PARACETAMOL STADA

PARACETAMOL STADA 500 mg tablets

Important notes (mandatory information)

Paracetamol Stada 500 mg Tablets. Indications: 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 consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Stada 500 mg Tablets
Active ingredient: Paracetamol

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• 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 side effects not listed in this leaflet.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What this leaflet contains

1. WHAT IS PARACETAMOL STADA AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL STADA
3. HOW TO TAKE PARACETAMOL STADA
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE PARACETAMOL STADA
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS PARACETAMOL STADA AND WHAT IS IT USED FOR?

Paracetamol Stada is a pain-relieving, fever-reducing medicine (analgesic and antipyretic). Paracetamol Stada is used for the symptomatic treatment of mild to moderate pain such as headaches, toothaches, period pain and/or fever.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL STADA

Paracetamol Stada must not be taken 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 taking Paracetamol Stada:

• if you are chronically addicted to alcohol.
• if you have impaired liver function (hepatitis, Gilbert's syndrome).
• 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 taken at the same time do not contain paracetamol. Prolonged high-dose, non-prescription use of painkillers can cause 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 autonomic symptoms may occur. Withdrawal symptoms subside within a few days. Until then, painkillers should not be taken again and should not be taken again without medical advice. You should not use Paracetamol Stada for a long time or in higher doses without medical or dental advice.

Taking Paracetamol Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Interactions are possible with the following medicines:

• Medicines for gout such as probenecid. If probenecid is taken at the same time, the dose of Paracetamol Stada should be reduced as the breakdown of Paracetamol Stada may be slowed down.
• Medicines for nausea (metoclopramide and domperidone). These can accelerate the absorption and onset of action of Paracetamol Stada.
• Medicines to lower elevated blood lipid levels (colestiramine). These medicines can reduce the absorption and thus the effectiveness of Paracetamol Stada.
• Medicines for HIV infections (zidovudine). The tendency to reduce white blood cells (neutropenia) is increased. Paracetamol Stada should therefore only be taken at the same time as zidovudine on medical advice.
• Medicines that slow down gastric emptying. If these medicines are taken at the same time as Paracetamol Stada, the absorption and onset of action of Paracetamol may be delayed.
• Sleeping pills, such as phenobarbital.
• Medicines for the treatment of epilepsy, such as phenytoin, carbamazepine.
• Medicines for the treatment of tuberculosis (rifampicin).
• Other medicines that may damage the liver: In some cases, taking these medicines at the same time as Paracetamol Stada may cause liver damage.

Effects of taking Paracetamol Stada on laboratory tests

Uric acid determination and blood sugar determination can be affected.

Taking Paracetamol Stada with food, drink and alcohol

Paracetamol Stada must not be taken or administered together with alcohol.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If necessary, Paracetamol Stada can be used during pregnancy. You should use the lowest possible dose that relieves your pain and/or fever, and you should use the medicine for the shortest possible time. Contact your doctor if the pain and/or fever is not relieved or if you need to take the medicine more often.

Breastfeeding

Paracetamol passes into breast milk. Since no adverse effects on the infant have been reported to date, it is usually not necessary to interrupt breastfeeding. Driving and ability to operate machinery Paracetamol Stada has no influence on the ability to drive and use machines. Nevertheless, caution is always advised after taking a painkiller.

Paracetamol Stada contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is virtually "sodium-free".

3. HOW TO TAKE PARACETAMOL STADA

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Paracetamol is dosed according to body weight and age, usually 10 to 15 mg per kg body weight as a single dose, up to a maximum of 60 mg per kg body weight as a total daily dose. The respective dosing interval depends on the symptoms and the maximum total daily dose. However, the interval between individual doses should not be less than 6 hours. The maximum daily dose (24 hours) must not be exceeded. If symptoms persist for more than 3 days, a doctor should be consulted.

The dosage is based on the information in the following table

Body weight (age)	Single dose in number of tablets	max. daily dose in number of tablets
17 to 32 kg (children: 4 to 11 years)	1/2 tablet (corresponding to 250 mg paracetamol)	2 tablets (i.e. 4 times 1/2 tablet corresponding to 1000 mg paracetamol)
33 to 43 kg (children: 11 to 12 years)	1 tablet (corresponding to 500 mg paracetamol)	4 tablets (corresponding to 2000 mg paracetamol)
from 43 kg children and adolescents from 12 years and adults	1 to 2 tablets (corresponding to 500 to 1000 mg paracetamol)	8 tablets (corresponding to 4000 mg paracetamol)

For children or patients with a body weight of 26 to 32 kg (age approx. 8 to 11 years), other dosage forms may be more suitable, which allow more precise dosing of the single dose of up to 400 mg paracetamol. In this patient group, the daily dose may be increased to 3 tablets (i.e. 6 times 1/2 tablet) in exceptional cases, i.e. up to 1500 mg paracetamol daily. The interval between doses must be at least 4 hours in this case.

Special patient groups:

• Liver dysfunction and mild renal impairment: In patients with liver or renal dysfunction and Gilbert's syndrome, the dose must be reduced or the dose interval extended.
• Severe renal insufficiency: In severe renal insufficiency (creatinine clearance < 10 ml per min), a dose 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 Stada is not recommended for children under 4 years of age or under 17 kg body weight, as the dosage strength is not suitable for these patient groups. However, suitable dosage strengths or dosage forms are available for these patient groups.

Method of administration

The tablets are taken whole with plenty of liquid. The tablet can be divided into equal doses. Taking after meals can lead to a delayed onset of action.

Duration of use

Do not take Paracetamol Stada for more than 3 days without medical or dental advice.

If you have taken more Paracetamol Stada than you should

The total dose of paracetamol must not exceed 4000 mg paracetamol daily for adults and adolescents aged 12 years and over or 43 kg body weight, and 60 mg/kg/day for children. 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 Stada has been taken than recommended, seek help from the nearest doctor!

If you forget to take Paracetamol Stada

Do not take 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 and pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Rare (may affect up to 1 in 1,000 people):

• slight increase in liver enzymes (serum transaminases).

Very rare (may affect up to 1 in 10,000 people):

• changes in the blood count such as a decrease in platelets (thrombocytopenia) or a severe decrease in certain white blood cells (agranulocytosis).
• allergic reactions such as a simple rash or hives (urticaria) up to a shock reaction.
• In sensitive individuals, a narrowing of the airways (analgesic asthma) can be triggered very rarely.
• severe skin reactions.

In the event of an allergic shock reaction, seek help from the nearest doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly to the 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 on the safety of this medicine.

5. HOW TO STORE PARACETAMOL STADA

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 blister pack after "use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Do not dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Paracetamol Stada 500 mg Tablets contains

The active substance is: Paracetamol. 1 tablet contains 500 mg paracetamol. The other ingredients are: Carboxymethyl starch sodium (Type A) (Ph.Eur.), Microcrystalline cellulose, Magnesium stearate (Ph.Eur.), Povidone K 90.

What Paracetamol Stada 500 mg Tablets looks like and contents of the pack

White, round tablet with break notch. Paracetamol Stada 500 mg Tablets are available in packs of 10 and 20 tablets.

Pharmaceutical entrepreneur

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in July 2020.

Source: Package leaflet information
Status: 10/2020
Indications: for the symptomatic treatment of mild to moderate pain such as headaches, toothaches, period pain and/or fever.