Pecto drill

Package leaflet: information for the patient

Pecto Drill, 750 mg, lozenges
Carbocisteinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Pecto Drill lozenges are and what they are used for
2. Important information before taking Pecto Drill lozenges
3. How to take Pecto Drill lozenges
4. Possible side effects
5. How to store Pecto Drill lozenges
6. Contents of the pack and other information

1. What Pecto Drill lozenges are and what they are used for

Pecto Drill contains carbocisteine as the active substance, which affects the composition of bronchial mucus. Carbocisteine makes the mucus less viscous and more fluid, thus facilitating its removal from the respiratory tract during coughing (so-called mucolytic action).
This medicine is used for symptomatic treatment of respiratory diseases associated with excessive production of thick and sticky mucus.
Pecto Drill is indicated for use only in adults.

2. Important information before taking Pecto Drill lozenges

When not to take Pecto Drill lozenges:

• if you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6);
• if you currently have an active peptic ulcer;
• in breastfeeding women;

Warnings and precautions
Before starting treatment with Pecto Drill, discuss it with your doctor, as special caution is required when using Pecto Drill:

• if you have had a peptic ulcer of the stomach or duodenum in the past;
• in patients with severe respiratory insufficiency, as it may lead to airway obstruction;
• if you experience abundant purulent mucus and fever, or if you have chronic bronchial or lung disease, you should visit your doctor, who may recommend other medicines;
• do not use simultaneously with antitussive medicines and (or) medicines that reduce bronchial mucus secretion. The cough reflex is a natural defense mechanism of the lungs,
  and should not be suppressed. Treatment with this medicine should be accompanied by an unimpeded cough reflex to facilitate mucus clearance.

Pecto Drill lozenges and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
During treatment with Pecto Drill, do not take other medicines containing carbocisteine (to avoid exceeding the maximum dose), antitussive medicines, or medicines reducing bronchial secretion.

Pregnancy, breastfeeding and fertility
Use of this medicine is not recommended in pregnant women.
Use of this medicine is contraindicated during breastfeeding (see "When not to take Pecto Drill lozenges").
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery
Pecto Drill lozenges have no effect or a negligible effect on the ability to drive or operate machinery.

Pecto Drill lozenges contain:

• 7.23 mg of aspartame in each lozenge. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion;
• 600.32 mg of sorbitol in each lozenge. Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in you (or your child), or if hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, has been diagnosed, you should contact your doctor before taking the medicine or giving it to your child;
• 3.31 mg of glucose in each lozenge. If intolerance to certain sugars has previously been diagnosed in you, you should contact your doctor before taking the medicine;
• less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free";
• 0.16536 µg of benzyl alcohol in each lozenge, which may cause allergic reactions. Pregnant or breastfeeding women and patients with liver or kidney disease should contact their doctor before using the medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis);
• 1.272 µg of butylated hydroxyanisole (BHA) in each lozenge, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes;
• flavouring substance Cytral, which may cause allergic reactions.

3. How to use Pecto Drill, lozenges

This medicine should always be used according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Dosage
Adults:
At the beginning of treatment, the recommended dose is one tablet three times a day. After achieving
a satisfactory response to treatment, the dose should be reduced to one tablet twice a day.
Do not use the medicine before going to sleep.
Route and method of administration
For oral use.
The tablet should be sucked or chewed.
Duration of treatment
Treatment should be limited to five days. If symptoms persist after this time, medical advice should be sought.
Do not exceed the recommended doses of the medicine.
After taking the medicine, do not suppress the cough reflex. This will help remove mucus and phlegm from the lungs.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor or pharmacist.
Taking more Pecto Drill lozenges than recommended
If you take more than the recommended dose, stop taking the medicine immediately and consult your doctor or pharmacist.
Symptoms of overdose may include gastrointestinal disturbances (such as nausea, vomiting, diarrhoea and abdominal pain).
Missed dose of Pecto Drill lozenges
If you forget to take a dose, take it as soon as possible, unless it is almost time for the next dose. In that case, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur with unknown frequency (frequency cannot be estimated from the available data):

• Gastrointestinal disorders: upper abdominal pain, nausea and vomiting, diarrhoea;
• Nervous system disorders: headache;
• Skin and subcutaneous tissue disorders: allergic reactions: skin redness (erythematous rash), itching, urticaria, angioedema (rapid swelling of the skin or mucous membranes, most commonly of the face or throat, which may cause difficulty in breathing and swallowing), and circular areas with red-violet skin reaction recurring in the same location upon re-administration of the medicine (drug eruption).

If any of these symptoms occur, consult a physician, who may recommend reducing the dose or discontinuing the medicine.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a physician or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Pecto Drill, lozenges

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Medicines must 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 pack and other information

What Pecto Drill, lozenges contains
The active substance is carbocysteine. One lozenge contains 750 mg of carbocysteine.
The other ingredients are: povidone, sorbitol, sodium saccharin, aspartame, flavouring
28M107 (contains, among others, sorbitol, glucose, benzyl alcohol, butylhydroxyanisole, d-
limonene, citral), talc, stearic acid, magnesium stearate, purified water.
What Pecto Drill, lozenges looks like and contents of the pack
Pecto Drill is white, round, odourless lozenges with a slightly sweet taste.
Pack: 20 lozenges in blisters, in a cardboard box.
Marketing Authorisation Holder
PIERRE FABRE MEDICAMENT
Les Cauquillous
81500 Lavaur
France
Manufacturer
Pierre Fabre Medicament Production
Site Progipharm, Rue du Lycee
45500 Gien
France
For further information, please contact the local representative of the Marketing Authorisation Holder:
Pierre Fabre Medicament Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
Poland
tel.: 22 559 63 00
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