Paracetamol Galena

Leaflet attached to the packaging: patient information

PARACETAMOL GALENA

120 mg/5 ml, syrup

Paracetamol

Read the 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 advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days in children and after 3 days in adults in case of fever and 5 days in case of pain, there is no improvement or the patient feels worse, they should consult a doctor.

Table of contents of the leaflet

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

1. What is Paracetamol Galena and what is it used for

Paracetamol Galena in the form of a syrup is a medicine with analgesic and antipyretic effects, intended primarily for children. Paracetamol Galena is used for pain of various origins with mild and moderate intensity (headache, toothache, muscle pain, joint pain, menstrual pain, neuralgia, and others), as well as during fever in colds and flu-like conditions.

2. Important information before taking Paracetamol Galena

When not to take Paracetamol Galena

• if the patient is allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in case of severe liver or kidney failure,
• while taking MAO inhibitors and for up to 2 weeks after their discontinuation,
• in case of congenital deficiency of glucose-6-phosphate dehydrogenase and methemoglobin reductase.

Warnings and precautions

Overdose of Paracetamol Galena can be life-threatening. During use, it should be controlled whether other medicines taken simultaneously contain paracetamol. Particular caution should be exercised in patients with liver or kidney failure and with asthma. There is a special risk of liver damage in starving people and those who regularly consume alcohol, which enhances the toxic effect of paracetamol.

Paracetamol Galena and other medicines

Consult a doctor in case of taking:

• oral anticoagulant medicines from the coumarin group, as paracetamol may enhance their effect,
• medicines that inhibit paracetamol metabolism (rifampicin, antiepileptic drugs, some sleeping pills), due to the increased risk of liver damage,
• MAO inhibitor medicines (medicines used in depression), as taking them with paracetamol may cause excitement and high fever,
• zydovudine (an antiviral medicine), as combining it with paracetamol may cause changes in blood count (decrease in the number of neutrophils) and increase the risk of liver damage,
• non-steroidal anti-inflammatory medicines, as taking them with paracetamol increases the risk of kidney function disorders.

Caffeine enhances the analgesic effect of paracetamol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine. Pregnancy Paracetamol Galena can be used during pregnancy if necessary. The lowest recommended dose that reduces pain and (or) fever should be taken for the shortest possible time and as infrequently as possible. Consult a doctor if pain and (or) fever do not decrease or if the patient needs to take the medicine more frequently. Breastfeeding Paracetamol passes into breast milk in amounts that are not clinically significant. Paracetamol can be used during pregnancy and breastfeeding if absolutely necessary. Fertility There is no data on the effect of paracetamol on fertility.

Driving and using machines

The medicine taken as recommended does not affect psychophysical fitness and the ability to drive vehicles or operate machines.

Paracetamol Galena contains glycerol

The medicine may cause headache, gastrointestinal disturbances, and diarrhea.

Paracetamol Galena contains sorbitol (E 420)

The medicine contains 357 mg of sorbitol in each 1 ml. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Paracetamol Galena contains propyl parahydroxybenzoate (E 216)

The medicine may cause allergic reactions (possible late-type reactions).

Paracetamol Galena contains cochineal red (E 124)

The medicine may cause allergic reactions.

Paracetamol Galena contains propylene glycol (a component of the fruit flavor)

The medicine contains 0.6973 mg of propylene glycol in each milliliter of syrup. Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Paracetamol Galena contains ethanol (a component of the fruit flavor)

This medicine contains 0.1426 mg of alcohol (ethanol) in each 1 ml of syrup. The amount of alcohol in 1 ml of this medicine is equivalent to less than 0.148 ml of beer or 0.059 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to take Paracetamol Galena

This medicine should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse. In case of doubts, consult a doctor, pharmacist, or nurse. Recommended dose ChildrenThe recommended single dose is 10 to 15 mg of paracetamol per kilogram of body weight, not more often than every 4 hours, up to 4 times a day. The maximum daily dose in children is 60 mg of paracetamol per kilogram of body weight. Dosage is determined based on the child's body weight. Below is an example dosage depending on body weight and approximate age: * According to the centile grid developed by I. Palczewska, Z. Niedźwiecka, 1999.In children under 3 months of age, do not take Paracetamol Galena without consulting a doctor. Without a doctor's recommendation, do not give for more than 3 days. AdultsThe recommended single dose is 0.3 g to 1.0 g of paracetamol (12.5 ml to 41.6 ml of syrup), not more often than every 4 hours, up to 4 times a day. The maximum daily dose is 4 g of paracetamol (166.7 ml of syrup) per day. Higher doses are toxic. Without a doctor's recommendation, do not give for more than 3 days in case of fever and 5 days in case of pain.

