Pharmaceutical forms present on the market

The pharmaceutical forms listed below are authorized for sale in Italy by the Ministry of Health:

• Seki® 10 mg tablets in packs of 20 tablets;
• Seki® 3.54 mg/mL syrup in 200 mL bottle
• Seki® 35.4 mg/mL drops  in 25 mL bottle.

Mechanism of action

Seki® is a drug belonging to the category of cough suppressants. It is a drug with antitussive and anti-edema activity as well as relaxing for the muscles of the bronchi.

The serum peak of the product is reached between 60 minutes and 90 minutes. The product is rapidly metabolized while the metabolites are mainly excreted in the urine.

How much?

Seki® is classified as a class C drug, therefore its cost is borne by the citizen. For the purchase it does not require a medical prescription as it is a normal over-the-counter drug.

• Seki® 10 mg tablets in packs of 20 tablets at the price of 4.90 euros
• Seki®  syrup 200 mL bottle, price 9.40 euros;
• Seki® drops at the price of 7.40 euros.

Posology and Method of Use

When following a therapy based on cloperastine hydrochloride it is advisable to follow the dosage indicated by the doctor or pharmacist or the one shown on the package leaflet.

In adults for the tablets: 2 tablets in the evening before going to bed. 1 tablet in the morning, 1 tablet in the afternoon, it is recommended to take them between meals. St

For the syrup : 2 small glasses in the evening before going to bed, 1 small glass in the morning and 1 small glass in the afternoon. The shot glass is included in the package up to the notch with Adults written on it.

For the 35.4 mg/mL oral drops : 30 drops in the evening before going to sleep, 15 drops in the morning and 15 drops in the afternoon.

To open the drop bottle and to use the dropper, press on the bottle cap and turn in the direction shown on the cap and indicated by the arrow. The dropper must be released from the protective sheath and screwed onto the bottle.

For patients suffering from renal insufficiency and in the event that the patient suffers from hepatic insufficiency, there are no particular precautions to be taken, but it is still a good idea to consult your doctor before taking any drug if you suffer from one of these pathologies.

Overdose

There are no data relating to an overdose, but in the event of a massive accidental intake of the drug, it is advisable to consult your doctor or the nearest hospital.

Following the directions given on the package leaflet, or the directions of your doctor or pharmacist reduces the risk of overdose.

Pregnancy and breastfeeding

Regarding the possibilities of using Seki® during pregnancy and breastfeeding, you need to ask your doctor’s opinion. If you are pregnant, think you are pregnant or are planning to, avoid taking the drug in the early months of pregnancy.

Even during breastfeeding it is advisable to avoid taking the drug. The medicine should be taken during pregnancy and lactation only if necessary and only under strict medical supervision.

It is currently unknown if the drug passes into breast milk. For this reason it is recommended to avoid taking the drug while breastfeeding.

Contraindications

The use of Seki® is contraindicated in the case of overt hypersensitivity to cloperastine hydrochloride or to any of the excipients present in the drug.

The other ingredients for the coated tablets are: microcrystalline cellulose, talc, magnesium stearate, silica, povidone, hypromellose, macrogol 4000, magnesium carbonate, titanium dioxide, sucrose, erythrosine E127.

For the oral drops and the syrup, the excipients are: polyoxyethylene stearate, methyl-para-hydroxybenzoate, sucrose, silica, banana flavor and purified water.

The medicine contains sucrose. If the patient has an intolerance to some sugars, the medicine should be taken only after medical supervision. People with diabetes mellitus or on a low-calorie diet should take the drug with caution and seek medical advice.

Syrup and drops contain parahydroxybenzoates then parabens and methyl parahydroxybenzoate and propyl parahydroxybenzoate which can cause allergic reactions.

Interactions with other drugs

If you are taking, have recently taken or are about to take any other medicines you should contact your doctor or pharmacist before taking Seki® .

Concomitant use with antihistamines, anticholinergics and sedatives should be monitored by your doctor as interactions may occur. It is recommended not to take Seki® during meals. Do not consume alcoholic beverages during Seki® therapy.

Side effects

Like all medicines, this medicine too could cause side effects, even if not everyone gets them. Uncommon side effects, that is, those that may affect up to 1 in 100 patients are: drowsiness and dry mouth.

Side effects with unknown frequency are: allergic reactions and urticaria. Paying attention to the instructions in the package leaflet minimizes the risk of undesirable effects.

If the patient notices side effects not listed on the leaflet, he should contact the doctor or pharmacist who will report the hitherto unknown symptoms to the Italian Medicines Agency.

It is also advisable to keep the leaflet of the medicine and to place it in the original packaging as it may be necessary to consult it at a later time.