SEDOTUSSIN

SEDOTUSSIN Cough Suppressant Syrup

Important notes (mandatory information)

Sedotussin Cough Suppressant Syrup. Active ingredient: Pentoxyverine citrate. Areas of application: for the symptomatic treatment of dry cough (antitussive). Warning: contains sorbitol

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sedotussin Cough Suppressant 2.13 mg/ml Syrup, oral solution for use in children aged 2 years and over and adults
Active ingredient: Pentoxyverine citrate

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or even worse within 2 weeks, contact your doctor.

What this leaflet contains

1. WHAT IS SEDOTUSSIN COUGH SUPPRESSANT SYRUP AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING SEDOTUSSIN COUGH SUPPRESSANT SYRUP?
3. HOW TO TAKE SEDOTUSSIN COUGH SUPPRESSANT SYRUP?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SEDOTUSSIN COUGH SUPPRESSANT SYRUP?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SEDOTUSSIN COUGH SUPPRESSANT SYRUP AND WHAT IS IT USED FOR?

Sedotussin Cough Suppressant Syrup is a medicine for the symptomatic treatment of dry cough (antitussive).

2. WHAT YOU NEED TO KNOW BEFORE TAKING SEDOTUSSIN COUGH SUPPRESSANT SYRUP?

Sedotussin Cough Suppressant Syrup must not be taken,

• if you are allergic (hypersensitive) to pentoxyverine, methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate or any of the other ingredients of this medicine listed in section 6.
• by children under 2 years of age.
• in the case of impaired breathing (respiratory insufficiency) or depression of the central nervous system.
• in the case of impaired liver function (hepatic insufficiency).
• during pregnancy.
• during breastfeeding.

Warnings and precautions

Please talk to your doctor or pharmacist before taking this medicine.

Special care should be taken when taking Sedotussin Cough Suppressant Syrup in the following cases:

• A combined use of preparations with expectorant and cough-suppressing effects can improve the therapy of productive cough (cough with expectoration), whereby expectoration is recommended during the day and cough suppression at night. However, in the case of a cough with considerable mucus production, you should only use a cough suppressant such as Sedotussin Cough Suppressant Syrup after consulting your doctor or pharmacist, as a reduced sensitivity to cough stimuli with a decrease in cough frequency may be undesirable under these circumstances.
• Patients who continue to suffer from a dry asthmatic cough despite standard therapy prescribed by a doctor may additionally use Sedotussin Cough Suppressant Syrup for a short period of time to relieve symptoms on the advice of a doctor.
• In patients with impaired kidney function (renal insufficiency) and in elderly patients, as sufficient data on the use of this medicine are not available for these patient groups.
• If you suffer from increased intraocular pressure (glaucoma) or benign enlargement of the prostate (prostate hyperplasia).

If the cough persists for more than 2 weeks, an exact clarification of the cause of the illness by your doctor is necessary.

Children

Sedotussin Cough Suppressant Syrup must not be used in children in the first two years of life. In individual cases, especially in infants, seizures and a decrease in respiratory activity have been observed, which is why infants should be carefully monitored after taking Sedotussin Cough Suppressant Syrup.

Taking Sedotussin Cough Suppressant Syrup with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No medicines that have a sedative or hypnotic effect on the brain and psyche (e.g. sedatives and hypnotics) should be used together with Sedotussin Cough Suppressant Syrup, as this can lead to an increase in the consciousness-reducing (sedative) and respiratory-reducing (respiratory depressant) effect of Sedotussin Cough Suppressant Syrup. Interactions with medicines that are mainly metabolised by the enzyme system cytochrome P450-2D6, such as pentoxyverine, are possible. These substances include, among others, active ingredients from the group of antidepressants (e.g. paroxetine, fluoxetine) and antiarrhythmics (e.g. propafenone). Please ask your doctor if you are not sure whether you are currently taking any of the medicines in this group.

Taking Sedotussin Cough Suppressant Syrup with food and drink

Do not consume alcohol, as alcohol in combination with Sedotussin Cough Suppressant Syrup significantly impairs reaction time.

Pregnancy, breastfeeding and

fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Sedotussin Cough Suppressant Syrup must not be taken during pregnancy because there is insufficient experience with this. If taken accidentally during pregnancy, no harmful effects on the unborn child are to be expected. Nevertheless, treatment should be discontinued immediately.

Breastfeeding

The active ingredient of Sedotussin Cough Suppressant Syrup passes into breast milk. Sedotussin Cough Suppressant Syrup must therefore not be taken during breastfeeding due to the risk of undesirable effects in the infant.

Fertility

Animal studies with pentoxyverine with regard to fertility have not been conducted. The effect on fertility in humans has not been investigated in studies.

Driving and using machines

This medicine can also occasionally lead to drowsiness when used as intended. Since drowsiness can alter the ability to react, there is a possibility that the ability to actively participate in road traffic or to operate machines may be impaired.

Sedotussin Cough Suppressant Syrup contains sorbitol

Therefore, please only take Sedotussin Cough Suppressant Syrup after consulting your doctor if you are known to suffer from an intolerance to certain sugars. The calorific value is 2.6 kcal/g sorbitol. Sorbitol can have a slightly laxative effect. Note for diabetics: 10 ml of solution contains 2.1 g of sorbitol (=0.18 BE).

