Package leaflet: Information for the patient

Adrimax, 30 mg/5 ml, syrup
Levodropropizinum
Please read all of this leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days or if symptoms worsen, contact your doctor.

Table of contents

What Adrimax is and what it is used for
Important information before taking Adrimax
How to take Adrimax
Possible side effects
How to store Adrimax
Contents of the pack and other information

1. What Adrimax is and what it is used for

Adrimax contains the active substance levodropropizine, which has antitussive and bronchospasmolytic properties.
Adrimax is indicated for symptomatic treatment of non-productive (dry) cough.
Numerous data indicate that this medicine effectively suppresses cough of various origins, such as cough associated with lung cancer, cough related to upper and lower respiratory tract infections, or whooping cough.
If there is no improvement after 7 days or if the patient feels worse, medical advice should be sought.

2. Important information before using Adrimax

When not to use Adrimax

if the patient is allergic to levodropropizine or any of the other ingredients of this medicine (listed in section 6);
if the patient has abundant bronchial secretions, a condition characterized by excessive mucus (phlegm) production;
if the patient has impaired ciliary function of the bronchial epithelium characterized by reduced ability to clear mucus (Kartagener syndrome, ciliary dyskinesia);
in pregnant and breastfeeding women (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting treatment with Adrimax, consult your doctor or pharmacist.
Adrimax is a medicine used for symptomatic treatment of non-productive (dry) cough
and should only be used while awaiting diagnosis of the underlying cause of cough and/or response to treatment of the disease causing the cough.
Elderly patients
Particular caution should be exercised when administering levodropropizine to elderly patients, as there is evidence of altered sensitivity to many drugs in this patient group.
Patients with renal impairment
Caution is recommended when using this medicine in patients with severe renal impairment (creatinine clearance < 35 ml/min).
Adrimax with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Human studies have not shown changes in EEG tracings when levodropropizine was administered concomitantly with benzodiazepines.
Caution should be exercised in particularly sensitive individuals when taking sedative medicines concomitantly.
Adrimax with food and drink
Due to lack of information on the effect of food on drug absorption, administration between meals is recommended.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The medicine is contraindicated in women who are pregnant or planning pregnancy, as well as during breastfeeding.
Driving and operating machinery
Studies evaluating the ability to drive vehicles and/or operate machinery have not been conducted.
However, since the medicine may rarely cause drowsiness (see also section 4. "Possible adverse effects"), caution should be exercised in patients intending to drive or operate mechanical equipment, and they should be informed of this possibility.

Adrimax contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 3 g of sucrose in 5 ml of syrup. This should be taken into account in patients with diabetes.
Adrimax contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 10 ml of syrup, meaning the medicine is considered "sodium-free".
Adrimax contains ethanol
The medicine contains small amounts of ethanol (alcohol), less than 100 mg per maximum daily dose.

3. How to use Adrimax

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use Adrimax for longer than 7 days without consulting a doctor.

Use in children over 2 years of age
Body weight 10–20 kg: the recommended dose is 3 ml of syrup three times daily;
Body weight 20–30 kg: the recommended dose is 5 ml of syrup three times daily.

Use in adults
The recommended dose is 10 ml of syrup up to three times daily.

Method of administration
Adrimax should be taken orally, three times daily at intervals of at least 6 hours. The syrup bottle is supplied with a measuring device allowing measurement of 3 ml, 5 ml, and 10 ml.
The bottle is equipped with an additional safety feature – a child-resistant cap. To open the bottle, press down on the cap and turn it in the direction indicated by the arrow.

Treatment should be continued until cough symptoms subside or as directed by a physician.
In any case where cough persists after 7 days of treatment, discontinue use and consult a doctor. Remember that cough is a symptom of disease. In such cases, a doctor should establish the correct diagnosis and initiate appropriate treatment.

Overdose of Adrimax
If an overdose is taken, inform a doctor or pharmacist immediately. In cases of overdose with clinical symptoms, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (e.g. gastric lavage, activated charcoal, intravenous fluid administration, etc.).

Missed dose of Adrimax
If a patient forgets to take a dose of Adrimax, they should take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
When using Adrimax, adverse reactions occur very rarely. In most cases, they are not severe complications,
and symptoms resolve after discontinuation of treatment, sometimes requiring specific pharmacological treatment.

Adrimax must be discontinued and immediate medical help sought if the patient experiences any of the following symptoms:

severe skin reactions (urticaria, itching) or skin diseases, for example, those involving blister formation (epidermolysis);
irregular heartbeat (risk of arrhythmia);
allergic and/or anaphylactic reaction, manifesting as swelling, shortness of breath, vomiting, and diarrhea;
dangerously low blood sugar levels leading to loss of consciousness (hypoglycaemic coma).

Immediately inform a doctor if the patient experiences any of the listed adverse reactions, as they may lead to life-threatening consequences.
Very rare (occurring in fewer than 1 in 10,000 patients):

urticaria, erythema, exanthema, itching, skin reactions, severe allergic reaction manifesting as swelling of the face, lips, larynx, and pharynx (angioedema);
stomach pain, abdominal pain, nausea, vomiting, diarrhea;
allergic reactions, including immediate reactions, general malaise;
dizziness, impaired balance, tremors, tingling, numbness;
palpitations, rapid heartbeat, low blood pressure;
irritability, drowsiness, depersonalization (disturbance in perception of self and surroundings);
shortness of breath, cough, swelling of the mucous membranes of the respiratory tract;
lack of strength (weakness) and weakness of the lower limbs.

In addition, the following adverse reactions have been reported:

glossitis and aphthous stomatitis with fever;
inflammation caused by impaired bile outflow from the liver (cholestatic hepatitis);
cases of generalized swelling, fainting, and weakness;
seizures – major epileptic seizure (clonic-tonic convulsions) and minor epileptic seizure (non-convulsive, so-called petit mal seizure);
pupil dilation and loss of vision. In both cases, symptoms resolved after discontinuation of the medicine.
eyelid swelling, which is most commonly considered angioedema, taking into account the concurrent occurrence of urticaria.
drowsiness, reduced muscle tone, and vomiting in a newborn, attributed to levodropropizine passing into the infant’s body through breast milk from a breastfeeding mother. These symptoms occurred after breastfeeding and resolved spontaneously after skipping several feeds.

Using Adrimax according to the recommendations provided in the patient leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Adrimax

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The shelf life after first opening the bottle is 6 months.
Store in the original orange bottle to protect from light.
Do not store in a refrigerator or freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Adrimax contains

The active substance is levodropropizine. 5 ml of syrup contains 30 mg of levodropropizine.
The other ingredients are: citric acid monohydrate, sodium hydroxide, sucrose, raspberry flavour, purified water, nitrogen with low oxygen content.
Raspberry flavour contains: flavouring substance, flavouring preparation, natural flavouring substance, propylene glycol (E1520), ethanol.

What Adrimax looks like and contents of the pack
Adrimax is a syrup.
The packaging consists of an amber glass bottle of type III with a child-resistant closure made of PP/PE or PP, a PE seal, and a PP measuring cup graduated at 2 ml, 2.5 ml, 3 ml, 4 ml, 5 ml, 6 ml, 7 ml, 7.5 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 12.5 ml and 15 ml, contained in a cardboard box.
Available pack sizes:

1 bottle of 120 ml.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. +48 22 364 61 01

Importer
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola, PLA3000
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
Malta Levodropropizine ELC