Molative Paediatric oral powder 6.9g sachets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Macrogol '3350'; Potassium; Sodium; Chloride; Bicarbonate
Available from:
Mylan
ATC code:
A06AD65
INN (International Name):
Macrogol '3350'; Potassium; Sodium; Chloride; Bicarbonate
Dosage:
105gram/1litre ; 5.4mmol/1litre ; 65mmol/1litre ; 53mmol/1litre ; 17mmol/1litre
Pharmaceutical form:
Powder
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01060400; GTIN: 5016695007175
Authorization number:
PL 04569/1506

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Package leaflet: Information for the patient

Molative Paediatric 6.9 g Powder for Oral Solution

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

Read all of this leaflet carefully before you start giving your child 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 your child only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as your child’s.

If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible

side effects not listed in this leaflet.

What is in this leaflet

What Molative Paediatric is and what it is used for

What you need to know before you give Molative Paediatric

How to give Molative Paediatric

Possible side effects

How to store Molative Paediatric

Contents of the pack and other information

1.

What Molative Paediatric is and what it is used for

The name of this medicine is Molative Paediatric 6.9 g, powder for oral solution. It is a laxative (a

medicine used to help your child pass stools) for the treatment of long-term (chronic) constipation in

children aged 2 to 11 years.

Also, this medicine is used for the treatment of faecal impaction, in children aged 5 to 11 years (a

condition where large amounts of stool builds up in the rectum and/or colon which cannot be passed

easily by your child).

Molative Paediatric helps your child to have a comfortable bowel movement even if they have been

constipated for a long time.

2.

What you need to know before you give Molative Paediatric

Do not give Molative Paediatric if your doctor has told you that your child:

is allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride

or any of the other ingredients of this medicine (listed in section 6).

has a blockage in their intestine (gut obstruction, ileus)

has a perforated gut wall

has severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic

megacolon.

Warnings and precautions

Talk to your doctor or pharmacist before you give Molative Paediatric if your child has a heart or

kidney problem, problems with their gag reflex, reflux oesophagitis (heart-burn caused by back-flow

of stomach contents into the oesophagus) or decreased level of consciousness.

When taking Molative Paediatric, you should continue to take plenty of fluids. The fluid content of

Molative Paediatric should not replace your regular liquid intake.

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Other medicines and Molative Paediatric

Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other

medicines.

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

Molative Paediatric.

When taking large volumes of Molative Paediatric (e.g. for faecal impaction), your child should not

take other medicines within one hour of taking this medicine.

Pregnancy and breast-feeding

This subsection is not relevant for Molative Paediatric since it is intended for children aged 2 to 11

years, however the following information is relevant to the active ingredient, macrogol 3350.

Molative Paediatric can be given during pregnancy and whilst breast-feeding.

If your child is pregnant or breast-feeding, you think she might be pregnant or is planning to have a

baby, ask your doctor or pharmacist for advice before giving this medicine.

Molative Paediatric contains potassium, sodium and sorbitol

This medicine contains 0.31 mmol (12.2 mg) of potassium per sachet. This should be taken into

consideration if your child is taking more than one sachet daily and has reduced kidney function, or if

your child is on a controlled potassium diet.

This medicine contains 4.06 mmol (93.4 mg) of sodium per sachet. This should be taken into

consideration if your child is on a controlled sodium diet.

The lemon lime flavour in this medicine contains sorbitol. If you have been told by your doctor that

your child has an intolerance to some sugars, contact your doctor before giving this medicine.

3.

How to give Molative Paediatric

Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

For Chronic constipation:

The dose of Molative Paediatric depends on the age of the child and their response to treatment.

The recommended dose is:

As a starting dose, children aged 2 to 6 years should be given 1 sachet each day.

Children aged 7 to 11 should be given 2 sachets each day.

Your doctor may tell you to increase the number of sachets taken until your child has a soft

bowel movement. If the dose does need increasing, this should be done every other day.

Normally, no more than 4 sachets should be taken in one day.