Method of administration Oral administration. A measuring cup is attached to the packaging, making it easier to measure the correct dose of the medicine.

Taking a higher dose of Paracetamol Galena than recommended

Nausea, vomiting, excessive sweating, drowsiness, and general weakness may occur. If a higher dose of the medicine than recommended is taken, consult a doctor or pharmacist immediately, even if the patient's condition is good. Treatment of paracetamol overdose involves inducing vomiting. If no more than 1 hour has passed since ingestion, 60 - 100 g of activated carbon should be given orally, preferably mixed with water. In the case of very high doses of the medicine, antidotes are given: methionine and acetylcysteine treatment is continued. Treatment of paracetamol poisoning should be carried out in a hospital, in intensive care unit conditions.

Missing a dose of Paracetamol Galena

Do not take a double dose to make up for a missed dose.

Stopping Paracetamol Galena

In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Consult a doctor immediately if any of the following side effects occur

• -fainting or dizziness and disorientation, these may be symptoms of a life-threatening anaphylactic shock (inadequate blood flow in organs due to circulatory failure), the frequency of these side effects is unknown,
• sudden wheezing, difficulty breathing, swelling of the eyelids, face, or lips,
• rash, hives, redness, petechiae, or itching (especially if they affect the whole body), the frequency of these side effects is unknown,
• severe skin reactions, such as: acute pustular rash all over the body, Stevens-Johnson syndrome, and toxic epidermal necrolysis characterized by redness of the skin, rash, blisters, and ulcers on the skin, in the mouth, eyes, and genitals, with large subepidermal blisters, extensive skin ulcers, and fever. These side effects are very rare;
• thrombocytopenia - a decrease in the number of platelets in the blood, manifested by bleeding, hemorrhages, easily forming bruises, and petechiae, very rare (isolated cases),
• methemoglobinemia - loss of the ability to transport oxygen by hemoglobin, manifested by cyanosis, fatigue, shortness of breath during exertion, rapid heart rate, pain, and dizziness or coma, very rare (isolated cases).

Other possible side effects of Paracetamol Galena

Very rare (less than 1 in 10,000 patients - isolated cases):

• agranulocytosis - lack of granulocytes in the blood, manifested by a tendency to infections.

Frequency not known (cannot be estimated from the available data):

• liver damage, occurring mainly after overdose, manifested by nausea, vomiting, abdominal distension, yellowing of the skin and eyes, and liver tenderness with increased liver enzyme activity,
• gastrointestinal disorders in people with hypersensitivity (nausea, vomiting, digestive disorders).

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol Galena

There are no special precautions for storing the medicine. Store in the original packaging. The medicine should be stored 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 specified month. Medicines should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Paracetamol Galena contains

• The active substance of the medicine is paracetamol. 5 ml of syrup contains 120 mg of paracetamol.
• The other ingredients of the medicine are: glycerol, liquid sorbitol, non-crystallizing (E 420), povidone, propyl parahydroxybenzoate (E 216), cochineal red (E 124), fruit flavor (containing: natural and synthetic flavoring substances and compounds, including d-limonene, eugenol, farnesol, geraniol, and linalol), propylene glycol, ethanol, lactic acid, purified water, acetic acid, trioctan glycerol, maltol, ascorbic acid), purified water.

What Paracetamol Galena looks like and what the packaging contains

Paracetamol Galena syrup is a clear, red liquid with a fruit flavor. The packaging consists of an amber glass bottle, closed with a metal screw cap with a tear-off strip. The bottle is equipped with a measuring cup. The single packaging contains 100 ml of syrup.

Marketing authorization holder:

Zakład Farmaceutyczny "Amara" sp. z o. o. ul. Stacyjna 5 30-851 Kraków Tel. +48 12 657 40 40 [email protected]

Manufacturer:

Farmaceutyczna Spółdzielnia Pracy "GALENA" ul. Krucza 62 53-411 Wrocław Poland

Date of last update of the leaflet: