Syrup. Ivy extracts.

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

– Save this information, you may need to read it again.

– If you need further information or advice, please contact the pharmacy staff.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

– You must talk to a doctor if you do not feel better or if you feel worse after 7 days of use.

In this leaflet:
1. What Hedexin is and what it is used for
2. What you need to know before you use Hedexin
3. How to use Hedexin
4. Possible side effects
5. How to store Hedexin
6. Contents of the packaging and other information

1. What Hedexin is and what it is used for

Hedexin is an herbal medicine used to help relieve cough with tough mucus.

The product contains a dry extract of leaves from ivy ( Hedera helix L.).

Hedexin is intended for adults, adolescents, and children from 2 years of age.

Talk to your doctor if you do not feel better or if you feel worse after 7 days of use.

2. What you need to know before using Hedexin

Do not use Hedexin

– if you are allergic to ivy, other aralia plants, or any of the other ingredients of this medicine (listed in section 6).

– in children under 2 years of age due to the risk of worsening of respiratory symptoms.

Warnings and cautions

Talk to your doctor or pharmacist before taking Hedexin.

In case of shortness of breath, fever, or prolonged vomiting, seek medical advice immediately.

If you have stomach problems, such as heartburn, abdominal burning, stomach pain, nausea, or stomach ulcers, you should consult a doctor before taking Hedexin.

At the first sign of a severe allergic reaction, stop taking this medicine immediately and consult a doctor (see section 4).

Children and young people

Children aged 2-4 years who suffer from prolonged or recurrent cough should be examined by a doctor before treatment.

Other medicines and Hedexin

In case of contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken this over-the-counter medicine.

There are no reports that Hedexin affects or is affected by other medicines. Concomitant use of Hedexin and other drugs has not been studied.

Hedexin with food, drink and alcohol

No effects of concomitant consumption of food, drink, or alcohol has been reported.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

In the absence of adequate data, the use of Hedexin during pregnancy or lactation is not recommended.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Hedexin contains excipients

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you do not tolerate certain sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder that prevents you from breaking down fructose, talk to your doctor before (or your child) is taking this medicine.

Children may experience gastrointestinal discomfort and a mild laxative effect.

3. How to use Hedexin

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults and adolescents from 12 years: 6 ml of syrup twice daily.

Children 6 – 11 years: 4 ml of syrup twice daily.

Children 2 – 5 years: 2 ml of syrup twice daily.

Use in children

Children aged 2-4 years who have a prolonged or recurrent cough should be examined by a doctor before treatment.

Hedexin should not be given to children under 2 years of age (see section “Do not use Hedexin”).

Method of administration

Hedexin syrup should be swallowed.

Use the supplied measuring spoon with graduations of 2 and 4 ml.

Dose a 6 ml is taken preferably with a tablespoonful (4 ml) + a half tablespoon (2 mL).

Shake the bottle before use.

Usage time

Talk to a doctor if you do not feel better or if you feel worse after 7 days.  

If you take more Hedexin then you should

Overdose can cause nausea, vomiting, diarrhea, and anxiety.

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Hedexin

Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur during treatment with Hedexin:

Common (may affect up to 1 in 10 people):

– Nausea, vomiting, diarrhea

Uncommon (may affect up to 1 in 100 people):

– Allergic reactions (hives, rash, anaphylactic reaction, shortness of breath)

At the first sign of a severe allergic reaction , stop taking this medicine immediately and consult a doctor.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hedexin

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

Do not store above 25 ° C after the first opening.

6. Contents of the packaging and other information

Content declaration

– The active substance is a dry ivy extract. 1 ml of syrup contains 8.25 mg of dry extract of ivy ( Hedera helix L.) folium, corresponding to 33-66 mg of dried leaves of ivy. Extractant: ethanol 36% V / V (30% m / m).

The other ingredients are liquid sorbitol (non-crystallising) (E 420), potassium sorbate, xanthan gum, anhydrous citric acid and water.

What the medicine looks like and contents of the pack

Hedexin syrup is a brown, opalescent liquid with a sweet taste that may have a little precipitate.

The package contains a brown glass bottle with 100 ml of Hedexin syrup , as well as a measuring spoon (with a graduation of 2 ml and 4 ml).

Marketing Authorization Holder and Manufacturer

Phytopharm Klęka SA

Klęka 1, 63 – 040 Nowe Miasto nad Wartą,

Poland

Tel .: + 48 61 28 68 700

Fax: + 48 61 28 68 709

Local representative:

Sana Pharma Medical AS

Muhammad Nadeem

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