Package leaflet: Information for the user

1.35 mg/ml oral solution Pentoxyverine

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. 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 or if you feel worse after 2 weeks.

What is in this leaflet 1. What is and what it is used for 2. What you need to know before you take 3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information

1. What is and what it is used for

is a medicine for short-term use to treat a dry cough (cough suppressant).

In general, the duration of use must not exceed 2 weeks (see section 3 “How to take ”).

2. What you need to know before you take

DO NOT take

 if you are allergic to pentoxyverine or any of the other ingredients of this medicine (listed in section 6)  if you have breathing problems (respiratory failure) or if your central nervous system is depressed  if your liver function is impaired (hepatic insufficiency)  during pregnancy and when breast-feeding  for treatment of children under 2 years of age

Warnings and precautions Talk to your doctor or pharmacist before taking .

Take special care with in the following cases:  if the cough is accompanied by the excessive formation of phlegm or if you suffer from asthmatic cough, because suppressing the cough is not advised. In this case, take only after consultation with your doctor.  in patients with impaired kidney function (renal insufficiency) and in elderly patients, since for these patient groups there is not enough data available concerning the use of this medicine.

Page 1 of 6  if you suffer from glaucoma (increased eye pressure).  if you suffer from benign prostate enlargement (prostatic hyperplasia).

If the cough persists for more than 2 weeks, the cause of your illness has to be assessed by your doctor in detail.

Children must not be used to treat children under two years of age.

In some cases – and in particular among infants – seizures and a decrease in respiratory activity have been observed, which is why infants must be carefully observed after taking .

Other medicines and

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

Medicines which have a sedative effect on the brain and mind (e.g. calming medicines and sleeping pills) should not be taken together with . This may lead to a strengthening of the sedating effect and a reduced breathing (respiratory depressant) effect of .

Talk to your doctor if you are taking medicines such as antidepressants (e.g. paroxetine, fluoxetine) and antiarrhythmics (e.g. propafenone) as their metabolism/breakdown can be influenced by each other. Ask your doctor if you are not quite sure if you are currently taking one of the medicines in this group.

with alcohol Do not consume any alcohol, since alcohol in combination with significantly impairs reaction time.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

must not be used in pregnancy and when breast-feeding, as it has not been tested sufficiently during these periods. The active substance pentoxyverine passes into the breast milk.

Driving and using machines This medicine may occasionally lead to tiredness even when used in accordance with instructions. Since tiredness can alter the reaction time, it is possible that the ability to drive or use machines may be impaired.

contains sorbitol, methyl 4-hydroxybenzoate and propyl 4- hydroxybenzoate and sodium This medicine contains 210 mg sorbitol in each ml. Sorbitol is a source of fructose. If you have been told by your doctor that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

Methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate may cause allergic reactions (possibly delayed).

Page 2 of 6 This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. How to take

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 dose is as follows:

Use in children and adolescents Children from the age of 2 to 5 years is to be taken according to body weight. The single doses should be spread evenly throughout the day. See Table 1.

Table 1 Children from the age of 2 to 5 years Body weight Daily intake amount of Corresponding daily dose of the child of pentoxyverine 11 to 13 kg 1.25 to 2 ml, 7 to 11 mg 4 times a day 13 to 15 kg 2 to 2.5 ml, 8 to 14 mg 3 to 4 times a day 15 to 17 kg 1.75 to 2.75 ml, 10 to 15 mg 4 times a day 17 to 19 kg 2.5 to 3 ml, 10 to 16 mg 3 to 4 times a day 19 to 21 kg 2 to 3.5 ml, 11 to 19 mg 4 times a day 21 to 23 kg 3 to 5 ml, 12 to 20 mg 3 times a day 23 to 25 kg 2.5 to 4.25 ml, 14 to 23 mg 4 times a day

Children from the age of 6 to 13 years is to be taken according to body weight. The single doses should be spread evenly throughout the day (see Table 2). With a body weight of less than 25 kg, the dosage table for 2 to 5-year-olds is to be used (See Table 1).

