Parasedol For Children 120 mg/5 ml (120 ml)
| SKU | 30014137 |
|---|---|
| Form | SYRUP |
| Content | 120 ml syrup |
| Weight | 0.15 kg |
€7,29
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Intended for use in children, Parasedol contains the active substance paracetamol with analgesic and antipyretic action. It is administered orally and relieves the pain of teething, toothache and sore throat. Lowers the temperature in colds, flu and childhood infections. It is also recommended to reduce the fever that occurs as a reaction after vaccination. If after 3 days the child does not feel better or his condition worsens, you should seek medical help.
Available in a package of 120 ml.
Parasedol contains liquid maltitol and sorbitol. If you have been told by your doctor that your child has an intolerance to some sugars, contact your doctor before giving this product to your child.
This medicine contains methyl and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Parasedol also contains the colorant azorubin (E 122), which may cause allergic reactions. This medicinal product contains less than 23 mg sodium per dose, ie essentially 'sodium-free'.
Composition:
- The active substance is: paracetamol 120 mg in 5 ml oral suspension.
- The other ingredients are: xanthan gum, liquid maltitol (E965), sorbitol (E420), citric acid monohydrate, sodium citrate, glycerol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), esorazoic (E216), ezorubin, ezorubin alcohol E1519, ethyl maltol E637, orange oil in propylene glycol E1520), liquid essence "Raspberry" (lactic acid, triacetin, vanillin, parahydroxybenzyl acetone, rose oil).
Usage
More Information
Do not use Parasedol:
- if your child is allergic to the active substance or any of the other ingredients of this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using Parasedol:
- if your child has kidney or liver disease;
- if the child is taking warfarin and similar medicines used to thin the blood;
- if the child has had trouble breathing when using this or a similar medicine in the past.
This medicine contains paracetamol. Other medicines also contain this active substance. Do not combine such drugs so as not to exceed the recommended daily dose.
Other medicines and Parasedol
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
There are no clinically significant drug interactions with limited use in children and the recommended dosing regimen.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
This medicine is intended for use in children.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In very rare cases (affecting less than 1 in 10,000 patients) there are changes in the blood picture (decreased number of platelets in the blood), allergic reactions, such as a skin rash.
Serious skin reactions have been reported very rarely.
Stop taking the medicine and talk to your doctor if you experience an allergic reaction with itching, rash, swelling of the face and throat, difficulty breathing and dizziness, blistering of the skin, mouth, around the eyes and genitals, unexpected bleeding or tendency to bruise the body.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
How to store Parasedol
Store below 25 ° C. Keep out of reach of children. The oral suspension can be used up to 6 months after opening the bottle.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Patient Leaflet
PARASEDOL FOR CHILDREN oral suspension 120 mg / 5 ml 120 ml SOPHARMA
Package leaflet: information for the user
Paracedol for children 120 mg/5 ml oral suspension
Paracetamol
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may have to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What is in this leaflet
1. What Parasedol is for children and what it is used for
2. What you need to know before you use Parasedol for children
3. How to use Parasedol for children
4. Possible side effects
5. How to store Parasedol for children
6. Contents of the pack and other information
1. What Parasedol is for children and what it is used for
Paracedol for children contains the active substance paracetamol, with analgesic and temperature lowering action. Parasedol for children is administered orally and is intended for use in childhood. Relieves teething pain, toothache and sore throat and lowers fever for colds, flu and childhood infections.
It is also recommended to lower the fever that has appeared as a reaction after vaccination.
If after 3 days the child does not feel better or his condition worsens, you should seek medical help.
2. What you need to know before you take Parasedol for kids
Do not use Parasedol for children
- if your child is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Parasedol for children
- if the child has kidney or liver disease;
- if the child is taking warfarin and similar medicines used to thin the blood
- if the child has had breathing problems using this or similar medicine in the past.
This medicine contains paracetamol. Other drugs also contain this active substance. Do not combine such drugs, so as not to exceed the recommended daily dose.
Other medicines and Parasedol for children
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
With the limited use in children and the recommended dosing regimen, there are no clinically significant drug interactions.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This medicinal product is intended for use in childhood. If necessary, Parasedol for children can be used during pregnancy. You should use the lowest possible dose that reduces pain and/or lowers the temperature and for the shortest possible time. Contact your doctor or midwife if your pain and/or fever has not subsided or if you need to take the medicine more often.
