Mucogel suspension – patient leaflet, side effects, dosage

1. What Mucogel is and what it is used for

suspension for the prompt relief of acid indigestion, upset stomach (gastritis), stomach or duodenal

Mucogel can be taken by adults and children aged 12 years and older.

2. What you need to know before you take Mucogel

Do not take Mucogel

• if you are allergic to aluminium hydroxide, magnesium hydroxide or any of the other ingredients of this medicine (listed in section 6). - if you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Mucogel.

Children

Mucogel is not recommended for children under 12 years of age. In young children the use of magnesium hydroxide can produce hypermagnesemia, especially if they suffer from kidney problems or dehydration.

Other medicines and Mucogel

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

This is particularly important if you are taking:

• salicylates (such as aspirin) - tetracycline antibiotics or vitamins, as antacids inhibit their absorption, so they should not be taken together. Some medicines may be affected by magnesium hydroxide.

Pregnancy and 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.

Driving and using machines

ability to drive and use machines. Mucogel contains:

This medicine contains 8.75 mg sorbitol (E 420) in each ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. This medicine containsmethyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).

May cause allergic reactions (possibly delayed).

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. How to take Mucogel

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults, elderly and children over 12 years

• Shake the bottle well before use. - Take 10-20 ml three times a day, 20-60 minutes after meals and at bedtime, or as required.

• Tell your doctor if symptoms do not go away.

Use in children under 12 years

Not recommended.

If you take more Mucogel than you should

Problems are unlikely but tell your doctor or pharmacist straight away.

4. Possible side effects

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

Side effects such as constipation or diarrhoea are unlikely but if you get any side effects tell your doctor or pharmacist.

Very rare (may affect up to 1 in 10,000 people):

Hypermagnesemia. This was seen after prolonged administration to patients with renal impairment. Not known (frequency cannot be estimated from the available data):

Abdominal pain.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow

Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Mucogel

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 label after EXP. The expiry date refers to the last day of that month. Do not use after 28 days from opening.

Store below 25ºC. Do not freeze. Do not throw away any medicines via wastewater. 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 Mucogel contains

• The active substances are dried aluminium hydroxide (44 mg/ml) and magnesium hydroxide (39 mg/ml).
• The other excipients are Sorbitol liquid (non-crystallising) (E 420), mannitol (E 421), hydrochloric acid, methyl

parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, simethicone emulsion 30%, saccharin sodium, hydrogen peroxide solution 35%,

peppermint oil, strong sodium

water.

See end of section 2 for further information on excipients.

What Mucogel looks like and contents of the pack

Mucogel is a white oral suspension with odour and taste of peppermint. Mucogel is available in bottle sizes of 100 ml, 120 ml, 125 ml, 200 ml, 240 ml, 250 ml 300 ml or 500 ml. Not all pack sizes may be marketed. Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Manufacturer

Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium.

November 2022

BN.

EXP.

06.08.2024

KJA

Mucogel Oral Suspension

N/A

500ml

500ml

N/A

R5T77RBF2

R5T77RBF1

207349

CR-01184

UKLB156 57 x 100mm N/A N/A

N/A 5016119000812 2 1 of 3

Univers 57 Condensed Univers 67 Condensed

7pt

06.08.2024

KJA

Mucogel Oral Suspension

N/A

500ml

500ml

N/A

R5T77RBF2 R5T77RBF1

207349

CR-01184

UKLB156

57 x 100mm N/A

N/A

N/A

5016119000812

2

Univers 57 Condensed Univers 67 Condensed

7pt

Braille reads: Braille Warning! Cirrus cannot accept responsibility for

Whilst extreme care is taken in the setting of Braille, the dried aluminium hydroxide and magnesium hydroxide

Mucogel^®

Suspension

MA Holder: Rosemont Pharmaceuticals Ltd, Leeds, LS11 9XE, UK.

500 ml

PL 00427/0287 207349

UK Only

R5T77RBF2

V1

For the prompt relief of acid indigestion, upset stomach (gastritis), stomach or

Each ml contains 44 mg dried aluminium hydroxide and 39 mg magnesium hydroxide. E 420, E 218 and E 216.

DOSES: Oral use. Shake the bottle well before use.

Adults, elderly and children over 12 years:

Take 10-20 ml three

times a day, 20-60

minutes after meals

and at bedtime, or as

required.

Tell your doctor if

symptoms do not go

away.

Childrenunder 12 years:

Not recommended.

Read the package

Do not use after 28

days from opening.

Store below 25ºC.

Do not freeze

Keep out of the sight and reach of children.

