Sinupret Extract coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sinupret extract, coated tablets

Dried extract obtained from a mixture of gentian root, primrose flowers, sorrel, elder flowers and verbena

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7–14 days.

Contents of the leaflet

1. What Sinupret extract is and what it is used for
2. What you need to know before taking Sinupret extract
3. How to take Sinupret extract
4. Possible adverse effects
5. How to store Sinupret extract
6. Contents of the pack and other information

1. What Sinupret extract is and what it is used for

Sinupret extract is a herbal medicinal product used for the treatment of nasal congestion, promoting secretion.

Congestion is often accompanied by headaches and facial pain, which usually intensify when bending forward or pressing with the thumb on the affected area of the face. It is also commonly associated with a sensation of pressure in the face, especially around the nose.

2. What you need to know before starting to take Sinupret extract

Do not take Sinupret extract:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have peptic ulcer disease.

Warnings and precautions

Consult your doctor if symptoms persist for more than 7–14 days, worsen, or recur periodically, or if you develop fever, nosebleeds, acute pain, purulent nasal discharge, vision problems, facial deformity, or facial numbness.

Special caution is recommended for patients suffering from gastritis or having a sensitive stomach. It is recommended to take Sinupret extract after meals with a glass of water.

Children and adolescents

Due to insufficient data, use is not recommended in children and adolescents under 18 years of age.

Other medicines and Sinupret extract

No systematic interaction studies have been conducted. For this reason, it cannot be excluded that Sinupret extract may increase or decrease the effects of other medicinal products.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

As a precautionary measure, avoid taking Sinupret extract during pregnancy.

It is unknown whether Sinupret extract is excreted in breast milk. Sinupret extract should not be used during breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Some patients may experience dizziness after taking Sinupret extract, which could affect their ability to drive or operate machinery (see section 4).

Sinupret extract contains glucose and sucrose

This medicine contains glucose and sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

Information for diabetics:

One coated tablet contains an average of 0.3 g of digestible carbohydrates.

3. How to take Sinupret extract

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults: 1 coated tablet, 3 times daily (a maximum of 3 coated tablets per day).

There are insufficient data available to make dose recommendations in patients with impaired renal/hepatic function.

Method of administration

Take Sinupret extract whole (without chewing) with some liquid (e.g., a glass of water), 3 times daily (morning, afternoon, and evening). If you have a sensitive stomach, we recommend taking Sinupret extract after meals.

Duration of treatment

Unless otherwise indicated, the treatment duration is 7 to 14 days. You should consult a doctor if you do not improve during treatment or if symptoms persist after completion of treatment.

If you take more Sinupret extract than you should

Inform your doctor if you have taken more Sinupret extract than you should. Your doctor will decide on any necessary measures. The adverse effects listed below (e.g., nausea, stomach pain, diarrhea) could become more intense.

If you forget to take Sinupret extract

If you have taken a lower dose of Sinupret extract by mistake or if you forgot to take Sinupret extract, do not take a double dose to make up for the missed doses. Continue treatment as directed by your doctor or as described in this leaflet.

If you stop treatment with Sinupret extract

Stopping treatment with Sinupret extract is generally harmless.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Frequent adverse effects (may affect up to 1 in 10 people)

Gastrointestinal disorders, e.g.: nausea, flatulence, diarrhea, dry mouth, stomach pain.

Frequent adverse effects (may affect up to 1 in 100 people)

Local hypersensitivity reactions (rashes, skin redness, itching of the skin or eyes).

Dizziness.

Frequency not known (frequency cannot be estimated from available data)

Severe allergic reactions (swelling of lips, tongue and throat or larynx with narrowing of the airways, difficulty breathing or facial swelling).

If you notice any signs of hypersensitivity, discontinue treatment with Sinupret extract immediately.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sinupret extract

Do not store at temperatures above 30°C.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and packaging (blister) after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at a SIGRE collection point at your pharmacy.

Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sinupret extract

• The active substance is a natural dry extract (3-6:1) obtained from the mixture (1:3:3:3:3) of gentian root (Gentiana lutea L.), primrose flowers (Primula veris L.), sorrel (Rumex crispus L.), elder flowers (Sambucus nigra L.), and vervain (Verbena officinalis L.).

First extraction solvent: ethanol 51% (m/m).

Each tablet contains 160.00 mg of dry extract.

• The other components are sucrose, talc, calcium carbonate (E170), microcrystalline cellulose, maltodextrin, powdered cellulose, hypromellose, dextrin, spray-dried acacia, hydrophobic colloidal silica, anhydrous colloidal silica, titanium dioxide (E171), glucose syrup, magnesium stearate [vegetable], stearic acid, powdered chlorophyll 25% (containing copper complexes of chlorophyllins, E141), aluminium lake indigo carmine (containing indigo carmine E132 and aluminium hydroxide), carnauba wax, and riboflavin (E101).

Appearance of Sinupret extract and contents of the pack

Pack containing 20 coated tablets, in 2 blisters of 10 coated tablets each.

Pack containing 40 coated tablets, in 4 blisters of 10 coated tablets each.

Only some pack sizes may be marketed.

Sinupret extract coated tablets are green in colour, round, biconvex, and have a smooth surface.

Marketing Authorization Holder and Manufacturer

BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt (Germany)
Tel.: +49 (0)9181 231-90
Fax: +49 (0)9181 231-265
Email: [email protected]

Date of the most recent revision of this leaflet: August 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.