Soledum iunior

Leaflet attached to the packaging: patient information

Soledum junior, 100 mg, enteric-coated soft capsules

Cineolum

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 7 days there is no improvement or the patient feels worse, the doctor should be contacted.

Table of contents of the leaflet

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

1. What is Soledum junior and what is it used for

The active substance of the medicine is 1,8-cyneol, which soothes inflammatory conditions in the respiratory tract, supports
the removal of excess secretions from the sinuses and bronchi, making it easier to cough up and relieving cough.
Soledum junior is used as an expectorant in productive cough (also known as wet cough), as a supportive treatment for acute, non-purulent sinusitis and as a supportive treatment for inflammatory respiratory diseases.
If after 7 days there is no improvement or the patient feels worse, the doctor should be consulted.

2. Important information before taking Soledum junior

When not to take Soledum junior

• if the patient is allergic to 1,8-cyneol or any of the other ingredients of this medicine (listed in section 6);
• in case of pertussis or pseudo-pertussis;
• in infants and children under 2 years of age.

Warnings and precautions

Before starting to take Soledum junior, the doctor or pharmacist should be consulted.

• If the patient has a disease associated with significant hypersensitivity of the respiratory tract.
• If the patient has bronchial asthma, treatment with Soledum junior should be carried out only under medical supervision.
• If symptoms persist for more than a week, if shortness of breath (breathing difficulties), fever or purulent or bloody coughing up of secretions occur, medical advice should be sought.
• Use in children under 6 years of age is not recommended.

Soledum junior and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as about medicines the patient plans to take.
In animal studies, it has been shown that 1,8-cyneol induces liver enzyme metabolism. Therefore, it cannot be ruled out that high doses of 1,8-cyneol may weaken or shorten the effect of other medicines.
So far, such an effect has not been observed in humans.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Pregnancy
There are no available data on the use of Soledum junior during pregnancy.
In case of pregnancy, Soledum junior can be used only after consulting a doctor.
In animal studies, it has been found that 1,8-cyneol, the active substance of Soledum junior, crosses the placental barrier into the fetal bloodstream. However, the results of animal studies so far do not indicate any fetal malformations.
Breastfeeding
1,8-cyneol passes into breast milk after oral administration, but so far, no noticeable problems have been reported in breastfed infants of mothers taking 1,8-cyneol. Soledum junior can be used during breastfeeding.

Driving and using machines

No special precautions are necessary.

Children

The use of Soledum junior is recommended for children from 6 years of age and older, and for children under 8 years of age, it should be supervised by a doctor. Use in children under 6 years of age is not recommended, and in children under 2 years of age, it is contraindicated.

Warnings about excipients

Soledum junior contains sorbitol and sodium.

Sorbitol

The medicine contains 11 mg of sorbitol (non-crystallizing liquid sorbitol) (E 420) per capsule.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".
One capsule of Soledum junior corresponds to 0.0013 carbohydrate units.
This should be taken into account in patients with diabetes.

3. How to take Soledum junior

This medicine should always be taken as advised by the doctor or pharmacist.
In case of doubt, the doctor or pharmacist should be consulted.
Recommended dose:

Children from 6 to 12 years of age: 1 capsule 3 times a day.
Adults and adolescents over 12 years of age: take 2 capsules 3 times a day.
In continuation of therapy or long-term treatment, a dose of 2 capsules 2 times a day is usually sufficient.
The duration of treatment should be adjusted according to the nature, severity, and progression of the disease. Patients should consult a doctor if symptoms persist for more than a week, if shortness of breath, fever, or purulent or bloody coughing up of secretions occur.
Method of administration:
Soledum junior should be swallowed whole (not chewed), with a sufficient amount of water at room temperature (preferably a 200 ml glass of water), about half an hour before a meal.
In case of a sensitive digestive system, the capsules should be taken during meals.
The doctor or pharmacist should be consulted if the patient feels that the effect of Soledum junior is too strong or too weak.

Taking a higher dose of Soledum junior than recommended

There are no detailed data on the symptoms of overdose of Soledum junior.
The doctor should be contacted if the patient suspects that they have taken too many capsules of Soledum junior. The doctor will decide on the course of action, taking into account the severity of the poisoning symptoms.
Possible symptoms of overdose of Soledum junior include central nervous system disorders such as impaired consciousness, fatigue, limb weakness, pupil constriction, and in severe cases, coma and respiratory disorders.

Missing a dose of Soledum junior

A double dose should not be taken to make up for a missed dose.
In case of any further questions about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Soledum junior can cause side effects, although not everybody gets them.
The use of Soledum junior should be stopped immediately if signs of hypersensitivity occur.
Uncommon (less than 1 in 100 patients)
Gastrointestinal disorders: nausea, diarrhea.
Rare (less than 1 in 1000 patients)
Hypersensitivity reactions (e.g., facial swelling, itching, breathing difficulties, cough) and swallowing difficulties.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. 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, tel.: +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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Soledum junior

Store at a temperature below 30 ºC.
The medicine should be stored out of sight and reach of children.
This medicine should not be used after the expiry date (EXP) stated on the carton and blister.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked what to do with unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Soledum junior contains

The active substance of the medicine is 1,8-cyneol (Cineolum).
One enteric-coated soft capsule contains 100 mg of 1,8-cyneol (Cineolum).
The other ingredients are: medium-chain triglycerides; Soft capsule shell: gelatin, liquid sorbitol, non-crystallizing (E 420), glycerol 85%, purified water; Enteric coating: Surelease - Nutrateric suspension (ethylcellulose, medium-chain triglycerides, oleic acid, ammonium hydroxide, purified water), NS Enteric - Nutrateric (sodium alginate, stearic acid), Candelilla wax.

What Soledum junior looks like and contents of the pack

Enteric-coated soft capsules.
The capsules are oval and colorless.
Aluminium/PVC/PVDC blister pack in a cardboard box.
The pack contains 20, 50, or 100 enteric-coated soft capsules.

Marketing authorization holder and manufacturer Marketing authorization holder:

M.C.M. Klosterfrau Healthcare Sp. z o.o.
ul. Hrubieszowska 2
01-209 Warsaw
Poland
tel. +48 22 231 8287
Manufacturer:
Klosterfrau Berlin GmbH
Motzener Strasse 41
12277 Berlin
Germany
Artesan Pharma GmbH & Co. KG
Wendlandstr. 1
29439 Lüchow
Germany

Date of last revision of the leaflet: