Respiromed

Package leaflet: Information for the patient

Respiromed, 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
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

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

1. What Respiromed is and what it is used for

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

2. Important information before taking Respiromed

When not to take Respiromed

• 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 Respiromed, consult your doctor or pharmacist.

• If the patient suffers from a condition involving significant airway hypersensitivity.
• If the patient has bronchial asthma, treatment with Respiromed should be carried out under medical supervision.
• If symptoms persist for more than one week, or if dyspnea, fever, or purulent or bloody sputum occur, medical advice should be sought.

Respiromed and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Animal studies have shown that 1,8-cineole induces hepatic enzyme metabolism. Therefore, it cannot be excluded that high doses of 1,8-cineole may reduce or shorten the effect of other medicines.
Such an effect has not been observed in humans so far.

Pregnancy and breastfeeding

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

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

Breastfeeding
1,8-cineole passes into breast milk after oral administration. However, no noticeable problems have been reported so far in infants breastfed by women taking 1,8-cineole.

Driving and operating machinery
No special precautions are required.

Respiromed 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 per capsule, meaning the medicine is considered "sodium-free".

3. How to take Respiromed

This medicine should always be taken as directed by the doctor or pharmacist.
If in doubt, consult the doctor or pharmacist.
Recommended dose:

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

Note for diabetic patients:
One capsule of Respiromed 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:
Respiromed capsules should be swallowed whole (do not chew), with an adequate 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 there is a perception that the effect of Respiromed is too strong or too weak.

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

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

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Not common (occurring in no more than 1 in 100 patients):
Gastrointestinal disorders (e.g. nausea, diarrhoea).

Rare (occurring in no more than 1 in 1000 patients):
Hypersensitivity reactions (e.g. facial swelling, itching, breathing difficulties, cough) and difficulty swallowing.

If signs of hypersensitivity reactions occur, discontinue use of Respiromed immediately and contact a doctor or the emergency department of the nearest hospital.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Respiromed

Store below 30°C.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Respiromed contains
The active substance in the medicinal product 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 - Nutrateric suspension (ethylcellulose, medium-chain triglycerides, oleic acid, concentrated ammonium hydroxide, purified water), NS Enteric - Nutrateric (sodium alginate, stearic acid), Candelilla wax.

What Respiromed looks like and contents of the pack
Enteric soft capsules.
The capsules are oval and colourless.
Aluminium/PVC/PVDC blister pack 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