Prospect: information for the patient

Sinupret extract, coated tablets

Dry extract obtained from the mixture of gentian root, primula flowers, sorrel, elderflower, and vervain

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

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

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

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

3. How to take Sinupret extract

4. Possible adverse effects

5. Conservation of Sinupret extract

6. Contents of the package and additional information

Sinupret extract is a plant-based medication for the treatment of nasal congestion, which promotes secretion.

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

Do not take Sinupret extract:

• if you are allergic to the active ingredient or to 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 from time to time, or if you have a fever, nasal bleeding, sharp pain, purulent nasal secretions, vision problems, facial deformity, or facial numbness.

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

Children and adolescents

Due to insufficient data, it is not recommended for use in children and adolescents under 18 years old.

Other medications and Sinupret extract

No systematic interaction studies have been conducted. Therefore, it cannot be ruled out that it may increase or decrease the effects of other medicinal products.

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

Pregnancy and breastfeeding

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

The excretion of Sinupret extract in breast milk is unknown. Sinupret extract should not be used during breastfeeding.

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

Driving and operating machinery

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

Sinupret extract contains glucose and saccharose

This medication contains glucose and saccharose. If your doctor has indicated 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.

Follow exactly 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 (a maximum of 3 coated tablets per day).

No sufficient data is available to make dosage recommendations for patients with renal/hepatic function impairment.

Administration form

Take Sinupret extract whole (do not chew) with some liquid (e.g., a glass of water), 3 times a day (morning, afternoon, and night). If you have a sensitive stomach, we recommend taking Sinupret extract after meals.

Treatment duration

Unless otherwise indicated, the treatment duration is 7 to 14 days. 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 any necessary measures. The adverse effects listed below (e.g., nausea, stomach pain, diarrhea) may be more intense.

If you forgot to take Sinupret extract

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

If you interrupt treatment with Sinupret extract

Interrupting treatment with Sinupret extract is generally harmless.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent adverse effects (may affect 1 in 10 people)

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

Frequent adverse effects (may affect 1 in 100 people)

Local hypersensitivity reactions (rashes, skin redness, skin or eye itching).

Dizziness.

Unknown frequency (frequency cannot be estimated from available data)

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

In the event of any hypersensitivity signs, discontinue treatment with Sinupret extract.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Do not store at temperatures above 30°C.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the packaging (blister) after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and the

medicines that you no longer need at the SIGRE collection pointof the pharmacy.

Ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. In this way, you will help protect the environment.

Composition of Sinupret extract

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

First solvent of extraction: ethanol at 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, liquid, magnesium stearate (vegetal), stearic acid, powdered chlorophyll 25% (contains copper complexes of chlorophyllins, E141), aluminium lake of indigo carmine (contains indigo carmine E132 and aluminium hydroxide), carnauba wax and riboflavin (E101).

Appearance of Sinupret extract and contents of the packaging

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 packaging sizes may be marketed.

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

Holder of the marketing authorization and responsible for manufacturing

BIONORICA SE

Kerschensteinerstrasse 11-15

92318 Neumarkt (Germany)

Phone: +49 (0)9181 231-90
Fax: +49 (0)9181 231-265
Email: info@bionorica.de

Last review date of this leaflet: August 2020

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