0.2 mg prolonged-release tablet is hyoscyamine sulphate 

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Egazil is and what it is used for 
2. What you need to know before using Egazil 
3. How to use Egazil 
4. Possible side effects 
5. How to store Egazil 
6. Contents of the packaging and other information 

1. What Egazil is and what it is used for

Egazil contains the active substance hyoscyamine sulphate. Hyoscyamine sulphate inhibits acetylcholine, which transmits impulses in certain nerves in, among other things, the gastrointestinal tract. This reduces normal and abnormal mobility (such as cramps) in the muscles of the gastrointestinal tract.

Egazil is used for cramping and abdominal pain in the gastrointestinal tract and bile ducts.

2. What you need to know before using Egazil

Do not use Egazil if:

  • you have prostate enlargement with difficulty holding your urine
  • you have narrowing of the lower abdomen
  • you are allergic to hyoscyamine sulphate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Egazil can slow emptying the contents of the stomach and intestines.

Careful oral hygiene is important to counteract the effects of reduced saliva production.

A dry mouth can lead to the risk of tooth and oral mucosal damage with prolonged use.

Other medicines and Egazil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, as the treatment effect may be affected if Egazil is taken with certain other medicines.

The effect of Egazil is increased by the concomitant use of certain drugs against:

  • Parkinson’s disease (amantadine, levodopa )
  • Allergic reactions ( antihistamines )
  • Sleep disorders and depression (phenothiazines, tricyclic antidepressants )

The effect of Egazil is reduced with concomitant use of metoclopramide (for nausea, vomiting).

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There is limited experience of use during pregnancy.

Breast-feeding

Egazil passes into breast milk but is unlikely to affect breastfed infants.

Driving and using machines

Egazil may affect your eyesight, which may cause you to have difficulty driving.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist

3. How to use Egazil

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will decide on a dose to suit you.

The recommended dose for adults is 2-3 tablets twice daily, in some cases 3 times daily.

Egazil is a form of preparation that gives an even effect throughout the day. It must not be chewed or shared but must be swallowed whole with at least ½ glass of liquid. The prolonged-release tablet is built around a shell that is completely insoluble in the stomach. Sometimes the shell of the tablet may come out with the stool, but the active substance has already been absorbed into the body.

If you use more Egazil than you should  

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital or the Poison Information Center for risk assessment and advice.

If you forget to take Egazil

Do not take a double dose to make up for a forgotten tablet.

4. Possible side effects

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

Common ( may affect up to 1 in 10 people ) : 

  • reduced saliva production with dry mouth
  • reduced tear production
  • constipation
  • visual disturbances in the form of blur and difficulty focusing the gaze
  • difficulty emptying the bladder.

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

  • hives and other allergic skin reactions
  • disorders of the heart rhythm
  • slowed emptying of stomach contents and intestine
  • confusion
  • hallucinations
  • nightmares.

Elderly patients may be more susceptible to developing psychological side effects.

5. How to store Egazil

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is hyoscyamine sulphate. 1 tablet contains 0.2 mg hyoscyamine sulphate.
  • The other ingredients are mannitol, magnesium stearate, polyvinyl chloride, ethylcellulose, hydroxypropyl cellulose.

Other ingredients are included to give the prolonged-release tablet the right properties and so that it can be manufactured.

What the medicine looks like and the contents of the pack

White, round, biconvex tablet with a diameter of 7 mm.

Plastic jar with 250 tablets.

Pressure pack with 100 tablets.

Not all pack sizes may be marketed.

Manufacturer

Manufacturer

ReciPharm Stockholm AB, Jordbro.

Muhammad Nadeem

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