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TUSSAL 35.4 mg ORAL SOLUTION IN SACHETS

TUSSAL 35.4 mg ORAL SOLUTION IN SACHETS

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Tarek Agami

General medicine11 years of experience

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use 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/.

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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for TUSSAL 35.4 mg ORAL SOLUTION IN SACHETS – subject to medical assessment and local rules.

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Doctor

Tarek Agami

General medicine11 years of experience

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

  • Diagnosis and treatment of acute and chronic conditions (high blood pressure, diabetes, respiratory infections, cardiovascular symptoms)
  • Evaluation of symptoms and guidance on further diagnostic testing
  • Preventive check-ups and regular health monitoring
  • Medical support during travel or after relocation
  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine18 years of experience

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
  • Family medicine: hypertension, diabetes, cholesterol, chronic disease management
  • Travel medicine: pre-travel advice, vaccinations, fit-to-fly certificates, travel-related illnesses
  • Sexual and reproductive health: PrEP, STD prevention, counselling, treatment
  • Weight management and wellness: personalised weight loss programmes, lifestyle guidance
  • Skin and ENT issues: acne, eczema, allergies, rashes, sore throat, sinusitis
  • Pain management: acute and chronic pain, post-surgical care
  • Public health: prevention, health screenings, long-term monitoring
  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
  • IMT medical certificates for driving licence exchange
Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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His approach is friendly, clear, and focused on delivering practical medical advice tailored to each patient’s needs.

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  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
  • sudden changes in how a child or adult feels
  • questions about existing treatment and whether adjustments are needed
  • renewal of prescriptions when clinically appropriate
Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.

She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.

With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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When clinically appropriate, Dr. Altaf can also provide health and fitness certificates, including documentation required for physical activity, sports participation or gym use, based on the patient’s health status and medical indications.

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In all consultations, Dr. Muhammad Tayyab Altaf focuses on clear communication, accurate diagnosis and patient-centred decision-making. His approach ensures that individuals and families feel informed, supported and confident in their next steps, no matter where they are.

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With a patient-centred approach, Dr. Raevskii helps individuals manage both chronic illnesses and complex oncological cases. His consultations are guided by current medical standards and adapted to each patient’s needs.

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Dr Kovalenko combines evidence-based practice with a respectful, patient-centred approach. She takes time to explain, listens attentively, and helps each person make confident, informed decisions about their health.

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