PARACETAMOL STADA

PARACETAMOL STADA 1000 mg suppositories

Important notes (mandatory information)

Paracetamol Stada 1000 mg 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 consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Paracetamol Stada 1000 mg suppositories for patients weighing 43 kg or more (children and adolescents aged 12 and over and adults)
Active ingredient: Paracetamol

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet.
• If you do not feel better or if you feel worse after 3 days, contact your doctor.

What this package leaflet contains

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

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

Paracetamol Stada is an analgesic, antipyretic drug (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 SHOULD YOU CONSIDER BEFORE USING PARACETAMOL STADA?

Paracetamol Stada must NOT be used if you are allergic to paracetamol, soya, peanuts 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 Stada:

• if you are chronically addicted to alcohol.
• if you have impaired liver function (hepatitis, Gilbert's syndrome).
• in case of damaged kidneys.

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 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 renewed use of painkillers should be avoided and should not be done without medical advice. You should not use Paracetamol Stada for a long period of time or in higher doses without medical or dental advice.

Use of Paracetamol Stada 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 the following medicines:

• Medicines for gout such as probenecid. When probenecid is used at the same time, the dose of Paracetamol Stada should be reduced as the breakdown of Paracetamol Stada may be slowed down.
• 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 used at the same time as zidovudine on medical advice.
• 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 using Paracetamol Stada on laboratory tests

Uric acid determination and blood sugar determination can be affected.

Use of Paracetamol Stada with food, drink and alcohol

Paracetamol Stada must not be used 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 become pregnant, ask your doctor or pharmacist for advice before using 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 using machines

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

3. HOW SHOULD PARACETAMOL STADA BE USED?

Always use 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 applications 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 kg (age) Single dose in number of suppositories max. daily dose in number of suppositories
from 43 kg (children and adolescents aged 12 and over and adults) 1 suppository (corresponding to 1000 mg paracetamol) 4 suppositories (corresponding to 4000 mg paracetamol)

Special patient groups:

• Hepatic impairment and mild renal impairment: In patients with hepatic or renal impairment and Gilbert's syndrome, the dose must be reduced or the dosing interval extended.
• Severe renal insufficiency: In severe renal insufficiency (creatinine clearance < 10 ml per 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 Stada should not be used in children under 12 years of age or under 43 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 suppository is inserted deep into the anus, preferably after a bowel movement. To improve the lubricity, the suppository may be warmed in the hand or briefly immersed in warm water.

Duration of use

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

If you have used more Paracetamol Stada than you should

The total dose of paracetamol for adults and adolescents aged 12 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 Stada has been used than recommended, seek help from the nearest doctor!

If you forget to use Paracetamol Stada

Do not use twice the amount if you have forgotten the previous application.

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 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.
• severe skin reactions.

In the event of an allergic shock reaction, seek help from the nearest doctor immediately. This medicine contains de-oiled phospholipids from soya beans, 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 package 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 SHOULD PARACETAMOL STADA 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 suppository bar after "use by". The expiry date refers to the last day of the month indicated. Do not store above +25°C. Store in the original package to protect the contents from light. Do not dispose of medicines in wastewater. 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 Stada 1000 mg suppositories contain

The active substance is: Paracetamol. 1 suppository contains 1000 mg paracetamol. The other ingredients are hard fat, phospholipids from soya beans.

What Paracetamol Stada 1000 mg suppositories look like and contents of the pack

White to ivory-coloured suppository. Paracetamol Stada 1000 mg suppositories are available in packs of 10 suppositories.

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: Information from the package leaflet
Status: 10/2020
Areas of application: for the symptomatic treatment of mild to moderate pain such as headaches, toothaches, period pain and/or fever.