INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FLEMSOLV (Syrup)

Western herbal medicine.
FLEMSOLV has not been evaluated by the Medicines Control Council.
FLEMSOLV is not intended to diagnose, treat, cure or prevent any disease.

SCHEDULING STATUS:
Not scheduled.

PROPRIETARY NAME
(and dosage form):

FLEMSOLV (Syrup)

COMPOSITION:
Each 1 mL of FLEMSOLV contains 7 mg
Hedera helix (English ivy) leaf extract (4 - 8:1) providing hederacoside C (standardised to a minimum of 0,7 mg), alpha-hederin and hederagenin.
Preservative: Potassium sorbate 0,134% m/v.
Inactive ingredients are anhydrous citric acid, maltodextrin, sodium carboxymethylcellulose, sorbitol 70% and water.
FLEMSOLV syrup contains 5,778 g sorbitol per 15 mL (the maximum daily dose for adults). Products containing sorbitol may have a laxative effect or cause diarrhoea.
FLEMSOLV contains sorbic acid.
FLEMSOLV is free from lactose.

PHARMACOLOGICAL CLASSIFICATION:
D 10.1 Antitussives and expectorants.

PHARMACOLOGICAL ACTION:
Pharmacodynamic properties:
Hedera helix L. extract has expectorant, antispasmodic and mucolytic actions. It soothes coughing, relaxes convulsive coughing and assists in loosening mucus, thereby enabling the body to expel viscous mucus.
Due to its secretolytic and spasmolytic effects, Hedera helix L. extract addresses the typical complaints experienced by patients with bronchitis and studies suggest it may be useful in chronic obstructive bronchitis.
Pharmacokinetic properties:
The pharmacokinetic properties of Hedera helix L. extract has not been established.

INDICATIONS:
FLEMSOLV
is indicated:
As an expectorant in cases of productive cough, to soothe coughing, relax convulsive coughing and assist in loosening mucus.
In acute catarrh (inflammation) of the respiratory tract accompanied by coughing.
In the symptomatic treatment of chronic inflammatory bronchial diseases.

CONTRAINDICATIONS:
FLEMSOLV
is contraindicated in:
Hypersensitivity to Hedera helix (English ivy), or to plants of the Araliaceae family, or to any of the inactive ingredients of FLEMSOLV.
Children under 2 years of age because of the risk of aggravation of respiratory symptoms.

WARNINGS AND SPECIAL PRECAUTIONS:
Persistent or recurrent cough in children between 2 and 4 years of age requires medical diagnosis before treatment. Use of FLEMSOLV in children between 2 and 4 years is therefore not recommended, unless medical advice has been obtained (see “DOSAGE AND DIRECTIONS FOR USE”).
As safety and efficacy have not been established in pregnancy and lactation, use of FLEMSOLV is not recommended (see “PREGNANCY AND LACTATION”).
In patients presenting with dyspnoea, fever or purulent sputum, a doctor or pharmacist should be consulted.
Caution is recommended in patients with gastritis or gastric ulcer.

Special warnings about other ingredients:
FLEMSOLV
contains sorbitol; therefore FLEMSOLV is not suitable for patients with inborn fructose intolerance.
Products containing sorbitol may have a laxative effect or cause diarrhoea.
In large quantities, sorbitol and maltodextrin may influence blood sugar levels.

Effects on the ability to drive or use machinery:
No studies on the effect on the ability to drive and use machines have been performed. It is unlikely that FLEMSOLV will affect the ability to drive or operate machines. However, advise patients to exercise care when driving or operating machinery until they know how FLEMSOLV affects them.

INTERACTIONS:
No interactions have been reported for Hedera helix, as in FLEMSOLV. However, concomitant use with antitussives such as codeine or dextromethorphan is not recommended without medical advice.

PREGNANCY AND LACTATION:
Use of FLEMSOLV is not recommended in pregnancy and lactation, as safety and efficacy have not been established (see “WARNINGS AND SPECIAL PRECAUTIONS”).

DOSAGE AND DIRECTIONS FOR USE:
DO NOT EXCEED THE RECOMMENDED DOSE.
FLEMSOLV may be taken without regard to meals.

Adult dose:
5 mL to 7,5 mL one to three times daily.
Do not exceed a total of 15 mL per day.

Children 6 to 12 years:
2,5 mL to 5 mL two to three times daily.
Do not exceed a total of 10 mL per day.

Children 2 –5 years:
2,5 mL two times daily (see “WARNINGS AND SPECIAL PRECAUTIONS”).

Children younger than 2 years:
Not recommended (see “CONTRAINDICATIONS”).

FLEMSOLV should be administered for a treatment period of at least 7 days. The duration of treatment will be determined by the severity of the symptoms presented by the patient. To ensure the patient receives the full benefit of therapy, treatment with FLEMSOLV should be maintained for 2 – 3 days after the symptoms have started to subside.
A dosing device is included.
SHAKE THE BOTTLE WELL BEFORE EACH USE.

SIDE-EFFECTS:
Immune system disorders:
Less frequent: Allergic reactions including urticaria, skin rash, couperoses, and dyspnoea.
Gastrointestinal disorders:
Frequent: Gastrointestinal reactions including nausea, vomiting, and diarrhoea.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdose may cause nausea, vomiting, diarrhoea and agitation. In the event of overdose, symptomatic and supportive treatment is suggested.

IDENTIFICATION:
Light brown, slightly opaque syrup, with a sweet herbal taste.

PRESENTATION:
100 mL or 200 mL polyethylene amber bottle, with a white plastic child-lock screw cap, packed in an outer carton. Dosing device included.

STORAGE INSTRUCTIONS:
Store in a cool, dry place at or below 25°C.
Keep the bottle tightly closed. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Building 9, Parc du Cap
Mispel Street
Bellville 7530
RSA

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 2014

© CIPLA MEDPRO (Pty) Ltd 2014

CM383A/SA Pro-Print

New addition to this site: November 2016
Source: http://www.cipla.co.za/wp-content/uploads/2014/05/Flemsolv-Syrup-PI.pdf

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