Document: leaflet MAH BRAND_PL 20692-0130 change

• leaflet MAH BRAND_PL 04569-1677
• leaflet MAH BRAND_PL 20692-0130

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Package leaflet: Information for the patient

Molative 13.8 g Powder for Oral Solution

(macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride)

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

•    Ask your pharmacist if you need more information or advice.

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

What is in this leaflet

1.    What Molative is and what it is used for

2.    What you need to know before you take Molative

3.    How to take Molative

4.    Possible side effects

5.    How to store Molative

6.    Contents of the pack and other information

1.    What Molative is and what it is used for

Molative is a laxative (a medicine used to help you pass stools) for the treatment of long-term (chronic) constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age.

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

Molative is also used for the treatment of faecal impaction (a condition where large amounts of stool builds up in the rectum and/or colon which cannot be passed easily).

2.    What you need to know before you take Molative

Do not take Molative:

•    if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride or any of the other ingredients of this medicine (listed in section 6).

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

•    if you have a perforated gut (bowel) wall

•    if you have severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease or toxic megacolon.

If any of these apply to you, please talk to your doctor or pharmacist for further advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Molative.

If you have a heart condition and are taking this medicine for faecal impaction, you must follow the specific instructions on how to take this medicine, which are given in section 3 of this leaflet.

During treatment

If you have possible signs of changes to electrolyte levels in the blood such as fluid retention in the body, shortness of breath, tiredness, dehydration or heart problems, stop taking Molative and talk to your doctor immediately (see section 4 "Possible side effects").

Children

Do not give this medicine to children below the age of 12 years.

Other medicines and Molative

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Some medicines, e.g. medicines to treat epilepsy, may not work as effectively during use with Molative.

Pregnancy and breast-feeding

Molative can be taken during pregnancy and whilst breast-feeding.

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.

Molative contains potassium, sodium and sorbitol

This medicine contains 0.63 mmol (24 mg) of potassium per sachet. This should be taken into consideration if you take more than one sachet daily and you have reduced kidney function, or if you are on a controlled potassium diet.

This medicine contains 8.1 mmol (187 mg) of sodium per sachet. This should be taken into consideration if you are on a controlled sodium diet.

The lemon lime flavour in Molative contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Molative

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.

Adults, children (aged 12 years and above) and the elderly:

The recommended dose for constipation is one sachet taken one to three times daily.

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

Constipation:

A dose of Molative is 1 sachet.

Take this 1 -3 times a day according to the severity of your constipation.

Faecal impaction:

A dose is 8 sachets a day of Molative is needed for the treatment of faecal impaction.

The 8 sachets should be taken within 24 hours for up to 3 days if required.

If you have a heart condition do not take more than 2 sachets within an hour.

How to mix:

Open the sachet and pour the contents into a glass. Add about 125ml or A pint of water to the glass. Stir well until all the powder has dissolved and the Molative solution is clear or slightly hazy, then drink it.

If you are taking Molative for faecal impaction, it may be easier to dissolve 8 sachets in 1 litre of water. You should cover the solution and keep it in a refrigerator for up to 24 hours, after which any unused solution should be thrown away.

Duration of treatment

Constipation:

Treatment with Molative usually lasts for about 2 weeks.

If you need to take Molative for longer, please see your doctor.

If your constipation is caused by an illness such as Parkinson's disease or multiple sclerosis (MS), or if you take medicines that cause constipation, your doctor may recommend that you take Molative 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 Molative can be for up to 3 days.

If you take more Molative than you should

This can cause severe pain and swelling in your abdomen (stomach), vomiting (sickness) or diarrhoea. If this happens, contact your doctor or pharmacist.

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

If you forget to take Molative

If you forget to take a dose, take it as soon as you remember and then continue on as before.

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

If you stop taking Molative

To get the most benefit from Molative, always finish the course of treatment according to the directions in this package leaflet. This will make sure that your constipation is cleared, otherwise your condition may persist.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following side effects, stop taking this medicine and contact your doctor immediately or go to the nearest hospital emergency department straight away:

Frequency not known (cannot be estimated from the available data)

•    serious allergic reaction which causes sudden signs of allergy such as shortness of breath, difficulty in breathing, or swelling of the face, lips, tongue, throat or other parts of the body (anaphylaxis, angioedema)

•    changes to electrolyte levels in the blood. You may experience tiredness, dehydration, shortness of breath, swelling of the feet and legs due to fluid build up or heart problems.

Other possible side effects

Frequency not known (cannot be estimated from the available data)

•    skin rash, itching, reddening of the skin or a nettle rash

•    swollen hands, feet or ankles

•    shortness of breath

•    headaches

•    high or low levels of potassium in the blood

•    indigestion, stomach ache or rumbles, feeling bloated (swollen stomach), wind

•    feeling sick (nausea) or being sick (vomiting)

•    soreness of the rectum and anus (bottom)

•    diarrhoea. You may experience mild diarrhoea when taking Molative. This side effect generally get better if you reduce the amount Molative you take.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Molative

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

Do not store above 25°C.

Do not use this medicine if you notice that any of the sachets are damaged.

Store the reconstituted solution in a refrigerator (2°C to 8°C), and use within 24 hours. After 24 hours, any unused solution should be thrown away.

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 information

What Molative contains

The active substances in each 13.8 g sachet are:

Macrogol 3350    13.125 g

Sodium chloride    350.7 mg

Sodium hydrogen carbonate    178.5 mg

Potassium chloride    46.6 mg

When made into a drink with 125 ml of water, each sachet provides:

Sodium    65 mmol/l

Chloride    53 mmol/l

Hydrogen carbonate    17 mmol/l

Potassium    5 mmol/l

The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour (orange flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum, alpha-tocopherol) and lemon lime flavour (lemon lime flavour contains: flavouring preparations, maltodextrin, mannitol, gluconolactone, sorbitol (see section 2, "Molative contains potassium, sodium and sorbitol"), acacia gum, colloidal anhydrous silica).

What Molative looks like and contents of the pack

Molative is a white powder.

Each sachet contains 13.8 g of powder and is packed in cartons containing 20, 30, 50 and 100 sachets.

Not all of these pack sizes are marketed.

Marketing Authorisation Holder

Vale Pharmaceuticals Ltd.,

1B Gurtnafleur Business Park, Gurtnafleur, Clonmel, Co. Tipperary, Ireland.

Manufacturer

Klocke Pharma-Service GmbH,

Strassburger Strasse 77, 77767 Appenweier, Germany.

Hermes Pharma Ges.m.b.H., Allgau 36,

9400 Wolfsberg, Austria.

This leaflet was last revised in 12/2015

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