SINUPRET

SINUPRET forte coated tablets

Important notes (Mandatory information)

Sinupret forte coated tablets. Indications: for acute and chronic inflammation of the paranasal sinuses.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sinupret forte coated tablets for use in adolescents from 12 years and adults
Active ingredients: powdered verbena, powdered gentian root, powdered common sorrel herb, powdered elderflower, powdered primula flower with calyx
Herbal medicinal product

Read the entire package leaflet carefully, as it contains important information for you. This medicinal product is available without prescription. However, to achieve the best possible treatment success, Sinupret forte must be used correctly.

• Keep this package leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If your symptoms worsen or do not improve after 7–14 days, you must consult a doctor.
• If any of the listed side effects seriously affect you, or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

This package leaflet contains

1. WHAT IS SINUPRET FORTE AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING SINUPRET FORTE?
3. HOW TO TAKE SINUPRET FORTE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SINUPRET FORTE?
6. FURTHER INFORMATION

1. WHAT IS SINUPRET FORTE AND WHAT IS IT USED FOR?

Sinupret forte is a herbal medicinal product for inflammation of the paranasal sinuses. Sinupret forte is used for acute and chronic inflammation of the paranasal sinuses.

2. WHAT YOU NEED TO KNOW BEFORE TAKING SINUPRET FORTE?

Do not take Sinupret forte if you are hypersensitive (allergic) to gentian root, verbena, common sorrel herb, elderflower, primula flower or any of the other ingredients of the medicinal product (other ingredients see under point 6 Further information).

Special precautions for taking Sinupret forte

If symptoms persist for more than 7 - 14 days or recur periodically, a doctor should be consulted.

Children

The medicinal product should not be used in children under 12 years of age. There are currently no sufficient studies on the use of Sinupret forte in children under 12 years of age.

When taking Sinupret forte with other medicinal products

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicinal products, including non-prescription medicinal products. No interactions with other medicinal products are known to date.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicinal products. Like all medicinal products, Sinupret forte should only be used during pregnancy and breastfeeding after careful benefit-risk assessment by the doctor.

Driving and operating machinery

No special precautions are required.

Important information about certain other ingredients of Sinupret forte

This medicinal product contains the sugars glucose, lactose, sucrose and sorbitol. Please take Sinupret forte only after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE SINUPRET FORTE?

Always take Sinupret forte exactly as instructed in this package leaflet. Please ask your doctor or pharmacist if you are not entirely sure. Unless otherwise prescribed by the doctor, the usual dose is: Adults and adolescents from 12 years: Single dose 1 coated tablet, total daily dose 3 coated tablets (3 times 1 coated tablet).

Method of administration

Sinupret forte is swallowed 3 times a day (morning, noon, evening) unchewed with some liquid (e.g. a glass of water). Sinupret forte can be taken with food, with drinks or independently of meals. If you have a sensitive stomach, you should preferably take Sinupret forte after meals.

Duration of administration

The duration of administration is 7 - 14 days, unless otherwise prescribed. If no improvement occurs by then, please consult a doctor.

If you have taken a larger quantity of Sinupret forte than you should

If you have taken a larger quantity of Sinupret forte than you should, please notify a doctor. They can decide on any necessary measures. The side effects listed below may occur more severely.

If you have forgotten to take Sinupret forte

If you have accidentally taken too little or forgotten to take Sinupret forte, do not take double the amount next time, but continue taking Sinupret forte as prescribed by your doctor or described in the package leaflet.

If you stop taking Sinupret forte

Discontinuing Sinupret forte is generally harmless.

If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicinal products, Sinupret forte can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequency information is used as a basis:
Very common:	more than 1 in 10 treated patients
Common:	1 to 10 in 100 treated patients
Uncommon:	1 to 10 in 1,000 treated patients
Rare:	1 to 10 in 10,000 treated patients
Very rare:	less than 1 in 10,000 treated patients
Not known:	Frequency cannot be estimated from the available data.

Significant side effects or signs you should look out for, and measures if you are affected

Occasionally, gastrointestinal complaints (including stomach pain, nausea) may occur. Rarely, hypersensitivity reactions of the skin (skin rash, skin redness, itching) as well as severe allergic reactions (swelling of the lips, tongue and throat and/or larynx with airway narrowing (angioedema), shortness of breath, facial swelling) may occur. At the first sign of a hypersensitivity reaction, Sinupret forte must not be taken again. If side effects occur, the preparation should be discontinued and a doctor consulted. The doctor can decide on the severity and any further necessary measures.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. HOW TO STORE SINUPRET FORTE?

Do not store above 30°C. Keep medicinal products out of the reach of children. Do not use the medicinal product after the expiry date stated on the folding carton or blister pack. The expiry date refers to the last day of that month.

6. FURTHER INFORMATION

What Sinupret forte contains

The active ingredients are: 1 coated tablet contains as medicinally active ingredients: powdered verbena 36 mg, powdered gentian root 12 mg, powdered common sorrel herb 36 mg, powdered elderflower 36 mg, powdered primula flower with calyx 36 mg. The other ingredients are: Calcium carbonate (E 170); chlorophyll powder 25% (E 141);