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

For Faecal impaction:

Before your child takes this medicine for faecal impaction, it should be confirmed medically that your

child has this condition.

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A course of treatment with Molative Paediatric is as follows:

Number of Molative Paediatric sachets

Age (years)

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

5 - 11

The daily number of sachets should be taken in divided doses, all taken within 12 hours (e.g. 8am –

8pm). Treatment can be stopped when the medicine has worked. You would notice by your child

passing large volumes of stool and/or watery diarrhoea.

How to mix

Open the sachet and pour the contents into a glass. Add ¼ glass (about 62.5ml) of water. Stir

well until all the powder has dissolved and the solution is clear or slightly hazy, then give it to

your child to drink.

If you like you can add a flavour such as orange squash to the drink. If your child is taking

Molative Paediatric for faecal impaction, it may be easier to dissolve several sachets in a larger

quantity of water, for example 12 sachets in 750ml, see table above. If your child cannot drink

it straight away, you may keep it in the refrigerator (see section 5 “How to store Molative

Paediatric”).

Duration of treatment

Chronic constipation:

Treatment needs to be for a prolonged period of time, at least 6 – 12 months.

Faecal impaction:

Treatment with Molative Paediatric can be for up to 7 days.

If your child takes more Molative Paediatric than they should

Your child may become sick and develop excessive diarrhoea. Your child may experience an intense

swollen or painful stomach. If this occurs, stop taking Molative Paediatric and drink plenty of fluids.

If you are worried contact your doctor or pharmacist.

If you forget to give your child Molative Paediatric

Give the dose as soon as you remember.

Do not take a double dose to make up for a forgotten dose, but continue the treatment as described in

this leaflet.

If you stop giving your child Molative Paediatric

To get the most benefit from Molative Paediatric, always finish the course of treatment according to

the directions in this package leaflet or as your doctor or pharmacist have told you. This will make

sure that your child’s constipation is cleared, otherwise your child’s 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 giving your child this medicine immediately

and contact your doctor or take your child to the nearest hospital casualty department straight

away:

Rare

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

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serious allergic reaction which causes sudden signs of allergy such as rash, itching or hives on

the skin, shortness of breath, difficulty in breathing or swelling of the face, lips, tongue, throat

or other parts of the body (anaphylaxis, angioedema)

Other possible side effects

Very common

(may affect more than 1 in 10 people):

stomach pains

stomach rumbles.

Common

(may affect up to 1 in 10 people):

diarrhoea

vomiting (being sick)

nausea (feeling sick)

anal discomfort (uncomfortable sensation around the bottom).

If your child is being treated for

chronic constipation

, diarrhoea will usually improve when the dose

is reduced.

Uncommon

(may affect up to 1 in 100 people):

swollen stomach

wind.

Not known

(frequency cannot be estimated from the available data):

skin rash (hives)

itching

reddening of the skin or a nettle rash

pain, swelling, redness and heat around the bottom (peri-anal inflammation)

shortness of breath

swollen hands, feet or ankles

headaches

indigestion

high or low levels of potassium in the blood.

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 Paediatric

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 after ‘EXP’.

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

Do not use this medicine if you notice any of the sachets have been damaged.

Do not store above 25°C.

Once you have dissolved Molative Paediatric in water, if your child cannot drink it straight away, you

may keep it in the refrigerator (2°C - 8°C) for up to 24 hours.

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Any unused solution should be thrown away after 24 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Molative Paediatric contains

One sachet of Molative Paediatric contains the following active ingredients:

Macrogol 3350

6.563 g

Sodium Chloride

175.4 mg

Sodium Hydrogen Carbonate

89.3 mg

Potassium Chloride

23.3 mg

When it is made into a drink with 62.5 ml (1/4 glass) of water, each sachet gives the equivalent of:

Sodium

65 mmol/l

Chloride

53 mmol/l

Potassium

5.0 mmol/l

Bicarbonate

17 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 Paediatric contains

potassium, sodium and sorbitol”), acacia gum, colloidal anhydrous silica).

