Patient Information Leaflet: Information for the User

Pentossiverina Opella Healthcare 2.13 mg/ml oral solution
Pentoxifylline citrate
Please read all of this leaflet carefully before 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 has instructed you.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If any side effects occur, contact your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

What Pentossiverina Opella Healthcare is and what it is used for
What you need to know before taking Pentossiverina Opella Healthcare
How to take Pentossiverina Opella Healthcare
Possible side effects
How to store Pentossiverina Opella Healthcare
Contents of the pack and other information

1. What Pentossiverina Opella Healthcare is and what it is used for

Pentossiverina Opella Healthcare is indicated for the symptomatic treatment of dry cough (non-productive cough) in adults and children aged 6 years and older. The medicine is an antitussive that works by reducing overstimulation of the cough center, thereby normalizing the cough reflex.
Consult your doctor if cough symptoms worsen, if chest pain occurs, or if the cough persists for more than one week. Pentossiverina Opella Healthcare is intended for occasional use and should not be used continuously for more than 2 weeks.

2. What you need to know before taking Pentoxiverine Opella Healthcare

Do not take Pentoxiverine Opella Healthcare:

if you are allergic to pentoxiverine or to any of the other ingredients of this medicine (listed in section 6)
if you suffer from breathing difficulties
if you have symptoms of central nervous system depression such as drowsiness, low muscle tone, reduced level of consciousness, and decreased responsiveness to external stimuli, etc.
if you are a pregnant or breastfeeding woman
this product must not be taken by children under 2 years of age.

Warnings and precautions
The use of Pentoxiverine Opella Healthcare is not recommended in case of impaired liver function.
Do not take this product unless your doctor has determined it is safe for you.
Talk to your doctor or pharmacist before taking Pentoxiverine Opella Healthcare if you have:

impaired kidney function,
long-lasting cough (for example due to asthma, reduced lung capacity, or smoking) or if the cough causes excessive mucus production,
increased intraocular pressure (glaucoma), enlarged prostate gland (benign prostatic hyperplasia), urinary retention, intestinal obstruction, or stomach or duodenal ulcer,
high blood pressure or irregular heartbeat,
a condition called myasthenia gravis.

Children and adolescents
Pentoxiverine Opella Healthcare must not be used in children under 6 years of age. Pentoxiverine Opella Healthcare is not recommended for children when cough leads to excessive mucus production.
Children who are prone to seizures should be closely monitored during treatment.

Other medicines and Pentoxiverine Opella Healthcare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pentoxiverine Opella Healthcare may enhance the effects of substances that cause central nervous system depression (e.g. hypnotics, medicines causing drowsiness and sedation, and antihistamines).

Pentoxiverine Opella Healthcare with food, drinks and alcohol
Pentoxiverine Opella Healthcare can be taken during meals or on an empty stomach. Pentoxiverine Opella Healthcare may enhance the effects of alcohol.

Pregnancy, breastfeeding and fertility
Pentoxiverine Opella Healthcare must not be taken during pregnancy or breastfeeding due to possible harmful effects on the baby (e.g. breathing difficulties, seizures, symptoms of central nervous system depression) (see section "Do not take Pentoxiverine Opella Healthcare").

Driving and using machines
This medicine may occasionally cause fatigue, even when taken as directed. Since fatigue may affect reaction times, your ability to drive vehicles or operate machinery may be impaired.

Pentoxiverine Opella Healthcare contains benzoic acid, sorbitol, propylene glycol, benzyl alcohol and sodium
Pentoxiverine Opella Healthcare contains 11.25 mg of benzoic acid in each 15 ml dosage unit.
Pentoxiverine Opella Healthcare contains 4.5 g of sorbitol in each 15 ml dosage unit.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot metabolize fructose, consult your doctor before you (or your child) take or receive this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
Pentoxiverine Opella Healthcare contains 1.5 g of propylene glycol in each 15 ml dosage unit.
If you suffer from liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring during treatment with this medicine.
Pentoxiverine Opella Healthcare oral solution contains:
0.708 mg of benzyl alcohol in each 15 ml dosage unit.
Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and may cause side effects (called "metabolic acidosis").
Pentoxiverine Opella Healthcare contains less than 1 mmol of sodium (23 mg) per 15 ml dosage unit, i.e. essentially "sodium-free".

