SINUPRET EXTRACT COATED TABLETS

Introduction

Patient Information: Summary of Product Characteristics

Sinupret extract, coated tablets

Dry extract obtained from a mixture of gentian root, primrose flowers, sorrel, elderflower, and verbena

Read the entire summary of product characteristics carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this summary or as indicated by your doctor or pharmacist.

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

Summary of Product Characteristics

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 side effects
5. Storage of Sinupret extract
6. Package contents and additional information

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

Sinupret extract is a herbal medicine for the treatment of nasal congestion, which promotes secretion.

Congestion often presents with headaches and facial pain, which can worsen when leaning forward or pressing the affected area of the face with the thumb. It is also often accompanied by a feeling of pressure on the face, especially around the nose.

2. What you need to know before taking Sinupret extract

Do not take Sinupret extract:

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you have a peptic ulcer.

Warnings and precautions

Consult your doctor if symptoms persist for more than 7-14 days, worsen, or recur periodically, or if you have a fever, nosebleeds, acute pain, purulent nasal secretions, vision problems, facial deformity or eye problems, or facial numbness.

Special care is recommended when taking this medication in patients who suffer from gastritis or have a sensitive stomach. It is recommended to take Sinupret extract after meals with a glass of water.

Children and adolescents

Due to the lack of sufficient data, the use of Sinupret extract is not recommended in children and adolescents under 18 years of age.

Other medications and Sinupret extract

No systematic interaction studies have been conducted. Therefore, it cannot be ruled out 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 may need to take any other medication.

Pregnancy and breastfeeding

For safety reasons, avoid taking Sinupret extract if you are pregnant.

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

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Some patients, when taking Sinupret extract, may experience dizziness that could affect their ability to drive and operate machinery (see section 4).

Sinupret extract contains glucose and sucrose

This medication contains glucose and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Indication for diabetics:

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

3. How to take Sinupret extract

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

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

There is not enough data to make dosage recommendations in patients with renal or hepatic function impairment.

Method of administration

Take Sinupret extract whole (without chewing) with some liquid (e.g., a glass of water), 3 times a day (morning, afternoon, and evening). If you have a sensitive stomach, it is recommended to take Sinupret extract after meals.

Duration of treatment

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

If you take more Sinupret extract than you should

Inform your doctor if you have taken a larger amount of Sinupret extract than you should. Your doctor will decide on the necessary measures. The side effects listed below (e.g., nausea, stomach pain, diarrhea) may be more intense.

If you forget to take Sinupret extract

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

If you stop taking Sinupret extract

Stopping treatment with Sinupret extract is generally harmless.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Common side effects (may affect 1 in 10 people)

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

Uncommon side effects (may affect 1 in 100 people)

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

Dizziness.

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

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

In case of any sign of hypersensitivity, stop treatment with Sinupret extract.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this summary. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Sinupret extract

Do not store above 30°C.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the box and blister package after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point.

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

6. Package contents and additional information

Composition of Sinupret extract

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

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

Each tablet contains 160.00 mg of dry extract.

• The other ingredients 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, liquid, vegetable magnesium stearate, stearic acid, chlorophyll powder 25% (contains copper complexes of chlorophyllins, E141), aluminum lake indigo carmine (contains indigo carmine E132 and aluminum hydroxide), carnauba wax, and riboflavin (E101).

Appearance of Sinupret extract and package contents

Box with 20 coated tablets, in 2 blisters of 10 coated tablets each.

Box with 40 coated tablets, in 4 blisters of 10 coated tablets each.

Only some package sizes may be marketed.

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

Marketing authorization holder and manufacturer

BIONORICA SE

Kerschensteinerstrasse 11-15

92318 Neumarkt (Germany)

Phone: +49 (0)9181 231-90 Fax: +49 (0)9181 231-265 Email: [email protected]

Date of last revision of this summary: August 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.