What Molative Paediatric looks like and contents of the pack

Molative Paediatric is a white powder.

Each sachet contains 6.9 g of powder and is packed in cartons containing 20, 30, 50 and 60 sachets.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Klocke Pharma-Service GmbH, Strassburger Strasse 77, 77767 Appenweier, Germany

This leaflet was last revised in 03/2017

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Object 1

Molative Paediatric 6.9 g Powder for Oral

Solution

Summary of Product Characteristics Updated 19-Dec-2017 | Generics UK T/A Mylan

1. Name of the medicinal product

Molative Paediatric 6.9 g Powder for Oral Solution

2. Qualitative and quantitative composition

Each sachet of Molative Paediatric contains the following active ingredients:

Macrogol 3350

6.563 g

Sodium Chloride

175.4 mg

Sodium Hydrogen Carbonate

89.3 mg

Potassium Chloride

23.3 mg

The content of electrolyte ions per sachet when made up to 62.5 ml of solution is as follows:

Sodium

65 mmol/l

Chloride

53 mmol/l

Potassium

5 mmol/l

Bicarbonate

17 mmol/l

Excipient with known effect:

Each sachet contains sorbitol.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Powder for oral solution

Single-dose sachet containing a free flowing white crystalline powder.

4. Clinical particulars

4.1 Therapeutic indications

For the treatment of chronic constipation in children 2 to 11 years of age.

For the treatment of faecal impaction in children from the age of five years, defined as refractory

constipation with faecal loading of the rectum and/or colon.

4.2 Posology and method of administration

Posology

Chronic constipation

The usual starting dose is 1 sachet daily for children aged 2 to 6 years, and 2 sachets daily for children

aged 7 – 11 years. The dose should be adjusted up or down as required to produce regular soft stools. If

the dose needs increasing this is best done every second day. The maximum dose needed does not

normally exceed 4 sachets a day.

Treatment of children with chronic constipation needs to be or a prolonged period (at least 6 – 12

months). However, safety and efficacy of Molative Paediatric has only been proved for a period of up to

three months. Treatment should be stopped gradually and resumed if constipation recurs.

Faecal impaction

A course of treatment for faecal impaction with Molative Paediatric is for up to 7 days as follows:

Daily dosage regimen:

Number of Molative Paediatric sachets

Age (years)

Day 1

Day 2

Day 3

Day 4

Day 5

Day 6

Day 7

5 - 11

The daily number of sachets should be taken in divided doses, all consumed within a 12 hour period. The

above dosage regimen should be stopped once disimpaction has occurred. An indicator of disimpaction is

the passage of a large volume of stools. After disimpaction it is recommended that the child follows an

appropriate bowel management program to prevent reimpaction (dosing for prevention of re-impaction

should be as for patients with chronic constipation; see above).

Molative Paediatric is not recommended for children below five years of age for the treatment of faecal

impaction, or in children below two years of age for the treatment of chronic constipation. For patients of

12 years and older it is recommended to use Molative.

Impaired cardiovascular function:

There are no clinical data for this group of patients. Therefore Molative Paediatric is not recommended

for treating faecal impaction in children with impaired cardiovascular function.

Renal impairment:

There are no clinical data for this group of patients. Therefore Molative Paediatric is not recommended

for treating faecal impaction in children with impaired renal function.

Method of administration

For oral use.

Each sachet should be dissolved in 62.5 ml (quarter of a glass) of water. The correct number of sachets

may be reconstituted in advance and kept covered and refrigerated for up to 24 hours. For example, for

use in faecal impaction, 12 sachets can be made up into 750 ml of water.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

Intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe

inflammatory conditions of the intestinal tract, such as Crohn's disease and ulcerative colitis and toxic

megacolon.

4.4 Special warnings and precautions for use

The fluid content of Molative Paediatric when reconstituted with water does not replace regular fluid

intake and adequate fluid must be maintained.

Diagnosis of faecal impaction/faecal loading of the rectum should be confirmed by the physical or

radiological examination of the abdomen and rectum.

