

Biseltoc oral solution is a clear to almost clear, colourless to almost colourless liquid with a characteristic pear-ginger flavour. It is supplied in amber glass bottles containing either 95 ml or 190 ml of solution. Each bottle is fitted with a child-resistant, safety-sealed screw cap (opened by pressing down and turning anti-clockwise simultaneously). A graduated polypropylene measuring cup is included, with markings at 5 ml, 7.5 ml, and 15 ml for accurate dose measurement.

Frequently Asked Questions About Biseltoc