Buscopan plus paracetamol 10 mg/ 500 mg film-coated tablets

Buscopan plus paracetamol 10 mg/ 500 mg film-coated tablets contain two active ingredients: Hyoscine-N-butylbromide has an antispasmodic effect on the smooth muscles of the gastrointestinal tract, the biliary and urinary tracts and the female genital organs, paracetamol has a rapid-onset analgesic, antipyretic and anti-inflammatory effect.

How is it applied?

What is Buscopan plus paracetamol and what is it used for?

Buscopan plus paracetamol 10 mg/ 500 mg film-coated tablets contain two active ingredients: Hyoscine-N-butylbromide has an antispasmodic effect on the smooth muscles of the gastrointestinal tract, the biliary and urinary tracts and the female genital organs, paracetamol has a rapid-onset analgesic, antipyretic and anti-inflammatory effect. Buscopan plus paracetamol film-coated tablets are used for cramp-like pain in the gastrointestinal tract, the biliary and urinary tracts and the female genital organs during menstruation.
Buscopan plus paracetamol film-coated tablets are used in adults and adolescents aged 12 and over
If you do not feel better or even worse after 3 days, contact your doctor.

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What should you pay attention to before taking it?

What should you be aware of before taking Buscopan plus paracetamol?

Buscopan plus paracetamol must not be taken

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• If you are allergic to hyoscine-N-butylbromide, other bromides, paracetamol or any of the other ingredients of this medicine listed in section 6
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• If you suffer from a certain form of muscle weakness (myasthenia gravis),
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• If you have been diagnosed with an organically caused narrowing of the gastrointestinal tract,
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• if you have been diagnosed with a paralytic or mechanical intestinal obstruction (ileus)
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• If you have a pathological enlargement of the colon,
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• if your liver or kidney function is severely restricted,
• If you drink alcohol regularly or in large quantities (see "Taking Buscopan plus paracetamol with food and drink").

Warnings and precautions
Please talk to your doctor or pharmacist before taking Buscopan plus paracetamol,

• If you have increased intraocular pressure (tendency to narrow-angle glaucoma),
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• if you suffer from chronic constipation,
• if you have difficulty urinating,
• If you suffer from too fast, irregular heartbeat sequence (tachyarrhythmias),
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• If your liver function is slightly to moderately impaired (e.g. after
  liver inflammation),
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• If your kidney function is slightly to moderately impaired or kidney damage exists due to previous
  diseases,
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• if you have a certain hereditary, very rare metabolic disorder (glucose-6-phosphate dehydrogenase deficiency),
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• If you have Gilbert's syndrome (Meulengracht's disease, a rare hereditary
  metabolic disorder),
• If you have sudden onset, severe, cutting pain,
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• If you are chronically alcoholic or have recently started alcohol withdrawal (see "Buscopan plus paracetamol must not be taken"),
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• If you have malnutrition or dehydration (e.g. if you drink too little),
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• If you are allergic to acetylsalicylic acid or other anti-inflammatory painkillers and rheumatism medicines (NSAIDs).

You must tell your doctor if any of the above circumstances apply to you. Your doctor may prescribe a lower dose or recommend increasing the dosing interval (the time between two doses) if you have liver or kidney dysfunction.
You need to see a doctor,

