TUSSAL 35.4 mg ORAL SOLUTION IN SACHETS

Introduction

Package Leaflet: Information for the User

Tussal 35.4 mg Syrup in Sachets

cloperastine fendizoate

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

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet:

1. What is Tussal and what is it used for
2. What you need to know before taking Tussal
3. How to take Tussal
4. Possible side effects
5. Storage of Tussal
6. Package Contents and Additional Information

1. What is Tussal and what is it used for

Cloperastine, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex. This medicine is indicated for the treatment of non-productive forms of cough, such as irritative 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.

2. What you need to know before taking Tussal

Do not take Tussal

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

Warnings and Precautions

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

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

Children and Adolescents

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

Other Medicines and Tussal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

This medicine may interact with other medicines such as:

• Medicines to help you sleep (sedatives, opioid analgesics, barbiturates, hypnotics, or benzodiazepines).
• Medicines for depression and medicines for the treatment of Parkinson's disease, as they may enhance the adverse effects of this medicine.
• Expectorant and mucolytic medicines used to eliminate excess mucus and phlegm, as taking them at the same time as a cough medicine like this one may prevent the elimination of excess mucus and produce choking.

Taking Tussal with Food, Drinks, and Alcohol

During treatment with this medicine, do not drink alcohol, as it may increase the effects of alcohol.

Taking this medicine with food and drinks does not affect its efficacy.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. It is contraindicated in pregnancy and breastfeeding.

Driving and Using Machines

This medicine may cause drowsiness at usual doses. If so, avoid driving and operating hazardous machinery.

Tussal contains saccharose, propyl hydroxybenzoate (E-216), and methyl hydroxybenzoate (E-218), propylene glycol (E-1520), ethanol, and sodium

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause allergic reactions (possibly delayed) because it contains propyl hydroxybenzoate (E-216) and methyl hydroxybenzoate (E-218).

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

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

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

3. How to Take Tussal

Follow exactly the administration instructions of the medicine contained in this package leaflet or as 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 medicine is contraindicated in children and adolescents from 0 to 12 years of age.

This medicine is taken orally.

Before taking this medicine in sachets, it should be homogenized by pressing the top and bottom of the sachet with your fingers several times. It can be taken directly from the sachet. The duration of treatment 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tussal

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that may occur, although they are rare, are: drowsiness and dry mouth.

The side effects that may occur are:

Uncommon (may affect up to 1 in 100 patients): drowsiness, dry mouth (at high doses).

Very rare (may affect up to 1 in 10,000 patients): allergic reaction, urticaria.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tussal

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients (excipients) are: methyl hydroxybenzoate (E-218), propyl hydroxybenzoate (E-216), microcrystalline cellulose-carmellose sodium, polysorbate 80, saccharose, banana flavor (contains propylene glycol (E-1520) and ethanol), and purified water. See section 2 "What you need to know before taking Tussal".

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Zinereo Pharma, S.L.U.

A Relva s/n,

36410 Pontevedra

Spain

Date of the Last Revision of this Package Leaflet: April 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.