Rarely symptoms indicating shifts of fluid/electrolytes e.g. oedema, shortness of breath, increasing

fatigue, dehydration and cardiac failure have been reported in adults when using preparations containing

macrogol. If this occurs Molative Paediatric should be stopped immediately, electrolytes measured, and

any abnormality should be treated appropriately.

When used in high doses to treat faecal impaction this medicinal product should be administered with

caution to patients with impaired gag reflex, reflux oesophagitis or diminished levels of consciousness.

Molative Paediatric solution when reconstituted has no calorific value.

The absorption of other medicinal products could transiently be reduced due to an increase in gastro-

intestinal transit rate induced by macrogol 3350 (see section 4.5).

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Medicinal products in solid dose form taken within one hour of administration of large volumes of

macrogol preparations (as used when treating faecal impaction) may be flushed from the gastrointestinal

tract and not absorbed.

Macrogol 3350 raises the solubility of medicinal products that are soluble in alcohol and relatively

insoluble in water.

There is a possibility that the absorption of other medicinal products could be transiently reduced during

use with macrogol 3350 (see section 4.4).There have been isolated reports of decreased efficacy with

some concomitantly administered medicinal products, e.g. antiepileptics.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are limited amount of data from the use of macrogol 3350 in pregnant women. Studies in animals

have shown indirect reproductive toxicity (see section 5.3). Clinically, no effects during pregnancy are

anticipated, since systemic exposure to macrogol 3350 is negligible.

Molative Paediatric can be used during pregnancy.

Breast-feeding

No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-

feeding woman to macrogol 3350 is negligible.

Molative Paediatric can be used during breast-feeding.

Fertility

There are no data on the effects of macrogol 3350 on fertility in humans. There were no effects on

fertility in studies in male and female rats (see section 5.3).

4.7 Effects on ability to drive and use machines

Macrogol 3350 has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Reactions related to the gastrointestinal tract occur most commonly.

These reactions may occur as a consequence of expansion of the contents of the gastrointestinal tract, and

an increase in motility due to the pharmacologic effects of macrogol 3350.

In the treatment of chronic constipation, diarrhoea or loose stools normally respond to a reduction in dose.

Diarrhoea, abdominal distension, anal discomfort and mild vomiting are more often observed during the

treatment for faecal impaction. Vomiting may be resolved if the dose is reduced or delayed.

The frequency of the adverse reactions listed below is defined using the following convention:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to

<1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).

System Organ Class

Frequency

Adverse event

Immune system disorders

Rare

Allergic reactions including anaphylactic

reaction.

Not known

Dyspnoea and skin reactions (see below).

Metabolism and nutrition

disorders

Not known

Electrolyte disturbances, particularly

hyperkalaemia and hypokalaemia.

Nervous system disorders

Not known

Headache.

Gastrointestinal disorders

Very common

Abdominal pain, borborygmi.

Common

Diarrhoea, vomiting, nausea, anal discomfort.

Uncommon

Abdominal distension, flatulence.

Not known

Dyspepsia and peri-anorectal inflammation.

Skin and subcutaneous tissue

Not known

Allergic skin reactions including angioedema,

disorders

urticaria, pruritus, rash, erythema.

General disorders and

administration site conditions

Not known

Peripheral oedema.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are

asked to report any suspected adverse reactions via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

4.9 Overdose

Severe pain or distension can be treated by nasogastric aspiration. Extensive fluid loss by diarrhoea or

vomiting may require correction of electrolyte disturbances.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Osmotically acting laxatives, ATC code: A06AD65

Mechanism of action

Macrogol 3350 acts by virtue of its osmotic action in the gut, which induces a laxative effect. Macrogol

3350 increases the stool volume, which triggers colon motility via neuromuscular pathways. The

physiological consequence is an improved propulsive colonic transportation of the softened stools and a

facilitation of the defaecation. Electrolytes combined with macrogol 3350 are exchanged across the

intestinal barrier (mucosa) with serum electrolytes and excreted in faecal water without net gain or loss of

sodium, potassium and water.

