Prospan Sugar-Free Productive Cough Syrup 100 ml

Product Title

Prospan Sugar-Free Productive Cough Syrup 100ml (Ivy Leaf Extract) – Grimberg

Brand

Laboratoires Grimberg

Barcode (EAN)

3400934212741

Product Type

OTC Medicine / Expectorant Syrup

Short Description (for Shopify)

Sugar-free expectorant syrup made with ivy leaf extract to help loosen mucus and support relief from productive (wet) cough. For adults, adolescents, and children from age 2. Cherry flavor. Includes a measuring cup.

Description (Full)

Prospan Sugar-Free Syrup (Laboratoires Grimberg) is an herbal medicinal syrup based on an ivy leaf (Hedera helix L.) hydroalcoholic extract. It is traditionally used as an expectorant to help relieve productive (wet) cough in adults, adolescents, and children over 2 years old.

Key Benefits

• Helps loosen mucus and support easier expectoration

• For wet/productive cough

• Sugar-free formula (contains sorbitol)

• Suitable for age 2+

• Cherry flavor

• Includes graduated measuring cup

Active Ingredient

• Ivy leaf (Hedera helix L.) dry extract: 0.700 g per 100 ml of syrup

  • Drug/extract ratio: 5–7.5 : 1

  • Extraction solvent: ethanol 30% (m/m)

Other Ingredients

Purified water, sorbitol (E420) 70% (crystallizable), cherry flavor, xanthan gum, potassium sorbate, anhydrous citric acid.
Cherry flavor components: vanillin, benzaldehyde, lemon essential oil, cacao distillate, cherry brandy, raspberry distillate.

Notable Excipients

• Ethanol

• Sorbitol (may have a mild laxative effect)

Directions (Dosage)

Shake well before use. Use the provided measuring cup.

Avoid taking at the end of the day to reduce nighttime coughing.

• Adults & adolescents (12+ years): 5 ml, 3 times daily

• Children 6–11 years: 5 ml, 2 times daily

• Children 2–5 years: 2.5 ml, 2 times daily

• Under 2 years: Do not use (contraindicated)

Treatment Duration

Recommended use: about 1 week.
If symptoms do not improve after 1 week or worsen, consult a healthcare professional.

Warnings & Contraindications

Do not use if:

• Child is under 2 years (risk of worsening respiratory symptoms)

• Allergy to ivy or any ingredient, or to plants in the Araliaceae family

• Hereditary fructose intolerance or intolerance to certain sugars (contains sorbitol — approx. 1925 mg per 5 ml)

Ask a doctor before use if you have:

• Shortness of breath, fever, purulent mucus

• Gastritis or gastric ulcer

• Sugar intolerance / hereditary fructose intolerance

• You are taking opioid antitussives (e.g., codeine, dextromethorphan)

Pregnancy & Breastfeeding

Not recommended / not authorized during pregnancy or breastfeeding due to lack of data.

Possible Side Effects

At recommended doses:

• Allergic reactions (hives, rash, breathing difficulty, swelling/angioedema)

• Gastrointestinal effects (nausea, vomiting, diarrhea); sorbitol may cause mild laxative effect

Overdose may cause nausea, vomiting, diarrhea, and/or agitation.

Package Contents

100 ml bottle + graduated measuring cup

Shopify Specs (Quick Copy)

• Size: 100 ml

• Age: 2+ years

• Cough Type: Productive / Wet cough

• Form: Syrup

• Flavor: Cherry

• Sugar-Free: Yes (contains sorbitol)

• EAN: 3400934212741

• Brand: Laboratoires Grimberg

• Please read the following full disclosure before purchasing or using this product.
  
  

  RÉSUMÉ DES CARACTÉRISTIQUES DU PRODUIT

  ANSM – Last updated: 25/03/2024

  1. NAME OF THE MEDICINAL PRODUCT

  PROSPAN SUGAR-FREE, syrup sweetened with sorbitol

  2. QUALITATIVE AND QUANTITATIVE COMPOSITION

  Climbing ivy (Hedera helix L.) (dry extract of leaf).......................................................... 0.700 g

  Extraction solvent: ethanol 30% (m/m)

  Drug/extract ratio: 5–7.5 : 1

  Per 100 ml of syrup

  Excipients with known effect: sorbitol (E420), ethanol

  For the full list of excipients, see section 6.1.

  3. PHARMACEUTICAL FORM

  Syrup.

  4. CLINICAL PARTICULARS

  4.1. Therapeutic indications

  Herbal medicinal product used as an expectorant in cases of productive cough.

  This medicinal product is indicated for adults, adolescents, and children over 2 years of age.

  4.2. Posology and method of administration

  Posology

  Adults and adolescents over 12 years of age

  5 ml 3 times daily.

  Children 6 to 11 years of age

  5 ml 2 times daily.

  Children 2 to 5 years of age

  2.5 ml 2 times daily.

  Paediatric population

  PROSPAN SUGAR-FREE is contraindicated in children under 2 years of age (see section 4.3).

  Method of administration

  Oral use. PROSPAN SUGAR-FREE should be used with the graduated dosing cup.

