Tussal 35.4 mg syrup in sachets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tussal 35.4 mg syrup in sachets
cloperastine fendizoate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read 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 adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or does not improve after 7 days.
Leaflet contents:
- What Tussal is and what it is used for
- What you need to know before taking Tussal
- How to take Tussal
- Possible side effects
- How to store Tussal
- Contents of the pack and other information
1. What Tussal is and what it is used for
Cloperastine, the active substance of this medicine, is an antitussive that inhibits the cough reflex. This medicine is indicated for the treatment of non-productive forms of cough, such as irritative cough or nervous cough, in adults and adolescents over 12 years of age.
You should consult a doctor if your condition 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 substance or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to antihistamines (medicines for allergies).
- 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 aged 0 to 12 years must not take this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
- If you have high intraocular pressure.
- If you have been diagnosed with prostate enlargement (hypertrophy).
- If your cough persists beyond 7 days of treatment.
Children and adolescents
This medicine must not be given to children and adolescents aged 0 to 12 years; it is contraindicated.
Other medicines and Tussal
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 used to treat Parkinson’s disease, as they may enhance the adverse effects of this medicine.
- Expectorants and mucolytics used to clear excess mucus and phlegm, because taking them at the same time as a cough medicine like this one may prevent the elimination of mucus and cause choking.
Taking Tussal with food, drinks, and alcohol
Do not drink alcohol during treatment with this medicine, 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine is contraindicated during pregnancy and breastfeeding.
Driving and using machines
This medicine may cause drowsiness at usual doses. If this occurs, refrain from driving or operating dangerous machinery.
Tussal contains sucrose, propyl parahydroxybenzoate (E-216), methyl parahydroxybenzoate (E-218), propylene glycol (E-1520), ethanol, and sodium
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.
This medicine may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (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% w/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 contained in this medicine does not produce any noticeable effect.
This medicine contains less than 1 mmol of sodium (23 mg) per 10 ml sachet; hence, it is essentially “sodium-free”.
3. How to take Tussal
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in 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 daily.
This medicine is contraindicated in children and adolescents from 0 to 12 years of age.
This medicine is taken orally.
Before taking the medicine from the sachets, homogenize the contents by pressing several times with your fingers on the top and bottom parts of the sachet. It can be taken directly from the sachet. The duration of treatment is 7 days.
If you take more Tussal than you should
Symptoms of overdose include: excitement and difficulty breathing.
In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 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. If your cough returns, take the medicine as indicated in section 3. How to take Tussal.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly occurring adverse effects, although they are uncommon, are: drowsiness and dry mouth.
The adverse effects that may occur are:
Uncommon (may affect up to 1 to 10 in every 1,000 patients): drowsiness, dry mouth (at high doses).
Very rare (may affect up to 1 in every 10,000 patients): allergic reaction, urticaria.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 any special storage conditions.
Medicines must not be disposed of via wastewater drains or in household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Tussal
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The active substance is cloperastine fendizoate. Each sachet contains 35.4 mg of cloperastine fendizoate (equivalent to 20 mg of cloperastine hydrochloride).
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The other components (excipients) are: methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), microcrystalline cellulose-sodium carmellose, polysorbate 80, sucrose, banana flavour (containing 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 contents of the pack
Tussal is presented as a white, banana-flavoured oral suspension in heat-sealed sachets made of an aluminum complex (polyester, aluminum, and polyethylene). It is available in cartons of 20 sachets of 10 ml each.
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 most recent review of this leaflet: April 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.