Label: information for the user

Tussal 35.4 mg syrup in sachets

cloperastina fendizoate

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Cloperastine, the active ingredient of this medication, is an antitussive that inhibits the cough reflex. This medication is indicated for the treatment of unproductive forms of cough, such as irritative cough or nervous cough, for adults and adolescents over 12 years of age.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not take Tussal

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are allergic to allergy medications (antihistamines).
• If you are taking medications for depression treatment.
• If you are pregnant, or think you may be pregnant, or if you are breastfeeding.
• Children and adolescents from 0 to 12 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have high intraocular pressure.
• If you have been told you have prostate hypertrophy.
• If your cough persists after 7 days of treatment.

Children and adolescents

Children and adolescents from 0 to 12 years old cannot take this medication, it is contraindicated.

Other medications and Tussal

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This medication may interact with other medications such as:

• Sleeping medications (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
• Depression medications and medications for Parkinson's disease treatment because they may potentiate the adverse effects of this medication.
• Expectorants and mucolytics used to eliminate excess mucus and phlegm, because taking them at the same time as a cough medication like this one may prevent the elimination of excess mucus and cause choking.

Taking Tussal with food, drinks, and alcohol

Do not take alcohol during treatment with this medication as it may increase the effects of alcohol.

The taking of this medication with food and drinks does not affect its efficacy.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or have the intention of becoming pregnant, consult your doctor or pharmacist before using this medication. It is contraindicated in pregnancy and lactation.

Driving and operating machinery

This medication may cause drowsiness at usual doses. If so, refrain from driving and operating hazardous machinery.

Tussal contains saccharose, propylparaben (E-216), methylparaben (E-218), propylene glycol (E-1520), ethanol, and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may cause allergic reactions (possibly delayed) because it contains propylparaben (E-216) and methylparaben (E-218).

This medication contains 26.4 mg of propylene glycol in each 10 ml sachet.

This medication contains 3.6 mg of alcohol (ethanol) in each 10 ml sachet (0.036% p/v). The amount in 10 ml of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medication does not produce any perceptible effect.

This medication contains less than 1 mmol of sodium (23 mg) per 10 ml sachet; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

For adults and adolescents over 12 years of age: 1 sachet of 10 ml 3 times a day.

This medication is contraindicated in children and adolescents from 0 to 12 years of age.

This medication is taken orally.

Before taking this medication in sachets, itmust be homogenized by pressing with your fingers the upper and lower part of the sachet several times. It can be taken directly from the sachet. The treatment duration is 7 days.

If you take more Tussal than you should

The symptoms of overdose are: excitement and difficulty breathing.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tussal

Do not take a double dose to compensate for the missed doses.

This treatment is symptomatic. If you do not have a cough, do not take it and if you have it again, take the medication as indicated in section 3. How to Take Tussal.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The adverse effects that may occur, although they are infrequent, are: drowsiness and dry mouth.

The adverse effects that may occur are:

Infrequent(may affect up to 1 to 10 of every 1,000 patients): drowsiness, dry mouth (at high doses).

Very Rare(may affect up to 1 of every 10,000 patients): allergic reaction, urticaria.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tussal

• The active ingredient is cloperastine fendizoate. Each sachet contains cloperastine fendizoate 35.4 mg (equivalent to 20 mg of cloperastine hydrochloride).

• The other components (excipients) are: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), microcrystalline cellulose-sodium carmellose, polisorbate 80, sucrose, banana flavor (contains propylene glycol (E-1520) and ethanol) and purified water. See section 2 “What you need to know before starting to take Tussal”.

Appearance of the product and contents of the packaging

Tussalis presented as an oral suspension of white color and banana flavor, in thermosolded sachets formed by a complex of aluminum (polyester, aluminum, and polyethylene). They are presented in boxes of 20 sachets of 10 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Zinereo Pharma, S.L.U.

A Relva s/n,

36410 Pontevedra

Spain

Last review date of this leaflet: April 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.