SEKI 10 mg Coated Tablet

Зміст інструкції

1. Seki 10 mg coated tablets
2. Seki 35.4mg/ml oral drops, suspension, 4.4 mg chewable tablets for children
   1. What is Seki and what is it used for?
   2. What you need to know before taking Seki
   3. How to take Seki
   4. Possible side effects
   5. How to store Seki
   6. Contents of the pack and other information
3. Seki 3.54 mg/ml syrup
   1. What is Seki and what is it used for?
   2. What you need to know before you take Seki
   3. How to take Seki
   4. Possible side effects
   5. How to store Seki
   6. Contents of the pack and other information

Seki 10 mg coated tablets

cloperastine hydrochloride

Seki 35.4mg/ml oral drops, suspension, 4.4 mg chewable tablets for children

cloperastine fendizoate

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

• 1. What Seki is and what it is used for
• 2. What you need to know before you take Seki
• 3. How to take Seki
• 4. Possible side effects
• 5. How to store Seki
• 6. Contents of the pack and other information

1. What is Seki and what is it used for?

Seki is a medicine that acts as a cough suppressant.
Seki is used to calm the urge to cough.
See your doctor if you do not feel better or if you feel worse after a short period of treatment.
See your doctor if the child does not feel better or feels worse after 7 days.

2. What you need to know before taking Seki

Do not use Seki

• if you are allergic to cloperastine or any of the other ingredients of this medicine (listed in section 6).
• in children under 2 years of age

Warnings and precautions
Talk to your doctor or pharmacist before taking Seki.
Caution is advised when used if you suffer from intraocular hypertension, prostatic hypertrophy or obstruction of the
bladder.
Extreme caution is recommended if you suffer from chronic productive cough (with mucus) such as that associated with
smoking, pulmonary emphysema or asthma, because suppressing the cough Seki may alter the ability to
eliminate mucus (expectoration) and increase airway resistance.

Other medicines and Seki
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Avoid the concurrent use of Seki with:

• antihistamine medicines (used to treat allergies);
• anticholinergic medicines;
• sedative medicines.

Use this medicine with caution and see your doctor if you are taking substances that depress or that
stimulate the central nervous system.

Seki with food and alcohol
Taking Seki during meals is not recommended (see “How to take Seki”).
Avoid drinking alcohol during treatment with Seki.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking Seki during the first months of pregnancy; in the further period, take this medicine
only if absolutely necessary and only under the direct supervision of your doctor.
It is not known whether the medicine and/or its metabolites are excreted in breast milk. Do not take Seki during
breastfeeding.
No data are available on the effect of Seki on fertility.

Driving and operating machinery
Seki may cause drowsiness. Be careful if you intend to drive vehicles or engage in operations that
require a degree of alertness.

Seki contains sucrose

• The tablets contain 38.07 mg of sucrose per dose.
• The drops contain approximately 140 mg of sucrose per ml.
• The chewable tablets contain approximately 36.8 mg of sucrose per dose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. Seki contains sucrose. To be taken into consideration in people affected by diabetes mellitus or who are following low-calorie diets.

Seki (drops) contains para-hydroxybenzoate (parabens)
The drops contain methyl-parahydroxybenzoate (E218) which may cause allergic reactions (even
delayed).

3. How to take Seki

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doses are:

Adults
Seki 10 mg coated tablets:
2 tablets in the evening at bedtime, 1 tablet in the morning and 1 tablet in the afternoon,
preferably between meals.

Seki 35.4 mg/ml oral drops, suspension
30 drops in the evening before bedtime, 15 drops in the morning and 15 drops in the afternoon.

Use in children over 2 years of age
Seki children 4.4 mg chewable tablets:

• children up to 7 years: 2 tablets in the evening at bedtime, 1 tablet in the morning and 1 tablet in the afternoon.
• children over 7 years: 4-6 tablets in the evening at bedtime, 2-3 tablets in the morning and 2-3 tablets in the afternoon.

Seki 35.4 mg/ml oral drops, suspension

• 14 drops in the evening before bedtime, 8 drops in the morning and 8 drops in the afternoon.

Taking the medicine during meals is not recommended.

Instructions for opening the drop bottle and using the dropper
SEKI 35.4 mg/ml oral drops, suspension is to be administered orally.

