BUSCOPAN

BUSCOPAN plus 10 mg/800 mg suppositories

Important notes (mandatory information)

Buscopan Plus suppositories. Areas of application: for spasmodic pain in diseases of the stomach and intestines, spasmodic pain and functional disorders in the area of the bile ducts, the excretory urinary tract and the female reproductive organs (e.g. painful menstrual bleeding).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Buscopan Plus 10 mg/800 mg per suppository for use in adults and adolescents aged 12 years and over
Active ingredients: Butylscopolamine bromide, 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 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 experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 - 4 days, contact your doctor.

What this leaflet contains

1. WHAT IS BUSCOPAN PLUS AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING BUSCOPAN PLUS?
3. HOW TO USE BUSCOPAN PLUS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BUSCOPAN PLUS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS BUSCOPAN PLUS AND WHAT IS IT USED FOR?

Buscopan Plus is a spasmolytic (combination of antispasmodic and analgesic active ingredients). Buscopan Plus is used for spasmodic pain in diseases of the stomach and intestines, spasmodic pain and functional disorders in the area of the bile ducts, the excretory urinary tract and the female reproductive organs (e.g. painful menstrual bleeding). If you do not feel better or if you feel worse after 3 - 4 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING BUSCOPAN PLUS?

Buscopan Plus must not be used:

• if you are hypersensitive (allergic) to butylscopolamine bromide, paracetamol, soya, peanuts or any of the other ingredients of Buscopan Plus.
• in the case of mechanical constrictions (stenoses) in the gastrointestinal tract (e.g. due to a tumour or due to a kink in the intestine).
• in the case of a pathological widening of the colon (megacolon).
• in the case of urinary retention due to mechanical constriction of the urinary tract (e.g. enlargement of the prostate gland).
• in the case of glaucoma (narrow-angle glaucoma).
• in the case of a pathologically accelerated heartbeat, heart palpitations and irregular heartbeat.
• in the case of a special form of pathological muscle weakness (myasthenia gravis).
• in the case of severe liver dysfunction.

Warnings and precautions

Please talk to your doctor or pharmacist before using Buscopan Plus. A doctor should be consulted immediately if severe abdominal pain persists or worsens or occurs together with symptoms such as fever, nausea, vomiting, changes in bowel movements, (pressure) sensitivity of the abdomen, drop in blood pressure, fainting or blood in the stool.

Use Buscopan Plus only after consulting your doctor:

• if you suffer from impaired liver function (e.g. due to chronic alcohol abuse or liver inflammation)
• if you suffer from Gilbert's syndrome (Meulengracht's disease)
• in the case of pre-damaged kidneys
• in the case of glucose-6-phosphate dehydrogenase deficiency Buscopan Plus should not be used for longer than 3 - 4 days without medical advice. If the pain persists or worsens or new symptoms occur, you should consult a doctor.

Severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed very rarely. Stop treatment immediately if redness or swelling occurs (signs of a hypersensitivity reaction) and consult a doctor. In the event of an overdose of Buscopan Plus, there is a risk of severe liver and kidney damage due to the paracetamol content. In order to prevent the risk of an overdose, it should be ensured that other medicines that are used at the same time do not contain paracetamol. With prolonged high-dose, non-intended use of painkillers, headaches can occur which must not be treated with increased doses of the medicine. In the event of abrupt discontinuation after prolonged high-dose, non-intended use of painkillers, headaches as well as tiredness, muscle pain, nervousness and vegetative symptoms can occur. The withdrawal symptoms subside within a few days. Until then, painkillers should not be taken again, and renewed intake should not take place without medical advice. Blood count, liver and kidney function should be monitored during prolonged use.

Children

Do not give Buscopan Plus to children under 12 years of age, as there is not yet sufficient experience for this age group.

Use of Buscopan Plus together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. The anticholinergic effects described in the side effects section may be increased if Buscopan Plus is used at the same time as other medicines that can themselves cause such effects, such as other anticholinergics (e.g. tiotropium, ipratropium, atropine-like compounds), amantadine, tri- and tetracyclic antidepressants, antipsychotics, quinidine, disopyramide and antihistamines. Concomitant therapy with dopamine antagonists, e.g. metoclopramide, can lead to a mutual weakening of the effect on the musculature of the gastrointestinal tract. Buscopan Plus can increase the accelerating effect of beta-sympathomimetics on the heartbeat.

Due to the paracetamol content of Buscopan Plus, further interactions with the following medicines are possible:

• Medicines for gout such as probenecid: If probenecid is taken at the same time, the dose of Buscopan Plus should be reduced, as the breakdown of paracetamol may be slowed down.
• If medicines are taken at the same time that lead to accelerated drug breakdown in the liver (enzyme induction), e.g. certain sleeping pills and antiepileptics (including phenobarbital, phenytoin, carbamazepine) as well as rifampicin (a tuberculosis drug), liver damage can also be caused by otherwise harmless doses of paracetamol (a component of Buscopan Plus). The same applies to alcohol abuse.
• Agents for lowering elevated blood lipid levels (cholestyramine): These can reduce the absorption and thus the effectiveness of Buscopan Plus.
• Medicines for HIV infections (zidovudine): The tendency to reduce white blood cells (neutropenia) is increased. Buscopan Plus should therefore only be used together with zidovudine after medical advice.
• If paracetamol and chloramphenicol are given at the same time, the excretion of chloramphenicol can be significantly slowed down and its toxicity increased.

