GELOPROSED

GELOPROSED powder for oral use

Important notes (mandatory information)

GeloProsed powder for oral use. Indications: for the relief of symptoms of colds and flu-like infections, such as pain, headache, sore throat and fever, when accompanied by swelling of the nasal mucosa.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

GeloProsed powder for oral use
Active ingredients: Paracetamol (1,000 mg) and phenylephrine hydrochloride (12.2 mg)

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, to get the best results from GeloProsed, it must be taken exactly as directed.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 3 days, you must see a doctor.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains

1. WHAT IS GELOPROSED AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GELOPROSED?
3. HOW TO TAKE GELOPROSED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE GELOPROSED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS GELOPROSED AND WHAT IS IT USED FOR?

GeloProsed is a powder for oral use and contains a combination of active ingredients for the relief of symptoms of colds and flu-like infections, such as pain, headache, sore throat and fever, when accompanied by swelling of the nasal mucosa. Paracetamol is a well-known painkiller (analgesic). It is effective against pain, including headache, and can also reduce fever (antipyretic). Phenylephrine hydrochloride (decongestant) reduces swelling of the nasal mucosa.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GELOPROSED?

GeloProsed must not be taken together with another paracetamol-containing medicine. You should also avoid consuming large amounts of alcohol while using this medicine.

GeloProsed must not be taken:

• if you are allergic to paracetamol or phenylephrine hydrochloride or any of the other ingredients of GeloProsed (for more information, see section 6).
• if you have a serious heart condition.
• if you have high blood pressure (hypertension) or a rare tumour of the adrenal gland (phaeochromocytoma).
• if you are being treated with a medicine from the group of so-called monoamine oxidase inhibitors (MAOIs) or have taken such a medicine within the last 14 days. These medicines are usually used to treat depression.
• if you have an overactive thyroid gland (hyperthyroidism).
• if your liver function is severely impaired.
• if you drink or have drunk a lot of alcohol in the past (alcohol abuse).

Warnings and precautions

Take special care with GeloProsed: Please ask your pharmacist before using GeloProsed:

• if you suffer from Raynaud's syndrome (pallor and numbness in fingers and toes due to poor blood circulation).
• if you have diabetes mellitus.
• if you are malnourished or dehydrated.
• if you have kidney problems.
• if you have a liver disease that is not associated with structural changes in the liver (non-cirrhotic liver disease).
• if you are taking medicines that impair liver function at the same time.
• if you suffer from blood anaemia (haemolytic anaemia).
• if you suffer from glutathione deficiency.
• if you suffer from an enlarged prostate (prostate hypertrophy).

Taking GeloProsed with other medicines

The effectiveness of certain treatments may be impaired by the concomitant use of GeloProsed. Some medicines can also affect the action of GeloProsed. GeloProsed must not be taken if you are being treated with a monoamine oxidase inhibitor (MAOI) or have recently (less than 2 weeks ago) stopped such treatment. Otherwise, there is a risk of a hypertensive crisis.

Ask your doctor or pharmacist before taking GeloProsed if you are using the following medicines:

• Blood pressure lowering agents from the group of beta-blockers
• Medicines for the treatment of high blood pressure, leg pain due to vascular problems or Raynaud's syndrome (vasodilators)
• Medicines for the treatment of depression from a certain class of medicines (tricyclic antidepressants)
• other decongestants
• medicines for the treatment of sleep disorders or epilepsy (barbiturates)
• medicines for lowering blood cholesterol levels (cholestyramine)
• medicines for the treatment of nausea and vomiting (metoclopramide and domperidone)
• blood thinners (warfarin and other coumarins). The blood-thinning effect may be enhanced by paracetamol.

Please note that these notes may also apply to medicines that you have used some time ago or will use in the foreseeable future. Please inform your pharmacist if you are currently using or have recently used other medicines, even if they are non-prescription medicines. Do not use nasal decongestant drops at the same time as GeloProsed.

Pregnancy and

breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

The use of this medicine during pregnancy is not recommended; phenylephrine can reduce the blood flow to the placenta. If you are a woman and have had pre-eclampsia (a pregnancy complication with high blood pressure and sudden formation of water retention (oedema)), you should use GeloProsed with caution.

Breastfeeding

As there is insufficient data on the use of this medicine, it should not be used during breastfeeding.

Fertility

The effects of this medicine on fertility in men and women have not been studied. If you are planning to become pregnant, you should talk to your doctor before using this medicine.

Driving and using machines

GeloProsed is not known to affect the ability to drive and use machines.