3. How to take Pentossiverina Opella Healthcare

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose, based on the user's age and weight, is shown in the following table:

Age	Body weight (kg)	Dosage (ml)
Children aged 6 to 15 years	20 – 26	5 ml 3-4 times daily
	27 – 45	7.5 ml 3-4 times daily
	46 – 60	15 ml 3-4 times daily
Adolescents over 15 years and adults	> 60	15 ml 3-4 times daily

If cough is accompanied by sore throat, it is recommended to gargle with the dose of oral solution before swallowing it.
If dry cough disturbs sleep, the last dose should be taken shortly before going to bed.
Use in children and adolescents
See the dosing table.
Contraindicated in children under 6 years of age.
If you take more Pentossiverina Opella Healthcare than you should
If you have taken an excessive amount of this medicinal product, contact your doctor or hospital immediately.
If you forget to take Pentossiverina Opella Healthcare
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions which may be severe:

Very rare (may affect up to 1 in 10,000 people):
Include the following symptoms: difficulty breathing or dizziness (anaphylactic shock), hypersensitivity, localized skin swelling, urticaria, skin rash with blister formation, itching, skin rash. If you experience any of these symptoms, stop using the medicine and consult a doctor immediately.

Other possible side effects:
Common (may affect up to 1 in 10 people): upper abdominal pain, diarrhoea, dry mouth, nausea, vomiting.
Uncommon (may affect up to 1 in 100 people): somnolence, fatigue.
Very rare (may affect up to 1 in 10,000 people): decrease in blood pressure, convulsions (especially in young children), apnoea, shortness of breath, respiratory depression (especially in young children), breathing difficulties, reduction in white blood cell count.
Frequency not known: restlessness, hallucinations, confusion, blurred vision, transient skin rash.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pentossiverina Opella Healthcare

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the bottle
after "EXP." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Usable period after first opening: 6 months.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pentossiverina Opella Healthcare contains

The active substance is pentoxyverine citrate. 1 ml of oral solution contains 2.13 mg of pentoxyverine citrate, equivalent to 1.35 mg of pentoxyverine.
The other ingredients are: benzoic acid, liquid sorbitol (non-crystallizable) (E420), glycerol, propylene glycol, monohydrate citric acid, disodium citrate dihydrate, sodium saccharin, pear flavour, juniper flavour (containing flavouring substances, benzyl alcohol [E1519] and alpha-tocopherol [E307]), purified water.

Description of the appearance of Pentossiverina Opella Healthcare and package contents
Pentossiverina Opella Healthcare is a transparent or almost transparent, colourless or almost colourless liquid.
95 ml and 190 ml dark glass bottles with child-resistant tamper-evident screw caps. The cap is opened by pressing it down and turning it simultaneously anticlockwise. The measuring cup made of polypropylene has graduated markings at 5 ml, 7.5 ml and 15 ml.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano, Italy

Manufacturer
NextPharma SAS
17, route de Meulan
78520 Limay
France

This medicinal product is authorised in the EEA Member States under the following names:
Austria: Macomat Reizhusten 2.13 mg/ml Lösung zum Einnehmen
Belgium: Pentoxyverine Sanofi 2.13 mg/ml drank
Denmark: Bisoltec
Finland: Biseltoc 2.13 mg/ml oraaliliuos
Greece: Bisoldry 2.13 mg/ml πόσιμο διάλυμα
Spain: Bisolvon Calmatos 2.13 mg/ml Solución Oral
Italy: Pentossiverina Opella Healthcare
Luxembourg: Pentoxyverine Sanofi 2.13 mg/ml Solution buvable
Netherlands: Bisolsek pento 2.13 mg/ml drank
Portugal: Pentoxiverina Bisoltussin
Norway: Biseltoc
Sweden: Biseltoc