Effects of taking Buscopan Plus on laboratory tests

The determination of uric acid and blood sugar can be influenced.

Use of Buscopan Plus with food, drink and alcohol

You should not drink alcohol during treatment with Buscopan Plus.

Pregnancy, breast-feeding and fertility

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. There is not sufficient experience with the use of Buscopan Plus in pregnant women. Although - also due to many years of experience with the individual substances of Buscopan Plus - there have been no indications of a harmful effect on the foetus, the use of Buscopan Plus is not recommended during pregnancy. During breast-feeding, Buscopan Plus should only be used after a strict risk-benefit assessment.

Driving and using machines

There is no experience regarding impairment of driving and the ability to operate machines.

3. HOW TO USE BUSCOPAN PLUS?

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 recommended dose is: Adults and adolescents aged 12 years and over: Single dose 1 suppository, maximum dose per 24 hours 3 - 4 suppositories. The maximum dose per day (24 hours) must not be exceeded, and the time interval until the next suppository is used (if necessary) must be at least 6 hours. The suppositories are removed from the wrapper and inserted into the empty rectum.

Removing the suppositories

Tear open the foil at the incision above the tip of the suppository, starting at the top and repeatedly grasping it close to the suppository. Please do not press the exposed suppository out of the foil, but "peel it out". The breaking off of smaller particles, e.g. at the edge of the cavity at the lower end of the suppository, does not impair the effectiveness. Do not use Buscopan Plus for longer than 3 - 4 days without medical advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Buscopan Plus is too strong or too weak.

If you have used more Buscopan Plus than you should

In the event of an overdose of Buscopan Plus, nausea, vomiting, sweating, drowsiness and a general feeling of illness as well as visual disturbances, acceleration of the heartbeat, dry mouth and skin redness may initially occur (1st day). Despite an improvement in the subjective general condition on the 2nd day, progressive damage to the liver can occur, leading to liver coma on the 3rd day. If an overdose of Buscopan Plus is suspected, a doctor must be notified immediately - even if the symptoms subside temporarily!

If you forget to use Buscopan Plus

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the known undesirable effects are due to the anticholinergic properties of Buscopan Plus. These anticholinergic effects are generally mild and transient.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon	1 to 10 in 1,000 treated persons
Rare	1 to 10 in 10,000 treated persons
Very rare	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Side effects

Uncommon

Skin reactions, e.g. abnormal sweating, itching, dry skin (inhibition of sweat secretion); dizziness; tiredness; dry mouth; diarrhoea; nausea; vomiting; stomach upset

Rare

Drop in blood pressure; skin redness; increase in heart rate (tachycardia); urination disorders such as post-dribbling, reduced urinary stream

Very rare

Eye adjustment disorders at different visual distances (accommodation disorders); severe increase in intraocular pressure with blurred vision and severe headaches (glaucoma attack). Severe skin reactions (such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP)) have been reported with paracetamol.

Frequency not known

Severe hypersensitivity reactions up to anaphylactic shock, massive swelling of the skin and mucous membranes (e.g. tongue, lips, face), shortness of breath, hives, skin rash (exanthema); skin redness; other hypersensitivity reactions; increase in liver values (liver transaminases); decreased number of platelets (thrombocytopenia), severe decrease in blood cells (agranulocytosis, leukopenia, pancytopenia); spasm of the bronchial musculature (bronchospasm), especially in patients with analgesic asthma; circulatory collapse; urinary retention

Other possible side effects

(3-sn-phosphatidyl)choline from soya beans can very rarely cause allergic reactions.

Reporting of side effects

If you experience 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 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 to provide more information about the safety of this medicine.

5. HOW TO STORE BUSCOPAN PLUS?

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 on the foil packaging. The expiry date refers to the last day of the month indicated. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you no longer use it. You help to protect the environment. Storage conditions: Do not store above 30°C.

6. Contents of the pack and other information

What Buscopan Plus contains

The active ingredients are: Butylscopolamine bromide, paracetamol. 1 suppository contains 10 mg butylscopolamine bromide and 800 mg paracetamol. The other ingredients are: Hard fat, (3-sn-phosphatidyl)choline from soya beans.

What Buscopan Plus looks like and contents of the pack

White to ivory-coloured, smooth, torpedo-shaped suppositories. Buscopan Plus is available in original packs of 5 suppositories and 10 suppositories.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Postal address

Postfach 80 08 60
65908 Frankfurt am Main
Telephone: 0800 56 56 010
Telefax: 0800 56 56 011
www.buscopan.de

Manufacturer

Istituto de Angeli, s.r.l.
Località Prulli, 103/c
50066 Reggello (Firenze)
Italy

This leaflet was last revised in June 2017.

Source: Information from the package leaflet
Status: 12/2017
Areas of application: for spasmodic pain in diseases of the stomach and intestines, spasmodic pain and functional disorders in the area of the bile ducts, the excretory urinary tract and the female reproductive organs (e.g. painful menstrual bleeding).