Sinuc Dragees, 20 pcs

Instructions for use for Sinuc Dragees, 20 pcs

Important notes (compulsory information):

Sinuc 25 mg coated tablets. Active substance: Ivy leaves dry extract. Applications: For colds of the respiratory tract; To improve the complaints in chronic inflammatory bronchial diseases. For longer-lasting complaints or at the occurrence of respiratory distress, fever as well as a purulent or bloody ejection, a doctor should be consulted immediately. Contain. Lactose u. Sucrose.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


Instructions for use: Information for patients
SINUC® plated tablets
Active substance: ivy leaves dry extract 25 mg / coated tablet

Read the entire leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine as described in this leaflet or just as your doctor or pharmacist is directed.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse after 1 week, contact your doctor.

What is in this leaflet

1. What is Sinuc and what is it used for?
2. What should you consider before taking Sinuc?
3. How to take Sinuc?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep SINUC?
6. Content of the pack and further information

1. What is Sinuc and what is it used for?

Sinuc is a PFL embossing medicine used as a mucous engine in productive cough.

2. What should you consider before taking Sinuc?

SINUC must not be taken,

• if you allergic against ivy, plants from the family of the Aralienges, z. B. Radiationalia (Scheffleara) or one of the other ingredients of this medicine referred to in Section 6
• from children under 2 years.

Warnings and Precautions
Please talk to your doctor or pharmacist before taking Sinuc. For fever, respiratory distress, purulent or bloody ejection as well as complaints that last longer than 1 week or unclear complaints, a doctor should be visited. Sinuc should not with cough-style medicines without a medical advice, such. B. Codein or Dextromethorphan are used.

Take special care with SINUC for patients with gastric mucosal inflammation (gastritis) or gastric ulcer because ivy preparations can cause irritation of the gastric mucosal.

children
For the use of this medicine in children, there are no sufficient investigations on the effectiveness of age-appropriate dosage and to compatibility. This medicine should therefore not be used in children under 12 years.

Taking SINUC together with other medicines
Inform your doctor or pharmacist if you take / use other medicines, recently taken / applied / applied or intend to take / use other medicines. Interactions with other medicines were not investigated. So far, no interactions have become known.

Taking SINUC along with food, drinks and alcohol
There are no special features to consider.

pregnancy and breast feeding period
If you are pregnant or breastfeeding, or if you suspect to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Sinuc should be in pregnancy and during the lactation is not applied because there are no sufficient investigations.

Driving and ability to use machines
There are no special precautions required.

SINUC contains sucrose (sugar) and lactose (less than 0.1 each G per coated tablet)
Please take SINUC only after consulting your doctor if you are familiar with any intolerance to certain sugars.

3. How to take Sinuc?

Always take this medicine exactly as described in this leaflet or just according to the consultation made with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure.

The recommended dose is
Adults and adolescents over 12 years 2 times a day 1 Plated tablet (corresponding to 300 mg drug per day).

Application in children
For children under 12 years, the application is not provided.
There are no sufficient data for concrete dosage recommendations for renal / liver function.

type of application
To take

Remove the coated tablets with sufficient fluid (preferably 1 glass of drinking water). Do not take over-covered tablets.

Duration of the application
Do not take SINUC without a medical advice no longer than 1 week. Please note the information under Section 2. Please contact your doctor or pharmacist if you have the impression that the effect of SINUC is too strong or too weak.

If you take a greater amount of SINUC than you should
Taking 1-2 tablets more than recommended, normally has no consequences. An intake of significantly higher amounts can cause nausea, vomiting, diarrhea and unrest. A 4-year-old child developed according to the accidental intake of an ivy extract according to 1800 mg of plant drug aggressiveness and diarrhea. In this case, you should consult your doctor.

If you forget to take SINUC
Do not take the double amount if you have forgotten the previous ingestion, but use the document as prescribed by the doctor or described in the package leaflet. If you have further questions about the application of this medicine, contact your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

The enumeration includes all known side effects under treatment with dry extract from ivy leaves, including those under higher dosage or long-term therapy.

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

possible side effects
Frequently, gastrointestinal discomfort (eg nausea, vomiting, diarrhea) can occur. Occasionally, after taking ivy-containing medicines, allergic reactions of the skin, z. B. Rash (Exanthem), Hesselucht (urticaria), roughness, itching, or serious systemic allergic states, eg. B. with swelling, respiratory distress, occur. In the first signs of a hypersensitivity reaction, SINUC may not be taken again. If necessary, a doctor is to visit.

Message of side effects
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leafletd. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de, ads. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep SINUC?

Keep this medicine inaccessible to children.

You may not use the drug after the expiry date specified on the blister and the outer carton to "usable until". The expiry date refers to the last day of the specified month.

Retention conditions
Do not store over 25 ºC.

Do not dispose of medicines in the wastewater. Ask your pharmacist how to dispose of the medicine if you do not use it anymore. You help to protect our environment.

6. Content of the pack and further information

What Sinuc contains
The active ingredient is: ivy leaves dry extract
1 Plated tablet contains 25 mg dry extract from ivy leaves in a ratio of drug to extract as 4-8: 1. The extension means is ethanol 30% (m / m).

The other ingredients are:
Arab rubber; Calcium carbonate; microcrystalline cellulose; Cellulose powder; Lactose monohydrate; Magnesium stearate (Ph.eur.); Montanglycol wax; Poly (O -Carboxymethyl) starch, sodium salt; Eudragit E 100; Sucrose (sugar); Hochdisperses silicon dioxide; Stearic acid (Ph.eur.); Talc; Titanium dioxide (E 171)

Like Sinuc looks and content of the pack
Sinuc is available in packs with 20, 40 and 100 plated tablets. Not all pack sizes may be placed on the market.

Pharmaceutic entrepreneur
Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: [email protected]

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Bar life

This leaflet was last revised in January 2013.

Source: Information of the leaflet
Status: 08/2014