Important information about certain other ingredients of GeloProsed

If you have phenylketonuria (an inherited genetic disorder), please note that this medicine contains the phenylalanine source aspartame.

This medicine contains 1 mmol (23.8 mg) sodium per dose

This should be taken into account by patients on a controlled sodium diet.

3. HOW TO TAKE GELOPROSED?

Read this leaflet carefully. Please ask your doctor or pharmacist if you are not sure how much of the medicine to take and when to take it.

Use in adults, the elderly and adolescents aged 12 years and over

GeloProsed is taken orally. Pour the contents of a single-dose sachet into the mouth directly onto the tongue. The powder dissolves there and can then be swallowed without water. Another dose can be taken after 4 to 6 hours. No more than 3 doses (contents of 3 sachets) should be taken within 24 hours. This medicine should not be used for more than 3 days. If the symptoms of your cold or flu-like infection have not improved or have worsened after 3 days, contact your doctor or pharmacist.

Use in children

GeloProsed must not be used in children under 12 years of age.

If you have taken more GeloProsed than you should

In the event of an overdose, contact a doctor immediately, even if you have no symptoms. There is a risk of delayed onset of serious liver damage, even if you have no symptoms.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. GeloProsed contains a combination of two different ingredients. The following section provides information on the undesirable effects. None of the serious undesirable effects of phenylephrine or paracetamol are particularly prominent. If you experience a serious undesirable effect and need help or further information, please contact your doctor or pharmacist.

Possible side effects of phenylephrine are

Common side effects (may affect up to 1 in 10 people):

• Gastrointestinal disorders (gastrointestinal disorders): decreased appetite, nausea and vomiting.

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

• Heart disease: Faster heartbeat or noticeable palpitations.
• Vascular disease: Increased blood pressure.
• Immune system disorders: Allergic or hypersensitivity reactions including rash, hives, severe allergic reaction leading to difficulty breathing or dizziness and bronchospasm.

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

• Nervous system: Sleep disorders, nervousness, tremors, anxiety, restlessness, confusion, irritability, dizziness and headache.

Possible side effects of paracetamol are

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

• Blood and lymphatic system disorders: Blood disorders that can increase the tendency to bleeding, bruising, fever and infections (including platelet disorders (platelets), agranulocytosis, leukopenia, thrombocytopenia, haemolytic anaemia, pancytopenia).
• Skin disorders: Hypersensitivity reactions with rash and hives, itching, sweating, dark red spots on the skin, severe allergic reaction leading to swelling of the face or throat (angioedema).
• Immune system disorders: Allergic or hypersensitivity reactions with rash, hives, severe allergic reaction leading to difficulty breathing or dizziness and bronchospasm.
• Liver disorders: Liver dysfunction (increased hepatic transaminases), liver failure, liver necrosis, liver disease with yellowing of the eyes and skin (jaundice).

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

• Kidney and urinary tract disorders: Kidney disease: interstitial nephritis after prolonged use of higher doses of paracetamol, cloudy urine (sterile pyuria).
• Skin disorders: Very rare cases of severe skin reactions have been reported.

Not known (frequency cannot be estimated from the available data):

• Fluid accumulation in the larynx,
• anaphylactic shock,
• decrease in the number of red blood cells, which can lead to pale skin and weakness or shortness of breath (anaemia),
• liver damage and liver inflammation,
• kidney damage (severe renal failure), blood in the urine (haematuria), difficulty urinating (anuria),
• gastrointestinal effects,
• dizziness and vertigo.

Other side effects in children and adolescents

It is assumed that the frequency, type and severity of side effects in children over 16 years of age are the same as in adults.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GELOPROSED?

Keep out of reach of children. Do not store above 25°C. Store in the original package. Do not use GeloProsed after the expiry date which is stated on the sachet and carton after "Use by:". The expiry date refers to the last day of the month. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What GeloProsed contains

The active ingredients are: Paracetamol 1,000 mg and phenylephrine hydrochloride 12.2 mg. The other ingredients are: Ascorbic acid, xylitol, ethylcellulose, sodium carbonate, tartaric acid, magnesium citrate, aspartame, magnesium stearate and blackcurrant flavouring.

What GeloProsed looks like and contents of the pack

GeloProsed is a white powder for oral use, packaged in single-dose sachets. Each pack contains 10 sachets (each 1,635 mg).

Pharmaceutical entrepreneur 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 revised in November 2014.

Source: Information from the package leaflet
Status: 11/2017
Indications: for the relief of symptoms of colds and flu-like infections, such as pain, headache, sore throat and fever, when accompanied by swelling of the nasal mucosa.