DIOPPEX 1000/12.2MG PULVERIS N5 (WICK)

ATC code: N02BE51 

Active substances: Paracetamolum, Kombinācijas, Izņemot Neiroleptikas

Vendor, principal: Procter & Gamble Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

DIOPPEX 1000MG/+12.2MG N5

PACKAGE LEAFLET: INFORMATION FOR THE USER

Dioppex, 1000mg/12.2mg powder for oral solution

Paracetamol, Phenylephrine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you.
-   Keep this leaflet. You may need 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must contact a doctor if your symptoms worsen or do not improve after 5 days.

What is in this leaflet:

1.   What Dioppex is and what it is used for
2.   What you need to know before you take Dioppex
3.   How to take Dioppex
4.   Possible side effects
5.   How to store Dioppex
6.   Contents of the pack and other information

1.   What Dioppex is and what it is used for

Dioppex is for relief of symptoms of colds and flu, such as headaches, aches and pains, sore throat, nasal congestion and lowering of temperature. It contains two active ingredients;
•   Paracetamol is a well known pain killer (analgesic) and can also reduce fever (antipyretic).
•   Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose and so relieves a blocked nose.

2.   What you need to know before you take Dioppex Do not take Dioppex if you:

•   are allergic to paracetamol, phenylephrine, or to any of the ingredients (see section 6)
•   have serious heart disease
•   have high blood pressure (hypertension)
•   have severe liver disease
•   have kidney disease or kidney problems
•   have severe over-activity of the thyroid (hyperthyroidism)
•   have glaucoma (increased pressure in the eye) of the narrow-angle type
•   are currently taking monoamine oxidase inhibitors (MAOIs) or have taken them within the last two weeks
•   are taking other decongestants for colds and flu
Important: Contains Paracetamol. Do not take with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Dioppex if you:
•   have a problem with your liver function
•   have an over-active thyroid (hyperthyroidism)
•   are male and have an enlarged prostate gland, as you may have more difficulty passing water
•   are diabetic or have a blood circulation problem (including Raynaud’s syndrome)
•   are suffering from malnutrition (if you are severely underweight)
•   suffer from glucose-6-phosphate dehydrogenase deficiency (a genetic disorder)
•   have pheochromocytoma
•   have aspirin-sensitive asthma as you may have hypersensitivity to paracetamol
•   are pregnant or breast-feeding

Children and adolescents

Do not give Dioppex to children under 16 years of age.

Other medicines and Dioppex

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor or pharmacist before you take Dioppex if you are taking:
•   medicine containing paracetamol or other decongestants for colds and flu.
If you are taking these, do not take Dioppex .
•   monoamine oxidase inhibitors ( MAOIs) used in the treatment of depression or Parkinson’s disease. Do not take Dioppex if you have taken MAOIs in the last 14 days.
•   tricyclic antidepressants for depression, such as amitriptyline or imipramine.
•   medicine for high blood pressure (antihypertensives), including beta-blockers, or for improving heart function or correcting abnormal heart rhythms (digoxin, lanoxin, digitoxin).
•   medicine for nausea and vomiting (such as metoclopramide or domperidone)
•   medicine for thinning the blood (anticoagulants), such as warfarin or other coumarins
•   medicine for high cholesterol (such as cholestyramine)
•   sedatives (barbiturates)
•   aspirin-containing products
•   chloramphenicol (an antibiotic)
•   probenecid or AZT (zidovudine)

Dioppex with food and drink

Do not take this product with alcoholic drinks.

Pregnancy, breast- feeding and fertility

Taking Dioppex during pregnancy or breast-feeding is not recommended: you should ask your doctor or pharmacist for advice before use.

Dioppex contains:

Aspartame (E951), a source of phenylalanine. May be harmful for people with phenylketonuria. Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.   How to take Dioppex

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist or nurse if you are not sure.
The recommended dose is:
Adults: 1 sachet every 4-6 hours as required
Adolescents (over 16 years of age and over): 1 sachet every 6 hours as required.
Do not take more than 4 sachets in any 24 hour period.
Do not exceed the recommended dose
Use in children and adolescents:
Do not give to children under 16 years of age, except on the advice of your doctor.
Method of administration:
This medicine is a powder to be dissolved in water and taken as a hot drink.
Pour one sachet of powder into a mug of standard size. Fill with hot, not boiling water (approx. 250ml). Allow to cool to a drinkable temperature.
Duration of treatment:
If symptoms persist for more than 5 days or worsen, consult your doctor.

If you take more Dioppex than you should:

Seek medical advice immediately if you accidentally take more than you should, even if you feel well because of the risk of 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 Like all medicines, this medicine
can cause side effects, although not everybody gets them. If you experience any of the following side effects, or anything else unusual happens, stop taking the medicine immediately.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Phenylephrine may rarely cause a rapid heart beat (palpitations).
High blood pressure with headache, vomiting and palpitations may also occur rarely. Phenylephrine may rarely cause trouble sleeping (insomnia), nervousness, shaking (tremor), anxiety, restlessness, confusion, irritability, headache or dizziness.
Loss of appetite, nausea or vomiting are common with phenylephrine.
Certain blood cell disorders have been reported with paracetamol, but this is very rare. If this happens, symptoms may include unusual bruising, or infections such as sore throats.
Allergic reactions (such as skin rashes or hives), and very rare cases of serious skin reactions have been reported. Severe allergic reaction (anaphylaxsis); wheezing or breathing difficulties may occur rarely

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 www.ravimiamet.ee . Reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Dioppex

Keep this medicine out of the sight and reach f children.

Do not store above 25°C.
Do not take Dioppex after the expiry date printed on the sachet or carton. The expiry date refers to the last day of the month stated.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer use. These measures will help to protect the environment.

6.   Contents of the pack and other information What Dioppex contains

-   The active substances are paracetamol and phenylephrine hydrochloride. One sachet contains 1000mg paracetamol and 12.2 mg phenylephrine hydrochloride (equivalent to 10mg phenylephrine).
-   The other ingredients are sucrose, sodium citrate, citric acid, ascorbic acid, acesulfame potassium (E950), aspartame (E951), quinoline yellow (E104), lemon flavours (lemon oil, citral, citronellol, linalool, citron, maltodextrin, sucrose, modified starch, acacia, butylated hydroxyanisole, triacetin, tocopherol), lemon juice (citral, maltodextrin, modified starch, silicon dioxide).

What Dioppex looks like and contents of the pack

Dioppex is a yellow powder for oral solution which is packed in laminated sachets in a carton box. The product is available in cartons of 5 and 10 sachets.
Not all pack sizes may be marketed

Marketing Authorisation Holder

Wick Pharma,
Sulzbacher Strasse 40,
65824 Schwalbach am Taunus,
Germany

Manufacturer

Wrafton Laboratories Limited Braunton,
Devon,
EX33 2DL UK

This leaflet was last revised in 06-2017

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