Package leaflet: Information for the user

RESPERO MYRTOL
300 mg, enteric soft capsules
Rectified essential oils distillate from a mixture of eucalyptus, sweet orange, common myrtle and common lemon.
Please read this leaflet carefully before taking this medicine because it contains important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 7 days, you should contact your doctor.

Contents of the leaflet

What Respero Myrtol is and what it is used for
Important information before taking Respero Myrtol
How to take Respero Myrtol
Possible side effects
How to store Respero Myrtol
Contents of the pack and other information

1. What Respero Myrtol is and what it is used for

Respero Myrtol is a herbal medicine. It helps loosen mucus and facilitates its clearance from the airways, making it easier to cough up, and reduces inflammation.
Indications: Relief of symptoms of acute upper respiratory tract inflammation.

2. Important information before taking Respero Myrtol

When not to take Respero Myrtol:

If the patient has inflammatory conditions of the stomach, intestines, or bile ducts, or if the patient suffers from severe liver disease,
if the patient is allergic to eucalyptus oil, sweet orange oil, myrtle oil, lemon oil, or cineole (the main component of eucalyptus oil), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting Respero Myrtol, discuss it with your doctor or pharmacist.

If symptoms persist or worsen, or if shortness of breath or fever occurs, or if the patient begins to cough up mucus containing blood or purulent discharge, medical advice should be sought immediately.
Patients suffering from bronchial asthma, whooping cough, or other respiratory disorders associated with marked respiratory tract hyperreactivity should take Respero Myrtol only after consultation with a doctor.

Respero Myrtol and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
No special precautions are required.

Respero Myrtol contains sorbitol and sodium
Respero Myrtol capsules contain no more than 50 mg of sorbitol per capsule.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Respero Myrtol

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
You must follow the dosing instructions below, otherwise Respero Myrtol may not be fully effective!
For acute inflammatory conditions, adults and children over 10 years of age should take one capsule 3-4 times daily.
If there is no improvement after 7 days, or if the patient feels worse, contact a doctor.
When and how to take Respero Myrtol?
The herbal capsules of Respero Myrtol should be taken whole, without chewing, approximately 30 minutes before meals, with a large amount of fluid. The last dose may be taken before bedtime.
Taking more Respero Myrtol than recommended
If you take more than the recommended dose, inform your doctor. The doctor will decide on any measures that may be necessary. The adverse reactions listed below may occur with increased intensity.
Missing a dose of Respero Myrtol
Do not take a double dose to make up for a missed dose. Continue taking Respero Myrtol as directed by your doctor or according to the dosing instructions.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
The following terms are used to describe the frequency of occurrence of adverse reactions:
Very common: affects more than 1 in 10 people
Common: affects 1 to 10 in 100 people
Uncommon: affects 1 to 10 in 1,000 people
Rare: affects 1 to 10 in 10,000 people
Very rare: affects less than 1 in 10,000 people
Not known: frequency cannot be estimated from available data

Possible adverse reactions:
Uncommon gastrointestinal disorders such as abdominal pain/discomfort in the epigastric region, as well as rare cases of nausea, vomiting or diarrhoea, may occur.
Rare cases of hypersensitivity reactions (e.g. skin rash, itching, facial swelling, shortness of breath or circulatory disturbances) have been reported.
In very rare cases, existing kidney or gallstones may become displaced.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of the safety of the medicine.

5. How to store Respero Myrtol

Store at a temperature not exceeding 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after:
Expiry date (EXP) and on the blister after: EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Respero Myrtol contains

The active substance is a distilled extract from a mixture of rectified essential oils of eucalyptus, sweet orange, common myrtle and common lemon. Each capsule contains 300 mg of distilled extract from a mixture of rectified essential oils: Eucalyptus globulus Labill. aetheroleum (eucalyptus essential oil), Citrus sinensis L. aetheroleum (sweet orange essential oil), Myrtus communis L. aetheroleum (common myrtle essential oil) and Citrus limon L. aetheroleum (common lemon essential oil).
Other ingredients are: refined rapeseed oil, gelatin, glycerol 85% (E 422), hypromellose acetate succinate, triethyl citrate, liquid non-crystallizing sorbitol (E 420), hydrochloric acid (13%), sodium lauryl sulfate, talc, dextrin, ammonium glycyrrhizinate.

What Respero Myrtol looks like and contents of the pack
Naturally coloured, transparent soft gelatin capsules.
Pack containing 20 enteric soft capsules
Pack containing 50 enteric soft capsules
Pack containing 100 enteric soft capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
G. Pohl-Boskamp GmbH & Co. KG
Kieler Straße 11
25551 Hohenlockstedt
Germany
Tel.: + 49 48 26 59-0
Fax: + 49 48 26 59-109
e-mail: [email protected]
For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Zygmunt Słomiński Street 4
00-204 Warsaw, Poland
Tel.: +22 566 21 00, Fax: +22 566 21 01
e-mail: [email protected]