Tripofed Syrup contains an antihistamine (Triprolidine) & decongestant (pseudoephedrine) which effectively relieve symptoms of:

·         Seasonal Allergic Rhinitis (Hay Fever).

·         Vasomotor Rhinitis (Perennial Rhinitis).

Nasal congestion associated with common cold.

The usual dose is as follows, to be taken orally:

 Children 6-12 years old: One teaspoonful (5 ml), three times daily.

Adults and children over 12 years: Two teaspoonfuls (10 ml), three times daily.

Do not exceed the stated dose.

• It should not be given for children lesser than 6 years old because there is no evidence that it works and can cause side effects, such as allergic reactions, effects on sleep or hallucinations. • Hypersensitivity to any component of Tripofed preparations. • It should not be given to patients who are taking or have taken treatment with monoamine oxidase inhibitors within the preceding two weeks. • Patients with severe hypertension or severe heart diseases. • Tripofed should not be used for persistent or chronic cough, such as occurs with asthma or where cough is accompanied by excessive secretions, unless directed by a physician.

Tripofed syrup should be use with caution in the following cases: ·         For children from 6-12 years. ·         Patients with hypertension, heart diseases, liver and kidney diseases, prostatic hypertrophy, urinary retention, diabetes, hyperthyroidism & glaucoma. ·         Do not exceed the stated dose.

Not more than 4 doses should be given in any 24 hours.

·         Concomitant use of Tripofed with sympathomimetic agents such as decongestants, appetite suppressants and amphetamine-like psychostimulants may cause rise in blood pressure.

·         Pseudoephedrine may reduce the effect of hypotensive drugs such as beta and alpha adrenergic blockers and methyldopa.

·         Triprolidine may potentiate the sedative effect of other antihistamines and central nervous system depressants.

Monoamine Oxidase Inhibitors should not be taken with Tripofed because it causes serious and life threatening side effect.

Pregnancy: Although pseudoephedrine and triprolidine have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.

Lactation: Pseudoephedrine and triprolidine are excreted in breast-milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that approximately 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast-milk over 24 hours.

Tripofed may cause drowsiness so patients under treatment should be cautious when driving car or operating machinery.

The following side effects may occur during the treatment:

·         Mild sedation, insomnia, dizziness, sleep and hearing disturbances, dry mouth, urinary retention & palpitation.

In rare cases, hallucinations, skin rashes and angioedema may occur.

The symptoms of acute toxicity may include drowsiness, dizziness, lethargy, weakness, respiratory depression, hyperactivity, convulsions, dysuria, hypertension, palpitation, tachycardia, nausea and vomiting.

Necessary measures should be taken to maintain and support respiration and circulation.

-Gastric lavage may be undertaken if indicated.

-Catheterisation of the bladder may be necessary.

-If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

Mode of Action of each ingredient:

Triprolidine provides symptomatic relief in conditions believed to depend wholly or partially upon the triggered release of histamine. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.

Pseudoephedrine has a direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant. Pseudoephedrine is substantially less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and considerably less potent in causing stimulation of the central nervous system.

After the administration of Tripofed syrup (containing 2.5 mg triprolidine hydrochloride and 60 mg pseudoephedrine hydrochloride) in healthy adult volunteers, the peak plasma concentration (Cmax) of triprolidine is approximately 5.5 ng/ml - 6.0 ng/nl, occurring at about 2.0 hours (Tmax) after drug administration. The plasma half life of triprolidine is approximately 3.2 hours. The Cmax of pseudoephedrine is approximately 180 ng/ml with Tmax approximately 2.0 hours after drug administration. The plasma half life of pseudoephedrine is approximately 5.5 hours (urine pH maintained between 5.0 - 7.0). The plasma half life of pseudoephedrine is markedly decreased by acidification of urine and increased by alkalinisation.

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.

There is insufficient information available to determine whether some of the active ingredients have mutagenic, carcinogenic, teratogenic potential, or the potential to impair fertility.

The excipients in each 100 ml are:

Sucrose	69.42gm
Sodium Benzoate	0.1gm
Methyl paraben	0.1gm
Glycerol	10gm
Quinoline yellow	0.01gm
Sunset yellow	0.1mg
essence orange	5mg
Distilled water up to	100ml

None reported.

2 years from the manufacturing date. The expiry date refers to the last day of the month.

Keep in a safe place, out of the reach and sight of children.

• Store below 25ºC, Protect from light

It is available in An amber colored type lll glass bottle size of 100 ml with narrow mouth and provided with child resistant cap.

Kuwait Saudi Pharmaceutical Industries Company

Tel: +965 24745012/3/4

Fax: +965 24745361, P. O. Box: 5512 , postal code: 13056 Safat, Kuwait

Website: www.kspico.comNo special requirements.