Adrimax

Package Leaflet: Information for the Patient

Adrimax, 30 mg/5 ml, Syrup

Levodropropizinum

Read the package 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 package leaflet for the patient or as directed by the doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or if you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

• 1. What is Adrimax and what is it used for
• 2. Important information before taking Adrimax
• 3. How to take Adrimax
• 4. Possible side effects
• 5. How to store Adrimax
• 6. Contents of the package and other information

1. What is Adrimax and what is it used for

Adrimax contains the active substance levodropropizine, which has antitussive and bronchodilatory effects.
Adrimax is indicated for the symptomatic treatment of non-productive (dry) cough.
Many data indicate that this medicine effectively inhibits cough of various origins, such as cough in lung cancer, cough associated with upper and lower respiratory tract infections, or whooping cough.
If there is no improvement after 7 days or if you feel worse, consult a doctor.

2. Important information before taking Adrimax

When not to take Adrimax

• if you are allergic to levodropropizine or any of the other ingredients of this medicine (listed in section 6);
• if you have excessive bronchial secretions, a condition characterized by a large amount of mucus production (phlegm);
• if you have disorders of ciliary function in the bronchial epithelium, characterized by reduced ability to clear mucus (Kartagener syndrome, ciliary dyskinesia);
• in pregnant or breastfeeding women (see section "Pregnancy and breastfeeding").

Warnings and precautions

Before starting treatment with Adrimax, discuss it with your doctor or pharmacist.
Adrimax is a medicine used for the symptomatic treatment of non-productive (dry) cough and should only be used while waiting for a diagnosis of the cause of the cough and/or the effect of treatment of the underlying disease.

Elderly patients

Particular caution should be exercised when using levodropropizine in elderly patients, as there is evidence of changes in sensitivity to many drugs in this group of patients.

Patients with renal impairment

Caution is recommended when using the medicine in patients with severe renal impairment (creatinine clearance <35 ml min.).< p>

Adrimax and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
In human studies, no changes in EEG recording were found during administration of levodropropizine in combination with benzodiazepines.
In sensitive individuals, caution should be exercised when taking sedatives.

Adrimax with food and drink

Due to the lack of information on the effect of meals on the absorption of the medicine, it is recommended to take it between meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
The medicine is contraindicated in pregnant or breastfeeding women, as well as in women planning to become pregnant.

Driving and using machines

No studies have been conducted to assess the ability to drive and/or operate machinery.
However, since the medicine may rarely cause drowsiness (see also section 4 "Possible side effects"), caution should be exercised in patients who intend to drive vehicles or operate mechanical equipment and inform them of this possibility.

• 4. "Possible side effects"), caution should be exercised in patients who intend to drive vehicles or operate mechanical equipment and inform them of this possibility.

Adrimax contains sucrose

If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the 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, which means 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 take Adrimax

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist. Do not take Adrimax for more 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 3 times a day;
Body weight 20-30 kg: the recommended dose is 5 ml of syrup 3 times a day.

Use in adults

The recommended dose is 10 ml of syrup up to 3 times a day.

Method of administration

Adrimax should be taken orally, 3 times a day, at intervals of at least 6 hours. The bottle of syrup comes with a measuring cup that allows you to measure 3 ml, 5 ml, and 10 ml.
The bottle is equipped with an additional safety feature, a child-resistant closure. To open the bottle, press the cap and turn it in the direction indicated by the arrow.
Treatment should be continued until the cough disappears or as directed by the doctor.
In any case, if the cough does not disappear after 7 days of treatment, discontinue use and consult a doctor. Remember that cough is a symptom of a disease. In this situation, the doctor should make a proper diagnosis and then initiate appropriate treatment.

Overdose of Adrimax

If you have taken more than the recommended dose of the medicine, tell your doctor or pharmacist immediately. In case of overdose with clinical symptoms, the doctor will immediately initiate symptomatic treatment and, if necessary, apply standard emergency procedures (gastric lavage, activated charcoal, parenteral fluid administration, etc.).

Missed dose of Adrimax

If you forget to take a dose of Adrimax, 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 about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Adrimax can cause side effects, although not everybody gets them.
During treatment with Adrimax, side effects are very rare. In most cases, they are not serious and symptoms disappear after discontinuation of treatment, sometimes only requiring specific pharmacological treatment.

Stop taking Adrimax and seek medical help immediately if you experience any of the following symptoms:

• severe skin reactions (hives, itching) or skin diseases, such as those involving blistering (epidermolysis);
• irregular heartbeat (risk of arrhythmia);
• allergic reaction and/or anaphylaxis, in the form of swelling, shortness of breath, vomiting, and diarrhea;
• dangerously low blood sugar levels, leading to loss of consciousness (hypoglycemic coma).

Tell your doctor immediately if you experience any of the following side effects, as they may be life-threatening.

Very rare(occurring in less than 1 in 10,000 patients):

• hives, rash, erythema, itching, skin reactions, severe allergic reaction with swelling of the face, lips, larynx, and throat (angioedema);
• stomach pain, abdominal pain, nausea, vomiting, diarrhea;
• allergic reactions, including immediate, general malaise;
• dizziness, balance disorders, tremors, tingling, numbness;
• palpitations, rapid heartbeat, low blood pressure;
• irritability, drowsiness, depersonalization (disorder of perception of oneself and the environment);
• shortness of breath, cough, swelling of the mucous membrane of the respiratory system;
• weakness or lack of strength (asthenia) and weakness of the lower limbs.

The following side effects have also been reported:

• inflammation of the tongue and aphthous stomatitis with fever;
• inflammatory condition caused by obstruction of bile flow from the liver (cholestatic hepatitis);
• cases of generalized edema, fainting, and weakness;
• seizures - grand mal seizure (clonic-tonic convulsions) and petit mal seizure (non-convulsive, so-called petit mal);
• pupil dilation and loss of vision. In both cases, symptoms disappeared after discontinuation of the medicine.
• eyelid edema, which can be considered angioedema, given the concurrent occurrence of hives.
• drowsiness, decreased muscle tone, and vomiting in newborns, attributed to the passage of levodropropizine into the baby through breast milk. These symptoms appeared after breastfeeding and disappeared spontaneously after skipping a few feedings (breastfeeding).

Taking Adrimax as directed in the package leaflet for the patient reduces the risk of side effects.

Reporting side effects

If you experience any side effects, including those not listed in the package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Adrimax

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified 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 the 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 of the medicine is levodropropizine. 5 ml of syrup contains 30 mg of levodropropizine.
• The other ingredients are: citric acid monohydrate, sodium hydroxide, sucrose, raspberry flavor, purified water, nitrogen with low oxygen content.
• Raspberry flavor contains: flavoring substance, flavoring preparation, natural flavoring substance, propylene glycol (E1520), ethanol.

What Adrimax looks like and what the package contains

Adrimax is a syrup.
The packaging consists of an orange glass type III bottle with a PP/PE or PP child-resistant closure and a PE seal, and a PP measuring cup scaled 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 in a cardboard box.
Available packages:

• 1 bottle of 120 ml.

Marketing authorization holder

Pharmaceutical Works POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Importer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Malta
Levodropropizine ELC
Date of last revision of the package leaflet:May 2023