It is for relief of allergic rhinitis caused by hay fever and other allergies and relief persistent dry irritant
coughs.

For oral administration.
Adults:
Two 5ml spoonfuls three times daily.
Children:
6 – 12 years: 5ml three times daily.
Not more than 3 doses should be given in any 24 hours.

Contra-indicated in patients with a known hypersensitivity to pseudoephedrine hydrochloride or chlorphenamine maleate or Dextromethorphan Hydrobromide or any of the other ingredients. Contra-indicated in epileptics because of the antihistamine content and in patients currently taking or within 2 weeks of stopping monoamine oxidase inhibitors. Contra-indicated in hypertension or in patients receiving antihypertensive therapy. Taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or Parkinson's disease, or for 2 weeks after stopping the medication. If you are not sure if your prescription medication contains one of these medicines, ask a doctor or pharmacist before taking this product. (See section 4.5). Not recommended for children under 6 years.

Asthmatics should consult a medical practitioner before using this product.
Caution should be exercised in patients with renal impairment, urinary retention, diabetes, hyperthyroidism, glaucoma,
hepatic impairment or cardiovascular disease and those taking other sympathomimetic agents, such as decongestants,
amphetamine-like psychostimulants and appetite suppressants.
The effects of single dose of Galpseud Plus on the blood pressure of these patients should be observed before
recommending repeated or unsupervised treatment. As with other sympathomimetic agents, caution should be
exercised in patients with prostatic enlargement or bladder dysfunction.
In severe hepatic or renal dysfunction, a single dose of Galpseud Plus should be given, and the patient's response used
as a guide to the dosage requirement for further administration.
Patients suffering from chronic cough as occurs with smoking, asthma or patients suffering from an acute
asthma attack, or where cough is accompanied by excessive secretions should be advised to consult a
Healthcare Professional before use.
Causes of chronic cough should be excluded if symptoms are persistent. Any accompanying symptoms should
be actively sought and appropriately investigated/ treated. Stop use and ask your healthcare professional if your
cough lasts more than 7 days, comes back or is accompanied by a fever, rash or persistent headache. These
could be signs of serious conditions
Drug dependence, tolerance and potential for abuse
For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic
doses. The risks are increased in individuals with current or past history of substance misuse disorder (including
alcohol misuse) or mental health disorder (e.g., major depression). Caution is particularly recommended for
adolescents and young adults as well as in patients with a history of drug abuse or psychoactive substances.
Drug withdrawal syndrome
The drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation,
rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also
develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal
cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically
determined. About 10% of the general population are poor metabolisers of CYP2D6. Poor metabolisers and
patients with concomitant use of CYP2D6 inhibitors may experience exaggerated and/or prolonged effects of
dextromethorphan. Caution should therefore be exercised in patients who are slow metabolizers of CYP2D6 or
use CYP2D6 inhibitors (see also section 4.5).
If symptoms persist consult your doctor.
Do not exceed the stated dose.
Do not take with other cough and cold medicines.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
Serotonin Syndrome
Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective
serotonin re-uptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine
oxidase inhibitors (MAOIs)) and CYP2D6 inhibitors.
Serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities,
and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Robitussin Dry Cough
should be discontinued.
Severe Skin reactions
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrinecontaining
products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and
numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on
the skin folds, trunk, and upper extremities. Patients should be carefully monitored. If signs and symptoms such as
pyrexia, erythema, or many small pustules are observed, administration of this product should be discontinued and
appropriate measures taken if needed.
Ischaemic colitis
Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued
and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
Ischaemic optic neuropathy
Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be
discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

The antibacterial agent furazolidone is known to cause progressive inhibition of monoamine oxidase and
although there are no reports of a hypertentive crisis having occurred, it should not be administered
concurrently with FLUMED
There may be an increased risk of arrythmias if pseudoephedrine is given to patients receiving cardiac
glycosides or tricyclic antidepressants. Pseudoephedrine may reduce the hypotensive effect of antihypertensives
with sympathomimetic activity. Concurrent use of pseudoephedrine with monoamine oxidase inhibitors may
cause a hypertensive crisis. Chlorphenamine may enhance the sedative effects of CNS depressants, including
alcohol, barbiturates, hypnotics, anxiolytics, sedatives and anti-psychotics. As chlorphenamine possesses
anticholinergic activity the effects of some anticholinergics may be potentiated.
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI), a selective serotonin
reuptake inhibitor (SSRI), or other medications for depression, psychiatric, or emotional conditions, or
Parkinson's disease, or for 2 weeks after stopping the medication. If you are not sure if your prescription
medication contains one of these drugs, ask a doctor or pharmacist before taking this product.
CYP2D6 inhibitors
Dextromethorphan is metabolized by CYP2D6 and has an extensive first-pass metabolism. Concomitant use of
potent CYP2D6 enzyme inhibitors can increase the dextromethorphan concentrations in the body to levels
multifold higher than normal. This increases the patient's risk for toxic effects of dextromethorphan (agitation,
confusion, tremor, insomnia, diarrhoea and respiratory depression) and development of serotonin syndrome.
Potent CYP2D6 enzyme inhibitors include fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use
with quinidine, plasma concentrations of dextromethorphan have increased up to 20-fold, which has increased the CNS adverse effects of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion,
methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism
of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient
should be monitored and the dextromethorphan dose may need to be reduced.