• 1. Shake before use.
• 2. Press on the bottle cap and turn in the direction indicated by the arrow (see fig. 1).
• 3. Remove the cap.
• 4. Take the dropper and unscrew the protective sheath of the pipette.
• 5. Screw the dropper onto the bottle (see fig. 2).
• 6. To use the dropper, press on the cap and turn in the direction indicated by the arrow (see fig. 3).
• 7. Put the dropper back on the bottle, simply screwing the cap back on (see fig. 2).

If you take more Seki than you should
In case of ingestion/accidental intake of an excessive dose of Seki, immediately inform your doctor
or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to take Seki
Do not take a double dose to make up for a missed dose.

If you stop taking Seki
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Urticaria is the side effect that has been reported most frequently.
Like all medicines, this medicine can cause side effects although not everybody gets them.

Uncommon(may affect up to 1 in 100 patients)

• drowsiness,
• dry mouth.

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

• serious allergic reactions which appear suddenly (anaphylactic/anaphylactoid reaction),
• urticaria,
• skin redness (erythema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
By reporting side effects you can help to provide more information on the safety of this medicine.

5. How to store Seki

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Store the coated tablets at a temperature below 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Seki contains
Seki 10 mg coated tablets

• The active ingredient is cloperastine hydrochloride. One tablet contains 10 mg of cloperastine hydrochloride.
• The other ingredients are: microcrystalline cellulose, silica, talc, magnesium stearate, hypromellose, povidone, macrogol 4000, sucrose, magnesium carbonate, titanium dioxide, erythrosine (E127).

Seki 35.4 mg/ml oral drops, suspension

• The active ingredient is cloperastine fendizoate. 100 ml contain 3.54g of cloperastine fendizoate equivalent to 1.8 g of cloperastine.
• The other ingredients are: polyoxyethylene stearate, silica, methyl parahydroxybenzoate, sucrose, banana flavour, purified water.

Seki children 4.4 mg chewable tablets

• The active ingredient is cloperastine fendizoate. One tablet contains 4.4 mg of cloperastine fendizoate.
• The other ingredients are: sucrose, mannitol, microcrystalline cellulose, starch, methylcellulose, magnesium stearate, talc, strawberry essence.

Description of the appearance of Seki and contents of the pack
Seki is presented as:

Coated tablets- 20 tablets

Oral drops, suspension- 25 ml bottle

Chewable tablets- 20 or 60 tablets

Marketing Authorisation Holder
Zambon Italia s.r.l.
Via Lillo del Duca 10 – 20091 Bresso (MI)

Manufacturer
Zambon S.p.A. - Vicenza

Seki 3.54 mg/ml syrup

cloperastine fendizoate

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

• 1. What Seki is and what it is used for
• 2. What you need to know before you take Seki
• 3. How to take Seki
• 4. Possible side effects
• 5. How to store Seki
• 6. Contents of the pack and other information

1. What is Seki and what is it used for?

Seki is a medicine that acts as a cough suppressant.
Seki is used to calm the urge to cough.
See your doctor if you do not feel better or if you feel worse after a short period of treatment.
See your doctor if the child does not feel better or feels worse after 7 days.

2. What you need to know before you take Seki

Do not use Seki

• if you are allergic to cloperastine or any of the other ingredients of this medicine (listed in section 6),
• in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Seki.
Caution is advised if you suffer from intraocular hypertension, prostatic hypertrophy or obstruction of the
bladder.
Extreme caution is recommended if you suffer from chronic productive cough (with mucus) such as that associated with
smoking, pulmonary emphysema or asthma, because by suppressing the cough Seki may alter the ability to
eliminate mucus (expectoration) and increase the resistance of the airways.

Other medicines and Seki
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Avoid the simultaneous use of Seki with:

• antihistamine medicines (used for the treatment of allergies);
• anticholinergic medicines;
• sedative medicines.

Use this medicine with caution and see your doctor if you are taking substances that depress or
stimulate the central nervous system.

Seki with food and alcohol
Taking Seki during meals is not recommended (see “How to take Seki”).
Avoid drinking alcohol during treatment with Seki.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking Seki during the first months of pregnancy; in the further period, take this medicine
only if absolutely necessary and only under the direct control of your doctor.
It is not known whether the medicine and/or its metabolites are excreted in breast milk. Do not take Seki during
breastfeeding.
No data are available on the effect of Seki on fertility.

