Download If you suffer from renal insufficiency or hepatic impairment, please

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
<(invented) name> syrup
Ivy leaf dry extract
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better after one week or if you feel worse.
What is in this leaflet
1.
What <(invented) name> syrup is and what it is used for
2.
What you need to know before you take <(invented) name> syrup
3.
How to take <(invented) name> syrup
4.
Possible side effects
5.
How to store <(invented) name> syrup
6.
Contents of the pack and other information
1.
What <(invented) name> syrup is and what it is used for
<(invented) name> syrup is a herbal medicinal product used as an expectorant in case of productive
cough, in adults, adolescents and children older than 2 years.
2.
What you need to know before you take <(invented) name> syrup
Do not use <(invented) name> syrup:
-
if you are allergic to ivy leaf or to plants of the Araliaceae family or to any of the other
ingredients in this medicine (listed in section 6)
-
in children under 2 years of age because of the risk of worsening of respiratory symptoms.
Warnings and precautions
Talk to your doctor or pharmacist before taking <(invented) name> syrup.
When dyspnoea, fever or purulent sputum occur a doctor or a pharmacist should be consulted
immediately.
If you suffer from gastritis or gastric ulcer, you should consult your doctor before taking <(invented)
name> syrup.
If you are using antitussives such as codeine or dextromethorphane, you should consult a doctor or a
pharmacist before taking <(invented) name> syrup.
Use in patients with impaired renal and/or liver function
If you suffer from renal insufficiency or hepatic impairment, please talk to your doctor or
pharmacist before taking <(invented) name> syrup. Data for dose recommendations in
these patients have not been established.
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Children
Persistent or recurrent cough in children between 2-4 years of age requires medical diagnosis before
treatment.
Other medicines and <(invented) name> syrup
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any
other medicines.
No interactions with other medicinal products and other forms of interaction are reported for invented
name.
Pregnancy,breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Pregnancy
In the absence of sufficient safety data, the use of <(invented) name> syrup during pregnancy is not
recommended.
Breast-feeding
In the absence of sufficient safety data, the use of <(invented) name> syrup during breast-feeding is
not recommended.
Fertility
There are no data on the effects of Ivy leaf dry extract on fertility available.
Driving and using machines
No studies on the effect on the ability to drive and use machines have been performed.
<(invented) name> syrup contains 495.6 mg/ml of sorbitol (E 420)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3.
How to take <(invented) name> syrup
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you. Check with your doctor or pharmacist if you are not sure.
The recommended doses are:
Adolescents, adults and elderly
4 ml of <(invented) name> syrup two to three times daily (corresponding to 66-99 mg daily dose of
ivy leaf dry extract).
Use in children
Children between 6-12 years of age:
4 ml of <(invented) name> syrup two times daily (corresponding to 66 mg daily dose of ivy leaf dry
extract).
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Children between 2-5 years of age:
2 ml of <(invented) name> syrup two times daily (corresponding to 33 mg daily dose of ivy leaf dry
extract).
Persistent or recurrent cough in children between 2-4 years of age requires medical diagnosis before
treatment.
Children under 2 years of age:
<(invented) name> syrup must not be administered to children under 2 years of age because of the risk
of aggravation of respiratory symptoms.
Shake the bottle well before use. Take <(invented) name> syrup orally, using the enclosed measuring
spoon. The measuring spoon is graduated in 1 ml, 2 ml, 3 ml and 4 ml, ensuring you always to take the
recommended dose.
You must talk to a doctor if you do not feel better after one week or if you feel worse.
If you take more <(invented) name> syrup than you should
Overdose can provoke nausea, vomiting, diarrhoea and agitation.
If you take more <(invented) name> syrup than you should, talk to your doctor who may decide about
required measures.
If you forget to take <(invented) name> syrup
Do not take a double dose to make up for a forgotten dose, but continue to take your usual dose at the
usual time.
If you have any further questions on the use of this medicine, 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 are common (may affect up to 1 in 10 people):
Nausea, vomiting, diarrhoea
The following side effects are uncommon (may affect up to 1 in 100 people):
Urticaria, skin rash, shortness of breath
If you notice one of the above mentioned side effects, stop taking <(invented) name> syrup and see
your doctor.
If you notice symptoms of hypersensitivity stop taking <(invented) name> syrup.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in Appendix V.
By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store <(invented) name> syrup
Keep this medicine out of the sight and reach of children.
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This medicine does not require any special storage conditions.
Do not store above 25°C after first opening.
Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP.
The expiry date refers to the last day of that month.
<(invented) name> syrup must not be used for more than 3 months after first opening of the bottle.
6.
Contents of the pack and other information
What <(invented) name> syrup contains
1 ml (corresponding to 1.18 g) of <(invented) name> syrup contains 8.25 mg (as dry extract) of
Hedera helix L., folium (ivy leaf) (DER 4-8:1), extraction solvent: ethanol 30 % m/m
The other ingredients are:
Sorbitol, liquid (non-crystallising) (E 420)
Xanthan gum
Potassium sorbate
Citric acid, anhydrous
Purified water
What <(invented) name> syrup looks like and contents of the pack
<(invented) name> syrup is a brown, opalescent liquid with a sweet taste filled in 100 ml bottles. The
bottles are closed with white plastic (polyethylene) screw caps.
The bottles are further packed into cartons together with a measuring spoon (graduations of 1 ml, 2
ml, 3 ml and 4 ml), ensuring to take the recommended dose.
<(invented) name> syrup is available in 100 ml bottles.
Marketing Authorisation Holder
[to be completed nationally]
Manufacturer
Phytopharm Klęka S.A.
Klęka 1
63-40 Nowe Miasto nad Wartą
Poland
This leaflet was last revised in {MM/YYYY}.
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