  Duration of treatment

  One week.

  If symptoms persist after one week of treatment, a doctor or pharmacist should be consulted.

  4.3. Contraindications

  Hypersensitivity to the active substance or to plants of the Araliaceae family or to any of the excipients listed in section 6.1.

  Children under 2 years of age due to the risk of worsening respiratory symptoms.

  4.4. Special warnings and precautions for use

  In cases of dyspnoea, fever, or purulent expectoration, a doctor or pharmacist should be consulted.

  Concomitant use with opioid antitussives such as codeine or dextromethorphan is not recommended without medical advice.

  Great caution is recommended in patients suffering from gastritis or gastric ulcer.

  This medicinal product contains 1925 mg of sorbitol per 5 ml dose. Patients with hereditary fructose intolerance (HFI) must not take this medicinal product.

  This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

  Paediatric population

  Persistent or recurrent cough in children aged 2 to 4 years requires a medical diagnosis before starting treatment.

  4.5. Interaction with other medicinal products and other forms of interaction

  Not reported.

  4.6. Fertility, pregnancy and lactation

  Pregnancy and breastfeeding

  Safety during pregnancy and breastfeeding has not been established.

  In the absence of sufficient data, use during pregnancy and breastfeeding is not recommended.

  Fertility

  No data are available regarding effects on fertility.

  4.7. Effects on ability to drive and use machines

  Effects on the ability to drive and use machines have not been studied.

  4.8. Undesirable effects

  Frequency not known (cannot be estimated from the available data):

  • Gastrointestinal disorders: nausea, vomiting, or diarrhoea have been observed.

  • Immune system disorders: allergic reactions (urticaria, skin rash, dyspnoea, angioedema/Quincke’s oedema) have been observed.

  Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

  Reporting of suspected adverse reactions

  Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres – Website: https://signalement.social-sante.gouv.fr.

  4.9. Overdose

  Overdose may cause nausea, vomiting, diarrhoea, and agitation.

  A case has been reported of a 4-year-old child who developed aggressiveness and diarrhoea after accidental ingestion of a climbing ivy extract corresponding to 1.8 g of plant material.

  5. PHARMACOLOGICAL PROPERTIES

  5.1. Pharmacodynamic properties

  Pharmacotherapeutic group: expectorants, ATC code: R05CA12.

  The mechanism of action is not known.

  5.2. Pharmacokinetic properties

  No data available.

  5.3. Preclinical safety data

  α-hederin, β- and δ-hederin isolated from climbing ivy leaves showed no mutagenic potential in the Ames test using Salmonella typhimurium strain TA 98, with or without S9 activation.

  Acute toxicity tests performed in various animal species with a dry climbing ivy leaf extract showed no symptoms of toxicity with oral doses up to 3 g/kg or subcutaneous doses up to 0.5 g/kg.

  In chronic toxicity studies, the dry climbing ivy leaf extract was administered orally to Wistar rats at an average dose of 30–750 mg/kg for 3 months. The results showed that the administered doses were well tolerated and that no organ damage or other pathological changes were detected in the animals. The only difference observed compared with the control group was a reversible increase in haematocrit and, only at higher doses, a decrease in ICSH secretion.

  No carcinogenicity or reproductive toxicity data are available.

  6. PHARMACEUTICAL PARTICULARS

  6.1. List of excipients

  Purified water, sorbitol (E420) 70% (cristallisable), cherry flavour*, xanthan gum, potassium sorbate, anhydrous citric acid.

  *Cherry flavour composition: vanillin, benzaldehyde, lemon essential oil, cacao distillate, cherry brandy, raspberry distillate.

  6.2. Incompatibilities

  Not applicable.

  6.3. Shelf life

  3 years.

  6.4. Special precautions for storage

  Store at a temperature not exceeding 25°C and protect from moisture.

  6.5. Nature and contents of container

  Brown glass bottle of 100 ml or 200 ml, transparent polyethylene pourer, cap with tamper-evident ring in white polypropylene.

  Brown glass bottle of 150 ml, transparent polyethylene pourer, polypropylene cap.

  Graduated dosing cup 2.5; 5.0; 7.5 ml in polypropylene.

  Not all pack sizes may be marketed.

  6.6. Special precautions for disposal and handling

  No special requirements.

  7. MARKETING AUTHORISATION HOLDER

  ENGELHARD ARZNEIMITTEL GmbH & Co. KG,
  HERZBERGSTRASSE 3
  D-61138 NIEDERDORFELDEN
  Germany

  8. MARKETING AUTHORISATION NUMBER(S)

  · 34009 342 127 4 1: 100 ml bottle.
  · 34009 350 869 6 9: 150 ml bottle.
  · 34009 359 735 2 8: 200 ml bottle.

  9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

  [to be completed later by the marketing authorisation holder]

  10. DATE OF REVISION OF THE TEXT

  [to be completed later by the marketing authorisation holder]

  11. DOSIMETRY

  Not applicable.

  12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

  Not applicable.

  CONDITIONS OF PRESCRIPTION AND SUPPLY

  Medicinal product not subject to medical prescription.