Driving and operating machinery
Seki may cause drowsiness. Be careful if you intend to drive vehicles or operate machinery that
requires alertness.

Seki contains sucrose
The syrup contains 1.687 g of sucrose per dose of 3.75 ml ( “Children” mark) and 3.375 g of sucrose per
dose of 7.5 ml (“Adults” mark).
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
Seki contains sucrose. To be taken into consideration in people affected by diabetes mellitus or who are following
low-calorie diets (hypocaloric).

Seki contains Ethanol (contained in banana flavour)
This medicine contains 0.0011 ml of alcohol (ethanol) in each dose of 3.75 ml (“Children” mark) and 0.0022
ml of alcohol (ethanol) in each dose of 7.5 ml (“Adults” mark).
The amount in a dose of this medicine is equivalent to less than 1 ml of beer or 1 of wine.
The small amount of alcohol in this medicine will not produce significant effects.

Seki contains Propylene Glycol (contained in banana flavour)
This medicine contains 8.6 mg of propylene glycol in 3.75 ml (“Children” mark) and 17.3 mg of propylene
glycol in 7.5 ml (“Adults” mark).

Seki contains Sodium (contained in sodium carboxymethylcellulose)
This medicine contains less than 1 mmol (23mg) of sodium per dose, i.e. essentially ‘sodium-free’.

Seki contains parabens (parahydroxybenzoates)
The syrup contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate (E218 and E216) which may
cause allergic reactions (even delayed).

3. How to take Seki

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended doses are:

Adults
Seki 3.54mg/ml syrup
Use the measuring cup included in the package, filling it up to the “Adults” mark; one “Adults” mark corresponds to 7.5 ml of syrup.
2 cups in the evening at bedtime, 1 cup in the morning and 1 cup in the afternoon.

Use in children
Seki 3.54mg/ml syrup

• children over 2 years: use the measuring cup included in the package up to the “Children” mark; one “Children” mark corresponds to 3.75 ml of syrup. 2 cups in the evening before bedtime, 1 cup in the morning and 1 cup in the afternoon.

Taking the medicine during meals is not recommended.

Instructions for use
Seki 3.54 mg/ml syrup is to be administered orally using the measuring cup included in the package.

• 1. Shake the bottle before use.
• 2. Place the bottle in an upright position, press on the cap

and unscrew in the direction indicated by the arrow (see fig. 1).

• 3. Use the cup according to the dose indicated above. For correct dosage, it is recommended to hold the cup horizontally and fill it up to the mark.
• 4. To close the bottle, screw it on tightly in the opposite direction to opening (see fig. 2).
• 5. It is recommended to wash the cup after each use.

If you take more Seki than you should
In case of ingestion/accidental intake of an excessive dose of Seki, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to take Seki
Do not take a double dose to make up for a missed dose.

If you stop taking Seki
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Urticaria is the side effect that has been reported most frequently.
Like all medicines, this medicine can cause side effects although not everybody gets them.

Uncommon(may affect up to 1 in 100 people)

• drowsiness,
• dry mouth.

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

• serious allergic reactions which appear suddenly (anaphylactic/anaphylactoid reaction),
• urticaria,
• skin redness (erythema).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Seki

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp”. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Store the syrup at a temperature below 30°C.
The bottle, after first opening, can be used for a period not exceeding 30 days.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Seki contains
Seki 3.54 mg/ml syrup

• The active ingredient is cloperastine fendizoate. 100 ml contain 354 mg of cloperastine fendizoate equivalent to 180 mg of cloperastine.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, polyoxyl 40 stearate, sucrose, methylparahydroxybenzoate, propylparahydroxybenzoate, banana flavour (containing ethanoland propylene glycol), purified water.

Description of the appearance of Seki and contents of the pack
Seki is presented as:

Syrup- 200 ml bottle with measuring cup.

Marketing Authorisation Holder
Zambon Italia s.r.l.
Via Lillo del Duca 10 – 20091 Bresso (MI)

Manufacturer
Zambon S.p.A. - Vicenza