PARACETAMOL-RATIOPHARM 125 SUPP N10

ATC code: N02BE01 

Active substances: Paracetamolum

Vendor, principal: Ratiopharm. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

PARACETAMOL- RATIOPHARM S 250MG N10

Package leaflet: Information for the user

Paracetamol-ratiopharm 250 S, rectal suppositories

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 need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   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.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days.

What is in this leaflet

1.   What Paracetamol-ratiopharm 250 S is and what it is used for
2.   What you need to know before you use Paracetamol-ratiopharm 250 S
3.   How to use Paracetamol-ratiopharm 250 S
4.   Possible side effects
5.   How to store Paracetamol-ratiopharm 250 S
6.   Contents of the pack and other information

1. What Paracetamol-ratiopharm 250 S is and what it is used for

Paracetamol-ratiopharm 250 S is a medicine with an analgesic and antipyretic effect. It is used to treat fever and mild pain in children.
Advice:
Without first talking to your doctor or dentist, use the Paracetamol-ratiopharm 250 S rectal suppositories only for a few days and in small quantities.
You must talk to a doctor if you do not feel better or if you feel worse after 3-4 days.

2. What you need to know before you use Paracetamol-ratiopharm 250 S Do not use Paracetamol-ratiopharm 250 S rectal suppositories

-   if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6);
-   if you have genetic glucose-6-phosphate dehydrogenase deficiency (there is a risk of haemolytic anaemia).

Warnings and precautions

Talk to your doctor or pharmacist before using Paracetamol-ratiopharm 250 S.
In the following cases, use the Paracetamol-ratiopharm 250 S rectal suppositories with utmost caution (i.e. with longer administration intervals and in smaller doses) and under a doctor’s supervision:
-   impaired liver function (e.g. chronic alcohol abuse, inflammations of the liver);
-   underlying kidney impairment;
-   congenital increased bilirubin count in the blood (Gilbert’s syndrome or Meulengracht disease);
-   in children up to the age of 6.
-   low levels of glutathione, as this may increase the risk of side effects
Without a doctor or dentist’ s recommendation, medicines containing paracetamol may be used only for a few days and in small quantities.
Long-term, non-prescribed use of analgesics may result in headaches that may not be treated with increased doses of the medicine.
In general, the habitual use of painkillers, especially in combination with other analgesic substances, may lead to irreversible renal impairment with a risk of renal failure (analgesic nephropathy).
Abrupt discontinuation of long-term, large-dosed and inappropriate use of painkillers may result in headaches, as well as fatigue, muscle pain, nervousness and vegetative symptoms. Withdrawal symptoms recede in a few days. Until then, treatment with analgesics may not be started again without a doctor’s recommendation.

Children

Due to the large content of the active substance, Paracetamol-ratiopharm 250 S rectal suppositories are not suitable for children with a weight of less than 20 kg. In infants, use rectal suppositories or solution with a smaller content of the active substance.

Other medicines and Paracetamol-ratiopharm 250 S

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant treatment with medicines that accelerate the breakdown of this medicine in the liver (enzyme induction), such as certain sedatives and anticonvulsants (incl. phenobarbital, phenytoin, carbamazepine), as well as rifampicin (medicine for tuberculosis), may cause hepatic impairment even in the case of regular therapeutic doses of paracetamol. The same applies to alcohol abuse. Concomitant use with diflunisal may increase the hepatoxicity of paracetamol.
The concomitant use of paracetamol and chloramphenicol may decrease the chloramphenicol elimination rate from the body and increase toxicity (adverse effect).
The interaction of paracetamol and coumarin derivatives (medicines that prevent blood clotting) has not yet been assessed in the sense of their clinical significance. Therefore, the long-term use of Paracetamol-ratiopharm 250 S rectal suppositories in patients being treated with oral anticoagulants (medicines that prevent blood clotting) must be carried out only under a doctor’s supervision.
The concomitant use of paracetamol and zidovudine increases the tendency of a decrease in white blood cells (neutropenia). Therefore, Paracetamol-ratiopharm 250 S rectal suppositories may be used concomitantly with zidovudine only under a doctor’ s supervision.
Probenecid may increase the toxic effect on the liver.
Using paracetamol may affect the results of some laboratory tests, such as urea tests and the estimation of blood glucose by the glucose oxidase-peroxidase method.
Attention! The interactions listed above may also apply in the case of short-term use of this medicine!

Paracetamol-ratiopharm 250 S with food, drink and alcohol

If possible, avoid alcohol consumption during the use of Paracetamol-ratiopharm 250 S rectal suppositories.

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.
Pregnancy
In general, the 250-mg rectal suppositories are used in children aged 6-12 years.
Paracetamol-ratiopharm 250S may be used during pregnancy. You should use the lowest possible dose that reduces pain and/or fever, and use the medicine for as short a time as possible. Talk to your doctor or midwife if the pain and/or fever does not recede or if you begin taking the medicine more often.
If you are pregnant, do not use Paracetamol-ratiopharm 250 S rectal suppositories for a long period, in large doses or in combination with other medicines, because in these cases, the safety of use has not been proven.
Breast-feeding
Paracetamol is excreted in breast milk. As no adverse effects to the infant are currently known, the interruption of breast-feeding during the treatment is not generally required.

