GRIPPOSTAD C CPS N24

ATC code: N02BE51 

Active substances: Paracetamolum, Pseudoephedrinum, Chlorpheniraminum

Vendor, principal: Stada Arzneimittel Ag. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

GRIPPOSTAD 600MG N5

Package leaflet: Information for the user

GRIPPOSTAD 600 mg powder for oral solution Paracetamol

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

Always use 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.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   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 3 days.

What is in this leaflet

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

1. What Grippostad is and what it is used for

Grippostad is a medicine used for alleviating pain and reducing fever (analgesic and antipyretic medicine).

Indications

-   Mild to moderate pain and fever
This medicine is used in children over 10 years of age, adolescents, and adults.
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before you use Grippostad Do not use Grippostad

-   If you are hypersensitive to paracetamol or any of the other ingredients of this medicine (listed in section 6).
-   If you have severe hepatic damage.
-   In children under 10 years of age and patients weighing less than 40 kg.

Warnings and precautions

Talk to your doctor or pharmacist before using Grippostad. Use this medicine only after talking to your doctor in case of the following conditions:
-   chronic alcoholism;
-   hepatic impairment (hepatitis, Gilbert’s syndrome);
-   renal impairment;
-   glucose-6-phosphate dehydrogenase deficiency;
-   chronic malnutrition (low liver glutathione levels).
Extended, non-prescribed use of analgesics in large doses can cause headaches that should not be treated with increased doses of the medicine.
In general, the habitual use of analgesics, especially the combined use of several analgesics, can cause persistent renal impairment, leading to renal failure (analgesic nephropathy).
The abrupt discontinuation of long-term non-prescribed administration of large doses of analgesics can cause headaches, fatigue, muscle pain, agitation, and vegetative symptoms. These symptoms will disappear in a few days. No analgesics should be used until the symptoms disappear and administration should not be continued without first talking to a doctor.
Do not use Grippostad for an extended period of time or in large doses without a doctor or dentist’s recommendation.

Other medicines and Grippostad

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Interactions can occur with:
•   probenecide, a gout medicine: the dose of Grippostad should be reduced in case of concomitant use, as the clearance of paracetamol can be reduced;
•   fenobarbital (hypnotic), phenytoin and carbamazepine (epilepsy medicine), rifampicin (tubercolosis medicine), as well as other liver-damaging medicines. There is an increased risk of liver damage in case of concomitant use with Grippostad;
•   metoclopramide and domperidone (anti-nausea medicine) that can accelerate the absorption and onset of the effects of paracetamol;
•   salicylamide (analgesic and antipyretic medicine) that can extend the activity of paracetamol;
•   concomitant use of paracetamol and chloramphenicol can significantly slow down the secretion and increase the toxicity of chloramphenicol;
•   anticoagulants (medicines inhibiting the coagulation of blood): recurrent use of paracetamol for longer than 1 week increases the activity of anticoagulants;
•   cholestyramine (medicine for reducing blood fat levels) can reduce the absorption of paracetamol, thereby decreasing its efficacy;
•   concomitant use with medicines delaying gastric emptying, such as propanthline, can delay the absorption of paracetamol and the onset of its effects;
•   zidovudine (HIV medicine): increased risk of neutropenia (low white blood cell count). Grippostad should thus be used concomitantly with zidovudine only under a doctor’s recommendation;
•   concomitant use of St. John’s wort may increase the amount of toxic metabolites of paracetamol and liver toxicity.
Effect in laboratory studies
Administration of paracetamol can affect uric acid tests and blood sugar analyses.
Remember that these precautions also apply to recently used medicines.

Grippostad with food, drink, and alcohol

Grippostad must not be used with alcohol.

Pregnancy and breast-feeding

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.
Pregnancy
Grippostad can be used during the entire course of pregnancy, after weighing the expected benefits and potential risks. During pregnancy, Grippostad must not be used over long periods of time, in large doses, or in combination with other medicines, as the safety of these situations has not been proven.
Breast-feeding
Paracetamol is secreted into breast milk. As no side effects on the infant have been detected, it is usually not necessary to stop using paracetamol while breast-feeding.

Driving and using machines

Grippostad has no effect on the ability to drive or use machines. However, caution is always required after using analgesics.

Grippostad contains sucrose

This medicine contains sucrose. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor or pharmacist before taking Grippostad.
Excipients: 1 sachet contains 3.8 g of sucrose (sugar), corresponding to approximately 0.32 bread units. This must be taken into account in patients with diabetes mellitus.

Grippostad contains aspartame

This medicine contains the sweetener aspartame - a source of phenylalanine that can be dangerous to patients with phenylketonuria.

3. How to use Grippostad

Always use 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.

