{"id":5708,"date":"2024-02-26T09:11:54","date_gmt":"2024-02-26T11:11:54","guid":{"rendered":"https:\/\/apotekar-online.rs\/?post_type=product&p=5708"},"modified":"2026-03-05T08:09:31","modified_gmt":"2026-03-05T10:09:31","slug":"paracetamol-alkaloid-120mg-5ml-oral-suspension","status":"publish","type":"product","link":"https:\/\/apotekar-online.rs\/en\/p\/paracetamol-alkaloid-120mg-5ml-oralna-suspenzija\/","title":{"rendered":"PARACETAMOL ALKALOID\u00ae 120mg\/5mL oral suspension"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"

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.<\/strong><\/b><\/p>\n

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79\/2010)\u00a0HERE<\/a>.<\/p>\n

PARACETAMOL ALKALOID\u00ae
\n, 120 mg\/5 mL, oral suspension
\nParacetamol
\nRead this instruction carefully before you start using this medicine, because it
\ncontains information that is important to you.
\nAlways use this medicine exactly as stated in these instructions or as explained to you
\nYour doctor or pharmacist.
\n- Save the instructions. You may need to read it again.
\n- If you have additional questions or need advice, contact your pharmacist.
\n- If your child experiences any side effects, contact your doctor or pharmacist.
\nThis includes any side effects not listed in this guide. See section 4.
\n- If a child older than 3 months does not feel better or feels worse after three days, and the child
\naged 2-3 months after two doses of the drug, you must contact your doctor.
\nIn this guide you will read:
\n1. What is the drug PARACETAMOL ALKALOID and what is it intended for
\n2. What you should know before taking the medicine PARACETAMOL ALKALOID
\n3. How to take the medicine PARACETAMOL ALKALOID
\n4. Possible side effects
\n5. How to store the medicine PARACETAMOL ALKALOID
\n6. Contents of the package and other information
\n2 out of 5
\n1. What is the drug PARACETAMOL ALKALOID and what is it intended for
\nThe drug PARACETAMOL ALKALOID, oral suspension contains the active substance paracetamol, which is
\nanalgesic (pain reliever) and antipyretic (reduces elevated body temperature).
\nThe medicine PARACETAMOL ALKALOID, oral suspension relieves the pain of teething, toothache and
\nsore throat, lowers the elevated body temperature that often accompanies colds, flu and other children's illnesses
\ninfectious diseases (such as chicken pox, whooping cough, small pox and mumps).
\n2. What you should know before taking the medicine PARACETAMOL ALKALOID
\nYou must not give PARACETAMOL ALKALOID to a child:
\n- if the child is allergic to paracetamol or any of the auxiliary substances of this medicine (listed
\nin section 6).
\n- if the child is taking any other medicine containing paracetamol.
\nWarnings and precautions:
\nTalk to your doctor or pharmacist before taking PARACETAMOL ALKALOID,
\ngive the oral suspension to a child who:
\n\uf02d has liver or kidney disease,
\n\uf02d has insufficient body mass or is malnourished,
\n\uf02d is premature and younger than 3 months,
\n\uf02d has a severe infection as this may increase the risk of metabolic acidosis.
\nSigns of metabolic acidosis include:
\n\u2022 deep, rapid, difficult breathing,
\n\u2022 nausea, vomiting,
\n\u2022 loss of appetite.
\nConsult a doctor immediately if your child experiences a combination of these symptoms.
\nOther medicines and PARACETAMOL ALKALOID
\nInform the doctor or pharmacist if your child is taking, has recently taken or may take
\ntake any other medicines.
\nBefore you give the medicine PARACETAMOL ALKALOID to your child, you need to consult
\ndoctor if your child:
\n\uf02d uses warfarin or other drugs to prevent blood clotting,
\n\uf02d uses metoclopramide or domperidone (to treat nausea and vomiting),
\n\uf02d uses cholestyramine (to lower blood fat levels),
\n\uf02d is taking any other medications or is under medical supervision,
\n\uf02d is taking or has recently taken any other medicines, including over-the-counter medicines
\nwithout a prescription.
\nPregnancy, breastfeeding and fertility
\nIf you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact your doctor
\ndoctor or pharmacist for advice before taking this medicine.
