PARACETAMOL ALKALOID® 120mg/5mL oral suspension

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.

PARACETAMOL ALKALOID®
, 120 mg/5 mL, oral suspension
Paracetamol
Read this instruction carefully before you start using this medicine, because it
contains information that is important to you.
Always use this medicine exactly as stated in these instructions or as explained to you
Your doctor or pharmacist.
- Save the instructions. You may need to read it again.
- If you have additional questions or need advice, contact your pharmacist.
- If your child experiences any side effects, contact your doctor or pharmacist.
This includes any side effects not listed in this guide. See section 4.
- If a child older than 3 months does not feel better or feels worse after three days, and the child
aged 2-3 months after two doses of the drug, you must contact your doctor.
In this guide you will read:
1. What is the drug PARACETAMOL ALKALOID and what is it intended for
2. What you should know before taking the medicine PARACETAMOL ALKALOID
3. How to take the medicine PARACETAMOL ALKALOID
4. Possible side effects
5. How to store the medicine PARACETAMOL ALKALOID
6. Contents of the package and other information
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1. What is the drug PARACETAMOL ALKALOID and what is it intended for
The drug PARACETAMOL ALKALOID, oral suspension contains the active substance paracetamol, which is
analgesic (pain reliever) and antipyretic (reduces elevated body temperature).
The medicine PARACETAMOL ALKALOID, oral suspension relieves the pain of teething, toothache and
sore throat, lowers the elevated body temperature that often accompanies colds, flu and other children's illnesses
infectious diseases (such as chicken pox, whooping cough, small pox and mumps).
2. What you should know before taking the medicine PARACETAMOL ALKALOID
You must not give PARACETAMOL ALKALOID to a child:
- if the child is allergic to paracetamol or any of the auxiliary substances of this medicine (listed
in section 6).
- if the child is taking any other medicine containing paracetamol.
Warnings and precautions:
Talk to your doctor or pharmacist before taking PARACETAMOL ALKALOID,
give the oral suspension to a child who:
 has liver or kidney disease,
 has insufficient body mass or is malnourished,
 is premature and younger than 3 months,
 has a severe infection as this may increase the risk of metabolic acidosis.
Signs of metabolic acidosis include:
• deep, rapid, difficult breathing,
• nausea, vomiting,
• loss of appetite.
Consult a doctor immediately if your child experiences a combination of these symptoms.
Other medicines and PARACETAMOL ALKALOID
Inform the doctor or pharmacist if your child is taking, has recently taken or may take
take any other medicines.
Before you give the medicine PARACETAMOL ALKALOID to your child, you need to consult
doctor if your child:
 uses warfarin or other drugs to prevent blood clotting,
 uses metoclopramide or domperidone (to treat nausea and vomiting),
 uses cholestyramine (to lower blood fat levels),
 is taking any other medications or is under medical supervision,
 is taking or has recently taken any other medicines, including over-the-counter medicines
without a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor
doctor or pharmacist for advice before taking this medicine.
If necessary, PARACETAMOL ALKALOID can be used during pregnancy. Should have
bi to use the lowest possible dose that relieves pain and/or lowers body temperature and u
in the shortest possible time. Contact your doctor if the pain and/or body temperature is not
reduced or if you need to take the medicine more often.
You can use this medicine during breastfeeding.
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Driving vehicles and operating machines
The drug PARACETAMOL ALKALOID has no effect on the ability to drive and operate vehicles
machines.
The medicine PARACETAMOL ALKALOID contains sorbitol and maltitol. In the case of individual intolerance
sugar, consult your doctor before using this medicine.
The drug PARACETAMOL ALKALOID contains 0.1173 mmol/mL sodium (a dose greater than 8.5 mL contains >
1 mmol sodium). Special caution is advised when using in patients who are on a diet
which controls sodium intake.
3. How to take the medicine PARACETAMOL ALKALOID
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
doctor or pharmacist. If you are not sure, check with your doctor or pharmacist.
The drug PARACETAMOL ALKALOID, oral suspension is intended for oral use in children.
Shake the suspension well before each use.
To measure the dose, use the graduated oral syringe (volume 5 mL) that is inside
of each package.
Do not use the medicine in babies younger than 2 months.
In infants aged 2-3 months, the drug can be used only on the recommendation of a doctor.
Do not apply more than two doses of the drug.
Apply the medicine with an interval of at least 4 hours between doses.
If it is necessary to apply more than two doses, consult a doctor.
Never apply more medicine than shown in the table.
Always use the lowest effective dose that relieves the child's symptoms.
Dosing of paracetamol in children aged ≥ 3 months:
Child's age Drug dose Frequency of dosing during 24 h
3-6 months 2.5 mL 4 times
6-24 months 5 mL 4 times
2-4 years 7.5 mL 4 times
4-8 years 10 mL 4 times
8-10 years 15 mL 4 times
10-12 years 20 mL 4 times
- Do not apply more than 4 doses of the drug in 24 hours.
- It is necessary that at least 4 hours pass between doses.
- The lowest dose necessary to achieve the effect should be applied.