Table 2 Children from the age of 6 to 13 years Body weight Daily intake amount of of the child Quantity in ml of solution (syrup) Measured out in the measuring cup 25 – 30 kg 5 ml, 5 times a day, Always fill the measuring if required 10 ml, 3 times a day cup up to the 5 ml mark or 10 ml mark 30 – 35 kg 10 ml, 3 times a day, Always fill the measuring

Page 3 of 6 if required 10 ml, 4 times a day cup up to the 10 ml mark 35 – 40 kg 10 ml, 3 times a day, Always fill the measuring if required 10 ml, 5 times a day cup up to the 10 ml mark 40 – 45 kg 10 ml, 4 times a day, Always fill the measuring if required 10 ml, 5 times a day cup up to the 10 ml mark 45 – 50 kg 10 ml, 4 times a day, Always fill the measuring if required 15 ml, 4 times a day cup up to the 10 ml mark or 15 ml mark 50 – 55 kg 15 ml, 3 times a day, Always fill the measuring if required 15 ml, 4 times a day cup up to the 15 ml mark 55 – 60 kg 15 ml, 3 times a day, Always fill the measuring if required 15 ml, 5 times a day cup up to the 15 ml mark More than The same dosage is to be taken as for adults 60 kg

Adolescents aged 14 years and over and adults Take 15 ml of solution 3 to 4 times a day (in each case 1 measuring cup filled up to the 15 ml mark) (equivalent to 60-80 mg of pentoxyverine a day).

If necessary, the total intake amount can be increased up to 90 ml of solution daily (up to 6 measuring cups, filled up to the 15 ml mark) (equivalent to 120 mg of pentoxyverine daily) - spread over the day.

Method of administration is taken with the help of the enclosed dosing pipette (for doses up to 5 ml) or the enclosed measuring cup (for doses of 5 ml and up) in undiluted form or with a little liquid. The measuring scales on the devices are suitable for dosing of children aged 2 to 5 years (dosing pipette) and patients aged 6 years and above (measuring cup). Pull out the graduated plunger until the marking of the required dose appears on the upper edge (finger grip collar) of the dosing pipette barrel.

Please clean the dosing pipette and the measuring cup after use with warm water. Before cleaning the pipette, remove the plunger from the pipette barrel.

Duration of use must not be taken for longer than 2 weeks without your doctor's consent.

If the cough persists for more than 2 weeks, the cause of your illness has to be assessed by your doctor in detail.

If you have the impression that the effect of is too strong or too weak, talk to your doctor or pharmacist.

If you take more than you should Taking excessive quantities of this medicine results in symptoms of the central nervous system and gastrointestinal tract, such as a reduction in respiratory drive, light-headedness and vomiting, as well as symptoms such as urinary retention, elevated intraocular pressure, accelerated heart rate, blurred vision, agitation, hallucinations.

In such cases you should call the nearest available doctor for help, who will then decide what to do next.

Page 4 of 6 If you forget to take If you have forgotten to take , or have taken too little, please continue to take the next time as described in the dosage instructions. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Common (may affect up to 1 in 10 people):  upper abdominal pain  vomiting  nausea  diarrhoea

Uncommon (may affect up to 1 in 100 people):  tiredness with exhaustion  drowsiness

Very rare (may affect up to 1 in 10,000 people):  swelling of the head and neck area (angioedema),  hypersensitivity reactions, including severe forms (anaphylactic reactions)  reduction in respiratory activity (especially in infants), difficulty breathing (usually reported in association with allergic reactions)  seizures (especially in infants)  rash (exanthema)  hives

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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

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

Do not use this medicine after the expiry date which is stated on the carton and bottle label. The expiry date refers to the last day of that month.

Storage conditions This medicine does not require any special storage conditions.

Shelf life after opening The shelf life after the first opening of the bottle is 1 year.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

Page 5 of 6 What contains

 The active substance is pentoxyverine (as pentoxyverine citrate) - 1 ml oral solution (syrup) contains 1.35 mg of pentoxyverine (equivalent to 2.13 mg of pentoxyverine citrate) - 5 ml oral solution (syrup) contain 6.75 mg of pentoxyverine (equivalent to 10.65 mg of pentoxyverine citrate) - 10 ml oral solution (syrup) contain 13.5 mg of pentoxyverine (equivalent to 21.3 mg of pentoxyverine citrate)  The other ingredients are propylene glycol, sorbitol, liquid 70 % (non-crystallising), glycerol (85 %), saccharin sodium, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium citrate, strawberry flavour, purified water

What looks like and contents of the pack

is a clear, colourless to yellowish solution in an amber glass bottle with a child proof screw cap. A measuring cup manufactured of Polypropylene and a dosing pipette (piston and barrel manufactured of LDPE, plunger manufactured of Polystyrol) are added.

Pack containing 100 ml of oral solution.

Marketing Authorisation Holder and Manufacturer

[to be completed nationally]

This leaflet was last revised in November 2019.

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