Package leaflet: Information for the user

19 mg/ml oral drops, 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.  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 propylene glycol (E1520), methyl benzoate and sodium This medicine contains 566.26 mg propylene glycol in each ml of solution. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you suffer from a kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

This medicine contains 0.002 mg methyl benzoate in each ml of solution.

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 of the Daily number of drops child 3 times 4 drops 11 to 13 kg to 4 times 5 drops 3 times 4 drops 13 to 15 kg to 4 times 6 drops 3 times 5 drops 15 to 17 kg to 4 times 6 drops 3 times 6 drops 17 to 19 kg to 4 times 7 drops 3 times 6 drops 19 to 21 kg to 4 times 8 drops 3 times 7 drops 21 to 23 kg to 4 times 9 drops 3 times 8 drops 23 to 25 kg to 4 times 10 drops

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 of the Daily number of drops child 3 times 16 drops 25 to 28 kg to 4 times 22 drops 3 times 17 drops 28 to 30 kg to 4 times 25 drops 3 times 19 drops 30 to 32 kg to 4 times 26 drops 32 to 34 kg 3 times 20 drops to 4 times 28 drops 3 times 21 drops 34 to 36 kg to 4 times 29 drops 3 times 22 drops 36 to 38 kg to 4 times 31 drops 3 times 25 drops 38 to 40 kg to 4 times 34 drops

Adolescents aged 14 years and over and adults Take 34 to 51 drops 3 to 4 times a day (equivalent to 57 to 114 mg of pentoxyverine).

Method of administration Unscrew the cap and hold the bottle upside down to dispense the required amount of drops.

The bottle must always be vertical when removing the drops in order to ensure the correct dosage.

is taken with a spoon in undiluted form or with a little liquid.

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.

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

What contains

 The active substance is pentoxyverine (as pentoxyverine citrate) - 1 ml solution (34 drops) contains 19 mg of pentoxyverine (equivalent to 30 mg of pentoxyverine citrate)  The other ingredients are propylene glycol, saccharin sodium, 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 plastic dropper and screw cap.

Pack containing 30 ml of solution

Marketing Authorisation Holder and Manufacturer

[to be completed nationally]

This leaflet was last revised in October 2020.