3. HOW TO TAKE SEDOTUSSIN COUGH SUPPRESSANT SYRUP?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Children aged 2 to 5 years take Sedotussin Cough Suppressant Syrup according to their body weight. The individual doses should be evenly distributed throughout the day.

Body weight of the child	Daily intake of Sedotussin Cough Suppressant Syrup
11 to 13 kg	1.25 to 2 ml 4 times a day
13 to 15 kg	2 to 2.5 ml 3 - 4 times a day
15 to 17 kg	1.75 to 2.75 ml 4 times a day
17 b to 19 kg	2.5 to 3 ml 3 - 4 times a day
19 to 21 kg	2 to 3.5 ml 4 times a day
21 to 23 kg	3 to 5 ml 3 times a day
23 to 25 kg	2.5 to 4.25 ml 4 times a day

Children aged 6 to 13 years take Sedotussin Cough Suppressant Syrup according to their body weight. The individual doses should be evenly distributed throughout the day. For a body weight below 25 kg, the dosage table for 2 - 5-year-olds should be used.

Body weight of the child	Daily intake of Sedotussin Cough Suppressant Syrup
	Indication in ml of solution (syrup)	Measurement in measuring cup
25 to 30 kg	5 ml 5 times a day, if necessary 10 ml 3 times a day	Fill measuring cup to 5 ml or 10 ml mark
30 to 35 kg	10 ml 3 times a day, if necessary 10 ml 4 times a day	Fill measuring cup to 10 ml mark
35 to 40 kg	10 ml 3 times a day, if necessary 10 ml 5 times a day	Fill measuring cup to 10 ml mark
40 to 45 kg	10 ml 4 times a day, if necessary 10 ml 5 times a day	Fill measuring cup to 10 ml mark
45 to 50 kg	10 ml 4 times a day, if necessary 15 ml 4 times a day	Fill measuring cup to 10 ml or 15 ml mark
50 to 55 kg	15 ml 3 times a day, if necessary 15 ml 4 times a day	Fill measuring cup to 15 ml mark
55 to 60 kg	15 ml 3 times a day, if necessary 15 ml 5 times a day	Fill measuring cup to 15 ml mark
over 60 kg	Take as for adults

Adults and adolescents aged 14 years and over

take 15 ml of syrup 3-4 times a day (1 measuring cup to the 15 ml mark each time) (corresponding to 60 to 80 mg of pentoxyverine daily). If necessary, the total intake can be increased to up to 90 ml daily (up to 6 measuring cups, filled to the 15 ml mark) (corresponding to 120 mg of pentoxyverine daily) - spread over the day.

Sedotussin Cough Suppressant Syrup is taken undiluted or with a little liquid using the enclosed measuring pipette (for doses up to 5 ml) or the enclosed measuring cup (for doses of 5 ml and above).

Using the pipette

1. After opening the bottle, immerse the lower end of the pipette approx. 2 cm into the liquid.
2. Then pull the inner part of the pipette upwards until the desired ml quantity appears above the ring. Please refer to the dosage schedule for the required quantity.
3. The measured dose can now be administered by pressing down on the inner part of the pipette.

Please clean the measuring pipette and measuring cup after use by filling and emptying them several times with warm water.

Sedotussin Cough Suppressant Syrup must not be taken for longer than 2 weeks without your doctor's consent. If the cough persists for more than 2 weeks, an exact clarification of the cause of the illness by your doctor is necessary. Please talk to your doctor or pharmacist if you have the impression that the effect of Sedotussin Cough Suppressant Syrup is too strong or too weak.

If you have taken more Sedotussin Cough Suppressant Syrup than you should

If you have taken considerably too much medicine, symptoms of the central nervous system and the gastrointestinal tract will occur, such as decreased respiratory drive, drowsiness and vomiting, as well as anticholinergic effects such as urinary retention, increased intraocular pressure, accelerated heart rate, blurred vision, agitation, hallucinations. In such a case, call the nearest doctor for help, who will decide on the further measures to be taken.

If you forget to take Sedotussin Cough Suppressant Syrup

If you have forgotten to take Sedotussin Cough Suppressant Syrup once, or have taken too little, please continue taking Sedotussin Cough Suppressant Syrup at the next time, as described in the dosage instructions.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Sedotussin Cough Suppressant Syrup can have side effects, although not everybody gets them.

The following categories are used to classify the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Nervous system disorders:

• Uncommon: drowsiness
• Very rare: seizures (especially in infants)

Respiratory, thoracic and mediastinal disorders:

• Very rare: shortness of breath (mostly reported in connection with allergic reactions), decreased respiratory activity (especially in infants)

Gastrointestinal disorders:

• Common: upper abdominal pain, diarrhoea, nausea, vomiting

Skin and subcutaneous tissue disorders:

• Very rare: swelling in the head–neck–area (angioedema), rash (exanthema), hives

General disorders and administration site conditions:

• Uncommon: fatigue with exhaustion

Immune system disorders:

• Very rare: hypersensitivity reactions, including severe forms (anaphylactic reactions)

Methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate in Sedotussin Cough Suppressant Syrup can cause hypersensitivity reactions, also with a time delay,

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SEDOTUSSIN COUGH SUPPRESSANT SYRUP?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after first opening: The shelf life after first opening the bottle is 6 months. Do not dispose of this medicine in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer need it. You will help to