- Do not give the medicine to a child for more than 3 days without consulting a doctor.
The drug PARACETAMOL ALKALOID must not be used with other drugs that contain it
Paracetamol.
If it is a premature child younger than 3 months, you should consult a doctor before
drug administration.
If the symptoms worsen in children older than 3 months or if they do not improve within 3 months
day, consult a doctor.
Long-term use of the drug without medical supervision can be harmful.
This medicine should be used only if it is really necessary.
Food and drink do not affect the absorption of the drug.
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If you have given your child more PARACETAMOL ALKALOID than needed
The recommended dose of the drug must not be exceeded.
In case of overdose, seek medical help immediately, even if the child seems to be fine, because there is
risk of delayed, severe damage to liver function.
If you forgot to give your child the medicine PARACETAMOL ALKALOID
Never give a child a double dose to make up for a missed dose.
4. Possible side effects
Like all medicines and the medicine PARACETAMOL ALKALOID can sample unwanted effects, although
they may not occur in all patients taking this medicine.
Stop using the medicine and contact your doctor immediately if any of the following occur in your child
mentioned and/or some other unwanted effects.
Very rare side effects (may occur in up to 1 in 10,000 patients taking the drug):
- allergic reactions such as skin rash, itching sometimes accompanied by difficulty breathing or
swelling of the lips, tongue, throat or face;
- very rare cases of serious skin reactions have been reported. Symptoms include:
widespread, severe rash accompanied by redness, blisters, peeling of the skin, the appearance of sores in
mouth, increased body temperature (Stevens-Johnson syndrome, toxic
epidermal necrolosis, acute generalized exanthematous pustulosis);
- breathing problem - in children who previously had a breathing problem after application
acetylsalicylic acid or nonsteroidal anti-inflammatory drugs (NSAIDs);
- unusual appearance of bruises or bleeding (due to a decrease in the number of blood platelets);
- tendency to infections, elevated body temperature, sore throat, superficial ulcers in
by mouth, flu-like symptoms (due to a decrease in the number of one type of white blood cell);
- changes in blood tests related to liver function.
Reporting adverse reactions
If you experience any unwanted reaction, you need to inform the doctor about it, or
pharmacist. This includes any possible side effects that are not listed in this guide.
By reporting side effects, you can help evaluate the safety of this medicine. Doubt
You can report adverse reactions to the Agency for Medicines and Medical Devices of Serbia
(ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store the medicine PARACETAMOL ALKALOID
Keep out of sight and reach of children.
You must not use the medicine PARACETAMOL ALKALOID after the expiration date indicated on
box after "Valid until:". The expiration date refers to the last day of the specified month.
Store at a temperature of up to 25°C, in the original packaging to protect from light.
The shelf life after first opening is 6 months, when stored at a temperature of up to 25°C, in the original packaging
packaging to protect from light.
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Unusable medicines are handed over to the pharmacy where the notice to that pharmacy is displayed
they collect unusable medicines from citizens. Unusable medicines must not be thrown away
sewage or together with municipal waste. These measures will help protect the environment.
Unused medicine is destroyed in accordance with current regulations.
6. Contents of packaging and other information
What does PARACETAMOL ALKALOID contain
- The active substance is paracetamol.
5 mL of oral suspension contains 120 mg of paracetamol.
1 mL of oral suspension contains 24 mg of paracetamol.
- Auxiliary substances are: sorbitol, liquid, non-crystallizing; glycerol; maltitol, liquid; xanthan
rubber; hydroxyethyl cellulose; sodium benzoate (E211); sodium citrate; citric acid,
monohydrate; saccharin-sodium; pineapple flavor 02662 (composition: propylene glycol, triacetin,
butylhydroxyanisole, flavor components); flavor masking flavor 501438 (composition: corn
maltodextrin, propylene glycol, glycerol, flavor components); simethicone emulsion 30%; water,
purified.
What the PARACETAMOL ALKALOID drug looks like and the contents of the package
PARACETAMOL ALKALOID is an almost white to light brown suspension with a fruity odor.
The inner package is a glass bottle of hydrolytic resistance type III brown color, with a cap with
with a polypropylene thread with a PE coating or alternatively with a safety screw cap for
children (child-resistant closure) made of polypropylene with a printed mark for opening and with a PE coating.
The outer packaging is a collapsible cardboard box containing 1 (one) bottle of 100 mL oral
suspensions with a means of measuring the dose - a graduated plastic syringe of 5 mL with a protective cap
closure (syringe body and protective closure are made of LDPE, piston made of polystyrene) and Instructions for the drug.
The syringe is graduated to 1 mL, 2 mL, 2.5 mL, 3 mL, 4 mL, and 5 mL.
License holder and manufacturer
License holder
ALKALOID D.O.O. WHITE CITY
Prahovska 3, Belgrade
Manufacturer
ALKALOID AD SKOPJE
Bulevar Aleksandar Makedonski 12, Skopje,
Republic of North Macedonia
This instruction was last approved
March, 2021.
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-00793-20-001 from 10.03.2021