GELOMYRTOL FORTE, 300 mg, gastro-resistant soft capsules, N100

Gelomyrtol forte 300 mg soft capsules do not dissolve in the stomach.

Distillate of a blend of purified eucalyptus, sweet orange, myrtle and lemon essential oils (66:32:1:1).

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

- Do not throw this leaflet away as you may need to read it again.

- If you want to know more or consult, contact your pharmacist.

- If side effects occur (even if they are not listed in this leaflet), contact your doctor or pharmacist. See Chapter 4.

- If your condition has not improved or even worsened within 10 days, consult a doctor.

1. What Gelomyrtol forte is and what it is used for.

This medicine is intended for relief of expectoration in acute and chronic bronchitis and relief of sinusitis symptoms.

Gelomyrtol forte liquefies bronchial and nasopharyngeal secretions and improves their removal.

If your condition has not improved or even worsened within 10 days, consult a doctor.

2. What you need to know before using Gelomyrtol forte

Gelomyrtol forte should not be used:

- if you are allergic to eucalyptus oil, sweet orange oil, myrtle oil, lemon oil or cineole (the main component of eucalyptus oil) or any of the excipients of this medicine (listed in section 6);

- if you suffer from inflammatory disease of the stomach, intestines or gall bladder and ducts or severe liver disease;

- for children younger than 6 years old

Warnings and precautions

Talk to your doctor or pharmacist before taking Gelomyrtol forte:.

- if you suffer from bronchial asthma, whooping cough or another respiratory disease characterized by increased sensitivity of the respiratory system, Gelomyrtol forte can only be used on a doctor's prescription.

If your condition does not improve or worsens, or if you develop shortness of breath or a fever, or if you begin to cough up mucus that contains blood or pus-like discharge, contact your doctor immediately.

For children

Gelomyrtol forte should not be used in children under 6 years of age.

Other drugs and Gelomyrtol forte

If the drug is used as recommended, drug interactions are not known.

Pregnancy, lactation and fertility.

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine.

Due to the fat-solubility of the active substance, it is very likely that small concentrations will pass into breast milk.

Data on the increased risk of using Gelomyrtol forte during breastfeeding have not been received so far.

As before using other medicinal products, you should consult your doctor during breastfeeding.

Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Driving and machine control.

No special precautions are required

Gelomyrtol forte contains sorbitol.

Each gastro-resistant soft capsule of this medicine contains no more than 50 mg of sorbitol.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you (or your child) have an intolerance to some carbohydrates,

or if you have been diagnosed with a rare genetic disorder called congenital fructose intolerance (CIF), in which the body cannot break down fructose,

before taking this medicine (or before giving it to your child), tell your doctor.

3. How to use Gelomyrtol forte.

Always take this medicine exactly as your doctor or pharmacist has told you.

If in doubt, ask your doctor or pharmacist.

Recommended dose:

For adults and teenagers from 12 years old

Acute diseases 1 capsule 3-4 times a day

Chronic diseases 1 capsule 2-3 times a day

For children and teenagers aged 6-12

1 capsule 1-3 times a day

1 capsule 1-2 times a day

How to use

The soft capsule does not dissolve in the stomach and is taken for 30 minutes. before meals, drinking a sufficient amount of cold liquid.

The last dose can be taken just before going to bed.

Duration of use.

The period of use of Gelomyrtol forte depends on the symptoms.

In case of chronic diseases, it can be used for a long time.

What to do if you take an overdose of Gelomyrtol forte?

Notify your doctor. Your doctor will decide what measures to take. The side effects listed below may increase.

If you forget to take Gelomyrtol forte

Do not take a double dose to make up for a missed dose.

If you miss a dose, continue to take Gelomyrtol forte as usual, as prescribed by your doctor or as indicated in the dosing recommendations.

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.

Uncommon (occurs in ≥ 1/1,000 to < 1/100 users)

Gastrointestinal disorders such as stomach pain, upper abdominal discomfort, taste changes and rarely nausea, vomiting or diarrhoea.

Rare (occurs in ≥ 1/10,000 to < 1/1,000 users)

Hypersensitivity reactions (such as skin rash, itching, swelling of the face, shortness of breath or impaired circulation).

Very rare (occurs in < 1/10,000 users)

Movement of existing kidney stones in the ureters or movement of gallstones in the bile ducts.

5. How to store Gelomyrtol.

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

Store at a temperature not higher than 25 ºC.

Store in the manufacturer's packaging to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.

The drug is suitable for use until the last day of the specified month.

Medicines must not be disposed of in the sewer or with household waste.

Ask your pharmacist how to dispose of unnecessary medicines. These measures will help protect the environment.

6. Package contents and other information.

Gelomyrtol forte composition - Active ingredient: Each gastro-resistant soft capsule contains 300 mg of purified eucalyptus, sweet orange, myrtle and lemon essential oil blend (66:32:1:1) distillate.

- Excipients are: Refined rapeseed oil, gelatin, glycerol (85%), liquid sorbitol (non-crystallizing) (E420), hypromellose acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, dextrin, ammonium glycyrrhizate, dilute hydrochloric acid.