• If your complaints worsen quickly,
• If the pain worsens when touched,
• If your body temperature is elevated,
• if you feel nauseous or have to vomit,
• If your blood pressure is low, you feel weak or have collapsed,
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• if you notice blood in your stool or unexpected changes in bowel activity (e.g. diarrhoea),
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• If new discomfort or redness or swelling occurs,
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• If you do not feel better or even worse after 3 days
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because in these cases the cause of your complaints must be clarified.
After prolonged use, your doctor will carry out checks (e.g. liver function, kidney function, blood count).
To avoid the risk of overdose, you must make sure that you do not use any other medicines containing paracetamol at the same time. Liver and kidney damage cannot be ruled out with prolonged use or excessive dosage (more than 2.0 g paracetamol per day, corresponding to 4 film-coated tablets). Even if you do not have liver disease, liver damage can occur even at low doses or with short-term use.
Prolonged use of painkillers such as paracetamol - especially in high doses - can cause headaches that must not be treated by increased doses of the same medicine. If you think you have such headaches, please consult your doctor.
Sudden discontinuation of painkillers such as paracetamol after prolonged use in high doses can trigger withdrawal symptoms (e.g. headache, tiredness or nervousness), which usually disappear within a few days. Painkillers may only be taken again after the doctor has given the appropriate instructions and the withdrawal symptoms have subsided.
In isolated cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Therefore, treatment with Buscopan plus paracetamol must be discontinued at the first signs of a hypersensitivity reaction. Contact a doctor immediately. Severe skin reactions
There have been reports of severe skin reactions associated with the use of paracetamol. If you experience a skin rash (including mucous membrane damage
in the mouth, throat, nose, eyes and genital area) please stop using Buscopan plus paracetamol and seek medical advice immediately.
In case of severe pain in the abdomen, painkilling medicines should preferably not be taken before the examination by the doctor, as they can mask the detection of important signs of the disease.
Children
Do not give Buscopan plus paracetamol to children under 12 years of age as there is insufficient experience to date for this age group.
Taking buscopan plus paracetamol with other medicines.
Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.
Interactions with paracetamol
Be sure to ask your doctor for advice before taking Buscopan plus Paracetamol Film-Coated Tablets if you are taking any of the following medicines at the same time, as these medicines and paracetamol may influence each other's effects and side effects:
Drugs that affect liver function, such as. Barbiturates (anaesthetics), phenobarbital, phenytoin (drugs for the treatment of epilepsy), glutethimide (sleeping pills and tranquillisers), carbamazepine (drugs for the treatment of depressive disorders) or certain antibiotics (such as rifampicin).These drugs increase the liver-damaging effect of paracetamol - liver damage is then possible even with otherwise harmless doses. This also applies to all other medicines for which possible liver damage is described and to alcohol abuse.
Salicylamide (anti-inflammatory painkiller) causes an increased harmful effect of paracetamol due to delayed excretion.
Probenecid (uric acid-lowering drug) reduces paracetamol excretion to about half. If probenecid is taken at the same time, your doctor will reduce the dose of paracetamol accordingly.
The harmful effect of chloramphenicol (certain antibiotic = medicine against infections) is increased by a delayed excretion of chloramphenicol.
Paracetamol may increase the risk of bleeding in patients taking warfarin and other vitamin K antagonists (blood thinning medicines).
The simultaneous intake of flucloxacillin (antibiotic) can lead to acidification of the blood and the body.
Colestyramine (certain medicine for lowering cholesterol) reduces the absorption of paracetamol.
Drugs that cause a slowing down of gastric emptying may lead to a reduced absorption and consequently to a delayed onset of the effect of paracetamol. Medicines that accelerate gastric emptying (e.g. metoclopramide or domperidone for vomiting and nausea) increase the absorption of paracetamol.
The simultaneous use of paracetamol and zidovudine (medicine for HIV infection).
makes a reduction in the number of white blood cells (neutropenia) more likely and must only be done on medical advice.
Interactions with hyoscine-N-butylbromide
Be sure to ask your doctor for advice before taking Buscopan plus Paracetamol Film-Coated Tablets if you are taking any of the following medicines at the same time, as the effects of these medicines may be increased by hyoscine-N-butylbromide:

• Antihistamines (against allergic diseases),
• Amantadine-containing medicines (against Parkinson's disease),
• Drugs containing quinidine or disopyramide (against cardiac arrhythmias),
• Tri- and tetracyclic antidepressants (against depression),
• Other anticholinergics (e.g. tiotropium, ipratropium - against breathing difficulties or atropine-like agents),
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• Antipsychotics (against psychoses),
• β-Sympathomimetics (against breathing difficulties).

You should also ask your doctor for advice if you are taking Buscopan plus at the same time.
Paracetamol film-coated tablets Take medicines to correct intestinal motility (e.g. medicines containing metoclopramide) as this may reduce the effect of both medicines. Influencing laboratory tests
Paracetamol may interfere with certain laboratory tests to determine uric acid levels and blood sugar levels.
Please therefore inform the doctor about taking Buscopan plus paracetamol film-coated tablets before laboratory tests.
Taking Buscopan plus Paracetamol with food, drink and diet. Alcohol
Simultaneous alcohol consumption increases the risk of liver damage with normally harmless doses of paracetamol and should therefore be avoided! This is especially true for alcohol abuse. Pregnancy and breastfeeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist before taking this medicine.
for advice.
The use of Buscopan plus paracetamol during pregnancy is not recommended.
Buscopan plus paracetamol may only be taken when breast-feeding if prescribed by a doctor. Your doctor will carefully check whether use is necessary and prescribe a low dose if necessary.
Driving ability and ability to operate machines
No studies have been carried out on the effects on the ability to drive and operate machinery. However, if taken correctly, no impairment is to be expected when actively participating in road traffic or operating machinery. Buscopan plus paracetamol contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it is almost "sodium-free".

How should the medicine be taken?

How should Buscopan plus paracetamol be taken?