\nIf necessary, PARACETAMOL ALKALOID can be used during pregnancy. Should have
\nbi to use the lowest possible dose that relieves pain and\/or lowers body temperature and u
\nin the shortest possible time. Contact your doctor if the pain and\/or body temperature is not
\nreduced or if you need to take the medicine more often.
\nYou can use this medicine during breastfeeding.
\n3 out of 5
\nDriving vehicles and operating machines
\nThe drug PARACETAMOL ALKALOID has no effect on the ability to drive and operate vehicles
\nmachines.
\nThe medicine PARACETAMOL ALKALOID contains sorbitol and maltitol. In the case of individual intolerance
\nsugar, consult your doctor before using this medicine.
\nThe drug PARACETAMOL ALKALOID contains 0.1173 mmol\/mL sodium (a dose greater than 8.5 mL contains >
\n1 mmol sodium). Special caution is advised when using in patients who are on a diet
\nwhich controls sodium intake.
\n3. How to take the medicine PARACETAMOL ALKALOID
\nAlways take this medicine exactly as stated in this leaflet or as explained to you by your doctor
\ndoctor or pharmacist. If you are not sure, check with your doctor or pharmacist.
\nThe drug PARACETAMOL ALKALOID, oral suspension is intended for oral use in children.
\nShake the suspension well before each use.
\nTo measure the dose, use the graduated oral syringe (volume 5 mL) that is inside
\nof each package.
\nDo not use the medicine in babies younger than 2 months.
\nIn infants aged 2-3 months, the drug can be used only on the recommendation of a doctor.
\nDo not apply more than two doses of the drug.
\nApply the medicine with an interval of at least 4 hours between doses.
\nIf it is necessary to apply more than two doses, consult a doctor.
\nNever apply more medicine than shown in the table.
\nAlways use the lowest effective dose that relieves the child's symptoms.
\nDosing of paracetamol in children aged \u2265 3 months:
\nChild's age Drug dose Frequency of dosing during 24 h
\n3-6 months 2.5 mL 4 times
\n6-24 months 5 mL 4 times
\n2-4 years 7.5 mL 4 times
\n4-8 years 10 mL 4 times
\n8-10 years 15 mL 4 times
\n10-12 years 20 mL 4 times
\n- Do not apply more than 4 doses of the drug in 24 hours.
\n- It is necessary that at least 4 hours pass between doses.
\n- The lowest dose necessary to achieve the effect should be applied.
\n- Do not give the medicine to a child for more than 3 days without consulting a doctor.
\nThe drug PARACETAMOL ALKALOID must not be used with other drugs that contain it
\nParacetamol.
\nIf it is a premature child younger than 3 months, you should consult a doctor before
\ndrug administration.
\nIf the symptoms worsen in children older than 3 months or if they do not improve within 3 months
\nday, consult a doctor.
\nLong-term use of the drug without medical supervision can be harmful.
\nThis medicine should be used only if it is really necessary.
\nFood and drink do not affect the absorption of the drug.
\n4 out of 5
\nIf you have given your child more PARACETAMOL ALKALOID than needed
\nThe recommended dose of the drug must not be exceeded.
\nIn case of overdose, seek medical help immediately, even if the child seems to be fine, because there is
\nrisk of delayed, severe damage to liver function.
\nIf you forgot to give your child the medicine PARACETAMOL ALKALOID
\nNever give a child a double dose to make up for a missed dose.
\n4. Possible side effects
\nLike all medicines and the medicine PARACETAMOL ALKALOID can sample unwanted effects, although
\nthey may not occur in all patients taking this medicine.
\nStop using the medicine and contact your doctor immediately if any of the following occur in your child
\nmentioned and\/or some other unwanted effects.
\nVery rare side effects (may occur in up to 1 in 10,000 patients taking the drug):
\n- allergic reactions such as skin rash, itching sometimes accompanied by difficulty breathing or
\nswelling of the lips, tongue, throat or face;
\n- very rare cases of serious skin reactions have been reported. Symptoms include:
\nwidespread, severe rash accompanied by redness, blisters, peeling of the skin, the appearance of sores in
\nmouth, increased body temperature (Stevens-Johnson syndrome, toxic
\nepidermal necrolosis, acute generalized exanthematous pustulosis);
\n- breathing problem - in children who previously had a breathing problem after application
\nacetylsalicylic acid or nonsteroidal anti-inflammatory drugs (NSAIDs);
\n- unusual appearance of bruises or bleeding (due to a decrease in the number of blood platelets);
\n- tendency to infections, elevated body temperature, sore throat, superficial ulcers in
\nby mouth, flu-like symptoms (due to a decrease in the number of one type of white blood cell);
\n- changes in blood tests related to liver function.
