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

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.

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)

-    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.

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.

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.

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)

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.

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.

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.

The product is available in cartons of 10 sachets.

Marketing authorisation holder and manufacturer:

G. Pohl-Boskamp GmbH & Co. KG

Kieler StraBe 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.

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

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.

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)

-    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.

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.

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.

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

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.

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.

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.

The product is available in cartons of 10 sachets.

Marketing authorisation holder and manufacturer:

G. Pohl-Boskamp GmbH & Co. KG

Kieler StraBe 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