Buscopan (Butylscopolamine) 10 Mg 20 Tablets

• Active substances: Each film contains 10 mg of hiyosin-N-butylbromide and 500 mg of paracetamol.

• Excipients: microcrystalline cellulose, dried corn starch, ethyl cellulose, colloidal silica, magnesium stearate, hydroxypropyl methyl cellulose, eudragit NE 30 D, polyethylene Glycol 6000, talc.

Before using this medicine, please read this INSTRUCTURE carefully because it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is BUSCOPAN PLUS and what is it used for? 2. Things to consider before using BUSCOPAN PLUS 3. How to use BUSCOPAN PLUS? 4. What are the possible side effects? 5. The BUSCOPAN PLUS storage

headers are included.

1. What is BUSCOPAN PLUS and what is it used for?

BUSCOPAN PLUS is included in the group of medications that are a combination of spasm relievers and pain relievers. One film contains 10 mg of Hiyosin-N-butyl bromide and 500 mg of paracetamol as active substance. Available in blister pack containing 20 film tablets. Film tablets are white in color and with a “05B ent printed on the other face and the symbol of the company.

Buscopan PLUS sudden occurring in muscle following organs severe seizures shaped contraction (spasms) implemented and used to remove the perceived pain:

• stomach

• intestines

• urinary bladder and urethra

• bile duct

1.6

Buscopan PLUS female reproductive organs of pain associated with functional impairment (eg painful menstruation).

2. Things to consider before using

BUSCOPAN PLUS DO NOT USE BUSCOPAN PLUS in the following cases;

- Ifto the active substance, hiyosin-N-butylbromide, paracetamol orBUSCOPAN PLUS

you have an allergy (hypersensitivity)any of the other substances contained in, - If you have an eye condition called glaucoma that causes excessive increase in intraocular pressureyou are

andnot receiving treatment for it, -in the urinary bladder and cause

If you have discomfortdiscomfort (eg in males, prostate gland growth) -due to mechanical obstruction in your digestive system or paralysis of bowel movements.

If you have a bowel obstructionthat causes excessive expansion of some part of the intestines,

If you have a diseaseand is manifested by stubborn constipation and abdominal enlargement, -a rarethat causes excessive weakening of the muscles called myasthenia gravis

If you havedisease, - If you are pregnant, - If you are breastfeeding, - If you are under 10 years old, use

BUSCOPAN PLUS in CAUTION if you;

- If you have anemia (anemia) - If you have anemia, - If you have lung disease, - Defect in your liver function - called Gilbert syndrome (congenital and familial disease. - If you have impaired renal function, - If you have a disorder called narrow-angle glaucoma, - If you have obstruction in your bowel or urinary tract - If you have heart rhythm disorder with an excessive increase in your heart rate, - If you have a thyroid gland that causes excessive thyroid hormone secretion If you

have constipation, - If you have constipation, - If you have elevated body temperature,

please consult your doctor if these warnings are true for you, even at any time in the past.

Using BUSCOPAN PLUS with food and drink There is no evidence that BUSCOPAN PLUS interacts with food or beverages. BUSCOPAN PLUS can be taken on an empty stomach or with food.

2/6

pregnancy

Consult your doctor or pharmacist before usingmedication.

You should tell your doctor if you think you are pregnant (or may be). BUSCOPAN PLUS should not be used during pregnancy.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

breastfeeding.

Consult your doctor or pharmacist before using lac

If you are breastfeeding, you should not use BUSCOPAN PLUS.

Vehicle and machine use In some people, a disorder may develop in the proximity of the eyes and distance to the eyes during the use of BUSCOPAN PLUS. If you experience any problems with your vision, do not use tools or machines until the symptoms have passed. Consult your doctor before using the tool or machine.

BUSCOPAN PLUS contains important information on certain auxiliaries in the content of BUSCOPAN PLUS. If you are administering a controlled sodium diet, your doctor should take this into account.

Use with other drugs

If you are using the following medicines, please inform your doctor as there is a risk of interacting with BUSCOPAN PLUS

: Interactions that may occur due to the active agent of-N-butylbromide::

HYOSINdry mouth, constipation, blurred vision, sweating, urine when used with the following drugsanticholinergic effects such as accumulation in the urinary bladder and accelerated heart rate may increase:

- Tricyclic antidepressant drugs used in the treatment of mental depression (antidepressant drugs) - Antihistaminic drugs effective against allergic diseases and vehicle retention amantadine, a drug used - other anticholinergic drugs used in diseases that cause shortness of breath such as asthma

(eg tiotropium, ipratropium) - Restore mental disordershaloperidol,used as an adjuvant in the

drugs such asflufenazine, butyrophenones, phenothiazinestreatment.

• Metoclopramide: is a dopamine anatagonist used to prevent vomiting. When used with BUSCOPAN PLUS, the effects of both drugs on the gastrointestinal tract are reduced.