Always take 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.
The recommended dose for adults and adolescents over 12 years of age is
1 film-coated tablet 3 times daily. If necessary, a single dose of 2 film-coated tablets can be administered.
A maximum daily dose of 4 film-coated tablets must not be exceeded. The time interval should be at least 8 hours until the next application.
For ingestion.
The film-coated tablets are to be taken unchewed with sufficient liquid.
The notch is not for dividing the tablet.
Special patient groups
Older patients
The same dosage recommendations apply to older patients.
Patients with impaired liver or kidney function
If you have a liver or kidney function disorder, your doctor may prescribe a lower dose or recommend that you increase the dosing interval (the time between two intakes). Buscopan plus paracetamol - film-coated tablets must not be taken in the event of severe liver or kidney function disorders.
Duration of use
Without medical advice, Buscopan plus Paracetamol 10 mg/ 500 mg Film-Coated Tablets should not be taken for longer than 3 days.
Please talk to your doctor or pharmacist if you have the impression that the effect of Buscopan plus Paracetamol Film-Coated Tablets is too strong or too weak.
Use in children and adolescents
Buscopan plus paracetamol 10 mg/ 500 mg film-coated tablets are not recommended for use in children under 12 years of age because of the high content of paracetamol. For adolescents, the dosage recommendations for adults apply.
If you have taken more Buscopan plus paracetamol than you should
.If you have taken more than the prescribed dose (too many film-coated tablets) or a child has swallowed film-coated tablets, please inform a doctor immediately, even if there are no symptoms yet! Have a pack of the medicine ready so that the doctor can find out about the active substances ingested. It will decide on necessary measures.
Signs of poisoning with paracetamol
As a rule, complaints occur within 24 hours: Nausea, vomiting, loss of appetite, pallor and abdominal pain. Afterwards, the condition may improve, but mild abdominal pain remains as an indication of liver damage.
Paracetamol overdose can cause permanent liver damage, which can subsequently lead to liver failure, bleeding in the gastrointestinal tract, blood hyperacidity and encephalopathy (non-inflammatory diseases of the brain), greatly increased bleeding tendency, coma and death. Clinical symptoms of liver damage usually become visible after 2 days and reach a maximum after 4 to 6 days.
Overdose can also lead to pancreatitis, acute kidney failure, cardiac dysfunction and pancytopenia (greatly reduced number of all blood cells associated with weakness, increased susceptibility to infection and increased bruising).
In elderly persons and small children as well as patients with impaired liver function, chronic alcohol consumption or chronic malnutrition and in patients who are simultaneously treated with medicines that stimulate liver metabolism, there is an increased risk of paracetamol poisoning with a possibly fatal outcome.
Signs of intoxication with hyoscine-N-butylbromide
Urinary retention, dry mouth, accelerated heartbeat, inhibition of intestinal motility, drowsiness and preliminary visual disturbances (disturbance of the ability of the eyes to adapt to different distances, glaucoma attacks [triggering of glaucoma]) may occur.This can lead to visual disturbances (disturbance of the eyes' ability to adapt to different distances, glaucoma attacks [triggering of glaucoma]).
Note to doctor: Information on overdose can be found at the end of this leaflet.
If you forget to take Buscopan plus paracetamol
Continue taking it at the next time. Do not take double the amount if you have forgotten to take it before.
If you stop taking Buscopan plus paracetamol
Buscopan plus paracetamol film-coated tablets are only taken when needed and should be stopped after the symptoms have subsided.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

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What are the possible side effects?

How to store Buscopan plus paracetamol?

Do not store above 30 °C.
Keep this medicine out of the reach of children.
You must not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month indicated.
Do not dispose of medicines in waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In doing so, they contribute to the protection of the environment.

Special notes on the content

Contents of the pack and other information

What Buscopan plus paracetamol contains

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• The active ingredients are: 10 mg hyoscine-N-butylbromide and 500 mg paracetamol per film-coated tablet
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• The other ingredients are:
  Tablet core: ethyl cellulose, highly dispersed silica, magnesium stearate, maize starch, microcrystalline cellulose, carmellose sodium,
  Tablet coating: Dimethicone, hypromellose, macrogol 6000, methacrylic acid-
  methyl methacrylate copolymer, talc, titanium dioxide (E171)
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What Buscopan plus paracetamol looks like and contents of the pack
White, elongated, outwardly curved film-coated tablets on both sides with a notch on one side. The code "05B" is stamped on both sides of the notch.
The notch is not for dividing the tablet.
Blister pack, consisting of aluminium foil (heat-sealable lacquered) and PVC film.
Pack of 20 film-coated tablets