Not to be used during pregnancy and lactation without prior consultant with a medical practitioner.
Pseudoephedrine is excreted in breast milk in small amounts.

May cause drowsiness, if affected do not drive or operate machinery. The drowsiness may be potentiated by
alcohol or other central sedatives.

Pseudoephedrine may cause anxiety, tremor, cardiac arrhythmias, palpitations, tachycardia, hypertension,
nausea, vomiting, headache and may occasionally cause insomnia and urinary retention in men. Rarely sleep
disturbance and hallucinations have been reported.
There have been rare cases of psychosis following misuse of pseudoephedrine.
Chlorphenamine may cause drowsiness, nausea, vomiting, headaches, blurred vision, anorexia and dryness of
the mouth.
The administration of antihistamines has also been associated with rash, angioedema, convulsions, parasthesias,
dizziness and constipation.
Eye disorders
Frequency unknown: Ischaemic optic neuropathy
Skin and subcutaneous tissue disorders
Frequency unknown: Severe skin reactions, including acute generalized exanthematous pustulosis (AGEP)
Gastrointestinal disorders
Frequency unknown: Ischaemic colitis
Adverse effects are rare, however the following side effects may be associated with dextromethorphan
hydrobromide:
Gastrointestinal Disorders
Rare: Gastrointestinal upset
Nervous System Disorders
Rare: Dizziness, drowsiness, mental confusion
Immune System Disorders
Hypersensitivity
Psychiatric disorders:
Frequency unknown: Drug dependence (see section 4.4)
General disorders and administration site conditions:
Frequency unknown: drug withdrawal syndrome
Reporting of suspected adverse reactions
The National Pharmacovigilance Centre (NPC):
Fax: +966-11-205-7662
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa

Symptoms of overdose may include restlessness, drowsiness, tetany, hallucinations, excitement, ataxia,
convulsions, fever, nausea, vomiting, difficulty in micturition, flushing, palpitations, tachycardia, cardiac
arrhythmias and respiratory difficulties. Overdose should be treated by general symptomatic and supportive
means. In the event of gross overdose the stomach may be emptied by airways protective gastric lavage. If
consciousness is impaired or if respiration or circulatory difficulties are evident, appropriate supportive
measures should be taken to maintain a patient's airway and to stabilise cardiovascular function. Convulsions
should be controlled by immediate appropriate measures.
Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion,
somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation),
ataxia, toxic psychosis with visual hallucinations, hyperexcitability.
In the event of massive overdose the following symptoms may be observed: coma, respiratory depression,
convulsions.
Management:
-Activated charcoal can be administered to asymptomatic patients who have ingested overdoses of
dextromethorphan within the preceding hour.
-For patients who have ingested dextromethorphan and are sedated or comatose, naloxone, in the usual doses
for treatment of opioid overdose, can be considered. Benzodiazepines for seizures and benzodiazepines and
external cooling measures for hyperthermia from serotonin syndrome can be used.

Pseudoephedrine has direct and indirect sympathomimetic activity and is an orally effective upper respiratory
tract decongestant.
Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation in
systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.
Chlorphenamine is one of the most potent anti-histamines. It is useful in the control of symptoms which are
allergic in origin. It helps to provide relief from nasal stuffiness and watering of the eyes.
Dextromethorphan hydrobromide is a cough suppressant which has a central action on the cough centre in the
medulla. It has no analgesic properties and little sedative activity.
Pharmacotherapeutic group: Cough suppressant

Pseudoephedrine hydrochloride is readily and completely absorbed from the gastro-intestinal tract. It is resistant
to metabolism by monoamine oxidase and is largely excreted unchanged in the urine.
Chlorphenamine maleate is readily absorbed from the gastro-intestinal tract. It is extensively metabolised in the
liver and excreted in the urine.
Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract.
Dextromethorphan undergoes rapid and extensive first-pass metabolism in the liver after oral administration.
Genetically controlled O-demethylation (CYD2D6) is the main determinant of dextromethorphan
pharmacokinetics in human volunteers.
It appears that there are distinct phenotypes for this oxidation process resulting in highly variable
pharmacokinetics between subjects. Unmetabolised dextromethorphan, together with the three demethylated
morphinan metabolites dextrorphan (also known as 3-hydroxy-N-methylmorphinan), 3- hydroxymorphinan and
3-methoxymorphinan have been identified as conjugated products in the urine.
Dextrorphan, which also has antitussive action, is the main metabolite. In some individuals metabolism
proceeds more slowly and unchanged dextromethorphan predominates in the blood and urine.

None stated

Glycerol,
Sorbitol solution,
sodium methyl hydroxybenzoate,
sodium benzoate , orange flavour
and purified water.

None stated

3 year

- Store below 30°C.
- Store the product in the original pack (bottle in a carton) to protect from light.

Clear, Colorless syrup with orange odor free from particles.
Pack: 100 ml Amber glass bottle with child resistant cap.

None stated.