Soledum forte

Package Leaflet: Information for the Patient

Soledum forte, 200 mg, gastro-resistant soft capsules

Cineolum

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 this package leaflet for the patient, or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should 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 Leaflet:

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

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

Soledum forte is used as an expectorant in the treatment of productive cough (also known as wet cough), as an adjunct in the treatment of acute, non-purulent sinusitis, and as an adjunct in the treatment of inflammatory respiratory tract diseases.
If after 7 days there is no improvement or you feel worse, you should consult your doctor.

2. Important information before taking Soledum forte

When not to take Soledum forte

• if you are allergic to 1,8-cineole or any of the other ingredients of this medicine (listed in section 6);
• in case of pertussis or pseudo-pertussis;
• in children under 12 years of age.

Warnings and precautions

Before taking Soledum forte, you should discuss it with your doctor or pharmacist.

• If you have a disease associated with significant hypersensitivity of the respiratory tract.
• If you have bronchial asthma, treatment with Soledum forte should be carried out under medical supervision.
• If symptoms persist for more than a week, if shortness of breath, fever, or purulent or bloody sputum occur, you should consult your doctor.

Soledum forte and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
In animal studies, it has been shown that 1,8-cineole induces liver enzyme metabolism. Therefore, it cannot be excluded that high doses of 1,8-cineole may weaken or shorten the effect of other medicines.
So far, such an effect has not been observed in humans.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no available data on the use of Soledum forte in pregnancy.
In case of pregnancy, Soledum forte can be used only after consulting a doctor.
In animal studies, it has been found that 1,8-cineole - the active substance of Soledum forte - 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-cineole passes into breast milk after oral administration, but so far, no noticeable problems have been reported in breastfed infants of mothers taking 1,8-cineole.

Driving and using machines

There is no need for special precautions.

Soledum forte contains sorbitol and sodium

Sorbitol

The medicine contains 17 mg of sorbitol (non-crystallizing 70% 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".

3. How to take Soledum forte

This medicine should always be taken exactly as advised by your doctor or pharmacist.
In case of doubt, you should consult your doctor or pharmacist.
Recommended dose:

Adults and adolescents over 12 years: take 1 capsule 3 times a day.
In continuation of therapy or long-term treatment, a dose of 1 capsule 2 times a day is usually sufficient.
Note for diabetic patients:
One capsule of Soledum forte corresponds to 0.0015 carbohydrate exchange units.
The duration of treatment should be adjusted according to the nature, severity, and progression of the disease. Patients should consult their doctor if symptoms persist for more than a week, if shortness of breath, fever, or bloody or purulent sputum occur.
Method of administration:
Soledum forte 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 sensitive stomach, capsules should be taken during meals.
You should consult your doctor or pharmacist if you feel that the effect of Soledum forte is too strong or too weak.

Taking a higher dose of Soledum forte than recommended

There are no reports of Soledum forte overdose.
You should contact your doctor if you suspect that you have taken too many Soledum forte capsules. The doctor will decide on the course of action, taking into account the severity of the overdose symptoms.
Possible symptoms of Soledum forte overdose include central nervous system disorders, such as impaired consciousness, fatigue, limb weakness, miosis (pupil constriction), and in severe cases, coma and respiratory disorders.

Missing a dose of Soledum forte

You should not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Soledum forte can cause side effects, although not everybody gets them.
Uncommon (less than 1 in 100 patients)
Gastrointestinal disorders (e.g., nausea, diarrhea).
Rare (less than 1 in 1,000 patients)
Hypersensitivity reactions (e.g., facial swelling, itching, respiratory difficulties, cough) and swallowing difficulties.
You should stop taking Soledum forte immediately if you experience signs of a hypersensitivity reaction.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, you can help provide more information on the safety of this medicine.

5. How to store Soledum forte

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Soledum forte contains

The active substance of Soledum forte is 1,8-cineole (Cineolum).
One gastro-resistant soft capsule contains 200 mg of 1,8-cineole.
The other ingredients are: medium-chain triglycerides, gelatin, non-crystallizing sorbitol (E 420), glycerol 85%, purified water, Surelease-Nutrateric suspension (ethylcellulose, medium-chain triglycerides, oleic acid, concentrated ammonia, purified water), NS Enteric-Nutrateric (sodium alginate, stearic acid), candelilla wax.

What Soledum forte looks like and contents of the pack

Gastro-resistant soft capsules.
The capsules are oval and colorless.
Aluminium/PVC/PVDC blister in a cardboard box.
The pack contains 20, 50, or 100 gastro-resistant 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: