Respero Mirtol

Package Leaflet: Information for the User

RESPERO MYRTOL

300 mg, gastro-resistant soft capsules

Distillate of a mixture of rectified essential oils of eucalyptus, sweet orange, common myrtle, and lemon.

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Respero Myrtol and what is it used for
• 2. Important information before taking Respero Myrtol
• 3. How to take Respero Myrtol
• 4. Possible side effects
• 5. How to store Respero Myrtol
• 6. Contents of the package and other information

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

Respero Myrtol is a herbal medicine. It loosens mucus and makes it easier to clear, making it easier to cough up, and reduces inflammation.
Indications for use: 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 stomach, intestinal, or bile duct inflammation, or if the patient has 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Respero Myrtol, you should discuss it with your doctor or pharmacist.

• If symptoms persist or worsen, or if shortness of breath or fever occurs, or if the patient starts coughing up mucus containing blood or pus, you should consult a doctor immediately.
• Patient with asthma, whooping cough, or other respiratory diseases with significant respiratory hypersensitivity should only take Respero Myrtol after consulting a doctor.

Respero Myrtol and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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 you have been previously diagnosed with intolerance to some sugars or previously diagnosed with hereditary fructose intolerance, a rare genetic disorder in which your body does not break down fructose, you should consult your doctor before taking this medicine or giving it to your child.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Respero Myrtol

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
Recommended dose
Follow the instructions below, otherwise Respero Myrtol may not be fully effective!
In acute inflammatory conditions, adults and children over 10 years of age should take one capsule 3-4 times a day.
If after 7 days there is no improvement or you feel worse, you should contact your doctor.
How and when to take Respero Myrtol?
Respero Myrtol herbal medicine capsules should be taken without chewing, about 30 minutes before a meal, with a large amount of liquid. The last dose can be taken before bedtime.

Overdose of Respero Myrtol

If you have taken more than the recommended dose of the medicine, inform your doctor. Your doctor will decide what measures may be necessary. The side effects listed below may occur with increased intensity.

Missed 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 dosage instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following terms are used to describe the frequency of side effects:
Very common:
occur in more than 1 in 10 patients
Common:
occur in 1 to 10 in 100 patients
Uncommon:
occur in 1 to 10 in 1,000 patients
Rare:
occur in 1 to 10 in 10,000 patients
Very rare:
occur in less than 1 in 10,000 patients
Not known:
frequency cannot be estimated from available data

Possible side effects:

Uncommoncases of gastrointestinal disorders, such as abdominal pain/discomfort in the upper abdomen, as well as rarecases of nausea, vomiting, or diarrhea.
Rarereports of hypersensitivity reactions (e.g., skin rash, itching, facial swelling, shortness of breath, or blood circulation disorders).
In very rarecases, any existing kidney or bile duct stones may move.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Respero Myrtol

Store in a temperature not exceeding 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP and on the blister after: EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Respero Myrtol contains

• The active substance of the medicine is a distillate of a mixture of rectified essential oils of eucalyptus, sweet orange, common myrtle, and lemon. One capsule contains 300 mg of the distillate of the mixture of rectified essential oils: Eucalyptus globulusLabill .aetheroleum (eucalyptus essential oil), Citrus sinensisL. aetheroleum (sweet orange essential oil), Myrtus communisL. aetheroleum (common myrtle essential oil), and Citrus limonL. aetheroleum (lemon essential oil).
• Other ingredients are: rapeseed oil, refined, gelatin, glycerol 85% (E 422), hypromellose acetate succinate, triethyl citrate, liquid sorbitol, non-crystallizing (E 420), hydrochloric acid (13%), sodium lauryl sulfate, talc, dextrin, ammonium glycyrrhizinate.

What Respero Myrtol looks like and contents of the package

Naturally colored, transparent soft gelatin capsules.
Packaging containing 20 gastro-resistant soft capsules
Packaging containing 50 gastro-resistant soft capsules
Packaging containing 100 gastro-resistant soft capsules
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

• G. Pohl-Boskamp GmbH & Co. KG Kieler Straße 11 25551 Hohenlockstedt Germany Phone: +49 48 26 59-0 Fax: +49 48 26 59-109 e-mail: [email protected]

To obtain more detailed information about this medicine, please contact the representative of the marketing authorization holder:

Berlin-Chemie/Menarini Polska Sp. z o.o.
ul. Zygmunta Słomińskiego 4
00-204 Warsaw, Poland
Phone: +22 566 21 00, Fax: +22 566 21 01
e-mail: [email protected]

Date of the last revision of the package leaflet: