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GELOPROM ORAL POWDER

Active substance(s): PARACETAMOL / PHENYLEPHRINE HYDROCHLORIDE

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GeloProm(t), GeloProsed, DCP

confidential

August 2014

Patient Information leaflet

GeloProm
Oral powder
Active substances: paracetamol and phenylephrine hydrochloride
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take GeloProm
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- If any of the side effects gets serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What GeloProm is and what it is used for
2. Before you take GeloProm
3. How to take GeloProm
4. Possible side effects
5. How to store GeloProm
6. Further Information
1.

What GeloProm is and what it is used for

GeloProm is an oral powder which contains a combination of ingredients that are effective in
relieving the symptoms associated with colds and influenza (aches and pains, headache, sore
throat and fever) when associated with nasal congestion.
Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains,
including headaches, and can also reduce a fever (antipyretic).
Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the nasal passage.
2.

Before you take GeloProm

Do not take this medicine with any other paracetamol-containing products. Also you should
not drink large quantities of alcohol, whilst taking this medicine.
Do not take GeloProm if:
− you are allergic to the active substances paracetamol or phenylephrine hydrochloride or
any of the other ingredients (see section 6 for further information)
− you have a serious heart condition
− you have high blood pressure (hypertension) or a rare tumour of the adrenal medulla
(phaeochromocytoma)

M1-3-1-PIL-common-0013

M 1; P 1

GeloProm(t), GeloProsed, DCP

confidential

August 2014

− you are taking or have taken within the last 14 days a medicine called monoamine oxidase
inhibitor (MAOI), usually used to treat depression
− you have an overactive thyroid (hyperthyroidism)
− your liver function is severely impaired
− you have a history of alcohol abuse
Take special care with GeloProm
You should ask your pharmacist before taking GeloProm if:
- you have Raynaud’s syndrome (poor blood circulation which makes the fingers or toes
pale and numb)
- you have diabetes mellitus
- you are suffering from malnutrition or if you are dehydrated
- you have a problem with your kidneys
- you have a liver disease that is not associated with changes in the structure of the liver
(non-cirrhotic liver disease)
- you are currently being treated with medication affecting liver functions
- you suffer from haemolytic anaemia
- you suffer from glutathione depletion
- you have problems with prostate (prostatic hypertrophy)
Taking other medicines
The effectiveness of certain other treatments may be affected by taking them with GeloProm.
Some drugs may affect the way in which this medicine works.
Do not take GeloProm if you currently receive or recently (within 2 weeks) stopped taking
monoamine oxidase inhibitors (MAOI). There is a risk of hypertensive crisis.
You should ask your doctor or pharmacist before taking GeloProm if you are taking the
following medicines:
- high blood pressure medicines known as beta-blockers
- drugs used to treat high blood pressure, leg pain due to vascular problems or Raynaud’s
syndrome (vasodilators)
- a specific class of drugs used to treat depression (tricyclic antidepressants)
- other decongestants
- drugs used to treat sleep problems or epilepsy (barbiturates)
- drugs used to treat blood cholesterol (cholestyramine)
- drugs used to treat nausea or vomiting (metoclopramide and domperidone)
- blood thinning medicines (warfarin and other coumarins). The effect of blood thinning
medicines may be increased by paracetamol.
Please note that these statements may also apply to products used some time ago or at some
time in the future.
Please tell your pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Do not combine decongestant nose drops with GeloProm.

M1-3-1-PIL-common-0013

M 1; P 2

GeloProm(t), GeloProsed, DCP

confidential

August 2014

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy: The use of this medicine in pregnancy is not recommended; phenylephrine may
reduce blood circulation in the placenta. If you are a woman with a history of pre-eclampsia
(a condition characterised by high blood pressure and sudden swelling in pregnancy) you
should use GeloProm with caution.
Breast-feeding: In view of the lack of data on the use of this medicine during lactation, it
should not be used while breast feeding.
Fertility: The effects of this medicine on male and female fertility have not been studied. If
you are planning to have a baby you should first discuss taking this medicine with your
doctor.
Driving and using machines
There are no known effects of this product on your ability to drive or operate machinery.
Important information on some of the ingredients of GeloProm
If you have phenylketonuria (an inherited genetic disorder) please note that this product
contains aspartame, a source of phenylalanine.
This medicinal product contains 1 mmol (or 23.8 mg) sodium per dose. To be taken into
consideration by patients on a controlled sodium diet.
3.

How to take GeloProm

Read these instructions carefully. If you are not sure how much medicine you should take and
when to take it, ask your doctor or pharmacist.
Adults, the elderly and children 12 years of age and over:
To be taken by mouth. Put the contents of 1 single-dose sachet directly onto the tongue. The
powder will dissolve and can then be swallowed without water.
The dose may be repeated in 4 to 6 hours. Do not take more than 3 sachets in a total of 24
hours.
This product must not be used for longer than 3 days.
If the symptoms of your cold or flu persist for more than 3 days, or worsen, consult your
doctor or pharmacist.
Use in children:
Do not give to children under 12 years of age.
If you take more GeloProm than you should
In the event of an overdose, talk to a doctor straight away as there is a risk of delayed, serious
liver damage even if you feel well.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible side effects

M1-3-1-PIL-common-0013

M 1; P 3

GeloProm(t), GeloProsed, DCP

confidential

August 2014

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

GeloProm contains a combination of two different ingredients.
The following side effects are associated with phenylephrine:
Common side effects: may affect up to 1 in 10 people
Gastrointestinal disorders
Loss of appetite, nausea and vomiting
Rare side effects: may affect up to 1 in 1,000 people
Disorders of the heart:
Faster heart beat or feeling your heartbeat
Disorders of the blood vessels:
Blood pressure increase
Immune system disorders:
Allergic or hypersensitivity reactions including skin rash, hives, serious allergic
reaction which causes difficulty in breathing or dizziness and bronchospasm.
Very rare side effects: may affect up to 1 in 10,000 people
Nervous system:
Difficulty in sleeping, nervousness, shaking, anxiety, restlessness, confusion,
irritability, dizziness and headache
The following side effects are associated with paracetamol:
Rare side effects: may affect up to 1 in 1,000 people
Blood and lymphatic system:
Blood disorders that make you more prone to bleeding, bruising, fever and infections
(including platelet disorders, agranulocytosis, leucopenia, thrombocytopenia,
haemolytic anaemia, pancytopenia)
Skin disorders:
Hypersensitivity including skin rash and hives, itching, sweating, purple-coloured
spots on the skin, serious allergic reaction which causes swelling of the face or throat
(angioedema)
Immune system disorders:
Allergic or hypersensitivity reactions including skin rash, hives, serious allergic
reaction which causes difficulty in breathing or dizziness and bronchospasm.
Liver disorders:
Abnormal liver function (increase in hepatic transaminases), liver failure, hepatic
necrosis, liver disorder associated with yellowing of the eyes and skin (jaundice).
Very rare side effects: may affect up to 1 in 10,000 people
Kidney and urinary disorders:
Kidney disease interstitial nephritis after prolonged use of high doses of paracetamol,
cloudy urine (sterile pyuria)

M1-3-1-PIL-common-0013

M 1; P 4

GeloProm(t), GeloProsed, DCP

confidential

August 2014

Skin disorders:
Very rare cases of serious skin reactions have been reported.
Not known: frequency cannot be estimated from the available data:
- accumulation of fluids in the larynx,
- anaphylactic shock,
- reduction in red blood cells which can make the skin pale and cause weakness or
breathlessness (anaemia),
- liver alteration and liver inflammation,
- kidney alteration (severe kidney impairment, blood in urine (haematuria),
difficulty to passing water (anuresis)),
- gastro intestinal effects,
- a feeling of dizziness and spinning
Additional side effects in children and adolescents
Frequency, type and severity of adverse reactions in children over the age of 16 years are
expected to be the same as in adults.
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 national
reporting system. By reporting side effects you can help provide more information on the
safety of this medicine.
5.

How to store GeloProm

Keep GeloProm out of the reach and sight of children.
Do not store above 25 °C.
Store in the original package.
Do not use GeloProm after the expiry date which is stated on the sachet and carton ‘use
before’. The expiry date refers to the last day of that 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.

Further information

What GeloProm contains
The active substances are paracetamol 1000 mg and phenylephrine hydrochloride 12.2 mg.
The other ingredients are: ascorbic acid, xylitol, ethyl cellulose, anhydrous sodium carbonate,
tartaric acid, anhydrous Magnesium citrate, aspartame, magnesium stearate and black currant
flavour.

What GeloProm looks like and contents of the pack
GeloProm is a white powder in single-dose sachets for oral application.

M1-3-1-PIL-common-0013

M 1; P 5

GeloProm(t), GeloProsed, DCP

confidential

August 2014

The product is available in cartons of 10 sachets.
Marketing authorisation holder and manufacturer:
G. Pohl-Boskamp GmbH & Co. KG
Kieler Straße 11 - 25551 Hohenlockstedt - Germany
tel: +49 4826 59-0 - fax: +49 4826 59-109
e-mail: info@pohl-boskamp.de
Internet: www.pohl-boskamp.de

This leaflet was last approved in 03/2014.

M1-3-1-PIL-common-0013

M 1; P 6

GeloProm(t), GeloProsed, DCP

confidential

November 2014

Patient Information leaflet

GeloProm
Oral powder
Active substances: paracetamol and phenylephrine hydrochloride
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to take GeloProm
carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must contact a doctor if your symptoms worsen or do not improve after 3 days.
- If any of the side effects gets serious, or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What GeloProm is and what it is used for
2. Before you take GeloProm
3. How to take GeloProm
4. Possible side effects
5. How to store GeloProm
6. Further Information
1.

What GeloProm is and what it is used for

GeloProm is an oral powder which contains a combination of ingredients that are effective in
relieving the symptoms associated with colds and influenza (aches and pains, headache, sore
throat and fever) when associated with nasal congestion.
Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains,
including headaches, and can also reduce a fever (antipyretic).
Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the nasal passage.
2.

Before you take GeloProm

Do not take this medicine with any other paracetamol-containing products. Also you should
not drink large quantities of alcohol, whilst taking this medicine.
Do not take GeloProm if:
− you are allergic to the active substances paracetamol or phenylephrine hydrochloride or
any of the other ingredients (see section 6 for further information)
− you have a serious heart condition
− you have high blood pressure (hypertension) or a rare tumour of the adrenal medulla
(phaeochromocytoma)

M1-3-1-PIL-common-0019

M 1; P 1

GeloProm(t), GeloProsed, DCP

confidential

November 2014

− you are taking or have taken within the last 14 days a medicine called monoamine oxidase
inhibitor (MAOI), usually used to treat depression
− you have an overactive thyroid (hyperthyroidism)
− your liver function is severely impaired
− you have a history of alcohol abuse
Take special care with GeloProm
You should ask your pharmacist before taking GeloProm if:
- you have Raynaud’s syndrome (poor blood circulation which makes the fingers or toes
pale and numb)
- you have diabetes mellitus
- you are suffering from malnutrition or if you are dehydrated
- you have a problem with your kidneys
- you have a liver disease that is not associated with changes in the structure of the liver
(non-cirrhotic liver disease)
- you are currently being treated with medication affecting liver functions
- you suffer from haemolytic anaemia
- you suffer from glutathione depletion
- you have problems with prostate (prostatic hypertrophy)
Taking other medicines
The effectiveness of certain other treatments may be affected by taking them with GeloProm.
Some drugs may affect the way in which this medicine works.
Do not take GeloProm if you currently receive or recently (within 2 weeks) stopped taking
monoamine oxidase inhibitors (MAOI). There is a risk of hypertensive crisis.
You should ask your doctor or pharmacist before taking GeloProm if you are taking the
following medicines:
- high blood pressure medicines known as beta-blockers
- drugs used to treat high blood pressure, leg pain due to vascular problems or Raynaud’s
syndrome (vasodilators)
- a specific class of drugs used to treat depression (tricyclic antidepressants)
- other decongestants
- drugs used to treat sleep problems or epilepsy (barbiturates)
- drugs used to treat blood cholesterol (cholestyramine)
- drugs used to treat nausea or vomiting (metoclopramide and domperidone)
- blood thinning medicines (warfarin and other coumarins). The effect of blood thinning
medicines may be increased by paracetamol.
Please note that these statements may also apply to products used some time ago or at some
time in the future.
Please tell your pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Do not combine decongestant nose drops with GeloProm.

M1-3-1-PIL-common-0019

M 1; P 2

GeloProm(t), GeloProsed, DCP

confidential

November 2014

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy: The use of this medicine in pregnancy is not recommended; phenylephrine may
reduce blood circulation in the placenta. If you are a woman with a history of pre-eclampsia
(a condition characterised by high blood pressure and sudden swelling in pregnancy) you
should use GeloProm with caution.
Breast-feeding: In view of the lack of data on the use of this medicine during lactation, it
should not be used while breast feeding.
Fertility: The effects of this medicine on male and female fertility have not been studied. If
you are planning to have a baby you should first discuss taking this medicine with your
doctor.
Driving and using machines
There are no known effects of this product on your ability to drive or operate machinery.
Important information on some of the ingredients of GeloProm
If you have phenylketonuria (an inherited genetic disorder) please note that this product
contains aspartame, a source of phenylalanine.
This medicinal product contains 1 mmol (or 23.8 mg) sodium per dose. To be taken into
consideration by patients on a controlled sodium diet.
3.

How to take GeloProm

Read these instructions carefully. If you are not sure how much medicine you should take and
when to take it, ask your doctor or pharmacist.
Adults, the elderly and children 12 years of age and over:
To be taken by mouth. Put the contents of 1 single-dose sachet directly onto the tongue. The
powder will dissolve and can then be swallowed without water.
The dose may be repeated in 4 to 6 hours. Do not take more than 3 sachets in a total of 24
hours.
This product must not be used for longer than 3 days.
If the symptoms of your cold or flu persist for more than 3 days, or worsen, consult your
doctor or pharmacist.
Use in children:
Do not give to children under 12 years of age.
If you take more GeloProm than you should
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is
because too much paracetamol can cause delayed, serious liver damage.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.

Possible side effects

M1-3-1-PIL-common-0019

M 1; P 3

GeloProm(t), GeloProsed, DCP

confidential

November 2014

Like all medicines, GeloProm can cause side effects, although not everybody gets them.
GeloProm contains a combination of two different ingredients.
You will find below information on side effects that have been oberserved. None of the
serious side effects of either phenylephrine or paracetamol stands out. Talk to your doctor or
pharmacist if you observe any severe side effect or if you need more information or advice
The following side effects are associated with phenylephrine:
Common side effects: may affect up to 1 in 10 people
Gastrointestinal disorders
Loss of appetite, nausea and vomiting
Rare side effects: may affect up to 1 in 1,000 people
Disorders of the heart:
Faster heart beat or feeling your heartbeat
Disorders of the blood vessels:
Blood pressure increase
Immune system disorders:
Allergic or hypersensitivity reactions including skin rash, hives, serious allergic
reaction which causes difficulty in breathing or dizziness and bronchospasm.
Very rare side effects: may affect up to 1 in 10,000 people
Nervous system:
Difficulty in sleeping, nervousness, shaking, anxiety, restlessness, confusion,
irritability, dizziness and headache
The following side effects are associated with paracetamol:
Rare side effects: may affect up to 1 in 1,000 people
Blood and lymphatic system:
Blood disorders that make you more prone to bleeding, bruising, fever and infections
(including platelet disorders, agranulocytosis, leucopenia, thrombocytopenia,
haemolytic anaemia, pancytopenia)
Skin disorders:
Hypersensitivity including skin rash and hives, itching, sweating, purple-coloured
spots on the skin, serious allergic reaction which causes swelling of the face or throat
(angioedema)
Immune system disorders:
Allergic or hypersensitivity reactions including skin rash, hives, serious allergic
reaction which causes difficulty in breathing or dizziness and bronchospasm.
Liver disorders:
Abnormal liver function (increase in hepatic transaminases), liver failure, hepatic
necrosis, liver disorder associated with yellowing of the eyes and skin (jaundice).
Very rare side effects: may affect up to 1 in 10,000 people

M1-3-1-PIL-common-0019

M 1; P 4

GeloProm(t), GeloProsed, DCP

confidential

November 2014

Kidney and urinary disorders:
Kidney disease interstitial nephritis after prolonged use of high doses of paracetamol,
cloudy urine (sterile pyuria)
Skin disorders:
Very rare cases of serious skin reactions have been reported.
Not known: frequency cannot be estimated from the available data:
- accumulation of fluids in the larynx,
- anaphylactic shock,
- reduction in red blood cells which can make the skin pale and cause weakness or
breathlessness (anaemia),
- liver alteration and liver inflammation,
- kidney alteration (severe kidney impairment, blood in urine (haematuria),
difficulty to passing water (anuresis)),
- gastro intestinal effects,
- a feeling of dizziness and spinning
Additional side effects in children and adolescents
Frequency, type and severity of adverse reactions in children over the age of 16 years are
expected to be the same as in adults.
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 national
reporting system. By reporting side effects you can help provide more information on the
safety of this medicine.
5.

How to store GeloProm

Keep GeloProm out of the sight and reach of children.
Do not store above 25 °C.
Store in the original package.
Do not use GeloProm after the expiry date which is stated on the sachet and carton ‘use
before’. The expiry date refers to the last day of that 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.

Further information

What GeloProm contains
The active substances are paracetamol 1000 mg and phenylephrine hydrochloride 12.2 mg.
The other ingredients are: ascorbic acid, xylitol, ethyl cellulose, anhydrous sodium carbonate,
tartaric acid, anhydrous Magnesium citrate, aspartame, magnesium stearate and black currant
flavour.

M1-3-1-PIL-common-0019

M 1; P 5

GeloProm(t), GeloProsed, DCP

confidential

November 2014

What GeloProm looks like and contents of the pack
GeloProm is a white powder in single-dose sachets for oral application.
The product is available in cartons of 10 sachets.
Marketing authorisation holder and manufacturer:
G. Pohl-Boskamp GmbH & Co. KG
Kieler Straße 11 - 25551 Hohenlockstedt - Germany
tel: +49 4826 59-0 - fax: +49 4826 59-109
e-mail: info@pohl-boskamp.de
Internet: www.pohl-boskamp.de

This leaflet was last approved in 11/2014.

M1-3-1-PIL-common-0019

M 1; P 6

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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