Soledum forte

Patient Information Leaflet

Soledum forte, 200 mg, enteric soft capsules
Cineolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the physician 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 adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement within 7 days, or if you feel worse, consult your doctor.

Table of Contents:

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

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

2. Important information before taking Soledum forte

When not to take Soledum forte

• if the patient is allergic to 1,8-cineole or to any of the other ingredients of this medicine (listed in section 6);
• in cases of whooping cough or pseudo-whooping cough;
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Soledum forte, discuss it with your doctor or pharmacist.

• If the patient suffers from a condition associated with marked hypersensitivity of the respiratory tract.
• If the patient has bronchial asthma, treatment with Soledum forte should be supervised by a doctor.
• If symptoms persist for more than one week, or if shortness of breath, fever, or purulent or bloody sputum occur, medical advice should be sought.

Soledum forte 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.

Animal studies have shown that 1,8-cineole induces enzyme metabolism in the liver. Therefore, it cannot be ruled out that high doses of 1,8-cineole may weaken or shorten the effect of other medicines.
To date, such an effect has not been observed in humans.

Pregnancy and breastfeeding

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

Pregnancy
There are no available data on the use of Soledum forte during pregnancy.
Soledum forte should be used during pregnancy only after consultation with a doctor.
Animal studies have shown that 1,8-cineole – the active substance of Soledum forte – crosses the placental barrier into the fetal circulation in rats. However, the available results from animal studies do not indicate the occurrence of any fetal abnormalities.

Breastfeeding
1,8-cineole passes into the breast milk of nursing women after oral administration, but to date no noticeable problems have been reported in infants breastfed by women taking 1,8-cineole.

Driving and operating machinery
No special precautions are necessary.

Soledum forte contains sorbitol and sodium.

Sorbitol
The medicine contains 17 mg of sorbitol (liquid sorbitol 70% (non-crystallizing)) (E 420) in each capsule.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium in each capsule, meaning the medicine is considered "sodium-free".

3. How to take Soledum forte

This medicine should always be taken according to the doctor's or pharmacist's instructions.
If in doubt, consult a doctor or pharmacist.
Recommended dose:

Adults and adolescents over 12 years of age: take 1 capsule three times daily.
For continuation of therapy or long-term treatment, a dose of 1 capsule twice daily is usually sufficient.

Note for diabetic patients:
One capsule of Soledum forte corresponds to 0.0015 carbohydrate exchange unit.

The duration of treatment should be adjusted according to the nature, severity, and progression of the disease. Patients should consult a physician if symptoms persist for more than one week, or if dyspnea, fever, or bloody or purulent sputum occur.

Method of administration:
Soledum forte capsules should be swallowed whole (not chewed), with a sufficient amount of water at room temperature (preferably a glass of water, 200 ml), approximately half an hour before meals.
In patients with sensitive stomach, capsules should be taken during meals.

Consult a physician or pharmacist if you feel the effect of Soledum forte is too strong or too weak.

Overdose of Soledum forte
There are no reports of poisoning with Soledum forte.
Contact a physician if the patient suspects having taken an excessive amount of Soledum forte capsules. The physician will decide on appropriate management based on the severity of poisoning symptoms.
Possible symptoms of Soledum forte poisoning include central nervous system disturbances such as altered consciousness, fatigue, limb weakness, miosis (pupillary constriction), and in severe cases, coma and respiratory disturbances.

Missed dose of Soledum forte
Do not take a double dose to make up for a missed dose.

If you have any further questions concerning the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone will experience them.
Uncommon (not more frequent than in 1 out of 100 patients):
Gastrointestinal disturbances (e.g. nausea, diarrhoea).
Rare (not more frequent than in 1 out of 1000 patients):
Hypersensitivity reactions (e.g. facial swelling, itching, breathing difficulties, cough) and
difficulty swallowing.
The use of Soledum forte should be discontinued immediately if signs of hypersensitivity
reactions occur.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Soledum forte

Store below 30ºC.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of the month indicated.
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 pack and other information

What Soledum forte contains
The active substance is 1,8-cineole (Cineolum).
One enteric soft capsule contains 200 mg of 1,8-cineole.
The other ingredients are: medium-chain triglycerides, gelatin, liquid sorbitol, non-crystallizing (E 420), 85% glycerol, purified water, Surelease suspension - Nutrateric (ethylcellulose, medium-chain triglycerides, oleic acid, concentrated ammonium hydroxide, purified water), NS Enteric - Nutrateric (sodium alginate, stearic acid), Candelilla wax.
What Soledum forte looks like and contents of the pack
Enteric soft capsules.
The capsules are oval and colourless.
Aluminium/PVC/PVDC blister in a cardboard box.
The pack contains 20, 50 or 100 enteric soft capsules.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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