Driving and using machines

There is no influence on the ability to drive and use machines.

3. How to use Paracetamol-ratiopharm 250 S

Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

In what quantities and how often should you use Paracetamol-ratiopharm 250 S

The dosing of Paracetamol-ratiopharm 250 S rectal suppositories depends on weight and age: children aged 6-12 years - 1-2 rectal suppositories, for example:
20-25 kg - 1 rectal suppository (250 mg);
25-40 kg - 2 rectal suppositories (500 mg).
The 250 mg rectal suppositories are not suitable for children with the weight of less than 20 kg. They should be given a rectal suppository that contains 125 mg of paracetamol.
A maximum of 4 doses may be administered a day. The interval between administering two suppositories should be at least 6 hours. Larger doses do not ensure better analgesic effect.
Advice:
In the case of both kidney and liver disorders and congenital increased bilirubin count in the blood, Paracetamol-ratiopharm 250 S rectal suppositories should be used with longer administration intervals or in smaller doses.

How and when should you use Paracetamol-ratiopharm 250 S

Rectal suppositories are pushed deep into the anus after defecation, if possible. To improve lubrication properties, the suppositories may be warmed in the hand or dipped in hot water for a second. Administer the entire rectal suppository - it may not be crushed before administration.

How long should you use Paracetamol-ratiopharm 250 S for

Do not use Paracetamol-ratiopharm 250 S rectal suppositories for more than 3-4 days without a doctor or dentist’s recommendation.

If you use more Paracetamol-ratiopharm 250 S than you should

The initial overdose symptoms of Paracetamol-ratiopharm 250 S (on the first day) may be nausea, vomiting, sweating, drowsiness and general malaise. Despite the improvement of the subjective general condition on the second day, worsening hepatic impairment leading to hepatic coma may occur on the third day.
If you suspect an overdose of Paracetamol-ratiopharm 250 S rectal suppositories, talk to your doctor immediately.
According to the time that has passed from administering the medicine, the doctor must implement the following means of counteraction:
-   N-acetyl cysteine is administered intravenously within the first eight hours of poisoning, if possible, in order to neutralise the metabolic products of paracetamol that affect the cells;
-   blood cleansing (dialysis) may reduce the concentration of paracetamol in the blood.
Further possibilities of treating paracetamol poisoning depend on the extent and progress of poisoning, as well as on the symptoms.

If you forget to use Paracetamol-ratiopharm 250 S

Do not take a double dose to make up for a forgotten dose but continue using the medicine as described in the instructions for use.

If you stop using Paracetamol-ratiopharm 250 S

The abrupt discontinuation of long-term, large-dosed and inappropriate use of painkillers may result in headaches, as well as fatigue, muscle pain, nervousness and vegetative symptoms.
These symptoms recede within a few days. Until then, do not use any painkillers. Even after that, use may not be continued without a doctor’s recommendation.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects have been reported as follows: very common (> 1/10); common (> 1/100 up to < 1/10); uncommon (> 1/1,000 up to < 1/100); rare (> 1/10,000 up to < 1/1,000); very rare (< 1/10,000); unknown (incidence cannot be estimated from available data).
Immune system disorders Unknown: hypersensitivity reactions.
Hepatic and biliary duct disorders Unknown: hepatic impairment.
Skin and subcutaneous tissue disorders
Severe skin reactions have been reported in very rare cases.
Unknown: exanthema.
Blood and lymphatic system disorders Unknown: thrombocytopenia, agranylocytosis.
Metabolic and nutrition disorders:
Uncommon: hypoglycaemia.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist.

Which countermeasures should be implemented when side effects occur

If you notice the side effects listed above, you must not use Paracetamol-ratiopharm 250 S rectal suppositories again. Talk to your doctor, so they can determine the severity of the symptoms and decide on further remedies.
If the initial hypersensitivity reactions occur, do not use Paracetamol-ratiopharm 250 S rectal suppositories again but talk to your doctor immediately.

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. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

4. How to store Paracetamol-ratiopharm 250 S

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “Use by:”. The expiry date refers to the last day of that month.
Do not store at a temperature higher than 30 °C.
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 protect the environment.

6. Contents of the pack and other information What Paracetamol-ratiopharm 250 S contains

The active substance is paracetamol. One rectal suppository contains 250 mg of paracetamol. The other ingredients are colloidal silica, polyethylene stearate, soya lecithin and fat.

What Paracetamol-ratiopharm 250 S looks like and contents of the pack

250 mg suppositories, 10 pcs. packed in foil in a carton.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
ratiopharm GmbH,
Graf-Arco-Str. 3,
89079 Ulm,
Germany
Manufacturer:
Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren,
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Teva Estonia UAB Sicor Biotech Estonian branch Hallivanamehe 4 11317 Tallinn Telephone: +372 6610801

This leaflet was last revised in April 2017

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