3/6

• Beta-adrenergic drugs: Blood pressure elevation, chest pain (angina) and the prevention of heart rhythm disorders and is used in the treatment of heart attack beta-adrenergic drugs used in combination with buscopan PLUS can increase the effect of the increase in the number of heart beats.

due to paracetamol active agent:

InterferencesBUSCOPAN PLUS can cause liver damage when used in combination with the following drugs and alcohol. - Sleep transmitter drugs and falling sickness (epilepsy) used in the treatment drugs

(örn.glutetimid, phenobarbital, phenytoin, carbamazepine) - rifampicin, an antibiotic used in the treatment of tuberculosis

• propantheline: criteria for irritable (sensitive) bowel syndrome and a spasm used in the treatment of various urinary incontinence format In cases where gastric emptying is slowed down with medication such as propantelin, which is a preventive drug, the absorption rate of paracetamol decreases and the onset of the effect of BUSCOPAN PLUS is delayed.

• Chloramphenicol: Chloramphenicol, an antibiotic used for the treatment of serious infections, increases the risk of toxicity (toxicity) as the half-life of chloramphenicol increases with the use of BUSCOPAN PLUS together with

AZT (zidovudine): ) and BUSCOPAN PLUS, together with paracetamol and AZT (zidovudine) in the content, may cause a decrease in the number of white blood cells (leukocytes). Therefore, BUSCOPAN PLUS and AZT should not be used together with the advice of a physician.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How to use BUSCOPAN PLUS?

Instructions for appropriate use and dose / frequency of administration: Always use BUSCOPAN PLUS as recommended by your doctor. BUSCOPAN PLUS is administered 1-2 tablets 3 times a day in adults. BUSCOPAN PLUS film can be used in children over 10 years of age when needed. The total daily dose should not exceed 6 tablets.

Do not use BUSCOPAN PLUS for a long time or in high doses without your doctor's approval.

Application route and method: BUSCOPAN PLUS is used only by mouth. Remove tablets as a whole with sufficient amounts of liquid (for example, with a glass of water).

Different age groups::

Use in childrenIt is not recommended to use BUSCOPAN PLUS in children under 10 years of age.

4/6

Use in the elderly: No dose adjustment is necessary in elderly patients.

Specific Use Conditions Liver / Kidney Failure: As the active substance contains paracetamol, patients with severe renal or hepatic dysfunctions should be closely monitored.

Talk to your doctor or pharmacist if you have an impression that BUSCOPAN PLUS is too strong or weak.

If you have used more BUSCOPAN PLUS than you should use, talk to a doctor or pharmacist if you have used more than you should use from BUSCOPAN PLUS. Overdose, dry mouth, accumulation of urine in the bladder, redness of the skin, decrease in gastrointestinal movements, temporary visual disturbances, drop in blood pressure, may cause breathing difficulties.

Ifforget to use BUSCOPAN PLUS

you, it is important to take your medication as described by your doctor. If you forget to take your medication, you should take it as soon as you remember this dose. If the time of the next dose has elapsed, skip the dose you did not take, continue your treatment with your normal dose. Do not take double doses to compensate for forgotten doses.

Effects that may occur when treatment with BUSCOPAN PLUS is not available None.

4. What are the possible side effects? As with all medicines, people who are susceptible to substances in the content of BUSCOPAN PLUS may have side effects.

Reported side effects are as follows:

Common (less than one in 10 patients, but more than one in 100 patients):

- Blurring in vision

Uncommon (less than one in 100 patients, but more than one in 1000 patients):

- Dishidrosis (especially in hands and feet that occurs by transpiration abnormal skin

disease) - skin reactions, nausea - dry mouth

Rare (less than one in 1000 patients, but can be seen more than a 10,000 patients)

- erythema - fall in blood pressure - accelerationof the heartbeat

density degreeaffects unknown side (from the available information, motion can not be calculated):

5/6

- Decrease in the number of blood cells, decrease in the number of blood flakes and white blood cells (can be seen depending on the active substance in the paracetamol) - Sudden severe allergic reaction (rash, itching, swelling of the face, lips or mouth or the swollen, swollen, or swollen, or faintness or dizziness (shock). This is a very serious side effect. You may need urgent medical attention or hospitalization. - Difficulty in breathing, hives, skin rash. - Spasm in the bronchi (in people with a history of asthma or allergies) - Increase in some liver enzymes (transaminases) - Accumulation of urine in the bladder and difficulty in urinationmentioned in

Inform your doctor or pharmacist if you encounter any side effects notthese instructions for use.

5. Save the

BUSCOPAN PLUS Keep BUSCOPAN PLUS in a place where children cannot see, reach and pack. Store at room temperature below 30 ° C. Use in accordance with expiration dates. Do not use the BUSCOPAN PLUS after the expiration date in the package / blister.