Clinical efficacy and safety

In an open study of macrogol in chronic constipation, weekly defaecation frequency was increased from

1.3 at baseline to 6.7, 7.2 and 7.1 at weeks 2, 4 and 12 respectively. In a study comparing macrogol and

lactulose as maintenance therapy after disimpaction, weekly stool frequency at the last visit was 9.4 (SD

4.46) in the macrogol group compared with 5.9 (SD 4.29). In the lactulose group 7 children re-impacted

(23%) compared with no children in the macrogol group.

For the indication of faecal impaction comparative studies have not been performed with other treatments

(e.g. enemas). In a non-comparative study in 63 children, macrogol (paediatric) cleared the faecal

impaction in the majority of patients within 3 - 7 days of treatment. For the 5 - 11 years age group the

average total number of sachets of macrogol paediatric required was 47.2.

5.2 Pharmacokinetic properties

Macrogol 3350 is unchanged along the gut. It is virtually unabsorbed from the gastro-intestinal tract. Any

macrogol 3350 that is absorbed is excreted via the urine.

5.3 Preclinical safety data

Preclinical studies provide evidence that macrogol 3350 has no significant systemic toxicity potential,

based on conventional studies of pharmacology, repeated dose toxicity and genotoxicity.

There were no direct embryotoxic or teratogenic effects in rats even at maternally toxic levels that are a

multiple of 66 x the maximum recommended dose in humans for chronic constipation and 25 x for faecal

impaction. Indirect embryofetal effects, including reduction in fetal and placental weights, reduced fetal

viability, increased limb and paw hyperflexion and abortions, were noted in the rabbit at a maternally

toxic dose that was 3.3 x the maximum recommended dose in humans for treatment of chronic

constipation and 1.3 x for faecal impaction. Rabbits are a sensitive animal test species to the effects of GI-

acting substances and the studies were conducted under exaggerated conditions with high dose volumes

administered, which are not clinically relevant. The findings may have been a consequence of an indirect

effect of macrogol related to poor maternal condition as the result of an exaggerated pharmacodynamic

response in the rabbit. There was no indication of a teratogenic effect.

There are long-term animal toxicity and carcinogenicity studies involving macrogol 3350. Results from

these and other toxicity studies using high levels of orally administered high molecular weight macrogols

provide evidence of safety at the recommended therapeutic dose.

6. Pharmaceutical particulars

6.1 List of excipients

Silica, colloidal anhydrous

Saccharin sodium

Orange flavour

(Orange flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia, alpha-

tocopherol)

Lemon lime flavour

(Lemon lime flavour contains: flavouring substances, maltodextrin, mannitol, gluconolactone, sorbitol,

acacia, colloidal anhydrous silica)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

36 months

Reconstituted solution: 24 hours.

6.4 Special precautions for storage

Sachet: Do not store above 25°C.

Reconstituted solution: Store in a refrigerator (2°C to 8°C).

6.5 Nature and contents of container

The sachet is composed of paper, polyethylene, aluminium and surlyn.

Sachets are packed in cartons of 20, 30, 50 and 60.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements.

After 24 hours, any unused solution should be discarded.

7. Marketing authorisation holder

Generics [UK] limited t/a Mylan

Station Close

Potters Bar

Hertfordshire

EN6 1TL

United Kingdom

8. Marketing authorisation number(s)

PL 04569/1506

9. Date of first authorisation/renewal of the authorisation

19/01/2016

10. Date of revision of the text

11/05/2017

Company Contact Details

Generics UK T/A Mylan

Address

Building 4, Trident Place, Mosquito Way, Hatfield, Hertfordshire, AL10 9UL

Telephone

+44 (0)1707 853 000

Medical Information Direct Line

+44 (0)1707 853 000

Customer Care direct line

+44 (0)1707 853 000 select option 2

Stock Availability

+44 (0)1707 853 000 select option 2

http://www.mylan.com

+44 (0)1707 261 803

Medical Information e-mail

[email

protected]

Medical Information Fax

+44 (0)1707 261 803

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