The recommended dose is:

Follow the data presented in the table below for dosing.
The dose of paracetamol depends on the age and body weight of the patient, in general, 10-15 mg/kg, and the standard maximum daily dose is 60 mg/kg.
A single dose (1 sachet) corresponds to 600 mg of paracetamol.

Body weight	Age	Single dose	Daily dose	Maximum daily dose    of paracetamol
Over 43 kg	Children over 12 years of age and adults	1 sachet	4 sachets (corresponds to 2,400 mg of paracetamol)	4,000 mg
40-43 kg	Children over 10 years of age, adolescents, and adults	1 sachet	3 sachets (corresponds to 1,800 mg of paracetamol)	2,000 mg

The interval between doses must be 6-8 hours and 3-4 doses can be taken per day. The interval between each dose must be at least 6 hours.
Do not exceed the single dose of 1 sachet.
In case of concomitant use of other medicines containing paracetamol, do not exceed the maximum daily dose of paracetamol. Talk to your doctor or pharmacist if the medicines you are concomitantly using contain paracetamol. Your doctor or pharmacist will instruct you regarding dosage and the best time for administration.
Patients with liver or kidney damage or Gilbert’s syndrome
The dose must be reduced and/or the interval between doses increased.
Patients with severe kidney damage
The interval between doses must be at least 8 hours in patients with severe kidney damage (creatinine clearance < 10 mL/min).
Elderly
No changes in dosage required.
Children, adolescents, and adults with low body weight
Grippostad should not be used in children under 10 or patients weighing less than 40 kg due to unsuitable dosage strength. Other paracetamol preparations with a suitable strength and/or pharmaceutical form (e.g. syrup or suppositories) are available for such patients.

Method of administration

Empty the contents of the Grippostad sachet into a cup, pour hot water, mix and drink while hot. The appearance of the drink after the dissolution of the powder is slightly hazy, clear to bright yellow in colour.
Administration of Grippostad after a meal can delay the onset of its effect.

Duration of use

Medicines containing paracetamol should not be used for longer than 3 days, unless recommended otherwise by a doctor or dentist. You must talk to a doctor if the symptoms do not recede in 3 days.
Talk to your doctor or pharmacist if you feel that the effect of Grippostad is too strong or too weak.

If you use more Grippostad than you should:

If you suspect a Grippostad overdose, immediately talk to a doctor so they could decide on
subsequent actions. The doctor will consider the symptoms and take the necessary measures
for the treatment of the overdose.
The following symptoms can accompany a Grippostad overdose:
-   Nausea
-   Vomiting
-   Loss of appetite
-   Paleness
-   Stomach pain
-   Sweating
-   Sleepiness
-   General malaise
A severe overdose can cause liver damage and even liver coma, myocardial damage, and pancreatitis.

If you forget to use Grippostad

Do not take a double dose to make up for a forgotten dose.
If you stop using Grippostad
No specific measures are needed if you have used the medicine as recommended.
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. Side effects are grouped as follows based on incidence:_

Very common Affects more than 1 user in 10 Common Affects 1-10 users in 100 Uncommon Affects 1-10 users in 1,000 Rare Affects 1-10 users in 10,000 Very rare Affects less than 1 user in 10,000 Unknown cannot be estimated from available data

Blood and lymphatic system disorders
Very rare: haematopoietic disorders, such as reduced blood thrombocyte count (thrombocytopenia), reduced white blood cell count (leucopenia, agranulocytosis), reduced blood cell count (pancytopenia)
Immune system disorders
Very rare: allergic reactions, from rashes or hives (urticaria), sweating, dyspnoea, nausea, reduced blood pressure to shock.
In very rare cases, sensitive patients can develop narrowing of the respiratory tract (analgesic asthma syndrome)
Hepatic and biliary duct disorders
Rare: slight increase in liver enzyme (transaminase) activity

Skin and subcutaneous tissue disorders

Severe skin reactions have been reported in very rare cases

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 Grippostad

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 30 °C.
Do not use this medicine after the expiry date which is stated on the carton and sachet. 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 Grippostad contains

The active ingredient is paracetamol.
One sachet contains 600 mg of paracetamol.

The other ingredients are:

50 mg of ascorbic acid (vitamin C), aspartame, anhydrous citric acid, ethyl cellulose, anhydrous colloidal silica, sucrose, lemon flavouring (contains gum acacia E414).
1 sachet contains 3.8 g of carbohydrates.

What Grippostad looks like and contents of the pack

White to slightly yellowish powder.
Grippostad is available in packages of 5 to 10 sachets containing 5 g of powder.

Manufacturer and Marketing Authorisation Holder:

STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Almar Sehver Tartu mnt 16 10117 Tallinn Phone 6605919 [email protected]

This leaflet was last revised in October 2015