\nReporting adverse reactions
\nIf you experience any unwanted reaction, you need to inform the doctor about it, or
\npharmacist. This includes any possible side effects that are not listed in this guide.
\nBy reporting side effects, you can help evaluate the safety of this medicine. Doubt
\nYou can report adverse reactions to the Agency for Medicines and Medical Devices of Serbia
\n(ALIMS):
\nAgency for Medicines and Medical Devices of Serbia
\nNational Center for Pharmacovigilance
\nVojvode Stepe 458, 11221 Belgrade
\nRepublic of Serbia
\nwebsite: www.alims.gov.rs
\ne-mail: nezeljene.reakcije@alims.gov.rs
\n5. How to store the medicine PARACETAMOL ALKALOID
\nKeep out of sight and reach of children.
\nYou must not use the medicine PARACETAMOL ALKALOID after the expiration date indicated on
\nbox after "Valid until:". The expiration date refers to the last day of the specified month.
\nStore at a temperature of up to 25\u00b0C, in the original packaging to protect from light.
\nThe shelf life after first opening is 6 months, when stored at a temperature of up to 25\u00b0C, in the original packaging
\npackaging to protect from light.
\n5 out of 5
\nUnusable medicines are handed over to the pharmacy where the notice to that pharmacy is displayed
\nthey collect unusable medicines from citizens. Unusable medicines must not be thrown away
\nsewage or together with municipal waste. These measures will help protect the environment.
\nUnused medicine is destroyed in accordance with current regulations.
\n6. Contents of packaging and other information
\nWhat does PARACETAMOL ALKALOID contain
\n- The active substance is paracetamol.
\n5 mL of oral suspension contains 120 mg of paracetamol.
\n1 mL of oral suspension contains 24 mg of paracetamol.
\n- Auxiliary substances are: sorbitol, liquid, non-crystallizing; glycerol; maltitol, liquid; xanthan
\nrubber; hydroxyethyl cellulose; sodium benzoate (E211); sodium citrate; citric acid,
\nmonohydrate; saccharin-sodium; pineapple flavor 02662 (composition: propylene glycol, triacetin,
\nbutylhydroxyanisole, flavor components); flavor masking flavor 501438 (composition: corn
\nmaltodextrin, propylene glycol, glycerol, flavor components); simethicone emulsion 30%; water,
\npurified.
\nWhat the PARACETAMOL ALKALOID drug looks like and the contents of the package
\nPARACETAMOL ALKALOID is an almost white to light brown suspension with a fruity odor.
\nThe inner package is a glass bottle of hydrolytic resistance type III brown color, with a cap with
\nwith a polypropylene thread with a PE coating or alternatively with a safety screw cap for
\nchildren (child-resistant closure) made of polypropylene with a printed mark for opening and with a PE coating.
\nThe outer packaging is a collapsible cardboard box containing 1 (one) bottle of 100 mL oral
\nsuspensions with a means of measuring the dose - a graduated plastic syringe of 5 mL with a protective cap
\nclosure (syringe body and protective closure are made of LDPE, piston made of polystyrene) and Instructions for the drug.
\nThe syringe is graduated to 1 mL, 2 mL, 2.5 mL, 3 mL, 4 mL, and 5 mL.
\nLicense holder and manufacturer
\nLicense holder
\nALKALOID D.O.O. WHITE CITY
\nPrahovska 3, Belgrade
\nManufacturer
\nALKALOID AD SKOPJE
\nBulevar Aleksandar Makedonski 12, Skopje,
\nRepublic of North Macedonia
\nThis instruction was last approved
\nMarch, 2021.
\nMode of administration of the drug:
\nThe drug is issued without a doctor's prescription.
\nLicense number and date:
\n515-01-00793-20-001 from 10.03.2021<\/p>\n

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