PARACETAMOL AL

PARACETAMOL AL 125 Infant Suppositories

Important notes (mandatory information)

Paracetamol AL 125 Suppositories Areas of application: for the symptomatic treatment of mild to moderate pain (such as headaches, toothaches, period pain) and/or fever.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


Patient information: Information for the user
Paracetamol AL 125 Suppositories
For use in children from 6 months to 2 years
Active ingredients: Paracetamol 125 mg

Read the entire patient information leaflet carefully before you start using this medicine, as it contains important information for you. Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.
o Keep the patient information leaflet. You may want to read it again later.
o Ask your pharmacist if you need more information or advice.
o If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet.
o If you do not feel better or even worse after 3 days, contact your doctor.

What is in this leaflet
1. WHAT IS PARACETAMOL AL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING PARACETAMOL AL?
3. HOW IS PARACETAMOL AL USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PARACETAMOL AL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PARACETAMOL AL AND WHAT IS IT USED FOR?
Paracetamol AL is a pain-relieving, fever-reducing medicine (analgesic and antipyretic).

Paracetamol AL is used for the symptomatic treatment of

o mild to moderate pain (such as headaches, toothaches, period pain) and/or
o fever.

2. WHAT SHOULD YOU CONSIDER BEFORE USING PARACETAMOL AL?
Paracetamol AL must NOT be used if you are allergic to paracetamol or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Paracetamol AL

o if you are chronically addicted to alcohol.
o if you have impaired liver function (hepatitis, Gilbert's syndrome).
o if you have a damaged kidney.
If your symptoms worsen or do not improve after 3 days or if you have a high fever, you must see a doctor. To prevent the risk of overdose, it should be ensured that other medicines used at the same time do not contain paracetamol. Prolonged, high-dose, non-prescription use of painkillers can lead to headaches that should not be treated with increased doses of the medicine. In general, the habitual use of painkillers, especially when several pain-relieving active ingredients are combined, can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). If abruptly discontinued after prolonged, high-dose, non-prescription use of painkillers, headaches, fatigue, muscle pain, nervousness and vegetative symptoms may occur. The withdrawal symptoms subside within a few days. Until then, the re-use of painkillers should be avoided and the re-use should not be done without medical advice. Do not use Paracetamol AL for a long period of time or in higher doses without medical or dental advice.

Use of Paracetamol AL together with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines.

Interactions are possible with

o Medicines for gout such as probenecid: When probenecid is used at the same time, the dose of Paracetamol AL should be reduced, as the breakdown of paracetamol may be slowed down.
o Sleeping pills such as phenobarbital, medicines for epilepsy such as phenytoin or carbamazepine, medicines for tuberculosis (rifampicin) or other medicines that may damage the liver: In some cases, liver damage may occur when used together with Paracetamol AL.
o Medicines for HIV infections (zidovudine): The tendency to reduce white blood cells (neutropenia) is increased. Paracetamol AL should therefore only be used together with zidovudine on medical advice.
o Agents for lowering elevated blood lipid levels (colestiramine): These can reduce the absorption and thus the effectiveness of Paracetamol AL.

Effects of using Paracetamol AL on laboratory tests
Uric acid determination and blood sugar determination can be affected.
Use of Paracetamol AL together with food and drink
Paracetamol AL must not be taken together with alcohol.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Paracetamol AL should only be used during pregnancy after careful consideration of the benefit-risk ratio. You should not use Paracetamol AL during pregnancy for a long period of time, in high doses or in combination with other medicines, as the safety of use for these cases has not been proven.
Breast-feeding
Paracetamol passes into breast milk. Since no adverse effects on the infant have been reported to date, it will usually not be necessary to interrupt breast-feeding.

Driving and using machines
Paracetamol AL has no influence on the ability to drive and use machines. Nevertheless, caution is always advised after taking a painkiller.

3. HOW IS PARACETAMOL AL USED?
Always use this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The dosage is based on the information in the following table. Paracetamol is dosed according to body weight and age, usually with 10 - 15 mg paracetamol per kg body weight as a single dose, up to a maximum of 60 mg/kg body weight as a total daily dose. The respective dosing interval depends on the symptoms and the maximum total daily dose. It should not be less than 6 hours. The maximum daily dose (24 hours) must not be exceeded under any circumstances. If symptoms persist for more than 3 days, a doctor should be consulted.
- Children 6 - 9 months 7 - 8 kg body weight: Single dose 1 suppository (equivalent to 125 mg paracetamol), Max. daily dose (24 hours) 3 suppositories (equivalent to 375 mg paracetamol)
- Children 9 months - 2 years 9 - 12 kg body weight: Single dose 1 suppository (equivalent to 125 mg paracetamol), Max. daily dose (24 hours) 4 suppositories (equivalent to 500 mg paracetamol)

Special patient groups
Hepatic impairment and mild renal impairment
In patients with hepatic or renal impairment as well as Gilbert's syndrome, the dose must be reduced or the dosing interval extended.

Severe renal insufficiency
In severe renal insufficiency (creatinine clearance < 10 ml/min), a dosing interval of at least 8 hours must be observed.

Elderly patients
No special dose adjustment is required.

Children and adolescents with low body weight
Paracetamol AL is not recommended for use in children under 6 months or under 7 kg body weight, as the dosage strength is not suitable for this patient group. However, suitable dosage strengths or dosage forms are available for this patient group.

Method of administration
The suppositories are inserted deep into the anus, if possible after a bowel movement. To improve the lubricity, the suppository may be warmed in the hand or briefly dipped in warm water.

Duration of use
Do not use Paracetamol AL for more than 3 days without medical or dental advice.

If you have used more Paracetamol AL than you should
The total dose for adults and adolescents aged 12 years and over or weighing 43 kg and over must not exceed 4000 mg paracetamol per day and for children 60 mg/kg/day. In the event of an overdose, symptoms generally occur within 24 hours, including nausea, vomiting, loss of appetite, pallor and abdominal pain.

If more Paracetamol AL has been used than recommended, call the nearest doctor for help!

If you forget to use Paracetamol AL
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. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can have side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Rare
o slight increase in liver enzymes (serum transaminases)

Very rare
o changes in the blood count such as a decrease in platelets (thrombocytopenia) or a severe decrease in certain white blood cells (agranulocytosis).
o allergic reactions such as a simple rash or hives (urticaria) up to an anaphylactic shock.
o In sensitive individuals, a narrowing of the airways (analgesic asthma) can be triggered very rarely.
o Very rarely, cases of severe skin reactions have been reported.
In the event of an anaphylactic shock, call the nearest doctor for help immediately. This medicine contains phospholipids from soybeans, which can very rarely cause allergic reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to

Federal Institute for Drugs and Medical Devices
Dept. of Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD PARACETAMOL AL BE STORED?
Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the foil strip after "Use by". The expiry date refers to the last day of the month indicated. Do not store above +25 °C.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Paracetamol AL 125 contains
The active ingredient is paracetamol. 1 suppository contains 125 mg paracetamol. The other ingredient is hard fat.

What Paracetamol AL 125 looks like and contents of the pack
White to ivory-coloured suppository.
Paracetamol AL 125 is available in packs of 10 suppositories.

Pharmaceutical entrepreneur

ALIUD PHARMA GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2-18
61118 Bad Vilbel

This leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 12/2014
Areas of application: for the symptomatic treatment of mild to moderate pain (such as headaches, toothaches, period pain) and/or fever.