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STRIGOL 13.72G POWDER FOR ORAL SOLUTION - patient leaflet, side effects, dosage

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Patient leaflet - STRIGOL 13.72G POWDER FOR ORAL SOLUTION

STRIGOL 13.72 g powder for oral solution

macrogol 3350, sodium chloride, sodium bicarbonate, potassium chloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • – Keep this leaflet. You may need to read it again.

  • – If you have any further questions, ask your doctor or pharmacist.

  • – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

  • – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

  • 1. What STRIGOL is and what it is used for

  • 2. What you need to know before you take STRIGOL

  • 3. How to take STRIGOL

  • 4. Possible side effects

  • 5. How to store STRIGOL

  • 6. Contents of the pack and other information

1. what strigol is and what it is used for

The name of this medicine is STRIGOL 13.72g powder for oral solution. It is a laxative for the treatment of chronic constipation in adults, adolescents and elderly and for the treatment of very bad constipation (called faecal impaction).

It is not recommended for children below 12 years of age.

STRIGOL helps you to have a comfortable bowel movement even if you have been constipated for a long time.

2. what you need to know before you take strigol

Do not take STRIGOL:

  • – if you are allergic to macrogol, sodium chloride, sodium bicarbonate, potassium chloride or any of the other ingredients in this medicine (listed in section 6).

  • – if you have a blockage in the intestine (gut obstruction, ileus)

  • – if you have a perforated gut wall

  • – if you have severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon.

Warnings and precautions

Talk to your doctor or pharmacist before taking STRIGOL.

If you develop side effects such as swelling, shortness of breath, feeling tired, dehydration (symptoms include increasing thirst, dry mouth and weakness) or heart problems you should stop taking Strigol and contact your doctor immediately.

When taking STRIGOL you should continue to take plenty of fluids. The fluid content of STRIGOL should not replace your regular liquid intake.

STRIGOL contains 0.6213 mmol (24.230 mg) of potassium per sachet. This should be taken into consideration if the patient takes more than one sachet daily and has reduced kidney function, or is on a controlled potassium diet.

Heart conditions

Follow the special instructions in section 3 if you are taking STRIGOL for faecal impaction.

Children

This medicine is not recommended for children below 12 years of age.

Other medicines and STRIGOL

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines, e.g. anti-epileptics, may not work as effectively during use with STRIGOL.

STRIGOL with food and drink

This medicine can be taken at any time with or without food or drink.

Pregnancy and breast-feeding

Driving and using machines

STRIGOL does not affect your ability to drive or use machines.

3. how to take strigol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

This medicine can be taken at any time with or without food or drink.

Chronic Constipation:

For adults, adolescents and the elderly the recommended dose is 1 sachet, 1–3 times a day according to the severity of your constipation.

Faecal impaction:

Before you take STRIGOL for faecal impaction, your doctor must check to confirm that you have this condition.

For adults, adolescents and the elderly the recommended dose is 8 sachets a day. All the 8 sachets should be taken within 6 hours, and for up to 3 days if required. If you have a heart conditions do not take more than 2 sachets per one hour.

Method of Administration

  • – Open the sachet and pour the contents into a glass.

  • – Add % glass (about 125ml) of water.

  • – Stir well until all the powder has dissolved and the STRIGOL solution is clear or slightly hazy, then drink it.

If you are taking STRIGOL for faecal impaction it may be easier to dissolve 8 sachets in litre of water.

Duration of treatment

Chronic constipation:

Treatment with STRIGOL usually lasts for about

  • 2 weeks. If you need to take STRIGOL for longer, please see your doctor.

If your constipation is caused by an illness such as Parkinson’s disease or multiple sclerosis (MS), or

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if you take medicines that cause constipation your doctor may recommend that you take STRIGOL for longer than 2 weeks.

Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day.

Faecal impaction:

Treatment with STRIGOL can be for up to 3 days.

If you take more STRIGOL than you should

You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking STRIGOL and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

If you forget to take STRIGOL

Take the dose as soon as you remember.

4. possible side effects

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

Tell your doctor immediately and stop taking STRIGOL if you:

  • – get a serious allergic reaction which causes difficulty in breathing, or swelling of the face, lips, tongue or throat.

Not known (frequency cannot be estimated from the available data):

  • – change in your body’s fluid or electrolyte levels (low levels of potassium, low levels of sodium)

Other side effects include:

  • – indigestion

  • – stomach pains – stomach rumbles

  • – mild diarrhoea (when starting taking STRIGOL)

  • – vomiting (being sick)

  • – nausea (feeling sick)

  • – anal discomfort (uncomfortable sensation around the bottom)

  • – swollen stomach

  • – wind

These side effects generally get better if you reduce the amount STRIGOL you take.

  • – allergic reactions which may cause a skin rash (hives), itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches and high and low levels of potassium in the blood.

5. how to store strigol

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 sachet. The expiry date refers to the last day of that month.

Once you have made up STRIGOL in water, if you cannot drink it straight away keep it covered and in the fridge (2 – 8°C). Throw away any solution not used within a 24 hour period.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationwhat strigol containseach 13.72 g sachet of strigol contains the following:

Macrogol 3350 13.125 g

Sodium chloride 350.7 mg

Sodium bicarbonate 178.5 mg

Potassium chloride 46.6 mg

The other ingredients are Acesulfame potassium and lemon flavor.

When it is made into a drink with 125 millilitres of water, each sachet gives the equivalent of:

Sodium

Chloride Potassium Bicarbonate


65 millimoles/litre

53 millimoles/litre

5.4 millimoles/li­tre

17 millimoles/litre

What STRIGOL looks like and contents of the pack

STRIGOL is a white crystalline powder which comes in single dose sachets. Boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets are available.

Not all pack sizes will be marketed.

Marketing Authorisation holder and Manufacturer

Marketing Authorisation holder

Strides Pharma UK Ltd.

Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS, United Kingdom.

Manufacturer

Strides Pharma UK Ltd.

Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS, United Kingdom.

This leaflet was last revised in 05/2020.

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160 × 300 mm

Font: Times New Roman 9 pt

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