COLDREX MAXGRIP LEMON+VIT.C PCK N5

ATC code: N02BE51 

Active substances: Paracetamolum, Phenylephrini Hydrochloridum, Acidum Ascorbicum

Vendor, principal: Glaxosmithkline Consumer Healt. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

COLDREX MAXGRIP LEMON 1000MG/+10MG/+40MG N5

Package leaflet: Information for the user

Coldrex MaxGrip Lemon 1,000 mg/10 mg/40 mg powder for oral solution

Paracetamol/phenylephrine hydrochloride/ascorbic acid

Read all of this leaflet carefully before you start using 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 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. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

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

1. What Coldrex MaxGrip Lemon is and what it is used for

Coldrex MaxGrip Lemon is used for reducing fever, alleviating mild pain and the symptomatic treatment of cold.
Coldrex MaxGrip Lemon contains:
•   paracetamol that relieves pain and reduces body temperature in case of a fever;
•   phenylephrine hydrochloride - a medicine reducing nasal congestion (decongestant) by opening the nose and sinuses and allowing you to breathe easier;
•   Vitamin C (ascorbic acid) to supplement vitamin C received from food.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before you use Coldrex MaxGrip Lemon Do not use Coldrex MaxGrip Lemon

•   if you are allergic to paracetamol, phenylephrine, ascorbic acid or any of the other ingredients of this medicine;
•   if you have liver or kidney problems;
•   if you have high blood pressure, heart disease, diabetes or hyperthyroidism;
•   if you are using or have used within the last two weeks medicines known as monoamine oxidase inhibitors (MAOIs), which are usually used in the treatment of depression.
Ask your doctor for advice if you have any of the diseases listed above.

Warnings and precautions

Do not take with other medicines meant for relieving cough and cold or nasal congestion.
Taking too much paracetamol may cause severe liver damage.
Do not take this medicine if you are taking another prescription or over-the-counter medicine containing paracetamol for pain, fever, a cold, the flu or sleep disorders.
Always follow the marking on the label.
Talk to your doctor before taking the medicine if:
-   you have a liver or kidney disorder;
-   you are underweight or malnourished;
-   you drink alcohol regularly.
You should discontinue using this medicine or take smaller doses of paracetamol.

>   Ask your doctor or pharmacist for advice before using Coldrex MaxGrip Lemon if:

•   you have a vascular disease, such as Raynaud’s syndrome (that can be expressed as pain in the fingers or toes in response to cold or stress);
•   you have glaucoma (elevated eye pressure);
•   you have pheochromocytoma (tumour near the kidneys);
•   you have prostate problems or urination problems;
•   you are pregnant, trying to have a baby, or breast-feeding;
•   you have a serious infection that may increase the risk of metabolic acidosis.
Symptoms of metabolic acidosis are as follows:
-   deep, rapid, laboured breathing;
-   feeling unwell (nausea), feeling sick (vomiting);
-   loss of appetite.
If a combination of these symptoms occur, talk to your doctor immediately.
If you are not sure whether you can use this medicine, ask your doctor or pharmacist.

Other medicines and Coldrex MaxGrip Lemon

>   Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
•   Warfarin and other similar medicines used for thinning blood;
•   medicines for controlling blood pressure, such as beta-blockers;
•   digoxine or other similar medicines for treating heart disease;
•   appetite suppressants or stimulants;
•   medicines used in the treatment of depression, such as antidepressants (e.g. amitriptyline);
•   metoclopramide or domperidone used in the treatment of nausea and vomiting;
•   cholestyramine used in the treatment of high blood cholesterol.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

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. You should not take this medicine during pregnancy and breast-feeding.

Driving and using machines

This medicine can cause dizziness. If this is the case, do not drive or work with machines.

COLDREX MAXGRIP LEMON contains sucrose and sodium.

Contains 4 g of sucrose per dose. Take this into consideration if you have diabetes. One sachet contains 0.12 g of sodium per dose. This must be taken into account in patients on a low sodium diet.

3. How to use Coldrex MaxGrip Lemon

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Always use the lowest dose that relieves your symptoms.

Adults (incl. elderly patients) and children over 12 years of age:

The usual dose is 1 sachet every 4-6 hours, as necessary.
Do not take more often than every 4 hours.
Do not take more than 4 sachets per 24 hours.
Do not exceed the prescribed dose.

Children:

Children under 12 years of age: not recommended, except under a doctor’s prescription.
COLDREX MAXGRIP LEMON is used as a hot drink.
•   Empty the contents of the sachet into a cup, add hot water and stir carefully.
•   Add cold water if necessary.
•   Add sugar or honey if desired.

Do not take for longer than 7 days.

If the symptoms persist after 7 days:

>   Stop taking the medicine and ask your doctor for advice.

If you take more COLDREX MAXGRIP LEMON than you should

>   Due to the risk of liver damage, immediately talk to a doctor.
For this reason, it is important that you talk to your doctor even if you do not have any symptoms.

If you forget to take COLDREX MAXGRIP LEMON

Take a dose when you remember it.
Do not take more often than one dose every 4 hours. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of paracetamol occur only rarely.
The following symptoms may be experienced after using the medicine: headache, dizziness, anxiety, sleep problems, elevated blood pressure, nausea and vomiting.
These reactions are rare:
•   if you have an allergic reaction, such as rash or pruritus, sometimes accompanied by respiratory problems or swollen lips, tongue, throat or face;
•   if you have a skin rash or skin peeling or mouth ulcers. Severe skin reactions have been reported in very rare cases.
•   if you have previously had respiratory problems when using aspirin or non-steroidal antiinflammatory drugs, you can get a similar reaction when using this medicine;
•   if you have unusual bleeding or haemorrhage;
•   if you have unusually high heart rate or unusually fast or irregular heart rhythm;
if you develop loss of vision that could be caused by abnormally high eye pressure. This is more likely in people with a glaucoma;
• if you have urination problems. This is more likely to occur in men with an enlarged prostate.

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

5. How to store Coldrex MaxGrip Lemon

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C.
Do not use this medicine after the expiry date which is stated on the bottle and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. 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 Coldrex MaxGrip Lemon contains

-   Active substances: One sachet contains 1,000 mg of paracetamol, 10 mg of phenylephrine hydrochloride and 40 mg of ascorbic acid (vitamin C).
-   The excipients are sucrose, citric acid, sodium citrate, corn starch, sodium cyclamate, anhydrous colloidal silica, sodium saccharine, lemon flavouring and natural curcumin (E100).

What Coldrex MaxGrip Lemon looks like and contents of the pack

One package contains 5 or 10 single-dose sachets, each sachet containing 6.4 g of powder.

Marketing Authorisation Holder

Richard Bittner AG,
Reisnerstraße 55-57 A-1030 Wien Austria

Manufacturer

SmithKline Beecham S.A.
Carretera de Ajalvir, km. 2.500 28806 Alcala de Henares Madrid Spain
or
Wrafton Laboratories Limited
Exeter Road
Wrafton
Braunton
Devon EX33 2DL
United Kingdom
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Representative of the Marketing Authorisation Holder:
Omega Pharma Baltics SIA K. Ulmaņa 119 Mārupe LV-2167 Latvia
E-mail: [email protected]
This leaflet was last revised in April 2018.