Information for the user Mucogel Suspension

dried aluminium hydroxide and

magnesium hydroxide

before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as

doctor or pharmacist have told you. –

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

  See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse.
• What Mucogel is and what it is used for 2. What you need to know before you take Mucogel
• How to take Mucogel
• Possible side effects
• How to store Mucogel
• 1. 1. What Mucogel is and what it is used for

suspension for the prompt relief of acid indigestion, upset stomach (gastritis), stomach or duodenal

Mucogel can be taken by adults and children aged 12 years and older.

1. 2. What you need to know before you take Mucogel Do not take Mucogel
2. - if you are allergic to aluminium hydroxide, magnesium hydroxide or any of the other ingredients of this medicine (listed in section 6). - if you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Mucogel. Children

Mucogel is not recommended for children under 12 years of age. In young children the use of magnesium hydroxide can produce hypermagnesemia, especially if they suffer from kidney problems or dehydration.

Other medicines and Mucogel

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

This is particularly important if you are

taking:

• salicylates (such as aspirin)
• tetracycline antibiotics or vitamins,

as antacids inhibit their absorption,

so they should not be taken together.

Some medicines may be affected by

magnesium hydroxide.

Pregnancy and 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.

Driving and using machines

ability to drive and use machines.

Mucogel contains:

This medicine contains 8.75 mg

sorbitol (E 420) in each ml. Sorbitol is a

source of fructose. If your doctor has

told you that you (or your child) have

an intolerance to some sugars or if

you have been diagnosed with

hereditary fructose intolerance (HFI),

a rare genetic disorder in which a

person cannot break down fructose,

talk to your doctor before you (or your

child) take or receive this medicine.

This medicine containsmethyl

parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216).

May cause allergic reactions (possibly

delayed).

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

1. 3. How to take Mucogel

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults, elderly and children over 12 years

• Shake the bottle well before use. - Take 10-20 ml three times a day, 20-60 minutes after meals and at bedtime, or as required. - Tell your doctor if symptoms do not go away. Use in children under 12 years

Not recommended. If you take more Mucogel than you should

Problems are unlikely but tell your doctor or pharmacist straight away.

1. 4. Possible side effects

Like all medicine, this medicine can cause side effects, although not everybody gets them. Side effects such as constipation or diarrhoea are unlikely but if you get any side effects tell your doctor or pharmacist.

Very rare (may affect up to 1 in 10,000 people):

Hypermagnesemia. This was seen after prolonged administration to patients with renal impairment. Not known (frequency cannot be

estimated from the available data):

Abdominal pain.

Reporting of side effects

If you get any side effects, talk to

your doctor or pharmacist. This

includes any possible side effects

You can also report side effects

directly via the Yellow Card Scheme

at:

www.mhra.gov.uk/yellowcard or

search for MHRA Yellow

Card in the Google Play or Apple

App Store.

By reporting side effects you can

help provide more information on

the safety of this medicine.

1. 5. How to store Mucogel

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

label after EXP. The expiry date

refers to the last day of that month.

Do not use after 28 days from

opening.

Store below 25ºC. Do not freeze.

Do not throw away any medicines

via wastewater. Ask your

pharmacist how to throw away

medicines you no longer use.

These measures will help protect

the environment.

1. 6. Contents of the pack and other information

What Mucogel contains

• The active substances are dried aluminium hydroxide (44 mg/ml) and magnesium hydroxide (39 mg/ml).
• The other excipients are Sorbitol liquid (non-crystallising) (E 420), mannitol (E 421), hydrochloric acid, methyl

parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, simethicone emulsion 30%, saccharin sodium, hydrogen peroxide solution 35%,

peppermint oil, strong sodium

water.

See end of section 2 for further information on excipients.

What Mucogel looks like and contents of the pack

Mucogel is a white oral suspension with odour and taste of peppermint. Mucogel is available in bottle sizes of 100 ml, 120 ml, 125 ml, 200 ml, 240 ml, 250 ml 300 ml or 500 ml. Not all pack sizes may be marketed. Marketing Authorisation Holder

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Manufacturer

Purna Pharmaceuticals NV, Rijksweg 17, 2870 Puurs, Belgium.

November 2022

BN.

EXP.

1

06.08.2024

KJA

Mucogel Oral Suspension

N/A

500ml

500ml

N/A

R5T77RBF2

R5T77RBF1

207349

CR-01184

UKLB156 57 x 100mm N/A N/A

N/A

5016119000812

2

Univers 57 Condensed Univers 67 Condensed

7pt

Braille reads: Braille Warning! Cirrus cannot accept responsibility for

Whilst extreme care is taken in the setting of Braille, the