Parasedol for children contains liquid maltitol. If you have been told by your doctor that your child is intolerant to some sugars, ask your child for advice before giving this product to your child.
This medicine contains 666.5 mg sorbitol in each 5 ml suspension, which is equivalent to 133.3 mg/ml. If you have been told by your doctor that you or your child are intolerant to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which people cannot break down fructose, talk to your doctor before you or your child take this medicine.
Sorbitol may cause gastrointestinal indisposition and low laxative effect when taken higher than 140 mg/kg/day.
This medicine contains methyl- and propylparahydroxybenzoate, which may cause allergic reactions (possibly of the delayed type).
Paracedol for children also contains the colorant azorubin (E122), which may cause allergic reactions.
This medicinal product contains sodium less than 23 mg per dose, i.e. essentially sodium free.
3. How to use Parasedol for children
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Paracedol for children is administered orally.
Shake the bottle well before use.
Do not give more than 60 mg/kg body weight over a period of 24 hours.
The recommended dose is:
| WEIGHT | AGE | DOSE (ml) |
| 4-6 kg | 2 months | 2,5 |
| 6-8 kg | 3-6 months | 4,0 |
| 8-10 kg | 6-12 months | 5,0 |
| 10-13 kg | 1-2 years | 7,0 |
| 13-15 kg | 2-3 years | 9,0 |
| 15-21 kg | 3-6 years | 10,0 |
| 21-29 kg | 6-9 years | 14,0 |
| 29-42 kg | 9-12 years | 20,0 |
Children from 2 to 3 months
A single dose of 2.5 ml (60 mg) of suspension for symptomatic relief of adverse reactions after vaccination. If necessary, you can repeat the same dose after 4-6 hours. Do not give the drug more than 2 times a day. If fever persists after taking the second dose, seek medical advice.
A graduated syringe is attached to the pack to make it easier to measure the exact dose (listed in the table above) depending on the weight of the child. If you are not sure about your child’s weight, use their age to determine the dose. With the syringe, withdraw the required amount of suspension from the bottle to the appropriate scale line. Put the end of the syringe in the child’s mouth and press the plunger down to pour the medicine. After use, wash the syringe with warm water and allow it to dry.
Do not give the drug to children younger than 2 months or to premature infants without consulting a doctor.
If necessary, this medicine can be administered every 4 hours. Do not give more than 4 doses in 24 hours.
Do not give the suspension at intervals shorter than 4 hours.
Do not give Parasedol for children to your child for more than 3 days without consulting a doctor. If your child’s condition does not improve, seek the advice of your doctor.
If you use more Parasedol for children than you should
Do not exceed the indicated dose. Taking too much can damage the liver. If you suspect taking a larger dose of paracetamol, consult a doctor immediately, even if your child feels well.
If you forget to use Parasedol for children
Give the dose you need when you remember. Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In very rare cases (affect less than 1 in 10,000 patients), changes in blood counts (decreased blood platelet counts), allergic reactions, such as skin rash, are observed.
Very rarely, serious skin reactions have been reported.
Stop taking the medicine and consult your doctor if you observe an allergic reaction with itching, rash, swelling of the face and throat, difficulty breathing and dizziness, blistering on the skin, mouth, around the eyes and genitals, unexpected bleeding or a tendency to bruise the body.
Reporting of adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Parasedol for children
Store below 25°C.Keep out of the reach of children.
The oral suspension can be used for up to 6 months after opening the bottle.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Parasedol contains for kids
- The active substance is paracetamol 120 mg in 5 ml oral suspension.
- The other ingredients are: xanthan gum, maltitol liquid (E965), sorbitol (E420), citric acid monohydrate, sodium citrate, glycerol, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), azorubin (E122), liquid essence “Strawberry” (benzyl alcohol E1519, ethyl maltol E637, orange oil in propylene glycol (E1520), liquid essence “Raspberry” (lactic acid, triacetin, vanillin, parahydroxybenzyl acetone, rose oil).
What Parasedol for children looks like and contents of the pack
Pink-colored oral suspension, with a specific smell of berries.
Oral suspension 120 ml in a dark brown glass bottle or a dark brown PET bottle with a polyethylene cap, together with a plastic graduated syringe and a package leaflet in a cardboard box.
Marketing Authorisation Holder and Manufacturer
SOPHARMA AD, Bulgaria
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